A repair system anchorable with leaflets

Abstract

The application relates to the field of medical devices, in particular to a repair system capable of anchoring to a valve leaflet, comprising a positioning support, a single anti-reflux prosthesis for replacing the function of a single native valve leaflet, an anchoring member, a puncture member and a manipulating member, one end of the single anti-reflux prosthesis being fixed on the positioning support, the proximal end of the positioning support being anchored on the ventricular tissue through the anchoring member, the proximal end of the positioning support being provided with an anchoring unit, the puncture member being fixedly connected on the anchoring unit, and the anchoring unit swinging to the distal end direction of the positioning support by pulling the manipulating member; when preassembling, the puncture member is constrained by the positioning support, the manipulating member is pulled to release the puncture member after the positioning support reaches the target position, and the anchoring unit rebounds to drive the puncture member to pass through the replaced native valve leaflet by releasing the manipulating member.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a repair system that can be anchored to a valve leaflet. Background Technology

[0002] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annular dilation. Clinically, it often presents as a manifestation of the underlying cause of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After tricuspid regurgitation occurs, patients may experience worsening of right heart failure symptoms such as fatigue, ascites, edema, liver pain, indigestion, and loss of appetite. Mild tricuspid regurgitation may not present with obvious clinical symptoms, but severe regurgitation requires surgical treatment.

[0003] Traditional treatments for mitral and tricuspid valve disease include medication for mild to severe regurgitation and surgical procedures when indicated. Surgical procedures include valve replacement and valve repair. Among these, typical open-heart surgery and open-heart surgery are highly invasive, require cardiopulmonary bypass, and have a high complication rate and infection risk. Many patients cannot tolerate the significant surgical risks and are left with no choice but to await death.

[0004] Following the report of the first aortic valve replacement surgery, numerous companies have conducted extensive research in interventional aortic valve technology, which has become increasingly mature. However, significant technological gaps remain in the interventional treatment of atrioventricular valves. Although a few products for interventional treatment of atrioventricular valves have been applied in transcatheter valve repair and angioplasty, no mature and usable products have yet been launched internationally for transcatheter valve replacement.

[0005] Patent CN202210730620.5 discloses a repair device for preventing valvular regurgitation, including a positioning stent and a single anti-regurgitation leaflet prosthesis for replacing the function of a single autologous leaflet; wherein one end of the single anti-regurgitation leaflet prosthesis is fixed to the positioning stent. The repair device replaces only the problematic single leaflet, thus preserving the original function of the remaining autologous leaflets without altering the morphology of the autologous valve annulus, minimizing damage to intracardiac tissue, and requiring a smaller implantation volume with less irritation. In this design, the positioning stent is anchored in the ventricle by an anchoring element, and its auxiliary abutment holds the autologous leaflet. However, during cardiac pulsation, the distal portion of the positioning stent cannot remain firmly against the cardiac tissue, causing the stent to tilt or sway, resulting in unstable positioning and potentially leading to problems such as paravalvular leakage and thrombosis.

[0006] Therefore, there is an urgent need in this field for an implantable device that can achieve reliable fixation, maximize the use of the original valve function, minimize the impact on cardiac motion and hemodynamics, reduce the difficulty of surgical operation, and has a simple structure. Summary of the Invention

[0007] In view of the foregoing and other concepts, the present invention is proposed.

[0008] One of the technical problems to be solved by the present invention is to provide an innovative repair system that can be anchored to the leaflet, which can reliably fix the valve, preserve the function of the main autologous leaflet, have little impact on cardiac motion and hemodynamics, and has a simple structure and low surgical difficulty.

[0009] The basic inventive concept of another aspect of the present invention is that the repair device of the present invention is intended to repair rather than replace the entire autologous heart valve. In other words, the repair device of the present invention is intended to replace one or two autologous leaflets, rather than all of the autologous leaflets. For the mitral valve, the repair device of the present invention is intended to replace one of the autologous leaflets while retaining the other autologous leaflet to function normally. For the tricuspid valve, the repair device of the present invention is intended to replace one of the autologous leaflets, such as the posterior leaflet, while retaining the other two autologous leaflets to function normally; or, two repair devices of the present invention are used to replace two autologous leaflets of the tricuspid valve while retaining the other autologous leaflet to function normally.

[0010] Specifically, according to one aspect of the present invention, a repair system anchorable to a valve leaflet is provided, comprising a positioning stent, a single anti-reflux prosthesis for replacing the function of a single autologous valve leaflet, an anchoring element, a puncture member, and an actuating member. One end of the single anti-reflux prosthesis is fixed to the positioning stent, the proximal end of the positioning stent is anchored to ventricular tissue via the anchoring element, the proximal end of the positioning stent is provided with an anchored unit, the puncture member is fixedly connected to the anchored unit, and pulling the actuating member causes the anchored unit to swing toward the distal end of the positioning stent. During pre-installation, the puncture member is constrained by the positioning stent. After the positioning stent reaches the target position, pulling the actuating member releases the puncture member, and releasing the actuating member causes the anchored unit to rebound and drive the puncture member through the replaced autologous valve leaflet.

[0011] According to one embodiment, the anchored unit and the positioning bracket are hinged by a torsion spring. When the actuating member is pulled, the anchored unit rotates about the center of the torsion spring toward the distal end of the positioning bracket, thereby releasing the puncture member.

[0012] According to one embodiment, the anchored unit is provided with a fabric layer, the anchoring element passes through the fabric layer and forms an anchor with the ventricular tissue, the fabric layer being made of implantable polyester fabric.

[0013] According to one embodiment, the free end of the puncture member is sharp, and the puncture member is configured with an arcuate structure to prevent the free end of the puncture member from puncturing the heart ventricle tissue after the puncture member is released.

[0014] According to one embodiment, after the positioning bracket is installed in place, the puncture component avoids the chordae tendineae tissue. This design can prevent the puncture component from hooking onto the chordae tendineae tissue during operation.

[0015] According to one embodiment, after the puncture member is released, the free end of the puncture member punctures the root of the autologous leaflet, so that the positioning bracket forms an effective fixed connection with the autologous leaflet.

[0016] According to one embodiment, the positioning bracket is provided with a limiting element, one end of the puncture member is fixed to the anchored unit, and during pre-installation, the other end of the puncture member is constrained by the limiting element. When the operating element is pulled, the anchored unit swings toward the distal end of the positioning bracket, and the other end of the puncture member disengages from the limiting element.

[0017] According to one embodiment, the distal end of the positioning bracket is provided with an atrial portion, the atrial portion being configured to adapt to the shape of the autologous valve annulus, and the atrial portion being provided with a fabric layer for leak prevention.

[0018] According to one embodiment, the atrial portion includes a leak-proof unit, wherein after the positioning bracket is installed in place, the leak-proof unit abuts against or conforms to the autologous valve annulus tissue, and when the autologous valve opens and closes, causing a change in the shape of the autologous valve annulus, the leak-proof unit undergoes adaptive deformation following the change in the shape of the autologous valve annulus, so that the leak-proof unit always abuts against or conforms to the autologous valve annulus tissue.

[0019] According to one embodiment, after the puncture member is released, the other end of the puncture member passes through the replaced autologous valve ring and is fixedly connected to the leak-proof unit.

[0020] According to one embodiment, the leak-proof unit is arc-shaped and has the function of elastic deformation, so that the leak-proof unit can adapt to the shape changes of the autologous valve ring.

[0021] According to one embodiment, the leak-proof unit includes multiple elastic wires and a flow-blocking membrane. Two ends of the elastic wires are fixed to the atrium, or one end of the elastic wire is fixed to the atrium and the other end is free. The flow-blocking membrane can block blood flow.

[0022] According to one embodiment, the repair system includes at least two anchors, and at least two anchors are pre-spaced axially, and the anchored unit of the positioning bracket is anchored to the interventricular septum tissue by the anchors.

[0023] According to one embodiment, when the autologous valve is in a closed state, the free edge of the single anti-reflux prosthesis works together with the free edges of the remaining autologous leaflets to achieve normal valve closure, or at least partially overlaps with the free edges of the remaining autologous leaflets to prevent valve regurgitation.

[0024] According to another embodiment, the anti-reflux prosthesis is selected from the following: an integral membrane made of flexible material; and a support frame and a biocompatible membrane or sheet covering the support frame; and an implantable balloon.

[0025] Compared with the prior art, the advantages of this application are: 1. In the prior art, the stent of the repair device is not stable after implantation in the heart and is prone to tilting, which can lead to blood reflux. Unlike the prior art, in one embodiment of the present invention, the anchored unit and the positioning stent are connected by a torsion spring. When the positioning stent reaches the release position, the operating member is pulled to rotate the anchored unit toward the distal end of the positioning stent, thereby releasing the puncture member. Furthermore, releasing the operating member allows the anchored unit to rebound, further allowing the free end of the puncture member to pass through the autologous valve leaflet. This enables the positioning stent to form an effective connection with the autologous valve leaflet and cooperates with the anchoring member to securely fix the positioning stent in the heart, avoiding tilting or swaying of the repair system after implantation, which could lead to paravalvular leakage.

[0026] 2. Unlike existing technologies, in one embodiment of the present invention, the puncture component is configured with an arc-shaped structure, which prevents the puncture component from scratching the ventricular tissue during the rebound of the anchored unit after release, ensuring the safety of the instrument operation. Furthermore, the free end of the puncture component punctures the root of the autologous leaflet. Since the muscle tissue in the root region of the autologous leaflet is relatively thick, it can withstand greater forces. Anchoring at the root of the autologous leaflet also allows the positioning stent to be close to one side of the heart wall, so that the replacement of the problematic leaflet will not affect the movement of other autologous leaflets.

[0027] 3. Unlike existing technologies, in one embodiment of the present invention, the proximal end of the positioning stent is fixed to the ventricular tissue by an anchor, the puncture component is anchored to the replaced autologous leaflet, and the distal end of the positioning stent is disposed on the autologous valve annulus. This allows the positioning stent to be stably attached to one side of the replaced autologous leaflet of the autologous valve, and only the problematic leaflet is replaced, thereby preserving the original function of the remaining autologous leaflet, while not changing the shape of the autologous valve annulus. This results in minimal damage to intracardiac tissue, a smaller implantation volume, and less irritation.

[0028] 4. Unlike the prior art, in one embodiment of the present invention, after the puncture component is released, the other end of the puncture component passes through the replaced autologous valve ring and is fixedly connected to the leak-proof unit. This can prevent one end of the puncture component from being in long-term contact with blood and generating thrombi, thereby causing complications. At the same time, it can enhance the anchoring effect and also prevent the sharp end of the puncture component from damaging the anti-reflux prosthesis, which has great clinical significance.

[0029] 5. Unlike existing technologies, in one embodiment of the present invention, the positioning stent is secure and risk-free; the fixable area of ​​the ventricular septum is much larger than that of the valve annulus and atrium, thus requiring less precise device positioning; and there are no other important branch vessels near the ventricular septum, preventing functional damage and ensuring high safety; during cardiac motion, the amplitude of ventricular septum movement is relatively small compared to the valve annulus, resulting in more stable fixation, higher success rate, and better effect.

[0030] 6. Unlike existing technologies, in one embodiment of the present invention, the positioning stent is fixed to the ventricular tissue by an anchor, the atrial portion can effectively prevent the repair device from tipping over, and the leak-proof unit can effectively block blood from entering between the atrial portion and the replaced autologous valve leaflet, preventing this blood from entering and accumulating at the root of the anti-reflux prosthesis, thus preventing thrombosis at the root of the anti-reflux prosthesis. Furthermore, the leak-proof unit can adapt to changes in the shape of the autologous valve annulus, ensuring that the leak-proof unit always fits tightly against the autologous valve annulus, dynamically filling the gap between the atrial segment and the autologous valve annulus. At the same time, the repair system replaces the problematic valve leaflet, thereby preserving the original function of the remaining autologous valve leaflet without changing the shape of the autologous valve annulus, resulting in minimal damage to intracardiac tissue. Additionally, the implantation volume is small, leading to less irritation.

[0031] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0032] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figures 1a-1e This is a schematic diagram of the overall repair device of the present invention.

[0033] Figures 2a-2d This is a schematic diagram of the leak-proof unit structure of the repair device of the present invention.

[0034] Figures 3a-3c This is a schematic diagram of the repair device of the present invention after implantation.

[0035] Figures 4a-4e This is a schematic diagram of the implantation process of the repair device of the present invention.

[0036] The names that the numbers in the attached diagram refer to are as follows: 1-Positioning bracket, 11-Anchored unit, 12-Restricting element, 13-Atrial part, 131-Leakage prevention unit, 1311-Elastic wire, 1312-Blocking membrane, 2-Anti-reflux prosthesis, 3-Anchoring component, 4-Puncture component, 5-Manipulation component, 6-Torsion spring. Detailed Implementation

[0037] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0038] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0039] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0040] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0041] In this application, "proximal" refers to the end closest to the apex of the heart, and "distal" refers to the end furthest from the apex of the heart.

[0042] Example 1 The tricuspid valve of the human heart has an anterior leaflet, a posterior leaflet, and a diaphragmatic leaflet. These leaflets are closed during cardiac contraction. Valvular regurgitation occurs when any of these leaflets fails to close properly.

[0043] Figures 1a-1e As shown, a repair system anchorable to a valve leaflet includes a positioning bracket 1, a single anti-reflux prosthesis 2 for replacing the function of a single autologous valve leaflet, an anchoring element 3, a puncture member 4, and an actuating member 5. One end of the single anti-reflux prosthesis 2 is fixed to the positioning bracket 1. The proximal end of the positioning bracket 1 is anchored to ventricular tissue via the anchoring element 3. The proximal end of the positioning bracket 1 is provided with an anchored unit 11. The puncture member 4 is fixedly connected to the anchored unit 11. Pulling the actuating member 5 causes the anchored unit 11 to swing toward the distal end of the positioning bracket 1. During pre-installation, the puncture member 4 is constrained by the positioning bracket 1. After the positioning bracket 1 reaches the target position, pulling the actuating member 5 releases the puncture member 4. Releasing the actuating member 5 causes the anchored unit 11 to rebound and drive the puncture member 4 through the replaced autologous valve leaflet.

[0044] The positioning bracket 1 does not affect the function of the remaining autologous leaflets after installation.

[0045] Repair systems that can be anchored to leaflets can have both constrained and released states.

[0046] According to another example, in the treatment of tricuspid valve, the leaflets of the septum can be replaced by a repair system that is anchored to the leaflets.

[0047] According to one example, the anchored unit 11 is connected to the positioning bracket 1 via a torsion spring 6. When the actuating member 5 is pulled, the anchored unit 11 rotates about the center of the torsion spring 6 toward the distal end of the positioning bracket 1, thereby releasing the puncture member 4.

[0048] According to one example, the anchored unit 11 is provided with a fabric layer, through which the anchor 3 passes and forms an anchor with the ventricular tissue. The fabric layer is made of implantable polyester fabric, such as... Figure 1b As shown.

[0049] According to one example, the free end of the puncture member 4 is sharp, and the puncture member 4 is configured with an arcuate structure to prevent the free end of the puncture member 4 from piercing the heart ventricular tissue after it is released. Figure 1c As shown.

[0050] According to one example, after the puncture member 4 is released, the free end of the puncture member 4 punctures the root of the autologous valve leaflet, thereby forming an effective fixed connection between the positioning bracket 1 and the autologous valve leaflet. Figures 3a-3b As shown.

[0051] According to one example, the positioning bracket 1 is provided with a limiting element 12, one end of the puncture member 4 is fixed to the anchored unit 11, and during pre-installation, the other end of the puncture member 4 is constrained by the limiting element 12. When the operating element is pulled, the anchored unit 11 swings toward the distal end of the positioning bracket 1, and the other end of the puncture member 4 disengages from the limiting element 12.

[0052] According to one example, the distal end of the positioning bracket 1 is provided with an atrial portion 13, which is configured to adapt to the shape of the autologous valve annulus, and the atrial portion 13 is provided with a fabric layer for leak prevention.

[0053] According to one example, the atrial portion 13 includes a leak-proof unit 131, wherein, after the positioning bracket 1 is installed in place, the leak-proof unit 131 abuts against or conforms to the autologous valve annulus tissue, and, when the autologous valve opens and closes, causing a change in the shape of the autologous valve annulus, the leak-proof unit 131 adaptively deforms to follow the change in the shape of the autologous valve annulus, so that the leak-proof unit 131 always abuts against or conforms to the autologous valve annulus tissue, such as... Figure 2c and 2d As shown.

[0054] According to one example, the leak-proof unit 131 is in an arc shape, such as... Figure 2a As shown, the leak-proof unit 131 has the function of elastic deformation, so that the leak-proof unit 131 can adapt to the morphological changes of the autologous valve ring.

[0055] According to one example, the leak-proof unit 131 includes multiple elastic wires 1311 and a flow-blocking membrane 1312. Two ends of the elastic wires 1311 are fixed to the atrial portion 13, or one end of the elastic wire 1311 is fixed to the atrial segment and the other end is free. The flow-blocking membrane 1312 can block blood flow, such as... Figure 2a and 2b As shown.

[0056] According to one example, after the puncture member 4 is released, the other end of the puncture member 4 passes through the replaced autologous valve annulus and is fixedly connected to the choke membrane 1312 of the leak-proof unit 131.

[0057] According to one example, the repair system includes at least two anchors 3, and the at least two anchors 3 are pre-spaced axially, and the anchored unit 11 of the positioning bracket 1 is anchored to the interventricular septum tissue by the anchors 3, as shown. Figure 3a As shown.

[0058] According to one example, when the autologous valve is in the closed state, the free edge of the single anti-regurgitation prosthesis 2 works together with the free edges of the remaining autologous leaflets to achieve normal valve closure, or at least partially overlaps with the free edges of the remaining autologous leaflets to prevent valve regurgitation, such as... Figure 3c As shown.

[0059] According to one example, the anti-backflow prosthesis 2 is an integral diaphragm made of flexible material.

[0060] According to another example, the fixed end of the single anti-reflux prosthesis 2 is fixedly connected to the positioning bracket 1, and the free end of the anti-reflux prosthesis 2 is movably connected to the positioning bracket 1 via a traction wire; wherein, after the repair device is installed in place, the free end of the single anti-reflux prosthesis 2 can move between a leaflet-open state and a leaflet-closed state; in the leaflet-open state, the single anti-reflux prosthesis 2, together with the other autologous leaflets of the valve except for the single autologous leaflet, opens together; in the leaflet-closed state, the single anti-reflux prosthesis 2, together with the other autologous leaflets, closes together to prevent valve regurgitation.

[0061] Anti-reflux prosthesis 2 can also be configured with traction wires in other ways similar to autologous valve construction.

[0062] Similar to the structure of a natural valve leaflet, the anti-reflux prosthesis 2 may have a curved surface structure similar to that of a natural valve leaflet.

[0063] An exemplary cardiac atrioventricular tricuspid valve surgery procedure for the leaflet-anchorable repair device of this embodiment is as follows: Figures 4a-4e As shown: 1. The repair system that can be anchored to the valve leaflets uses a transfemoral approach, entering the atrium via the femoral vein and superior vena cava, and then reaching the atrioventricular orifice of the right atrium; 2. Move the entire repair system toward the ventricle and pull the operating mechanism 5 to release the puncture component 4. At this time, the puncture component 4 and the positioning bracket 1 form an angle. Move the repair system so that the autologous valve leaflet is located between the puncture component 4 and the positioning bracket 1. 3. Further adjust the atrial portion 13 to position it at the autologous valve annulus, then release the manipulator 5 to allow the anchoring unit 11 to return, the puncture member 4 passes through the autologous valve leaflet, and then disassemble the manipulator 5 and the puncture member 4. 5. Continue the surgical procedure by fixing the positioning stent 1 to the ventricular septum using the anchor 3. This completes the main surgical procedure for the repair device.

[0064] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope and equivalents of this invention are intended to be defined by the appended claims.

Claims

1. A prosthetic system anchorable to a valve leaflet, comprising a positioning support, a single anti-regurgitation prosthesis for replacing the function of a single autologous valve leaflet, an anchoring element, a puncture component, and an anchored unit, wherein one end of the single anti-regurgitation prosthesis is fixed to the distal end of the positioning support, the distal end of the positioning support having an atrial portion configured to adapt to the morphology of an autologous valve annulus, characterized in that: The anchored unit is connected to the proximal end of the positioning bracket. One end of the puncture member is fixedly connected to the anchored unit. After the positioning bracket is installed in place, the anchored unit is anchored to the ventricular tissue by the anchoring element, and the other end of the puncture member passes through the replaced autologous valve leaflet. The system also includes an actuating member, which is detachably connected to the anchored unit. During pre-installation, the other end of the puncture member is constrained by the positioning bracket, and the anchored unit and the positioning bracket are hinged by a torsion spring. When the actuating member is pulled, the anchored unit rotates about the center of the torsion spring toward the distal end of the positioning bracket, releasing the puncture member. After the positioning bracket reaches the target position, releasing the actuating member causes the anchored unit to spring back and drive the puncture member through the replaced autologous valve leaflet.

2. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The anchored unit has a fabric layer, and the anchoring element passes through the fabric layer and forms an anchor with the ventricular tissue.

3. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The free end of the puncture member is sharp, and the puncture member is configured with an arcuate structure to prevent the free end of the puncture member from puncturing the heart ventricle tissue after the puncture member is released.

4. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: After the positioning bracket is installed in place, the puncture component avoids the chordae tendineae tissue.

5. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The positioning bracket is provided with a limiting element. One end of the puncture member is fixed to the anchored unit. During pre-installation, the other end of the puncture member is constrained by the limiting element. When the operating member is pulled, the anchored unit swings towards the distal end of the positioning bracket, and the other end of the puncture member disengages from the limiting element.

6. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The atrium is provided with a fabric layer for leak prevention.

7. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The atrial portion includes a leak-proof unit. After the positioning bracket is installed, the leak-proof unit abuts against or conforms to the autologous valve annulus tissue. Furthermore, when the autologous valve opens and closes, causing a change in the shape of the autologous valve annulus, the leak-proof unit undergoes adaptive deformation to follow the change in the shape of the autologous valve annulus, ensuring that the leak-proof unit always abuts against or conforms to the autologous valve annulus tissue.

8. The repair system capable of anchoring to the leaflet according to claim 7, characterized in that: After the puncture member is released, the other end of the puncture member passes through the replaced autologous valve ring and is fixedly connected to the leak-proof unit.

9. The repair system capable of anchoring to the leaflet according to claim 7, characterized in that: The leak-proof unit is arc-shaped and has the function of elastic deformation, so that the leak-proof unit can adapt to the shape changes of the autologous valve ring.

10. The repair system capable of anchoring to the leaflet according to claim 7, characterized in that: The leak-proof unit includes multiple elastic wires and a flow-blocking membrane. Two ends of the elastic wires are fixed to the atrium, or one end of the elastic wire is fixed to the atrium and the other end is free. The flow-blocking membrane can block blood flow.

11. The repair system capable of anchoring to the leaflet according to claim 1, characterized in that: The repair system includes at least two anchors, and at least two anchors are pre-spaced axially, and the anchored unit of the positioning bracket is anchored to the interventricular septum tissue by the anchors.

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