A heart valve prosthesis anchorable with native leaflets

Abstract

The application relates to the field of medical devices, in particular to a heart valve prosthesis capable of being anchored with autologous leaflets, comprising a valve support, a leaflet clamping fixing device connected with the valve support, the leaflet clamping fixing device comprising a clamping mechanism and an anchoring ring, the proximal end of the clamping mechanism being connected with the valve support, the distal end of the clamping mechanism being free, and at least part of the anchoring ring being arranged on the clamping mechanism; after the valve support is installed in place, autologous leaflets are pulled by the anchoring ring, autologous leaflets or / and chordae tendineae tissues are clamped between the valve support and the leaflet clamping fixing device, and the anchoring ring is tightened around the valve support; in the scheme, the anchoring ring can also curl part of the autologous leaflets, reduces the influence of the original leaflet tissues on blood flow after replacement, solves two technical pain points in the treatment of mitral valve replacement in the prior art, and has good clinical significance.

Description

[0001] Cross-reference to related applications: This application claims priority to patent application CN202111160970.4, filed on September 30, 2021, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical devices, specifically to a heart valve prosthesis that can be anchored to an autologous valve leaflet. Background Technology

[0003] From a cardiac structural perspective, both the mitral and tricuspid valves have unique physiological structures, making accurate product positioning and fixation extremely difficult. The mitral valve's location within the heart and its complex anatomical structure, in particular, pose a significant challenge to mitral valve replacement.

[0004] Current anchoring techniques mostly employ radial support from the stent to the atrioventricular valve annulus. A drawback of this technique is that it can easily compress surrounding tissues, potentially affecting the outflow tract due to the stent and the compressed tissue. In the long term, as regurgitation decreases, ventricular and atrial pressures drop, and the heart restructures, large-sized stents can lead to a reduction in valve annulus size, thus impacting the heart's internal structure.

[0005] Furthermore, with existing prostheses, after replacement, the anterior leaflet will adhere to the periphery of the stent, which will severely affect the blood flow supply to the left ventricular outflow tract, thereby affecting the function of the aorta.

[0006] In conclusion, although the above technologies have achieved some clinical success, they all have shortcomings, and there is an urgent need for a new transcatheter heart valve replacement system to solve these problems. Summary of the Invention

[0007] In view of the above and other concepts, this application is made. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0008] In terms of applications in atrioventricular valve surgery, this application aims to provide a heart valve prosthesis that can be anchored to the patient's own valve leaflet for patients with atrioventricular valve disease who require interventional treatment. This would solve the problems of compression of the original valve annulus and obstruction of the outflow tract by the valve leaflet in the existing heart valve replacement system.

[0009] According to one aspect of this application, a heart valve prosthesis anchorable to an autologous leaflet is provided, comprising a valve stent and a valve clamping device connected to the valve stent. The valve clamping device includes a clamping mechanism and an anchoring ring. The proximal end of the clamping mechanism is connected to the valve stent, and the distal end of the clamping mechanism is free. At least a portion of the anchoring ring is disposed on the clamping mechanism. After the valve stent is installed in place, the autologous leaflet is lifted by the anchoring ring, and the autologous leaflet and / or chordae tendineae are clamped between the valve stent and the valve clamping device. The anchoring ring tightens the valve stent.

[0010] According to one embodiment, the valve stent is provided with an artificial leaflet, which can be made of biological materials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0011] According to one embodiment, the valve clamping device is configured to present a first form and a second form, wherein when the valve clamping device is in the first form, the clamping mechanism is configured to capture the autologous leaflet; the radial expansion of the valve stent causes the anchoring ring to pull the chordae tendineae and drive the autologous leaflet to be lifted upward, at which time the valve clamping device is in the second form.

[0012] According to one embodiment, when the valve clamping device is in the first configuration, the clamping mechanism is located between the autologous valve leaflet and the ventricular wall, and a portion of the anchoring ring is located between the autologous valve leaflet and the chordae tendineae tissue.

[0013] According to one embodiment, the valve stent and the clamping mechanism are an integral structure, and in the natural state, at least part of the clamping mechanism is attached to the outside of the valve stent.

[0014] According to one embodiment, the anchoring ring and part of the clamping mechanism are covered with a fabric layer; this design can effectively increase the friction of the anchoring ring and clamping mechanism against the self-petal leaflet.

[0015] According to one embodiment, the anchoring ring is a closed-loop structure or the anchoring ring cooperates with the clamping mechanism to form a closed-loop structure.

[0016] According to one embodiment, the anchoring ring and the clamping mechanism have at least two connection points, and the heights of the connection points of the anchoring ring and the clamping mechanism are different; or, the anchoring ring, the clamping mechanism, and the valve stent have at least two connection points, and the heights of the connection points of the anchoring ring, the clamping mechanism, and the valve stent are different.

[0017] According to one embodiment, the clamping mechanism includes a single clamping arm, the anchoring ring is connected to both the clamping arm and the valve stent, and the height of the connection point between the anchoring ring and the valve stent is lower than the height of the connection point between the anchoring ring and the clamping arm.

[0018] According to another embodiment, when the heart valve prosthesis is used to treat mitral valve, and when the valve clamping device is in a first configuration, the clamping arm captures and clamps the anterior leaflet, and the connection point between the anchoring ring and the valve stent is located in the posterior leaflet region.

[0019] According to another embodiment, the clamping mechanism includes a first clamping arm and a second clamping arm, the anchoring ring being connected to the first clamping arm and the second clamping arm respectively, and the first clamping arm and the second clamping arm being configured to capture and clamp different autologous leaflets respectively; and the diameter of the anchoring ring is smaller than the diameter of the valve stent; and the diameter of the anchoring ring is smaller than the diameter of the autologous valve annulus.

[0020] According to one embodiment, the flap fixing device further includes a control wire, which is detachably connected to the first clamping arm and the second clamping arm respectively, and pulling the control wire causes the first clamping arm and the second clamping arm to open and capture the autologous flap.

[0021] According to another embodiment, the clamping mechanism includes multiple clamping arms, and the different heights of the connection points between the anchoring ring and the multiple clamping arms make the anchoring ring have a wavy shape.

[0022] According to one embodiment, the distal end of the valve stent is provided with multiple auxiliary support rods. After the valve stent is installed in place, the auxiliary support rods are located in the atrium, and at least a portion of the auxiliary support rods are abutted against the atrial wall. When the valve stent is used to treat mitral valve disease, the distance from the free end of the auxiliary support rod in the anterior leaflet region to the center point of the valve stent is greater than the distance from the free end of the auxiliary support rod in the posterior leaflet region to the center point of the valve stent. The purpose of this design is to allow the valve stent to be positioned closer to the posterior leaflet region, thereby reducing obstruction of the left ventricular outflow tract after implantation.

[0023] According to one embodiment, the heart valve prosthesis further includes a sealing device configured to adapt to the physiological structure of the valve annulus. The sealing device includes an adaptive segment and an abutment segment. The adaptive segment includes a first arc-shaped segment, a second arc-shaped segment, and a leak-proof membrane. The first arc-shaped segment is connected to the valve stent, and the valve stent provides a fulcrum for the first arc-shaped segment. After the valve stent is installed in place, at least a portion of the first arc-shaped segment is in contact with the atrial wall. When the atrial wall compresses the first arc-shaped segment, the first arc-shaped segment rotates around the fulcrum toward the center of the valve stent, and the first arc-shaped segment drives the second arc-shaped segment to rotate in the same direction.

[0024] According to one embodiment, the leak-proof membrane covers the first arc-shaped segment and the second arc-shaped segment, and the leak-proof membrane connects the free end of the first arc-shaped segment and the free end of the second arc-shaped segment.

[0025] According to one embodiment, when the heart valve prosthesis is used for mitral valve treatment, the adaptive segment is located in the anterior leaflet region and the abutment segment is located in the posterior leaflet region.

[0026] According to one embodiment, the valve stent has barbs in the posterior leaflet region for anchoring the autologous leaflet.

[0027] According to one embodiment, the anchoring ring is generally sheet-like, filament-like, or rope-like.

[0028] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following: 1. Traditional valve prostheses mostly rely on radial support annulus for anchoring, which can compress the native annulus, resulting in obvious anchoring defects. Furthermore, existing methods using leaflet anchoring stents cannot address the obstruction of the left ventricular outflow tract. In one embodiment of this application, a clamping mechanism is used to guide the anchoring ring to a position below the autologous leaflet. Further manipulation positions the anchoring ring between the chordae tendineae and the autologous leaflet. When the valve stent expands radially, the anchoring ring is tensioned, pulling the chordae tendineae and lifting the autologous leaflet upwards. This prevents the autologous leaflet from obstructing the outflow tract after stent implantation. Simultaneously, the radial expansion of the valve stent, in conjunction with the anchoring ring, ultimately clamps the autologous leaflet and chordae tendineae between the valve stent and the anchoring ring. This anchoring method avoids significant radial expansion of the autologous annulus by the valve stent, preventing compression and excessive traction of the heart's native tissue, reducing postoperative complications, and addressing two major technical challenges in existing mitral valve replacement surgery. This has significant clinical implications.

[0029] 2. In the prior art, the anchoring ring only serves to fix the valve stent and cannot solve the problem of the autologous leaflet obstructing the left ventricular outflow tract. Unlike the prior art, in one embodiment of this application, the anchoring ring can both encircle the leaflet, fixing the valve stent to the autologous leaflet and avoiding radial support of the original valve annulus, and at the same time, the anchoring ring can also pull the chordae tendineae and further lift the autologous leaflet, which can effectively avoid the obstruction of the outflow tract by the autologous leaflet and has good clinical significance.

[0030] 3. Unlike the prior art, in one embodiment of this application, the height of the connection point of the anchoring ring on the flap member is different. Specifically, the height of the anchoring ring in the anterior flap region is greater than the height of the anchoring ring in the posterior flap region. This can significantly lift the anterior flap to avoid obstructing the outflow tract of the left ventricle, and also avoid excessive traction of the chordae tendineae in the posterior flap region by the clamping member, thus protecting the chordae tendineae tissue.

[0031] 4. In existing technologies, the cross-sectional area of ​​the sealing device must be larger than that of the autologous valve annulus in the cross-sectional direction perpendicular to the central axis of the valve stent. This ensures that the sealing device completely covers the entire autologous valve annulus, and the free edge of the sealing device must be in close contact with the atrial wall to achieve a better leak-proof effect. However, the inner wall of the atrium is not perfectly regular or smooth. Therefore, certain parts of the atrial wall exert greater pressure on the sealing device, causing wrinkles and gaps in the sealing device, leading to blood regurgitation. Furthermore, after long-term implantation of the prosthesis, the atrium will remodel and shrink to its pre-lesion size due to reduced valvular regurgitation. This will also increase the pressure of the atrial wall on the sealing device. Excessive size can cause wrinkles and gaps in the sealing device, leading to blood backflow. Unlike existing technologies, in one embodiment of the present invention, the sealing device includes an adaptive segment and a contact segment. The adaptive segment includes a first arc segment, a second arc segment, and a leak-proof membrane. When the first arc segment is compressed by the atrial wall, the first arc segment rotates around the fulcrum toward the center of the valve stent, and the first arc segment drives the second arc segment to rotate in the same direction to promptly contact the underside of the autologous valve leaflet, making real-time repositioning to prevent blood backflow. Furthermore, the sealing device will contact the entire prosthesis toward the posterior valve leaflet area, making it as far open as possible to the left ventricular outflow tract and avoiding obstruction of the left ventricular outflow tract.

[0032] The embodiments of this application can achieve other beneficial 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

[0033] 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-1c This is a schematic diagram of the overall structure of the heart valve prosthesis of the present invention.

[0034] Figures 2a-2c This is a schematic diagram of the structure of the heart valve prosthesis sealing device of the present invention, wherein... Figure 2c This is a bottom view of the heart valve prosthesis sealing device of the present invention.

[0035] Figure 3a and 3b This is a schematic diagram of the heart valve prosthesis implanted according to the present invention, wherein... Figure 3b This is a schematic diagram illustrating the principle that the second arc segment rotates along with the first arc segment. The dashed lines represent the schematic diagram of the rotation of the first and second arc segments after the sealing device is compressed.

[0036] Figures 4a-4f This is a schematic diagram of the implantation process of the artificial valve prosthesis of the present invention, wherein... Figure 4f for Figure 4e A magnified view of a portion of the image.

[0037] Figure 5a and 5b This is a schematic diagram of another embodiment of the present invention.

[0038] Figure 6a and 6b This is a schematic diagram of another embodiment of the present invention.

[0039] The parts referred to by the numbers in the attached diagram are as follows: 1-valve stent, 11-auxiliary support rod, 12-sealing device, 121-adaptive segment, 1211-first arc segment, 1212-second arc segment, 1213-leak-proof membrane, 122-adhesive segment, 13-barbs, 2-valve clamping and fixing device, 21-clamping mechanism, 211-clamping arm, 2111-first clamping arm, 2112-second clamping arm, 22-anchoring ring, 23-fabric layer, 24-control wire, 3-conveying device. Detailed Implementation

[0040] 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.

[0041] 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.

[0042] 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 and their equivalents, as well as any possible additional items.

[0043] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0044] In this application, the proximal end refers to the end closest to the apex of the heart, and the distal end refers to the end furthest from the apex of the heart. Specific implementation examples: Example 1: like Figures 1a-1c As shown, in this embodiment, a heart valve prosthesis anchorable to an autologous leaflet includes a valve stent 1 and a valve clamping and fixing device 2 connected to the valve stent 1. The valve clamping and fixing device 2 includes a clamping mechanism 21 and an anchoring ring 22. The proximal end of the clamping mechanism 21 is connected to the valve stent 1, and the distal end of the clamping mechanism 21 is free. At least a portion of the anchoring ring 22 is disposed on the clamping mechanism 21. After the valve stent 1 is installed in place, the autologous leaflet is lifted by the anchoring ring 22, and the autologous leaflet and / or chordae tendineae tissue are clamped between the valve stent 1 and the valve clamping and fixing device 2. The anchoring ring 22 clamps the valve stent 1.

[0046] According to one embodiment, the valve stent 1 is provided with an artificial leaflet, which can be made of biological materials such as bovine pericardium or porcine pericardium, or it can be made of polymer materials.

[0047] According to one embodiment, the flap clamping device 2 is configured to present a first form and a second form, wherein when the flap clamping device 2 is in the first form, the clamping mechanism 21 is configured to capture the autologous flap, such as... Figure 4b and 4cAs shown; when the valve clamping and fixing device 2 is in the second configuration, the valve stent 1 expands radially, causing the anchoring ring 22 to pull the chordae tendineae and lift the autologous valve leaflets upwards, as shown. Figure 4d and 4e As shown.

[0048] According to one embodiment, when the valve clamping device 2 is in the first configuration, the clamping mechanism 21 is located between the autologous valve leaflet and the ventricular wall, and part of the anchoring ring 22 is located between the autologous valve leaflet and the chordae tendineae tissue.

[0049] According to one embodiment, the valve stent 1 and the clamping mechanism 21 are an integral structure, and in the natural state, at least part of the clamping mechanism 21 is attached to the outside of the valve stent 1.

[0050] According to one embodiment, the anchoring ring 22 and part of the clamping mechanism 21 are covered with a fabric layer 23; this design can effectively increase the frictional force between the anchoring ring 22, the clamping mechanism 21 and the self-leaf, such as Figure 1c As shown.

[0051] According to one embodiment, the anchoring ring 22 is a closed-loop structure or the anchoring ring 22 cooperates with the clamping mechanism 21 to form a closed-loop structure.

[0052] According to one embodiment, the anchoring ring 22 and the clamping mechanism 21 include at least two connection points, and the connection points of the anchoring ring 22 and the clamping mechanism 21 are at different heights.

[0053] According to one embodiment, the clamping mechanism 21 includes a first clamping arm 2111 and a second clamping arm 2112, and the anchoring ring 22 is connected to the first clamping arm 2111 and the second clamping arm 2112 respectively. The first clamping arm 2111 and the second clamping arm 2112 are configured to capture and clamp different autologous leaflets respectively. The diameter of the anchoring ring 22 is smaller than the diameter of the valve stent 1. The diameter of the anchoring ring 22 is smaller than the diameter of the autologous valve annulus.

[0054] According to one embodiment, the flap fixing device 2 further includes a control wire 24, which is detachably connected to the first clamping arm 2111 and the second clamping arm 2112 respectively, and pulling the control wire 24 causes the first clamping arm 2111 and the second clamping arm 2112 to open and capture the autologous flap.

[0055] According to one embodiment, the distal end of the valve stent 1 is provided with multiple auxiliary support rods 11. After the valve stent 1 is installed in place, the auxiliary support rods 11 are located in the atrium, and at least a portion of the auxiliary support rods 11 are abutted against the atrial wall. When the valve stent 1 is used to treat mitral valve disease, the distance from the free end of the auxiliary support rod 11 in the anterior leaflet region to the center point of the valve stent 1 is greater than the distance from the free end of the auxiliary support rod 11 in the posterior leaflet region to the center point of the valve stent 1. Figure 1c and 2a As shown, the purpose of this design is to allow the valve stent 1 to be positioned so that it fits against the posterior leaflet region, thereby reducing obstruction of the left ventricular outflow tract after implantation.

[0056] According to one embodiment, the heart valve prosthesis further includes a sealing device 12, the sealing device 12 being configured to adapt to the physiological structure of the valve annulus. The sealing device 12 includes an adaptive segment 121 and a contact segment 122. The adaptive segment 121 includes a first arcuate segment 1211, a second arcuate segment 1212, and a leak-proof membrane 1213. Figures 2a-2c As shown, the first arc-shaped segment 1211 is connected to the valve stent 1, and the valve stent 1 provides a fulcrum for the first arc-shaped segment 1211. After the valve stent 1 is installed in place, at least a portion of the first arc-shaped segment 1211 is in contact with the atrial wall. When the atrial wall compresses the first arc-shaped segment 1211, the first arc-shaped segment 1211 rotates around the fulcrum toward the center of the valve stent 1, and the first arc-shaped segment 1211 drives the second arc-shaped segment 1212 to rotate in the same direction. Figure 3a and 3b As shown.

[0057] According to one embodiment, the leak-proof membrane 1213 covers the first arc-shaped segment 1211 and the second arc-shaped segment 1212, and the leak-proof membrane 1213 connects the free end of the first arc-shaped segment 1211 and the free end of the second arc-shaped segment 1212.

[0058] According to one embodiment, when the heart valve prosthesis is used for mitral valve treatment, the adaptive segment 121 is located in the anterior leaflet region, and the abutment segment 122 is located in the posterior leaflet region.

[0059] According to one embodiment, the valve stent 1 is provided with barbs 13 in the posterior leaflet region for anchoring the autologous leaflet, such as... Figure 1c As shown.

[0060] According to one embodiment, the anchoring ring 22 is generally sheet-like, filament-like, or rope-like.

[0061] According to one embodiment, the heart valve prosthesis further includes a delivery device 3 for delivering it to the surgical site.

[0062] The following is an exemplary procedure for repairing a mitral valve using a heart valve prosthesis that can be anchored to the patient's own leaflet, as shown in the figure. Figures 4a-4f As shown: 1. Operate the delivery device 3 from the apical approach, so that the distal portion of the delivery device 3 is located in the left atrium; 2. Operate the delivery device 3 to release the distal portion of the valve stent 1. At this time, the sealing device 12 and the auxiliary support rod 11 have not yet been fully released. Pull the control wire 24 to open the first clamping arm 2111 and the second clamping arm 2112 and capture the autologous valve leaflet. Figure 4b and 4c As shown; 3. When the first clamping arm 2111 and the second clamping arm 2112 are located behind the anterior leaflet and the posterior leaflet respectively, and the anchoring ring 22 is between the autologous leaflet and the chordae tendineae tissue, the delivery device 3 is further operated so that the sealing device 12 and the auxiliary support rod 11 are completely released and supported in the left atrium. 4. Operate the delivery device 3 to release the proximal portion of the valve stent 1 until the valve stent 1 is fully radially expanded and engages with the anchoring ring 22, ultimately securing the autologous leaflet and chordae tendineae tissue between the valve stent 1 and the anchoring ring 22. Then, remove the delivery device 3 to complete the implantation. Figures 4d to 4f As shown.

[0063] Example 2: Example 2 is largely the same as Example 1, except that the clamping mechanism 21 in this example has only a single clamping arm 211, and the anchoring ring 22 is connected to both the clamping arm 211 and the valve stent 1. Figure 5a As shown.

[0064] In this embodiment, the clamping mechanism 21 includes a single clamping arm 211. The anchoring ring 22 is connected to both the clamping arm 211 and the valve stent 1. The height of the connection point between the anchoring ring 22 and the valve stent 1 is lower than the height of the connection point between the anchoring ring 22 and the clamping arm 211. After the valve stent 1 is installed in place, the clamping arm 211 captures and clamps the anterior leaflet. The connection point between the anchoring ring 22 and the valve stent 1 is in the posterior leaflet region. This design aims to significantly lift the anterior leaflet, avoiding obstruction of the left ventricular outflow tract, and to prevent excessive traction of the chordae tendineae in the posterior leaflet region by the clamping device, thus protecting the chordae tendineae tissue. Figure 5b As shown.

[0065] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0066] Example 3: Embodiment 3 is largely the same as Embodiment 3, except that the clamping mechanism 21 in this embodiment includes multiple clamping arms 211, such as... Figure 6a As shown.

[0067] In this embodiment, the clamping mechanism 21 includes multiple clamping arms 211. The different heights of the connection points between the anchoring ring 22 and the multiple clamping arms 211 result in a wavy shape for the anchoring ring 22. After the valve stent 1 is installed, the connection point between the anchoring ring 22 and the clamping arm 211 in the anterior leaflet region is higher than the connection point between the anchoring ring 22 and the clamping arm 211 in the posterior leaflet region. The purpose of this design is to significantly lift the anterior leaflet, avoiding obstruction of the left ventricular outflow tract, and to prevent excessive traction of the chordae tendineae in the posterior leaflet region by the clamping device, thus protecting the chordae tendineae tissue. Figure 6b As shown.

[0068] In this embodiment, the circumference of the anchoring ring 22 is greater than the circumference of the valve stent 1, and the circumference of the anchoring ring 22 is less than the circumference of the autologous valve annulus.

[0069] In this regard, the relevant construction and concept of Embodiment 3 are similar to those of Embodiment 1, and therefore will not be described again here.

[0070] The foregoing description of exemplary embodiments of this application has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations and / or constructions disclosed. Clearly, many modifications and variations can be made by those skilled in the art based on the teachings above without departing from the invention. The scope and equivalents of this invention are intended to be defined by the appended claims.

Claims

1. A heart valve prosthesis anchorable to an autologous valve leaflet, comprising a valve stent and a valve clamping and fixing device connected to the valve stent, characterized in that: The valve clamping and fixing device includes a clamping mechanism and an anchoring ring. The proximal end of the clamping mechanism is connected to the valve stent, and the distal end of the clamping mechanism is free. At least a portion of the anchoring ring is disposed on the clamping mechanism. After the valve stent is installed in place, the autologous leaflet is lifted by the anchoring ring, and the autologous leaflet and / or chordae tendineae are clamped between the valve stent and the valve clamping and fixing device. The anchoring ring tightens the valve stent. The anchoring ring is a closed-loop structure or the anchoring ring cooperates with the clamping mechanism to form a closed-loop structure. The anchoring ring and the clamping mechanism include at least two [parts / components]. The connection points are such that the anchoring ring and the clamping mechanism have different heights; or, the anchoring ring, the clamping mechanism, and the valve stent have at least two connection points, and the connection points are different heights; the valve clamping device is configured to present a first form and a second form, wherein, when the valve clamping device is in the first form, the clamping mechanism is configured to capture the autologous leaflet; the valve stent expands radially such that the anchoring ring pulls the chordae tendineae and pulls the autologous leaflet upward, and the valve clamping device is in the second form.

2. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 1, characterized in that: When the valve clamping device is in the first configuration, the clamping mechanism is located between the autologous valve leaflet and the ventricular wall, and part of the anchoring ring is located between the autologous valve leaflet and the chordae tendineae tissue.

3. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 1, characterized in that: The valve stent and the clamping mechanism are an integral structure, and in the natural state, at least part of the clamping mechanism is attached to the outside of the valve stent.

4. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 1, characterized in that: The clamping mechanism includes a single clamping arm, and the anchoring ring is connected to both the clamping arm and the valve stent. Furthermore, the height of the connection point between the anchoring ring and the valve stent is lower than the height of the connection point between the anchoring ring and the clamping arm.

5. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 4, characterized in that: When the heart valve prosthesis is used to treat mitral valve disease, and when the valve clamping device is in the first configuration, the clamping arm captures and clamps the anterior leaflet, and the connection point between the anchoring ring and the valve stent is located in the posterior leaflet region.

6. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 1, characterized in that: The clamping mechanism includes a first clamping arm and a second clamping arm, and the anchoring ring is connected to the first clamping arm and the second clamping arm respectively. Furthermore, the first clamping arm and the second clamping arm are configured to capture and clamp different autologous leaflets respectively.

7. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 6, characterized in that: The flap fixing device also includes a control wire, which is detachably connected to the first clamping arm and the second clamping arm respectively. Pulling the control wire causes the first clamping arm and the second clamping arm to open and capture the autologous flap.

8. A heart valve prosthesis that can be anchored to an autologous valve leaflet according to claim 1, characterized in that: The clamping mechanism includes multiple clamping arms, and the different heights of the connection points between the anchoring ring and the multiple clamping arms make the anchoring ring have a wavy shape.

9. A heart valve prosthesis anchorable to an autologous valve leaflet according to claim 1, characterized in that: The distal end of the valve stent is provided with multiple auxiliary support rods. After the valve stent is installed in place, the auxiliary support rods are located in the atrium, and at least a portion of the auxiliary support rods are attached to the atrial wall.

10. A heart valve prosthesis anchorable to an autologous valve leaflet according to claim 1, characterized in that: The heart valve prosthesis also includes a sealing device, which includes an adaptive segment and a contact segment. The adaptive segment includes a first arc segment, a second arc segment, and a leak-proof membrane. The first arc segment is connected to the valve stent, and the valve stent provides a fulcrum for the first arc segment. After the valve stent is installed in place, at least a portion of the first arc segment is in contact with the atrial wall. When the atrial wall compresses the first arc segment, the first arc segment rotates around the fulcrum toward the center of the valve stent, and the first arc segment drives the second arc segment to rotate in the same direction.

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