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

Abstract

Provided is a double-disk-shaped integrally-formed degradable atrial septum foramen ovale occluder (100), which comprises: a first disk part (10), a second disk part (20), and an occlusion part (30), wherein the first disk part (10) and the second disk part (20) are respectively connected to two ends of the occlusion part (30), and the first disk part (10), the second disk part (20), and the occlusion part (30) are of an integrally formed structure and are degradable parts; the first disk part (10) and the second disk part (20) are both elastic parts capable of automatically restoring the original shape. A plane where an edge of the first disk part (10) is located is a first plane (a), a plane where an edge of the second disk part (20) is located is a second plane (b), an included angle between the axis of the occlusion part (30) and the first plane (a) is an acute angle, and / or an included angle between the axis of the occlusion part (30) and the second plane (b) is an acute angle.

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 202410451556.6 and the application date of April 15, 2024, and the Chinese patent application with the application number 202420776702.8 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-cerebral hypoxia, etc.

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

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

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

[0008] Application content

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

[0010] The double-disc integrally-formed degradable heart atrial septal oval foramen occluder according to the embodiments of the present application comprises a first disc part, a second disc part and an occlusion part, the first disc part and the second disc part are connected at two ends of the occlusion part, the first disc part, the second disc part and the occlusion part are integrally-formed and degradable; the first disc part and the second disc part are both elastic parts that can automatically restore to original shape; the plane where the edge of the first disc part is located is a first plane, the plane where the edge of the second disc part is located is a second plane, the angle between the axis of the occlusion part and the first plane is an acute angle, and / or the angle between the axis of the occlusion part and the second plane is an acute angle.

[0011] The double-disc integrally-formed degradable heart atrial septal oval foramen occluder according to the embodiments of the present application is integrally-formed and degradable, provides a temporary bridge for self-repair of the heart, and provides a place for 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 human body is uniform, there is no risk of structural disintegration, all the shortcomings of the existing woven structure occluder can be overcome, and the operation can be simplified. And the first disc part and / or the second disc part are inclined relative to the occlusion part, so that the first disc part and the second disc part can adapt to the different shape of the heart wall structure, and the occlusion effect is improved.

[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] The first plane and the second plane are arranged in parallel.

[0014] At least part of at least one of the first disc part and the second disc part is a conical ring, which is arranged to extend from the center to the edge towards the direction close to the center of the double-disc integrally-formed degradable heart atrial septal oval foramen occluder.

[0015] At least part of the first disc part is a conical ring, at least part of the second disc part is a conical ring, and the first disc part and the second disc part are arranged in interlocking.

[0016] At least part of at least one of the first disc part and the second disc part is an inverted conical ring, which is arranged to extend from the center to the edge towards the direction away from the center of the double-disc integrally-formed degradable heart atrial septal oval foramen occluder.

[0017] At least part of the first disc part is an inverted conical ring, at least part of the second disc part is an inverted conical ring, and the first disc part and the second disc part are in a mutually facing away disc structure.

[0018] The first disc part and the second disc part are parallel disc bodies.

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

[0020] The first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface being arranged towards the second disc part, the first support rib protruding from at least one of the first inner surface and the first outer surface; the second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface being arranged towards the first disc part, the second support rib protruding from at least one of the second inner surface and the second outer surface.

[0021] The cross-sectional shape of the first annular plate and the second annular plate is circular, quasi-circular or polygonal.

[0022] The first support rib comprises a plurality of first radial ribs extending along the radial direction of the first annular plate, the plurality of first radial ribs being arranged at intervals along the circumferential direction of the first annular plate; the second support rib comprises a plurality of second radial ribs extending along the radial direction of the second annular plate, the plurality of second radial ribs being arranged at intervals along the circumferential direction of the second annular plate.

[0023] 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 apart 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 apart from the outer edge of the second annular plate.

[0024] The first support rib further comprises a first annular rib extending along the circumferential direction of the first annular plate, the first annular rib being at least one; the second support rib further comprises a second annular rib extending along the circumferential direction of the second annular plate, the second annular rib being at least one.

[0025] The first support rib further comprises at least one first annular rib extending along the circumferential direction of the first annular plate, the at least one first annular rib being connected with the plurality of first radial ribs; the second support rib further comprises at least one second annular rib extending along the circumferential direction of the second annular plate, the at least one second annular rib being connected with the plurality of second radial ribs.

[0026] At least one of the first annular ribs is arranged on the outer edge of the first annular plate, and outer ends of the plurality of first radial ribs are connected to the first annular ribs arranged on the outer edge of the first annular plate; at least one of the second annular ribs is arranged on the outer edge of the second annular plate, and outer ends of the plurality of second radial ribs are connected to the second annular ribs arranged on the outer edge of the second annular plate.

[0027] The occluder further comprises a delivery device connecting portion integrally formed at one end of the occlusion portion, and the delivery device connecting portion is adapted to be connected with a pushing assembly in an occluder delivery device.

[0028] The delivery device connecting portion is configured as a connecting block, and the surface of the connecting block is provided with anti-skid lines.

[0029] Additional aspects and advantages of the present application will be in part apparent and in part pointed out hereinafter. BRIEF DESCRIPTION OF DRAWINGS

[0030] The above and / or additional aspects and advantages of the present application will become apparent and be readily appreciated from the following description, including the appended drawings.

[0031] Fig. 1 is a structural schematic view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to one embodiment of the present application;

[0032] Fig. 2 is a sectional view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to one embodiment of the present application;

[0033] Fig. 3 is a structural schematic view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to another embodiment of the present application;

[0034] Fig. 4 is a structural schematic view of a double-disc integrally formed degradable heart atrial septal oval foramen occluder according to still another embodiment of the present application.

[0035] Reference Signs:

[0036] 100 - occluder;

[0037] 10 - first disc portion; 11 - first annular plate; 12 - first support rib; 121 - first radial rib; 122 - first annular rib;

[0038] 20 - second disc portion; 21 - second annular plate; 22 - second support rib; 221 - second radial rib; 222 - second annular rib;

[0039] 30 - occlusion portion;

[0040] a - first plane; b - second plane; c - axis of the occlusion portion;

[0041] 40 - delivery device connection portion. DETAILED DESCRIPTION

[0042] Embodiments of the present application are described below in detail, examples of which are shown in the drawings, wherein the same or similar notations represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary, and are intended to explain the present application, and cannot be understood as a limitation of the present application.

[0043] 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.

[0044] The double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder 100 according to 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 both 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 both 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 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 their original state.

[0045] The double-disc integrally formed degradable heart atrial septal patent foramen ovale occluder 100 of the present application is a degradable member, which can be degraded and absorbed in the body within 6 months to 2 years after the operation, the occluder 100 provides a temporary bridge for the heart itself to repair, for the self-cell tissue to climb and grow, and is degraded by the body after completing the mission, so that the atrial septal defect is completely repaired by the self-tissue, avoiding the influence of the permanent retention of the occluder in the human body, and will not affect the surgical treatment after possible future heart disease.

[0046] The double-disc integrally-formed degradable heart atrial septal patent foramen ovale occluder 100 of the present application is an integrally-formed degradable member, compared with the occluder in the related art which is formed by weaving a nickel-titanium alloy wire into a net frame and then covering a flow-blocking film, the occluder 100 of the present application can avoid long-term complications and safety hazards caused by metal retention in the body, and the occluder 100 of the present application is of an integrated structure, the structural integrity of the occluder 100 is strong, the occluder 100 is formed of the same material, the degradation rate of the occluder 100 in the human body is uniform, there is no risk of structural disintegration, and all the shortcomings of the woven structure occluder in the related art can be overcome, and the surgical operation can be simplified.

[0047] The occluder for interventional treatment needs to be introduced to the lesion site through a small sheath tube, the occluder 100 of the present application can deform, the volume of the occluder 100 is reduced to be accommodated in the sheath tube, and the occluder 100 is convenient to transport; after the occluder 100 is transported out of the sheath tube, the occluder 100 can automatically recover to the original state, and the occluder 100 recovers to the original state to occlude the atrial septal patent foramen ovale.

[0048] The following briefly describes the process of using the occluder 100 of the present application, when the integrally-formed degradable atrial septal patent foramen ovale occluder 100 of the present application is used, the sheath tube is extended to the atrial septal patent foramen ovale, the push assembly pushes the occluder 100 along the sheath tube to the atrial septal defect, the second disc portion 20 is released from the sheath tube on the left atrial side, the second disc portion 20 automatically recovers to the original state after being released, and the second disc portion 20 abuts against the left atrial wall; then the occlusion portion 30 is released from the sheath tube, the occlusion portion 30 is positioned in the atrial septal patent foramen ovale, and the atrial septal defect is occluded; finally, the first disc portion 10 is released from the sheath tube on the right atrial side, the first disc portion 10 automatically recovers to the original state after being released, and the first disc portion 10 abuts against the right atrial wall, so as to realize the occlusion of the atrial septal patent foramen ovale by the occluder 100.

[0049] In addition, compared with the occluder in the related art which is formed by weaving a nickel-titanium alloy wire into a net frame and then covering a flow-blocking film, the occluder 100 of the present application is an elastic member, the occluder 100 can deform to a smaller volume, so it can be transported by a sheath tube with a smaller diameter, which is beneficial to reduce the risk of surgery. When the occluder 100 is sent out of the sheath tube, the occluder 100 can automatically recover to the original state, so it is not necessary to additionally provide a driving member to drive the occluder 100 to recover to the original state, which can reduce the manufacturing cost and simplify the surgical operation.

[0050] The shape of the atrial septal patent foramen ovale is relatively complex, and when the axial direction of the occlusion portion is parallel to the axial directions of the first disc portion and the second disc portion, the expansion of the first disc portion and the second disc portion may be blocked by the inner wall of the heart after the occlusion portion is processed to occlude the patent foramen ovale, which reduces the occlusion effect.

[0051] Therefore, the occlusion part 30 of the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occlusion device 100 is obliquely arranged, the plane where the edge of the first disc part 10 is located is the first plane a, the plane where the edge of the second disc part 20 is located is the second plane b, the angle between the axis c of the occlusion part 30 and the first plane a is an acute angle, and / or the angle between the axis c of the occlusion part 30 and the second plane b is an acute angle.

[0052] The first disc part 10 and / or the second disc part 10 are obliquely arranged relative to the occlusion part 30, and the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occlusion device 100 can select the occlusion part 30, the first disc part 10 and the second disc part 20 according to the shape of the heart wall surface in actual application, so as to improve the occlusion effect of the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occlusion device 100.

[0053] According to the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occlusion device 100, the occlusion device 100 is an integrally-formed degradable member, the occlusion device 100 provides a temporary bridge for the self-repair of the heart, so that the cell tissue can climb and grow, and then be degraded and absorbed in the body. The long-term complications and safety hazards caused by the metal remaining in the body can be avoided, the structural integrity of the occlusion device 100 is strong, the degradation rate of the occlusion device 100 in the human body is uniform, there is no risk of structural disintegration, all the shortcomings of the existing braided structure occlusion device 100 can be overcome, and the operation can be simplified. The first disc part 10 and / or the second disc part 10 are obliquely arranged relative to the occlusion part 30, so that the first disc part 10 and the second disc part 20 can adapt to the heart wall surface structure of different shapes, and the occlusion effect is improved.

[0054] In some embodiments of the present application, as shown in FIG. 1, the angle between the axis c of the occlusion part 30 and the first plane a is an acute angle, the angle between the axis c of the occlusion part 30 and the second plane b is an acute angle, the angle between the axis c of the occlusion part 30 and the first plane a is equal to the angle between the axis c of the occlusion part 30 and the second plane b, and the first plane a and the second plane b are arranged in parallel.

[0055] The occlusion part 30 is obliquely arranged relative to the first plane a and the second plane b, and the double-disc integrally-formed degradable heart atrial septal patent foramen ovale occlusion device 100 is suitable for the case that the foramen ovale is oblique relative to the heart wall surface. After the occlusion part 30 occludes the foramen ovale, at least the edges of the first disc part 10 and the second disc part 20 can reliably contact the heart wall surface, so as to further improve the occlusion effect, and the contact between the first disc part 10 and the second disc part 20 and the heart wall surface is conducive to the climbing and growth of the cell tissue, so as to improve the repair effect.

[0056] In some embodiments of the present application, as shown in FIG. 1, the angle between the axis c of the occlusion part 30 and the first plane a is equal to the angle between the axis c of the occlusion part 30 and the second plane b, and the angle a between the axis c of the occlusion part 30 and the first plane a satisfies: 20°≤a<90°.

[0057] In some embodiments of the present application, as shown in FIGS. 1 and 2, at least part of at least one of the first disc part 10 and the second disc part 20 is a tapered ring, which extends from the center to the edge towards the direction close to the center of the double-disc integrally formed degradable heart atrial septal oval foramen occluder 100.

[0058] It is worth noting that the first disc part 10 and the second disc part 20 are respectively connected at both ends of the occlusion part 30 in the length direction, so the central position of the double-disc integrally formed degradable heart atrial septal oval foramen occluder 100 is the middle part of the occlusion part 30.

[0059] At least part of at least one of the first disc part 10 and the second disc part 20 is a tapered ring, when at least part of the first disc part 10 is a tapered ring, the tapered ring extends from the center to the edge towards the direction of the second disc part 20; when at least part of the second disc part 20 is a tapered ring, the tapered ring extends from the center to the edge towards the direction of the first disc part 10.

[0060] In some embodiments of the present application, as shown in FIGS. 1 and 2, at least part of the first disc part 10 is a tapered ring, and at least part of the second disc part 20 is a tapered ring, and the first disc part 10 and the second disc part 20 are arranged in a buckling manner. By arranging the first disc part 10 and the second disc part 20 in a buckling manner, the first disc part 10 and the second disc part 20 can reliably abut on the heart atrium wall, which can increase the contact area of the first disc part 10 with the heart atrium wall, and can increase the contact area of the second disc part 20 with the heart atrium wall, which can improve the arrangement stability of the occluder 100, and is also beneficial to the cell tissue climbing growth and improves the repair effect.

[0061] In some embodiments of the present application, as shown in FIG. 4, at least part of at least one of the first disc part 10 and the second disc part 20 is an inverted tapered ring, which extends from the center to the edge towards the direction away from the center of the double-disc integrally formed degradable heart atrial septal oval foramen occluder 100.

[0062] At least part of at least one of the first disc part 10 and the second disc part 20 is an inverted tapered ring, when at least part of the first disc part 10 is an inverted tapered ring, the tapered ring extends from the center to the edge towards the direction away from the second disc part 20; when at least part of the second disc part 20 is an inverted tapered ring, the tapered ring extends from the center to the edge towards the direction away from the first disc part 10.

[0063] In some embodiments of the present application, as shown in FIG. 4, at least part of the first disc part 10 is a reverse conical ring, at least part of the second disc part 20 is a reverse conical ring, and the first disc part 10 and the second disc part 20 are in a disc-shaped structure facing away from each other.

[0064] The first disc part 10 and the second disc part 20 are both reverse conical rings, and the first disc part 10 and the second disc part 20 are in a reverse buckle shape facing away from each other. By arranging the first disc part 10 and the second disc part 20 to face away from each other, the first disc part 10 and the second disc part 20 can be avoided to hinder the occlusion part 30, and the situation that the first disc part 10 or the second disc part 20 hinders the formation of the interatrial septal foramen of the heart can be reduced, thereby improving the working reliability of the double-disc integrally formed degradable interatrial septal foramen occluder 100.

[0065] In some embodiments of the present application, at least part of one of the first disc part 10 and the second disc part 20 is a conical ring extending from the center to the edge towards the direction close to the center of the double-disc integrally formed degradable interatrial septal foramen occluder 100, and at least part of the other of the first disc part 10 and the second disc part 20 is a reverse conical ring extending from the center to the edge towards the direction away from the center of the double-disc integrally formed degradable interatrial septal foramen occluder 100.

[0066] One of the first disc part 10 and the second disc part 20 is arranged to buckle towards the middle position of the occlusion part 10, and the other of the first disc part 10 and the second disc part 20 is arranged to extend away from the middle position of the occlusion part 10, which also falls within the protection scope of the present application.

[0067] In some embodiments of the present application, as shown in FIG. 3, the first disc part 10 and the second disc part 20 are parallel discs. The first disc part 10 and the second disc part 20 are arranged in parallel, and the contact area of the first disc part 10 and the second disc part 20 with the heart wall surface after restoration is larger, which can improve the occlusion effect.

[0068] In some embodiments of the present application, as shown in FIG. 2, the first disc part 10 includes a first annular plate 11 and a first support rib 12, the first annular plate 11 is the main part of the first disc part 10, and the first support rib 12 is arranged on the first annular plate 11 and is used to support the first annular plate 11 to restore its original shape. The second disc part 20 includes a second annular plate 21 and a second support rib 22, the second annular plate 21 is the main part of the second disc part 20, and the second support rib 22 is arranged on the second annular plate 21 and is used to support the second annular plate 21 to restore its original shape.

[0069] It is worth mentioning that the first annular plate 11 and the second annular plate 21 are configured as a sheet structure, compared with a three-dimensional occluder in the prior art which is woven by a nickel-titanium alloy wire into a net rack and then covered with a flow-blocking film, the space volume of the occluder 100 is smaller, the occluder 100 can be deformed into a smaller volume and accommodated in a sheath, and the occluder 100 can be delivered through a sheath with a smaller diameter, which is beneficial to reducing the risk of surgery.

[0070] Compared with automatically restoring to the original shape only by the structure of the first annular plate 11 itself or only by the structure of the second annular plate 21 itself, the first support rib 12 can improve the speed of the first annular plate 11 to restore to the original shape, the second support rib 22 can improve the speed of the second annular plate 21 to restore to the original shape, and the situation that the first annular plate 11 and the second annular plate 21 are blocked and cannot completely restore to the original shape is reduced, which is beneficial to the release of the occluder 100, improves the working reliability of the occluder 100, and improves the efficiency of the surgery.

[0071] In some embodiments of the present application, the first annular plate 11 has a first inner surface and a first outer surface opposite to each other, the first inner surface is arranged towards the second disc portion 20, and the first support rib 12 protrudes from at least one of the first inner surface and the first outer surface; the second annular plate 21 has a second inner surface and a second outer surface opposite to each other, the second inner surface is arranged towards the first disc portion 10, and the second support rib 22 protrudes from at least one of the second inner surface and the second outer surface.

[0072] Optionally, the first support rib 12 can protrude from the first annular plate 11 in the direction of the first inner surface, or, optionally, the first support rib 12 can also protrude from the first annular plate 11 in the direction of the first outer surface, or, optionally, the first support rib 12 can protrude from both the first inner surface and the first outer surface.

[0073] Optionally, the second support rib 22 can protrude from the second inner surface, or, optionally, the second support rib 22 can also protrude from the second outer surface, or, optionally, the second support rib 22 can protrude from both the second outer surface and the second inner surface.

[0074] In some embodiments of the present application, the cross-sectional shape of the first annular plate 11 and the second annular plate 21 is circular, quasi-circular or polygonal. The first annular plate 11 or the second annular plate 21 with a corresponding cross-sectional shape can be selected according to the shape of the atrial wall of the affected part to fit the affected part.

[0075] It is worth mentioning that the occluder 100 of the embodiments of the present application can directly trim the first annular plate 11 or the second annular plate 21, so that the shapes of the first disc part 10 and the second disc part 20 fit the affected area. Since the occluder 100 of the embodiments of the present application is a one-piece structure, directly trimming the first annular plate 11 or the second annular plate 21 will not damage the integrity of the first disc part 10 and the second disc part 20, and the first disc part 10 and the second disc part 20 can work normally, so 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 custom parts.

[0076] Alternatively, the first support rib 12 can only include a plurality of first radial ribs 121, the first radial ribs 121 are arranged at intervals along the circumference of the first annular plate 11, and the first radial ribs 121 extend along the radial direction of the first annular plate 11; and the second support rib 22 only includes a plurality of second radial ribs 221, the second radial ribs 221 are arranged at intervals along the circumference of the second annular plate 21, and the second radial ribs 221 extend along the radial direction of the second annular plate 21.

[0077] Alternatively, the first support rib 12 can only include a first annular rib 122, the first annular rib 122 extends along the circumference of the first annular plate 11, and the first annular rib 122 is at least one; and the second support rib 22 only includes a second annular rib 222, the second annular rib 222 extends along the circumference of the second annular plate 21, and the second annular rib 222 is at least one.

[0078] Alternatively, as shown in FIG. 2, the first support rib 12 includes the first radial rib 121 and the first annular rib 122, a plurality of first radial ribs 121 are arranged at intervals along the circumference of the first annular plate 11, the first radial rib 121 extends along the radial direction of the first annular plate 11, the first annular rib 122 extends along the circumference of the first annular plate 11, and the first annular rib 122 is connected with the plurality of first radial ribs 121; and the second support rib 22 includes the second radial rib 221 and the second annular rib 222, a plurality of second radial ribs 221 are arranged at intervals along the circumference of the second annular plate 21, the second radial rib 221 extends along the radial direction of the second annular plate 21, the second annular rib 222 extends along the circumference of the second annular plate 21, and the second annular rib 222 is connected with the plurality of second radial ribs 221.

[0079] In some embodiments of the present application, as shown in FIG. 2, the inner end of the first radial rib 121 is connected with the occlusion part 30, and the outer end of the first radial rib 121 extends to the outer edge of the first annular plate 11 or is spaced apart from the outer edge of the first annular plate 11; and the inner end of the second radial rib 221 is connected with the occlusion part 30, and the outer end of the second radial rib 221 extends to the outer edge of the second annular plate 21 or is spaced apart from the outer edge of the second annular plate 21.

[0080] The inner end of the first radial rib 121 is connected with the blocking part 30, which can improve the structural strength of the first radial rib 121 and is beneficial to support the first annular plate 11 to restore the original state; the inner end of the second radial rib 221 is connected with the blocking part 30, which can improve the structural strength of the second radial rib 221 and is beneficial to support the second annular plate 22 to restore the original state.

[0081] In some embodiments, the outer end of the first radial rib 121 can extend to the outer edge of the first annular plate 11, so as to facilitate the first annular plate 11 to restore the original state.

[0082] In other embodiments, the outer end of the first radial rib 121 can also extend towards the outer edge of the first annular plate 11 and be spaced from the outer edge of the first annular plate 11.

[0083] In some embodiments, the outer end of the second radial rib 221 can extend to the outer edge of the second annular plate 21, so as to facilitate the second annular plate 22 to restore the original state.

[0084] In other embodiments, the outer end of the second radial rib 221 extends towards the outer edge of the second annular plate 21 and is spaced from the outer edge of the second annular plate 21.

[0085] In some embodiments of the present application, as shown in FIG. 2, at least one first annular rib 122 is arranged on the outer edge of the first annular plate 11, and at least one second annular rib 222 is arranged on the outer edge of the second annular plate 21. The first annular rib 122 is arranged on the outer edge of the first annular plate 11, which is beneficial to the first annular plate 11 to restore the original state, and the second annular rib 222 is arranged on the outer edge of the second annular plate 21, which is beneficial to the second annular plate 21 to restore the original state.

[0086] In some embodiments of the present application, the first support rib 12 includes the first radial rib 121 and the first annular rib 122, and the second support rib 22 includes the second radial rib 221 and the second annular rib 222. At least one first annular rib 122 is arranged on the outer edge of the first annular plate 11, and the outer end of the plurality of first radial ribs 121 is connected with the first annular rib 122 arranged on the outer edge of the first annular plate 11. At least one second annular rib 222 is arranged on the outer edge of the second annular plate 21, and the outer end of the plurality of second radial ribs 221 is connected with the second annular rib 222 arranged on the outer edge of the second annular plate 21.

[0087] The outer ends of the plurality of first radial ribs 121 are connected with the first annular rib 122 located on the outer edge of the first annular plate 11 to connect the first support rib 12 as a whole, improve the structural stability of the first support rib 12, and facilitate the first annular plate 11 to restore to its original state. The outer ends of the plurality of second radial ribs 221 are connected with the second annular rib 222 located on the outer edge of the second annular plate 21 to connect the second support rib 22 as a whole, improve the structural stability of the second support rib 22, and facilitate the first annular plate 11 to restore to its original state.

[0088] In some embodiments of the present application, the first radial rib 121 includes 1-100; the second radial rib 221 includes 1-100.

[0089] Optionally, the first radial rib 121 can be 1, 4, 5, 6, 8, 10, 20, 50, 100, etc.

[0090] Optionally, the second radial rib 221 can be 1, 4, 5, 8, 10, 16, 30, 50, 100, etc.

[0091] In some embodiments of the present application, the first annular rib 122 includes 1-10, and the second annular rib 222 includes 1-10.

[0092] Too many first annular ribs 122 are not conducive to the deformation of the first annular plate 11; similarly, too many second annular ribs 222 are not conducive to the normal operation of the occluder 100.

[0093] Optionally, the first annular rib 122 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0094] Optionally, the second annular rib 222 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0095] In some embodiments of the present application, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0096] The shape, projection area and thickness of the first disc portion 10 and the second disc portion 20 are consistent; the number, structure and size of the first radial rib 121 on the first disc portion 10 are the same as the number, structure and size of the second radial rib 221 on the second disc portion 20, and the number, structure and size of the first annular rib 122 on the first disc portion 10 are the same as the number, structure and size of the second annular rib 222 on the second disc portion 20.

[0097] In some other embodiments of the present application, the first disc portion 10 and the second disc portion 20 are asymmetrically arranged.

[0098] Optionally, the number, structure and size of the first radial ribs 121 on the first disc part 10 are different from the number, structure and size of the second radial ribs 221 on the second disc part 20; or, optionally, the number, structure and size of the first annular ribs 122 on the first disc part 10 are different from the number, structure and size of the second annular ribs 222 on the second disc part 20.

[0099] In some embodiments of the present application, as shown in FIGS. 1-4, the occluder 100 further comprises a delivery device connecting part 40 integrally formed at one end of the occlusion part 30, which is adapted to be connected with a pushing assembly in a delivery device of the occluder 100.

[0100] The pushing assembly is selectively connected with the delivery device connecting part 40, and when the pushing assembly is connected with the delivery device connecting part 40, the pushing assembly can drive the occluder 100 to move, and when the pushing assembly is separated from the delivery device connecting part 40, the pushing assembly can be recycled.

[0101] In some embodiments of the present application, as shown in FIGS. 1 and 2, the delivery device connecting part 40 is arranged on one side of the first disc part 10 on the occlusion part 30.

[0102] In some embodiments of the present application, the delivery device connecting part 40 can be a hole, a pit or a protruding structure, and the pushing assembly is connected with the delivery device connecting part 40 in cooperation. Optionally, the hole, the pit or the protruding structure can be in a circular, elliptical, triangular, or composite geometric shape; the hole can be a through structure, the pit or the protruding structure can be a non-through structure, and the protruding structure can be a flat protrusion or a cylindrical protrusion structure.

[0103] In some embodiments of the present application, as shown in FIG. 1, the delivery device connecting part 40 is configured as a connecting block, and the surface of the connecting block is provided with anti-slip lines.

[0104] The occluder 100 of the present application is an integrated structure, and the occluder 100 is an elastic member capable of automatically restoring to the original state. When the occluder 100 is sent out from a sheath, the occluder 100 can automatically restore to the original state, so that a driving member for driving the occluder 100 to restore to the original state is not required, the manufacturing cost can be reduced, and the operation of the surgery can be simplified. The delivery device connecting part 40 is configured as a connecting block, a clamping member can be used as a pushing assembly, the clamping member clamps the connecting block to be connected with the occluder 100, and the connection and release operations of the clamping member are simple, so that the operation of the surgery can be simplified.

[0105] The anti-slip lines can improve the surface friction of the connecting block, further improve the connection stability of the pushing assembly and the connecting block, and improve the working reliability of the occluder 100.

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

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

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

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

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

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

Claims

1. A bi- disc shaped integrally formed degradable heart atrial septal patent foramen ovale occluder, wherein, The bi-disc integrally formed degradable heart atrial septal oval foramen occluder comprises: a first disc part and a second disc part connected at two ends of a blocking part, the first disc part, the second disc part and the blocking part being an integrally formed piece and being a degradable piece; the first disc part and the second disc part are both elastic pieces capable of automatically restoring to original shape; an edge of the first disc part is located on a first plane, an edge of the second disc part is located on a second plane, an angle between an axis of the blocking part and the first plane is an acute angle, and / or an angle between the axis of the blocking part and the second plane is an acute angle.

2. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, The first plane and the second plane are arranged in parallel.

3. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, At least part of at least one of the first disc part and the second disc part is a conical ring, which is arranged to extend from the center to the edge towards the center of the bi-disc integrally formed degradable heart atrial septal oval foramen occluder.

4. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 3, wherein, At least part of the first disc part is a conical ring, at least part of the second disc part is a conical ring, and the first disc part and the second disc part are arranged in interlocking.

5. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 1, wherein, At least part of at least one of the first disc part and the second disc part is an inverted conical ring, which is arranged to extend from the center to the edge away from the center of the bi-disc integrally formed degradable heart atrial septal oval foramen occluder.

6. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 5, wherein, At least part of the first disc part is an inverted conical ring, at least part of the second disc part is an inverted conical ring, and the first disc part and the second disc part are arranged in a mutually facing away disc structure.

7. The bi-disc integrally formed degradable heart atrial septal oval foramen occluder of claim 1, wherein the first disc part and the second disc part are parallel discs.

8. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-7, wherein, The first disc part comprises a first annular plate and a first support rib, the first support rib being arranged on the first annular plate, and the first support rib being used for supporting the first annular plate to restore to original shape. The second disc part comprises a second annular plate and a second support rib, the second support rib being arranged on the second annular plate, and the second support rib being used for supporting the second annular plate to restore to original shape.

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

10. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first annular plate and the second annular plate have a circular, quasi-circular or polygonal cross-sectional shape.

11. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first support rib comprises a plurality of first radial ribs, the first radial ribs extending along a radial direction of the first annular plate, and the first radial ribs being arranged in intervals along a circumferential direction of the first annular plate. The second support rib comprises a plurality of second radial ribs, the second radial ribs extending along a radial direction of the second annular plate, and the second radial ribs being arranged in intervals along a circumferential direction of the second annular plate.

12. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 11, wherein, 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.

13. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 8, wherein, The first support rib further comprises: at least one first annular rib extending along the circumference of the first annular plate. The second support rib further comprises: at least one second annular rib extending along the circumference of the second annular plate.

14. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 11, wherein, The first support rib further comprises: at least one first annular rib extending along the 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 the circumference of the second annular plate, and the at least one second annular rib is connected with the plurality of second radial ribs.

15. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 14, 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.

16. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of any one of claims 1-7, wherein, Further comprising: A delivery device connecting part integrally formed at one end of the blocking part, the delivery device connecting part being adapted to be connected with a pushing assembly in a delivery device for occluder.

17. The dual-disk one-piece integrally formed degradable heart atrial septal patent foramen ovale occluder of claim 16, wherein, The delivery device connecting part is configured as a connecting block, and an anti-slip pattern is arranged on the surface of the connecting block.

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