Heart valve prosthesis that can be anchored to the patient's own valve leaflets

Abstract

A cardiac valve prosthesis capable of being anchored to a native valve leaflet, in which a proximal end of a clamping mechanism (21) is connected to a valvular stent (1), an anchor ring (22) is placed on the clamping mechanism (21), and after the valvular stent (1) is attached to a predetermined position, the native valve leaflet is pulled up by the anchor ring (22), and at least one of the native valve leaflet and chordae tendineae tissue is clamped between the valvular stent (1) and the valve clamping fixation device (2), and the anchor ring (22) tightens the valvular stent (1).

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to a patent application filed on September 30, 2021, bearing patent application number 202111160970.4, the disclosure of which is incorporated herein by reference.

[0002] This application relates to the field of medical devices, and more particularly to heart valve prostheses that are anchorable to native valve leaflets. [Background technology]

[0003] The cardiac structure, whether mitral or tricuspid, has a special physiological structure, making accurate positioning and fixation of the product extremely difficult. In particular, the location of the mitral valve in the heart and its complex anatomical structure pose a significant challenge to mitral valve replacement surgery.

[0004] Most of the anchoring techniques in the related art use stents to provide radial support for the atrioventricular annulus. The drawback of this technique is that it is prone to compressing the tissues around the annulus, and the stent and compressed tissues are likely to affect the outflow tract. In the long term, as regurgitation decreases, ventricular and atrial pressures decrease, cardiac structure is remodeled, and large stents can reduce the size of the annulus and affect the internal structure of the heart.

[0005] Furthermore, after replacement of the existing prosthesis, the anterior valve leaflet is placed on the outer periphery of the stent, which seriously affects the blood flow supply of the left ventricular outflow tract and affects the flow state of the aorta.

[0006] In conclusion, although all of the above technologies have some clinical benefits, they all have shortcomings, and new transcatheter heart valve replacement systems are urgently needed to solve these problems. Summary of the Invention [Problem to be solved by the invention]

[0007] According to various embodiments of the present application, the present application provides a cardiac valve prosthesis that can be anchored to native valve leaflets. The primary objective of the present application is to overcome some of the problems and deficiencies of the related art.

[0008] In the application to atrioventricular valve surgery, the present application intends to provide a cardiac valve prosthesis that can be anchored to the patient's own valve leaflets for patients who have developed lesions in their atrioventricular valves and require interventional treatment, thereby solving problems in related art cardiac valve replacement systems, such as compression of the native valve annulus and obstruction of the outflow tract by the valve leaflets. [Means for solving the problem]

[0009] According to one aspect of the present application, there is provided a cardiac valve prosthesis capable of being anchored to a native valve leaflet, comprising a valvular stent and a valve clamping / fixation device connected to the valvular stent, wherein the valve clamping / fixation device comprises a clamping mechanism whose proximal end is connected to the valvular stent and whose distal end is free, and an anchor ring at least a portion of which is disposed on the clamping mechanism, and after the valvular stent is attached to a predetermined position, the native valve leaflet is pulled up by the anchoring ring, and the native valve leaflet and / or chordae tendineae tissue is clamped between the valvular stent and the valve clamping / fixation device, and the anchoring ring tightens the valvular stent.

[0010] According to one embodiment, the valvular stent is provided with artificial valve leaflets, which may be made of biological materials such as bovine pericardium, porcine pericardium, etc., or may be made of polymeric materials.

[0011] According to one embodiment, the valve clamping fixation device is configured to be capable of assuming a first form and a second form, and when the valve clamping fixation device is in the first form, the clamping mechanism is configured to capture the native valve leaflet, and when the valvular stent expands radially, the anchor ring pulls the chordae tendineae, moving the native valve leaflet so that it is pulled upward, and at this time, the valve clamping fixation 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 between the native valve leaflet and the ventricular wall, and a portion of the anchoring ring is between the native valve leaflet and chordae tendineae tissue.

[0013] According to one embodiment, the valvular stent and the clamping mechanism are of an integral structure, and in a natural state, at least a portion of the clamping mechanism is applied to the outside of the valvular stent.

[0014] According to one embodiment, the anchoring ring and a part of the clamping mechanism are covered with a fabric layer, and this design can effectively increase the friction force of the anchoring ring and the clamping mechanism against the native valve leaflets.

[0015] According to one embodiment, the anchoring ring is a closed loop structure or forms a closed loop structure in cooperation with the clamping mechanism.

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

[0017] According to one embodiment, the clamping mechanism comprises a single clamping arm, the anchor ring is connected to the clamping arm and the valvular stent respectively, and the height of the connection point between the anchor ring and the valvular stent must be lower than the height of the connection point between the anchor ring and the clamping arm.

[0018] According to another embodiment, when the cardiac valve prosthesis is used to treat a mitral valve and the valve clamping device is in the first configuration, the clamping arms capture and clamp the anterior valve leaflet, and the connection point between the anchoring ring and the valvular stent is located in the posterior valve leaflet region.

[0019] According to another embodiment, the clamping mechanism comprises a first clamping arm and a second clamping arm, the anchor ring is connected to the first clamping arm and the second clamping arm, respectively, and the first clamping arm and the second clamping arm are configured to capture and clamp different native valve leaflets, respectively, and the diameter of the anchor ring is smaller than the diameter of the valvular stent and smaller than the diameter of the native valve annulus.

[0020] According to one embodiment, the valve clamping and fixation device further includes a control string that is removably connected to the first clamping arm and the second clamping arm, respectively, and that, when pulled, causes the first clamping arm and the second clamping arm to open and capture the native valve leaflet.

[0021] According to another embodiment, the clamping mechanism comprises a plurality of clamping arms, and the anchor ring has connection points with the clamping arms at different heights, thereby forming a wave-like shape.

[0022] According to one embodiment, the distal end of the valvular stent is provided with a plurality of auxiliary support rods, which are positioned in the atrium and at least a portion of which is applied to the atrial wall after the valvular stent is attached in place; when the valvular stent is used to treat the mitral valve, the distance from the free end of the auxiliary support rods in the anterior leaflet region to the center point of the valvular stent must be greater than the distance from the free end of the auxiliary support rods in the posterior leaflet region to the center point of the valvular stent; the purpose of this design is to allow the entire valvular stent to be applied to the posterior leaflet region, thereby reducing the obstruction to the left ventricular outflow tract after the valvular stent is implanted.

[0023] According to one embodiment, the cardiac valve prosthesis further comprises a sealing device configured to adapt to the physiological structure of the valve annulus, the sealing device comprising a self-adapting segment comprising a first arcuate segment, a second arcuate segment and a leak-proof membrane, and an application segment, the first arcuate segment being connected to the valvular stent to provide a fulcrum for the first arcuate segment, and after the valvular stent is attached in place, at least a portion of the first arcuate segment is applied to the atrial wall, and when the atrial wall presses against the first arcuate segment, the first arcuate segment rotates around the fulcrum towards the center of the valvular stent and moves the second arcuate 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 to repair a mitral valve, the self-adapting segment is located in the anterior leaflet region and the applicator segment is located in the posterior leaflet region.

[0026] According to one embodiment, the valvular stent is provided with barbs for anchoring the native leaflets in the posterior leaflet region.

[0027] According to one embodiment, the anchoring ring is generally sheet-like, thread-like, or rope-like. [Effects of the Invention]

[0028] Compared with the related art, the advantages and beneficial technical effects of the present application include at least the following:

[0029] 1. Conventional valvular prostheses often anchor the prosthesis by supporting the annulus radially, which puts pressure on the native annulus and has obvious anchoring defects. Furthermore, the existing method of anchoring a stent using the valve leaflets cannot solve the effect of left ventricular outflow tract obstruction. In one embodiment of the present application, a clamping mechanism is used to bring the anchor ring to a position below the native valve leaflets, and the anchor ring is then manipulated to be positioned between the chordae tendineae tissue and the native valve leaflets. When the valvular stent is expanded radially, the anchor ring is stretched and pulls the chordae tendineae. The stent is stretched, causing the native valve leaflets to move upward and be pulled up, preventing the native valve leaflets from obstructing the outflow tract after the stent is implanted. At the same time, the stent radially expands and anchors, ultimately clamping the native valve leaflets and chordae tendineae between the stent and the anchor ring. This anchoring method prevents the stent from significantly expanding the native valve annulus radially, avoiding compression and excessive tension on the cardiac native tissue and reducing postoperative complications. This solves two major technical pain points in the treatment of mitral valve replacement in related art, and has good clinical significance.

[0030] 2. In the related art, the anchor ring only serves to fix the valvular stent and does not resolve the impact of the native valve leaflets obstructing the left ventricular outflow tract. In contrast to the related art, in one embodiment of the present application, the anchor ring surrounds the valve leaflets to fix the valvular stent to the native valve leaflets, avoiding radial support of the native annulus, while also pulling the chordae tendineae and moving the native valve leaflets so that they are pulled upward, effectively preventing the native valve leaflets from obstructing the outflow tract, which has good clinical significance.

[0031] 3. To distinguish from the related art, in one embodiment of the present application, the height of the connection point of the anchor ring to the valve clamping member is different; specifically, the height of the anchor ring in the anterior valve leaflet region must be higher than the height of the anchor ring in the posterior valve leaflet region, which significantly raises the anterior valve leaflet and prevents obstruction to the left ventricular outflow tract, and also prevents excessive tension on the chordae tendineae in the posterior valve leaflet region by the clamping member, thereby protecting the chordae tendineae tissue.

[0032] 4. In the related art, in the cross-sectional direction perpendicular to the central axis of the valvular stent, the cross-sectional area of ​​the sealing device must be larger than that of the native annulus so that the sealing device can completely cover the entire native annulus, and the free edge of the sealing device must be applied to the atrial wall. In this way, an excellent leak prevention effect can be achieved. However, because the inner wall surface of the atrium is not very orderly or smooth, some parts of the atrial wall press against the sealing device with great force. As a result, wrinkles form in the sealing device, gaps appear, and blood reflux occurs. Furthermore, when the prosthesis is implanted for a long period of time, the regurgitation of the valvular leaflets is reduced, and the atrium is remodeled and reduced to its pre-lesion size, which also leads to the atrial wall pressing against the sealing device. If the pressing force is too large, wrinkles will form in the sealing device, resulting in gaps and allowing blood to flow back. To distinguish from the related art, in one embodiment of the present application, the sealing device comprises a self-adapting segment, which includes a first arc-shaped segment, a second arc-shaped segment, and a leak-proof membrane, and an application segment. When the first arc-shaped segment is pressed by the atrial wall, the first arc-shaped segment rotates around a fulcrum toward the center of the valvular stent, and the second arc-shaped segment rotates in the same direction to move to contact the underside of the native valve leaflet in a timely manner, creating a prosthesis in real time and preventing blood from flowing back. The sealing device also applies the entire prosthesis to the posterior leaflet region, avoiding the left ventricular outflow tract as much as possible, thereby avoiding blocking the left ventricular outflow tract.

[0033] The embodiments of the present application may achieve other beneficial technical effects not specifically listed, some of which may be described below and which can be anticipated and understood by those skilled in the art after reading the present application. [Brief explanation of the drawings]

[0034] The above-mentioned and other features and advantages of these embodiments, as well as methods for achieving them, will become more apparent and the embodiments of the present application can be better understood by referring to the following description in conjunction with the drawings.

[0035] [Figures 1a-1c] 1 is a schematic diagram of the overall structure of a cardiac valve prosthesis according to some embodiments of the present application; [Figures 2a-2c] 2A and 2B are structural schematic diagrams of a sealing device of a cardiac valve prosthesis according to some embodiments of the present application, in which FIG. 2C is a bottom view of the sealing device of a cardiac valve prosthesis according to some embodiments of the present application. [Figure 3a-3b] 3A and 3B are schematic diagrams of a cardiac valve prosthesis according to some embodiments of the present application after implantation, in which FIG. 3B illustrates the principle of the second arc-shaped segment rotating in conjunction with the rotation of the first arc-shaped segment, and the dashed lines illustrate the rotation of the first arc-shaped segment and the second arc-shaped segment after the sealing device is pressed. [Figures 4a-4f] 4A to 4E are schematic diagrams illustrating the implantation process of an artificial valvular prosthesis according to some embodiments of the present application, in which FIG. 4F is a partially enlarged view of FIG. 4E. [Figure 5a-5b] FIG. 2 is a schematic diagram of another embodiment of the present application. [Figure 6a-6b] FIG. 2 is a schematic diagram of another embodiment of the present application. [Explanation of symbols]

[0036] 1···Valvular stent, 11···Auxiliary support rod, 12···Sealing device, 121···Self-adaptive segment, 1211···First arc-shaped segment, 1212···Second arc-shaped segment, 1213···Leak-proof membrane, 122···Fastening segment, 13···Barbed barb, 2···Valve clamping and fixing device, 21···Clamping mechanism, 211···Clamping arm, 2111···First clamping arm, 2112···Second clamping arm, 22···Anchor ring, 23···Fabric layer, 24···Control thread, 3···Delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0037] The details of one or more embodiments of the present application are set forth in the following description of the drawings and detailed description. Other features, objects, and advantages of the present application will become apparent from the description, drawings, and claims.

[0038] It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments and may be practiced or carried out in various ways. Each example is provided as a way to construe the disclosed embodiments, not as a limitation. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or substance of the present disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still yield yet another embodiment. Accordingly, the present disclosure includes all such modifications and variations within the scope of the appended claims and their equivalents.

[0039] Likewise, it is understood that the phrases and terms used herein are for purposes of description and should not be regarded as limiting. The use herein of "including," "including," or "having" and variations thereof is intended to openly include the items listed thereafter and equivalents thereof, and possible additional items.

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

[0041] In this application, the proximal end is the end closest to the apex of the heart, and the distal end is the end farther from the apex of the heart.

[0042] Specific Examples

[0043] Example 1 As shown in Figures 1a to 1c, in this embodiment, the cardiac valve prosthesis that can be anchored to the native valve leaflets comprises a valvular stent 1 and a valve clamping and fixing device 2 connected to the valvular stent 1, and the valve clamping and fixing device 2 comprises a clamping mechanism 21 whose proximal end is connected to the valvular stent 1 and whose distal end is free, and an anchor ring 22, at least a portion of which is disposed on the clamping mechanism 21. After the valvular stent 1 is attached to a predetermined position, the native valve leaflets are pulled up by the anchor ring 22, and the native valve leaflets and / or chordae tendineae tissue are clamped between the valvular stent 1 and the valve clamping and fixing device 2, and the anchor ring 22 tightens the valvular stent 1.

[0044] According to one embodiment, artificial valve leaflets are provided within the valvular stent 1, and the artificial valve leaflets may be made of biological materials such as bovine pericardium, porcine pericardium, etc., or may be made of polymeric materials.

[0045] According to one embodiment, the valve clamping / fixation device 2 is configured to be capable of assuming a first form and a second form, wherein when the valve clamping / fixation device 2 is in the first form, the clamping mechanism 21 is configured to capture the native valve leaflet, as shown in Figures 4b and 4c, and when the valve clamping / fixation device 2 is in the second form, as shown in Figures 4d and 4e, the valvular stent 1 expands radially, causing the anchor ring 22 to pull the chordae tendineae and move the native valve leaflet so that it is pulled upward.

[0046] According to one embodiment, when the valve clamping device 2 is in the first configuration, the clamping mechanism 21 is between the native valve leaflet and the ventricular wall, and a portion of the anchoring ring 22 is between the native valve leaflet and the chordae tendineae tissue.

[0047] According to one embodiment, the valvular stent 1 and the clamping mechanism 21 are an integral structure, and at least a portion of the clamping mechanism 21 is positioned on the outside of the valvular stent 1 in the natural state.

[0048] According to one embodiment, as shown in FIG. 1c, the anchor ring 22 and a portion of the clamping mechanism 21 are covered with a fabric layer 23, which design can effectively increase the frictional force of the anchor ring 22 and the clamping mechanism 21 against the native valve leaflets.

[0049] According to one embodiment, the anchor ring 22 is a closed loop structure or cooperates with the clamping mechanism 21 to form a closed loop structure.

[0050] According to one embodiment, the anchor ring 22 and the clamping mechanism 21 have at least two connection points at different heights.

[0051] According to one embodiment, the clamping mechanism 21 comprises a first clamping arm 2111 and a second clamping arm 2112, the anchor ring 22 is connected to the first clamping arm 2111 and the second clamping arm 2112, respectively, and the first clamping arm 2111 and the second clamping arm 2112 are configured to capture and clamp different native valve leaflets, respectively, and the diameter of the anchor ring 22 is smaller than the diameter of the valvular stent 1, and the diameter of the anchor ring 22 is smaller than the diameter of the native valve annulus.

[0052] According to one embodiment, the valve clamping and fixing device 2 further includes a control thread 24 that is detachably connected to the first clamping arm 2111 and the second clamping arm 2112, respectively, and that, when pulled, causes the first clamping arm 2111 and the second clamping arm 2112 to open and capture the native valve leaflet.

[0053] According to one embodiment, the distal end of the valvular stent 1 is provided with a plurality of auxiliary support rods 11, which are positioned within the atrium and at least a portion of which is applied to the atrial wall after the valvular stent 1 is attached to a predetermined position. When the valvular stent 1 is used to treat the mitral valve, as shown in Figures 1c and 2a, the distance from the free end of the auxiliary support rods 11 in the anterior leaflet region to the center point of the valvular stent 1 must be greater than the distance from the free end of the auxiliary support rods 11 in the posterior leaflet region to the center point of the valvular stent 1. The purpose of this design is to allow the entire valvular stent 1 to be applied to the posterior leaflet region, thereby reducing the obstruction to the left ventricular outflow tract after the valvular stent 1 is implanted.

[0054] According to one embodiment, as shown in FIGS. 2a to 2c, the cardiac valve prosthesis further comprises a sealing device 12 configured to adapt to the physiological structure of the valve annulus, the sealing device 12 comprising a self-adapting segment 121 and an application segment 122, the self-adapting segment 121 comprising a first arc-shaped segment 1211, a second arc-shaped segment 1212 and a leak-proof membrane 1213, as shown in FIGS. 3a and 3b, the first arc-shaped segment 1211 is connected to the valvular stent 1, providing a fulcrum for the first arc-shaped segment 1211, after the valvular stent 1 is mounted in place, at least a portion of the first arc-shaped segment 1211 is applied to the atrial wall, and when the atrial wall presses against the first arc-shaped segment 1211, the first arc-shaped segment 1211 rotates around the fulcrum toward the center of the valvular stent 1 and causes the second arc-shaped segment 1212 to rotate in the same direction.

[0055] 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.

[0056] According to one embodiment, when the cardiac valve prosthesis is used to repair a mitral valve, the self-adapting segment 121 is located in the anterior leaflet region and the applicator segment 122 is located in the posterior leaflet region.

[0057] According to one embodiment, as shown in FIG. 1c, the valvular stent 1 is provided with barbs 13 for anchoring the native leaflets in the posterior leaflet region.

[0058] According to one embodiment, the anchor ring 22 is generally sheet-like, thread-like, or rope-like.

[0059] According to one embodiment, the heart valve prosthesis further comprises a delivery device 3 for delivering it to the surgical site.

[0060] The operation process for repairing an exemplary mitral valve leaflet using the native leaflet anchorable heart valve prosthesis of Example 1 is shown in Figures 4a to 4f. 1. The delivery device 3 is operated so that the distal end is positioned in the left atrium by approaching from the apex of the heart. 2. As shown in Figures 4b and 4c, the delivery device 3 is operated to release the distal end of the valvular stent 1, and at this time, the sealing device 12 and the auxiliary support rod 11 are not completely released, and the first clamping arm 2111 and the second clamping arm 2112 are opened to capture the native valve leaflets by pulling the control string 24; 3. When the first clamping arm 2111 and the second clamping arm 2112 are positioned behind the anterior and posterior leaflets, respectively, and the anchoring ring 22 is between the native valve leaflets and the chordae tendineae tissue, further operate the delivery device 3 so that the sealing device 12 and the auxiliary support rod 11 are completely released and supported within the left atrium; 4. As shown in Figures 4d to 4f, the delivery device 3 is operated to release the proximal end portion of the valvular stent 1, and when the valvular stent 1 has fully expanded radially and cooperated with the anchor ring 22 to finally clamp the native valve leaflets and chordae tendineae tissue between the valvular stent 1 and the anchor ring 22, the delivery device 3 is withdrawn, completing the implantation.

[0061] Example 2 Example 2 is almost the same as Example 1, but differs in that the clamping mechanism 21 in this example has only a single clamping arm 211, and the anchor ring 22 is connected to the clamping arm 211 and the valvular stent 1, respectively, as shown in Figure 5a.

[0062] In this embodiment, as shown in FIG. 5b, the clamping mechanism 21 comprises a single clamping arm 211, and the anchor ring 22 is connected to the clamping arm 211 and the valvular stent 1, respectively. The height of the connection point between the anchor ring 22 and the valvular stent 1 must be lower than the height of the connection point between the anchor ring 22 and the clamping arm 211. After the valvular stent 1 is attached in place, the clamping arm 211 captures and clamps the anterior valve leaflet, and the connection point between the anchor ring 22 and the valvular stent 1 is in the posterior valve leaflet region. The purpose of this design is to significantly lift the anterior valve leaflet and avoid obstruction to the left ventricular outflow tract, and to prevent the clamping material from applying excessive tension to the chordae tendineae in the posterior valve leaflet region, thereby protecting the chordae tendineae tissue.

[0063] In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and therefore will not be repeated here.

[0064] Example 3 The third embodiment is almost the same as the first embodiment, but differs from the first embodiment in that the clamping mechanism 21 in this embodiment includes a plurality of clamping arms 211, as shown in FIG. 6a.

[0065] In this embodiment, as shown in FIG. 6b, the clamping mechanism 21 includes multiple clamping arms 211, and the anchor ring 22 has a wave-like shape because the connection points between the anchor ring 22 and the multiple clamping arms 211 are at different heights. After the valvular stent 1 is attached in place, the connection point between the anchor ring 22 and the clamping arms 211 in the anterior leaflet region must be higher than the connection point between the anchor ring 22 and the clamping arms 211 in the posterior leaflet region. The purpose of this design is to significantly lift the anterior leaflet and avoid obstruction to the left ventricular outflow tract, and to prevent excessive tension on the chordae tendineae in the posterior leaflet region by the clamping material, thereby protecting the chordae tendineae tissue.

[0066] In this embodiment, the circumferential length of the anchor ring 22 is greater than that of the valvular stent 1, and is smaller than that of the native annulus.

[0067] In this regard, the configuration and concept of the third embodiment are similar to those of the first embodiment, and therefore will not be repeated here.

[0068] The foregoing description of exemplary embodiments of the present application is presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the present application to the precise arrangements and / or configurations disclosed; given the guidance above, it will be apparent to those skilled in the art that numerous modifications and variations may be made without departing from the present application. The scope and equivalents of the present application are intended to be limited by the appended claims.

Claims

1. 1. A cardiac valve prosthesis anchorable to a native valve leaflet, comprising a valvular stent and a valve clamping and fixation device connected to the valvular stent, the valve clamping and fixation device comprises a clamping mechanism having a proximal end connected to the valvular stent and a distal end free, and an anchor ring at least a portion of which is disposed on the clamping mechanism, the anchor ring being configured to lift the native valve leaflets after the valvular stent is attached in place, so that at least one of the native valve leaflets and chordae tendineae tissue is clamped between the valvular stent and the valve clamping and fixation device, and the anchor ring clamps the valvular stent; the anchor ring is connected to the clamping mechanism, the clamping mechanism including at least one clamping arm; The cardiac valve prosthesis anchorable to the native valve leaflets further comprises a sealing device including a self-adapting segment and an applicator segment. A cardiac valve prosthesis capable of being anchored to a native valve leaflet.

2. The valve clamping and fixation device is configured to be capable of assuming a first configuration and a second configuration, and when the valve clamping and fixation device is in the first configuration, the clamping mechanism is configured to capture the native valve leaflet, and when the valvular stent expands in the radial direction, the anchoring ring pulls the chordae tendineae, moving the native valve leaflet so as to be pulled up, and the valve clamping and fixation device is in the second configuration.

2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

3. When the valve clamping device is in the first configuration, the clamping mechanism is between the native valve leaflet and the ventricular wall, and a portion of the anchoring ring is between the native valve leaflet and chordae tendineae tissue.

3. The cardiac valve prosthesis according to claim 2, which can be anchored to the native valve leaflets.

4. The valvular stent and the clamping mechanism are an integral structure, and in a natural state, at least a portion of the clamping mechanism is positioned on the outside of the valvular stent.

2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

5. The anchor ring and the clamping mechanism have at least two first connection points at different heights, or The anchor ring and the clamping mechanism have a first connection point, and the anchor ring and the valvular stent have a second connection point having a height different from that of the first connection point.

2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

6. the clamping mechanism includes a single clamping arm, the anchor ring is connected to the clamping arm and the valvular stent, and a height of a first connection point between the anchor ring and the clamping arm is higher than a height of a second connection point between the anchor ring and the valvular stent; 2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

7. When used to treat a mitral valve, and when the valve clamping device is in a first configuration, the clamping arms capture and clamp the anterior valve leaflet, and the second connection point between the anchoring ring and the valvular stent is located in a posterior valve leaflet region.

7. The cardiac valve prosthesis according to claim 6, which can be anchored to the native valve leaflets.

8. The at least one clamping arm comprises a first clamping arm and a second clamping arm each connected to the anchor ring and configured to capture and clamp different native valve leaflets, respectively.

2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

9. The valve clamping and fixing device further includes a control string that is detachably connected to the first clamping arm and the second clamping arm, respectively, and that, when pulled, causes the first clamping arm and the second clamping arm to open and capture the native valve leaflet.

9. The cardiac valve prosthesis according to claim 8, which can be anchored to the native valve leaflets.

10. The clamping mechanism includes a plurality of clamping arms, and the anchor ring has a wave-like shape because the heights of the connection points between the clamping arms and the anchor ring are different.

2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

11. a plurality of auxiliary support rods are provided at the distal end of the valvular stent, the auxiliary support rods being positioned in the atrium and at least a portion of which is applied to the atrial wall after the valvular stent is attached in place; 2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

12. The self-adapting segment comprises a first arc-shaped segment, a second arc-shaped segment, and a leak-proof membrane; the first arcuate segment is connected to the valvular stent providing a fulcrum for the first arcuate segment, and after the valvular stent is attached in place, at least a portion of the first arcuate segment is applied to the atrial wall, and when the atrial wall presses against the first arcuate segment, the first arcuate segment rotates around the fulcrum toward the center of the valvular stent and moves the second arcuate segment to rotate in the same direction; 2. The cardiac valve prosthesis according to claim 1, which can be anchored to the native valve leaflets.

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