An occluder and occluder input system
By introducing an auxiliary support component into the occluder, the occlusion disc is driven to conform to the atrial septum, which solves the safety problem of nickel-titanium alloy occluders and the problem of incomplete deployment of biodegradable occluders, thus achieving reliable occlusion and reducing the risk of thrombosis.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- WUHAN VICKOR MEDICAL TECH CO LTD
- Filing Date
- 2024-06-30
- Publication Date
- 2026-06-12
AI Technical Summary
Existing nickel-titanium alloy occluders have problems such as metal corrosion, nickel ion precipitation, conduction blockage, and nuclear magnetic resonance effects. Furthermore, biodegradable occluders cannot fully return to their unfolded form after release, leading to the risk of blood leakage at the atrial septum and thrombus detachment.
Design an occluder comprising an occluder body and an auxiliary support assembly. The occluder disc is driven to flatten against the interatrial septum by a support disc. The support disc is gradually unfolded and fixed in place by the connection between the first and second connectors, ensuring that the occluder disc is completely fitted against the interatrial septum.
It achieves reliable deployment and fit of the occluder, eliminates the risk of leakage and thrombus dislodgement, improves the occlusion effect, is suitable for biodegradable materials, and reduces the risk of long-term foreign body retention and allergies.
Smart Images

Figure CN118845126B_ABST
Abstract
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 nickel-titanium alloy occluder under X-ray visualization to close the defect. With the advancement of technology, occluder interventional surgery has become a routine procedure for treating structural heart diseases. However, nickel-titanium occluders have some issues due to their metallic material, such as: metal corrosion, nickel ion release, nickel ion allergies in a few patients, conduction block, metal residue affecting subsequent cardiac interventional procedures, and the impact of metal implants on MRI scans. Furthermore, the first clinical implantation of a nickel-titanium alloy occluder was more than 20 years ago, and its long-term safety remains questionable.
[0003] Therefore, there is great potential for the development of biodegradable occluders. Biodegradable occluders are made of biodegradable metals and biodegradable polymers. However, currently, occluders made of either metal or polymer materials cannot fully return to their unfolded shape after being released from the delivery sheath. The disc cannot fit the atrial septum, making it prone to leakage at the atrial septum, and the protruding disc poses a risk of thrombus dislodgement. Summary of the Invention
[0004] This application provides an occluder and an occluder input system to address the problems of low reliability in the occluder's ability to autonomously return to its fully deployed state, and the high risk of leakage and thrombosis.
[0005] To solve the above-mentioned technical problems, this application adopts the following technical solution: providing an occluder. The occluder includes: an occluder body comprising a first occluder disc, a second occluder disc, and a waist section connected between the first and second occluder discs; and an auxiliary support assembly comprising a first connector, a second connector, and a support plate, wherein the first connector is connected to the support plate, and the second connector is mounted on the second occluder disc; wherein the first connector passes through the waist section to connect with the second connector, and causes the support plate to drive the first occluder disc to lie flat against one side of the interatrial septum.
[0006] In some embodiments, the connection between the first connector and the second connector is a threaded connection, a snap-fit connection, or a knot.
[0007] In some embodiments, the first connector passes through the first sealing disc, and the support disc is disposed on the side of the first sealing disc opposite to the second sealing disc, and is used to flatten the first sealing disc.
[0008] In some embodiments, the support plate is connected to the inner or outer side of the first sealing plate and is used to drive the first sealing plate to lie flat against one side of the interatrial partition.
[0009] In some embodiments, the support plate is connected to the first sealing plate by a wire or membrane.
[0010] In some embodiments, the outer edge of the support plate is provided with an inner buckling structure, which is used to press against the first sealing plate.
[0011] In some embodiments, the support plate includes a plurality of support members, the first ends of the plurality of support members being connected to each other and extending radially, and the first connector being connected to the first ends of the plurality of support members;
[0012] The support plate includes an original state and an unfolded state. When the support plate is in the original state, the multiple support members together form a cone shape. When the support plate is in the unfolded state, the first end of the multiple support members is subjected to the tension of the first connector, so that the second end of each support member acts on the first sealing plate, and the multiple support members together form a flat plate shape.
[0013] In some embodiments, the support includes spokes and support lobes.
[0014] In some embodiments, the second end of the spoke is further provided with a support pad, which is used to press against the first sealing disc.
[0015] In some embodiments, the supporting leaflet includes a leaflet portion and a leaf stem portion, wherein the width dimension of the leaflet portion in the radial direction is greater than the width dimension of the leaf stem portion, and each of the leaf stem portions is connected to each other.
[0016] In some embodiments, there are two support plates. The first connector and the second connector are respectively connected to the corresponding support plates. The support plate connected to the second connector is disposed on one side of the second sealing plate and is used to make the second sealing plate flat against the other side of the interatrial partition.
[0017] In some embodiments, the occluder is a biodegradable occluder.
[0018] To solve the above-mentioned technical problems, another technical solution adopted in this application is to provide an occluder input system. The occluder input system includes a delivery device and an occluder as described above. A first connector of the delivery device passes through a second connector and the waist section, connecting to the first connector. A second connector of the delivery device connects to the second connector. During operation of the delivery device, the second connector abuts against the interatrial septum, causing the second occluder disc to lie flat against one side of the interatrial septum. The first connector retracts, causing the first connector to pass through the waist section and connect to the second connector.
[0019] The beneficial effects of this application are as follows: Unlike existing technologies, this application discloses an occluder and an occluder input system. This application, by setting an auxiliary support component on the occluder body, further supports at least one of the first and second occluder discs, driving the supported occluder disc to actively unfold, so that the disc surface of the supported occluder disc completely conforms to the atrial septum, thereby achieving occlusion of the defective channel. Furthermore, the unfolded shape of the occluder disc after being driven is complete and reliable, and all parts of the occluder disc surface are relatively flat, eliminating the risk of thrombus dislodgement due to protruding disc surfaces present in existing occluders. Specifically, during the connection process of the first and second connecting parts, the support disc on the first connecting part... Driven by the interaction with the atrial septum, it gradually unfolds and drives the first occlusion plate to gradually flatten against one side of the atrial septum. At the same time as the support plate is fully unfolded, the first occlusion plate is also flattened against one side of the atrial septum. After the connection is completed, the support plate is fixed, thus maintaining the force on the first occlusion plate, so that the first occlusion plate can reliably flatten against one side of the atrial septum, eliminating the risk of the first occlusion plate protruding or the edge lifting. Therefore, it eliminates the risk of leakage and thrombosis of the first occlusion plate. The second connector also applies a certain force to the second occlusion plate, improving the reliability of the second occlusion plate flattening against the atrial septum. Attached Figure Description
[0020] 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:
[0021] Figure 1 This is a schematic diagram of the structure of a current nickel-titanium alloy plugging device;
[0022] Figure 2 This is a schematic diagram of the structure of a current biodegradable plugging device;
[0023] Figure 3 This is a schematic diagram of the structure of an embodiment of the occluder provided in this application;
[0024] Figure 4 Is it like this? Figure 1 The diagram shows a structural schematic of a occluder installed on an atrial septum.
[0025] Figure 5 This is a schematic diagram of the structure of two embodiments of the occluder provided in this application;
[0026] Figure 6 These are schematic diagrams of the structures of three embodiments of the occluder provided in this application;
[0027] Figure 7 These are schematic diagrams of the structures of four embodiments of the occluder provided in this application;
[0028] Figure 8 Is it like this? Figures 3 to 7 A schematic diagram of the structure of a support disk in one embodiment of the occluder shown;
[0029] Figure 9 Is it like this? Figures 3 to 7 The diagram shows a structural schematic of the second embodiment of the occluder supporting the disk. Detailed Implementation
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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.
[0034] Currently, most commercially available occluder frames are made of nickel-titanium alloy. Nickel-titanium alloy has excellent shape memory properties; after being released from the delivery device, it returns to its original shape, allowing for a good fit to the atrial septum. For example... Figure 1 As shown, Figure 1 The occluder is made of nickel-titanium alloy, where 101 is the atrial septum, and the first occluder plate 102 and the second occluder plate 103 can be restored to their designed shape and fit the atrial septum 101.
[0035] See Figure 2 , Figure 2 This is a schematic diagram of the biodegradable occluder. The skeleton material of the biodegradable occluder has no memory function. After being released from the delivery device, its first occluder disc 202 and second occluder disc 203 cannot return to their designed shape and cannot fit the atrial septum 201. This greatly reduces the occlusion effect of the biodegradable occluder and also increases the risk of thrombus dislodgement.
[0036] Currently available biodegradable polymer occluders are designed with a pull point at the center of the second occluder disc 203 to make the first occluder disc 202 and the second occluder disc 203 fit into the interatrial septum. However, due to the poor memory and strength of biodegradable materials, the adhesion of the edge of the second occluder disc 203 is still insufficient, and leakage still occurs.
[0037] This application provides a clogging device 100, see reference. Figure 3 and Figure 4 ,, Figure 3 This is a schematic diagram of an embodiment of the occluder provided in this application. Figure 4 Is it like this? Figure 1 The diagram shows a schematic of the occluder installed on the interatrial septum.
[0038] The occluder 100 includes an occluder body 10 and an auxiliary support assembly 20. The occluder body 10 includes a first occluder disc 11, a second occluder disc 12, and a waist section 13 connecting the first occluder disc 11 and the second occluder disc 12. The auxiliary support assembly 20 includes a first connector 21, a second connector 22, and a support plate 23. The first connector 21 is connected to the support plate 23, and the second connector 22 is mounted on the second occluder disc 12. The first connector 11 passes through the waist section 13 to connect with the second connector 22, and the support plate 23 drives the first occluder disc 11 to lie flat against one side of the interatrial septum.
[0039] The occluder 100 is installed in the foramen ovale of the atrial septum 101 of the atrium to block the defect channel formed by the foramen ovale in the atrial septum 101. The first occluder disc 11 and the second occluder disc 12 respectively cover the two sides of the foramen ovale and fit against the two sides of the atrial septum 101, which can fix the occluder 100 and block blood flow; the waist 13 passes through the defect channel.
[0040] The occluder 100 can also be applied to the ventricular septum, with two first occluder discs 11 and a second occluder disc 12 covering both sides of the defective passage of the ventricular septum and fitting against both sides of the ventricular septum, and the waist 13 passing through the defective passage of the ventricular septum.
[0041] The occluder body 10 can be made of braided silk or printed with biocompatible materials, and the first occluder disc 11 and the second occluder disc 12 can be covered with a flow-blocking membrane. The occluder body 10 made of shape memory metal has good shape memory and can be fixed in a contracted state during delivery to facilitate delivery in blood vessels. After installation and release of fixation, it can return to the initial disc shape to cover the foramen ovale, thereby occluding the foramen ovale.
[0042] Even the occluder body 10 made of shape memory metal can have issues such as disc protrusion and inability to reliably fit the intercompartment due to factors like compression deformation.
[0043] Optionally, the occluder body 10 may also be made of biodegradable metal or biodegradable polymer material. Because the biodegradable occluder body 10 cannot be fully restored to its unfolded form after being released from the delivery sheath, the disc surface cannot reliably fit the atrial septum, making it easy for blood to leak from the location of the defective channel on the atrial septum, and the protruding disc surface has the risk of thrombus dislodgement.
[0044] This application provides an auxiliary support component 20 on the occluder body 10. The auxiliary support component 20 is used to further support at least one of the first occluder disc 11 and the second occluder disc 12. It can drive the supported occluder disc to actively unfold, so that the disc surface of the supported occluder disc is completely attached to the interatrial septum 101, thereby achieving the occlusion of the defective channel. Moreover, the unfolded shape of the occluder disc after being driven is complete and reliable, and all parts of the disc surface can be relatively flat, eliminating the risk of thrombus dislodgement due to protruding disc surfaces in existing occluders.
[0045] The auxiliary support component 20 may be made of shape memory metal or biodegradable material.
[0046] Optionally, the occluder 100 is a biodegradable occluder, meaning that both the occluder body 10 and the auxiliary support component 20 are made of biodegradable metal or biodegradable polymer materials, specifically polylactic acid (PLA), polycaprolactone (PCL), or other biocompatible polymers. This biodegradable material can gradually decompose in the human body and eventually be absorbed or naturally metabolized, allowing the occluder 100 to be removed without a second surgery, reducing the potential risks and discomfort of long-term foreign body retention. Furthermore, 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 require long-term cardiac monitoring or may undergo other cardiac interventional procedures in the future, the biodegradable occluder 100 will not affect subsequent diagnosis and treatment, such as atrial fibrillation radiofrequency ablation or left atrial appendage occlusion, without the need to worry about interference from the original metal material.
[0047] Optionally, the occluder 100 is made of traditional shape memory metal materials such as nickel-titanium alloy, that is, the occluder body 10 and the auxiliary support component 20 are both made of shape memory metal.
[0048] In this embodiment, as Figure 3 As shown, after the first connector 21 and the support plate 23 are connected, they can be connected to the first sealing plate 11 without direct connection. The first connector 21 and the support plate 23 are pre-installed on the first sealing plate 11 after being connected.
[0049] Optionally, see Figure 5 or Figure 6 At least one of the first connector 21 and the support plate 23 can also be directly connected to the first occlusion plate 11 without pre-installation before the interventional procedure.
[0050] The second connector 22 is installed on the second sealing plate 12. The second connector 22 can be fixedly connected to the second sealing plate 12, for example, by using wire to bind the second connector 22 to the second sealing plate 12, or the second connector 22 can be riveted to the second sealing plate 12.
[0051] See Figure 3 and Figure 4 The connection between the first connector 21 and the second connector 22 can be a threaded connection, a snap-fit connection, or a knotted connection. For example, the first connector 21 and the second connector 22 can be either a screw or a nut, which can be threaded together; or, the first connector 21 and the second connector 22 can be either a male thread or a female thread, which can be snapped together; or, the first connector 21 can be a thread, and the second connector 22 can be a fastener, which can be a fastener rod or a fastener with a fastener hole, allowing the thread to be driven to knot and connect to the fastener, or the fastener can have a thread that cooperates with the first connector 21 to knot, and the two threads can be knotted under drive.
[0052] When the occluder 100 is delivered, the support plate 23 is retracted and inserted into a smaller delivery sheath. After the occluder 100 is released from the delivery sheath, the support plate 23 can also be deployed. As the first connector 21 is pulled towards the second connector 22, the support plate 23 can interact with one side of the interatrial septum or with one side of the interatrial septum through the first occluder 21, causing the support plate 23 to gradually and fully deploy to its designed shape. This also drives the first occluder 21 to deploy to its designed shape and completely flatten against one side of the interatrial septum.
[0053] The above method enables the first connector 21 and the second connector 22 to be easily connected. During the connection process, the support plate 23 gradually unfolds under the action of the first connector 21 and interacts with the interatrial partition, driving the first sealing plate 11 to gradually flatten against one side of the interatrial partition. While the support plate 23 is fully unfolded, the first sealing plate 11 is also flattened against one side of the interatrial partition. After the connection is completed, the support plate 23 is fixed, thus maintaining the force on the first sealing plate 11, so that the first sealing plate 11 can reliably flatten against one side of the interatrial partition, eliminating the risk of the first sealing plate 11 protruding or its edges lifting.
[0054] The second connector 22 is installed on the second sealing plate 12, which can apply a certain force to the second sealing plate 12 to improve the reliability of the second sealing plate 12 being flat against the room partition.
[0055] In one embodiment, see Figure 3 The first connector 21 and the support plate 23 are independently configured and are pre-installed on the first occlusion plate 21 before the operation. Specifically, the first connector 21 can be inserted into the first occlusion plate 11, and the support plate 23 is located on the side of the first occlusion plate 11 opposite to the second occlusion plate 12 and is used to flatten the first occlusion plate 11.
[0056] The first sealing disc 11 has a mesh structure and a flow-blocking membrane is sewn onto it, while the support disc 23 may not have a flow-blocking membrane sewn onto it. During pre-installation, the first connector 21 can pass through the mesh on the first sealing disc 11 and be installed on the first sealing disc 11, and is connected to the support disc 23. The support disc 23 is located on the side of the first sealing disc 11 opposite to the second sealing disc 12, and the support disc 23 can be retracted and installed into a smaller delivery sheath together with the sealing device body 10.
[0057] See Figure 4 The diameter of the support plate 23 can be slightly smaller than the diameter of the first sealing plate 11, and the edge strength of the support plate 23 can be set higher, so that the edge of the first sealing plate 11 can be pressed and effectively fit against the room partition.
[0058] like Figure 3 As shown, the occluder 100 is pre-installed externally. The support plate 23 is connected to the first connector 301 of the delivery device 300 via the first connector 21. The first connector 301 can be a core wire or a rod. The second occluder plate 12 is connected to the second connector 302 of the delivery device 300 via the second connector 22. The second connector 302 can be a push rod.
[0059] The pre-installed occluder 100 is conveyed to the oval orifice of the interatrial septum 101 via the conveying device 300 and released. Then, the second connector 302 presses against the second connector 22 on the interatrial septum, so that the second occluder disc 12 is flat against the interatrial septum 101. At the same time, the first connector 301 is retracted, so that the first connector 21 passes through the first occluder disc 11 and the waist 13 and connects with the second connector 22. After the connection is completed, both the first occluder disc 11 and the second occluder disc 12 are flat against the interatrial septum 101. The support disc 23 is flat against the first occluder disc 11, and the edge of the first occluder disc 11 is reliably attached to the interatrial septum 101, thereby effectively preventing the occurrence of perineural leakage.
[0060] See Figure 5 or Figure 6 In another embodiment, the support plate 23 is connected to the inner or outer side of the first sealing plate 11, that is, the support plate 23 and the first sealing plate 11 are connected as one unit, and under the control of the conveying device 300, the first connecting member 21 is connected to the second connecting member 22 on the second sealing plate 12. The support plate 23 is used to drive the first sealing plate 11 to be flat against one side of the interatrial partition, and the second connecting member 22 also applies a certain force to the second sealing plate 12 to drive the second sealing plate 12 to be flat against the other side of the interatrial partition, so that the first sealing plate 11 and the second sealing plate 12 are tightly attached to the interatrial partition.
[0061] See Figure 5 , Figure 5 The middle support plate 23 is connected to the outside of the first sealing plate 11; or refer to Figure 6 , Figure 6 The middle support plate 23 is connected to the inner side of the first sealing plate 11.
[0062] The support plate 23 is connected to the first sealing plate 11 by a wire or a membrane. The wire can be a memory wire, a biodegradable metal wire, or a biodegradable polymer wire. The membrane can be a biocompatibility biofilm, such as bovine tripe or bovine pericardium. In other words, a biofilm is used as a connector between the support plate 23 and the first sealing plate 11.
[0063] By connecting the support plate 23 and the first sealing plate 11 as a whole, the fit between the support plate 23 and the first sealing plate 11 is better, which can avoid wrinkles or protrusions on the first sealing plate 11, and also helps to ensure smooth connection between the first connector 21 and the second connector 22.
[0064] The way the plugger 100 and the conveying device 300 cooperate is the same as in the previous embodiment, and will not be described again.
[0065] Based on the above embodiments, such as Figure 3 As shown, the outer edge of the support plate 23 is provided with an inner buckling structure 230, which is used to press against the first sealing plate 11. The inner buckling structure 230 can increase the edge strength of the support plate 23 and provide stronger pressure when the inner buckling structure 230 is pressed against the first sealing plate 11, so that the edge of the first sealing plate 11 can effectively fit against the room partition.
[0066] The inner buckling structure 230 can be a folded edge that bends towards the first sealing plate 11 relative to the main body of the support plate 223; or, the inner buckling structure 230 can be a protrusion provided at the edge of the support plate 223.
[0067] See Figure 8 or Figure 9 The support plate 23 includes multiple support members 232. The first ends of the multiple support members 232 are connected to each other and spread out radially. The second ends of the support members 232 extend outward relative to each other. The second end of each support member 23 may be provided with an inner buckling structure 230. The first connector 21 is connected to the first end of the multiple support members 232.
[0068] The support plate 23 has two different shape states before and after driving the first sealing plate 11. The support plate 23 includes an original state and an unfolded state, such as... Figure 3 , Figure 5 and Figure 6 As shown, the support plate 23 drives the first sealing plate 11 in its original position; as Figure 4As shown, after the first connector 21 and the second connector 22 are connected, the support plate 23 is in the unfolded state. When the support plate 23 is in the original state, the multiple support members 232 together form a cone shape; when the support plate 23 is in the unfolded state, the first ends of the multiple support members 232 are pulled by the first connector 21, so that the second ends of each support member 232 act on the first sealing plate 11, and the multiple support members 232 together form a flat plate shape.
[0069] The support member 232 may be made of thicker wire or rod as the skeleton of the support plate 23, thereby providing a stronger force on the first sealing plate 11, so that the first sealing plate 11 can reliably fit into the room partition.
[0070] When the support plate 23 is set independently relative to the first sealing plate 11, the support plate 23 may further include a flow-blocking membrane or connecting line set on each support member 232, which can make the overall integrity of each support member 232 stronger, thereby strengthening the support plate 23 and making the force on the first sealing plate 11 stronger and more reliable.
[0071] The support member 232 includes spokes and support leaflets, and the support member 232 can be either spokes or support leaflets.
[0072] Optionally, such as Figure 8 As shown, the support member 232 is a spoke, and the first ends of each spoke are connected and arranged radially. The second end of the spoke is provided with a support pad 231. The support pad 231 is used to press against the first sealing plate 11. The function of the support pad 231 is the same as that of the inner buckling structure 230, which can increase the edge strength of the support plate 23 and provide stronger pressure to the first sealing plate 11.
[0073] Optionally, such as Figure 9 As shown, the support member 232 is a support leaflet, which includes a leaflet portion 233 and a leaf stem portion 234. The support leaflets are arranged radially, and each leaf stem portion 234 is connected to each other. The width dimension of the leaflet portion 233 along the radial direction is greater than the width dimension of the leaf stem portion 234, that is, the mass of the leaflet portion 233 is greater than the mass of the leaf stem portion 234. The mass difference between the leaflet portion 233 and the leaf stem portion 234 can make the leaflet portion 233 provide a greater force on the first sealing disk 11.
[0074] The support leaflets are single-leaf structures, and each support leaflet is relatively independent. Therefore, the occluder 100 can avoid the situation where the adjacent support leaflets at the protruding position cannot fit into the atrial septum due to the local protrusion of the atrial septum.
[0075] The aforementioned support plate 23 can be set independently relative to the first sealing plate 11; or the support plate 23 can be connected to the first sealing plate 11 as a whole, and each support member 232 can be sewn onto the first sealing plate 11 by thread or membrane.
[0076] Further, see Figure 7 The number of support plates 23 can also be two. The first connector 21 and the second connector 22 are respectively connected to the corresponding support plates 23. The support plate 23 connected to the second connector 22 is located on the side where the second sealing plate 12 is located, and is used to make the second sealing plate 12 flat against the other side of the interatrial partition when the first connector 21 and the second connector 22 are connected.
[0077] In other words, both the first sealing plate 11 and the second sealing plate 12 have corresponding support plates 23 providing support, thus allowing the second sealing plate 12 to more reliably adhere to the other side of the room partition. The arrangement relationship between the support plate 23 connected to the second connector 22 and the second sealing plate 12 is similar to the arrangement relationship between the support plate 23 connected to the first connector 21 and the first sealing plate 12, and will not be repeated here.
[0078] Based on this, this application also provides an occluder input system, which includes a delivery device 300 and an occluder 100 as described above. The first connector 301 of the delivery device 300 passes through the second connector 22 and the waist 13 to connect to the first connector 21, and the second connector 302 of the delivery device 300 connects to the second connector 22. When the delivery device 300 is in operation, the second connector 302 abuts against the interatrial septum, causing the second occluder disc 12 to lie flat against one side of the interatrial septum. The first connector 301 retracts, causing the first connector 21 to pass through the waist 13 and connect the first connector 21 to the second connector 22.
[0079] Unlike existing technologies, this application discloses an occluder and an occluder input system. This application incorporates an auxiliary support component on the occluder body. This auxiliary support component further supports at least one of a first and a second occluder disc, driving the supported occluder disc to actively unfold, ensuring its surface completely conforms to the atrial septum, thereby occluding the defective passage. The unfolded shape of the occluder disc after being driven is complete and reliable, and all surfaces of the occluder disc are relatively flat, eliminating the risk of thrombus dislodgement due to protruding disc surfaces present in existing occluders. Specifically, during the connection process between the first and second connecting members, the support disc... Driven by the interaction with the atrial septum, it gradually unfolds and drives the first occlusion plate to gradually flatten against one side of the atrial septum. At the same time as the support plate is fully unfolded, the first occlusion plate is also flattened against one side of the atrial septum. After the connection is completed, the support plate is fixed, thus maintaining the force on the first occlusion plate, so that the first occlusion plate can reliably flatten against one side of the atrial septum, eliminating the risk of the first occlusion plate protruding or the edge lifting. Therefore, it eliminates the risk of leakage and thrombosis of the first occlusion plate. The second connector also applies a certain force to the second occlusion plate, improving the reliability of the second occlusion plate flattening against the atrial septum.
[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: The occluder body includes a first occluder disc, a second occluder disc, and a waist section connecting the first occluder disc and the second occluder disc; An auxiliary support assembly includes a first connector, a second connector, and a support plate, wherein the first connector is connected to the support plate, and the second connector is installed on the second sealing plate; The first connector is used to pass through the waist and connect with the second connector, so that the support plate drives the first sealing plate to lie flat against one side of the interatrial partition. The first connector is inserted through the first sealing plate, and the support plate is disposed on the side of the first sealing plate opposite to the second sealing plate, and is used to flatten the first sealing plate; The support plate includes multiple support members, the first ends of the multiple support members are connected to each other and spread out radially, the second ends of the support members extend outward relative to each other, and the first connector is connected to the first ends of the multiple support members; The support plate includes an original state and an unfolded state. When the support plate is in the original state, the multiple support members together form a cone shape. When the support plate is in the unfolded state, the first end of the multiple support members is subjected to the tension of the first connecting member, so that the second end of each support member acts on the first sealing plate, and the multiple support members together form a flat plate shape.
2. The occluder according to claim 1, characterized in that, The connection between the first connector and the second connector is a threaded connection, a snap-fit connection, or a knot.
3. The occluder according to claim 1, characterized in that, The outer edge of the support plate is provided with an inner buckling structure, which is used to press against the first sealing plate.
4. The occluder according to claim 1, characterized in that, The support includes spokes and support lobes.
5. The plugging device according to claim 4, characterized in that, The first ends of each spoke are connected and arranged radially, and the second end of each spoke is provided with a support pad, which is used to press against the first sealing plate.
6. The occluder according to claim 4, characterized in that, The supporting leaflet includes a leaflet portion and a leaf stem portion. The width of the leaflet portion in the radial direction is greater than the width of the leaf stem portion, and each of the leaf stem portions is connected to each other.
7. The plugging device according to claim 1, characterized in that, The number of support plates is two. The first connector and the second connector are respectively connected to the corresponding support plates. The support plate connected to the second connector is located on one side of the second sealing plate and is used to make the second sealing plate flat against the other side of the interatrial partition.
8. The occluder according to claim 1, characterized in that, The plugging device is a biodegradable plugging device.
9. 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 8, wherein a first connector of the delivery device passes through the second connector and the waist portion and is connected to the first connector, and a second connector of the delivery device is connected to the second connector; When the conveying device is in operation, the second connector abuts against the interseptum, causing the second sealing plate to lie flat against one side of the interseptum. The first connector retracts, causing the first connecting member to pass through the waist and connect the first connecting member with the second connecting member.