Double-disk-shaped integrally-formed degradable atrial septum foramen ovale occluder

Abstract

Disclosed in the present application is a double-disk-shaped integrally-formed degradable atrial septum foramen ovale occluder (100). The occluder (100) comprises: a first disk part (10), a second disk part (20), and an occlusion part (30). The first disk part (10) and the second disk part (20) are respectively connected to two axial ends of the occlusion part (30). The first disk part (10), the second disk part (20), and the occlusion part (30) are of an integrally-formed structure, and both the first disk part (10) and the second disk part (20) are elastic parts capable of automatically restoring the original shape.

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 202410451539.2 and the application date of April 15, 2024, and the Chinese patent application with the application number 202420776636.4 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-orthopnea hypoxemia, etc.

[0005] The method of treating patent foramen ovale 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 atrial septal defect in the delivery catheter to implement 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, the main body support of the atrial septal defect occluder used in the clinic at present is mainly made of nickel-titanium alloy wire. 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) the nickel-titanium alloy is a non-degradable metal alloy material, although its biocompatibility has been demonstrated, but the long-term risk of 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 growth and development of the heart of the 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 body's own cells to climb and grow, and be degraded by the body after completing the mission, so that the defect is completely repaired by the body's own tissue, thereby avoiding the long-term complications and safety hazards caused by the retention of metal in the body. The occluder currently 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 retention of metal in the body.

[0010] The double-disc integrally formed degradable heart atrial septal oval foramen occluder according to the embodiments of the present application comprises: a first disc portion, a second disc portion and an occlusion portion, the first disc portion and the second disc portion are connected at the axial ends of the occlusion portion, the first disc portion, the second disc portion and the occlusion portion are integrally formed members and are degradable members; the first disc portion and the second disc portion are both elastic members that can automatically restore to their original shape.

[0011] The double-disc integrally-formed degradable heart atrial septal oval foramen occluder according to the embodiments of the present application is an integrally-formed degradable member, provides a temporary bridge for the self-repair of the heart, and provides a temporary bridge for the self-cell tissue to climb and grow, and is then 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 is strong, the degradation rate of the occluder in the body is uniform, there is no risk of structural disintegration, all the shortcomings of the existing braided structure occluder can be overcome, and the surgical operation can be simplified.

[0012] In addition, the double-disc integrally-formed degradable heart atrial septal oval foramen occluder according to the above embodiments of the present application can also have the following additional technical features:

[0013] At least part of the first disc part and at least part of the second disc part are in the form of a tapered ring; when at least part of the first disc part is in the form of a tapered ring, the tapered ring is arranged to extend from the center to the edge in the direction of the second disc part; when at least part of the second disc part is in the form of a tapered ring, the tapered ring is arranged to extend from the center to the edge in the direction of the first disc part; the axial size of the occlusion part is L1, the distance between the outer edge of the first disc part and the outer edge of the second disc part is L2, and L2 < L1.

[0014] 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 thereto, 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 away from 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 approaches the second disc part in the 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 thereto, 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 away from 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 approaches the first disc part in the direction away from the center of the occlusion part in the radial direction of the occlusion part.

[0015] The thickness of the first inner ring section gradually decreases in the extension direction from the inner edge of the first inner ring section to the outer edge of the first inner ring section; the thickness of the first outer ring section gradually decreases in the extension direction from the inner edge of the first outer ring section to the outer edge of the first outer ring section; the thickness of the second inner ring section gradually decreases in the extension direction from the inner edge of the second inner ring section to the outer edge of the second inner ring section; and the thickness of the second outer ring section gradually decreases in the extension direction from the inner edge of the second outer ring section to the outer edge of the second outer ring section.

[0016] The thickness of the first inner ring section and the first outer ring section is consistent; and the thickness of the second inner ring section and the second outer ring section is consistent.

[0017] The first inner ring section, the first outer ring section, the second inner ring section and the second outer ring section are circular, quasi-circular or polygonal in cross-sectional shape perpendicular to the axial direction of the closure part; the first inner ring section and the first outer ring section are connected by a circular arc transition; and the second inner ring section and the second outer ring section are connected by a circular arc transition.

[0018] The first disc part further comprises a first support rib provided on the first annular plate, the first support rib being used for supporting the first annular plate to restore its original shape; and the second disc part further comprises a second support rib provided on the second annular plate, the second support rib being used for supporting the second annular plate to restore its original shape.

[0019] The first annular plate has opposite first inner and outer surfaces, the first inner surface being arranged towards the second disc part, and at least one of the first inner and outer surfaces being provided with the first support rib; and the second annular plate has opposite second inner and outer surfaces, the second inner surface being arranged towards the first disc part, and at least one of the second inner and outer surfaces being provided with the second support rib.

[0020] The first support rib comprises a plurality of first radial ribs arranged at intervals in the circumferential direction of the first annular plate, the first radial ribs being located on the first inner surface and extending from the inner edge of the first inner ring section to the outer edge of the first outer ring section; and the second support rib comprises a plurality of second radial ribs arranged at intervals in the circumferential direction of the second annular plate, the second radial ribs being located on the second inner surface and extending from the inner edge of the second inner ring section to the outer edge of the second outer ring section.

[0021] An inner end of the first radial rib is connected with the blocking part, and an outer end of the first radial rib extends to or is spaced from an outer edge of the first annular plate; an inner end of the second radial rib is connected with the blocking part, and an outer end of the second radial rib extends to or is spaced from an outer edge of the second annular plate.

[0022] The first support rib further comprises a first annular rib extending along a circumference of the first annular plate, and the first annular rib is at least one and arranged on the first outer ring segment; the second support rib further comprises a second annular rib extending along a circumference of the second annular plate, and the second annular rib is at least one and arranged on the second outer ring segment.

[0023] The first support rib further comprises at least one first annular rib extending along a circumference of the first annular plate, and the at least one first annular rib is connected with the plurality of first radial ribs; the second support rib further comprises at least one second annular rib extending along a circumference of the second annular plate, and the at least one second annular rib is connected with the plurality of second radial ribs.

[0024] The at least one first annular rib is arranged on an outer edge of the first annular plate, and outer ends of the plurality of first radial ribs are connected with the first annular rib arranged on the outer edge of the first annular plate; the at least one second annular rib is arranged on an outer edge of the second annular plate, and outer ends of the plurality of second radial ribs are connected with the second annular rib arranged on the outer edge of the second annular plate.

[0025] The first radial rib and the blocking part are connected through a circular arc transition, and the second radial rib and the blocking part are connected through a circular arc transition.

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

[0027] The first disc part, the second disc part and the blocking part are arranged in parallel along an axis.

[0028] The first disc part and the second disc part are symmetrically arranged or asymmetrically arranged.

[0029] The first outer surface has a larger surface roughness than the first inner surface; and the second outer surface has a larger surface roughness than the second inner surface.

[0030] The occluder further comprises a delivery device connecting part integrally formed at an 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.

[0031] The delivery device connecting portion is configured as a flat block extending along an axial direction of the occluding portion.

[0032] The surface of the delivery device connecting portion is provided with a plurality of protrusions arranged along the axial direction.

[0033] Additional aspects and advantages of the present application will be made apparent from the following description of embodiments, given by way of example only, which must not be considered limiting. BRIEF DESCRIPTION OF DRAWINGS

[0034] The above and / or additional aspects and advantages of the present application will become apparent and be readily appreciated from the following description, given by way of example, and with reference to the following drawings, wherein:

[0035] Fig. 1 is a schematic view of a structure of a double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder according to an embodiment of the present application;

[0036] Fig. 2 is a sectional view of a double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder according to another embodiment of the present application;

[0037] Fig. 3 is a sectional view of a double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder according to still another embodiment of the present application.

[0038] Reference numerals: 100 - occluder; 10 - first disc portion; 11 - outer edge of the first disc portion; 12 - first annular plate; 121 - first inner annular segment; 122 - first outer annular segment; 13 - first support rib; 131 - first radial rib; 132 - first annular rib; 20 - second disc portion; 21 - outer edge of the second disc portion; 22 - second annular plate; 221 - second inner annular segment; 222 - second outer annular segment; 23 - second support rib; 231 - second radial rib; 232 - second annular rib; 30 - occluding portion; 40 - delivery device connecting portion; 41 - protrusion. DETAILED DESCRIPTION

[0039] Embodiments of the present application are described in detail below with reference to the attached drawing figures, wherein the same or like reference numerals and characters are used throughout the figures to denote the same or like components. The embodiments described below are exemplary, and are intended to be illustrative of the present application and are not to be construed as limiting thereof.

[0040] A double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder 100 according to some embodiments of the present application is described below with reference to Fig. 1.

[0041] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiments 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 at 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.

[0042] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiments 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 at 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.

[0043] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiments 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 at 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.

[0044] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 according to the embodiments 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 at 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.

[0045] The following briefly describes a process of using the occluder 100 of the embodiments of the present application. When the integrated degradable atrial septal oval foramen occluder 100 of the present application is used, the sheath tube is extended to the atrial septal oval foramen, the pushing assembly pushes the occluder 100 along the sheath tube to the atrial septal defect, the second disc part 20 is released from the sheath tube on the left atrial side, and the second disc part 20 automatically restores to the original shape after being released, and the second disc part 20 abuts against the left atrial wall. Then the occlusion part 30 is released from the sheath tube, the occlusion part 30 is positioned in the atrial septal oval foramen, and the atrial septal defect is occluded. Finally, the first disc part 10 is released from the sheath tube on the right atrial side, the first disc part 10 automatically restores to the original shape after being released, and the first disc part 10 abuts against the right atrial wall, so as to achieve the occlusion of the atrial septal oval foramen by the occluder 100.

[0046] In addition, compared with the occluder in the related art, which is woven from a nickel-titanium alloy wire and then covered with a resistance film, the occluder 100 of the embodiments of the present application is a resilient member, and the occluder 100 can be deformed to a smaller volume, so that it can be transported by a sheath tube with a smaller diameter, thereby facilitating the reduction of the risk of surgery. When the occluder 100 is sent out from the sheath tube, the occluder 100 can automatically restore to the original shape, so that it is not necessary to additionally provide a driving member for restoring the occluder 100 to the original shape, thereby reducing the manufacturing cost and simplifying the operation of the surgery.

[0047] The double-disc integrated degradable atrial septal oval foramen occluder 100 according to the embodiments of the present application is an integrated degradable member, and the occluder 100 provides a temporary bridge for the self-repair of the heart, so that the cells and tissues of the heart can climb and grow, and then be degraded and absorbed in the body. The long-term complications and safety hazards caused by the retention of metal in the body can be avoided, the structural integrity of the occluder 100 is strong, the degradation rate of the occluder 100 in the body is uniform, and there is no risk of structural disintegration, so that all the shortcomings of the existing woven structure occluder 100 can be overcome, and the operation of the surgery can be simplified.

[0048] In some embodiments of the present application, at least part of the first disc part 10 and at least part of the second disc part 20 are in the form of a tapered ring, and the first disc part 10 and the second disc part 20 are arranged in a buckling manner. When at least part of the first disc part 10 is in the form of a tapered ring, the tapered ring extends from the center to the edge in the direction of the second disc part 20; when at least part of the second disc part 20 is in the form of a tapered ring, the tapered ring extends from the center to the edge in the direction of the first disc part 10.

[0049] In some embodiments of the present application, as shown in FIG. 2, at least part of the first disc part 10 extends in the direction of the second disc part 20, and at least part of the second disc part 20 extends in the direction of the first disc part 10; the axial size of the occlusion part 30 is L1, the distance between the outer edge 11 of the first disc part and the outer edge 21 of the second disc part is L2, and L2 < L1.

[0050] The first disc part 10 is connected to one axial end of the blocking part 30, and the second disc part 20 is connected to the other axial end of the blocking part 30. The outer edge 11 of the first disc part 10 is a free end of the first disc part 10 away from the connection with the blocking part 30, and the outer edge 21 of the second disc part 20 is a free end of the second disc part 20 away from the connection with the blocking part 30. The first disc part 10 and the second disc part 20 are arranged in a buckling manner, so that the spacing L2 between the outer edge 11 of the first disc part 10 and the outer edge 21 of the second disc part 20 is smaller than the axial dimension L1 of the blocking part 30. The first disc part 10 and the second disc part 20 can reliably abut against the heart chamber wall, can increase the contact area of the first disc part 10 with the heart chamber wall, and can increase the contact area of the second disc part 20 with the heart chamber wall, can improve the arrangement stability of the occluder 100, is also beneficial to the cell tissue climbing growth, and can improve the repair effect.

[0051] In some embodiments of the present application, part of the first disc part 10 gradually approaches the second disc part 20 in a direction radially away from the center of the blocking part 30, and part of the second disc part 20 gradually approaches the first disc part 10 in a direction radially away from the center of the blocking part 30. The included angle between the first disc part 10 and the second disc part 20 and the heart chamber wall is small, which can reduce the risk of local thrombosis of the contact part of the first disc part 10 and the second disc part 20 with the heart chamber wall, is beneficial to the cell tissue climbing growth, and makes the heart atrial septal defect be repaired by the self tissue earlier and the healing time be shorter.

[0052] In some embodiments of the present application, as shown in FIG. 1, the first disc part 10 includes a first annular plate 12, the first annular plate 12 is configured as a main part of the first disc part 10, the first annular plate 12 defines the main profile of the first disc part 10, and the inner end of the first annular plate 12 is connected to the blocking part 30 around the axis of the blocking part 30. The first annular plate 12 is configured as an annular structure. Similarly, the second disc part 20 includes a second annular plate 22, the second annular plate 22 is configured as a main part of the second disc part 20, the second annular plate 22 defines the main profile of the second disc part 20, and the inner end of the second annular plate 22 is also connected to the blocking part 30 around the axis of the blocking part 30. The second annular plate 22 is also configured as an annular structure.

[0053] The first annular plate 12 and the second annular plate 22 surround the blocking part 30 and abut against the heart chamber wall, can block the blood impact, improve the working reliability of the occluder 100, and the first annular plate 12 and the second annular plate 22 provide complete support. After the cell tissue climbing growth, the atrial septal defect can be occluded, and the repair effect is improved.

[0054] As shown in FIG. 2 and FIG. 3, the first annular plate 12 comprises a first inner ring segment 121 and a first outer ring segment 122 connected with each other, both of which are annular, the first inner ring segment 121 is arranged closer to the occlusion part 30 than the first outer ring segment 122, the first inner ring segment 121 is connected with the occlusion part 30, and the first outer ring segment 122 has the outer edge 11 of the first disc part. The inner edge of the first inner ring segment 121 is connected with the occlusion part 30, and the first inner ring segment 121 extends away from the second disc part 20; the inner edge of the first outer ring segment 122 is connected with the outer edge of the first inner ring segment 121, and the first outer ring segment 122 gradually approaches 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.

[0055] By arranging the first outer ring segment 122, the first disc part 10 is configured as a structure of being buckled inwardly toward the second disc part 20, so that the spacing L2 between the outer edge 11 of the first disc part and the outer edge 21 of the second disc part is smaller than the axial dimension L1 of the occlusion part 30. It is worth noting that the first inner ring segment 121 extends in a direction away from the second disc part 20, the first outer ring segment 122 extends in a direction approaching the second disc part 20, the first disc part 10 is configured as a structure of being turned outwardly first and then buckled inwardly, a transitional structure can be formed on the first disc part 10, the first disc part 10 is more likely to deform and automatically recover to the original state, and the working reliability of the first disc part 10 is improved.

[0056] It is also worth noting that since the spacing L2 between the outer edge 11 of the first disc part and the outer edge 21 of the second disc part is smaller than the axial dimension L1 of the occlusion part 30, when the first disc part 10 and the second disc part 20 are bent and deformed to be accommodated in the sheath in directions toward each other, the first disc part 10 and the second disc part 20 will shield the occlusion part 30, and the release of the first disc part 10 and the second disc part 20 is more difficult, the first disc part 10 or the second disc part 20 will be released together with the occlusion part 30, and the situation that the first disc part 10 or the second disc part 20 is blocked by the oval foramen and cannot completely recover to the original state may occur. Therefore, at least one of the first disc part 10 and the second disc part 20 is bent and deformed to be accommodated in the sheath in a direction away from the other one, so as to expose the occlusion part 30, which can reduce the situation that the first disc part 10 and the second disc part 20 are blocked and cannot completely recover to the original state, and improve the working reliability of the occluder 100. By arranging the first inner ring segment 121, the first disc part 10 is more likely to be bent and deformed in a direction away from the second disc part 20, the first disc part 10 is more likely to automatically recover to the original state, and the working reliability of the first disc part 10 is improved.

[0057] The first outer ring segment 122 gradually approaches 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 first outer ring segment 122 smoothly transitions from the first inner ring segment 121 to the heart chamber wall, and the included angle between the first outer ring segment 122 and the heart chamber wall is small, which is conducive to cell climbing growth and can improve the repair effect.

[0058] Optionally, the first inner ring segment 121 gradually moves away from the second disc portion 20 in a direction away from the center of the occlusion portion 30 in the radial direction of the occlusion portion 30; or, alternatively, the first inner ring segment 121 extends away from the second disc portion 20 in the axial direction of the occlusion portion 30.

[0059] As shown in FIGS. 2 and 3, the second annular plate 22 comprises a second inner ring segment 221 and a second outer ring segment 222 connected to each other, both of which are annular, the second inner ring segment 221 is arranged closer to the occlusion portion 30 than the second outer ring segment 222, the second inner ring segment 221 is connected to the occlusion portion 30, and the second outer ring segment 222 has the outer edge 21 of the second disc portion. The inner edge of the second inner ring segment 221 is connected to the occlusion portion 30, and the second inner ring segment 221 extends away from the first disc portion 10; the inner edge of the second outer ring segment 222 is connected to the outer edge of the second inner ring segment 221, and the second outer ring segment 222 gradually moves closer to the first disc portion 10 in a direction away from the center of the occlusion portion 30 in the radial direction of the occlusion portion 30.

[0060] Similarly, by arranging the second outer ring segment 222, the second disc portion 20 is configured as a structure that is buckled inward toward the first disc portion 10, so that the distance L2 between the outer edge 11 of the first disc portion and the outer edge 21 of the second disc portion is smaller than the axial size L1 of the occlusion portion 30. By arranging the second inner ring segment 221, the second inner ring segment 221 extends away from the first disc portion 10, the second outer ring segment 222 extends toward the first disc portion 10, the second disc portion 20 is configured as a structure that is first turned outward and then buckled inward, a transitional structure can be formed on the second disc portion 20, the second disc portion 20 is more likely to bend and deform away from the first disc portion 10, and is more likely to automatically recover to the original state, thereby improving the working reliability of the second disc portion 20.

[0061] The second outer ring segment 222 gradually moves closer to the first disc portion 10 in a direction away from the center of the occlusion portion 30 in the radial direction of the occlusion portion 30, the second outer ring segment 222 smoothly transitions from the second inner ring segment 221 to the heart chamber wall, and the included angle between the second outer ring segment 222 and the heart chamber wall is small, which is conducive to cell climbing and growth, and can improve the repair effect.

[0062] Optionally, the second inner ring segment 221 gradually moves away from the first disc portion 10 in a direction away from the center of the occlusion portion 30 in the radial direction of the occlusion portion 30; or, alternatively, the second inner ring segment 221 extends away from the first disc portion 10 in the axial direction of the occlusion portion 30.

[0063] In some embodiments of the present application, as shown in FIG. 2, the first inner ring segment 121 and the first outer ring segment 122 are arc-shaped in the axial cross-sectional shape of the occlusion part 30, and the second inner ring segment 221 and the second outer ring segment 222 are arc-shaped in the axial cross-sectional shape of the occlusion part 30. The stress concentration points at the first ring plate 12 and the second ring plate 22 can be reduced, the first disc part 10 and the second disc part 20 are more prone to deformation, and are more prone to automatic recovery, thereby improving the working reliability of the first disc part 10 and the second disc part 20.

[0064] In some embodiments of the present application, as shown in FIG. 2, the inner edge of the first inner ring segment 121 is connected to the occlusion part 30 in an arc transition, and the inner edge of the second inner ring segment 221 is connected to the occlusion part 30 in an arc transition. The stress at the connection between the first ring plate 12 and the occlusion part 30 can be reduced, the stress at the connection between the first ring plate 12 and the occlusion part 30 can be reduced, the 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 can be improved.

[0065] In some embodiments of the present application, as shown in FIG. 2, the first inner ring segment 121 and the first outer ring segment 122 are connected in an arc transition, and the second inner ring segment 221 and the second outer ring segment 222 are connected in an arc transition. The first inner ring segment 121 and the first outer ring segment 122 are smoothly transitioned, and the second inner ring segment 221 and the second outer ring segment 222 are smoothly transitioned. The stress concentration on the first ring plate 12 and the second ring plate 22 can be reduced, the fracture damage of the first disc part 10 and the second disc part 20 can be reduced, the first disc part 10 and the second disc part 20 are more prone to deformation, and are more prone to automatic recovery, thereby improving the working reliability of the first disc part 10 and the second disc part 20.

[0066] In some embodiments of the present application, the first inner ring segment 121, the first outer ring segment 122, the second inner ring segment 221, and the second outer ring segment 222 are circular, circular-like, or polygonal in the cross-sectional shape perpendicular to the axial direction of the occlusion part 30. The first ring plate 12 or the second ring plate 22 with a corresponding cross-sectional shape can be selected according to the atrial wall shape of the affected area to fit the affected area.

[0067] The cross-sectional shape of the first inner ring segment 121 and the first outer ring segment 122 perpendicular to the axial direction of the occlusion part 30 can be consistent, and the cross-sectional shape of the first inner ring segment 121 and the first outer ring segment 122 perpendicular to the axial direction of the occlusion part 30 can also be different. The cross-sectional shape of the second inner ring segment 221 and the second outer ring segment 222 perpendicular to the axial direction of the occlusion part 30 can be consistent, and the cross-sectional shape of the second inner ring segment 221 and the second outer ring segment 222 perpendicular to the axial direction of the occlusion part 30 can also be different.

[0068] It is worth mentioning that the occluder 100 of the embodiment of the present application can directly trim the first annular plate 12 or the second annular plate 22, 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 embodiment of the present application is a one-piece structure, directly trimming the first annular plate 12 or the second annular plate 22 will not damage the integrity of the first disc 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 application range of the occluder 100 is wide, the targeting is strong, which is beneficial to improve the repair effect, and can save the manufacturing cost of customized parts.

[0069] In some embodiments of the present application, the projection area of the first annular plate 12 and the second annular plate 22 in the axial direction of the occlusion part 30 is independently 3mm2-2000mm2.

[0070] Optionally, the projection area of the first annular plate 12 in the axial direction of the occlusion part 30 can be 5mm2, 55mm2, 100mm2, 300mm2, 900mm2, 1000mm2, (625*π)mm2, 2000mm2, etc.

[0071] Optionally, the projection area of the second annular plate 22 in the axial direction of the occlusion part 30 can be 5mm2, 55mm2, 100mm2, 300mm2, 900mm2, 1000mm2, (625*π)mm2, 2000mm2, etc.

[0072] In some embodiments of the present application, in the extension direction from the inner edge of the first inner ring segment 121 to the outer edge of the first inner ring segment 121, the thickness of the first inner ring segment 121 gradually decreases; in the extension direction from the inner edge of the first outer ring segment 122 to the outer edge of the first outer ring segment 122, the thickness of the first outer ring segment 122 gradually decreases. In the extension direction from the inner edge of the second inner ring segment 221 to the outer edge of the second inner ring segment 221, the thickness of the second inner ring segment 221 gradually decreases; in the extension direction from the inner edge of the second outer ring segment 222 to the outer edge of the second outer ring segment 222, the thickness of the second outer ring segment 222 gradually decreases.

[0073] The thickness of the first annular plate 12 gradually decreases as it extends from the occluding portion 30 toward the outer edge 11 of the first disc portion. The thickness of the second annular plate 22 gradually decreases as it extends from the occluding portion 30 toward the outer edge 21 of the second disc portion. Thickness directly affects the degradation rate of the occluder 100. The first and second disc portions 10, 20 provide a temporary bridge for the heart's own cells to grow and climb. The outer edges 11, 21 of the first and second disc portions contact the atrial wall, and cells grow and climb along the outer edges 11, 21 of the first and second disc portions toward the occluding portion 30. The outer edges of the first and second annular plates 12, 22 have the lowest thickness. The first annular plate 12 gradually degrades along its outer edge toward the occluding portion 30, while the second annular plate 22 gradually degrades along its outer edge toward the occluding portion 30, maintaining complete support for the growth of cells. Once the cells have grown, the atrial septal defect is sealed, improving the repair effect.

[0074] In some other embodiments of the present application, the first inner ring segment 121 and the first outer ring segment 122 have the same thickness, and the second inner ring segment 221 and the second outer ring segment 222 have the same thickness.

[0075] In some other embodiments of the present application, the thickness of the first annular plate 12 gradually increases in the extension direction from the sealing portion 30 to the outer edge 11 of the first disk portion, so that the first disk portion 10 can easily restore to a shape that is inwardly bent toward the second disk portion 20; in the extension direction from the sealing portion 30 to the outer edge 21 of the second disk portion, the thickness of the second annular plate 22 gradually increases so that the second disk portion 20 can easily restore to a shape that is inwardly bent toward the first disk portion 10.

[0076] In some embodiments of the present application, the thickness of the first annular plate 12 and the second annular plate 22 are independently 0.01 mm-8 mm.

[0077] Optionally, the thickness of the first annular plate 12 may be 0.01 mm, 0.05 mm, 0.1 mm, 0.4 mm, 0.46 mm, 0.5 mm, 1 mm, 8 mm, etc.

[0078] Optionally, the thickness of the second annular plate 22 may be 0.01 mm, 0.05 mm, 0.1 mm, 0.4 mm, 0.46 mm, 0.5 mm, 1 mm, 8 mm, etc.

[0079] It is worth noting that the first annular plate 12 and the second annular plate 22 are configured as a sheet structure, compared with the prior art, the occluder 100 has a smaller space volume, and the occluder 100 can be deformed to a smaller volume and accommodated in a sheath, and can be transported through a sheath with a smaller diameter, thereby reducing the risk of surgery.

[0080] In some embodiments of the present application, as shown in FIG. 2, the first disc part 10 further comprises a first support rib 13 arranged on the first annular plate 12, and the first support rib 13 is used to support the first annular plate 12 to restore to the original state. The second disc part 20 further comprises a second support rib 23 arranged on the second annular plate 22, and the second support rib 23 is used to support the second annular plate 22 to restore to the original state.

[0081] The occluder 100 of the present application is deformed to reduce the volume to be accommodated in the sheath, facilitating transportation. After the occluder 100 is transported out of the sheath, the first support rib 13 supports the first annular plate 12 to restore to the original state, and the second support rib 23 supports the second annular plate 22 to restore to the original state. The occluder 100 restores to the original state to occlude the atrial septal oval foramen.

[0082] Compared with automatically restoring to the original state only by the structure of the first annular plate 12 itself or only by the structure of the second annular plate 22 itself, the first annular plate 12 can restore to the original state faster by arranging the first support rib 13, and the second annular plate 22 can restore to the original state faster by arranging the second support rib 23. The situation that the first annular plate 12 and the second annular plate 22 are blocked and cannot completely restore to the original state is reduced, which is beneficial to the release of the occluder 100, improves the working reliability of the occluder 100, and improves the operation efficiency.

[0083] In some embodiments of the present application, as shown in FIG. 2, the first annular plate 12 has a first inner surface and a first outer surface opposite to each other, the first inner surface faces the second disc part 20, and at least one of the first inner surface and the first outer surface is externally provided with the first support rib 13; the second annular plate 22 has a second inner surface and a second outer surface opposite to each other, the second inner surface faces the first disc part 10, and at least one of the second inner surface and the second outer surface is externally provided with the second support rib 23.

[0084] 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 positions of the above-mentioned inner edge, outer edge and the like. The occluder 100 is configured as a structure in which the first disc part 10 and the second disc part 20 are buckled, the first inner surface and the second inner surface are oppositely arranged in the axial direction of the occluder 100, and the first outer surface and the second outer surface are oppositely arranged in the axial direction of the occluder 100.

[0085] The first support rib 13 can protrude from the first annular plate 12 in the direction of the first inner surface, or the first support rib 13 can also protrude from the first annular plate 12 in the direction of the first outer surface, or the first support rib 13 can protrude from both the first inner surface and the first outer surface. The second support rib 23 can protrude from the second inner surface, or the second support rib 23 can also protrude from the second outer surface, or the second support rib 23 can protrude from both the second outer surface and the second inner surface.

[0086] In some embodiments of the present application, the first support rib 13 is arranged only on the first inner surface, or most of the first support rib 13 protrudes from the first inner surface, and only part of the first support rib 13 is located on the first outer surface, and the second support rib 23 is arranged only on the second inner surface, or most of the second support rib 23 protrudes from the first inner surface, and only part of the second support rib 23 is located on the second outer surface. The first outer surface and the second outer surface are support surfaces for cell tissue to climb and grow. Arranging all or most of the first support rib 13 on the first inner surface and arranging all or most of the second support rib 23 on the second inner surface can ensure that the first outer surface and the second outer surface are continuous and flat support surfaces, which is conducive to cell climbing and growth, and can reduce the risk of local thrombosis of the first disc portion 10 and the second disc portion 20 and improve the repair effect.

[0087] In some embodiments of the present application, as shown in FIGS. 1 and 3, the first support rib 13 includes a plurality of first radial ribs 131 arranged at intervals along the circumference of the first annular plate 12, the first radial rib 131 is located on the first inner surface, and the first radial rib 131 extends from the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122. The second support rib 23 includes a plurality of second radial ribs 231 arranged at intervals along the circumference of the second annular plate 22, the second radial rib 231 is located on the second inner surface, and the second radial rib 231 extends from the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222.

[0088] The first radial rib 131 is arranged on the first inner surface, and the second radial rib 231 is arranged on the second inner surface, so that the first outer surface and the second outer surface are continuous and flat support surfaces, which is conducive to cell climbing and growth, reduces the risk of local thrombosis, and improves the repair effect.

[0089] The first radial rib 131 extends along the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122, and has a tendency to support the first annular plate 12 to restore to the original shape when the first disc part 10 is compressed and deformed, and can support the first annular plate 12 to restore to the original shape by expanding radially after the compression of the first disc part 10 is cancelled. Similarly, the second radial rib 231 extends along the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222, and has a tendency to support the second annular plate 22 to restore to the original shape when the second disc part 20 is compressed and deformed, and can support the second annular plate 22 to restore to the original shape by expanding radially after the compression of the second disc part 20 is cancelled.

[0090] The first radial rib 131 is a plurality of and is arranged along the circumference of the first annular plate 12, and the stress of the first annular plate 12 is uniform, which is beneficial to the first annular plate 12 to restore to the original shape. The second radial rib 231 is a plurality of and is arranged along the circumference of the second annular plate 22, and the stress of the second annular plate 22 is uniform, which is beneficial to the second annular plate 22 to restore to the original shape.

[0091] It is worth noting that the first radial rib 131 extends along the inner edge of the first inner ring segment 121 to the outer edge of the first outer ring segment 122, and the projection shape of the first radial rib 131 in the axial direction of the plugging part 30 can be a straight line. The first radial rib 131 extends along the radial direction of the plugging part 30, which can improve the structural stability of the first disc part 10 and is beneficial to the first disc part 10 to restore to the original shape. Alternatively, the projection shape of the first radial rib 131 in the axial direction of the plugging part 30 can also be a curve, so that the first disc part 10 can be compressed and stored in the sheath tube, which is beneficial to the deformation of the first disc part 10. Similarly, the second radial rib 231 extends along the inner edge of the second inner ring segment 221 to the outer edge of the second outer ring segment 222, and the projection shape of the second radial rib 231 in the axial direction of the plugging part 30 can be a straight line. The projection shape of the second radial rib 231 in the axial direction of the plugging part 30 can also be a curve.

[0092] In some embodiments of the present application, the extension direction of the first radial rib 131 is the length direction of the first radial rib 131, the axial direction of the plugging part 30 is the width direction of the first radial rib 131, and the circumference direction of the first annular plate 12 is the thickness direction of the first radial rib 131. The extension direction of the second radial rib 231 is the length direction of the second radial rib 231, the axial direction of the plugging part 30 is the width direction of the second radial rib 231, and the circumference direction of the second annular plate 22 is the thickness direction of the second radial rib 231. The cross-sectional shape of the first radial rib 131 in the thickness direction can be cylindrical, trapezoidal, triangular or composite geometric shape. The cross-sectional shape of the second radial rib 231 in the thickness direction can be cylindrical, trapezoidal, triangular or composite geometric shape.

[0093] In some embodiments of the present application, as shown in FIGS. 1-3, the inner end of the first radial rib 131 is connected with the occlusion part 30, and the outer end of the first radial rib 131 extends to or is spaced from the outer edge of the first annular plate 12; the inner end of the second radial rib 231 is connected with the occlusion part 30, and the outer end of the second radial rib 231 extends to or is spaced from the outer edge of the second annular plate 22.

[0094] The inner end of the first radial rib 131 is connected with the occlusion part 30, which can improve the structural strength of the first radial rib 131 and is conducive to supporting the first annular plate 12 to restore its original shape; the inner end of the second radial rib 231 is connected with the occlusion part 30, which can improve the structural strength of the second radial rib 231 and is conducive to supporting the second annular plate 22 to restore its original shape.

[0095] The thickness directly affects the degradation speed of the occluder 100. The thickness of the first disc part 10 and the thickness of the second disc part 20 are much smaller than the thickness of the occlusion part 30. Therefore, after the first disc part 10 and the second disc part 20 are degraded, the occlusion part 30 still remains at the atrial septal defect, which improves the working reliability of the occluder 100 and provides support for cell repair. When the thickness of the first radial rib 131 and the thickness of the second radial rib 231 are greater than the thickness of the first annular plate 12 and the thickness of the second annular plate 22, after the first annular plate 12 and the second annular plate 22 are degraded, the first radial rib 131 and the second radial rib 231 can still be connected with the occlusion part 30 through the inner end, which reduces the occurrence of the situation that the undegraded first radial rib and the second radial rib 231 are separated from the occluder 100 and cause discomfort.

[0096] Alternatively, the outer end of the first radial rib 131 can extend to the outer edge of the first annular plate 12, or alternatively, the outer end of the first radial rib 131 can also extend towards the outer edge of the first annular plate 12 and be spaced from the outer edge of the first annular plate 12. Alternatively, as shown in FIGS. 1 and 3, the outer end of the second radial rib 231 can extend to the outer edge of the second annular plate 22, or alternatively, as shown in FIG. 2, the outer end of the second radial rib 231 extends towards the outer edge of the second annular plate 22 and is spaced from the outer edge of the second annular plate 22.

[0097] In some embodiments of the present application, as shown in FIGS. 1-3, the first support rib 13 further comprises a first annular rib 132 extending along the circumference of the first annular plate 12, and the first annular rib 132 is at least one and is arranged on the first outer ring segment 122; the second support rib 23 further comprises a second annular rib 232 extending along the circumference of the second annular plate 22, and the second annular rib 232 is at least one and is arranged on the second outer ring segment 222.

[0098] When the first disc part 10 is compressed and deformed, the first annular rib 132 has a tendency to support the first annular plate 12 to restore its original shape, and after the extrusion on the first disc part 10 is cancelled, the first annular rib 132 can support the first annular plate 12 to restore its original shape by expanding circumferentially. Similarly, when the second disc part 20 is compressed and deformed, the second annular rib 232 has a tendency to support the second annular plate 22 to restore its original shape, and after the extrusion on the second disc part 20 is cancelled, the second annular rib 232 can support the second annular plate 22 to restore its original shape by expanding circumferentially.

[0099] Optionally, the first annular rib 132 can be one, and optionally, the first annular rib 132 can also be multiple, and multiple first annular ribs 132 are arranged along the extension direction of the inner edge to the outer edge of the first annular plate 12. At least one first annular rib 132 is arranged on the first outer ring segment 122, which improves the weight of the first outer ring segment 122, and is conducive to the extension of the first outer ring segment 122 towards the second disc part 20, and is conducive to the restoration of the first annular plate 12 to its original shape.

[0100] Optionally, the second annular rib 232 can be one, and optionally, the second annular rib can also be multiple, and multiple second annular ribs 232 are arranged along the extension direction of the inner edge to the outer edge of the second annular plate 22. At least one second annular rib 232 is arranged on the second outer ring segment 222, which improves the weight of the second outer ring segment 222, and is conducive to the extension of the second outer ring segment 222 towards the first disc part 10, and is conducive to the restoration of the second annular plate 22 to its original shape.

[0101] In some embodiments of the present application, the cross section of the first annular rib 132 is circular, sector, triangular or composite geometric shape; the cross section of the second annular rib 232 is circular, sector, triangular or composite geometric shape.

[0102] In some embodiments of the present application, as shown in FIGS. 2 and 3, the cross section of the first annular rib 132 is circular, the first annular rib 132 is located on the first outer ring segment 122, and the first annular rib 132 protrudes from the first inner surface and an outer surface; the cross section of the second annular rib 232 is circular, the first annular rib 132 is located on the second outer ring segment 222, and the second annular rib 232 protrudes from the second inner surface and the second outer surface.

[0103] In some embodiments of the present application, the first support rib 13 comprises a plurality of first radial ribs 131 arranged along the circumference of the first annular plate 12, the first radial ribs 131 extending along the radial direction of the first annular plate 12, and at least one first annular rib 132 extending along the circumferential direction of the first annular plate 12, the at least one first annular rib 132 being connected to the plurality of first radial ribs 131. The at least one first annular rib 132 is connected to the plurality of first radial ribs 131 to connect the first support rib 13 as a whole, improve the structural stability of the first support rib 13, and facilitate the first annular plate 12 to restore to its original state.

[0104] As shown in FIGS. 1 and 3, the second support rib 23 comprises a plurality of second radial ribs 231 arranged along the circumference of the second annular plate 22, and at least one second annular rib 232 extending along the circumferential direction of the second annular plate 22, the at least one second annular rib 232 being connected to the plurality of second radial ribs 231. Similarly, the at least one second annular rib 232 is connected to the plurality of second radial ribs 231 to connect the second support rib 23 as a whole, improve the structural stability of the second support rib 23, and facilitate the second annular plate 22 to restore to its original state.

[0105] Moreover, after the first annular plate 12 and the second annular plate 22 are degraded, the first annular rib 132 can still be connected to the first radial rib 131, and the second annular rib 232 can still be connected to the second radial rib 231, reducing the occurrence of discomfort caused by the undegraded first annular rib 132 and the second annular rib 232 being detached from the occluder 100.

[0106] In some embodiments of the present application, as shown in FIGS. 1 and 3, the at least one first annular rib 132 is arranged on the outer edge of the first annular plate 12, and the outer ends of the plurality of first radial ribs 131 are connected to the first annular rib 132 arranged on the outer edge of the first annular plate 12; the at least one second annular rib 232 is arranged on the outer edge of the second annular plate 22, and the outer ends of the plurality of second radial ribs 231 are connected to the second annular rib 232 arranged on the outer edge of the second annular plate 22.

[0107] The first annular rib 132 is arranged on the outer edge of the first annular plate 12, facilitating the first outer annular segment 122 to stretch towards the second disc portion 20, and facilitating the first annular plate 12 to restore to its original state. Similarly, the second annular rib 232 is arranged on the outer edge of the second annular plate 22, facilitating the second outer annular segment 222 to stretch towards the first disc portion 10, and facilitating the second annular plate 22 to restore to its original state.

[0108] The outer ends of the plurality of first radial ribs 131 are connected with the first annular rib 132 located on the outer edge of the first annular plate 12 to connect the first support rib 13 as a whole, improve the structural stability of the first support rib 13, and facilitate the first annular plate 12 to restore to its original state. The outer ends of the plurality of second radial ribs 231 are connected with the second annular rib 232 located on the outer edge of the second annular plate 22 to connect the second support rib 23 as a whole, improve the structural stability of the second support rib 23, and facilitate the first annular plate 12 to restore to its original state.

[0109] In some embodiments of the present application, as shown in FIG. 2, at least one first annular rib 132 is arranged on the outer edge of the first annular plate 12, and the outer ends of the plurality of first radial ribs 131 are arranged at intervals with the first annular rib 132 located on the outer edge of the first annular plate 12; at least one second annular rib 232 is arranged on the outer edge of the second annular plate 22, and the outer ends of the plurality of second radial ribs 231 are arranged at intervals with the second annular rib 232 located on the outer edge of the second annular plate 22.

[0110] In some embodiments of the present application, as shown in FIG. 2, the first radial rib 131 and the occlusion part 30 are connected through a circular arc transition, and the second radial rib 231 and the occlusion part 30 are connected through a circular arc transition. The stress concentration at the connection between the first radial rib 131 and the occlusion part 30 can be reduced, the stress concentration at the connection between the second radial rib 231 and the occlusion part 30 can be reduced, the fracture and damage of the first radial rib 131 and the second radial rib 231 can be reduced, the deformation of the first radial rib 131 and the second radial rib 231 can be facilitated, and the working reliability of the first disc part 10 and the second disc part 20 can be improved.

[0111] In some embodiments of the present application, as shown in FIG. 2, the connection between the first radial rib 131 and the occlusion part 30 is closer to the axial inner side of the occlusion part 30 than the inner end of the first inner ring segment 121, and the connection between the second radial rib 231 and the occlusion part 30 is closer to the axial inner side of the occlusion part 30 than the inner end of the second inner ring segment 221. After the degradation of the first annular plate 12 and the second annular plate 22, the first radial rib 131 and the second radial rib 231 can still be connected with the occlusion part 30 through the inner end, and the occurrence of the situation that the undegraded first radial rib and the second radial rib 231 are separated from the occluder 100 can be reduced.

[0112] In some embodiments of the present application, as shown in FIG. 2 and FIG. 3, the width of the first radial rib 131 gradually decreases in the direction extending from the occlusion part 30 to the outer edge 11 of the first disc part, and the width of the second radial rib 231 gradually decreases in the direction extending from the occlusion part 30 to the outer edge 21 of the second disc part. The first radial rib 131 gradually degrades in the direction from the outer edge 11 of the first disc part to the occlusion part 30, and the second radial rib 231 gradually degrades in the direction from the outer edge 21 of the second disc part to the occlusion part 30. The degradation of the first radial rib 131 is consistent with the degradation of the first annular plate 12, and the degradation of the second radial rib 231 is consistent with the degradation of the second annular plate 22, which can provide complete support for the growth of cell tissue climbing, and improve the repair effect.

[0113] In some embodiments of the present application, the first radial rib 131 includes 1-100 radial ribs; and the second radial rib 231 includes 1-100 radial ribs.

[0114] Optionally, the first radial rib 131 can be 2, 4, 5, 6, 8, 10, 20, 50, 100, etc.

[0115] Optionally, the second radial rib 231 can be 2, 4, 5, 8, 10, 16, 30, 50, 100, etc.

[0116] In some embodiments of the present application, the first annular rib 132 includes 1-10 annular ribs, and the second annular rib 232 includes 1-10 annular ribs.

[0117] Too many first annular ribs 132 are not conducive to the deformation and accommodation of the first annular plate 12; similarly, too many second annular ribs 232 are not conducive to the normal operation of the occluder 100.

[0118] Optionally, the first annular rib 132 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0119] Optionally, the second annular rib 232 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0120] In some embodiments of the present application, the axes of the first disc part 10, the second disc part 20 and the occlusion part 30 are arranged in parallel. The first disc part 10 and the second disc part 20 are arranged opposite to each other, and the occlusion part 30 is arranged behind the heart wall. The first disc part 10 and the second disc part 20 are arranged on both sides of the heart wall, and the occlusion effect is better.

[0121] In some embodiments, the two ends of the occlusion part 30 are connected at the centers of the first disc part 10 and the second disc part 20, respectively.

[0122] In some embodiments of the present application, the first disc part 10 and the second disc part 20 are symmetrically arranged.

[0123] The blocking part 30 is a columnar structure, the first disc part 10 is connected to one axial end of the blocking part 30, and the second disc part 20 is connected to the other axial end of the blocking part 30. The first disc part 10 and the second disc part 20 are symmetrically arranged with a radial plane at the center of the blocking part 30 in the axial direction as a symmetric surface, the distance between the connection of the first disc part 10 and the blocking part 30 and the symmetric surface is the same as the distance between the connection of the second disc part 20 and the blocking part 30 and the symmetric surface; the shape, projection area and thickness of the first disc part 10 and the second disc part 20 are the same; the number, structure and size of the first radial rib 131 on the first disc part 10 are the same as the number, structure and size of the second radial rib 231 on the second disc part 20, and the number, structure and size of the first annular rib 132 on the first disc part 10 are the same as the number, structure and size of the second annular rib 232 on the second disc part 20.

[0124] In some embodiments of the present application, the first disc part 10 and the second disc part 20 are symmetrically arranged.

[0125] The radial plane at the center of the blocking part 30 in the axial direction is a center surface. Optionally, as shown in FIG. 2, the distance between the connection of the first disc part 10 and the blocking part 30 and the center surface is different from the distance between the connection of the second disc part 20 and the blocking part 30 and the center surface.

[0126] Optionally, the shape, projection area and thickness of the first disc part 10 and the second disc part 20 are different. The first disc part 10 and the second disc part 20 with corresponding cross-sectional shape and slope can be selected according to the shape of the atrial wall of the affected part, so that the shape of the first disc part 10 and the second disc part 20 fits the affected part, which is conducive to the growth of cell tissue and improves the repair effect. For example, the first disc part 10 abuts against the left atrial wall, and the second disc part 20 abuts against the right atrial wall. The projection area of the first disc part 10 is larger than that of the second disc part 20, so as to increase the contact area of the first disc part 10 and the left atrial wall. Since the left atrial pressure of the heart is greater than the right atrial pressure, for patients with patent foramen ovale of the atrial septum, blood usually flows from the left atrium to the right atrium through the patent foramen ovale. The occluder 100 with the above structure can improve the supporting force of the first disc part 10, which can resist the impact of blood flow, and the occluder 100 is firmly arranged at the atrial septal defect, which is conducive to improving the working reliability of the occluder 100.

[0127] Optionally, the number, structure and specification size of the first radial ribs 131 on the first disc part 10 are different from the number, structure and specification size of the second radial ribs 231 on the second disc part 20; or, optionally, the number, structure and specification size of the first annular rib 132 on the first disc part 10 are different from the number, structure and specification size of the second annular rib 232 on the second disc part 20.

[0128] In some embodiments of the present application, the surface roughness of the first outer surface is greater than that of the first inner surface; the surface roughness of the second outer surface is greater than that of the second inner surface. The first outer surface and the second outer surface have a certain roughness, which is conducive to cell climbing growth and improves the repair effect.

[0129] Several embodiments of the one-piece degradable atrial septal oval foramen plugging device of the present application are described below with reference to the accompanying drawings.

[0130] In the first embodiment of the present application, as shown in FIG. 3, the first disc part 10 includes six first radial ribs 131 and a first annular rib 132, the first annular rib 132 is arranged on the outer edge of the first annular plate 12, and the outer ends of the six first radial ribs 131 are connected with the first annular rib 132. The second disc part 20 includes six second radial ribs 231 and a second annular rib 232, the second annular rib 232 is arranged on the outer edge of the second annular plate 22, and the outer ends of the six second radial ribs 231 are connected with the second annular rib 232.

[0131] In the second embodiment of the present application, as shown in FIG. 2, the first disc part 10 includes six first radial ribs 131 and a first annular rib 132, the first annular rib 132 is arranged on the outer edge of the first annular plate 12, and the outer ends of the six first radial ribs 131 are spaced apart from the first annular rib 132. The second disc part 20 includes six second radial ribs 231 and a second annular rib 232, the second annular rib 232 is arranged on the outer edge of the second annular plate 22, and the outer ends of the six second radial ribs 231 are spaced apart from the second annular rib 232.

[0132] In the third embodiment of the present application, as shown in FIG. 1, the first disc part 10 includes ten first radial ribs 131 and two first annular ribs 132, one of which is arranged on the outer edge of the first annular plate 12, and the other is arranged on the first outer ring segment 122 and located inside the outer edge of the first annular plate 12, the ten first radial ribs 131 are connected with the two first annular ribs 132, and the outer ends of the ten first radial ribs 131 are connected with the first annular rib 132 arranged on the outer edge of the first annular plate 12.

[0133] The second disc part 20 comprises ten second radial ribs 231 and two second annular ribs 232, wherein one of the second annular ribs 232 is arranged on the outer edge of the second annular plate 22, and the other second annular rib 232 is arranged on the second outer ring segment 222 and is located inside the outer edge of the second annular plate 22, the ten second radial ribs 231 are connected with the second annular ribs 232 located inside, and the outer ends of the ten second radial ribs 231 are all connected with the second annular rib 232 located on the outer edge of the second annular plate 22.

[0134] In the fourth embodiment of the present application, the first disc part 10 comprises ten first radial ribs 131 and two first annular ribs 132, wherein one of the first annular ribs 132 is arranged on the outer edge of the first annular plate 12, and the other first annular rib 132 is arranged on the first outer ring segment 122 and is located inside the outer edge of the first annular plate 12, the ten first radial ribs 131 are connected with the first annular rib 132 located inside, and the outer ends of the ten first radial ribs 131 are all arranged spaced apart from the first annular rib 132 located on the outer edge of the first annular plate 12.

[0135] The second disc part 20 comprises ten second radial ribs 231 and two second annular ribs 232, wherein one of the second annular ribs 232 is arranged on the outer edge of the second annular plate 22, and the other second annular rib 232 is arranged on the second outer ring segment 222 and is located inside the outer edge of the second annular plate 22, the ten second radial ribs 231 are connected with the second annular rib 232 located inside, and the outer ends of the ten second radial ribs 231 are all arranged spaced apart from the second annular rib 232 located on the outer edge of the second annular plate 22.

[0136] In the fifth embodiment of the present application, the first disc part 10 comprises eight first radial ribs 131 and one first annular rib 132, the first annular rib 132 is arranged on the first outer ring segment 122 and is arranged spaced apart from the outer edge of the first annular plate 12, and the outer ends of the six first radial ribs 131 are all connected with the first annular rib 132 and are arranged spaced apart from the outer edge of the first annular plate 12. The second disc part 20 comprises six second radial ribs 231 and one second annular rib 232, the second annular rib 232 is arranged on the second outer ring segment 222 and is arranged spaced apart from the outer edge of the second annular plate 22, and the outer ends of the six second radial ribs 231 are all connected with the second annular rib 232 and are arranged spaced apart from the outer edge of the second annular plate 22.

[0137] In some embodiments of the present application, as shown in FIGS. 1-3, the occluder 100 further comprises a delivery device connecting part 40, which is integrally formed at one axial end of the occlusion part 30, and the delivery device connecting part 40 is adapted to be connected with a pushing assembly in the delivery device of the occluder 100.

[0138] The pushing assembly is selectively connected with the delivery device connecting portion 40, and when the pushing assembly is connected with the delivery device connecting portion 40, the pushing assembly can drive the occluder 100 to move, and when the pushing assembly is separated from the delivery device connecting portion 40, the pushing assembly can be recycled.

[0139] In some embodiments of the present application, as shown in FIGS. 1 and 2, the delivery device connecting portion 40 is arranged on the first disc portion 10 side of the occlusion portion 30.

[0140] In the surgical operation, first, the pushing assembly is stably connected with the delivery device connecting portion 40, and the occluder 100 is driven by the delivery device to move along the sheath until reaching the lesion. The occluder 100 is continuously driven by the delivery device to move, so as to release the second disc portion 20 from the sheath on the left atrium side, and the second disc portion 20 automatically restores to the original shape after being released, and the second disc portion 20 abuts against the left atrium wall. Then, the occluder 100 is continuously driven by the delivery device to move, so as to release the occlusion portion 30 from the sheath, and the occlusion portion 30 occludes the atrial septal defect. Then, the occluder 100 is continuously driven by the delivery device to move, so as to release the first disc portion 10 from the sheath on the right atrium side, and the first disc portion 10 automatically restores to the original shape after being released, and the first disc portion 10 abuts against the right atrium wall, so as to realize the occlusion of the atrial septal oval foramen by the occluder 100. Finally, the pushing assembly is separated from the delivery device connecting portion 40, and the pushing assembly and the sheath are removed from the human body from the lesion.

[0141] In some embodiments of the present application, the delivery device connecting portion 40 can be a hole, a pit or a protruding structure, and the pushing assembly is connected with the delivery device connecting portion 40 in cooperation. Alternatively, the hole, the pit or the protruding structure can be in a circular, elliptical, triangular, composite geometric shape or the like geometric shape. The hole can be a through structure, and the pit or the protruding structure can be a non-through structure. The protruding structure can be a flat protrusion or a cylindrical protrusion structure.

[0142] In some embodiments of the present application, as shown in FIG. 1, the delivery device connecting portion 40 is configured as a flat block, and the flat block extends along the axial direction of the occlusion portion 30.

[0143] The occluder 100 of the present application is a one-piece structure, and the occluder 100 is an elastic member capable of automatically restoring to the original shape. When the occluder 100 is sent out from the sheath, the occluder 100 can automatically restore to the original shape, so that it is not necessary to additionally arrange a driving member for driving the occluder 100 to restore to the original shape, which can reduce the manufacturing cost and simplify the surgical operation. The delivery device connecting portion 40 is configured as a flat block, and a clamping member can be used as the pushing assembly, and the clamping member clamps the flat block to be connected with the occluder 100. The clamping member clamps the flat block to be connected with the occluder 100, and the connection and release operations of the clamping member are simple, which can simplify the surgical operation.

[0144] Exemplarily, the flat block can be gripped by the forceps, and the occluder 100 is delivered to the lesion along the sheath.

[0145] In some embodiments of the present application, as shown in FIG. 1 and FIG. 3, the surface of the flat block is provided with a plurality of convex ribs 41 arranged in an axial direction. The convex ribs 41 can increase the surface friction of the flat block, and the convex ribs 41 can prevent slipping and further improve the connection stability between the pushing assembly and the flat block, thereby improving the working reliability of the occluder 100.

[0146] In some embodiments of the present application, as shown in FIG. 1 and FIG. 2, the delivery device connecting portion 40 is arranged on the first disc portion 10 side of the occlusion portion 30, and the thickness of the first inner ring segment 121 is less than the thickness of the second inner ring segment 221, so as to reduce the deformation of the first disc portion 10 and the interference with the delivery device connecting portion 40.

[0147] In the description of the present application, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, and does 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 a limitation of the present application. In addition, the terms "first" and "second" are only for the purpose of description, 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" and "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, for example, two, three, etc., unless otherwise specifically limited.

[0148] In this application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting", "fixing" and the like should be interpreted broadly, for example, can be fixed connection, can also be detachable connection, or integrated; can be directly connected, can also 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 this application can be understood according to the specific circumstances. In this application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0149] In the description of this specification, the description of the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" and the like means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the 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, those skilled in the art can combine and combine different embodiments or features of different embodiments or examples described in this specification without contradiction.

[0150] Although the embodiments of the present application have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be understood as limiting the present application, and those skilled in the art can make changes, modifications, replacements and variations to the above 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 one-piece and degradable plug comprising a first disc part, a second disc part and a blocking part, wherein the first disc part and the second disc part are connected to the axial ends of the blocking part, the first disc part, the second disc part and the blocking part are one-piece and degradable, and the first disc part and the second disc part are elastic and can automatically restore to the original state. At least part of the first disc part and at least part of the second disc part are in the shape of a conical ring.

2. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, When at least part of the first disc part is in the shape of a conical ring, the conical ring is arranged to extend from the center to the edge in the direction of the second disc part. When at least part of the second disc part is in the shape of a conical ring, the conical ring is arranged to extend from the center to the edge in the direction of the first disc part. The axial dimension of the blocking part is L1, the distance between the outer edge of the first disc part and the outer edge of the second disc part is L2, and L2 < L1. The first disc part comprises a first annular plate, and the second disc part comprises a second annular plate.

3. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 2, wherein, 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, the inner edge of the first inner ring segment is connected to the blocking part, and the first inner ring segment is arranged to extend away from 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 approaches the second disc part in the direction away from the center of the blocking part in the radial direction of the blocking 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, the inner edge of the second inner ring segment is connected to the blocking part, and the second inner ring segment is arranged to extend away from 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 approaches the first disc part in the direction away from the center of the blocking part in the radial direction of the blocking part. In the extending direction from the inner edge of the first inner ring segment to the outer edge of the first inner ring segment, the thickness of the first inner ring segment gradually decreases; in the extending direction from the inner edge of the first outer ring segment to the outer edge of the first outer ring segment, the thickness of the first outer ring segment gradually decreases.

4. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 3, wherein, In the extending direction from the inner edge of the second inner ring segment to the outer edge of the second inner ring segment, the thickness of the second inner ring segment gradually decreases; in the extending direction from the inner edge of the second outer ring segment to the outer edge of the second outer ring segment, the thickness of the second outer ring segment gradually decreases. The thickness of the first inner ring segment and the first outer ring segment is consistent; the thickness of the second inner ring segment and the second outer ring segment is consistent.

5. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 3, wherein, The first inner ring segment, the first outer ring segment, the second inner ring segment and the second outer ring segment are circular, quasi-circular or polygonal in the cross-sectional shape perpendicular to the axial direction of the blocking part.

6. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 3, wherein, The first inner ring segment and the first outer ring segment are connected through a circular arc transition; The second inner ring segment and the second outer ring segment are connected through a circular arc transition. The first disc part further comprises a first supporting rib arranged on the first annular plate, and the first supporting rib is used for supporting the first annular plate to restore to the original state.

7. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 3, wherein, ​ The second disc part further comprises a second supporting rib provided on the second annular plate, and the second supporting rib is used for supporting the second annular plate to restore the original state.

8. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 7, wherein, 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 at least one of the first inner surface and the first outer surface is provided with the first supporting rib; The second annular plate has a second inner surface and a second outer surface opposite to each other, the second inner surface is arranged towards the first disc part, and at least one of the second inner surface and the second outer surface is provided with the second supporting rib.

9. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first supporting rib comprises a plurality of first radial ribs arranged at intervals in the circumferential direction of the first annular plate, the first radial ribs are located on the first inner surface, and the first radial ribs extend from the inner edge of the first inner ring segment to the outer edge of the first outer ring segment. The second supporting rib comprises a plurality of second radial ribs arranged at intervals in the circumferential direction of the second annular plate, the second radial ribs are located on the second inner surface, and the second radial ribs extend from the inner edge of the second inner ring segment to the outer edge of the second outer ring segment.

10. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The inner end of the first radial rib is connected with the blocking part, and the outer end of the first radial rib extends to the outer edge of the first annular plate or is spaced from the outer edge of the first annular plate. The inner end of the second radial rib is connected with the blocking part, and the outer end of the second radial rib extends to the outer edge of the second annular plate or is spaced from the outer edge of the second annular plate.

11. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first supporting rib further comprises a first annular rib extending in the circumferential direction of the first annular plate, and the first annular rib is at least one and is arranged on the first outer ring segment. The second supporting rib further comprises a second annular rib extending in the circumferential direction of the second annular plate, and the second annular rib is at least one and is arranged on the second outer ring segment.

12. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first supporting rib further comprises at least one first annular rib extending in the circumferential direction of the first annular plate, and the at least one first annular rib is connected with the plurality of first radial ribs. The second supporting rib further comprises at least one second annular rib extending in the circumferential direction of the second annular plate, and the at least one second annular rib is connected with the plurality of second radial ribs.

13. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 12, wherein, The 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 with the first annular rib arranged on the outer edge of the first annular plate. The 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 with the second annular rib arranged on the outer edge of the second annular plate.

14. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first radial rib and the blocking part are connected through a circular arc transition, and the second radial rib and the blocking part are connected through a circular arc transition.

15. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 9, wherein, The first radial rib comprises 1-100 radial ribs, and the second radial rib comprises 1-100 radial ribs.

16. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-15, wherein, The axes of the first disc part, the second disc part and the blocking part are arranged in parallel.

17. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-15, wherein, The first disc part and the second disc part are symmetrically arranged or asymmetrically arranged.

18. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first outer surface has a greater surface roughness than the first inner surface; and the second outer surface has a greater surface roughness than the second inner surface.

19. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-15, wherein, Also included are: A delivery device connection portion integrally formed at an axial end of the occlusion portion, the delivery device connection portion adapted to connect with a push assembly in an occlusion device delivery device.

20. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 19, wherein, The delivery device connection portion is configured as a flat block extending along an axial direction of the occlusion portion.

21. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 20, wherein, A surface of the delivery device connection portion is provided with a plurality of ribs spaced along the axial direction.

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