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. At least part of at least one of the first disc part and the second disc part is an inverted-cone-shaped ring, and the inverted-cone-shaped ring extends in the direction away from the center of the double-disc-shaped integrally-formed degradable heart atrial septal foramen ovale plugging device from the center to the edge. The plugging device is an integrally-formed degradable part, is used for self cell tissues to climb and grow, and then is degraded and absorbed in vivo. All the defects of an existing plugging device of a woven structure can be overcome, and surgical operation can be simplified. And moreover, the condition that the first disc part or the second disc part hinders the atrial septum foramen ovale of the heart can be reduced, and the working reliability is improved.

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] The dual-disc integrally molded biodegradable foramen ovale occluder of the atrial septum according to an embodiment of the present invention includes: a first disc portion, a second disc portion, and an occluding portion. The first disc portion and the second disc portion are connected to the two axial ends of the occluding portion. The first disc portion, the second disc portion, and the occluding portion are integrally molded and biodegradable. The first disc portion and the second disc portion are both elastic elements that can automatically return to their original shape. At least a portion of at least one of the first disc portion and the second disc portion is an inverted conical ring, which extends from the center to the edge toward a direction away from the center of the dual-disc integrally molded biodegradable foramen ovale occluder of the atrial septum.

[0008] According to an embodiment of this utility model, the dual-disc, one-piece biodegradable foramen ovale occluder of 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 structure occluders and simplifies surgical procedures. Furthermore, by setting the first or second disc portion opposite to each other, the likelihood of the first or second disc portion obstructing the foramen ovale of the atrial septum is reduced, improving operational reliability.

[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 is an inverted conical ring, and at least a portion of the second disc portion is an inverted conical ring. The portion of the first disc portion forming the inverted conical ring extends from the center to the edge in a direction away from the second disc portion, and the portion of the second disc portion forming the inverted conical ring extends from the center to the edge in a direction away from 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, where L2>L1.

[0011] In some embodiments, one of the first disk portion and the second disk portion is an inverted conical ring, and the other of the first disk portion and the second disk portion is a conical ring.

[0012] In some embodiments, the axes of the first disc portion, the second disc portion, and the sealing portion are all arranged in parallel.

[0013] 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 toward 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 moving away from 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 toward 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 moving away from the first disc portion in a direction radially away from the center of the sealing portion.

[0014] In some embodiments, the first disc portion includes a first annular plate, which gradually moves away from the second disc portion in a direction radially away from the center of the blocking portion; the second disc portion includes a second annular plate, which gradually moves away from the first disc portion in a direction radially away from the center of the blocking portion.

[0015] In some embodiments, the cross-sectional shape of the first annular plate and the second annular plate in the axial direction perpendicular to the sealing portion is circular, near-circular, or polygonal.

[0016] 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.

[0017] 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 the first support rib protruding from at least one of the first inner surface and the first outer surface; 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 the second support rib protruding from at least one of the second inner surface and the second outer surface.

[0018] In some embodiments, the first support rib includes: a first radial rib, wherein there are multiple first radial ribs, the multiple first radial ribs are spaced apart circumferentially along the first annular plate, and the first radial ribs extend radially along the first annular plate; the second support rib includes: a second radial rib, wherein there are multiple second radial ribs, the multiple second radial ribs are spaced apart circumferentially along the second annular plate, and the second radial ribs extend radially along the second annular plate.

[0019] 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.

[0020] In some embodiments, the first support rib includes a first annular rib extending circumferentially along the first annular plate; the second support rib includes a second annular rib extending circumferentially along the second annular plate.

[0021] In some embodiments, the first support rib includes: a first radial rib and a first annular rib, wherein there are multiple first radial ribs spaced apart circumferentially along the first annular plate, the first radial ribs extend radially along the first annular plate, the first annular ribs extend circumferentially along the first annular plate, and the first annular ribs are connected to the multiple first radial ribs; the second support rib includes: a second radial rib and a second annular rib, wherein there are multiple second radial ribs spaced apart circumferentially along the second annular plate, the second radial ribs extend radially along the second annular plate, the second annular ribs extend circumferentially along the second annular plate, and the second annular ribs are connected to the multiple second radial ribs.

[0022] 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.

[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 first disk portion and the second disk portion are arranged symmetrically or asymmetrically.

[0025] In some embodiments, the occluder further includes a delivery device connection portion 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.

[0026] In some embodiments, the connecting part of the conveying device is configured as a connecting block, and the surface of the connecting block is provided with anti-slip texture.

[0027] 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

[0028] 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:

[0029] 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;

[0030] Figure 2This is a cross-sectional view of a dual-disc, integrally molded, biodegradable atrial septum foramen ovale occluder according to another embodiment of the present invention.

[0031] Figure label:

[0032] 100-Occluder;

[0033] 10-First disc section; 11-First annular plate; 111-First inner ring section; 112-First outer ring section; 12-First supporting rib; 121-First radial rib; 122-First annular rib;

[0034] 20 - Second disc section; 21 - Second annular plate; 211 - Second inner ring section; 212 - Second outer ring section; 22 - Second supporting rib; 221 - Second radial rib; 222 - Second annular rib;

[0035] 30 - Sealing section;

[0036] 40 - Conveying device connection part. Detailed Implementation

[0037] 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.

[0038] The following is for reference. Figure 1 and Figure 2 Description of a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for atrial septum according to some embodiments of the present invention.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is an inverted conical ring, which extends from the center to the edge toward the center away from the center of the double-disc integrally molded biodegradable cardiac atrial septum foramen ovale occluder 100.

[0045] It is worth noting that the first disc 10 and the second disc 20 are respectively connected to the two ends of the occlusion part 30 along its length. Therefore, the center of the double-disc integrally formed biodegradable atrial septum foramen ovale occluder 100 is the middle part of the occlusion part 30.

[0046] When at least a portion of the first disc portion 10 is an inverted conical ring, the conical ring extends from the center to the edge in a direction away from the second disc portion 20; when at least a portion of the second disc portion 20 is an inverted conical ring, the conical ring extends from the center to the edge in a direction away from the first disc portion 10.

[0047] By setting the first disc portion 10 or the second disc portion 20 away from each other, the first disc portion 10 or the second disc portion 20 can be prevented from blocking the sealing portion 30, thereby reducing the obstruction of the foramen ovale formation by the first disc portion 10 or the second disc portion 20 and improving the working reliability of the dual-disc integrally molded biodegradable foramen ovale occluder 100.

[0048] According to an embodiment of this utility model, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is an integrally molded 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 remaining 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. Furthermore, by setting the first disc portion 10 or the second disc portion 20 opposite to each other, the likelihood of the first disc portion 10 or the second disc portion 20 obstructing the foramen ovale of the atrial septum can be reduced, improving operational reliability.

[0049] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, at least a portion of the first disc portion 10 is an inverted conical ring, and at least a portion of the second disc portion 20 is an inverted conical ring. The portion of the first disc portion 10 with the inverted conical ring extends from its center to its edge in a direction away from the second disc portion 20, and the portion of the second disc portion 20 with the inverted conical ring extends from its center to its edge in a direction away from the first disc portion 10. The axial dimension of the sealing portion 30 is L1, and the distance between the outer edges of the first disc portion 10 and the outer edges of the second disc portion 20 is L2, where L2 > L1.

[0050] Both the first disc portion 10 and the second disc portion 20 are inverted conical rings, and are interlocked opposite to each other. By arranging the first disc portion 10 and the second disc portion 20 opposite to each other, the first disc portion 10 and the second disc portion 20 can be prevented from obstructing the sealing portion 30, reducing the possibility of the first disc portion 10 or the second disc portion 20 obstructing the formation of the foramen ovale of the atrial septum, and improving the working reliability of the dual-disc integrally molded biodegradable atrial septum foramen ovale occluder 100.

[0051] In some other embodiments of the present invention, one of the first disc portion 10 and the second disc portion 20 is an inverted conical ring, and the other of the first disc portion 10 and the second disc portion 20 is a conical ring.

[0052] One of the first disc portion 10 and the second disc portion 20 is recessed toward the middle position of the sealing portion 10, and the other of the first disc portion 10 and the second disc portion 20 is extended toward the direction away from the middle position of the sealing portion 10. This also falls within the protection scope of this application.

[0053] 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 in parallel.

[0054] The parallel alignment of the axes helps the occluder 100 better adapt to the internal structure of the heart, resulting in more precise occlusion and reducing the possibility of blood leakage from the foramen ovale. The parallel axis design also makes the operation of the occluder 100 more intuitive and simple, allowing physicians to more easily place it in the correct position and ensure its stability during the procedure.

[0055] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the first disc portion 10 includes a first annular plate 11, which is configured as the main body of the first disc portion 10. The first annular plate 11 defines the main outline of the first disc portion 10. The inner end of the first annular plate 11 is connected to the sealing portion 30 around the axis of the sealing portion 30. The first annular plate 11 is configured as an annular structure. Similarly, the second disc portion 20 includes a second annular plate 21, which is configured as the main body of the second disc portion 20. The second annular plate 21 defines the main outline of the second disc portion 20. The inner end of the second annular plate 21 is also connected to the sealing portion 30 around the axis of the sealing portion 30. The second annular plate 21 is also configured as an annular structure.

[0056] The first annular plate 11 and the second annular plate 21 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 11 and the second annular plate 21 provide complete support, and the atrial septal defect can be sealed after the cells and tissues climb and grow, thus improving the repair effect.

[0057] In some embodiments, such as Figure 2As shown, the first annular plate 11 includes a first inner ring segment 111 and a first outer ring segment 112. Both the first inner ring segment 111 and the first outer ring segment 112 are annular. The first inner ring segment 111 is closer to the sealing part 30 than the first outer ring segment 112. The inner edge of the first inner ring segment 111 is connected to the sealing part 30. The first inner ring segment 111 extends toward the second disc part 20. The inner edge of the first outer ring segment 112 is connected to the outer edge of the first inner ring segment 111. The first outer ring segment 112 gradually moves away from the second disc part 20 in a radial direction away from the center of the sealing part 30.

[0058] By setting the first outer ring segment 112, the first disc portion 10 is constructed with an inwardly folded structure in the direction away from the second disc portion 20, so that the distance L2 between the outer edges of the first disc portion 10 and the outer edges of the second disc portion 20 is greater than the axial dimension L1 of the sealing portion 30. It is worth noting that the first inner ring segment 111 extends towards the second disc portion 20, and the first outer ring segment 112 extends away from the second disc portion 20. The first disc portion 10 is constructed with an inwardly folded structure followed by an outward fold, which can form a transitional structure on the first disc portion 10. The first disc portion 10 is more likely to automatically return to its original shape, improving the working reliability of the first disc portion 10.

[0059] Similarly, the second annular plate 21 includes: a second inner ring segment 211 and a second outer ring segment 212. Both the second inner ring segment 211 and the second outer ring segment 212 are annular. The second inner ring segment 211 is closer to the sealing part 30 than the second outer ring segment 212. The inner edge of the second inner ring segment 211 is connected to the sealing part 30. The second inner ring segment 211 extends toward the first disc part 10. The inner edge of the second outer ring segment 212 is connected to the outer edge of the second inner ring segment 211. The second outer ring segment 212 gradually moves away from the first disc part 10 in a radial direction away from the center of the sealing part 30.

[0060] By providing a second outer ring segment 212, the second disc portion 20 is configured to be inwardly folded away from the first disc portion 10, so that the distance L2 between the outer edges of the first disc portion 10 and the second disc portion 20 is greater than the axial dimension L1 of the sealing portion 30. By providing a second inner ring segment 211 that extends towards the first disc portion 10 and a second outer ring segment 212 that extends away from the first disc portion 10, the second disc portion 20 is configured to be inwardly folded and then outwardly folded, which can form a transitional structure on the second disc portion 20, making it easier for the second disc portion 20 to automatically return to its original shape and improving the operational reliability of the second disc portion 20.

[0061] In some embodiments of this utility model, the cross-sectional shapes of the first inner ring segment 111 and the first outer ring segment 112 in the axial direction of the sealing portion 30 are arc-shaped, and the cross-sectional shapes of the second inner ring segment 211 and the second outer ring segment 212 in the axial direction of the sealing portion 30 are also arc-shaped. This can reduce the stress concentration points at the first annular plate 11 and the second annular plate 21, 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, thereby improving the working reliability of the first disc portion 10 and the second disc portion 20.

[0062] In some embodiments of this utility model, the inner edge of the first inner ring segment 111 is connected to the sealing part 30 by an arc transition, and the inner edge of the second inner ring segment 211 is connected to the sealing part 30 by an arc transition. This can reduce the stress at the connection between the first annular plate 11 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.

[0063] In some embodiments of this utility model, such as Figure 2 As shown, the first inner ring segment 111 and the first outer ring segment 112 are connected by a circular arc transition, as are the second inner ring segment 211 and the second outer ring segment 212. This smooth transition between the first inner ring segment 111 and the first outer ring segment 112, and between the second inner ring segment 211 and the second outer ring segment 212, reduces stress concentration on the first annular plate 11 and the second annular plate 21, lowers the likelihood of fracture or damage to the first disc portion 10 and the second disc portion 20, and improves the operational reliability of the first disc portion 10 and the second disc portion 20.

[0064] In some embodiments of this utility model, the cross-sectional shapes of the first inner ring segment 111, the first outer ring segment 112, the second inner ring segment 211, and the second outer ring segment 212 in the axial direction perpendicular to the sealing portion 30 are circular, near-circular, or polygonal. The cross-sectional shapes of the first inner ring segment 111 and the first outer ring segment 112 in the axial direction perpendicular to the sealing portion 30 may be the same, or they may be different; the cross-sectional shapes of the second inner ring segment 211 and the second outer ring segment 212 in the axial direction perpendicular to the sealing portion 30 may be the same, or they may be different.

[0065] In other embodiments of this application, such as Figure 1As shown, the first disc portion 10 includes a first annular plate 11, which gradually moves away from the second disc portion 20 in a radial direction away from the center of the sealing portion 30; the second disc portion 20 includes a second annular plate 21, which gradually moves away from the first disc portion 10 in a radial direction away from the center of the sealing portion 30.

[0066] The first annular plate 11 is constructed as the main body of the first disc portion 10, and the first annular plate 11 extends away from the second disc portion 20. The second annular plate 12 is constructed as the main body of the second disc portion 20, and the second annular plate 12 extends away from the first disc portion 10. This avoids the first disc portion 10 and the second disc portion 20 obstructing the sealing portion 30, reduces the possibility of the first disc portion 10 or the second disc portion 20 obstructing the foramen ovale of the atrial septum, and improves the operational reliability of the dual-disc integrally molded biodegradable atrial septum foramen ovale occluder 100.

[0067] In some embodiments of this invention, the cross-sectional shape of the first annular plate 11 and the second annular plate 21 perpendicular to the axial direction of the blocking portion 30 is circular, near-circular, or polygonal. The first annular plate 11 or the second annular plate 21 with a corresponding cross-sectional shape can be selected according to the shape of the atrial wall at the affected area to fit the affected area.

[0068] It is worth noting that the occluder 100 of this embodiment can be directly trimmed on the first annular plate 11 or the second annular plate 21 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 11 or the second annular plate 21 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, the occluder 100 can be personalized, it is highly targeted, which is beneficial to improving the repair effect and can save the manufacturing cost of customized parts.

[0069] In some embodiments of this utility model, the projected areas of the first annular plate 11 and the second annular plate 21 in the axial direction of the sealing portion 30 are each independently 5mm². 2 -2000mm 2 .

[0070] Optionally, the projected area of ​​the first annular plate 11 in the axial direction of the sealing portion 30 can be 5 mm². 2 55mm 2 100mm 2 500mm 2 900mm 2 1000mm 2 1500mm 2 2000mm2 wait.

[0071] Optionally, the projected area of ​​the second annular plate 21 in the axial direction of the sealing portion 30 can be 5 mm². 2 55mm 2 100mm 2 500mm 2 900mm 2 1000mm 2 1500mm 2 2000mm 2 wait.

[0072] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the first disc portion 10 further includes a first support rib 12 provided on the first annular plate 11, the first support rib 12 being used to support the first annular plate 11 to restore its original state, and the second disc portion 20 further includes a second support rib 22 provided on the second annular plate 21, the second support rib 22 being used to support the second annular plate 21 to restore its original state.

[0073] The design of the first disc section 10 and the second disc section 20 takes into account structural stability and functionality. First supporting ribs 12 and second supporting ribs 22 are respectively provided on the first annular plate 11 and the second annular plate 21. These supporting ribs play a crucial role in ensuring that the annular plates can return to their original shape after deformation. This increases the speed at which the first annular plate 11 and the second annular plate 21 return to their original shape, reducing the possibility of the first annular plate 11 and the second annular plate 21 being blocked and unable to fully return to their original shape. This facilitates the release of the occluder 100, improves the operational reliability of the occluder 100, and increases surgical efficiency.

[0074] Furthermore, the design of the support ribs also helps to improve the overall performance of the occluder 100. When the first annular plate 11 and the second annular plate 21 need to fit tightly against the affected area or other areas requiring occlusion, the support ribs can ensure that the annular plates maintain appropriate tension and shape, thereby achieving more precise and effective occlusion.

[0075] In some embodiments of the present invention, the first annular plate 11 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 20, and the first support rib 12 protruding from at least one of the first inner surface and the first outer surface; the second annular plate 21 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 10, and the second support rib 22 protruding from at least one of the second inner surface and the second outer surface.

[0076] 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 plugger 100, which is different from the orientation of the inner edge, outer edge, and other structures mentioned above. The first disc portion 10 and the second disc portion 20 are connected to the two ends of the plugging portion 30 in the axial direction. The first inner surface and the second inner surface are arranged opposite each other in the axial direction of the plugger 100, and the first outer surface and the second outer surface are arranged opposite each other in the axial direction of the plugger 100.

[0077] The first support rib 12 may protrude from the first annular plate 11 only in the direction of the first inner surface or the first outer surface; or, the first support rib 12 may protrude from both the first inner surface and the first outer surface. The second support rib 22 may protrude from only the second inner surface or only the second outer surface; or, the second support rib 22 may protrude from both the second outer surface and the second inner surface.

[0078] In some embodiments of this utility model, optionally, the first support rib 12 may include only a plurality of first radial ribs 121, the first radial ribs 121 being arranged at intervals along the circumference of the first annular plate 11 and extending radially along the first annular plate 11; the second support rib 22 may include only a plurality of second radial ribs 221, the second radial ribs 221 being arranged at intervals along the circumference of the second annular plate 21 and extending radially along the second annular plate 21.

[0079] When the first disc portion 10 is compressed and deformed, the first radial rib 121 tends to support the first annular plate 11 to restore its original shape. After the compression of the first disc portion 10 is removed, the first radial rib 121 can support the first annular plate 11 to expand radially and restore its original shape. Similarly, when the second disc portion 20 is compressed and deformed, the second radial rib 221 tends to support the second annular plate 21 to restore its original shape. After the compression of the second disc portion 20 is removed, the second radial rib 221 can support the second annular plate 21 to expand radially and restore its original shape.

[0080] The first radial ribs 121 are multiple and are spaced apart along the circumference of the first annular plate 11, so that the first annular plate 11 is subjected to uniform force, which is conducive to the first annular plate 11 restoring its original shape; the second radial ribs 221 are multiple and are spaced apart along the circumference of the second annular plate 21, so that the second annular plate 21 is subjected to uniform force, which is conducive to the second annular plate 21 restoring its original shape.

[0081] In some embodiments of this utility model, the inner end of the first radial rib 121 is connected to the sealing part 30, and the outer end of the first radial rib 121 extends to the outer edge of the first annular plate 11 or is spaced apart from the outer edge of the first annular plate 11; the inner end of the second radial rib 221 is connected to the sealing part 30, and the outer end of the second radial rib 221 extends to the outer edge of the second annular plate 21 or is spaced apart from the outer edge of the second annular plate 21.

[0082] The inner end of the first radial rib 121 is connected to the sealing part 30, which can improve the structural strength of the first radial rib 121 and help support the first annular plate 11 to restore its original shape; the inner end of the second radial rib 221 is connected to the sealing part 30, which can improve the structural strength of the second radial rib 221 and help support the second annular plate 22 to restore its original shape.

[0083] In some embodiments of this utility model, the first support rib 12 may only include the first annular rib 122, which extends circumferentially along the first annular plate 11; the second support rib 22 may only include the second annular rib 222, which extends circumferentially along the second annular plate 21.

[0084] When the first disc portion 10 is compressed and deformed, the first annular rib 122 tends to support the first annular plate 11 to restore its original shape. After the compression of the first disc portion 10 is removed, the first annular rib 122 can support the first annular plate 11 to unfold circumferentially and restore its original shape. Similarly, when the second disc portion 20 is compressed and deformed, the second annular rib 222 tends to support the second annular plate 21 to restore its original shape. After the compression of the second disc portion 20 is removed, the second annular rib 222 can support the second annular plate 21 to unfold circumferentially and restore its original shape.

[0085] Optionally, there may be one first annular rib 122, or there may be multiple first annular ribs 122, which are spaced apart along the extension direction from the inner edge to the outer edge of the first annular plate 11. Optionally, there may be one second annular rib 222, or there may be multiple second annular members, which are spaced apart along the extension direction from the inner edge to the outer edge of the second annular plate 21.

[0086] In some embodiments of this utility model, the cross-section of the first annular rib 122 is circular, fan-shaped, triangular, or a composite geometric shape; the cross-section of the second annular rib 222 is circular, fan-shaped, triangular, or a composite geometric shape.

[0087] In some embodiments of this utility model, such as Figure 1As shown, the first support rib 12 includes a first radial rib 121 and a first annular rib 122. A plurality of first radial ribs 121 are arranged at intervals along the circumference of the first annular plate 11. The first radial ribs 121 extend radially along the first annular plate 11, and the first annular ribs 122 extend circumferentially along the first annular plate 11. The first annular ribs 122 are connected to the plurality of first radial ribs 121. The second support rib 22 includes a second radial rib 221 and a second annular rib 222. A plurality of second radial ribs 221 are arranged at intervals along the circumference of the second annular plate 21. The second radial ribs 221 extend radially along the second annular plate 21, and the second annular ribs 222 extend circumferentially along the second annular plate 21. The second annular ribs 222 are connected to the plurality of second radial ribs 221.

[0088] The first annular rib 122 is connected to multiple first radial ribs 121 to connect the first supporting ribs 12 into a whole, thereby improving the structural stability of the first supporting ribs 12 and facilitating the restoration of the first annular plate 11 to its original shape. Similarly, the second annular rib 222 is connected to multiple second radial ribs 221 to connect the second supporting ribs 22 into a whole, thereby improving the structural stability of the second supporting ribs 22 and facilitating the restoration of the second annular plate 21 to its original shape.

[0089] In other embodiments of this utility model, such as Figure 2 As shown, the first support rib 12 includes a first radial rib 121 and a first annular rib 122. A plurality of first radial ribs 121 are arranged circumferentially around the first annular plate 11. The first radial ribs 121 extend radially around the first annular plate 11, and the first annular ribs 122 extend circumferentially around the first annular plate 11. The outer edge of the first radial rib 121 is spaced apart from the first annular rib 122. The second support rib 22 includes a second radial rib 221 and a second annular rib 222. A plurality of second radial ribs 221 are arranged circumferentially around the second annular plate 21. The second radial ribs 221 extend radially around the second annular plate 21, and the second annular ribs 222 extend circumferentially around the second annular plate 21. The outer edge of the second radial rib 221 is spaced apart from the second annular rib 222.

[0090] In some embodiments of the present invention, at least one first annular rib 122 is provided on the outer edge of the first annular plate 11, and the outer ends of a plurality of first radial ribs 121 are connected to the first annular rib 122 located on the outer edge of the first annular plate 11; at least one second annular rib 222 is provided on the outer edge of the second annular plate 21, and the outer ends of a plurality of second radial ribs 221 are connected to the second annular rib 222 located on the outer edge of the second annular plate 21.

[0091] The first annular rib 122 is provided on the outer edge of the first annular plate 11, which is conducive to the extension of the first annular plate 11 and the restoration of the first annular plate 11 to its original shape. Similarly, the second annular rib 222 is provided on the outer edge of the second annular plate 21, which is conducive to the extension of the second outer ring segment and the restoration of the second annular plate 21 to its original shape.

[0092] The outer ends of multiple first radial ribs 121 are connected to first annular ribs 122 located on the outer edge of the first annular plate 11, so as to connect the first support ribs 12 into a whole, improve the structural stability of the first support ribs 12, and help support the first annular plate 11 to restore its original shape. The outer ends of multiple second radial ribs 221 are connected to second annular ribs 222 located on the outer edge of the second annular plate 21, so as to connect the second support ribs 22 into a whole, improve the structural stability of the second support ribs 22, and help support the first annular plate 11 to restore its original shape.

[0093] In some embodiments of this utility model, the first radial rib 121 includes 1-100 ribs; the second radial rib 221 includes 1-100 ribs.

[0094] Optionally, the first radial rib 121 may be 1, 5, 6, 8, 10, 12, 20, 50, 100, etc.

[0095] Optionally, the second radial rib 221 can be 1, 5, 6, 8, 10, 16, 30, 50, 100, etc.

[0096] In some embodiments of this utility model, the first annular rib 122 includes 1-10 ribs, and the second annular rib 222 includes 1-10 ribs.

[0097] Too many first annular ribs 122 are not conducive to the deformation and storage of the first annular plate 11; similarly, too many second annular ribs 222 are also not conducive to the normal operation of the plugger 100.

[0098] Optionally, the first annular rib 122 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0099] Optionally, the second annular rib 222 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0100] In some embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0101] The first disc portion 10 and the second disc portion 20 have the same shape, projected area, and thickness; the number, structure, and dimensions of the first radial ribs 121 on the first disc portion 10 are the same as the number, structure, and dimensions of the second radial ribs 221 on the second disc portion 20, and the number, structure, and dimensions of the first annular ribs 122 on the first disc portion 10 are the same as the number, structure, and dimensions of the second annular ribs 222 on the second disc portion 20.

[0102] In some other embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are arranged asymmetrically.

[0103] Optionally, the number, structure, and dimensions of the first radial ribs 121 on the first disc portion 10 are different from the number, structure, and dimensions of the second radial ribs 221 on the second disc portion 20; or, alternatively, the number, structure, and dimensions of the first annular ribs 122 on the first disc portion 10 are different from the number, structure, and dimensions of the second annular ribs 222 on the second disc portion 20.

[0104] In some embodiments of this utility model, such as Figure 1 and Figure 2 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.

[0105] 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.

[0106] 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.

[0107] In some embodiments of this utility model, the connecting part 40 of the conveying device is constructed as a connecting block. The surface of the connecting block is provided with anti-slip texture, which can improve the surface friction of the connecting block, further improve the connection stability between the pushing component and the connecting block, and improve the working reliability of the blocker 100.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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 at least one of the first disc portion and the second disc portion is an inverted conical ring, the inverted conical ring extending from the center to the edge toward a direction away from the center of the dual-disc integrally molded biodegradable cardiac atrial septal foramen ovale occluder; At least a portion of the first disc portion is an inverted conical ring, and at least a portion of the second disc portion is an inverted conical ring. The portion of the first disc portion forming the inverted conical ring extends from the center to the edge in a direction away from the second disc portion, and the portion of the second disc portion forming the inverted conical ring extends from the center to the edge in a direction away from the first disc portion. The axial dimension of the sealing part is L1, and the distance between the outer edge of the first disk part and the outer edge of the second disk part is L2, where L2>L1.

2. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, characterized in that, One of the first disk portion and the second disk portion is an inverted conical ring, and the other of the first disk portion and the second disk portion is a conical ring.

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

4. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 3, 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 toward 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 moves away from the second disc part in a radial direction 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 toward the first disc part. 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 moves away from the first disc part in a direction radially away from the center of the sealing part.

5. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 3, characterized in that, The first disc portion includes a first annular plate, which gradually moves away from the second disc portion in a direction radially away from the center of the sealing portion; The second disc portion includes a second annular plate, which gradually moves away from the first disc portion in a radial direction away from the center of the sealing portion.

6. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 4 or 5, characterized in that, The cross-sectional shape of the first annular plate and the second annular plate perpendicular to the axial direction of the sealing part is circular, near-circular, or polygonal.

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

8. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 7, 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 being disposed toward the second disc portion, and the first support rib protruding from at least one of the first inner surface and the first outer surface; 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 the second support rib protruding from at least one of the second inner surface and the second outer surface.

9. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, characterized in that, The first supporting rib includes: a first radial rib, there are multiple first radial ribs, the multiple first radial ribs are arranged at intervals along the circumference of the first annular plate, and the first radial ribs extend radially along the first annular plate; The second support rib includes: a second radial rib, there are multiple second radial ribs, the multiple second radial ribs are arranged at intervals along the circumference of the second annular plate, and the second radial ribs extend radially along the second annular plate.

10. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 9, 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.

11. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 8, characterized in that, The first supporting rib includes: a first annular rib, which extends circumferentially along the first annular plate; The second supporting rib includes a second annular rib, which extends circumferentially along the second annular plate.

12. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 8, characterized in that, The first supporting rib includes: a first radial rib and a first annular rib. There are multiple first radial ribs and they are spaced apart along the circumference of the first annular plate. The first radial ribs extend radially along the first annular plate, and the first annular ribs extend circumferentially along the first annular plate. The first annular ribs are connected to the multiple first radial ribs. The second supporting rib includes: a second radial rib and a second annular rib. There are multiple second radial ribs and they are spaced apart along the circumference of the second annular plate. The second radial ribs extend radially along the second annular plate, and the second annular ribs extend circumferentially along the second annular plate. The second annular ribs are connected to the multiple second radial ribs.

13. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 12, 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.

14. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 9, 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 claim 6, characterized in that, The first disk section and the second disk section are arranged symmetrically or asymmetrically.

16. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, 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.

17. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 16, characterized in that, The connecting part of the conveying device is constructed as a connecting block, and the surface of the connecting block is provided with anti-slip texture.

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