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

Abstract

This utility model discloses a dual-disc, one-piece biodegradable foramen ovale occluder for the atrial septum. The occluder includes a first disc, a second disc, and a sealing portion. The first and second discs are connected to the axial ends of the sealing portion. The first, second, and sealing portions are integrally molded and biodegradable. Both the first and second discs are elastic components that can automatically return to their original shape, and they are arranged in parallel. As an integrally molded biodegradable component, the occluder provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids the long-term complications and safety hazards caused by metal residue in the body. The occluder has strong structural integrity, degrades uniformly within the body, and has no risk of structural disintegration. It overcomes all the shortcomings of existing woven occluders and simplifies surgical procedures.

Description

Technical Field

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

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

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

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

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

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

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

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

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

[0010] In some embodiments, the axes of the first disc portion, the second disc portion, and the sealing portion are all arranged in parallel.

[0011] In some embodiments, the thickness of the first disk portion gradually increases in the direction of extension from the inner edge to the outer edge of the first disk portion; and the thickness of the second disk portion gradually increases in the direction of extension from the inner edge to the outer edge of the second disk portion.

[0012] In some embodiments, the first disc portion includes: a first annular plate and a first support rib, the first support rib being disposed on the first annular plate and used to support the first annular plate to return to its original shape; the second disc portion includes: a second annular plate and a second support rib, the second support rib being disposed on the second annular plate and used to support the second annular plate to return to its original shape.

[0013] In some embodiments, the first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface being disposed toward the second disc portion, and at least one of the first inner surface and the first outer surface being externally provided with the first supporting rib; the second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface being disposed toward the first disc portion, and at least one of the second inner surface and the second outer surface being externally provided with the second supporting rib.

[0014] In some embodiments, the first support rib includes: a plurality of first radial ribs extending radially along the first annular plate, the plurality of first radial ribs being circumferentially spaced along the first annular plate; the second support rib includes: a plurality of second radial ribs extending radially along the second annular plate, the plurality of second radial ribs being circumferentially spaced along the second annular plate.

[0015] In some embodiments, the inner end of the first radial rib is connected to the sealing portion, and the outer end of the first radial rib extends to the outer edge of the first annular plate or is spaced apart from the outer edge of the first annular plate; the inner end of the second radial rib is connected to the sealing portion, and the outer end of the second radial rib extends to the outer edge of the second annular plate or is spaced apart from the outer edge of the second annular plate.

[0016] In some embodiments, the first support rib further includes: a first annular rib extending circumferentially along the first annular plate, wherein at least one first annular rib is present; the second support rib further includes: a second annular rib extending circumferentially along the second annular plate, wherein at least one second annular rib is present.

[0017] In some embodiments, the first support rib further includes at least one first annular rib extending circumferentially along the first annular plate, the at least one first annular rib being connected to a plurality of first radial ribs; the second support rib further includes at least one second annular rib extending circumferentially along the second annular plate, the at least one second annular rib being connected to a plurality of second radial ribs.

[0018] In some embodiments, at least one of the first annular ribs is disposed on the outer edge of the first annular plate, and the outer ends of a plurality of the first radial ribs are connected to the first annular ribs located on the outer edge of the first annular plate; at least one of the second annular ribs is disposed on the outer edge of the second annular plate, and the outer ends of a plurality of the second radial ribs are connected to the second annular ribs located on the outer edge of the second annular plate.

[0019] In some embodiments, the first radial rib and the sealing portion are connected by an arc transition, and the second radial rib and the sealing portion are connected by an arc transition.

[0020] In some embodiments, the first disk portion and the second disk portion are symmetrically arranged, or the first disk portion and the second disk portion are asymmetrically arranged.

[0021] In some embodiments, the occluder further includes a delivery device connection portion integrally formed at one axial end of the occluder portion, the delivery device connection portion being adapted to connect to a push component in the occluder delivery device.

[0022] In some embodiments, the connecting portion of the conveying device is configured as a flat block that extends axially along the sealing portion, and the surface of the flat block is provided with anti-slip ribs.

[0023] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0024] The above and / or additional aspects and advantages of this utility model will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0025] Figure 1 This is a cross-sectional view of a dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to an embodiment of the present invention;

[0026] Figure 2 This is a schematic diagram of the structure of a double-disc, one-piece biodegradable atrial septum foramen ovale occluder according to another embodiment of the present invention.

[0027] Figure label:

[0028] 100-Occluder;

[0029] 10-First plate; 11-First annular plate; 12-First supporting rib; 121-First radial rib; 122-First annular rib;

[0030] 20 - Second plate; 21 - Second annular plate; 22 - Second supporting rib; 221 - Second radial rib; 222 - Second annular rib;

[0031] 30 - Sealing section;

[0032] 40 - Conveying device connection part; 410 - Anti-slip rib. Detailed Implementation

[0033] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model. Where specific techniques or conditions are not specified in the embodiments, they are performed according to the techniques or conditions described in the literature in the art or according to the product instructions. Reagents or instruments used, unless otherwise specified, are all conventional products that can be obtained commercially.

[0034] The following is for reference. Figure 1 and Figure 2 Description of a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for atrial septum according to some embodiments of the present invention.

[0035] According to an embodiment of the present invention, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 of the atrial septum is a biodegradable component. Optionally, the occluder 100 may be at least one of a biodegradable polymer material, a biodegradable metal material, a bioceramic material, or a bioglass material. The occluder 100 includes a first disc portion 10, a second disc portion 20, and a sealing portion 30. The first disc portion 10, the second disc portion 20, and the sealing portion 30 are manufactured by an integral molding process, forming a complete structure. The first disc portion 10 and the second disc portion 20 are connected to the two axial ends of the sealing portion 30. The sealing portion 30 passes through the atrial septum to seal the foramen ovale. The first disc portion 10 and the second disc portion 20 are respectively located on both sides of the foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 together clamp the atrial wall.

[0036] The present invention relates to a biodegradable, one-piece molded, double-disc atrial septal defect occluder 100. This biodegradable component allows the occluder 100 to be degraded and absorbed in the body within 6 months to 2 years after surgery. The occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow. After fulfilling its function, it is degraded by the body, enabling the atrial septal defect to be completely repaired by the body's own tissues. This avoids the permanent presence of the occluder in the body and will not affect future surgical treatment for possible heart diseases.

[0037] The dual-disc, one-piece biodegradable foramen ovale occluder 100 of this invention is a one-piece biodegradable component. Compared with occluders in related technologies that use nickel-titanium alloy wires woven into a mesh frame and then covered with a flow-blocking membrane, the occluder 100 of this invention can avoid long-term complications and safety hazards caused by metal remaining in the body. Furthermore, the occluder 100 of this invention has a one-piece structure with strong structural integrity. The occluder 100 is formed from the same material, and the degradation rate of the occluder 100 in the human body is uniform with no risk of structural disintegration. It can overcome all the disadvantages of woven structure occluders in related technologies and can also simplify surgical procedures.

[0038] In interventional treatments, the occluder needs to be inserted into the lesion site through a thin sheath. The occluder 100 of this invention is deformable; both the first disc portion 10 and the second disc portion 20 are elastic elements that can automatically return to their original shape. The occluder 100 deforms to reduce its volume so that it can be housed within the sheath for easy delivery. After being delivered from the sheath, the occluder 100 automatically returns to its original shape, thus sealing the foramen ovale of the atrial septum.

[0039] Furthermore, in this embodiment of the occluder 100, the first disc portion 10 and the second disc portion 20 are arranged in parallel. After the first disc portion 10 and the second disc portion 20 return to their original state, the contact area with the heart wall is large, which can improve the occlusion effect.

[0040] In addition, compared to related technologies where occluders utilize a mesh frame woven from nickel-titanium alloy wires covered with a flow-blocking membrane, the occluder 100 in this embodiment is an elastic element. The occluder 100 can deform into a smaller volume, allowing it to be delivered through a smaller diameter sheath, thus reducing surgical risks. When the occluder 100 is withdrawn from the sheath, it automatically returns to its original shape, eliminating the need for an additional drive mechanism to restore it to its original state. This reduces manufacturing costs and simplifies the surgical procedure.

[0041] According to an embodiment of this utility model, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is a biodegradable component. The occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids long-term complications and safety hazards caused by metal residue in the body. The occluder 100 has strong structural integrity, a uniform degradation rate within the body, and no risk of structural disintegration. It overcomes all the shortcomings of existing woven-structure occluders 100 and simplifies surgical procedures.

[0042] In some embodiments of this utility model, the axes of the first disc portion 10, the second disc portion 20, and the sealing portion 30 are all arranged in parallel.

[0043] The parallel alignment of the axes helps the occluder 100 better adapt to the internal structure of the heart, resulting in more precise occlusion and reducing the possibility of blood leakage from the foramen ovale. The parallel axis design also makes the operation of the occluder 100 more intuitive and simple, allowing physicians to more easily place it in the correct position and ensure its stability during the procedure.

[0044] In some embodiments of the present invention, the thickness of the first disk portion 10 gradually increases in the direction of extension from the inner edge to the outer edge of the first disk portion 10; and the thickness of the second disk portion 20 gradually increases in the direction of extension from the inner edge to the outer edge of the second disk portion 20.

[0045] The inner edge of the first disc portion 10 is connected to the sealing portion 30, providing strong support stability. However, the outer edge of the first disc portion 10 is located further away from the supporting sealing portion 30 than the inner edge, making it more prone to deformation. Increasing the thickness at the outer edge of the first disc portion 10 helps it recover its original shape after deformation. Similarly, increasing the thickness at the outer edge of the second disc portion 20 helps it recover its original shape after deformation.

[0046] In some embodiments of this utility model, the thickness of the first disc portion 10 and the second disc portion 20 are independently 0.01mm-8mm.

[0047] In some embodiments of this utility model, such as Figure 1 and Figure 2As shown, the first disc portion 10 includes a first annular plate 11 and a first supporting rib 12. The first annular plate 11 is the main body of the first disc portion 10, and the first supporting rib 12 is disposed on the first annular plate 11 and is used to support the first annular plate 11 to restore its original shape. The second disc portion 20 includes a second annular plate 21 and a second supporting rib 22. The second annular plate 21 is the main body of the second disc portion 20, and the second supporting rib 22 is disposed on the second annular plate 21 and is used to support the second annular plate 21 to restore its original shape.

[0048] The occluder 100 of this utility model deforms to reduce its volume so that it can be stored in the sheath for easy transport. After the occluder 100 is transported out of the sheath, the first support rib 12 supports the first annular plate 11 to return to its original shape, and the second support rib 22 supports the second annular plate 21 to return to its original shape. The occluder 100 returns to its original shape to block the foramen ovale of the interatrial septum.

[0049] Compared to simply relying on the structure of the first annular plate 11 to automatically restore it to its original state, the speed at which the first annular plate 11 restores its original state can be increased by setting the first support rib 12. Similarly, the speed at which the second annular plate 21 restores its original state can be increased by setting the second support rib 22. This reduces the occurrence of situations where the first annular plate 11 and the second annular plate 21 are blocked and cannot fully restore their original state, which is beneficial for the release of the occluder 100, improves the working reliability of the occluder 100, and improves the efficiency of the operation.

[0050] In some embodiments of this invention, the cross-sectional shape of the first annular plate 21 and the second annular plate 22 perpendicular to the axial direction of the blocking portion 30 is circular, near-circular, or polygonal. The first annular plate 11 or the second annular plate 21 with a corresponding cross-sectional shape can be selected according to the shape of the atrial wall at the affected area to fit the affected area.

[0051] The cross-sectional shapes of the first annular plate 21 and the second annular plate 22 in the axial direction perpendicular to the sealing part 30 can be the same, or the cross-sectional shapes of the first annular plate 21 and the second annular plate 22 in the axial direction perpendicular to the sealing part 30 can be different.

[0052] It is worth noting that the occluder 100 of this embodiment can be directly trimmed on the first annular plate 11 or the second annular plate 21 to make the shape of the first disc portion 10 and the second disc portion 20 conform to the affected area. Since the occluder 100 of this embodiment is a one-piece structure, directly trimming the first annular plate 11 or the second annular plate 21 will not damage the integrity of the first disc portion 10 and the second disc portion 20, and the first disc portion 10 and the second disc portion 20 can function normally. Therefore, this invention supports custom trimming, has a wide range of applications, is highly targeted, helps improve the repair effect, and can save on the manufacturing cost of customized parts.

[0053] It is worth noting that the first annular plate 11 and the second annular plate 21 are constructed as sheet-like structures. Compared with the three-dimensional occluders in related technologies that use nickel-titanium alloy wires woven into a mesh frame and then covered with a flow-blocking membrane, the occluder 100 of this utility model has a smaller spatial volume. The occluder 100 can be deformed into a smaller volume and stored in a sheath, and can be delivered through a sheath with a smaller diameter, which helps to reduce surgical risks.

[0054] In some embodiments of the present invention, the first annular plate 11 has a first inner surface and a first outer surface facing away from each other, the first inner surface is disposed facing the second disc portion 20, and at least one of the first inner surface and the first outer surface is provided with a first supporting rib 12; the second annular plate 21 has a second inner surface and a second outer surface facing away from each other, the second inner surface is disposed facing the first disc portion 10, and at least one of the second inner surface and the second outer surface is provided with a second supporting rib 22.

[0055] It is worth noting that the inner and outer directions are based on the center of the plugger 100, which is different from the orientation of the inner edge, outer edge, and other structures mentioned above. The first disc portion 10 and the second disc portion 20 are connected to the two ends of the plugging portion 30 in the axial direction. The first inner surface and the second inner surface are arranged opposite each other in the axial direction of the plugger 100, and the first outer surface and the second outer surface are arranged opposite each other in the axial direction of the plugger 100.

[0056] Optionally, the first support rib 12 may protrude from the first annular plate 11 in the direction of the first inner surface, or alternatively, the first support rib 12 may also protrude from the first annular plate 11 in the direction of the first outer surface, or alternatively, the first support rib 12 may protrude from both the first inner surface and the first outer surface.

[0057] Optionally, the second support rib 22 may protrude from the second inner surface, or alternatively, the second support rib 22 may also protrude from the second outer surface, or alternatively, the second support rib 22 may protrude from both the second outer surface and the second inner surface.

[0058] In some embodiments of this invention, the first support rib 12 is only disposed on the first inner surface, or most of it protrudes from the first inner surface and only a portion is located on the first outer surface; the second support rib 22 is only disposed on the second inner surface, or most of it protrudes from the first inner surface and only a portion is located on the second outer surface. The first and second outer surfaces serve as support surfaces for cell tissue climbing and growth. By disposing all or most of the first support rib 12 on the first inner surface and all or most of the second support rib 22 on the second inner surface, it is ensured that the first and second outer surfaces are continuous and flat support surfaces, which is conducive to cell climbing and growth. At the same time, it can reduce the risk of local thrombosis in the first disc portion 10 and the second disc portion 20, and improve the repair effect.

[0059] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the first support rib 12 includes: a plurality of first radial ribs 121, which are spaced apart circumferentially along the first annular plate 11 and extend radially along the first annular plate 11; the second support rib 22 includes: a plurality of second radial ribs 221, which are spaced apart circumferentially along the second annular plate 21 and extend radially along the second annular plate 21.

[0060] The first radial rib 121 extends radially along the first annular plate 11. When the first disc portion 10 is compressed and deformed, the first radial rib 121 tends to support the first annular plate 11 to restore its original shape. After the compression of the first disc portion 10 is removed, the first radial rib 121 can support the first annular plate 11 to expand radially and restore its original shape. Similarly, the second radial rib 221 extends along the second annular plate 21. When the second disc portion 20 is compressed and deformed, the second radial rib 221 tends to support the second annular plate 21 to restore its original shape. After the compression of the second disc portion 20 is removed, the second radial rib 221 can support the second annular plate 21 to expand radially and restore its original shape.

[0061] The first radial ribs 121 are spaced circumferentially along the first annular plate 11, meaning that the first radial ribs 121 are evenly distributed around the first annular plate 11. This arrangement can provide uniform support force, ensure the shape consistency and reliability of the plugger 100 during use, and facilitate the restoration of the first annular plate 11 to its original shape. Similarly, the second annular ribs 221 are spaced circumferentially along the second annular plate 21, which facilitates the restoration of the second annular plate 21 to its original shape.

[0062] It is worth noting that the first radial rib 121 extends radially along the first annular plate 11, and the projection shape of the first radial rib 121 in the axial direction of the sealing portion 30 can be a straight line; or, the projection shape of the first radial rib 121 in the axial direction of the sealing portion 30 can also be a curve. Similarly, the second radial rib 221 extends radially along the second annular plate 21, and the projection shape of the second radial rib 221 in the axial direction of the sealing portion 30 can be a straight line, or the projection shape of the second radial rib 221 in the axial direction of the sealing portion 30 can also be a curve.

[0063] In some embodiments of this utility model, the cross-sectional shape of the first radial rib 121 in the thickness direction can be a column, a frustum, a triangle or a composite geometric shape, and the cross-sectional shape of the second radial rib 221 in the thickness direction can be a column, a frustum, a triangle or a composite geometric shape.

[0064] In some embodiments of this utility model, such as Figure 1 and Figure 2As shown, the inner end of the first radial rib 121 is connected to the sealing part 30, and the outer end of the first radial rib 121 extends to the outer edge of the first annular plate 11, or is spaced apart from the outer edge of the first annular plate 11; the inner end of the second radial rib 221 is connected to the sealing part 30, and the outer end of the second radial rib 221 extends to the outer edge of the second annular plate 21, or is spaced apart from the outer edge of the second annular plate 21.

[0065] The inner end of the first radial rib 121 is connected to the sealing part 30, which can improve the structural strength of the first radial rib 121 and help support the first annular plate 11 to restore its original shape; the inner end of the second radial rib 221 is connected to the sealing part 30, which can improve the structural strength of the second radial rib 221 and help support the second annular plate 22 to restore its original shape.

[0066] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the first support rib 12 further includes a first annular rib 122, which extends circumferentially along the first annular plate 11, and there is at least one first annular rib 122; the second support rib 22 further includes a second annular rib 222, which extends circumferentially along the second annular plate 21, and there is at least one second annular rib 222.

[0067] When the first disc portion 10 is compressed and deformed, the first annular rib 122 tends to support the first annular plate 11 to restore its original shape. After the compression of the first disc portion 10 is removed, the first annular rib 122 can support the first annular plate 11 to unfold circumferentially and restore its original shape. Similarly, when the second disc portion 20 is compressed and deformed, the second annular rib 222 tends to support the second annular plate 21 to restore its original shape. After the compression of the second disc portion 20 is removed, the second annular rib 22 can support the second annular plate 21 to unfold circumferentially and restore its original shape.

[0068] Optionally, there may be one first annular rib 122, or there may be multiple first annular ribs 122, which are spaced apart along the extension direction from the inner edge to the outer edge of the first annular plate 11.

[0069] Optionally, there may be one second annular rib 222, or there may be multiple second annular ribs 222, which are spaced apart along the extension direction from the inner edge to the outer edge of the second annular plate 21.

[0070] In some embodiments of this utility model, the cross-section of the first annular rib 122 is circular, fan-shaped, triangular, or a composite geometric shape; the cross-section of the second annular rib 222 is circular, fan-shaped, triangular, or a composite geometric shape.

[0071] In some embodiments of this utility model, the first support rib 12 includes: a first radial rib 121 and a first annular rib 122. Multiple first radial ribs 121 are spaced apart circumferentially along the first annular plate 11, and extend radially along the first annular plate 11. At least one first annular rib 122 is present, and at least one first annular rib 122 is connected to multiple first radial ribs 121. The connection between the first annular rib 122 and the multiple first radial ribs 121 connects the first support rib 12 into a whole, improving the structural stability of the first support rib 12 and facilitating the restoration of the first annular plate 11 to its original shape.

[0072] The second supporting rib 22 includes: a second radial rib 221 and a second annular rib 222. Multiple second radial ribs 221 are spaced apart circumferentially along the second annular plate 21. At least one second annular rib 222 is connected to multiple second radial ribs 221. Similarly, the second annular rib 222 is connected to multiple second radial ribs 221 to connect the second supporting rib 22 into a whole, improving the structural stability of the second supporting rib 22 and facilitating the restoration of the second annular plate 21 to its original state.

[0073] Furthermore, after the first annular plate 11 and the second annular plate 21 degrade, the first annular rib 122 can still be connected to the first radial rib 121, and the second annular rib 222 can still be connected to the second radial rib 221, reducing the occurrence of discomfort caused by the undegraded first annular rib 122 and the second annular rib 222 detaching from the plugger 100.

[0074] In some embodiments of the present invention, at least one first annular rib 122 is provided on the outer edge of the first annular plate 11, and the outer ends of a plurality of first radial ribs 121 are connected to the first annular rib 122 located on the outer edge of the first annular plate 11; at least one second annular rib 222 is provided on the outer edge of the second annular plate 21, and the outer ends of a plurality of second radial ribs 221 are connected to the second annular rib 222 located on the outer edge of the second annular plate 21.

[0075] The first annular rib 122 is provided on the outer edge of the first annular plate 11, which helps the first annular plate 11 to return to its original shape. Similarly, the second annular rib 222 is provided on the outer edge of the second annular plate 21, which helps the second annular plate 21 to return to its original shape.

[0076] The outer ends of multiple first radial ribs 121 are connected to first annular ribs 122 located on the outer edge of the first annular plate 11, so as to connect the first support ribs 12 into a whole, improve the structural stability of the first support ribs 12, and help support the first annular plate 11 to restore its original shape. The outer ends of multiple second radial ribs 221 are connected to second annular ribs 222 located on the outer edge of the second annular plate 21, so as to connect the second support ribs 22 into a whole, improve the structural stability of the second support ribs 22, and help support the first annular plate 11 to restore its original shape.

[0077] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the first radial rib 121 and the sealing portion 30 are connected by a circular arc transition, and the second radial rib 221 and the sealing portion 30 are also connected by a circular arc transition. This reduces stress concentration at the connection between the first radial rib 121 and the sealing portion 30, reduces stress concentration at the connection between the second radial rib 221 and the sealing portion 30, reduces the occurrence of fracture damage to the first radial rib 121 and the second radial rib 221, facilitates deformation of the first radial rib 121 and the second radial rib 221, and improves the operational reliability of the first disc portion 10 and the second disc portion 20.

[0078] In some embodiments of this utility model, the first radial rib 121 includes 2-50 ribs; the second radial rib 221 includes 2-50 ribs.

[0079] Optionally, the first radial rib 121 may be 2, 5, 6, 8, 10, 16, 20, 50, etc.

[0080] Optionally, the second radial rib 221 can be 2, 5, 6, 8, 10, 16, 20, 50, etc.

[0081] In some embodiments of this utility model, the first annular rib 122 includes 1-10 ribs, and the second annular rib 222 includes 1-10 ribs.

[0082] Optionally, the first annular rib 122 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0083] Optionally, the second annular rib 222 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0084] In some embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0085] The sealing part 30 has a columnar structure. The first disc part 10 is connected to one axial end of the sealing part 30, and the second disc part 20 is connected to the other axial end of the sealing part 30. The first disc part 10 and the second disc part 20 are symmetrically arranged with respect to the radial plane at the center of the sealing part 30 in the axial direction. The distance between the connection point of the first disc part 10 and the sealing part 30 and the plane of symmetry is the same as the distance between the connection point of the second disc part 20 and the sealing part 30 and the plane of symmetry. The shape, projected area, and thickness of the first disc part 10 and the second disc part 20 are identical. The number, structure, and dimensions of the first radial ribs 121 on the first disc part 10 are the same as the number, structure, and dimensions of the second radial ribs 221 on the second disc part 20, and the number, structure, and dimensions of the first annular ribs 122 on the first disc part 10 are the same as the number, structure, and dimensions of the second annular ribs 222 on the second disc part 20.

[0086] In some other embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are arranged asymmetrically.

[0087] The radial surface at the center of the sealing part 30 in the axial direction is the center surface. Optionally, the distance between the connection between the first disc part 10 and the sealing part 30 and the center surface is different from the distance between the connection between the second disc part 20 and the sealing part 30 and the center surface.

[0088] Optionally, the first disc portion 10 and the second disc portion 20 have different shapes, projected areas, and thicknesses. The first disc portion 10 and the second disc portion 20 can be selected according to the shape of the atrial wall at the affected area, with corresponding cross-sectional shapes and slopes, so that the shapes of the first disc portion 10 and the second disc portion 20 conform to the affected area, facilitating cell and tissue growth and improving the repair effect. For example, the first disc portion 10 abuts against the left atrial wall, and the second disc portion 20 abuts against the right atrial wall. The projected area of ​​the first disc portion 10 is larger than that of the second disc portion 20 to increase the contact area between the first disc portion 10 and the left atrial wall. Since the pressure in the left atrium is greater than that in the right atrium, for patients with patent foramen ovale of the atrial septum, blood usually flows from the left atrium into the right atrium through the foramen ovale. The occluder 100 with the above structure can enhance the support of the first disc portion 10, resisting the impact of blood flow. The occluder 100 is firmly installed at the atrial septal defect, which helps improve the working reliability of the occluder 100.

[0089] Optionally, the number, structure, and dimensions of the first radial ribs 121 on the first disc portion 10 are different from the number, structure, and dimensions of the second radial ribs 221 on the second disc portion 20; or, alternatively, the number, structure, and dimensions of the first annular ribs 122 on the first disc portion 10 are different from the number, structure, and dimensions of the second annular ribs 222 on the second disc portion 20.

[0090] In some embodiments of this invention, the first outer surface has a greater surface roughness than the first inner surface; the second outer surface has a greater surface roughness than the second inner surface. The roughness of both the first and second outer surfaces facilitates cell growth and improves the repair effect.

[0091] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the plugger 100 also includes a conveying device connection portion 40, which is formed at one axial end of the plugging portion 30 and is adapted to be connected to the pushing component in the conveying device of the plugger 100.

[0092] The push component can be selectively connected to the conveying device connection part 40. When the push component is connected to the conveying device connection part 40, it can drive the blocker 100 to move. When the push component is separated from the conveying device connection part 40, the push component can be recycled.

[0093] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, the conveying device connection part 40 is provided on one side of the first disc part 10 on the sealing part 30.

[0094] During the surgical procedure, the pusher component and the delivery device connection 40 are first stably connected. The occluder 100 delivery device drives the occluder 100 to move along the sheath until it reaches the affected area. The occluder 100 delivery device drives the occluder 100 to continue moving, releasing the second disc 20 from the sheath on the left atrial side. After release, the second disc 20 automatically returns to its original position and abuts against the left atrial wall. Subsequently, the occluder 100 delivery device drives the occluder 100 to continue moving, releasing the occlusion part 30 from the sheath. The occlusion part 30 seals the atrial septal defect. Then, the occluder 100 delivery device drives the occluder 100 to continue moving, releasing the first disc 10 from the sheath on the right atrial side. After release, the first disc 10 automatically returns to its original position and abuts against the right atrial wall, thus sealing the foramen ovale of the atrial septum with the occluder 100. Finally, the push component is separated from the delivery device connection 40, and the push component and sheath are removed from the affected area and out of the body.

[0095] In some embodiments of this utility model, the connecting part 40 of the conveying device can be a hole, a recess, or a protrusion, and the pushing component is connected to the connecting part 40 of the conveying device. Optionally, the shape of the hole, recess, or protrusion can be a circular, elliptical, triangular, or composite geometric shape; the hole can be a through structure, the recess or protrusion can be a non-through structure, and the protrusion can be a flat protrusion or a cylindrical protrusion.

[0096] In some embodiments of this utility model, such as Figure 1As shown, the connecting part 40 of the conveying device is constructed as a flat block, which extends along the axial direction of the sealing part 30, and the surface of the flat block is provided with anti-slip ribs 410.

[0097] The occluder 100 of this invention has an integrated structure and is an elastic element that can automatically return to its original shape. When the occluder 100 is delivered from the sheath, it automatically returns to its original shape. Therefore, there is no need to set up an additional driving component to drive the occluder 100 to return to its original shape, which can reduce manufacturing costs and simplify surgical operations. The delivery device connecting part 40 is constructed as a flat block, and a clamping member can be used as a pushing component. The clamping member clamps the flat block to connect with the occluder 100. The connection and release operation of the clamping member is simple, which can simplify surgical operations.

[0098] For example, the occluder 100 can be delivered to the affected area by gripping the flat block with pliers along the sheath.

[0099] By setting anti-slip ribs 410, the surface friction of the flat block can be increased, which can further improve the connection stability between the pushing component and the flat block and improve the working reliability of the plugger 100.

[0100] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0101] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this utility model, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0102] In this utility model, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0103] In this utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0104] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0105] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A dual-disc, one-piece, biodegradable foramen ovale occluder for atrial septum, characterized in that, include: The device comprises a first disc, a second disc, and a sealing portion. The first disc and the second disc are connected to the two ends of the sealing portion along their axial direction. The first disc, the second disc, and the sealing portion are integrally formed and are biodegradable. The first disc and the second disc are both elastic components that can automatically return to their original shape. The sealing device can be at least one of the following: biodegradable polymer material, biodegradable metal material, bioceramic material, and bioglass material. The first disk section and the second disk section are arranged in parallel. The first disc portion includes: a first annular plate and a first supporting rib, wherein the first supporting rib is disposed on the first annular plate and is used to support the first annular plate to restore its original shape; The second disc portion includes: a second annular plate and a second supporting rib, the second supporting rib being disposed on the second annular plate and used to support the second annular plate to restore its original shape.

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

3. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 1, characterized in that, The thickness of the first disk portion gradually increases in the direction extending from the inner edge to the outer edge of the first disk portion; The thickness of the second disk gradually increases in the direction of extension from the inner edge to the outer edge of the second disk.

4. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, characterized in that, The cross-sectional shape of the first annular plate and the second annular plate perpendicular to the axial direction of the sealing part is circular, near-circular, or polygonal.

5. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, characterized in that, The first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface is disposed facing the second disc portion, and at least one of the first inner surface and the first outer surface is provided with the first supporting rib. The second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface is disposed facing the first disc portion, and at least one of the second inner surface and the second outer surface is provided with the second supporting rib.

6. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 5, characterized in that, The first support rib includes: a plurality of first radial ribs, the first radial ribs extending radially along the first annular plate, and the plurality of first radial ribs being spaced apart circumferentially along the first annular plate; The second support rib includes: a plurality of second radial ribs, the second radial ribs extending radially along the second annular plate, and the plurality of second radial ribs being spaced apart circumferentially along the second annular plate.

7. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 6, characterized in that, The inner end of the first radial rib is connected to the sealing part, and the outer end of the first radial rib extends to the outer edge of the first annular plate, or is spaced apart from the outer edge of the first annular plate. The inner end of the second radial rib is connected to the sealing part, and the outer end of the second radial rib extends to the outer edge of the second annular plate, or is spaced apart from the outer edge of the second annular plate.

8. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 7, characterized in that, The first supporting rib further includes: a first annular rib, which extends circumferentially along the first annular plate, and there is at least one first annular rib; The second supporting rib further includes: a second annular rib, which extends circumferentially along the second annular plate, and there is at least one second annular rib.

9. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 6, characterized in that, The first support rib further includes: at least one first annular rib extending circumferentially along the first annular plate, wherein at least one first annular rib is connected to a plurality of first radial ribs; The second support rib further includes at least one second annular rib extending circumferentially along the second annular plate, and the at least one second annular rib is connected to a plurality of second radial ribs.

10. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 9, characterized in that, At least one of the first annular ribs is disposed on the outer edge of the first annular plate, and the outer ends of a plurality of the first radial ribs are connected to the first annular ribs located on the outer edge of the first annular plate. At least one of the second annular ribs is disposed on the outer edge of the second annular plate, and the outer ends of a plurality of the second radial ribs are connected to the second annular ribs located on the outer edge of the second annular plate.

11. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 6, characterized in that, The first radial rib and the sealing part are connected by an arc transition, and the second radial rib and the sealing part are connected by an arc transition.

12. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-11, characterized in that, The first disk portion and the second disk portion are arranged symmetrically, or the first disk portion and the second disk portion are arranged asymmetrically.

13. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-11, characterized in that, Also includes: A conveying device connection portion is integrally formed at one axial end of the plugging portion, and the conveying device connection portion is adapted to connect with the pushing component in the plugging device conveying device.

14. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 13, characterized in that, The connecting part of the conveying device is constructed as a flat block, which extends along the axial direction of the sealing part, and the surface of the flat block is provided with anti-slip ribs.

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