Double-disk-shaped integrally-formed degradable atrial septal oval foramen occluder

Abstract

Disclosed in the present application is a double-disk-shaped integrally-formed degradable atrial septal oval foramen occluder (100). The occluder (100) comprises: a first disk part (10), a second disk part (20), and an occluding part (30), wherein the first disk part (10) and the second disk part (20) are connected to two axial ends of the occluding part (30), the first disk part (10), the second disk part (20), and the occluding part (30) are integrally-formed parts, and the first disk part (10) and the second disk part (20) are both elastic parts capable of automatically restoring the original shape. At least a portion of at least one of the first disk part (10) and the second disk part (20) is an inverted-cone-shaped ring, and the inverted-cone-shaped ring extends from the center to an edge in a direction away from the center of the double-disk-shaped integrally-formed degradable atrial septal oval foramen occluder (100).

Description

Double-disc integrally-formed degradable heart atrial septal oval foramen occluder

[0001] Cross-reference to Related Applications

[0002] The present application is based on the Chinese patent application with the application number 202410451741.5 and the application date of April 15, 2024, and the Chinese patent application with the application number 202420776724.4 and the application date of April 15, 2024, and claims the priority of the above-mentioned Chinese patent applications, the entire contents of the above-mentioned Chinese patent applications are hereby incorporated by reference into the present application. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, in particular to a double-disc integrally-formed degradable heart atrial septal oval foramen occluder. BACKGROUND

[0004] The oval foramen is a physiological channel of the heart atrial septum during the embryonic period. After birth, the secondary septum and the primary septum of the atrial septum of most people are mutually adhered and fused to form a permanent atrial septum in about 5-7 months. If they are not fused, a patent foramen ovale (PFO) is formed. Because the flow rate of PFO is too small, it has been believed for a long time that PFO will not cause clinical consequences. In recent years, more and more studies have found that the risk of stroke, migraine, peripheral arterial embolism, decompression disease, etc. in PFO patients is several times higher than that in normal people, and the pathogenic effect of PFO has attracted the attention of experts and scholars. Clinical exploration is carried out to close PFO to prevent recurrent events of stroke, treat migraine and orthodeoxia-gravity hypoxemia, etc.

[0005] The method of treating patent foramen ovale of the atrial septum by minimally invasive intervention has been very mature. Compared with traditional surgery, minimally invasive intervention is a modern high-tech minimally invasive treatment. Through femoral vein puncture, under the guidance of medical imaging equipment, a guide wire is inserted along the femoral vein, inferior vena cava and into the right atrium, and then the guide wire is passed through the atrial septal defect into the left atrium. Then a delivery catheter is placed in the atrial septal defect along the guide wire, and finally an atrial septal defect occluder is pushed into the delivery catheter to the atrial septal defect for occlusion treatment. Such minimally invasive intervention has the advantages of no incision, small trauma, few complications, fast recovery, good effect, wide range of indications and relatively low operation cost.

[0006] The treatment method of implanting an atrial septal defect occluder through minimally invasive interventional surgery has many advantages over traditional surgical operation. However, since the main body support of the atrial septal defect occluder used in the clinic is mainly made of nickel-titanium alloy wire, and since this kind of metal material cannot be degraded in the human body, long-term implantation will cause inflammation, blood coagulation and other reactions with human tissues, and even a certain degree of damage, so there are certain defects, and the following use risks still exist: (1) nickel-titanium alloy is a non-degradable metal alloy material, although its biocompatibility has been demonstrated, but the long-term risk of long-term permanent implantation cannot be completely controlled; (2) since the nickel-titanium alloy is permanently implanted and non-degradable, the permanent retention of the heart may affect the development of the heart of the growing child; (3) nickel precipitation, nickel allergy and other complications still have no clear scientific evidence.

[0007] After the surface of the heart occluder is completely endothelialized and the heart defect is repaired by the body's own tissue, the heart occluder has no need to remain in the body. Therefore, the ideal heart occluder should provide a temporary bridge for the heart to repair itself, allowing the self-cell tissue to climb and grow, and be degraded by the body after completing the mission, so that the defect is completely repaired by the self-tissue, thereby avoiding the long-term complications and safety hazards caused by the metal remaining in the body. The occluder widely used in the clinic is a woven metal-nonwoven fabric occluder based on the Amplatzer occluder, which is gradually optimized, and the material is mainly nickel-titanium alloy or other metals and non-degradable nonwoven fabric. It not only has no biodegradation performance and needs to be permanently retained in the human body, but also has the disadvantages of high stress, metal corrosion, nickel poisoning and other unavoidable disadvantages.

[0008] Application content

[0009] The present application aims to at least solve one of the technical problems in the related art. To this end, one object of the present application is to provide a double-disc integrally formed degradable heart atrial septal oval foramen occluder, which is an integrally formed degradable member, which can avoid the long-term complications and safety hazards caused by the metal remaining in the body.

[0010] According to an embodiment of the present application, a double-disc-shaped, one-piece, degradable cardiac atrial septum foramen ovale occluder comprises: a first disc portion, a second disc portion, and a closure portion, wherein the first disc portion and the second disc portion are connected to the axial ends of the closure portion, the first disc portion, the second disc portion, and the closure portion are an integrally formed part, and are degradable parts; the first disc portion and the second disc portion are both elastic parts that can automatically restore their original shape; at least a portion of at least one of the first disc portion and the second disc portion is in the form of an inverted conical ring, and the inverted conical ring extends from the center to the edge toward a direction away from the center of the double-disc-shaped, one-piece, degradable cardiac atrial septum foramen ovale occluder.

[0011] According to the double-disc-shaped one-piece degradable heart atrial septum oval foramen occluder of the embodiment of the present application, the occluder is an one-piece degradable part. The occluder provides a temporary bridge for the heart to repair itself, allowing its own cell tissue to climb and grow, and then be degraded and absorbed in the body. It can avoid long-term complications and safety hazards caused by metal retention in the body. The occluder has strong structural integrity, and the occluder degrades at a uniform rate in the human body without the risk of structural disintegration. It can overcome all the shortcomings of existing braided structure occluders and simplify surgical operations. By setting the first disc part or the second disc part away from each other, the situation where the first disc part or the second disc part obstructs the heart atrial septum oval foramen ovale can be reduced, thereby improving work reliability.

[0012] In addition, the double-disc-shaped integrally formed degradable cardiac atrial septal foramen ovale occluder according to the above embodiment of the present application may also have the following additional technical features:

[0013] At least a portion of the first disc portion is in the form of an inverted conical ring, and at least a portion of the second disc portion is in the form of an inverted conical ring. The portion of the first disc portion in the form of 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 in the form of 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 edge of the first disc portion and the outer edge of the second disc portion is L2, and L2>L1.

[0014] One of the first disc portion and the second disc portion is in the shape of an inverted conical ring, and the other of the first disc portion and the second disc portion is in the shape of a conical ring.

[0015] The axes of the first disc portion, the second disc portion and the blocking portion are all arranged in parallel.

[0016] The first disc part comprises a first annular plate, and the second disc part comprises a second annular plate; the first annular plate comprises a first inner ring segment and a first outer ring segment connected to each other, the first inner ring segment is annular, an inner edge of the first inner ring segment is connected to the occlusion part, and the first inner ring segment is arranged to extend towards the second disc part; the first outer ring segment is annular, an inner edge of the first outer ring segment is connected to an outer edge of the first inner ring segment, and the first outer ring segment gradually moves away from the second disc part in a direction away from the center of the occlusion part in the radial direction of the occlusion part; the second annular plate comprises a second inner ring segment and a second outer ring segment connected to each other, the second inner ring segment is annular, an inner edge of the second inner ring segment is connected to the occlusion part, and the second inner ring segment is arranged to extend towards the first disc part; the second outer ring segment is annular, an inner edge of the second outer ring segment is connected to an outer edge of the second inner ring segment, and the second outer ring segment gradually moves away from the first disc part in a direction away from the center of the occlusion part in the radial direction of the occlusion part.

[0017] The first disc part comprises a first annular plate, and the second disc part comprises a second annular plate; the first annular plate comprises a first inner ring segment and a first outer ring segment connected to each other, the first inner ring segment is annular, an inner edge of the first inner ring segment is connected to the occlusion part, and the first inner ring segment is arranged to extend towards the second disc part; the first outer ring segment is annular, an inner edge of the first outer ring segment is connected to an outer edge of the first inner ring segment, and the first outer ring segment gradually moves away from the second disc part in a direction away from the center of the occlusion part in the radial direction of the occlusion part; the second annular plate comprises a second inner ring segment and a second outer ring segment connected to each other, the second inner ring segment is annular, an inner edge of the second inner ring segment is connected to the occlusion part, and the second inner ring segment is arranged to extend towards the first disc part; the second outer ring segment is annular, an inner edge of the second outer ring segment is connected to an outer edge of the second inner ring segment, and the second outer ring segment gradually moves away from the first disc part in a direction away from the center of the occlusion part in the radial direction of the occlusion part.

[0018] The first annular plate and the second annular plate are circular, circular-like or polygonal in cross-sectional shape perpendicular to the axial direction of the occlusion part.

[0019] The first disc part further comprises a first support rib arranged on the first annular plate and used for supporting the first annular plate to restore its original shape; and the second disc part further comprises a second support rib arranged on the second annular plate and used for supporting the second annular plate to restore its original shape.

[0020] The first annular plate has a first inner surface and a first outer surface opposite to each other, the first inner surface is arranged towards the second disc part, and the first support rib protrudes from at least one of the first inner surface and the first outer surface; and the second annular plate has a second inner surface and a second outer surface opposite to each other, the second inner surface is arranged towards the first disc part, and the second support rib protrudes from at least one of the second inner surface and the second outer surface.

[0021] The first support ribs comprise first radial ribs, and the first radial ribs are multiple and arranged along the circumference of the first annular plate, and the first radial ribs extend along the radial direction of the first annular plate; the second support ribs comprise second radial ribs, and the second radial ribs are multiple and arranged along the circumference of the second annular plate, and the second radial ribs extend along the radial direction of the second annular plate.

[0022] The inner ends of the first radial ribs are connected with the blocking part, and the outer ends of the first radial ribs extend to the outer edge of the first annular plate or are spaced from the outer edge of the first annular plate; the inner ends of the second radial ribs are connected with the blocking part, and the outer ends of the second radial ribs extend to the outer edge of the second annular plate or are spaced from the outer edge of the second annular plate.

[0023] The first support ribs comprise first annular ribs, and the first annular ribs extend along the circumference of the first annular plate; the second support ribs comprise second annular ribs, and the second annular ribs extend along the circumference of the second annular plate.

[0024] The first support ribs comprise first radial ribs and first annular ribs, the first radial ribs are multiple and arranged along the circumference of the first annular plate, and the first radial ribs extend along the radial direction of the first annular plate, and the first annular ribs extend along the circumference of the first annular plate, and the first annular ribs are connected with the multiple first radial ribs; the second support ribs comprise second radial ribs and second annular ribs, the second radial ribs are multiple and arranged along the circumference of the second annular plate, and the second radial ribs extend along the radial direction of the second annular plate, and the second annular ribs extend along the circumference of the second annular plate, and the second annular ribs are connected with the multiple second radial ribs.

[0025] At least one of the first annular ribs is arranged on the outer edge of the first annular plate, and the outer ends of the multiple first radial ribs are connected with the first annular rib arranged on the outer edge of the first annular plate; at least one of the second annular ribs is arranged on the outer edge of the second annular plate, and the outer ends of the multiple second radial ribs are connected with the second annular rib arranged on the outer edge of the second annular plate.

[0026] The first radial ribs comprise 1-100 first radial ribs; and the second radial ribs comprise 1-100 second radial ribs.

[0027] The first disc part and the second disc part are symmetrically arranged or asymmetrically arranged.

[0028] The occluder further comprises a delivery device connecting part formed at one axial end of the blocking part, and the delivery device connecting part is adapted to be connected with a pushing assembly in an occluder delivery device.

[0029] The delivery device connecting portion is configured as a connecting block, and the surface of the connecting block is provided with anti-skid lines.

[0030] Additional aspects and advantages of the present application will be in part apparent and in part pointed out below. BRIEF DESCRIPTION OF DRAWINGS

[0031] The above and / or additional aspects and advantages of the present application will become apparent and be readily appreciated from the following description, including the appended drawings, wherein:

[0032] Fig. 1 is a structural schematic view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to one embodiment of the present application;

[0033] Fig. 2 is a sectional view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to another embodiment of the present application.

[0034] Reference signs: 100-occluder; 10-first disc portion; 11-first annular plate; 111-first inner ring segment; 112-first outer ring segment; 12-first support rib; 121-first radial rib; 122-first annular rib; 20-second disc portion; 21-second annular plate; 211-second inner ring segment; 212-second outer ring segment; 22-second support rib; 221-second radial rib; 222-second annular rib; 30-occluding portion; 40-delivery device connecting portion. DETAILED DESCRIPTION

[0035] Embodiments of the present application are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference signs represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by reference to the accompanying drawings are exemplary and are intended to explain the present application, and cannot be understood as limiting the present application.

[0036] A double-disc integrally formed degradable heart atrial septal oval foramen occluder 100 according to some embodiments of the present application is described below with reference to Figs. 1 and 2.

[0037] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiment of the present application is a degradable member, which can be at least one of a degradable high polymer material member, a degradable metal material member, a bioceramic member, and a bioglass member. The occluder 100 includes a first disc portion 10, a second disc portion 20, and an occlusion portion 30. The first disc portion 10 and the second disc portion 20 are connected to the axial two ends of the occlusion portion 30. The occlusion portion 30 penetrates the atrial septum to occlude the patent foramen ovale. The first disc portion 10 and the second disc portion 20 are respectively located on the two sides of the patent foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 jointly clamp the heart atrium wall. The first disc portion 10, the second disc portion 20, and the occlusion portion 30 are integrally-formed members, and the first disc portion 10 and the second disc portion 20 are both elastic members that can automatically restore to the original state.

[0038] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiment of the present application is a degradable member, which can be at least one of a degradable high polymer material member, a degradable metal material member, a bioceramic member, and a bioglass member. The occluder 100 includes a first disc portion 10, a second disc portion 20, and an occlusion portion 30. The first disc portion 10 and the second disc portion 20 are connected to the axial two ends of the occlusion portion 30. The occlusion portion 30 penetrates the atrial septum to occlude the patent foramen ovale. The first disc portion 10 and the second disc portion 20 are respectively located on the two sides of the patent foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 jointly clamp the heart atrium wall. The first disc portion 10, the second disc portion 20, and the occlusion portion 30 are integrally-formed members, and the first disc portion 10 and the second disc portion 20 are both elastic members that can automatically restore to the original state.

[0039] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiment of the present application is a degradable member, which can be at least one of a degradable high polymer material member, a degradable metal material member, a bioceramic member, and a bioglass member. The occluder 100 includes a first disc portion 10, a second disc portion 20, and an occlusion portion 30. The first disc portion 10 and the second disc portion 20 are connected to the axial two ends of the occlusion portion 30. The occlusion portion 30 penetrates the atrial septum to occlude the patent foramen ovale. The first disc portion 10 and the second disc portion 20 are respectively located on the two sides of the patent foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 jointly clamp the heart atrium wall. The first disc portion 10, the second disc portion 20, and the occlusion portion 30 are integrally-formed members, and the first disc portion 10 and the second disc portion 20 are both elastic members that can automatically restore to the original state.

[0040] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiment of the present application is a degradable member, which can be at least one of a degradable high polymer material member, a degradable metal material member, a bioceramic member, and a bioglass member. The occluder 100 includes a first disc portion 10, a second disc portion 20, and an occlusion portion 30. The first disc portion 10 and the second disc portion 20 are connected to the axial two ends of the occlusion portion 30. The occlusion portion 30 penetrates the atrial septum to occlude the patent foramen ovale. The first disc portion 10 and the second disc portion 20 are respectively located on the two sides of the patent foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 jointly clamp the heart atrium wall. The first disc portion 10, the second disc portion 20, and the occlusion portion 30 are integrally-formed members, and the first disc portion 10 and the second disc portion 20 are both elastic members that can automatically restore to the original state.

[0041] In addition, compared with the occluder in the prior art, which is woven by a nickel-titanium alloy wire into a net frame and then covered with a resistance film, the occluder 100 is an elastic member, and the occluder 100 can be deformed into a smaller volume, so that the occluder 100 can be delivered by a sheath with a smaller diameter, thereby reducing the risk of surgery. When the occluder 100 is sent out from the sheath, the occluder 100 can automatically restore to the original shape, so that a driving member for restoring the occluder 100 to the original shape does not need to be additionally arranged, the manufacturing cost can be reduced, and the operation of the surgery can be simplified.

[0042] At least part of at least one of the first disc part 10 and the second disc part 20 is an inverted conical ring extending from the center to the edge towards the direction away from the center of the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100.

[0043] It is worth noting that the first disc part 10 and the second disc part 20 are respectively connected at both ends of the length direction of the occlusion part 30, so the center position of the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 is the middle part of the occlusion part 30.

[0044] When at least part of the first disc part 10 is an inverted conical ring, the conical ring extends from the center to the edge towards the direction away from the second disc part 20; when at least part of the second disc part 20 is an inverted conical ring, the conical ring extends from the center to the edge towards the direction away from the first disc part 10.

[0045] By arranging the first disc part 10 or the second disc part 20 away from each other, the first disc part 10 or the second disc part 20 can avoid shielding the occlusion part 30, the situation that the first disc part 10 or the second disc part 20 forms an obstacle to the heart atrial septal patent foramen ovale can be reduced, and the working reliability of the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 can be improved.

[0046] According to the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100, the occluder 100 is an integrally-formed degradable member, the occluder 100 provides a temporary bridge for the self-repair of the heart, so that the self-cell tissue can climb and grow, and then be degraded and absorbed in the body. The long-term complications and safety hazards caused by the metal remaining in the body can be avoided, the structural integrity of the occluder 100 is strong, the degradation rate of the occluder 100 in the human body is uniform, and there is no risk of structural disintegration, all the shortcomings of the existing woven structure occluder 100 can be overcome, and the operation of the surgery can be simplified. By arranging the first disc part 10 or the second disc part 20 away from each other, the situation that the first disc part 10 or the second disc part 20 forms an obstacle to the heart atrial septal patent foramen ovale can be reduced, and the working reliability can be improved.

[0047] In some embodiments of the present application, as shown in FIGS. 1 and 2, at least a portion of the first disc portion 10 is an inverted conical ring, at least a portion of the second disc portion 20 is an inverted conical ring, the portion of the first disc portion 10 that is an inverted conical ring is arranged to extend from the center to the edge in a direction away from the second disc portion 20, and the portion of the second disc portion 20 that is an inverted conical ring is arranged to extend from the center to the edge in a direction away from the first disc portion 10. The axial dimension of the blocking portion 30 is L1, the distance between the outer edge of the first disc portion 10 and the outer edge of the second disc portion 20 is L2, and L2>L1.

[0048] The first disc portion 10 and the second disc portion 20 are both inverted conical rings, and the first disc portion 10 and the second disc portion 20 are arranged in a mutually facing away reverse buckle shape. By arranging the first disc portion 10 and the second disc portion 20 to face away from each other, the first disc portion 10 and the second disc portion 20 can be prevented from obstructing the blocking portion 30, and the occurrence of the first disc portion 10 or the second disc portion 20 obstructing the formation of the interatrial septal foramen of the heart can be reduced, thereby improving the working reliability of the double-disc integrally formed degradable interatrial septal foramen occluder 100.

[0049] In other embodiments of the present application, 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.

[0050] One of the first disc portion 10 and the second disc portion 20 is arranged to be inwardly buckled towards the middle position of the blocking portion 10, and the other of the first disc portion 10 and the second disc portion 20 is arranged to extend away from the middle position of the blocking portion 10, which also falls within the scope of protection of the present application.

[0051] In some embodiments of the present application, the axes of the first disc portion 10, the second disc portion 20, and the blocking portion 30 are all arranged in parallel.

[0052] The parallel arrangement of the axes helps the occluder 100 to better adapt to the structure inside the heart, thereby achieving a more precise occlusion effect and reducing the possibility of blood leakage from the foramen ovale. The design of parallel axes makes the operation of the occluder 100 more intuitive and simple, and doctors can more easily place the occluder 100 to the correct position and ensure its stability during the operation.

[0053] In some embodiments of the present application, as shown in FIGS. 1 and 2, the first disc part 10 comprises a first annular plate 11 configured as a main body of the first disc part 10, which defines a main body profile of the first disc part 10, and the inner end of the first annular plate 11 is connected to the occlusion part 30 around the axis of the occlusion part 30, and the first annular plate 11 is configured as an annular structure. Similarly, the second disc part 20 comprises a second annular plate 21 configured as a main body of the second disc part 20, which defines a main body profile of the second disc part 20, and the inner end of the second annular plate 21 is also connected to the occlusion part 30 around the axis of the occlusion part 30, and the second annular plate 21 is also configured as an annular structure.

[0054] The first annular plate 11 and the second annular plate 21 are in abutment with the heart atrial wall around the occlusion part 30, which can block the blood impact and improve the working reliability of the occlusion device 100, and the first annular plate 11 and the second annular plate 21 provide complete support, so that the atrial septal defect can be occluded after the cell tissue climbs and grows, and the repair effect is improved.

[0055] In some embodiments, as shown in FIG. 2, the first annular plate 11 comprises a first inner annular segment 111 and a first outer annular segment 112, both of which are annular, the first inner annular segment 111 is closer to the occlusion part 30 than the first outer annular segment 112, the inner edge of the first inner annular segment 111 is connected to the occlusion part 30, and the first inner annular segment 111 extends towards the second disc part 20; the inner edge of the first outer annular segment 112 is connected to the outer edge of the first inner annular segment 111, and the first outer annular segment 112 gradually moves away from the second disc part 20 in a direction away from the center of the occlusion part 30 in the radial direction of the occlusion part 30.

[0056] By providing the first outer annular segment 112, the first disc part 10 is configured as a structure that is first inwardly buckled and then outwardly turned, so that the spacing L2 between the outer edge of the first disc part 10 and the outer edge of the second disc part 20 is greater than the axial dimension L1 of the occlusion part 30. It is worth noting that the first inner annular segment 111 extends towards the second disc part 20, and the first outer annular segment 112 extends away from the second disc part 20, and the first disc part 10 is configured as a structure that is first inwardly buckled and then outwardly turned, which can form a transitional structure on the first disc part 10, the first disc part 10 is more likely to automatically recover to its original state, and the working reliability of the first disc part 10 is improved.

[0057] Similarly, the second annular plate 21 comprises a second inner ring segment 211 and a second outer ring segment 212, both of which are annular, the second inner ring segment 211 is closer to the blocking part 30 than the second outer ring segment 212, the inner edge of the second inner ring segment 211 is connected to the blocking part 30, and the second inner ring segment 211 extends towards 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, and the second outer ring segment 212 gradually moves away from the first disc part 10 in a direction away from the center of the blocking part 30 in the radial direction of the blocking part 30.

[0058] By arranging the second outer ring segment 212, the second disc part 20 is configured as a structure that is buckled inwards away from the first disc part 10, so that the spacing L2 between the outer edge of the first disc part 10 and the outer edge of the second disc part 20 is greater than the axial dimension L1 of the blocking part 30. By arranging the second inner ring segment 211, which extends towards the first disc part 10, and the second outer ring segment 212, which extends away from the first disc part 10, the second disc part 20 is configured as a structure that is first buckled inwards and then turned outwards, a transitional structure can be formed on the second disc part 20, the second disc part 20 is more likely to automatically recover to its original state, and the working reliability of the second disc part 20 is improved.

[0059] In some embodiments of the present application, the cross-sectional shape of the first inner ring segment 111 and the first outer ring segment 112 in the axial direction of the blocking part 30 is arc-shaped, and the cross-sectional shape of the second inner ring segment 211 and the second outer ring segment 212 in the axial direction of the blocking part 30 is arc-shaped. The stress concentration points at the first annular plate 11 and the second annular plate 21 can be reduced, the first disc part 10 and the second disc part 20 are more likely to deform and automatically recover to their original states, and the working reliability of the first disc part 10 and the second disc part 20 is improved.

[0060] In some embodiments of the present application, the inner edge of the first inner ring segment 111 is connected to the blocking part 30 in a circular arc transition, and the inner edge of the second inner ring segment 211 is connected to the blocking part 30 in a circular arc transition. The stress at the connection between the first annular plate 11 and the blocking part 30 can be reduced, the stress at the connection between the first annular plate 11 and the blocking part 30 can be reduced, the occurrence of fracture damage of the first disc part 10 and the second disc part 20 can be reduced, and the working reliability of the first disc part 10 and the second disc part 20 is improved.

[0061] In some embodiments of the present application, as shown in FIG. 2, the first inner ring segment 111 and the first outer ring segment 112 are connected by a circular arc transition, and the second inner ring segment 211 and the second outer ring segment 212 are connected by a circular arc transition. The smooth transition of the first inner ring segment 111 and the first outer ring segment 112 and the smooth transition of the second inner ring segment 211 and the second outer ring segment 212 can reduce stress concentration on the first annular plate 11 and the second annular plate 21, reduce the occurrence of fracture damage of 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.

[0062] In some embodiments of the present application, 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 have a circular, circular-like, or polygonal cross-sectional shape perpendicular to the axial direction of the occlusion part 30. The first inner ring segment 111 and the first outer ring segment 112 can have the same cross-sectional shape perpendicular to the axial direction of the occlusion part 30, or different cross-sectional shapes perpendicular to the axial direction of the occlusion part 30; the second inner ring segment 211 and the second outer ring segment 212 can have the same cross-sectional shape perpendicular to the axial direction of the occlusion part 30, or different cross-sectional shapes perpendicular to the axial direction of the occlusion part 30.

[0063] In some embodiments of the present application, as shown in FIG. 1, the first disc part 10 includes the first annular plate 11, which gradually extends away from the second disc part 20 in a direction away from the center of the occlusion part 30 in the radial direction of the occlusion part 30; the second disc part 20 includes the second annular plate 21, which gradually extends away from the first disc part 10 in a direction away from the center of the occlusion part 30 in the radial direction of the occlusion part 30.

[0064] The first annular plate 11 is configured as a main part of the first disc part 10, and the first annular plate 11 is integrally arranged to extend away from the second disc part 20; the second annular plate 12 is configured as a main part of the second disc part 20, and the second annular plate 12 is integrally arranged to extend away from the first disc part 10. This can avoid the first disc part 10 and the second disc part 20 from interfering with the occlusion part 30, reduce the occurrence of interference of the first disc part 10 or the second disc part 20 with the heart atrial septal foramen, and improve the working reliability of the double-disc integrally formed degradable heart atrial septal foramen occluder 100.

[0065] In some embodiments of the present application, the first annular plate 11 and the second annular plate 21 have a circular, circular-like, or polygonal cross-sectional shape perpendicular to the axial direction of the occlusion part 30. 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 of the affected area to fit the affected area.

[0066] It is worth mentioning that the occluder 100 of the embodiments of the present application can directly trim the first annular plate 11 or the second annular plate 21, so that the shapes of the first disc part 10 and the second disc part 20 fit the affected area. Since the occluder 100 of the embodiments of the present application 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 part 10 and the second disc part 20, and the first disc part 10 and the second disc part 20 can work normally. Therefore, the present application can support custom trimming, the occluder 100 can be personalized, has strong pertinence, is beneficial to improve the repair effect, and can save the manufacturing cost of custom parts.

[0067] In some embodiments of the present application, the projection areas of the first annular plate 11 and the second annular plate 21 in the axial direction of the occlusion part 30 are independently 5mm2-2000mm2.

[0068] Alternatively, the projection area of the first annular plate 11 in the axial direction of the occlusion part 30 can be 5mm2, 55mm2, 100mm2, 500mm2, 900mm2, 1000mm2, 1500mm2, 2000mm2, etc.

[0069] Alternatively, the projection area of the second annular plate 21 in the axial direction of the occlusion part 30 can be 5mm2, 55mm2, 100mm2, 500mm2, 900mm2, 1000mm2, 1500mm2, 2000mm2, etc.

[0070] In some embodiments of the present application, as shown in FIGS. 1 and 2, the first disc part 10 further comprises a first support rib 12 provided on the first annular plate 11, and the first support rib 12 is used to support the first annular plate 11 to restore to its original shape. The second disc part 20 further comprises a second support rib 22 provided on the second annular plate 21, and the second support rib 22 is used to support the second annular plate 21 to restore to its original shape.

[0071] The design of the first disc part 10 and the second disc part 20 takes into account the stability and functionality of the structure. By respectively providing the first support rib 12 and the second support rib 22 on the first annular plate 11 and the second annular plate 21, these support ribs play a key role to ensure that the annular plate can restore to its original shape after deformation. The speed of restoring the first annular plate 11 to its original shape and the speed of restoring the second annular plate 21 to its original shape can be improved, and the situation that the first annular plate 11 and the second annular plate 21 are blocked and cannot completely restore to their original shapes can be reduced, which is beneficial to the release of the occluder 100, improves the working reliability of the occluder 100, and improves the operation efficiency.

[0072] And the design of the support ribs also helps to improve the performance of the entire occluder 100. When the first annular plate 11 and the second annular plate 21 need to be closely attached to the affected area or other parts that need to be occluded, the support ribs can ensure that the annular plates maintain appropriate tension and shape, thereby achieving more accurate and effective occlusion.

[0073] In some embodiments of the present application, the first annular plate 11 has a first inner surface and a first outer surface facing away from each other, the first inner surface is arranged towards the second disc part 20, and the first support rib 12 protrudes 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 is arranged towards the first disc part 10, and the second support rib 22 protrudes from at least one of the second inner surface and the second outer surface.

[0074] It is worth noting that the inner and outer 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 above-mentioned inner edge, outer edge and other structures. The first disc part 10 and the second disc part 20 are connected at the axial ends of the occlusion part 30, the first inner surface and the second inner surface are arranged opposite in the axial direction of the occluder 100, and the first outer surface and the second outer surface are arranged opposite in the axial direction of the occluder 100.

[0075] The first support rib 12 can only protrude from the first inner surface or the first outer surface of the first annular plate 11; or the first support rib 12 can protrude from both the first inner surface and the first outer surface. The second support rib 22 can only protrude from the second inner surface or only protrude from the second outer surface; or the second support rib 22 can protrude from both the second outer surface and the second inner surface.

[0076] In some embodiments of the present application, optionally, the first support rib 12 can only include a plurality of first radial ribs 121, the first radial ribs 121 are arranged in a circumferential direction of the first annular plate 11 and extend in a radial direction of the first annular plate 11; and the second support rib 22 only includes a plurality of second radial ribs 221, the second radial ribs 221 are arranged in a circumferential direction of the second annular plate 21 and extend in a radial direction of the second annular plate 21.

[0077] When the first disc part 10 is compressed and deformed, the first radial rib 121 has a tendency to support the first annular plate 11 to restore its original shape, and after the extrusion on the first disc part 10 is cancelled, 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 part 20 is compressed and deformed, the second radial rib 221 has a tendency to support the second annular plate 21 to restore its original shape, and after the extrusion on the second disc part 20 is cancelled, the second radial rib 221 can support the second annular plate 21 to expand radially and restore its original shape.

[0078] The first radial ribs 121 are multiple and are arranged at intervals along the circumference of the first annular plate 11, the first annular plate 11 is uniformly stressed, which is conducive to the first annular plate 11 to restore its original shape; the second radial ribs 221 are multiple and are arranged at intervals along the circumference of the second annular plate 21, the second annular plate 21 is uniformly stressed, which is conducive to the second annular plate 21 to restore its original shape.

[0079] In some embodiments of the present application, the inner ends of the first radial ribs 121 are connected with the blocking part 30, and the outer ends of the first radial ribs 121 extend to the outer edge of the first annular plate 11 or are spaced apart from the outer edge of the first annular plate 11; the inner ends of the second radial ribs 221 are connected with the blocking part 30, and the outer ends of the second radial ribs 221 extend to the outer edge of the second annular plate 21 or are spaced apart from the outer edge of the second annular plate 21.

[0080] The inner ends of the first radial ribs 121 are connected with the blocking part 30, which can improve the structural strength of the first radial ribs 121 and is conducive to supporting the first annular plate 11 to restore its original shape; the inner ends of the second radial ribs 221 are connected with the blocking part 30, which can improve the structural strength of the second radial ribs 221 and is conducive to supporting the second annular plate 22 to restore its original shape.

[0081] In some embodiments of the present application, the first support rib 12 can only include the first annular rib 122, and the first annular rib 122 extends along the circumference of the first annular plate 11; the second support rib 22 only includes the second annular rib 222, and the second annular rib 222 extends along the circumference of the second annular plate 21.

[0082] When the first disc part 10 is compressed and deformed, the first annular rib 122 has a tendency to support the first annular plate 11 to restore its original shape, and after the extrusion on the first disc part 10 is cancelled, the first annular rib 122 can support the first annular plate 11 to expand circumferentially and restore its original shape; similarly, when the second disc part 20 is compressed and deformed, the second annular rib 222 has a tendency to support the second annular plate 21 to restore its original shape, and after the extrusion on the second disc part 20 is cancelled, the second annular rib 222 can support the second annular plate 21 to expand circumferentially and restore its original shape.

[0083] Alternatively, the first annular rib 122 can be one, and alternatively, the first annular rib 122 can also be multiple, and multiple first annular ribs 122 are arranged at intervals along the extension direction of the inner edge to the outer edge of the first annular plate 11. Alternatively, the second annular rib 222 can be one, and alternatively, the second annular rib can also be multiple, and multiple second annular ribs 222 are arranged at intervals along the extension direction of the inner edge to the outer edge of the second annular plate 21.

[0084] In some embodiments of the present application, the first annular rib 122 has a circular, sector, triangular or composite geometric cross section; and the second annular rib 222 has a circular, sector, triangular or composite geometric cross section.

[0085] In some embodiments of the present application, as shown in FIG. 1, the first support rib 12 includes first radial ribs 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 along the radial direction of the first annular plate 11, the first annular rib 122 extends along the circumferential direction of the first annular plate 11, and the first annular rib 122 is connected to the plurality of first radial ribs 121; and the second support rib 22 includes second radial ribs 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 along the radial direction of the second annular plate 21, the second annular rib 222 extends along the circumferential direction of the second annular plate 21, and the second annular rib 222 is connected to the plurality of second radial ribs 221.

[0086] The first annular rib 122 is connected to the plurality of first radial ribs 121 to connect the first support rib 12 as a whole, thereby improving the structural stability of the first support rib 12 and facilitating the restoration of the first annular plate 11. Similarly, the second annular rib 222 is connected to the plurality of second radial ribs 221 to connect the second support rib 22 as a whole, thereby improving the structural stability of the second support rib 22 and facilitating the restoration of the second annular plate 21.

[0087] In some embodiments of the present application, as shown in FIG. 1, the first support rib 12 includes first radial ribs 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 along the radial direction of the first annular plate 11, the first annular rib 122 extends along the circumferential direction of the first annular plate 11, and the first annular rib 122 is connected to the plurality of first radial ribs 121; and the second support rib 22 includes second radial ribs 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 along the radial direction of the second annular plate 21, the second annular rib 222 extends along the circumferential direction of the second annular plate 21, and the second annular rib 222 is connected to the plurality of second radial ribs 221.

[0088] In some embodiments of the present application, at least one first annular rib 122 is arranged on the outer edge of the first annular plate 11, and the outer ends of the plurality of first radial ribs 121 are connected to the first annular rib 122 arranged on the outer edge of the first annular plate 11; and at least one second annular rib 222 is arranged on the outer edge of the second annular plate 21, and the outer ends of the plurality of second radial ribs 221 are connected to the second annular rib 222 arranged on the outer edge of the second annular plate 21.

[0089] The first annular rib 122 is arranged on the outer edge of the first annular plate 11, which is conducive to the expansion of the first annular plate 11 and the restoration of the first annular plate 11. Similarly, the second annular rib 222 is arranged on the outer edge of the second annular plate 21, which is conducive to the expansion of the second annular plate 21 and the restoration of the second annular plate 21.

[0090] The outer ends of the plurality of first radial ribs 121 are connected with the first annular rib 122 located on the outer edge of the first annular plate 11, so as to connect the first support rib 12 as a whole, improve the structural stability of the first support rib 12, and facilitate the restoration of the first annular plate 11. The outer ends of the plurality of second radial ribs 221 are connected with the second annular rib 222 located on the outer edge of the second annular plate 21, so as to connect the second support rib 22 as a whole, improve the structural stability of the second support rib 22, and facilitate the restoration of the first annular plate 11.

[0091] In some embodiments of the present application, the first radial rib 121 includes 1-100; the second radial rib 221 includes 1-100.

[0092] Optionally, the first radial rib 121 can be 1, 5, 6, 8, 10, 12, 20, 50, 100, etc.

[0093] Optionally, the second radial rib 221 can be 1, 5, 6, 8, 10, 16, 30, 50, 100, etc.

[0094] In some embodiments of the present application, the first annular rib 122 includes 1-10, and the second annular rib 222 includes 1-10.

[0095] 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 not conducive to the normal operation of the occluder 100.

[0096] Optionally, the first annular rib 122 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0097] Optionally, the second annular rib 222 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0098] In some embodiments of the present application, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0099] The first disc part 10 and the second disc part 20 are identical in shape, projected area and thickness; the first disc part 10 and the second disc part 20 are identical in number, structure and size of the first radial rib 121 and the second radial rib 221, and identical in number, structure and size of the first annular rib 122 and the second annular rib 222.

[0100] In some embodiments of the present application, the first disc part 10 and the second disc part 20 are asymmetrically arranged.

[0101] Optionally, the first disc part 10 and the second disc part 20 are different in number, structure and size of the first radial rib 121 and the second radial rib 221; or, optionally, the first disc part 10 and the second disc part 20 are different in number, structure and size of the first annular rib 122 and the second annular rib 222.

[0102] In some embodiments of the present application, as shown in FIG. 1 and FIG. 2, the occluder 100 further comprises a delivery device connecting part 40, which is integrally formed at an axial end of the occlusion part 30, and is adapted to be connected with a pushing assembly in a delivery device of the occluder 100.

[0103] The pushing assembly is selectively connected with the delivery device connecting part 40, and when the pushing assembly is connected with the delivery device connecting part 40, the pushing assembly can drive the occluder 100 to move, and when the pushing assembly is separated from the delivery device connecting part 40, the pushing assembly can be recycled.

[0104] In some embodiments of the present application, the delivery device connecting part 40 can be a hole, a pit or a protruding structure, and the pushing assembly is connected with the delivery device connecting part 40 in a matching manner. Optionally, the hole, the pit or the protruding structure can be in a circular, elliptical, triangular, or composite geometric shape; the hole can be a through structure, and the pit or the protruding structure can be a non-through structure, and the protruding structure can be a flat protrusion or a cylindrical protrusion.

[0105] In some embodiments of the present application, the delivery device connecting part 40 is configured as a connecting block, and the surface of the connecting block is provided with an anti-skid pattern, which can improve the surface friction of the connecting block, further improve the connection stability of the pushing assembly and the connecting block, and improve the working reliability of the occluder 100.

[0106] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0107] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0108] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be broadly understood, for example, can be fixedly connected, or can be detachably connected, or can be integrated; can be directly connected, or can be indirectly connected through an intermediate medium; can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0109] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be direct contact between the first and second features, or indirect contact between the first and second features through an intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be directly above or obliquely above the first feature, or only indicate that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "below" and "below" the second feature can be directly below or obliquely below the first feature, or only indicate that the horizontal height of the first feature is less than that of the second feature.

[0110] In the description of the specification, the description of the terms "one embodiment", "some embodiments", "an example", "a specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are contained in at least one embodiment or example of the present application. In the specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any appropriate manner in any one or more embodiments or examples. In addition, the person skilled in the art can combine and combine the different embodiments or examples described in the specification and the features of the different embodiments or examples without contradiction.

[0111] Although the embodiments of the present application have been shown and described above, it is understood that the above-described embodiments are exemplary and are not to be construed as limiting the present application, and the person skilled in the art can make changes, modifications, replacements and variations to the above-described embodiments within the scope of the present application.

Claims

1. A bi- discoid integrally formed degradable heart atrial septal patent foramen ovale occluder, wherein, The application relates to a double-disc integrated and formed degradable heart atrial septal oval foramen occluder. The first disc part and the second disc part are connected at the axial two ends of the occlusion part, the first disc part, the second disc part and the occlusion part are an integrated and formed piece and are degradable pieces; the first disc part and the second disc part are elastic pieces which can automatically restore original shapes. At least part of at least one of the first disc part and the second disc part is an inverted conical ring which is arranged to extend from the center to the edge in a direction away from the center of the double-disc integrated and formed degradable heart atrial septal oval foramen occluder.

2. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, At least part of the first disc part is an inverted conical ring, at least part of the second disc part is an inverted conical ring, the part of the first disc part in the inverted conical ring is arranged to extend from the center to the edge in a direction away from the second disc part, and the part of the second disc part in the inverted conical ring is arranged to extend from the center to the edge in a direction away from the first disc part. The axial dimension of the occlusion part is L1, the spacing between the outer edge of the first disc part and the outer edge of the second disc part is L2, and L2>L1.

3. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, One of the first disc part and the second disc part is an inverted conical ring, and the other of the first disc part and the second disc part is a conical ring.

4. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 2, wherein, The axial lines of the first disc part, the second disc part and the occlusion part are arranged in parallel.

5. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 4, wherein, The first disc part comprises a first annular plate, and the second disc part comprises a second annular plate. The first annular plate comprises a first inner ring segment and a first outer ring segment which are connected, the first inner ring segment is annular, the inner edge of the first inner ring segment is connected to the occlusion part, and the first inner ring segment is arranged to extend in a direction towards the second disc part; the first outer ring segment is annular, the inner edge of the first outer ring segment is connected to the outer edge of the first inner ring segment, and the first outer ring segment gradually moves away from the second disc part in a direction radially away from the center of the occlusion part; The second annular plate comprises a second inner ring segment and a second outer ring segment which are connected, the second inner ring segment is annular, the inner edge of the second inner ring segment is connected to the occlusion part, and the second inner ring segment is arranged to extend in a direction towards the first disc part; the second outer ring segment is annular, the inner edge of the second outer ring segment is connected to the outer edge of the second inner ring segment, and the second outer ring segment gradually moves away from the first disc part in a direction radially away from the center of the occlusion part.

6. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 4, wherein, The first disc part comprises a first annular plate which gradually moves away from the second disc part in a direction radially away from the center of the occlusion part. The second disc part comprises a second annular plate which gradually moves away from the first disc part in a direction radially away from the center of the occlusion part.

7. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 5 or 6, wherein, The first annular plate and the second annular plate are circular, quasi-circular or polygonal in cross-sectional shape perpendicular to the axial direction of the occlusion part.

8. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 7, wherein, The first disc part further comprises a first support rib arranged on the first annular plate, and the first support rib is used for supporting the first annular plate to restore the original shape. The second disc part further comprises a second support rib provided on the second annular plate, and the second support rib is used for supporting the second annular plate to restore the original state.

9. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first annular plate has opposite first inner and outer surfaces, the first inner surface is arranged towards the second disc part, and the first support rib protrudes from at least one of the first inner and outer surfaces. The second annular plate has opposite second inner and outer surfaces, the second inner surface is arranged towards the first disc part, and the second support rib protrudes from at least one of the second inner and outer surfaces.

10. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first support rib comprises a plurality of first radial ribs, the plurality of first radial ribs are arranged at intervals along the circumference of the first annular plate, and the first radial ribs extend along the radial direction of the first annular plate. The second support rib comprises a plurality of second radial ribs, the plurality of second radial ribs are arranged at intervals along the circumference of the second annular plate, and the second radial ribs extend along the radial direction of the second annular plate.

11. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 10, wherein, The inner ends of the first radial ribs are connected to the blocking part, and the outer ends of the first radial ribs extend to the outer edge of the first annular plate or are spaced apart from the outer edge of the first annular plate. The inner ends of the second radial ribs are connected to the blocking part, and the outer ends of the second radial ribs extend to the outer edge of the second annular plate or are spaced apart from the outer edge of the second annular plate.

12. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first support rib comprises a first annular rib extending along the circumference of the first annular plate. The second support rib comprises a second annular rib extending along the circumference of the second annular plate.

13. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first support rib comprises a plurality of first radial ribs arranged at intervals along the circumference of the first annular plate and extending along the radial direction of the first annular plate, and a first annular rib extending along the circumference of the first annular plate and connected to the plurality of first radial ribs. The second support rib comprises a plurality of second radial ribs arranged at intervals along the circumference of the second annular plate and extending along the radial direction of the second annular plate, and a second annular rib extending along the circumference of the second annular plate and connected to the plurality of second radial ribs.

14. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 13, wherein, At least one first annular rib is arranged on the outer edge of the first annular plate, and the outer ends of the plurality of first radial ribs are connected to the first annular rib arranged on the outer edge of the first annular plate. At least one second annular rib is arranged on the outer edge of the second annular plate, and the outer ends of the plurality of second radial ribs are connected to the second annular rib arranged on the outer edge of the second annular plate.

15. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 10, wherein, The first radial rib comprises 1-100 first radial ribs, and the second radial rib comprises 1-100 second radial ribs.

16. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 7, wherein, The first disc part and the second disc part are symmetrically arranged or asymmetrically arranged.

17. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-16, wherein, Further comprising: A delivery device connection portion is integrally formed at one axial end of the occlusion portion, and is adapted to be connected with a push assembly in an occluder delivery device.

18. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 17, wherein, The delivery device connection portion is configured as a connection block, and the surface of the connection block is provided with anti-skid lines.

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