A valve prosthesis device with segmented conical structure

Abstract

The present invention relates to a cardiac surgical instrument, specifically a valve prosthesis device with a segmented conical structure. It comprises an outer support and an inner support; the outer support comprises a disc-shaped structure unfolded on the atrial side, an annular structure adapted on the valve ring side, and a split structure with different tapers unfolded on the ventricular side; the resilient clamp is distributed on the circumferential side of the outer support according to the original valve leaflets; the inner support is connected to the inside of the outer support, and a valve body is arranged in the inner support. It also comprises barbs or protrusions selectively or integrally distributed on the annular structure of the outer support, which are used to anchor the prosthesis to the congenital valve ring of the heart. The disc-shaped structure and the annular structure are circular structures or special-shaped structures, and the split structures with different tapers are distributed at 60°-120°. The use of a split conical structure can reduce outflow tract obstruction and improve the adaptability of the prosthesis.

Description

Technical Field

[0001] The invention relates to a cardiac surgical instrument, in particular to a valve prosthesis device with a segmented conical structure. Background Art

[0002] The conditions that currently affect the function of the mitral valve of the heart include: mitral regurgitation, mitral valve leaflet prolapse and mitral valve stenosis. Mitral valve regurgitation refers to the failure of the mitral valve leaflets to close under the peak blood pressure during cardiac systole, causing blood to leak from the left ventricle to the left atrium. The structural reasons that lead to the failure of the mitral valve leaflets to close normally include: leaflet damage, valve ring enlargement, chordae tendineae rupture and papillary muscle ischemia. Leaflet prolapse or leaflet bulging toward the atrial side causing abnormal leaflet structure can also lead to mitral valve regurgitation. The function of the normal mitral valve can also be affected by mitral valve stenosis or narrowing of the mitral valve opening, which will cause obstruction of blood flow from the atrium to the ventricle during cardiac diastole.

[0003] Mitral regurgitation is treated with medication and surgery to reduce the amount of blood flowing back into the atria. For example, repairs can be performed by clipping or shearing the dilated annulus to allow the leaflets to close properly. Clipping the annulus shrinks the dilated annulus by implanting a circumferential ring around the annulus. Other repairs can also involve suturing or clipping the leaflets to allow them to close properly. Alternatively, more invasive procedures can involve replacing the entire native valve with a mechanical or biological valve. This type of surgery is more likely to be performed through an open-chest extracorporeal circulation, which can be more traumatic for the patient, more likely to cause pain and death, and require a longer recovery time.

[0004] Less invasive aortic valve replacement procedures have been developed in recent years. These aortic valve prostheses include an expandable stent and a trileaflet prosthesis. The expandable stent is designed to fit into the relatively rigid aortic root, which is symmetrical and circumferential. These characteristics of the aortic root determine that the expandable stent can fit into it and is not easily displaced or dislodged.

[0005] Compared with the aortic valve anatomy, the complex anatomical structure of the mitral valve poses challenges to mitral valve replacement. First, unlike the relatively symmetrical and native rigid annulus of the aorta, the mitral valve annulus is D-shaped and saddle-shaped, lacking symmetry, and the size of the annulus varies greatly during the cardiac cycle. These uncertainties pose challenges to designing a suitable valve prosthesis that can fit the mitral valve annulus. If there is insufficient contact between the valve prosthesis and the mitral valve annulus, resulting in a gap, blood flow regurgitation will occur. Implanting an expandable stent may cause paravalvular leaks.

[0006] Current aortic valve replacement device designs are not suitable for mitral valves. First, many devices require direct structures to fit the mitral valve ring and connect the supporting leaflet prosthesis. In some devices, these stent structures used to support the leaflets also fit the valve ring or other surrounding tissues, and directly bear the deformation pressure from the valve ring or surrounding tissues or blood during heart contraction. Most valve prostheses use tri-leaflet valves, which require symmetrical circumferential support structures to enable the tri-leaflet valve to open and close freely for a long time. If this support structure is subjected to deformation pressure from the valve ring or surrounding tissues and bends and deforms, the tri-leaflet valve may fail to function. Moreover, in general, the valve ring size of patients with mitral regurgitation is much larger than that of the aortic valve. When the valve size increases, the force on the leaflets increases sharply. Therefore, a leaflet structure that is more suitable for the blood flow dynamics of the mitral valve is needed.

[0007] In addition to the irregular and indeterminate shape of the mitral valve annulus, it lacks important radial support structures. While the aortic valve is surrounded by fibroelastic tissue at the root, which helps anchor the valve prosthesis, the mitral valve is only surrounded by cardiac tissue. As a result, the mitral valve annulus has strong radial forces. Such radial forces may cause the implanted valve prosthesis to fail.

[0008] The chordae tendineae of the ventricle may also affect the valve prosthesis. Such chordae do not exist in the aortic valve. Such chordae may cause confusion in the repair or replacement of the mitral valve through the sheath intervention, increasing the difficulty of surgical positioning and placement. Positioning or placement of the valve prosthesis from the ventricular side may also be difficult due to the interference of the chordae tendineae.

[0009] The tricuspid valve on the right side of the heart, although it normally has three leaflets, is also as difficult to treat as the mitral valve. Therefore, the treatment of the tricuspid valve also requires the design and invention of a well-designed valve prosthesis.

[0010] Existing valve prosthesis devices can basically be used to treat heart valve diseases in a simple and efficient manner. In the prior art, the unfolded structure of the ventricular side of the valve prosthesis device is usually an integral conical or annular structure. However, this design makes the prosthesis device as a whole too high, occupying unnecessary space on the ventricular side, which may cause flow obstruction. At the same time, due to the integral design of the ventricular side, the valve ring side structure may not fit closely to the native valve ring when it is squeezed and deformed, resulting in poor adaptability on the valve ring side. Summary of the invention

[0011] The present invention provides a valve prosthesis device, which adopts a split conical structure on the ventricular side, which can reduce the obstruction of the outflow tract and improve the adaptability of the prosthesis instead of fitting the ventricular wall.

[0012] The present invention specifically adopts the following technical means:

[0013] A valve prosthesis device comprises an outer support and an inner support; the outer support comprises a disc-shaped structure unfolded on the atrial side, a ring-shaped structure adapted on the valve ring side, and a split structure with different tapers unfolded on the ventricular side; the resilient clamps are distributed on the circumferential side of the outer support according to the original valve leaflets; the inner support is connected to the inside of the outer support, and a valve body is arranged in the inner support.

[0014] Furthermore, it also includes barbs or protrusions selectively or integrally distributed on the annular structure of the outer stent, which are used to anchor the prosthesis to the congenital heart valve ring.

[0015] Furthermore, the barbs or protrusions are distributed at the middle position of the tricuspid valve leaflet; or distributed at the anterior leaflet A2 and the posterior leaflet P1, P3 of the mitral valve.

[0016] Furthermore, the disc-shaped structure unfolded on the atrial side is a circular structure or a special-shaped structure; the ring-shaped structure unfolded on the valve ring side is a circular structure or a special-shaped structure.

[0017] Furthermore, the special-shaped structure is a D-shaped or saddle-shaped structure.

[0018] Furthermore, the split structures with different tapers are distributed at 60°-120°; the split structures of the prosthetic device adapted to the mitral valve are distributed at 120°; and the split structures of the prosthetic device adapted to the tricuspid valve are distributed at equal angles.

[0019] Furthermore, the disc-shaped structure on the atrial side is also provided with a developing structure that can be identified by ultrasound.

[0020] Furthermore, the inner stent and the outer stent are made of memory alloy or biocompatible metal material, wherein the inner stent is deployable or self-expandable.

[0021] Furthermore, the outer bracket is formed by cutting and shaping a memory alloy tubular material or by weaving and shaping a filamentary material, and the inner bracket is formed by cutting and shaping a memory alloy tubular material.

[0022] Furthermore, the inner and outer brackets are integrally manufactured or connected and sutured.

[0023] Furthermore, the outer stent and the inner stent are covered with biocompatible materials to prevent blood from leaking between the prosthesis and the native valve ring. The structures on the atrial side, the native valve ring side and the ventricular side are provided with PET coatings, and the inner edge of the inner stent is provided with PET coatings or other biocompatible materials.

[0024] Furthermore, the clamping member has an annular structure, which is formed by filamentary weaving or flat plate cutting and shaping.

[0025] Furthermore, a woven flexible material is attached to the clamping member.

[0026] Furthermore, the prosthetic device adapted for the mitral valve includes two clamps, the front anchoring component is used to capture the native anterior leaflet and fix the prosthesis, and the rear anchoring component is used to capture the native posterior leaflet and fix the prosthesis; the prosthetic device adapted for the tricuspid valve includes three clamps, one clamp is used to capture the native anterior leaflet and fix the prosthesis, the rear clamp is used to capture the native posterior leaflet and fix the prosthesis, and the other clamp is used to capture the native septal leaflet and fix the prosthesis.

[0027] Furthermore, the valve body is a biological tissue leaflet, including bovine pericardium or porcine pericardium.

[0028] The present invention has the following beneficial effects:

[0029] The ventricular side adopts a split cone structure, which reduces the height of the valve prosthesis and reduces the occupied space on the ventricular side, increases the utilization space of the outflow tract, and thus reduces the obstruction of the outflow tract. The split cone structure of the ventricular side can better adapt to the saddle-shaped structure of the mitral valve ring, making it more adaptable. The barbs or protrusions are selectively distributed in specific positions to reduce unnecessary anchoring structures, maintain the anchoring effect while reducing damage to the congenital valve ring, reduce the impact on the conduction system such as the atrioventricular bundle and atrioventricular node, and reduce the weight of the valve prosthesis device. The inner and outer stents are made of memory alloy and have excellent elasticity and mechanical properties. The annular structure of the outer stent can change with the changes of the valve ring during the cardiac cycle, and can fit well with the atrial wall on the valve ring. The inner stent can provide support for the prosthetic device to prevent collapse. The clamp can control the folding and rebounding through the control handle. If the capture is not good, it can be re-pulled and re-captured, which improves the success rate of the operation. The valve prosthesis stent is anchored at the native valve device with the atrial side part, the valve ring part and the ventricular side part to prevent the valve prosthesis from shifting or separating during the heart's contraction / diastole. The synergistic effect of the three makes it more superior than valve prostheses with only one or a combination of some of the anchoring methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic diagram of the structure of the present invention;

[0031] Figure 2 It is a structural schematic diagram of another perspective of the present invention;

[0032] Figure 3 is a schematic diagram of an external support of a certain embodiment of the present invention;

[0033] Figure 4 is a schematic diagram of an external bracket from another perspective of a certain embodiment of the present invention;

[0034] Figure 5It is a structural schematic diagram of a certain embodiment of the present invention;

[0035] Figure 6 It is a structural schematic diagram of another perspective of a certain embodiment of the present invention;

[0036] Figure 7 is a schematic structural diagram of another embodiment of the present invention;

[0037] Figure 8 is a structural schematic diagram of another embodiment of the present invention;

[0038] Fig. 9 is a schematic diagram of the distribution of barbs or protrusions according to another embodiment of the present invention;

[0039] Fig.10 It is a schematic diagram of the structure of the present invention with a developing structure;

[0040] Fig.11 is a three-dimensional diagram of an outer bracket structure of another embodiment of the present invention;

[0041] Fig.12 is a side view of an outer support structure of another embodiment of the present invention;

[0042] Fig.13 It is a structural schematic diagram of an embodiment of the present invention;

[0043] Fig.14 It is a schematic diagram of the structure of the barb of the present invention;

[0044] Fig.15 It is a schematic diagram of the structure of the clamping member of the present invention;

[0045] Fig.16 is a schematic structural diagram of another clamping member of the present invention;

[0046] Fig.17 It is a schematic structural diagram of a certain embodiment of the external support of the present invention;

[0047] Fig.18 Schematic diagrams of the structures of some embodiments of the inner stent of the present invention; wherein Figures (m) and (n) respectively represent inner stents of two different structures;

[0048] Fig.19 is a schematic structural diagram of a valve body according to a certain embodiment of the present invention;

[0049] Fig. 20 It is a schematic diagram of the structure of the present invention in an unexpanded state;

[0050] Fig.21 It is a schematic diagram of the structure of another undeployed state of the present invention;

[0051] Fig. 22 is a side view of the structure of the present invention in an unfolded state;

[0052] Fig.23 It is a structural stereogram of the present invention in an unfolded state;

[0053] Fig.24 Schematic diagram of the release process of the present invention through the sheath; (a)-(j) are different shape changes of the pretend device during the release process;

[0054] Fig.25 It is a schematic diagram of the mitral valve structure;

[0055] Fig.26 It is a schematic diagram of delivery through the apex of the heart;

[0056] Fig. 27 It is a schematic diagram of the present invention when the release is completed.

[0057] Numbers in the figure:

[0058] 1. External support; 2. Internal support; 10. Disc-shaped structure; 20. Ring-shaped structure; 30. Split structure; 40. Clamping piece; 50. Barb; 60. Valve body; 70. Covering; 80. Sheath; 90. Pull wire; 100. Development structure. DETAILED DESCRIPTION

[0059] In order to make the purpose, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0060] See also Figure 1 and 2 A valve prosthesis device includes an outer stent 1 and an inner stent 2; the outer stent 1 includes a disc-shaped structure 10 deployed on the atrial side, a ring-shaped structure 20 adapted to the valve ring side, and a split structure 30 with different tapers deployed on the ventricular side; the resilient clamps 40 are distributed on the circumferential side of the outer stent 1 according to the original valve leaflets; the inner stent 2 is connected to the inside of the outer stent 1, and a valve body is arranged in the inner stent 2.

[0061] When deployed, the atrial side portion of the valve prosthesis is deployed in the radial direction to fit against the atrial wall of the heart, and can anchor at least one side of the valve prosthesis. The atrial side portion of the valve prosthesis has an axially low posture (extending only a small length toward the atrium) to minimize the formation of blood flow vortex thrombi. In a preferred embodiment, the atrial side portion is covered with a material with good biocompatibility, such as PET or other synthetic prosthetic materials to seal the atrial side portion. When blood flows through, it will not leak between the prosthesis and the atrial wall.

[0062] See also Figure 5-8 In some examples, the disc-shaped structure 10 on the atrial side is circular. In some examples, the disc-shaped structure 10 on the atrial side is a special-shaped structure, preferably a D-shaped structure or a saddle-shaped structure, so as to be well fitted with the atrial wall on the valve ring. Fig.10 In order to position the valve prosthesis when it is deployed and released, in some instances, a developing structure 100 is also provided on the disc-shaped structure 10 on the atrial side, which can be particularly identified by ultrasound, thereby reducing the use of radiation developing equipment.

[0063] The valve prosthesis valve ring portion is used to anchor on the congenital valve ring of the heart. In some instances, the annular structure 20 of the valve ring portion is circular. In some instances, the annular structure 20 of the valve ring portion is a special-shaped structure, preferably a D-shaped structure or a saddle shape, so as to be able to fit well with the atrial wall on the valve ring.

[0064] The distribution of the valve prosthesis annulus is as follows Fig.14 The barbs 50 or protrusions make the prosthetic device fit and anchor better with the native valve ring. The barbs 50 are integrally covered on the outer edge of the valve ring of the outer stent 1, or selectively distributed on the side of the prosthetic valve ring according to the characteristics of the native valve, which can reduce the damage to the native valve ring caused by too many barbs or protrusions. Fig.13 , the barbs 50a are evenly distributed throughout. Fig. 9 and two Schematic diagram of the cusp valve, when the barbs 50b are locally distributed, the barbs are distributed in the middle of the tricuspid valve leaflet; or distributed in the anterior leaflet A2 and the posterior leaflet P1, P3 of the mitral valve. In a preferred embodiment, the valve ring is covered with a biocompatible material, such as PET or other synthetic prosthetic materials to seal the valve ring. When blood flows through, it will not leak between the prosthesis and the native valve ring.

[0065] The ventricular side portion of the valve prosthesis is deployed in a radial direction when the prosthesis is deployed, and has a low posture, and is provided with a split structure 30 with the same or different tapers, which can reduce obstruction of the outflow tract or make it more adaptable, rather than fitting the ventricular wall. In some instances, the split structure 30 with a taper on the ventricular side can be distributed at 60°-120°. For the mitral valve, preferably, a 120° distribution is used to make it more adaptable. For the tricuspid valve, preferably, the same taper split is used to make it more adaptable. In a preferred instance, the ventricular side portion of the valve prosthesis is covered with a material with good biocompatibility, such as PET or other synthetic prosthetic materials to seal the ventricular side portion. When blood flows through, it will not leak between the prosthesis and the congenital valve ring.

[0066] In order to anchor the valve prosthesis, a clamping member 40 is provided on the ventricular side, and the clamping member 40 is evenly distributed around the valve prosthesis according to the original leaflet characteristics. Figure 8 As shown, two clamps 40 are preferably used, the front clamp 40 is used to capture the native anterior leaflet and fix the prosthesis, and the rear clamp 40 is used to capture the native posterior leaflet and fix the prosthesis. Fig.23 As shown, three clamps 40 are preferably used, one clamp 40 for capturing the native anterior leaflet and fixing the prosthesis, one clamp 40 for capturing the native posterior leaflet and fixing the prosthesis, and one clamp 40 for capturing the native septal leaflet and fixing the prosthesis.

[0067] In some examples, the clamp 40 is Fig.15 It has a ring structure, which can be woven in a filamentous manner or cut and shaped from a flat plate. The structure can be stretched and rebounded to capture the native leaflets between the external stent 1 of the valve prosthesis.

[0068] The valve prosthesis stent is anchored at the native valve device by the atrial side portion, the valve ring portion and the ventricular side portion to prevent the valve prosthesis from shifting or separating during the heart's contraction / diastole. The synergistic effect of the three makes it more advantageous than a valve prosthesis with only one or only some of the anchoring methods. In some instances, such as Figure 8 As shown, the structure of the valve prosthesis combined with the outer stent 1 and the inner stent 2 has a certain gap on the blood inflow side. When the outer stent 1 of the valve is squeezed by the native valve ring on the inflow side, it deforms inwardly to the valve ring so as to fit closely with the native valve ring during the entire cardiac cycle, while the inner stent 2 will not deform, so that the valve prosthesis leaflets can have good hemodynamic performance.

[0069] See also Figure 17-18 , the inner stent 2 is designed to be deployable or self-expandable. The inner stent 2 can be made of memory alloy, such as nickel-titanium alloy. Other biocompatible metal materials can also be used for manufacturing. The outer stent 1 can also be made of memory alloy, such as nickel-titanium alloy or other biocompatible metal materials. The inner and outer stents 1 can be manufactured as a whole or connected and sutured. In this example, they are connected by sewing. In some inventive examples, the annular structure 20 of the outer stent 1 can change with the changes of the valve annulus during the cardiac cycle, and is designed to be a D-shaped structure or a saddle shape to adapt to the changes of the valve annulus, which is particularly suitable for the mitral valve. In some embodiments, the prosthetic device is cut from a memory alloy tubular material or woven from a filamentary material, and has good elasticity.

[0070] The inner support 2 and the outer support 1 are composed of a plurality of rhombus lattice units, and a valve body 60 is sutured in the inner support 2. In this embodiment, the valve body is a biological tissue leaflet, such as Fig.19The biological valve tissue shown includes bovine pericardium or porcine pericardium, and is composed of three independent valves or three valves formed in one piece.

[0071] See also Fig.24 In order to release the valve prosthesis in the heart, the valve prosthesis is first compressed and loaded into a suitable sheath 80. The valve prosthesis body is compressed into the sheath 80, and the clamp 40 is reversely pulled into the sheath 80 through the pull wire 90 or other similar metal wires according to the number of anchoring features of the valve prosthesis. In some embodiments, the distal ends of these pull wires 90 or metal wires are connected to the valve prosthesis through a loop, and the proximal ends are controlled by a control handle to control the reflexion and rebound of the clamp 40. Fig.26 As shown, the valve prosthesis loaded into the sheath 80 is then delivered through the apical approach. When the valve prosthesis is delivered to the designated atrial side, the sheath 80 is retracted by manipulating the delivery handle so that the valve prosthesis can be gradually exposed and deployed. In some self-expanding examples, once the valve prosthesis is gradually pushed to expose, the valve prosthesis will partially unfold. In expandable examples, a balloon is required to expand and unfold.

[0072] Please continue to refer to the valve prosthesis intervention process of Figures (a)-(j). The unfolding of the valve prosthesis may be released according to the characteristics of the native valve. For example, in the mitral valve prosthesis example, the valve prosthesis includes two front and rear clamps 40. When the sheath 80 is withdrawn a little and the valve prosthesis is gradually pushed out, the atrial side of the valve prosthesis has been partially unfolded. The relative position of the native leaflets and the valve prosthesis can be identified through ultrasound guidance, and the front and rear clamps 40 can be adjusted to match the native leaflets. When the position matches, the sheath 80 is withdrawn again to gradually expose the valve prosthesis. At this time, the atrial part and the valve ring part of the valve prosthesis are unfolded and fit with the native valve ring device until the clamp 40 is exposed outside the sheath and the sheath is stopped. At this time, the valve prosthesis has been well anchored at the native valve ring. Then, the clamp 40 is controlled by the pull wire 90 or the metal wire to capture the native leaflets and release to let the clamp 40 rebound. If the capture is not good, it can be re-pulled and re-captured. Once the release position of the valve prosthesis is satisfactory and the clamping member 40 is successfully matched, the valve prosthesis is finally released after the pull wire or wire is dissociated, and the two clamping members 40 capture the native anterior and posterior leaflets between the prosthesis stent and the anchoring member, the barbs 50 or protrusions are supported under the native valve ring, and the clamping member 40 is supported on the leaflet fiber structure, and the prosthesis device is anchored stably. Finally, the delivery sheath 80 is completely withdrawn to complete the implantation operation.

[0073] Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0074] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A valve prosthesis device with a segmented conical structure, characterized in that: It comprises an outer support and an inner support; the outer support comprises a disc-shaped structure unfolded on the atrial side, an annular structure adapted on the valve ring side, and a split structure with different tapers unfolded on the ventricular side; the resilient clamping parts are distributed on the annular side of the outer support according to the original valve leaflets; the inner support is connected to the inside of the outer support, and a valve body is arranged in the inner support; it also comprises barbs or protrusions selectively distributed on the annular structure of the outer support, which are used to anchor the valve prosthesis device on the congenital valve ring of the heart; the barbs or protrusions are only distributed in the middle position of the tricuspid valve leaflets; or only distributed in the anterior leaflet A2 and the posterior leaflet P1, P3 positions of the mitral valve; The prosthetic device adapted to the mitral valve includes two clamps, one of which is used to capture the native anterior leaflet and the fixed valve prosthesis, and the other is used to capture the native posterior leaflet and the fixed valve prosthesis; the prosthetic device adapted to the tricuspid valve includes three clamps, one of which is used to capture the native anterior leaflet and the fixed valve prosthesis, the posterior clamp is used to capture the native posterior leaflet and the fixed valve prosthesis, and the other is used to capture the native septal leaflet and the fixed valve prosthesis; The valvular prosthetic device intervention procedure includes: First, the valve prosthesis device is compressed and loaded into a suitable sheath; the main body of the valve prosthesis device is compressed into the sheath, and according to the number of anchoring features of the valve prosthesis device, the clamp is reversely pulled into the sheath through the pull wire; the distal ends of these pull wires are connected to the valve prosthesis device through a loop, and the proximal ends are controlled by the control handle to control the folding and rebound of the clamp; the valve prosthesis device loaded into the sheath is then delivered through the transapical method; when the valve prosthesis device is delivered to the designated atrial side, the sheath is retracted by controlling the delivery handle to allow the valve prosthesis device to be gradually exposed and unfolded; During the release of the mitral valve prosthesis, the valve prosthesis device includes two front and rear clamps; when the sheath is withdrawn a little and the valve prosthesis device is gradually pushed out, the atrial side of the valve prosthesis device has been partially unfolded, and the relative position of the native leaflets and the valve prosthesis device can be identified through ultrasound guidance, and can be adjusted so that the front and rear clamps match the native leaflets; when the positions match, the sheath is withdrawn again to gradually expose the valve prosthesis device, at which time the atrial part and the valve ring part of the valve prosthesis device are unfolded and fit with the native valve ring device until the clamps Stop withdrawing the sheath when the valve is exposed outside the sheath; then control the clamps through the pull wire to capture the native leaflets and release them to allow the clamps to rebound; if the capture is not good, you can pull it back and capture it again; once the release position of the valve prosthesis is satisfactory and the clamps are successfully matched, the pull wire is released and the valve prosthesis is finally released. The two clamps capture the native anterior and posterior leaflets between the outer bracket and the clamps, with the barbs or protrusions supported under the native valve ring and the clamps supported on the leaflet fiber structure; finally, completely withdraw the sheath to complete the implantation operation.

2. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The disc-shaped structure unfolded on the atrial side is a circular structure or an irregular structure; the ring-shaped structure unfolded on the valve ring side is a circular structure or an irregular structure.

3. The valve prosthesis device with a segmented conical structure according to claim 2, characterized in that: The special-shaped structure is a D-shaped or saddle-shaped structure.

4. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The split structures with different tapers are distributed at 60°-120°; among them, the split structure of the prosthetic device adapted to the mitral valve is distributed at 120°.

5. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The disc-shaped structure on the atrial side is also provided with a developing structure that can be identified by ultrasound.

6. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The inner support and the outer support are made of memory alloy or biocompatible metal material, wherein the inner support is deployable or self-expandable.

7. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The outer bracket is formed by cutting and shaping memory alloy tubular material or braiding and shaping filamentary material, and the inner bracket is formed by cutting and shaping memory alloy tubular material.

8. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The inner and outer brackets are integrally manufactured or connected and sutured.

9. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The outer stent and the inner stent are covered with biocompatible materials to prevent blood from leaking between the valve prosthesis and the native valve ring.

10. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The clamping piece has an annular structure, which is formed by filamentary weaving or flat plate cutting and shaping.

11. The valve prosthesis device with a segmented conical structure according to claim 10, characterized in that: The clamping piece is attached with a braided flexible material.

12. The valve prosthesis device with a segmented conical structure according to claim 1, characterized in that: The valve body is a biological tissue leaflet, including bovine pericardium or porcine pericardium.

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