A plug and a plug input system

Abstract

This application discloses an occluder and an occluder input system. The occluder includes: two occluder discs; and a waist section connected between the two occluder discs. At least one end of the waist section is flexibly connected to the corresponding occluder disc, allowing the corresponding occluder disc to self-adjust and level itself during installation. Through this method, the waist section of the occluder provided in this application can better adapt to the posture of the defective channel, relatively reducing the traction constraint on the occluder discs, allowing the occluder discs to self-adjust and avoid peripheral leakage. Furthermore, it reduces the restoring force of the occluder at the flexible connection between the occluder disc and the waist section, thus reducing the risk of tissue damage to the atrial septum and foramen ovale due to pressure.

Description

Technical Field

[0001] This application relates to the field of occluder technology, and in particular to an occluder and an occluder input system. Background Technology

[0002] The main treatments for patients with congenital heart disease are open-heart surgery and percutaneous interventional surgery. Open-heart surgery uses patches or simple sutures to repair the heart defect, while percutaneous interventional surgery involves implanting a NiTi alloy occluder under X-ray visualization to close the defect. Occluder interventional surgery has become a routine procedure for treating structural heart diseases, but some problems still exist in the application of cardiac occluders.

[0003] Because the orientation of the defect channel on the atrial septum varies among patients, and the actual defect channel is usually not perpendicular to the atrial septum but rather a sloping, narrow channel, the waist of the occluder and the occluding disc are constrained by the orientation of the defect channel. This can lead to poor occlusion and a risk of peripheral leakage. Furthermore, the occluder may compress the atrial septum and the defect channel, causing tissue damage. All of these factors will significantly hinder the efficacy of the occlusion interventional procedure. Summary of the Invention

[0004] This application provides an occluder and an occluder input system to solve the problems of poor occlusion effect and high risk of tissue damage caused by the constraint of the atrial septal defect channel posture of the occluder.

[0005] To solve the above-mentioned technical problems, this application adopts a technical solution as follows: providing a sealing device. The sealing device includes: two sealing discs; a waist section connected between the two sealing discs, at least one end of the waist section being flexibly connected to a corresponding sealing disc, so that the corresponding sealing disc can adaptively level itself during installation.

[0006] In some embodiments, the waist is a flexible waist.

[0007] In some embodiments, the waist portion is a cylindrical membrane or mesh; or

[0008] The waist section includes at least one connector that connects the two sealing discs.

[0009] In some embodiments, the connector includes a thread, a strip, and an elastic cord, wherein the elastic cord applies a preload to the two occlusion discs when the two occlusion discs respectively occlude both sides of the interatrial septum.

[0010] In some embodiments, the waist section is a rigid waist section, and at least one end of the waist section is flexibly connected to the corresponding sealing disc using a wire.

[0011] In some embodiments, the waist section is integrally formed with one of the two sealing discs, and the suspended end of the waist section is flexibly connected to the other of the two sealing discs by a wire; or

[0012] The two ends of the waist section are flexibly connected to the corresponding sealing discs using silk threads.

[0013] In some embodiments, at least one of the sealing discs includes a central flexible portion and an outer ring rigid portion surrounding the central flexible portion, the central flexible portion being connected to one end of the waist portion.

[0014] In some embodiments, the occluder further includes at least one occlusion structure disposed on the waist portion, the occlusion structure being used to seal the oval aperture after installation.

[0015] In some embodiments, the occlusion structure includes a memory ring and a flow-blocking membrane. The memory ring is connected to the waist portion, and the flow-blocking membrane is connected to the memory ring. The outer diameter of the flow-blocking membrane is larger than the outer diameter of the memory ring. The memory ring is used to unfold within the atrial septal defect channel and abut against the wall of the atrial septal defect channel. The flow-blocking membrane is used to block the atrial septal defect channel and fill the gap between the memory ring and the wall of the atrial septal defect channel.

[0016] In some embodiments, the memory ring is a corrugated ring; or

[0017] The memory ring includes a bottom circular structure and multiple umbrella ribs. One end of each umbrella rib is connected to the other end, and the other end of each umbrella rib is uniformly connected to the bottom circular structure. The bottom circular structure and the multiple umbrella ribs are used to unfold within the atrial septal defect channel, such that the bottom circular structure abuts against the wall of the atrial septal defect channel. The flow-blocking membrane is connected to the bottom circular structure or the multiple umbrella ribs, and the outer diameter of the flow-blocking membrane is larger than the outer diameter of the bottom circular structure.

[0018] In some embodiments, the sealing structure is an expansion member that expands after being immersed in a liquid to seal the oval pore.

[0019] In some embodiments, the expansion member comprises modified medical hydrogel, polyvinyl alcohol, and gelatin sponge.

[0020] In some embodiments, the occluder is made of a biodegradable material.

[0021] To address the aforementioned technical problems, another technical solution adopted in this application is to provide an occluder input system. This occluder input system includes a delivery device and an occluder as described above, wherein the delivery device is used to deliver the occluder to the orifice ovalis of the interatrial septum.

[0022] The beneficial effects of this application are as follows: Unlike the prior art, this application discloses an occluder and an occluder input system. By flexibly connecting at least one end of the waist section to the corresponding occluder disc, the flexible connection can deform flexibly under force. On the one hand, this facilitates the adaptation of the waist section's posture to the defective channel of the foramen ovale, reduces the traction constraint on the occluder disc, and allows the occluder disc to self-adjust and avoid edge warping, thereby eliminating peripheral leakage of the corresponding occluder disc. On the other hand, the flexible connection can eliminate the stress at the connection between the waist section and the corresponding occluder disc, preventing wire breakage, and weakening the restoring force of the occluder at the flexible connection, which can reduce the risk of tissue damage to the interatrial septum and foramen ovale due to pressure. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort, wherein:

[0024] Figure 1 This is a schematic diagram of the structure of commonly used plugging devices;

[0025] Figure 2 This is a schematic diagram of the structure of Embodiment 1 of the occluder provided in this application;

[0026] Figure 3 This is a schematic diagram of the structure of Embodiment 2 of the occluder provided in this application;

[0027] Figure 4 This is a schematic diagram of the structure of Embodiment 3 of the occluder provided in this application;

[0028] Figure 5 This is a schematic diagram of the structure of Embodiment 4 of the occluder provided in this application;

[0029] Figure 6 Is it like this? Figures 2 to 3 A schematic diagram of the waist section and the sealing structure above the plugging device shown in the diagram;

[0030] Figure 7 Is it like this? Figure 6 A schematic diagram of another embodiment of the sealing structure shown in the figure;

[0031] Figure 8 Is it like this? Figure 6 The diagram shows another embodiment of the sealing structure. Detailed Implementation

[0032] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0033] The terms "first," "second," and "third" used in the embodiments of this application are 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," "second," or "third" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0034] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a mutually exclusive, independent, or alternative embodiment. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0035] An occluder is an advanced medical device primarily used in interventional treatments of the cardiovascular system, especially for certain types of heart disease, such as atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA) among congenital heart diseases. Its design and application embody the principles of minimally invasive surgery, aiming to achieve therapeutic effects with less trauma and reducing the risks and recovery time associated with traditional open-heart surgery.

[0036] See Figure 1 , Figure 1This is a schematic diagram of a commonly used occluder. In existing occluders, the connection between the waist section 01 and the occlusion disc 02 is a rigid vertical connection. However, in practice, the orifice 03 is usually not perpendicular to the atrial septum 04, but rather a narrow channel inclined relative to the atrial septum 04. In this case, the waist section 01 of the occluder is constrained by the orifice 03 into an inclined state relative to the occlusion disc 02. The connection point between the waist section 01 and the occlusion disc 02 will be under stress for a long time, posing a risk of wire breakage. Furthermore, the occluder is made of shape memory material, which causes the occlusion disc 02 to have a force that allows it to return to being perpendicular to the waist section 01. This will cause the atrial septum 04 and the orifice 03 to bear greater pressure, leading to damage. In addition, the inclined state of the waist section 01 will also cause the edge 05 of the occlusion disc 02 to lift up, forming a peripheral leak.

[0037] Commercially available occluders rely on occlusion discs 02 for sealing, so the edges of the occlusion discs 02 are designed with an inward-facing structure, and the edge strength 05 of the occlusion discs 02 is designed to be high, especially for metal occluders. This increases the risk of damaging the atrial septum 04.

[0038] In this application, the performance of the occluder 100 is described using the atrial septum as an example. The occluder 100 can also be applied to the ventricular septum to block the ventricular septal defect channel. The atrial septum described in the embodiment can also be the ventricular septum, and the atrial septal defect channel can be the ventricular septal defect channel.

[0039] This application provides a clogging device 100, see reference. Figure 2 , Figure 2 This is a schematic diagram of an embodiment of the plugging device provided in this application.

[0040] The occluder 100 includes two occluder discs 10 and a waist section 20. The waist section 20 is connected between the two occluder discs 10, and at least one end of the waist section 20 is flexibly connected to the corresponding occluder disc 10, so that the corresponding occluder disc 10 can be self-leveled during installation.

[0041] The occluder 100 is installed in the foramen ovale of the atrial septum to block the defect channel formed by the foramen ovale in the atrial septum. Two occlusion discs 10 are respectively sealed on both sides of the foramen ovale and fit against both sides of the atrial septum, which can fix the occluder 100 and block blood flow; the waist part 20 passes through the defect channel.

[0042] The occluder 100 can also be applied to the ventricular septum, with two occluder discs 10 covering both sides of the defective passage of the ventricular septum and fitting against both sides of the ventricular septum, and the waist 20 passing through the defective passage of the ventricular septum.

[0043] The waist section 20 can be connected to the corresponding sealing disc 10 by using a wire, or the waist section 20 can be made flexible, or a part of the sealing disc 10 can be made flexible, so as to achieve a flexible relationship between the sealing disc 10 and the waist section 20.

[0044] At least one end of the waist section 20 is flexibly connected to the corresponding occlusion disc 10, so that the flexible connection can be flexibly deformed under force. On the one hand, it is easier for the waist section 30 to adapt to the defective channel of the foramen ovale, reducing the traction and restraint on the occlusion disc 10, so that the occlusion disc 10 can self-adjust and avoid edge lifting, thereby eliminating the leakage of the corresponding occlusion disc 10. On the other hand, the flexible connection can eliminate the stress at the connection between the waist section 20 and the corresponding occlusion disc 10, avoid wire breakage, and reduce the recovery force of the occluder 100 at the flexible connection, which can reduce the risk of tissue damage caused by pressure on the interatrial septum and foramen ovale.

[0045] If one end of the waist section 20 is flexibly connected to the corresponding occlusion plate 10, the occlusion plate 10 can at least adaptively level itself to avoid leakage, and the stress at the flexible connection can be greatly reduced or even eliminated, thereby greatly reducing the risk of damage to the atrial septum and foramen ovale; or if both ends of the waist section 20 are flexibly connected to the corresponding occlusion plate 10, the occlusion plates 10 on both sides of the atrial septum can adaptively level themselves to avoid leakage, the waist section 20 can adapt more freely and flexibly to the shape of the defect channel, and the two flexible connections can adaptively deform to reduce or even eliminate the stress caused by the original hard connection, thereby greatly reducing the risk of damage to both sides of the atrial septum and the entire defect channel.

[0046] In this embodiment, the occluder 100 is made of a biodegradable material, such as a biodegradable metal or a biodegradable polymer, specifically polylactic acid (PLA), polycaprolactone (PCL), or other biocompatible polymers. This biodegradable material can be gradually decomposed in the human body and eventually absorbed or naturally metabolized, so that the occluder 100 can be removed without a second surgery, reducing the potential risks and discomfort of long-term foreign body retention in the body. Moreover, due to the better biocompatibility of biodegradable materials, for patients who may have allergic reactions to metal materials (such as nickel), the biodegradable occluder 100 can significantly reduce the risk of allergies and other complications. For patients who need long-term cardiac monitoring or may undergo other cardiac interventional surgeries in the future, the biodegradable occluder 100 will not affect subsequent diagnosis and treatment, such as when performing atrial fibrillation radiofrequency ablation, left atrial appendage occlusion, etc., there is no need to worry about interference from the original metal material.

[0047] Optionally, the occluder 100 may be made of traditional shape memory metal materials such as nickel-titanium alloy.

[0048] The occlusion disc 10 can be made of woven silk or printed with biocompatible materials, and it can be covered with a flow-blocking membrane. The occlusion disc 10 may also be uncovered with a flow-blocking membrane. The occlusion disc 10 has good memory properties and can be fixed in a contracted state during delivery to facilitate delivery in the blood vessel. After installation and release of fixation, it can return to its initial disc shape to cover the foramen ovale, thereby occluding the foramen ovale.

[0049] See Figure 1 In one embodiment, the waist 20 is a flexible waist made of a flexible material, such as a flexible metal material, a polymer material or a biomaterial, so that it can better adapt to the defective channel of the foramen ovale and avoid stress on the occlusion disc 10, and cause less damage to the interatrial septum and the foramen ovale.

[0050] The end of the flexible waist 20 can be directly wrapped or bound to the sealing plate 10. For example, if the flexible waist 20 is made of flexible filament, the corresponding position on the sealing plate 10 can be used as the starting point for weaving the flexible waist 20; or the end of the flexible waist 20 can be bound to the sealing plate 10 with filament, or fasteners can be used to connect the flexible waist 20 to the sealing plate 10, such as rivets or screws.

[0051] Optionally, such as Figure 1 As shown, the flexible waist 20 is a cylindrical membrane or mesh. The membrane is a biocompatible biomembrane, such as bovine tripe or pericardium. The biomembrane itself has good flexibility, can adapt to the defect channel, and will not generate additional stress on the sealing disc 10. The mesh can be made of nickel-titanium alloy, biodegradable metal, or biodegradable polymer material. The flexibility of the waist 20 can be improved and the additional stress generated on the sealing disc 10 can be reduced by reducing the density or diameter of the filaments used to weave the mesh, or by selecting flexible filaments. Furthermore, the waist 20 still has shape memory and can restore its original shape when released into the defect channel to increase the fixation performance with the defect channel.

[0052] For example, the flexible waist 20 is a cylindrical biofilm, and the end of the waist 20 is sewn to the sealing plate 10 using thread 101. The thread 101 allows for a large degree of deformation freedom between the waist 20 and the corresponding sealing plate 10. This degree of deformation freedom can be adjusted by adjusting the tightness of the thread 101 connecting the waist 20 and the sealing plate 10, so that the sealing plate 10 can self-adjust and the waist 20 does not add additional stress to the sealing plate 10. Alternatively, the waist 20 can be directly sewn to the sealing plate 10 using braiding yarn when weaving the sealing plate 10.

[0053] See Figure 3 , Figure 3This is a schematic diagram of the structure of Embodiment 2 of the occluder provided in this application. Optionally, the flexible waist 20 includes at least one connector 22 connected between the two occlusion discs 10. The connector 22 is flexible, such as a flexible thread or rope, which is more flexible and will not generate stress on the occlusion discs 10 at both ends. Moreover, the flexible waist 20 and the occlusion discs 10 can avoid damage to the atrial septum and the foramen ovale.

[0054] For example, the flexible waist 20 includes one, two, three, five, six, eight, twelve, or fifteen connectors 22. Each connector 22 can be independent of the others, or they can intersect. Because the connection between the connectors 22 is weak and the connectors 22 themselves are relatively soft, they are more flexible and better adapted to the posture of the missing passage. They do not generate any stress on the sealing plate 10, so the sealing plate 10 can adaptively conform to the interatrial septum and avoid peristaltic leakage.

[0055] The connector 22 includes threads, strips, and elastic ropes. That is, the connector 22 can be any of the threads, strips, and elastic ropes. For example, the connector 22 is the braided thread of the braided occlusion disc 10, or the connector 22 is a flexible strip made of biomembrane, or the connector 22 is an elastic rope made of biomaterial, which can be fascia. The elastic rope also applies a certain warning force to the two occlusion discs 10 when they are sealing the two sides of the atrial septum, so that the occlusion discs 10 can fit more tightly to the atrial septum, avoid edge lifting, and prevent percutaneous leakage.

[0056] See Figure 4 , Figure 4 This is a schematic diagram of the structure of Embodiment 3 of the occluder provided in this application. In another embodiment, the waist portion 20 is a rigid waist portion, and at least one end of the waist portion 20 is flexibly connected to the corresponding occlusion disc 10 by a wire.

[0057] In existing occluders, the two occluder discs 02 and the waist section 01 between them are integrally woven from braided threads, resulting in a rigid vertical connection between the waist section 01 and the occluder discs 02. In this embodiment, the waist section 20 is the same as the waist section 01 in existing occluders. The difference is that after the waist section 20 is formed, at least one end is independent of the corresponding occluder disc 10. Then, a thread 101 is used to connect one end of the waist section 20 to the independent occluder disc 10, achieving a flexible connection. This ensures that the waist section 20 does not add additional stress to the occluder disc 10 when adapting to a damaged channel, and the occluder disc 10 can adaptively level itself without being restricted by the waist section 20.

[0058] like Figure 4As shown, the waist section 20 is integrally formed with one of the two sealing discs 10. For example, the waist section 20 and one of the sealing discs 10 are woven together with braided wire, while the other sealing disc 10 is woven independently. The suspended end of the waist section 20 is flexibly connected to the other of the two sealing discs 10 with wire 101.

[0059] Or refer to Figure 2 The waist section 20 and the two sealing discs 10 are each independently woven and formed. The two ends of the waist section 20 are flexibly connected to the corresponding sealing discs 10 by silk threads 101. Thus, when the waist section 20 is adapted to the defective channel, it will not add extra stress to the sealing discs 10 on both sides, and the sealing discs 10 on both sides can be self-adjusted.

[0060] See Figure 5 , Figure 5 This is a schematic diagram of the structure of Embodiment 4 of the occluder provided in this application. In another embodiment, at least one occluder disc 10 includes a central flexible portion 11 and an outer ring rigid portion 12 surrounding the central flexible portion 11. The central flexible portion 11 is connected to one end of the waist portion 20, thereby achieving a flexible connection with the waist portion 20.

[0061] Optionally, the central flexible portion 11 is woven with sparser braided threads relative to the outer ring rigid portion 12, thereby improving the flexibility of the central area of ​​the sealing disc 10 toward the waist portion 20. The waist portion 20 can be woven together with the sealing disc 10 or connected by threads.

[0062] Alternatively, the central flexible part 11 can also be a flexible biomembrane, and the outer ring rigid part 12 can be woven together with the flexible biomembrane, or formed by connecting with threads.

[0063] In this case, the waist 20 can be a flexible waist or a rigid waist. For example, the waist 20 can be a cylindrical membrane or mesh, or the waist 20 can include at least one connector 22 as described above.

[0064] See also Figures 2 to 6 Based on the above embodiments, the occluder 100 further includes at least one occlusion structure 30 disposed on the waist 20. After installation, the occlusion structure 30 is used to block the foramen ovale, thereby blocking the blood flow through the defective channel of the atrial septum.

[0065] The waist section 30 may be provided with one, two, three or four layers of sealing structures 30. By adopting multi-layer sealing structures 30, the reliability of sealing the defective channel can be improved.

[0066] When there is one sealing structure 30, it can be positioned in the middle of the waist 20; when there are two or three or more sealing structures 30, they can be evenly distributed on the waist 20 at intervals.

[0067] By providing at least one layer of sealing structure 30 on the waist 30, the waist 20 has the ability to seal the orifice of ovum, thus eliminating the need to provide a flow-blocking membrane on the sealing disc 10, or the waist 30 can form a multi-layer seal for the orifice of ovum together with the sealing disc 10, thereby improving the reliability of sealing the orifice of ovum.

[0068] Optionally, see Figure 6 The occlusion structure 30 includes a memory ring 32 and a flow-blocking membrane 34. The memory ring 32 is connected to the waist 20, and the flow-blocking membrane 34 is connected to the memory ring 32. The outer diameter of the flow-blocking membrane 34 is larger than the outer diameter of the memory ring 32. The memory ring 32 is used to unfold within the atrial septal defect channel and abut against the wall of the atrial septal defect channel. The flow-blocking membrane 34 is used to block the atrial septal defect channel and fill the gap between the memory ring 32 and the wall of the atrial septal defect channel.

[0069] The memory ring 32 is made of a memory material and can be compressed and installed into a smaller delivery sheath along with the waist 20. The memory ring 32 can be sewn onto the waist 20. When the waist 20 is in the defect channel, the memory ring 32 can unfold due to its memory property and adapt to the cross-section of the defect channel.

[0070] The maximum outer diameter of the memory ring 32 can be set to be larger than the longest axis of the cross-section of the defect channel. This ensures that the unfolded memory ring 32 can abut against the wall of the defect channel and be in a certain compressed state, thereby sealing the defect channel more reliably. The outer diameter of the flow-blocking membrane 34 is larger than the outer diameter of the memory ring 32. When the memory ring 32 fails to completely fit the wall of the defect channel, the flow-blocking membrane 34 at the edge can fill the gap between the memory ring 32 and the wall of the atrial septal defect channel to seal it.

[0071] Optionally, such as Figure 6 As shown, the memory ring 32 is a corrugated ring made of memory material. The flow-blocking membrane 34 is sewn onto the corrugated ring. The flow-blocking membrane 34 can seal the defect channel as the corrugated ring unfolds, and the flow-blocking membrane 34 also fills the gap between the corrugated ring and the wall of the atrial septal defect channel.

[0072] Optionally, see Figure 7 The memory ring 32 includes a bottom circular structure 320 and multiple umbrella ribs 322. One end of the multiple umbrella ribs 322 is connected to each other, and the other end of the multiple umbrella ribs 322 is uniformly connected to the bottom circular structure 320. The bottom circular structure 320 and the multiple umbrella ribs 322 are used to unfold within the atrial septal defect channel, so that the bottom circular structure 320 abuts against the wall of the atrial septal defect channel. The flow-blocking membrane 34 is connected to the bottom circular structure 320 or the multiple umbrella ribs 322, and the outer diameter of the flow-blocking membrane 34 is larger than the outer diameter of the bottom circular structure 320.

[0073] The bottom circular structure 320 can be a circle made of shape memory yarn, and the umbrella rib 322 can be made of shape memory yarn; such as Figure 7 As shown, each umbrella rib 322 is a single filament; or as... Figure 8 As shown, each umbrella rib 322 can be an umbrella leaf structure made of filament composite material, or the umbrella rib 322 can be an umbrella leaf structure made of biofilm or polymer material.

[0074] The memory ring 32, composed of a bottom circular structure 320 and multiple umbrella-shaped ribs 322, is conical in shape and has memory properties. It can be compressed and installed into a smaller delivery sheath. The diameter of the bottom circular structure 320 is set to be larger than the long axis of the cross-section of the atrial septal defect channel, ensuring that the bottom circular structure 320 can fully fill the channel when it rebounds within the atrial septal defect channel for blood flow occlusion. Figure 8 As shown, the flow-blocking membrane 34 can be sewn onto multiple umbrella ribs 322 to form a conical side surface; or as... Figure 7 As shown, the flow-blocking membrane 34 can be sewn onto the bottom circular structure 320.

[0075] Optionally, the sealing structure 30 can also be an expandable element that expands upon immersion in a liquid to seal the oval orifice. This expandable element can be made of expandable medical materials, such as modified medical hydrogel, polyvinyl alcohol, or gelatin sponge.

[0076] An expansion member is fixed on the waist 20. The expansion member is initially very small. After the occluder 100 is installed on the foramen ovale of the atrial septum for a period of time, the expansion member will expand due to being immersed in blood and adapt to the size of the atrial septal defect channel to block blood flow.

[0077] The waist 20 can be a flexible waist, such as a cylindrical membrane or mesh. The expansion member can be installed in the waist 20 through threads, so that when it expands, it squeezes the flexible waist, causing the flexible waist to adhere tightly to the wall of the atrial septal defect channel, thereby blocking blood flow. Alternatively, the waist 20 can include multiple threads, and the expansion member is connected to these multiple threads. Alternatively, the waist 20 can also be a rigid waist, with the expansion member installed in the waist 20. When it expands, it squeezes the waist 20, thereby blocking the atrial septal defect channel.

[0078] Based on this, this application also provides an occluder input system, which includes a delivery device and an occluder 100 as described above. The delivery device is used to deliver the occluder 100 to the orifice ovalis of the interatrial septum. Before delivery, the occluder 100 can be compressed into the delivery sheath of the delivery device. At the orifice ovalis, the occluder 100 can be released from the delivery sheath and unfolded, so that two occlusion discs 10 cover both sides of the orifice ovalis of the interatrial septum, and the waist 20 is located in the defective channel of the orifice ovalis.

[0079] Unlike existing technologies, this application discloses an occluder and an occluder input system. By flexibly connecting at least one end of the waist section to the corresponding occluder disc, the flexible connection can deform flexibly under stress. On the one hand, this facilitates the adaptation of the waist section's posture to the defective channel of the foramen ovale, reduces the traction and restraint on the occluder disc, and allows the occluder disc to self-adjust and avoid edge warping, thus eliminating peripheral leakage of the corresponding occluder disc. On the other hand, the flexible connection eliminates stress at the connection between the waist section and the corresponding occluder disc, preventing wire breakage, and reduces the restoring force of the occluder at the flexible connection, thereby reducing the risk of tissue damage to the atrial septum and foramen ovale due to pressure.

[0080] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.

Claims

1. A sealing device, characterized in that, include: Two sealing discs; The waist section is connected between the two sealing discs, and at least one end of the waist section is flexibly connected to the corresponding sealing disc, so that the corresponding sealing disc can be self-adjusted during installation; At least one of the sealing discs includes a central flexible portion and an outer ring rigid portion surrounding the central flexible portion, the central flexible portion being connected to one end of the waist portion.

2. The occluder according to claim 1, characterized in that, The occluder also includes at least one occlusion structure disposed on the waist, the occlusion structure being used to seal the oval aperture after installation.

3. The occluder according to claim 2, characterized in that, The occlusion structure includes a memory ring and a flow-blocking membrane. The memory ring is connected to the waist portion, and the flow-blocking membrane is connected to the memory ring. The outer diameter of the flow-blocking membrane is larger than the outer diameter of the memory ring. The memory ring is used to unfold within the atrial septal defect channel and abut against the wall of the atrial septal defect channel. The flow-blocking membrane is used to block the atrial septal defect channel and fill the gap between the memory ring and the wall of the atrial septal defect channel.

4. The occluder according to claim 3, characterized in that, The memory ring is a corrugated ring; or The memory ring includes a bottom circular structure and multiple umbrella ribs. One end of each umbrella rib is connected to the other end, and the other end of each umbrella rib is uniformly connected to the bottom circular structure. The bottom circular structure and the multiple umbrella ribs are used to unfold within the atrial septal defect channel, such that the bottom circular structure abuts against the wall of the atrial septal defect channel. The flow-blocking membrane is connected to the bottom circular structure or the multiple umbrella ribs, and the outer diameter of the flow-blocking membrane is larger than the outer diameter of the bottom circular structure.

5. The plugging device according to claim 2, characterized in that, The sealing structure is an expansion member, which expands after being immersed in liquid to seal the oval pore.

6. The occluder according to claim 5, characterized in that, The expansion component comprises modified medical hydrogel, polyvinyl alcohol, and gelatin sponge.

7. The plugging device according to claim 1, characterized in that, The plugging device is made of a biodegradable material.

8. A plugging device input system, characterized in that, The occluder input system includes a delivery device and an occluder as described in any one of claims 1 to 7, the delivery device being used to deliver the occluder to the orifice ovalis of the interatrial septum.

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