Double-disc-shaped integrally-formed degradable atrial septum foramen ovale plugging device

Abstract

The utility model discloses a double-disc-shaped integrally-formed degradable heart atrial septum foramen ovale plugging device which comprises a first disc part, a second disc part and a plugging part, the first disc part and the second disc part are connected to the two axial ends of the plugging part, and the first disc part, the second disc part and the plugging part are integrally formed pieces. And the first disc part and the second disc part are elastic pieces capable of automatically restoring to original shapes. The plugging device is an integrally-formed degradable part and provides a temporary bridge for self-repairing of the heart, so that self cell tissues can climb and grow, and then the plugging device is degraded and absorbed in the body. Long-term complications and potential safety hazards caused by metal remaining in a human body can be avoided, the plugging device is high in structural integrity, the degradation rate of the plugging device in the human body is uniform, no structural disintegration risk exists, all the defects of an existing plugging device of a woven structure can be overcome, and surgical operation can be simplified.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and more specifically, to a dual-disc, one-piece biodegradable atrial septum foramen ovale occluder. Background Technology

[0002] The foramen ovale is a physiological passage in the atrial septum during embryonic development. Around 5-7 months after birth, in most individuals, the secondary and primary septa of the atrial septum adhere and fuse to form a permanent atrial septum. If fusion fails, a patent foramen ovale (PFO) is formed. Because the shunt volume of the PFO is so small, it was long believed that PFO would not cause clinical consequences. In recent years, however, increasing research has found that patients with PFO have a significantly higher risk of stroke, migraine, peripheral artery embolism, and decompression sickness compared to the general population. This has drawn the attention of experts and scholars to the pathogenic effects of PFO, leading to clinical explorations using methods such as PFO closure to prevent recurrent stroke events and treat migraines and recumbent-orthostatic hypoxemia.

[0003] Minimally invasive interventional treatment for patent foramen ovale (PFO) is now a well-established method. Compared to traditional surgery, minimally invasive intervention is a modern, high-tech, minimally invasive treatment. Guided by medical imaging equipment, a guide wire is inserted through the femoral vein and inferior vena cava into the right atrium, then through the atrial septal defect (ASD) into the left atrium. A delivery catheter is then placed along the guide wire at the ASD site, and finally, an ASD occluder is advanced through the delivery catheter to the ASD site for closure. This minimally invasive intervention offers advantages such as no incision, minimal trauma, fewer complications, faster recovery, better efficacy, a wider range of indications, and relatively lower costs.

[0004] Although the treatment method of implanting an atrial septal defect occluder through minimally invasive interventional surgery has many advantages over traditional surgery, the main material used in the atrial septal defect occluder currently used in clinical practice is nickel-titanium alloy wire. Since this type of metal material cannot be degraded in the human body, long-term implantation may cause inflammation, coagulation and other reactions with human tissues, or even a certain degree of damage. Therefore, it has certain defects and may still have the following risks: (1) Nickel-titanium alloy is a non-degradable metal alloy material. Although its biocompatibility has been demonstrated, the long-term risks of long-term permanent implantation cannot be completely controlled; (2) Since nickel-titanium alloy is permanently implanted and non-degradable, there is a lack of long-term follow-up data on the safety of permanent heart implantation and the impact of a fixed-size heart occluder on the continuously growing and developing heart of children. It may affect the development and growth of the heart of patients who have not yet reached maturity; (3) Complications such as nickel precipitation and nickel allergy have not yet been clearly demonstrated by science.

[0005] Once the surface of the cardiac occluder is completely endothelialized and the cardiac defect is repaired by the body's own tissues, there is absolutely no need for the occluder to remain in the body. Therefore, an ideal cardiac occluder should provide a temporary bridge for the heart's self-repair, allowing the body's own cells and tissues to climb and grow, and then be degraded by the body after fulfilling its function, so that the defect can be completely repaired by the body's own tissues, thus avoiding the long-term complications and safety hazards caused by metal remaining in the body. Currently, the occluders widely used in clinical practice are woven metal-nonwoven occluders that have been gradually optimized based on the Amplatzer occluder. The materials are mostly nickel-titanium alloys or other metals and non-degradable nonwoven fabrics. Not only do they lack biodegradability and need to remain permanently in the human body, but they also have unavoidable drawbacks such as excessive stress, metal corrosion, and nickel poisoning. Utility Model Content

[0006] This invention aims to at least partially solve one of the technical problems in related technologies. Therefore, one objective of this invention is to provide a dual-disc, one-piece, biodegradable foramen ovale occluder for the atrial septum. This occluder is a one-piece biodegradable component, which can avoid long-term complications and safety hazards caused by metal remaining in the body.

[0007] According to an embodiment of the present invention, a dual-disc integrally molded biodegradable foramen ovale occluder for atrial septum includes: a first disc portion, a second disc portion, and an occlusion portion. The first disc portion and the second disc portion are connected to the two axial ends of the occlusion portion. The first disc portion, the second disc portion, and the occlusion portion are integrally molded and biodegradable. Both the first disc portion and the second disc portion are elastic elements that can automatically return to their original shape.

[0008] According to an embodiment of this utility model, the dual-disc, one-piece biodegradable foramen ovale occluder for the atrial septum is a one-piece biodegradable component. The occluder provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids the long-term complications and safety hazards caused by metal residue in the body. The occluder has strong structural integrity, degrades uniformly within the body, and has no risk of structural disintegration. It overcomes all the shortcomings of existing woven occluders and simplifies surgical procedures.

[0009] In addition, the dual-disc, one-piece biodegradable atrial septum foramen ovale occluder according to the above embodiments of this utility model may also have the following additional technical features:

[0010] In some embodiments, at least a portion of the first disc portion and at least a portion of the second disc portion are conical annular; when at least a portion of the first disc portion is a conical annular, the conical annular extends from the center to the edge toward the second disc portion; when at least a portion of the second disc portion is a conical annular, the conical annular extends from the center to the edge toward the first disc portion; the axial dimension of the sealing portion is L1, and the distance between the outer edges of the first disc portion and the outer edges of the second disc portion is L2. <L1。

[0011] In some embodiments, the first disc portion includes a first annular plate, and the second disc portion includes a second annular plate; the first annular plate includes a first inner ring segment and a first outer ring segment connected together, the first inner ring segment being annular, the inner edge of the first inner ring segment being connected to the sealing portion, and the first inner ring segment extending away from the second disc portion; the first outer ring segment being annular, the inner edge of the first outer ring segment being connected to the outer edge of the first inner ring segment, and the first outer ring segment gradually approaching the second disc portion in a direction radially away from the center of the sealing portion; the second annular plate includes a second inner ring segment and a second outer ring segment connected together, the second inner ring segment being annular, the inner edge of the second inner ring segment being connected to the sealing portion, and the second inner ring segment extending away from the first disc portion; the second outer ring segment being annular, the inner edge of the second outer ring segment being connected to the outer edge of the second inner ring segment, and the second outer ring segment gradually approaching the first disc portion in a direction radially away from the center of the sealing portion.

[0012] In some embodiments, the thickness of the first inner ring segment gradually decreases in the extension direction from the inner edge to the outer edge of the first inner ring segment; the thickness of the first outer ring segment gradually decreases in the extension direction from the inner edge to the outer edge of the first outer ring segment; the thickness of the second inner ring segment gradually decreases in the extension direction from the inner edge to the outer edge of the second inner ring segment; and the thickness of the second outer ring segment gradually decreases in the extension direction from the inner edge to the outer edge of the second outer ring segment.

[0013] In some embodiments, the thickness of the first inner ring segment and the first outer ring segment is the same; the thickness of the second inner ring segment and the second outer ring segment is the same.

[0014] In some embodiments, the cross-sectional shape of the first inner ring segment, the first outer ring segment, the second inner ring segment, and the second outer ring segment in the axial direction perpendicular to the blocking portion is circular, near-circular, or polygonal; the first inner ring segment and the first outer ring segment are connected by an arc transition; the second inner ring segment and the second outer ring segment are connected by an arc transition.

[0015] In some embodiments, the first disc portion further includes: a first support rib disposed on the first annular plate, the first support rib being used to support the first annular plate to return to its original shape; the second disc portion further includes: a second support rib disposed on the second annular plate, the second support rib being used to support the second annular plate to return to its original shape.

[0016] In some embodiments, the first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface being disposed toward the second disc portion, and at least one of the first inner surface and the first outer surface being externally provided with the first supporting rib; the second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface being disposed toward the first disc portion, and at least one of the second inner surface and the second outer surface being externally provided with the second supporting rib.

[0017] In some embodiments, the first support rib includes: a plurality of first radial ribs spaced apart circumferentially along the first annular plate, the first radial ribs being located on the first inner surface and extending from the inner edge of the first inner ring segment to the outer edge of the first outer ring segment; the second support rib includes: a plurality of second radial ribs spaced apart circumferentially along the second annular plate, the second radial ribs being located on the second inner surface and extending from the inner edge of the second inner ring segment to the outer edge of the second outer ring segment.

[0018] In some embodiments, the inner end of the first radial rib is connected to the sealing portion, and the outer end of the first radial rib extends to the outer edge of the first annular plate or is spaced apart from the outer edge of the first annular plate; the inner end of the second radial rib is connected to the sealing portion, and the outer end of the second radial rib extends to the outer edge of the second annular plate or is spaced apart from the outer edge of the second annular plate.

[0019] In some embodiments, the first support rib further includes a first annular rib extending circumferentially along the first annular plate, the first annular rib being at least one and disposed on the first outer ring segment; the second support rib further includes a second annular rib extending circumferentially along the second annular plate, the second annular rib being at least one and disposed on the second outer ring segment.

[0020] In some embodiments, the first support rib further includes at least one first annular rib extending circumferentially along the first annular plate, the at least one first annular rib being connected to a plurality of first radial ribs; the second support rib further includes at least one second annular rib extending circumferentially along the second annular plate, the at least one second annular rib being connected to a plurality of second radial ribs.

[0021] In some embodiments, at least one of the first annular ribs is disposed on the outer edge of the first annular plate, and the outer ends of a plurality of the first radial ribs are connected to the first annular ribs located on the outer edge of the first annular plate; at least one of the second annular ribs is disposed on the outer edge of the second annular plate, and the outer ends of a plurality of the second radial ribs are connected to the second annular ribs located on the outer edge of the second annular plate.

[0022] In some embodiments, the first radial rib and the sealing portion are connected by an arc transition, and the second radial rib and the sealing portion are connected by an arc transition.

[0023] In some embodiments, the first radial rib includes 1-100 ribs; the second radial rib includes 1-100 ribs.

[0024] In some embodiments, the axes of the first disc portion, the second disc portion, and the sealing portion are all arranged in parallel.

[0025] In some embodiments, the first disk portion and the second disk portion are arranged symmetrically or asymmetrically.

[0026] In some embodiments, the first outer surface has a greater surface roughness than the first inner surface; the second outer surface has a greater surface roughness than the second inner surface.

[0027] In some embodiments, the occluder further includes a delivery device connection portion integrally formed at one axial end of the occluder portion, the delivery device connection portion being adapted to connect to a push component in the occluder delivery device.

[0028] In some embodiments, the conveying device connection is configured as a flat block that extends axially along the sealing portion.

[0029] In some embodiments, the surface of the connecting portion of the conveying device is provided with a plurality of raised ribs spaced apart along the axial direction.

[0030] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0031] The above and / or additional aspects and advantages of this utility model will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0032] Figure 1 This is a schematic diagram of the structure of a double-disc-shaped, one-piece biodegradable atrial septum foramen ovale occluder according to an embodiment of the present invention;

[0033] Figure 2 This is a cross-sectional view of a dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to another embodiment of the present invention;

[0034] Figure 3 This is a cross-sectional view of a double-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to another embodiment of the present invention.

[0035] Figure label:

[0036] 100-Occluder;

[0037] 10-First disc portion; 11-Outer edge of the first disc portion; 12-First annular plate; 121-First inner ring segment; 122-First outer ring segment; 13-First supporting rib; 131-First radial rib; 132-First annular rib;

[0038] 20 - Second disc section; 21 - Outer edge of the second disc section; 22 - Second annular plate; 221 - Second inner ring section; 222 - Second outer ring section; 23 - Second support rib; 231 - Second radial rib; 232 - Second annular rib;

[0039] 30 - Sealing section;

[0040] 40 - Connecting part of conveying device; 41 - Raised rib. Detailed Implementation

[0041] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the art or according to the product instructions. Reagents or instruments used, unless otherwise specified, are all conventional products that can be obtained commercially.

[0042] The following is for reference. Figure 1 Description of a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for atrial septum according to some embodiments of the present invention.

[0043] According to an embodiment of the present invention, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is a biodegradable component. Optionally, the occluder 100 may be at least one of a biodegradable polymer material, a biodegradable metal material, a bioceramic material, or a bioglass material. The occluder 100 includes a first disc portion 10, a second disc portion 20, and a sealing portion 30. The first disc portion 10 and the second disc portion 20 are connected to the two axial ends of the sealing portion 30. The sealing portion 30 passes through the atrial septum to seal the foramen ovale. The first disc portion 10 and the second disc portion 20 are located on both sides of the foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 together clamp the atrial wall. The first disc portion 10, the second disc portion 20, and the sealing portion 30 are integrally molded components, and both the first disc portion 10 and the second disc portion 20 are elastic components that can automatically return to their original shape.

[0044] The present invention relates to a biodegradable, one-piece molded, double-disc atrial septal defect occluder 100. This biodegradable component allows the occluder 100 to be degraded and absorbed in the body within 6 months to 2 years after surgery. The occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow. After fulfilling its function, it is degraded by the body, enabling the atrial septal defect to be completely repaired by the body's own tissues. This avoids the permanent presence of the occluder in the body and will not affect future surgical treatment for possible heart diseases.

[0045] The dual-disc, one-piece biodegradable foramen ovale occluder 100 of this invention is a one-piece biodegradable component. Compared with occluders in related technologies that use nickel-titanium alloy wires woven into a mesh frame and then covered with a flow-blocking membrane, the occluder 100 of this invention can avoid long-term complications and safety hazards caused by metal remaining in the body. Furthermore, the occluder 100 of this invention has a one-piece structure with strong structural integrity. The occluder 100 is formed from the same material, and the degradation rate of the occluder 100 in the human body is uniform with no risk of structural disintegration. It can overcome all the disadvantages of woven structure occluders in related technologies and can also simplify surgical procedures.

[0046] The occluder used in interventional treatment needs to be introduced to the lesion site through a thin sheath. The occluder 100 of this invention can deform to reduce its volume so that it can be stored in the sheath for easy delivery. After the occluder 100 is delivered from the sheath, it can automatically return to its original shape to seal the foramen ovale of the atrial septum.

[0047] The following is a brief description of the process of using the occluder 100 of this utility model embodiment. When using the integrated biodegradable foramen ovale occluder 100 of this utility model, the sheath is extended to the foramen ovale of the atrial septum, and the pushing component pushes the occluder 100 along the sheath to the atrial septal defect. The second disc 20 is released from the sheath on the left atrial side and automatically returns to its original state after release, abutting against the left atrial wall. Then, the occluding part 30 is released from the sheath and positioned inside the foramen ovale of the atrial septum to block the atrial septal defect. Finally, the first disc 10 is released from the sheath on the right atrial side and automatically returns to its original state after release, abutting against the right atrial wall, thereby achieving the occluder 100 blocking the foramen ovale of the atrial septum.

[0048] In addition, compared to related technologies where occluders utilize a mesh frame woven from nickel-titanium alloy wires covered with a flow-blocking membrane, the occluder 100 in this embodiment is an elastic element. The occluder 100 can deform into a smaller volume, allowing it to be delivered through a smaller diameter sheath, thus reducing surgical risks. When the occluder 100 is withdrawn from the sheath, it automatically returns to its original shape, eliminating the need for an additional drive mechanism to restore it to its original state. This reduces manufacturing costs and simplifies the surgical procedure.

[0049] According to an embodiment of this utility model, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is a biodegradable component. The occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids long-term complications and safety hazards caused by metal residue in the body. The occluder 100 has strong structural integrity, a uniform degradation rate within the body, and no risk of structural disintegration. It overcomes all the shortcomings of existing woven-structure occluders 100 and simplifies surgical procedures.

[0050] In some embodiments of this utility model, at least a portion of the first disc portion 10 and at least a portion of the second disc portion 20 are conical rings, and the first disc portion 10 and the second disc portion 20 are interlocked. When at least a portion of the first disc portion 10 is a conical ring, the conical ring extends from the center to the edge toward the second disc portion 20; when at least a portion of the second disc portion 20 is a conical ring, the conical ring extends from the center to the edge toward the first disc portion 10.

[0051] In some embodiments of this utility model, such as Figure 2 As shown, at least a portion of the first disc portion 10 extends toward the second disc portion 20, and at least a portion of the second disc portion 20 extends toward the first disc portion 10; the axial dimension of the sealing portion 30 is L1, and the distance between the outer edge 11 of the first disc portion and the outer edge 21 of the second disc portion is L2. <L1。

[0052] The first disc portion 10 is connected to one axial end of the occlusion portion 30, and the second disc portion 20 is connected to the other axial end of the occlusion portion 30. The outer edge 11 of the first disc portion is the free end of the first disc portion 10 away from the connection with the occlusion portion 30, and the outer edge 21 of the second disc portion is the free end of the second disc portion 20 away from the connection with the occlusion portion 30. The first disc portion 10 and the second disc portion 20 are interlocked so that the distance L2 between the outer edges 11 of the first disc portion and the outer edges 21 of the second disc portion is less than the axial dimension L1 of the occlusion portion 30. The first disc portion 10 and the second disc portion 20 reliably abut against the atrial wall, which increases the contact area between the first disc portion 10 and the atrial wall, and also increases the contact area between the second disc portion 20 and the atrial wall. This improves the arrangement stability of the occluder 100, and also facilitates cell and tissue growth, thus enhancing the repair effect.

[0053] In some embodiments of this invention, a portion of the first disc portion 10 gradually approaches the second disc portion 20 in a radial direction away from the center of the sealing portion 30, and the second disc portion 20 gradually approaches the first disc portion 10 in a radial direction away from the center of the sealing portion 30. The small angle between the first disc portion 10 and the second disc portion 20 and the atrial wall reduces the risk of local thrombosis at the contact points between the first disc portion 10, the second disc portion 20 and the atrial wall, promotes cell and tissue growth, and allows the atrial septal defect to be repaired by its own tissue earlier, resulting in a shorter healing time.

[0054] In some embodiments of this utility model, such as Figure 1 As shown, the first disc portion 10 includes a first annular plate 12, which is configured as the main body of the first disc portion 10. The first annular plate 12 defines the main outline of the first disc portion 10. The inner end of the first annular plate 12 is connected to the sealing portion 30 around the axis of the sealing portion 30. The first annular plate 12 is configured as an annular structure. Similarly, the second disc portion 20 includes a second annular plate 22, which is configured as the main body of the second disc portion 20. The second annular plate 22 defines the main outline of the second disc portion 20. The inner end of the second annular plate 22 is also connected to the sealing portion 30 around the axis of the sealing portion 30. The second annular plate 22 is also configured as an annular structure.

[0055] The first annular plate 12 and the second annular plate 22 surround the occlusion portion 30 and abut against the atrial wall, which can block blood impact and improve the working reliability of the occluder 100. In addition, the first annular plate 12 and the second annular plate 22 provide complete support, and the atrial septal defect can be sealed after the cells and tissues climb and grow, thus improving the repair effect.

[0056] like Figure 2 and Figure 3As shown, the first annular plate 12 includes a first inner ring segment 121 and a first outer ring segment 122 connected to each other. Both the first inner ring segment 121 and the first outer ring segment 122 are annular. The first inner ring segment 121 is positioned closer to the sealing portion 30 than the first outer ring segment 122. The first inner ring segment 121 is connected to the sealing portion 30. The first outer ring segment 122 has an outer edge 11 of a first disc portion. The inner edge of the first inner ring segment 121 is connected to the sealing portion 30, and the first inner ring segment 121 extends away from the second disc portion 20. The inner edge of the first outer ring segment 122 is connected to the outer edge of the first inner ring segment 121, and the first outer ring segment 122 gradually approaches the second disc portion 20 in a direction radially away from the center of the sealing portion 30.

[0057] By setting the first outer ring segment 122, the first disc portion 10 is configured to be inwardly folded toward the second disc portion 20, so that the distance L2 between the outer edge 11 of the first disc portion and the outer edge 21 of the second disc portion is less than the axial dimension L1 of the sealing portion 30. It is worth noting that the first inner ring segment 121 extends away from the second disc portion 20, and the first outer ring segment 122 extends toward the second disc portion 20. The first disc portion 10 is configured to first fold outward and then fold inward, which can form a transition structure on the first disc portion 10. The first disc portion 10 is more likely to deform and more likely to automatically return to its original shape, thus improving the working reliability of the first disc portion 10.

[0058] It is also worth noting that, since the distance L2 between the outer edges 11 and 21 of the first disc is less than the axial dimension L1 of the sealing part 30, when the first disc 10 and the second disc 20 are bent and deformed towards each other and housed in the sheath, the first disc 10 and the second disc 20 will block the sealing part 30, making it difficult to release them. Either the first disc 10 or the second disc 20 may be released together with the sealing part 30, potentially resulting in the first disc 10 or the second disc 20 being blocked by the oval orifice and unable to fully return to its original shape. Therefore, at least one of the first disc 10 and the second disc 20 should be bent and deformed away from each other and housed in the sheath to expose the sealing part 30. This reduces the likelihood of the first disc 10 and the second disc 20 being blocked and unable to fully return to their original shape, thus improving the operational reliability of the sealing device 100. By setting the first inner ring segment 121, the first disc 10 is more likely to bend and deform in a direction away from the second disc 20, and the first disc 10 is also more likely to automatically return to its original shape, thus improving the working reliability of the first disc 10.

[0059] The first outer ring segment 122 gradually approaches the second disc segment 20 in a radial direction away from the center of the sealing part 30. The first outer ring segment 122 smoothly transitions from the first inner ring segment 121 to the atrial wall. The angle between the first outer ring segment 122 and the atrial wall is small, which is conducive to cell climbing and growth and can improve the repair effect.

[0060] Optionally, the first inner ring segment 121 may gradually move away from the second disc portion 20 in a direction that is radially away from the center of the sealing portion 30; or, alternatively, the first inner ring segment 121 may extend along the axial direction of the sealing portion 30, and the first inner ring segment 121 may extend away from the second disc portion 20.

[0061] like Figure 2 and Figure 3 As shown, the second annular plate 22 includes a connected second inner ring segment 221 and a second outer ring segment 222. Both the second inner ring segment 221 and the second outer ring segment 222 are annular. The second inner ring segment 221 is positioned closer to the sealing portion 30 than the second outer ring segment 222. The second inner ring segment 221 is connected to the sealing portion 30. The second outer ring segment 222 has an outer edge 21 of the second disc portion. The inner edge of the second inner ring segment 221 is connected to the sealing portion 30, and the second inner ring segment 221 extends away from the first disc portion 10. The inner edge of the second outer ring segment 222 is connected to the outer edge of the second inner ring segment 221, and the second outer ring segment 222 gradually approaches the first disc portion 10 in a radial direction away from the center of the sealing portion 30.

[0062] Similarly, by providing a second outer ring segment 222, the second disc portion 20 is configured to bend inward toward the first disc portion 10, so that the distance L2 between the outer edge 11 of the first disc portion and the outer edge 21 of the second disc portion is less than the axial dimension L1 of the sealing portion 30. By providing a second inner ring segment 221 that extends away from the first disc portion 10 and a second outer ring segment 222 that extends toward the first disc portion 10, the second disc portion 20 is configured to first fold outward and then bend inward, which can form a transitional structure on the second disc portion 20. The second disc portion 20 is easier to bend and deform in the direction away from the first disc portion 10, and it is also easier to automatically return to its original shape, thus improving the working reliability of the second disc portion 20.

[0063] The second outer ring segment 222 gradually approaches the first disc segment 10 in a radial direction away from the center of the occlusion portion 30. The second outer ring segment 222 smoothly transitions from the second inner ring segment 221 to the atrial wall. The angle between the second outer ring segment 222 and the atrial wall is small, which is conducive to cell climbing and growth and can improve the repair effect.

[0064] Optionally, the second inner ring segment 221 may gradually move away from the first disc portion 10 in a radial direction away from the center of the sealing portion 30; or, alternatively, the second inner ring segment 221 may extend along the axial direction of the sealing portion 30, and the second inner ring segment 221 may extend away from the first disc portion 10.

[0065] In some embodiments of this utility model, such as Figure 2As shown, the first inner ring segment 121 and the first outer ring segment 122 have arc-shaped cross-sections along the axial direction of the sealing portion 30, and the second inner ring segment 221 and the second outer ring segment 222 also have arc-shaped cross-sections along the axial direction of the sealing portion 30. This reduces stress concentration points at the first annular plate 12 and the second annular plate 22, making the first disc portion 10 and the second disc portion 20 more prone to deformation and more likely to automatically recover their original shape, thus improving the operational reliability of the first disc portion 10 and the second disc portion 20.

[0066] In some embodiments of this utility model, such as Figure 2 As shown, the inner edge of the first inner ring segment 121 is connected to the sealing part 30 by an arc transition, and the inner edge of the second inner ring segment 221 is connected to the sealing part 30 by an arc transition. This can reduce the stress at the connection between the first annular plate 12 and the sealing part 30, reduce the occurrence of breakage damage to the first disc part 10 and the second disc part 20, and improve the working reliability of the first disc part 10 and the second disc part 20.

[0067] In some embodiments of this utility model, such as Figure 2 As shown, the first inner ring segment 121 and the first outer ring segment 122 are connected by an arc transition, as are the second inner ring segment 221 and the second outer ring segment 222. This smooth transition between the first inner ring segment 121 and the first outer ring segment 122, and between the second inner ring segment 221 and the second outer ring segment 222, reduces stress concentration on the first annular plate 12 and the second annular plate 22, lowers the likelihood of fracture or damage to the first disc portion 10 and the second disc portion 20, makes the first disc portion 10 and the second disc portion 20 more prone to deformation, and makes it easier for them to automatically recover their original shape, thus improving the operational reliability of the first disc portion 10 and the second disc portion 20.

[0068] In some embodiments of this utility model, the cross-sectional shape of the first inner ring segment 121, the first outer ring segment 122, the second inner ring segment 221, and the second outer ring segment 222 perpendicular to the axial direction of the blocking part 30 is circular, near-circular, or polygonal. The first annular plate 12 or the second annular plate 22 with a corresponding cross-sectional shape can be selected according to the shape of the atrial wall of the affected area to fit the affected area.

[0069] The cross-sectional shapes of the first inner ring segment 121 and the first outer ring segment 122 perpendicular to the axial direction of the sealing part 30 can be the same, or they can be different. The cross-sectional shapes of the second inner ring segment 221 and the second outer ring segment 222 perpendicular to the axial direction of the sealing part 30 can be the same, or they can be different.

[0070] It is worth noting that the occluder 100 of this embodiment can be directly trimmed on the first annular plate 12 or the second annular plate 22 to make the shape of the first disc portion 10 and the second disc portion 20 conform to the affected area. Since the occluder 100 of this embodiment is a one-piece structure, directly trimming the first annular plate 12 or the second annular plate 22 will not damage the integrity of the first disc portion 10 and the second disc portion 20, and the first disc portion 10 and the second disc portion 20 can function normally. Therefore, this invention supports custom trimming, has a wide range of applications, is highly targeted, helps improve the repair effect, and can save on the manufacturing cost of customized parts.

[0071] In some embodiments of this utility model, the projected areas of the first annular plate 12 and the second annular plate 22 in the axial direction of the sealing portion 30 are each independently 3mm². 2 -2000mm 2 .

[0072] Optionally, the projected area of ​​the first annular plate 12 in the axial direction of the sealing portion 30 can be 5 mm². 2 55mm 2 100mm 2 300mm 2 900mm 2 1000mm 2 (625*π)mm 2 2000mm 2 wait.

[0073] Optionally, the projected area of ​​the second annular plate 22 in the axial direction of the sealing portion 30 can be 5 mm². 2 55mm 2 100mm 2 300mm 2 900mm 2 1000mm 2 (625*π)mm 2 2000mm 2 wait.

[0074] In some embodiments of this utility model, the thickness of the first inner ring segment 121 gradually decreases in the extension direction from its inner edge to its outer edge; similarly, the thickness of the first outer ring segment 122 gradually decreases in the extension direction from its inner edge to its outer edge. Similarly, the thickness of the second inner ring segment 221 gradually decreases in the extension direction from its inner edge to its outer edge; and the thickness of the second outer ring segment 222 gradually decreases in the extension direction from its inner edge to its outer edge.

[0075] The thickness of the first annular plate 12 gradually decreases in the direction extending from the occlusion portion 30 to the outer edge 11 of the first disc portion, and the thickness of the second annular plate 22 gradually decreases in the direction extending from the occlusion portion 30 to the outer edge 21 of the second disc portion. The thickness directly affects the degradation rate of the occluder 100. The first disc portion 10 and the second disc portion 20 provide a temporary bridge for the heart's self-repair, allowing cells and tissues to climb and grow. The outer edges 11 and 21 of the first and second disc portions contact the atrial wall, and cells climb and grow towards the occlusion portion 30 along these edges. The outer edges of the first and second annular plates 12 and 22 have the lowest thickness. The first and second annular plates 12 and 22 gradually degrade along their outer edges towards the occlusion portion 30, maintaining complete support for the climbing and growth of cells and tissues. After the cells and tissues have grown, they can seal the atrial septal defect, improving the repair effect.

[0076] In some other embodiments of this utility model, the first inner ring segment 121 and the first outer ring segment 122 have the same thickness, and the second inner ring segment 221 and the second outer ring segment 222 have the same thickness.

[0077] In some other embodiments of the present invention, the thickness of the first annular plate 12 gradually increases in the extension direction from the sealing portion 30 to the outer edge 11 of the first disc portion, so that the first disc portion 10 can easily be restored to a shape that is folded inward toward the second disc portion 20; and the thickness of the second annular plate 22 gradually increases in the extension direction from the sealing portion 30 to the outer edge 21 of the second disc portion, so that the second disc portion 20 can easily be restored to a shape that is folded inward toward the first disc portion 10.

[0078] In some embodiments of this utility model, the thickness of the first annular plate 12 and the second annular plate 22 are independently 0.01mm-8mm.

[0079] Optionally, the thickness of the first annular plate 12 can be 0.01mm, 0.05mm, 0.1mm, 0.4mm, 0.46mm, 0.5mm, 1mm, 8mm, etc.

[0080] Optionally, the thickness of the second annular plate 22 can be 0.01mm, 0.05mm, 0.1mm, 0.4mm, 0.46mm, 0.5mm, 1mm, 8mm, etc.

[0081] It is worth noting that the first annular plate 12 and the second annular plate 22 are constructed as sheet-like structures. Compared with the three-dimensional occluders in related technologies that use nickel-titanium alloy metal wires woven into a mesh frame and then cover it with a flow-blocking membrane, the occluder 100 of this utility model has a smaller spatial volume. The occluder 100 can be deformed into a smaller volume and stored in a sheath, and can be delivered through a sheath with a smaller diameter, which helps to reduce surgical risks.

[0082] In some embodiments of this utility model, such as Figure 2 As shown, the first disc portion 10 further includes a first support rib 13 provided on the first annular plate 12, the first support rib 13 being used to support the first annular plate 12 to restore its original state, and the second disc portion 20 further includes a second support rib 23 provided on the second annular plate 22, the second support rib 23 being used to support the second annular plate 22 to restore its original state.

[0083] The occluder 100 of this utility model deforms to reduce its volume so that it can be stored in the sheath for easy transport. After the occluder 100 is transported out of the sheath, the first support rib 13 supports the first annular plate 12 to return to its original shape, and the second support rib 23 supports the second annular plate 22 to return to its original shape. The occluder 100 returns to its original shape to block the foramen ovale of the interatrial septum.

[0084] Compared to automatically restoring to its original state using only the structure of the first annular plate 12 or only the structure of the second annular plate 22, the speed at which the first annular plate 12 can restore to its original state can be increased by setting the first support rib 13, and the speed at which the second annular plate 22 can restore to its original state can be increased by setting the second support rib 23. This reduces the occurrence of situations where the first annular plate 12 and the second annular plate 22 are blocked and cannot fully restore to their original state, which is beneficial for the release of the occluder 100, improves the working reliability of the occluder 100, and improves the efficiency of the operation.

[0085] In some embodiments of this utility model, such as Figure 2 As shown, the first annular plate 12 has a first inner surface and a first outer surface facing away from each other, the first inner surface is disposed facing the second disc portion 20, and at least one of the first inner surface and the first outer surface is provided with a first support rib 13; the second annular plate 22 has a second inner surface and a second outer surface facing away from each other, the second inner surface is disposed facing the first disc portion 10, and at least one of the second inner surface and the second outer surface is provided with a second support rib 23.

[0086] It is worth noting that the inward and outward directions of the first inner surface, the first outer surface, the second inner surface, and the second outer surface are based on the center of the occluder 100, which is different from the orientation of the inner edge, outer edge, and other structures mentioned above. The occluder 100 is constructed as a structure in which the first disc portion 10 and the second disc portion 20 interlock, the first inner surface and the second inner surface are arranged opposite each other in the axial direction of the occluder 100, and the first outer surface and the second outer surface are arranged opposite each other in the axial direction of the occluder 100.

[0087] The first support rib 13 may protrude from the first annular plate 12 in the direction of the first inner surface, or the first support rib 13 may also protrude from the first annular plate 12 in the direction of the first outer surface, or the first support rib 13 may protrude from both the first inner surface and the first outer surface. The second support rib 23 may protrude from the second inner surface, or the second support rib 23 may also protrude from the second outer surface, or the second support rib 23 may protrude from both the second outer surface and the second inner surface.

[0088] In some embodiments of this invention, the first support rib 13 is only disposed on the first inner surface, or most of it protrudes from the first inner surface and only a portion is located on the first outer surface; the second support rib 23 is only disposed on the second inner surface, or most of it protrudes from the first inner surface and only a portion is located on the second outer surface. The first and second outer surfaces serve as support surfaces for cell tissue climbing and growth. By disposing all or most of the first support rib 13 on the first inner surface and all or most of the second support rib 23 on the second inner surface, it is ensured that the first and second outer surfaces are continuous and flat support surfaces, which is conducive to cell climbing and growth. At the same time, it can reduce the risk of local thrombosis in the first disc portion 10 and the second disc portion 20, and improve the repair effect.

[0089] In some embodiments of this utility model, such as Figure 1 and Figure 3 As shown, the first support rib 13 includes: a plurality of first radial ribs 131 spaced apart circumferentially along the first annular plate 12, the first radial ribs 131 being located on the first inner surface, and the first radial ribs 131 extending from the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122; the second support rib 23 includes: a plurality of second radial ribs 231 spaced apart circumferentially along the second annular plate 22, the second radial ribs 231 being located on the second inner surface, and the second radial ribs 231 extending from the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222.

[0090] The first radial rib 131 is disposed on the first inner surface, and the second radial rib 231 is disposed on the second inner surface, so that the first outer surface and the second outer surface are continuous and flat support surfaces, which is conducive to cell climbing and growth, reduces the risk of local thrombosis, and improves the repair effect.

[0091] The first radial rib 131 extends from the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122. When the first disc portion 10 is compressed and deformed, the first radial rib 131 tends to support the first annular plate 12 to restore its original shape. After the compression of the first disc portion 10 is removed, the first radial rib 131 can support the first annular plate 12 to expand radially and restore its original shape. Similarly, the second radial rib 231 extends from the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222. When the second disc portion 20 is compressed and deformed, the second radial rib 231 tends to support the second annular plate 22 to restore its original shape. After the compression of the second disc portion 20 is removed, the second radial rib 231 can support the second annular plate 22 to expand radially and restore its original shape.

[0092] The first radial ribs 131 are multiple and are spaced apart along the circumference of the first annular plate 12, so that the first annular plate 12 is subjected to uniform force, which is conducive to the first annular plate 12 restoring its original shape; the second radial ribs 231 are multiple and are spaced apart along the circumference of the second annular plate 22, so that the second annular plate 22 is subjected to uniform force, which is conducive to the second annular plate 22 restoring its original shape.

[0093] It is worth noting that the first radial rib 131 extends from the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122. The projection shape of the first radial rib 131 in the axial direction of the sealing portion 30 can be a straight line. The radial extension of the first radial rib 131 along the sealing portion 30 can improve the structural stability of the first disc portion 10 and help the first disc portion 10 return to its original shape. Alternatively, the projection shape of the first radial rib 131 in the axial direction of the sealing portion 30 can also be a curve, so that the first disc portion 10 can be compressed and housed in the rib sheath tube, which is beneficial to the deformation of the first disc portion 10. Similarly, the second radial rib 231 extends from the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222. The projection shape of the second radial rib 231 in the axial direction of the sealing portion 30 can be a straight line or a curve.

[0094] In some embodiments of this utility model, the extension direction of the first radial rib 131 is the length direction of the first radial rib 131, the axial direction of the sealing portion 30 is the width direction of the first radial rib 131, and the circumferential direction of the first annular plate 12 is the thickness direction of the first radial rib 131. The extension direction of the second radial rib 231 is the length direction of the second radial rib 231, the axial direction of the sealing portion 30 is the width direction of the second radial rib 231, and the circumferential direction of the second annular plate 22 is the thickness direction of the second radial rib 231. The cross-sectional shape of the first radial rib 131 in the thickness direction can be cylindrical, frustum, triangular, or a composite geometric shape, and the cross-sectional shape of the second radial rib 231 in the thickness direction can be cylindrical, frustum, triangular, or a composite geometric shape.

[0095] In some embodiments of this utility model, such as Figures 1-3 As shown, the inner end of the first radial rib 131 is connected to the sealing part 30, and the outer end of the first radial rib 131 extends to the outer edge of the first annular plate 12, or is spaced apart from the outer edge of the first annular plate 12; the inner end of the second radial rib 231 is connected to the sealing part 30, and the outer end of the second radial rib 231 extends to the outer edge of the second annular plate 22, or is spaced apart from the outer edge of the second annular plate 22.

[0096] The inner end of the first radial rib 131 is connected to the sealing part 30, which can improve the structural strength of the first radial rib 131 and help support the first annular plate 12 to restore its original shape; the inner end of the second radial rib 231 is connected to the sealing part 30, which can improve the structural strength of the second radial rib 231 and help support the second annular plate 22 to restore its original shape.

[0097] Thickness directly affects the degradation rate of the occluder 100. The thickness of the first disc portion 10 and the second disc portion 20 is much smaller than the thickness of the occlusion portion 30. Therefore, after the first disc portion 10 and the second disc portion 20 degrade, the occlusion portion 30 remains at the atrial septal defect site, improving the working reliability of the occluder 100 and providing support for cell repair. When the thickness of the first radial rib 131 and the second radial rib 231 is greater than the thickness of the first annular plate 12 and the second annular plate 22, after the first annular plate 12 and the second annular plate 22 degrade, the first radial rib 131 and the second radial rib 231 can still be connected to the occlusion portion 30 through their inner ends, reducing the possibility of undegraded first radial ribs and second radial ribs 231 detaching from the occluder 100 and causing discomfort.

[0098] Optionally, the outer end of the first radial rib 131 may extend to the outer edge of the first annular plate 12; alternatively, the outer end of the first radial rib 131 may also extend toward the outer edge of the first annular plate 12 and be spaced apart from the outer edge of the first annular plate 12. Alternatively, as... Figure 1 and Figure 3 As shown, the outer end of the second radial rib 231 may extend to the outer edge of the second annular plate 22, or alternatively, as shown in the figure. Figure 2 As shown, the outer end of the second radial rib 231 extends toward the outer edge of the second annular plate 22 and is spaced apart from the outer edge of the second annular plate 22.

[0099] In some embodiments of this utility model, such as Figures 1-3 As shown, the first support rib 13 further includes a first annular rib 132 extending circumferentially along the first annular plate 12, and the first annular rib 132 is at least one and is disposed on the first outer ring segment 122; the second support rib 23 further includes a second annular rib 232 extending circumferentially along the second annular plate 22, and the second annular rib 232 is at least one and is disposed on the second outer ring segment 222.

[0100] When the first disc portion 10 is compressed and deformed, the first annular rib 132 tends to support the first annular plate 12 to restore its original shape. After the compression of the first disc portion 10 is removed, the first annular rib 132 can support the first annular plate 12 to unfold circumferentially and restore its original shape. Similarly, when the second disc portion 20 is compressed and deformed, the second annular rib 232 tends to support the second annular plate 22 to restore its original shape. After the compression of the second disc portion 20 is removed, the second annular rib 232 can support the second annular plate 22 to unfold circumferentially and restore its original shape.

[0101] Optionally, there may be one first annular rib 132, or alternatively, there may be multiple first annular ribs 132, which are spaced apart along the extension direction from the inner edge to the outer edge of the first annular plate 12. At least one first annular rib 132 is provided on the first outer ring segment 122 to increase the weight of the first outer ring segment 122, which is beneficial for the first outer ring segment 122 to extend toward the second disc portion 20 and for the first annular plate 12 to return to its original shape.

[0102] Optionally, there may be one second annular rib 232. Alternatively, there may be multiple second annular members, with multiple second annular ribs 232 spaced apart along the extension direction from the inner edge to the outer edge of the second annular plate 22. At least one second annular rib 232 is provided on the second outer ring segment 222 to increase the weight of the second outer ring segment 222, which is beneficial for the second outer ring segment 222 to extend toward the first disc portion 10 and for the second annular plate 22 to return to its original shape.

[0103] In some embodiments of this utility model, the cross-section of the first annular rib 132 is a circle, a sector, a triangle, or a composite geometric shape; the cross-section of the second annular rib 232 is a circle, a sector, a triangle, or a composite geometric shape.

[0104] In some embodiments of this utility model, such as Figure 2 and Figure 3 As shown, the first annular rib 132 has a circular cross-section, is located on the first outer ring segment 122, and protrudes from the first inner surface and an outer surface; the second annular rib 232 has a circular cross-section, is located on the second outer ring segment 222, and protrudes from the second inner surface and the second outer surface.

[0105] In some embodiments of this utility model, the first support rib 13 includes a plurality of first radial ribs 131 spaced apart circumferentially along the first annular plate 12. The first radial ribs 131 extend radially along the first annular plate 12, and the first annular ribs 132 extend circumferentially along the first annular plate 12. There is at least one first annular rib 132, and at least one first annular rib 132 is connected to the plurality of first radial ribs 131. The connection between the first annular ribs 132 and the plurality of first radial ribs 131 connects the first support rib 13 into a whole, improving the structural stability of the first support rib 13 and facilitating the restoration of the first annular plate 12 to its original state.

[0106] like Figure 1 and Figure 3 As shown, the second supporting rib 23 includes a plurality of second radial ribs 231 spaced apart circumferentially along the second annular plate 22, and a second annular rib 232 extending circumferentially along the second annular plate 22. There is at least one second annular rib 232, and at least one second annular rib 232 is connected to the plurality of second radial ribs 231. Similarly, the second annular rib 232 is connected to the plurality of second radial ribs 231 to connect the second supporting rib 23 into a whole, improving the structural stability of the second supporting rib 23 and facilitating the restoration of the second annular plate 22 to its original state.

[0107] Furthermore, after the first annular plate 12 and the second annular plate 22 degrade, the first annular rib 132 can still be connected to the first radial rib 131, and the second annular rib 232 can still be connected to the second radial rib 231, reducing the occurrence of discomfort caused by the undegraded first annular rib 132 and the second annular rib 232 detaching from the plugger 100.

[0108] In some embodiments of this utility model, such as Figure 1 and Figure 3 As shown, at least one first annular rib 132 is provided on the outer edge of the first annular plate 12, and the outer ends of a plurality of first radial ribs 131 are connected to the first annular rib 132 located on the outer edge of the first annular plate 12; at least one second annular rib 232 is provided on the outer edge of the second annular plate 22, and the outer ends of a plurality of second radial ribs 231 are connected to the second annular rib 232 located on the outer edge of the second annular plate 22.

[0109] The first annular rib 132 is located at the outer edge of the first annular plate 12, which facilitates the extension of the first outer ring segment 122 toward the second disc portion 20 and helps the first annular plate 12 to return to its original shape. Similarly, the second annular rib 232 is located at the outer edge of the second annular plate 22, which facilitates the extension of the second outer ring segment 222 toward the first disc portion 10 and helps the second annular plate 22 to return to its original shape.

[0110] The outer ends of multiple first radial ribs 131 are connected to first annular ribs 132 located on the outer edge of the first annular plate 12, so as to connect the first support ribs 13 into a whole, improve the structural stability of the first support ribs 13, and help support the first annular plate 12 to restore its original shape. The outer ends of multiple second radial ribs 231 are connected to second annular ribs 232 located on the outer edge of the second annular plate 22, so as to connect the second support ribs 23 into a whole, improve the structural stability of the second support ribs 23, and help support the first annular plate 12 to restore its original shape.

[0111] In other embodiments of this utility model, such as Figure 2 As shown, at least one first annular rib 132 is provided on the outer edge of the first annular plate 12, and the outer ends of a plurality of first radial ribs 131 are spaced apart from the first annular ribs 132 located on the outer edge of the first annular plate 12; at least one second annular rib 232 is provided on the outer edge of the second annular plate 22, and the outer ends of a plurality of second radial ribs 231 are spaced apart from the second annular ribs 232 located on the outer edge of the second annular plate 22.

[0112] In some embodiments of this utility model, such as Figure 2 As shown, the first radial rib 131 and the sealing portion 30 are connected by a circular arc transition, and the second radial rib 231 and the sealing portion 30 are also connected by a circular arc transition. This reduces stress concentration at the connection between the first radial rib 131 and the sealing portion 30, reduces stress concentration at the connection between the second radial rib 231 and the sealing portion 30, reduces the occurrence of fracture or damage to the first radial rib 131 and the second radial rib 231, facilitates deformation of the first radial rib 131 and the second radial rib 231, and improves the operational reliability of the first disc portion 10 and the second disc portion 20.

[0113] In some embodiments of this utility model, such as Figure 2 As shown, the connection point between the first radial rib 131 and the sealing portion 30 is closer to the axial inner side of the sealing portion 30 than the inner end of the first inner ring segment 121, and the connection point between the second radial rib 231 and the sealing portion 30 is closer to the axial inner side of the sealing portion 30 than the inner end of the second inner ring segment 221. After the first annular plate 12 and the second annular plate 22 degrade, the first radial rib 131 and the second radial rib 231 can still be connected to the sealing portion 30 through their inner ends, reducing the likelihood of discomfort caused by the undegraded first radial component and the second radial rib 231 detaching from the sealing device 100.

[0114] In some embodiments of this utility model, such as Figure 2 and Figure 3As shown, the width of at least a portion of the first radial rib 131 gradually decreases in the direction extending from the sealing portion 30 to the outer edge 11 of the first disc portion, and the width of at least a portion of the second radial rib 231 gradually decreases in the direction extending from the sealing portion 30 to the outer edge 21 of the second disc portion. The first radial rib 131 gradually degrades along the outer edge 11 of the first disc portion towards the sealing portion 30, and the second radial rib 231 gradually degrades along the outer edge 21 of the second disc portion towards the sealing portion 30. The degradation change of the first radial rib 131 is consistent with that of the first annular plate 12, and the degradation change of the second radial rib 231 is consistent with that of the second annular plate 22, which can provide complete support for cell tissue climbing and growth, and improve the repair effect.

[0115] In some embodiments of this utility model, the first radial rib 131 includes 1-100 ribs; the second radial rib 231 includes 1-100 ribs.

[0116] Optionally, the first radial rib 131 can be 2, 4, 5, 6, 8, 10, 20, 50, 100, etc.

[0117] Optionally, the second radial rib 231 can be 2, 4, 5, 8, 10, 16, 30, 50, 100, etc.

[0118] In some embodiments of this utility model, the first annular rib 132 includes 1-10 ribs, and the second annular rib 232 includes 1-10 ribs.

[0119] Too many first annular ribs 132 will hinder the deformation and containment of the first annular plate 12; similarly, too many second annular ribs 232 will also hinder the normal operation of the plugger 100.

[0120] Optionally, the first annular rib 132 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0121] Optionally, the second annular reinforcement 232 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0122] In some embodiments of this utility model, the axes of the first disc portion 10, the second disc portion 20, and the sealing portion 30 are all arranged parallel to each other. The first disc portion 10 and the second disc portion 20 are arranged facing each other. After the sealing portion 30 passes through the heart wall, the first disc portion 10 and the second disc portion 20 are sandwiched between the two sides of the heart wall, resulting in a better sealing effect.

[0123] In some embodiments, the two ends of the occluder 30 are respectively connected to the center of the first disc portion 10 and the second disc portion 20.

[0124] In some embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0125] The sealing part 30 has a columnar structure. The first disc part 10 is connected to one axial end of the sealing part 30, and the second disc part 20 is connected to the other axial end of the sealing part 30. The first disc part 10 and the second disc part 20 are symmetrically arranged with respect to the radial plane at the center of the sealing part 30 in the axial direction. The distance between the connection point of the first disc part 10 and the sealing part 30 and the plane of symmetry is the same as the distance between the connection point of the second disc part 20 and the sealing part 30 and the plane of symmetry. The shape, projected area, and thickness of the first disc part 10 and the second disc part 20 are identical. The number, structure, and dimensions of the first radial ribs 131 on the first disc part 10 are the same as the number, structure, and dimensions of the second radial ribs 231 on the second disc part 20, and the number, structure, and dimensions of the first annular ribs 132 on the first disc part 10 are the same as the number, structure, and dimensions of the second annular ribs 232 on the second disc part 20.

[0126] In some other embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are arranged asymmetrically.

[0127] The radial surface at the center of the axial direction of the sealing part 30 is the center surface, optionally, such as... Figure 2 As shown, the distance between the connection point of the first disc portion 10 and the sealing portion 30 and the center surface is different from the distance between the connection point of the second disc portion 20 and the sealing portion 30 and the center surface.

[0128] Optionally, the first disc portion 10 and the second disc portion 20 have different shapes, projected areas, and thicknesses. The first disc portion 10 and the second disc portion 20 can be selected according to the shape of the atrial wall at the affected area, with corresponding cross-sectional shapes and slopes, so that the shapes of the first disc portion 10 and the second disc portion 20 conform to the affected area, facilitating cell and tissue growth and improving the repair effect. For example, the first disc portion 10 abuts against the left atrial wall, and the second disc portion 20 abuts against the right atrial wall. The projected area of ​​the first disc portion 10 is larger than that of the second disc portion 20 to increase the contact area between the first disc portion 10 and the left atrial wall. Since the pressure in the left atrium is greater than that in the right atrium, for patients with patent foramen ovale of the atrial septum, blood usually flows from the left atrium into the right atrium through the foramen ovale. The occluder 100 with the above structure can enhance the support of the first disc portion 10, resisting the impact of blood flow. The occluder 100 is firmly installed at the atrial septal defect, which helps improve the working reliability of the occluder 100.

[0129] Optionally, the number, structure, and dimensions of the first radial ribs 131 on the first disc portion 10 are different from the number, structure, and dimensions of the second radial ribs 231 on the second disc portion 20; or, alternatively, the number, structure, and dimensions of the first annular ribs 132 on the first disc portion 10 are different from the number, structure, and dimensions of the second annular ribs 232 on the second disc portion 20.

[0130] In some embodiments of this invention, the first outer surface has a greater surface roughness than the first inner surface; the second outer surface has a greater surface roughness than the second inner surface. The roughness of both the first and second outer surfaces facilitates cell growth and improves the repair effect.

[0131] The following is a brief description of several embodiments of the integrated biodegradable foramen ovale sealing device of this utility model, with reference to the accompanying drawings.

[0132] In Embodiment 1 of this utility model, as Figure 3 As shown, the first disc portion 10 includes six first radial ribs 131 and one first annular rib 132. The first annular rib 132 is located on the outer edge of the first annular plate 12, and the outer ends of the six first radial ribs 131 are all connected to the first annular rib 132. The second disc portion 20 includes six second radial ribs 231 and one second annular rib 232. The second annular rib 232 is located on the outer edge of the second annular plate 22, and the outer ends of the six second radial ribs 231 are all connected to the second annular rib 232.

[0133] In the second embodiment of this utility model, as Figure 2 As shown, the first disc portion 10 includes six first radial ribs 131 and one first annular rib 132. The first annular rib 132 is located on the outer edge of the first annular plate 12, and the outer ends of the six first radial ribs 131 are spaced apart from the first annular rib 132. The second disc portion 20 includes six second radial ribs 231 and one second annular rib 232. The second annular rib 232 is located on the outer edge of the second annular plate 22, and the outer ends of the six second radial ribs 231 are spaced apart from the second annular rib 232.

[0134] In Embodiment 3 of this utility model, as Figure 1 As shown, the first disc portion 10 includes ten first radial ribs 131 and two first annular ribs 132. The first annular ribs 132 are located on the outer edge of the first annular plate 12, and the other first annular rib 132 is located on the first outer ring segment 122 and inside the outer edge of the first annular plate 12. The ten first radial ribs 131 are connected to the two first annular ribs 132, and the outer ends of the ten first radial ribs 131 are all connected to the first annular ribs 132 located on the outer edge of the first annular plate 12.

[0135] The second disc portion 20 includes ten second radial ribs 231 and two second annular ribs 232. The second annular ribs 232 are located on the outer edge of the second annular plate 22, and the other second annular rib 232 is located on the second outer ring segment 222 and inside the outer edge of the second annular plate 22. The ten second radial ribs 231 are connected to the two second annular ribs 232, and the outer ends of the ten second radial ribs 231 are all connected to the second annular ribs 232 located on the outer edge of the second annular plate 22.

[0136] In the fourth embodiment of this utility model, the first disc portion 10 includes ten first radial ribs 131 and two first annular ribs 132. The first annular ribs 132 are disposed on the outer edge of the first annular plate 12, and the other first annular rib 132 is disposed on the first outer ring segment 122 and located inside the outer edge of the first annular plate 12. The ten first radial ribs 131 are connected to the first annular ribs 132 located on the inner side, and the outer ends of the ten first radial ribs 131 are all spaced apart from the first annular ribs 132 located on the outer edge of the first annular plate 12.

[0137] The second disc portion 20 includes ten second radial ribs 231 and two second annular ribs 232. The second annular ribs 232 are located on the outer edge of the second annular plate 22, and the other second annular rib 232 is located on the second outer ring segment 222 and inside the outer edge of the second annular plate 22. The ten second radial ribs 231 are connected to the second annular ribs 232 located on the inner side. The outer ends of the ten second radial ribs 231 are all spaced apart from the second annular ribs 232 located on the outer edge of the second annular plate 22.

[0138] In Embodiment 5 of this utility model, the first disc portion 10 includes eight first radial ribs 131 and one first annular rib 132. The first annular rib 132 is disposed on the first outer ring segment 122 and spaced apart from the outer edge of the first annular plate 12. The outer ends of the six first radial ribs 131 are all connected to the first annular rib 132 and spaced apart from the outer edge of the first annular plate 12. The second disc portion 20 includes six second radial ribs 231 and one second annular rib 232. The second annular rib 232 is disposed on the second outer ring segment 222 and spaced apart from the outer edge of the second annular plate 22. The outer ends of the six second radial ribs 231 are all connected to the second annular rib 232 and spaced apart from the outer edge of the second annular plate 22.

[0139] In some embodiments of this utility model, such as Figures 1-3 As shown, the plugging device 100 also includes a conveying device connection part 40, which is integrally formed on one axial end of the plugging part 30. The conveying device connection part 40 is adapted to be connected to the pushing component in the conveying device of the plugging device 100.

[0140] The push component can be selectively connected to the conveying device connection part 40. When the push component is connected to the conveying device connection part 40, it can drive the blocker 100 to move. When the push component is separated from the conveying device connection part 40, the push component can be recycled.

[0141] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the conveying device connection part 40 is provided on one side of the first disc part 10 on the sealing part 30.

[0142] During the surgical procedure, the pusher component and the delivery device connection 40 are first stably connected. The occluder 100 delivery device drives the occluder 100 to move along the sheath until it reaches the affected area. The occluder 100 delivery device drives the occluder 100 to continue moving, releasing the second disc 20 from the sheath on the left atrial side. After release, the second disc 20 automatically returns to its original position and abuts against the left atrial wall. Subsequently, the occluder 100 delivery device drives the occluder 100 to continue moving, releasing the occlusion part 30 from the sheath. The occlusion part 30 seals the atrial septal defect. Then, the occluder 100 delivery device drives the occluder 100 to continue moving, releasing the first disc 10 from the sheath on the right atrial side. After release, the first disc 10 automatically returns to its original position and abuts against the right atrial wall, thus sealing the foramen ovale of the atrial septum with the occluder 100. Finally, the push component is separated from the delivery device connection 40, and the push component and sheath are removed from the affected area and out of the body.

[0143] In some embodiments of this utility model, the connecting part 40 of the conveying device can be a hole, a recess, or a protrusion, and the pushing component is connected to the connecting part 40 of the conveying device. Optionally, the shape of the hole, recess, or protrusion can be a circular, elliptical, triangular, or composite geometric shape; the hole can be a through structure, the recess or protrusion can be a non-through structure, and the protrusion can be a flat protrusion or a cylindrical protrusion.

[0144] In some embodiments of this utility model, such as Figure 1 As shown, the connecting part 40 of the conveying device is constructed as a flat block, which extends along the axial direction of the sealing part 30.

[0145] The occluder 100 of this invention has an integrated structure and is an elastic element that can automatically return to its original shape. When the occluder 100 is delivered from the sheath, it automatically returns to its original shape. Therefore, there is no need to set up an additional driving component to drive the occluder 100 to return to its original shape, which can reduce manufacturing costs and simplify surgical operations. The delivery device connecting part 40 is constructed as a flat block, and a clamping member can be used as a pushing component. The clamping member clamps the flat block to connect with the occluder 100. The connection and release operation of the clamping member is simple, which can simplify surgical operations.

[0146] For example, the occluder 100 can be delivered to the affected area by gripping the flat block with pliers along the sheath.

[0147] In some embodiments of this utility model, such as Figure 1 and Figure 3 As shown, the surface of the flat block is provided with multiple ribs 41 spaced apart along the axial direction. By providing the ribs 41, the surface friction of the flat block can be increased, and the ribs 41 play an anti-slip role, which can further improve the connection stability between the pushing component and the flat block, and improve the working reliability of the plugger 100.

[0148] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the conveying device connection part 40 is provided on one side of the first disc part 10 on the sealing part 30. The thickness of the first inner ring section 121 is less than the thickness of the second inner ring section 221, which reduces the occurrence of interference between the deformation of the first disc part 10 and the conveying device connection part 40.

[0149] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0150] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this utility model, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0151] In this utility model, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0152] In this utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0153] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0154] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A dual-disc, one-piece, biodegradable foramen ovale occluder for atrial septum, characterized in that, include: The device comprises a first disc portion, a second disc portion, and a sealing portion. The first disc portion and the second disc portion are connected to the two axial ends of the sealing portion. The first disc portion, the second disc portion, and the sealing portion are integrally molded and are biodegradable. The sealing device may be at least one of biodegradable polymer material, biodegradable metal material, bioceramic material, and bioglass material. The first disc portion and the second disc portion are both elastic components that can automatically return to their original shape. At least a portion of the first disk portion and at least a portion of the second disk portion are conical rings; When at least a portion of the first disk portion is a conical ring, the conical ring extends from the center to the edge toward the second disk portion; When at least a portion of the second disk portion is a conical ring, the conical ring extends from the center to the edge toward the first disk portion; The axial dimension of the sealing part is L1, and the distance between the outer edges of the first disk and the outer edges of the second disk is L2. <L1。 2. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, characterized in that, The first disk portion includes a first annular plate, and the second disk portion includes a second annular plate; The first annular plate includes a first inner ring segment and a first outer ring segment connected together. The first inner ring segment is annular, and its inner edge is connected to the sealing part. The first inner ring segment extends away from the second disc part. The first outer ring segment is annular, and its inner edge is connected to the outer edge of the first inner ring segment. The first outer ring segment gradually approaches the second disc part in a direction radially away from the center of the sealing part. The second annular plate includes a second inner ring segment and a second outer ring segment connected together. The second inner ring segment is annular, and its inner edge is connected to the sealing part. The second inner ring segment extends away from the first disc portion. The second outer ring segment is annular, and its inner edge is connected to the outer edge of the second inner ring segment. The second outer ring segment gradually approaches the first disc portion in a direction radially away from the center of the sealing part.

3. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 2, characterized in that, The thickness of the first inner ring segment gradually decreases in the direction extending from the inner edge to the outer edge of the first inner ring segment; the thickness of the first outer ring segment gradually decreases in the direction extending from the inner edge to the outer edge of the first outer ring segment. The thickness of the second inner ring segment gradually decreases in the direction extending from the inner edge to the outer edge of the second inner ring segment; similarly, the thickness of the second outer ring segment gradually decreases in the direction extending from the inner edge to the outer edge of the second outer ring segment.

4. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 2, characterized in that, The first inner ring segment and the first outer ring segment have the same thickness; the second inner ring segment and the second outer ring segment have the same thickness.

5. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 2, characterized in that, The cross-sectional shape of the first inner ring segment, the first outer ring segment, the second inner ring segment, and the second outer ring segment perpendicular to the axial direction of the blocking part is circular, near-circular, or polygonal; The first inner ring segment and the first outer ring segment are connected by a circular arc transition. The second inner ring segment and the second outer ring segment are connected by a circular arc transition.

6. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 2, characterized in that, The first disc portion further includes: a first support rib disposed on the first annular plate, the first support rib being used to support the first annular plate to restore its original shape; The second plate also includes a second support rib disposed on the second annular plate, the second support rib being used to support the second annular plate to restore its original shape.

7. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 6, characterized in that, The first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface is disposed facing the second disc portion, and at least one of the first inner surface and the first outer surface is provided with the first supporting rib. The second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface is disposed facing the first disc portion, and at least one of the second inner surface and the second outer surface is provided with the second supporting rib.

8. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 7, characterized in that, The first support rib includes: a plurality of first radial ribs spaced apart circumferentially along the first annular plate, the first radial ribs being located on the first inner surface, and the first radial ribs extending from the inner edge of the first inner ring segment to the outer edge of the first outer ring segment; The second support rib includes: a plurality of second radial ribs spaced apart circumferentially along the second annular plate, the second radial ribs being located on the second inner surface, and the second radial ribs extending from the inner edge of the second inner ring segment to the outer edge of the second outer ring segment.

9. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, characterized in that, The inner end of the first radial rib is connected to the sealing part, and the outer end of the first radial rib extends to the outer edge of the first annular plate, or is spaced apart from the outer edge of the first annular plate. The inner end of the second radial rib is connected to the sealing part, and the outer end of the second radial rib extends to the outer edge of the second annular plate, or is spaced apart from the outer edge of the second annular plate.

10. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 7, characterized in that, The first supporting rib further includes a first annular rib extending circumferentially along the first annular plate, and the first annular rib is at least one and is disposed on the first outer ring segment; The second supporting rib further includes a second annular rib extending circumferentially along the second annular plate, wherein there is at least one second annular rib and it is disposed on the second outer ring segment.

11. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 8, characterized in that, The first support rib further includes: at least one first annular rib extending circumferentially along the first annular plate, wherein at least one first annular rib is connected to a plurality of first radial ribs; The second support rib further includes at least one second annular rib extending circumferentially along the second annular plate, and the at least one second annular rib is connected to a plurality of second radial ribs.

12. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 11, characterized in that, At least one of the first annular ribs is disposed on the outer edge of the first annular plate, and the outer ends of a plurality of the first radial ribs are connected to the first annular ribs located on the outer edge of the first annular plate. At least one of the second annular ribs is disposed on the outer edge of the second annular plate, and the outer ends of a plurality of the second radial ribs are connected to the second annular ribs located on the outer edge of the second annular plate.

13. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, characterized in that, The first radial rib and the sealing part are connected by an arc transition, and the second radial rib and the sealing part are connected by an arc transition.

14. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 8, characterized in that, The first radial rib includes 1-100 ribs; the second radial rib includes 1-100 ribs.

15. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-14, characterized in that, The axes of the first disc section, the second disc section, and the sealing section are all arranged in parallel.

16. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-14, characterized in that, The first disk section and the second disk section are arranged symmetrically or asymmetrically.

17. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 7, characterized in that, The first outer surface has a greater surface roughness than the first inner surface; the second outer surface has a greater surface roughness than the second inner surface.

18. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-14, characterized in that, Also includes: A conveying device connection portion is integrally formed at one axial end of the plugging portion, and the conveying device connection portion is adapted to connect with the pushing component in the plugging device conveying device.

19. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 18, characterized in that, The connecting part of the conveying device is constructed as a flat block, which extends axially along the sealing part.

20. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 19, characterized in that, The surface of the connecting part of the conveying device is provided with a plurality of raised ribs spaced apart along the axial direction.

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