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 atrial septum. The occluder includes a first disc, a second disc, and an occluding part. The first and second discs are connected to the two ends of the occluding part. The first, second, and occluding parts are one-piece molded and biodegradable. Both the first and second discs are elastic components that can automatically return to their original shape. The plane containing the edge of the first disc is a first plane, and the plane containing the edge of the second disc is a second plane. The angle between the axis of the occluding part and the first plane is an acute angle, and / or the angle between the axis of the occluding part and the second plane is an acute angle. The occluder is a one-piece biodegradable component, which can avoid long-term complications and safety hazards caused by metal remaining in the body. Furthermore, the first and / or second discs are inclined relative to the occluding part, thereby allowing the first and second discs to adapt to different shapes of heart wall structures and improving the occlusion effect.

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 both ends of the occlusion portion. The first disc portion, the second disc portion, and the occlusion portion are integrally molded and biodegradable. Both the first disc portion and the second disc portion are elastic elements that can automatically return to their original shape. The plane containing the edge of the first disc portion is a first plane, and the plane containing the edge of the second disc portion is a second plane. The angle between the axis of the occlusion portion and the first plane is an acute angle, and / or the angle between the axis of the occlusion portion and the second plane is an acute angle.

[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, a uniform degradation rate within the body, and no risk of structural disintegration. It overcomes all the shortcomings of existing woven structure occluders and simplifies surgical procedures. Furthermore, the first and / or second disc portions are inclined relative to the occluding portion, allowing them to adapt to different heart wall structures and improving the occlusion effect.

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

[0011] In some embodiments, at least a portion of at least one of the first disc portion and the second disc portion is a conical ring extending from the center to the edge toward the center of the dual-disc integrally molded biodegradable foramen ovale occluder.

[0012] In some embodiments, at least a portion of the first disc portion is a conical ring, at least a portion of the second disc portion is a conical ring, and the first disc portion and the second disc portion are interlocked.

[0013] In some embodiments, at least a portion of at least one of the first disc portion and the second disc portion is an inverted conical ring, the inverted conical ring extending from the center to the edge toward a direction away from the center of the dual-disc integrally molded biodegradable foramen ovale occluder.

[0014] In some embodiments, at least a portion of the first disk portion is an inverted conical ring, at least a portion of the second disk portion is an inverted conical ring, and the first disk portion and the second disk portion are disk-shaped structures facing away from each other.

[0015] In some embodiments, the first disk portion and the second disk portion are parallel disk bodies.

[0016] 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.

[0017] In some embodiments, the first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface being disposed toward the second disc portion, and the first support rib protruding from at least one of the first inner surface and the first outer surface; the second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface being disposed toward the first disc portion, and the second support rib protruding from at least one of the second inner surface and the second outer surface.

[0018] In some embodiments, the cross-sectional shape of the first annular plate and the second annular plate is circular, near-circular, or polygonal.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] In some embodiments, the first support rib further includes: at least one first annular rib extending circumferentially along the first annular plate, and 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, and at least one second annular rib being connected to a plurality of second radial ribs.

[0023] 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.

[0024] In some embodiments, the occluder further includes a delivery device connection portion integrally formed at one end of the occluder portion, the delivery device connection portion being adapted to connect to a push component in the occluder delivery device.

[0025] In some embodiments, the connecting part of the conveying device is configured as a connecting block, and the surface of the connecting block is provided with anti-slip texture.

[0026] 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

[0027] 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:

[0028] Figure 1 This is a schematic diagram of the structure of a double-disc-shaped, one-piece biodegradable atrial septum foramen ovale occluder according to an embodiment of the present invention;

[0029] Figure 2 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;

[0030] Figure 3 This is a schematic diagram of the structure of a double-disc-shaped, one-piece biodegradable atrial septum foramen ovale occluder according to another embodiment of the present invention;

[0031] Figure 4 This is a schematic diagram of the structure of a double-disc-shaped, one-piece biodegradable atrial septum foramen ovale occluder according to another embodiment of the present invention.

[0032] Figure label:

[0033] 100-Occluder;

[0034] 10-First plate; 11-First annular plate; 12-First supporting rib; 121-First radial rib; 122-First annular rib;

[0035] 20 - Second plate; 21 - Second annular plate; 22 - Second supporting rib; 221 - Second radial rib; 222 - Second annular rib;

[0036] 30 - Sealing section;

[0037] a - First plane; b - Second plane; c - Axis of the sealing part;

[0038] 40 - Conveying device connection part. Detailed Implementation

[0039] 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.

[0040] The following is for reference. Figure 1 Description of a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for atrial septum according to some embodiments of the present invention.

[0041] According to an embodiment of the present invention, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is a biodegradable component. Optionally, the occluder 100 may be at least one of a biodegradable polymer material, a biodegradable metal material, a bioceramic material, or a bioglass material. The occluder 100 includes a first disc portion 10, a second disc portion 20, and a sealing portion 30. The first disc portion 10 and the second disc portion 20 are connected to both ends of the sealing portion 30. The sealing portion 30 passes through the atrial septum to seal the foramen ovale. The first disc portion 10 and the second disc portion 20 are located on both sides of the foramen ovale of the atrial septum, and the first disc portion 10 and the second disc portion 20 together clamp the atrial wall. The first disc portion 10, the second disc portion 20, and the sealing portion 30 are integrally molded components, and both the first disc portion 10 and the second disc portion 20 are elastic components that can automatically return to their original shape.

[0042] 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.

[0043] 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.

[0044] The occluder used in interventional treatment needs to be introduced to the lesion site through a thin sheath. The occluder 100 of this invention can deform to reduce its volume so that it can be stored in the sheath for easy delivery. After the occluder 100 is delivered from the sheath, it can automatically return to its original shape to seal the foramen ovale of the atrial septum.

[0045] The following is a brief description of the process of using the occluder 100 of this utility model embodiment. When using the integrated biodegradable foramen ovale occluder 100 of this utility model, the sheath is extended to the foramen ovale of the atrial septum, and the pushing component pushes the occluder 100 along the sheath to the atrial septal defect. The second disc 20 is released from the sheath on the left atrial side and automatically returns to its original state after release, abutting against the left atrial wall. Then, the occluding part 30 is released from the sheath and positioned inside the foramen ovale of the atrial septum to block the atrial septal defect. Finally, the first disc 10 is released from the sheath on the right atrial side and automatically returns to its original state after release, abutting against the right atrial wall, thereby achieving the occluder 100 blocking the foramen ovale of the atrial septum.

[0046] 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.

[0047] The shape of the foramen ovale in the atrial septum is relatively complex. When the axis of the occlusion part is set parallel to the axis of the first disc and the second disc, the expansion of the first disc and the second disc may be blocked by the inner wall of the heart after the occlusion part is processed and the foramen ovale is sealed, which reduces the occlusion effect.

[0048] Therefore, in this embodiment of the present invention, the sealing portion 30 of the double-disc integrally molded biodegradable atrial septum foramen ovale occluder 100 is inclined, the plane containing the edge of the first disc portion 10 is the first plane a, the plane containing the edge of the second disc portion 20 is the second plane b, the angle between the axis c of the sealing portion 30 and the first plane a is an acute angle, and / or the angle between the axis c of the sealing portion 30 and the second plane b is an acute angle.

[0049] The first disc portion 10 and / or the second disc portion 10 are inclined relative to the blocking portion 30. The dual-disc integrally molded biodegradable atrial septum foramen ovale occluder 100 of this utility model embodiment can select the blocking portion 30, the first disc portion 10 and the second disc portion 20 according to the shape and structure of the heart wall in actual application, thereby improving the blocking effect of the dual-disc integrally molded biodegradable atrial septum foramen ovale occluder 100.

[0050] According to an embodiment of this utility model, a dual-disc, integrally molded, biodegradable foramen ovale occluder 100 for the atrial septum is an integrally molded biodegradable component. The occluder 100 provides a temporary bridge for the heart's self-repair, allowing its own cells and tissues to climb and grow, subsequently being degraded and absorbed within the body. This avoids long-term complications and safety hazards caused by metal 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. The first disc portion 10 and / or the second disc portion 20 are inclined relative to the occlusion portion 30, allowing the first disc portion 10 and the second disc portion 20 to adapt to different shapes of the heart wall structure, improving the occlusion effect.

[0051] In some embodiments of this utility model, such as Figure 1 As shown, the angle between the axis c of the sealing part 30 and the first plane a is an acute angle, the angle between the axis c of the sealing part 30 and the second plane b is an acute angle, and the angle between the axis c of the sealing part 30 and the first plane a is equal to the angle between the axis c of the sealing part 30 and the second plane b. The first plane a and the second plane b are arranged in parallel.

[0052] The occlusion portion 30 is inclined relative to both the first plane a and the second plane b. The double-disc integrally molded biodegradable atrial septum foramen ovale occluder 100 of this utility model embodiment is suitable for situations where the foramen ovale is inclined relative to the heart wall. After the occlusion portion 30 occludes the foramen ovale, at least the edges of the first disc portion 10 and the second disc portion 20 are in reliable contact with the heart wall, which can further improve the occlusion effect. Furthermore, the contact between the first disc portion 10 and the second disc portion 20 and the heart wall is conducive to cell and tissue climbing and growth, which can improve the repair effect.

[0053] In some embodiments of this utility model, such as Figure 1As shown, the angle between the axis c of the sealing part 30 and the first plane a is equal to the angle between the axis c of the sealing part 30 and the second plane b. The angle α between the axis c of the sealing part 30 and the first plane a satisfies: 20°≤α<90°.

[0054] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, at least a portion of at least one of the first disc portion 10 and the second disc portion 20 is a conical ring, which extends from the center to the edge toward the center of the double-disc integrally molded biodegradable atrial septum foramen ovale occluder 100.

[0055] It is worth noting that the first disc 10 and the second disc 20 are respectively connected to the two ends of the occlusion part 30 along its length. Therefore, the center of the double-disc integrally formed biodegradable atrial septum foramen ovale occluder 100 is the middle part of the occlusion part 30.

[0056] At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is a conical ring. When at least a portion of the first disc portion 10 is a conical ring, the conical ring extends from the center to the edge toward the second disc portion 20. When at least a portion of the second disc portion 20 is a conical ring, the conical ring extends from the center to the edge toward the first disc portion 10.

[0057] In some embodiments of this utility model, such as Figure 1 and Figure 2 As shown, at least a portion of the first disc portion 10 is a conical ring, and at least a portion of the second disc portion 20 is a conical ring, with the first disc portion 10 and the second disc portion 20 interlocked. By interlocking the first disc portion 10 and the second disc portion 20, they reliably abut against the atrial wall, increasing the contact area between the first disc portion 10 and the atrial wall, and increasing the contact area between the second disc portion 20 and the atrial wall. This improves the arrangement stability of the occluder 100, facilitates cell and tissue growth, and enhances the repair effect.

[0058] In some embodiments of this utility model, such as Figure 4 As shown, at least a portion of at least one of the first disc portion 10 and the second disc portion 20 is an inverted conical ring, which extends from the center to the edge toward the center away from the center of the double-disc integrally molded biodegradable cardiac atrial septum foramen ovale occluder 100.

[0059] At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is an inverted conical ring. When at least a portion of the first disc portion 10 is an inverted conical ring, the conical ring extends from the center to the edge in a direction away from the second disc portion 20. When at least a portion of the second disc portion 20 is an inverted conical ring, the conical ring extends from the center to the edge in a direction away from the first disc portion 10.

[0060] In some embodiments of this utility model, such as Figure 4 As shown, at least a portion of the first disc portion 10 is an inverted conical ring, and at least a portion of the second disc portion 20 is an inverted conical ring. The first disc portion 10 and the second disc portion 20 have disc-shaped structures that are opposite to each other.

[0061] Both the first disc portion 10 and the second disc portion 20 are inverted conical rings, and are interlocked opposite to each other. By arranging the first disc portion 10 and the second disc portion 20 opposite to each other, the first disc portion 10 and the second disc portion 20 can be prevented from obstructing the sealing portion 30, reducing the possibility of the first disc portion 10 or the second disc portion 20 obstructing the formation of the foramen ovale of the atrial septum, and improving the working reliability of the dual-disc integrally molded biodegradable atrial septum foramen ovale occluder 100.

[0062] In some other embodiments of the present invention, at least a portion of one of the first disc portion 10 and the second disc portion 20 is a conical ring extending from the center to the edge toward the center of the double-disc integrally molded biodegradable foramen ovale occluder 100. At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is an inverted conical ring extending from the center to the edge toward the center of the double-disc integrally molded biodegradable foramen ovale occluder 100.

[0063] One of the first disc portion 10 and the second disc portion 20 is recessed towards the middle position of the sealing portion 10, and the other of the first disc portion 10 and the second disc portion 20 is extended in a direction away from the middle position of the sealing portion 10. This also falls within the protection scope of this utility model.

[0064] In some embodiments of this utility model, such as Figure 3 As shown, the first disc 10 and the second disc 20 are parallel discs. The first disc 10 and the second disc 20 are arranged in parallel, and after the first disc 10 and the second disc 20 are restored to their original state, the contact area with the heart wall is large, which can improve the occlusion effect.

[0065] In some embodiments of this utility model, such as Figure 2 As 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.

[0066] 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.

[0067] Compared to automatically restoring to its original state using only the structure of the first annular plate 11 or only the structure of the second annular plate 21, the speed at which the first annular plate 11 restores to its original state can be increased by setting the first support rib 12, and the speed at which the second annular plate 21 restores to 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 to 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.

[0068] In some embodiments of the present invention, the first annular plate 11 has a first inner surface and a first outer surface facing away from each other, the first inner surface being disposed toward the second disc portion 20, and the first support rib 12 protruding from at least one of the first inner surface and the first outer surface; the second annular plate 21 has a second inner surface and a second outer surface facing away from each other, the second inner surface being disposed toward the first disc portion 10, and the second support rib 22 protruding from at least one of the second inner surface and the second outer surface.

[0069] 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.

[0070] 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.

[0071] In some embodiments of this invention, the cross-sectional shape of the first annular plate 11 and the second annular plate 21 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.

[0072] 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.

[0073] Optionally, the first support rib 12 may include only 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 may include only 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.

[0074] Alternatively, the first support rib 12 may include only the first annular rib 122, which extends circumferentially along the first annular plate 11, and the first annular rib 122 may be at least one; the second support rib 22 may include only the second annular rib 222, which extends circumferentially along the second annular plate 21, and the second annular rib 222 may be at least one.

[0075] Alternatively, such as Figure 2 As shown, the first support rib 12 includes a first radial rib 121 and a first annular rib 122. A plurality of first radial ribs 121 are arranged at intervals along the circumference of the first annular plate 11. The first radial ribs 121 extend radially along the first annular plate 11, and the first annular ribs 122 extend circumferentially along the first annular plate 11. The first annular ribs 122 are connected to the plurality of first radial ribs 121. The second support rib 22 includes a second radial rib 221 and a second annular rib 222. A plurality of second radial ribs 221 are arranged at intervals along the circumference of the second annular plate 21. The second radial ribs 221 extend radially along the second annular plate 21, and the second annular ribs 222 extend circumferentially along the second annular plate 21. The second annular ribs 222 are connected to the plurality of second radial ribs 221.

[0076] In some embodiments of this utility model, such as Figure 2 As 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.

[0077] 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.

[0078] In some embodiments, the outer end of the first radial rib 121 may extend to the outer edge of the first annular plate 11 so that the first annular plate 11 can be restored to its original shape.

[0079] In other embodiments, the outer end of the first radial rib 121 may also extend toward the outer edge of the first annular plate 11 and be spaced apart from the outer edge of the first annular plate 11.

[0080] In some embodiments, the outer end of the second radial rib 221 may extend to the outer edge of the second annular plate 21 so that the second annular plate 22 can be restored to its original shape.

[0081] In other embodiments, the outer end of the second radial rib 221 extends toward the outer edge of the second annular plate 21 and is spaced apart from the outer edge of the second annular plate 21.

[0082] In some embodiments of this utility model, such as Figure 2 As shown, at least one first annular rib 122 is provided on the outer edge of the first annular plate 11, and at least one second annular rib 222 is provided on the outer edge of the second annular plate 21. The first annular rib 122 being provided on the outer edge of the first annular plate 11 helps the first annular plate 11 to return to its original shape. Similarly, the second annular rib 222 being provided on the outer edge of the second annular plate 21 helps the second annular plate 21 to return to its original shape.

[0083] In some embodiments of this utility model, the first support rib 12 includes a first radial rib 121 and a first annular rib 122, and the second support rib 22 includes a second radial rib 221 and a second annular rib 222. At least one first annular rib 122 is disposed 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 disposed 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.

[0084] 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.

[0085] In some embodiments of this utility model, the first radial rib 121 includes 1-100 ribs; the second radial rib 221 includes 1-100 ribs.

[0086] Optionally, the first radial rib 121 can be 1, 4, 5, 6, 8, 10, 20, 50, 100, etc.

[0087] Optionally, the second radial rib 221 can be 1, 4, 5, 8, 10, 16, 30, 50, 100, etc.

[0088] 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.

[0089] Too many first annular ribs 122 are not conducive to the deformation and storage of the first annular plate 11; similarly, too many second annular ribs 222 are also not conducive to the normal operation of the plugger 100.

[0090] Optionally, the first annular rib 122 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0091] Optionally, the second annular rib 222 can be 1, 2, 3, 4, 5, 6, 8, 10, etc.

[0092] In some embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are symmetrically arranged.

[0093] The first disc portion 10 and the second disc portion 20 have the same shape, projected area, and thickness; the number, structure, and dimensions of the first radial ribs 121 on the first disc portion 10 are the same as the number, structure, and dimensions of the second radial ribs 221 on the second disc portion 20, and the number, structure, and dimensions of the first annular ribs 122 on the first disc portion 10 are the same as the number, structure, and dimensions of the second annular ribs 222 on the second disc portion 20.

[0094] In some other embodiments of this utility model, the first disc portion 10 and the second disc portion 20 are arranged asymmetrically.

[0095] 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.

[0096] In some embodiments of this utility model, such as Figures 1-4 As shown, the plugger 100 also includes a conveying device connection part 40, which is integrally formed at one end of the plugging part 30. The conveying device connection part 40 is adapted to be connected to the pushing component in the conveying device of the plugger 100.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] In some embodiments of this utility model, such as Figure 1 As shown, the connecting part 40 of the conveying device is constructed as a connecting block, and the surface of the connecting block is provided with anti-slip texture.

[0101] 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 connecting block, and a clamping member can be used as a pushing component. The clamping member clamps the connecting block to connect with the occluder 100. The connection and release operation of the clamping member is simple and can simplify surgical operations.

[0102] By setting anti-slip textures, the surface friction of the connecting block can be increased, which can further improve the connection stability between the pushing component and the connecting block and improve the working reliability of the plugger 100.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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 first disc portion, the second disc portion, and the sealing portion are connected to the two ends of the sealing portion. The first disc portion, the second disc portion, and the sealing portion are integrally formed and are biodegradable. The first disc portion and the second disc portion are both elastic components that can automatically return to their original shape. The plane containing the edge of the first disc is a first plane, the plane containing the edge of the second disc is a second plane, the angle between the axis of the sealing part and the first plane is an acute angle, and / or the angle between the axis of the sealing part and the second plane is an acute angle.

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

3. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 1, characterized in that, At least a portion of at least one of the first disc portion and the second disc portion is a conical ring, the conical ring extending from the center to the edge toward the center of the dual-disc integrally molded biodegradable atrial septal foramen ovale occluder.

4. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 3, characterized in that, At least a portion of the first disc portion is a conical ring, and at least a portion of the second disc portion is a conical ring, with the first disc portion and the second disc portion being interlocked.

5. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 1, characterized in that, At least a portion of at least one of the first disc portion and the second disc portion is an inverted conical ring, which extends from the center to the edge toward the center of the dual-disc integrally molded biodegradable atrial septal foramen ovale occluder.

6. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 5, characterized in that, At least a portion of the first disc portion is an inverted conical ring, at least a portion of the second disc portion is an inverted conical ring, and the first disc portion and the second disc portion are disc-shaped structures that are opposite to each other.

7. The dual-disc integrally molded biodegradable cardiac atrial septum foramen ovale occluder according to claim 1, wherein the first disc portion and the second disc portion are parallel disc bodies.

8. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-7, characterized in that, 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.

9. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, characterized in that, The first annular plate has a first inner surface and a first outer surface facing away from each other, the first inner surface being disposed toward the second disc portion, and the first support rib protruding from at least one of the first inner surface and the first outer surface; The second annular plate has a second inner surface and a second outer surface facing away from each other, the second inner surface being disposed toward the first disc portion, and the second support rib protruding from at least one of the second inner surface and the second outer surface.

10. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, characterized in that, The cross-sectional shape of the first annular plate and the second annular plate is circular, near-circular, or polygonal.

11. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 8, 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.

12. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 11, 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.

13. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 8, 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.

14. The dual-disc, integrally molded, biodegradable foramen ovale occluder for atrial septum according to claim 11, characterized in that, The first supporting rib further includes: at least one first annular rib, the first annular rib extending circumferentially along the first annular plate, and 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, the second annular rib extending circumferentially along the second annular plate, and at least one second annular rib being connected to a plurality of second radial ribs.

15. The dual-disc, integrally molded, biodegradable foramen ovale occluder for claim 14, 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.

16. The dual-disc, integrally molded, biodegradable foramen ovale occluder for any one of claims 1-7, characterized in that, Also includes: The conveying device connection part is integrally formed at one end of the blocking part and is adapted to be connected to the pushing component in the blocking device conveying device.

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

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