CN117100458A

CN117100458A - Valve prosthesis device with selectively distributed barbs

Info

Publication number: CN117100458A
Application number: CN202311077232.2A
Authority: CN
Inventors: 余鹏; 孙超; 危攀
Original assignee: Shanghai Quanxin Medical Technology Co ltd
Current assignee: Shanghai Quanxin Medical Technology Co ltd
Priority date: 2023-08-24
Filing date: 2023-08-24
Publication date: 2023-11-24

Abstract

The invention relates to heart surgical instruments, in particular to a valve prosthesis device with selectively distributed barbs. Comprises an outer bracket and an inner bracket; the outer support comprises a disc-shaped structure which is unfolded at the atrial side, an annular structure which is matched with the annular side, and a conical structure which is unfolded at the ventricular side; the outer support ring structure is externally selectively provided with barbs or protrusions for anchoring the prosthesis to the heart's congenital annulus; the rebounding clamping pieces are distributed on the circumferential side of the outer bracket 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. Wherein the disk-shaped structure and the annular structure are of circular structures or special-shaped structures, and barbs or bulges are distributed at the middle position of the tricuspid valve leaflet; or at the anterior leaflet A2 and posterior leaflet P1, P3 of the mitral valve. The barbs or projections distributed at specific locations maintain the anchoring effect while reducing damage to the native annulus.

Description

Valve prosthesis device with selectively distributed barbs

Technical Field

The invention relates to heart surgical instruments, in particular to a valve prosthesis device with selectively distributed barbs.

Background

Current conditions affecting the functioning of the mitral valve of the heart are: mitral regurgitation, mitral valve leaflet prolapse, mitral stenosis, and the like. Mitral regurgitation is the leakage of blood flow from the left ventricle to the left atrium due to the inability of the mitral valve leaflets to coapt at peak blood pressure during systole. Structural reasons for the failure of the mitral valve leaflet to close properly are: leaflet damage, annulus enlargement, chordae tendineae rupture, papillary muscle ischemia, and the like. Mitral regurgitation can also be caused by leaflet prolapse or leaflet bulge toward the atrial side causing leaflet structural abnormalities. Normal mitral valve function can also be affected by mitral stenosis or narrowing of the mitral valve opening, which can result in obstruction of diastolic blood flow from the atrium through the ventricle.

Mitral regurgitation is primarily a medication and surgical treatment to reduce regurgitation of blood flow to the atria. For example, the expanded annulus is clamped or sheared by repair to allow the leaflets to coapt well. The clamping of the annulus allows the expanded annulus to contract by implanting a circumferential ring around the annulus. Other repair procedures also include suturing or clamping the leaflets to allow the leaflets to coapt well. Alternatively, more interventional procedures involve replacing the entire native valve with a mechanical or biological valve. This procedure is more often performed by open chest extracorporeal circulation, which can make the patient more traumatic, more prone to pain and death, and longer recovery time.

Less invasive aortic valve replacement procedures have been developed in recent years. These aortic valve prostheses include expandable stents and a tri-leaflet valve prosthesis. The expandable stent is adapted to fit a symmetrical circumferential, relatively rigid aortic root. The characteristics of the aortic root determine to which the expandable stent can fit so as not to translocate or fall off.

Whereas the complex anatomy of the mitral valve presents challenges for mitral valve replacement relative to the aortic valve anatomy. First, unlike the relatively symmetrical and native rigid annulus of the aorta, the mitral valve annulus assumes a D-saddle shape, lacks symmetry, and varies widely in the size of the annulus during the cardiac cycle of the heart. These uncertainties present challenges in designing a proper valve prosthesis that can fit the mitral annulus. If there is insufficient contact between the valve prosthesis and the mitral valve annulus, there is a gap, which can result in regurgitation of blood flow. Implantation of an expandable stent may result in paravalvular leakage.

Current aortic valve replacement instrument designs are not suitable for mitral valves. First, many devices require straightforward structures to adapt the mitral valve annulus and to connect support leaflet prostheses. In some devices, these stent structures for supporting the valve leaflets are also fitted to the annulus or to other surrounding tissue, directly subjected to deformation pressure from the annulus or surrounding tissue or blood during systole. Most valve prostheses use tri-leaflet valves, which require a symmetrical circumferential support structure to allow the tri-leaflet valve to open and close freely over a long period of time. Such tri-leaflet may be rendered ineffective if the support structure is subjected to deformation pressure from the annulus or surrounding tissue to flex. More, the size of the annulus of a mitral regurgitant patient will typically be much larger than the size of the aortic valve. And as the valve size increases, the force of the valve She Chengshou increases dramatically. There is a need for a leaflet structure that is more suitable for mitral valve hemodynamics.

In addition to the feature of mitral valve annulus irregularities and indeterminate shapes, it lacks significant radial support structures. While the aortic valve is surrounded by fibrous elastic tissue at the root, helping to anchor the valve prosthesis. The mitral valve is only surrounded by heart tissue. Thus, the mitral annulus possesses a strong radial force. Such radial forces may cause failure of the implanted valve prosthesis structure.

Ventricular chordae tissue may also have an impact on the valve prosthesis. Such chordae aortic valves are absent. The chordae tendineae cause confusion for the mitral valve to be repaired or replaced through sheath intervention, and the operation positioning and placement difficulty are increased. Positioning or placement of the valve prosthesis from the ventricular side can also be difficult due to chordal interference.

While the tricuspid valve on the right side of the heart, while normally having three leaflets, has the same difficulty in treatment of the mitral valve. Therefore, there is also a need to design a well-invented valve prosthesis for treatment of tricuspid valve.

The existing valve prosthesis device can be basically and simply and efficiently inserted to treat heart valve diseases. In the prior art, barbs or raised structures with anchoring function are often distributed outside the valve prosthetic device for securing the prosthetic device at the native annulus, however the anchoring structures are distributed either entirely or without regard to the relative position to the annulus, too many barbs may damage the native annulus, and the localized distribution may be anchoring unstable, resulting in slippage of the prosthetic device. There is thus a need for a valve prosthesis device that reduces damage to the native annulus and yet anchors securely.

Disclosure of Invention

The present invention provides a valve prosthesis device having selective distribution of barbs or projections on the ring structure of the outer stent of the device, the barbs or projections being distributed at specific locations to maintain anchoring while reducing damage to the native annulus.

The invention adopts the following technical means:

a valve prosthesis device comprising an outer stent and an inner stent; the outer support comprises a disc-shaped structure which is unfolded at the atrial side, an annular structure which is matched with the annular side, and a conical structure which is unfolded at the ventricular side; the outer support ring structure is externally selectively provided with barbs or protrusions for anchoring the prosthesis to the heart's congenital annulus; the rebounding clamping pieces are distributed on the circumferential side of the outer bracket 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.

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

Further, the tapered structure deployed on the ventricular side includes split structures of different taper.

Further, the split structures with different conicities are distributed at 60-120 degrees; wherein the split structure of the prosthesis device adapted to the mitral valve is distributed at 120 degrees; the split structure of the prosthetic device is suitable for the equiangular distribution of the prosthetic device of the tricuspid valve.

Further, the disc-shaped structure unfolded at the atrial side is a circular structure or a special-shaped structure; the annular structure of the side of the valve ring is a circular structure or a special-shaped structure.

Further, the special-shaped structure is a D-shaped or saddle-shaped structure.

Further, the disk-like structure of the atrial side portion is further provided with a developing structure which can be recognized by ultrasound.

Further, the inner and outer stents are fabricated from a memory alloy or biocompatible metallic material, wherein the inner stent is expandable or self-expanding.

Further, the outer bracket is formed by cutting and shaping a memory alloy tubular material or weaving and shaping a wire-shaped material, and the inner bracket is formed by cutting and shaping a memory alloy tubular material.

Further, the inner and outer brackets are integrally manufactured or connected and sewed.

Further, the outer and inner stents are coated with biocompatible material to prevent leakage of blood flow from between the prosthesis and the native annulus. Wherein the structures of the atrial side, the primary annulus side and the ventricular side are provided with PET (polyethylene terephthalate) coating films, and the inner edge of the inner bracket is provided with PET coating films or other biocompatible materials.

Further, the clamping piece is provided with an annular structure, and the annular structure is formed by silk braiding or flat plate cutting and shaping.

Further, the clamping piece is attached with a woven flexible material.

Further, the prosthetic device adapted to the mitral valve comprises two clamps, an anterior anchoring member for capturing the native anterior leaflet and the stationary prosthesis, and a posterior anchoring member for capturing the native posterior leaflet and the stationary prosthesis; the prosthetic device adapted to the tricuspid valve comprises three clamps, one for capturing the native anterior leaflet and the immobilized prosthesis, the posterior clamp for capturing the native posterior leaflet and the immobilized prosthesis, and the other for capturing the native septal leaflet and the immobilized prosthesis.

Further, the valve body is a biological tissue leaflet, including bovine pericardium or porcine pericardium.

The invention has the following beneficial effects:

the selective distribution of barbs or projections at specific locations as shown in fig. 9 reduces unnecessary anchoring structures, maintains anchoring effects while reducing damage to the native annulus, reduces the impact on the conduction system such as the atrioventricular node, and reduces the weight of the valve prosthesis device. The ventricular side part adopts a split type conical structure, so that the height of the valve prosthesis is reduced, the occupied space of the ventricular side is reduced, the utilization space of the outflow tract is increased, and the obstruction of the outflow tract can be reduced. The split taper structure of the ventricular side portion can be better adapted to the saddle-type structure of the mitral valve annulus so as to be better adapted. The inner and outer brackets are made of memory alloy, have excellent elasticity and mechanical properties, the annular structure of the outer bracket can change along with the change of an annular valve of a cardiac cycle, the inner bracket can be well attached to the atrial wall on the annular valve, and the inner bracket can provide supporting force for the prosthesis device to prevent collapse. The clamping piece can control reverse folding and rebound through the control handle, if capturing is poor, reverse folding and capturing can be carried out again, and the success rate of operation is improved. The combination of the valve prosthesis support with anchoring of the atrial side portion, the annular portion and the ventricular side portion at the native valve device prevents displacement or separation of the valve prosthesis during systole/diastole, the synergy of the three providing advantages over valve prostheses that have only one or a combination of only some of these anchoring means.

Drawings

FIG. 1 is a schematic diagram of the structure of the present invention;

FIG. 2 is a schematic view of another view of the present invention;

FIG. 3 is a schematic illustration of an outer stent according to an embodiment of the present invention;

FIG. 4 is a schematic illustration of an external stent from another perspective in accordance with an embodiment of the present invention;

FIG. 5 is a schematic diagram of an embodiment of the present invention;

FIG. 6 is a schematic diagram of another view of an embodiment of the present invention;

FIG. 7 is a schematic view of another embodiment of the present invention;

FIG. 8 is a schematic view of another embodiment of the present invention;

figure 9 is a schematic view of the barb or projection distribution of another embodiment of the present invention;

FIG. 10 is a schematic view of the structure with developing structure of the present invention;

FIG. 11 is a perspective view of an outer bracket structure according to another embodiment of the present invention;

FIG. 12 is a side view of an outer stent structure according to another embodiment of the present invention;

FIG. 13 is a schematic diagram of an embodiment of the present invention;

figure 14 is a schematic view of the structure of the barb of the present invention;

FIG. 15 is a schematic view of the structure of the clamping member of the present invention;

FIG. 16 is a schematic view of another clamping member of the present invention;

FIG. 17 is a schematic view of the structure of an embodiment of the outer bracket of the present invention;

FIG. 18 is a schematic view of some embodiments of an inner stent of the present invention; wherein the figures (m) and (n) respectively represent two different structural inner brackets;

FIG. 19 is a schematic view of a valve body according to an embodiment of the present invention;

FIG. 20 is a schematic view of the structure of the present invention in an undeployed state;

FIG. 21 is a schematic view of the structure of another undeployed state of the invention;

FIG. 22 is a structural side view of the present invention in its deployed state;

FIG. 23 is a structural perspective view of the present invention in its deployed state;

FIG. 24 is a schematic view of the release process through a sheath according to the present invention; wherein (a) - (j) are different shape changes of the counterfeit device during release;

FIG. 25 is a schematic view of the mitral valve configuration;

FIG. 26 is a schematic view of delivery through the apex of the heart;

fig. 27 is a schematic representation of the present invention upon completion of release.

The numbers in the figure are as follows:

1. an outer bracket; 2. an inner bracket; 10. a disk-like structure; 20. a ring-shaped structure; 30. a split structure; 40. a clamping member; 50. a barb; 60. a valve body; 70. coating a film; 80. a sheath; 90. a pull wire; 100. developing the structure.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail below with reference to the accompanying drawings, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Referring to fig. 1 and 2, a valve prosthesis device comprises an outer stent 1 and an inner stent 2; the outer support 1 comprises a disc-shaped structure 10 which is unfolded at the atrial side, an annular structure 20 which is matched at the annular side, and a split structure 30 which is unfolded at the ventricular side and has different conicity; the resilient clamping members 40 are distributed on the circumferential side of the outer frame 1 according to the original leaflet; the inner support 2 is connected inside the outer support 1, and a valve body is arranged in the inner support 2.

When deployed, the valve prosthesis atrial side portion deploys in a radial direction to enable abutment with the heart atrial wall, enabling at least one side of the valve prosthesis to be anchored. The axially low profile of the atrial side portion of the valve prosthesis (extending only a small length toward the atrium) minimizes blood flow vortex thrombosis. In a preferred embodiment, the atrial side portion is covered with a biocompatible material, such as PET or other synthetic prosthetic material, to enable sealing of the atrial side portion. When blood flows through, it does not leak from between the prosthesis and the atrial wall.

Referring to fig. 5-8, in some examples, the atrial-side partial disk structure 10 is circular. In some examples, the atrial side portion disk structure 10 is a contoured structure, preferably a D-shaped or saddle-shaped structure, to enable good coaptation with the atrial wall on the valve annulus. Referring to fig. 10, to allow the valve prosthesis to be oriented upon deployment and release, in some examples, a visualization structure 100 is also provided on the atrial-side disc structure 10, particularly to be ultrasonically identifiable, reducing the use of radiation visualization devices.

The prosthetic annulus portion is used to anchor to the heart's native annulus. In some examples, the annular structure 20 of the annulus portion is circular. In some examples, the annular structure 20 of the valve ring portion is a contoured structure, preferably having a D-shaped structure or saddle shape, to enable good fit with the upper atrial wall of the valve ring.

The distribution of the prosthetic annulus portions of the valve as the barbs 50 or raised structures of fig. 14 allows the prosthetic device to anchor better against the native annulus. The barbs 50 are integrally covered on the outer periphery of the annulus of the outer stent 1 or selectively distributed around the circumference of the prosthetic valve according to the characteristics of the native valve to reduce damage to the native valve from excessive barbs or projections. Referring to fig. 13, barbs 50a are equally distributed throughout. Referring to fig. 9 and the mitral valve schematic, when barbs 50b are partially distributed, the barbs are distributed at the middle of the tricuspid valve leaflet; or at the anterior leaflet A2 and posterior leaflet P1, P3 of the mitral valve. In a preferred example, the annular portion is covered with a biocompatible material, such as PET or other synthetic prosthetic material, to enable sealing of the annular portion. When blood flows through, it does not leak from between the prosthesis and the native annulus.

The ventricular side portion of the valve prosthesis is deployed in a radial direction as the prosthesis is deployed and has a low profile, with split structures 30 of the same or different taper, to reduce obstruction of the outflow tract or to make it more adaptable rather than fitting the ventricular wall. In some examples, the split-structure 30 with the taper on the ventricular side may exhibit a 60 ° -120 ° distribution. For mitral valves, a 120 ° distribution is preferably used to enable more flexibility. For the tricuspid valve, it is preferable to use the same taper split to enable greater adaptability. The ventricular side portion of the valve prosthesis is, in a preferred example, covered with a biocompatible material, such as PET or other synthetic prosthetic material, to enable sealing of the ventricular side portion. When blood flows through, it does not leak from between the prosthesis and the native annulus.

For anchoring the valve prosthesis, clamps 40 are provided at the ventricular side portion, which clamps 40 are equally distributed on the circumferential side of the valve prosthesis according to the original leaflet characteristics. For mitral valves, as shown in fig. 8, it is preferable to use two clamps 40, an anterior clamp 40 for capturing the native anterior leaflet and the stationary prosthesis, and a posterior clamp 40 for capturing the native posterior leaflet and the stationary prosthesis. For the tricuspid valve, as shown in fig. 23, three clamps 40 are preferably used, one clamp 40 for capturing the native anterior leaflet and the immobilized prosthesis, the posterior clamp 40 for capturing the native posterior leaflet and the immobilized prosthesis, and one clamp 40 for capturing the native septal leaflet and the immobilized prosthesis.

In some examples, the clip 40 has a loop structure, as shown in fig. 15, which may be a wire weave or may be cut and formed from a flat sheet, which is capable of stretch-elastic recoil for capturing the native leaflets between the valve prosthesis outer stent 1.

The anchoring of the valve prosthesis support in combination with the atrial side portion, the annular portion and the ventricular side portion at the native valve device can prevent the valve prosthesis from shifting or separating during systole/diastole. The synergistic effect of the three results in an advantage over valve prostheses that have only one or a combination of only some of the anchoring means. In some examples, as shown in fig. 8, the valve prosthesis has a structure in which the outer stent 1 and the inner stent 2 are combined with a certain clearance on the inflow side of blood, when the outer stent 1 is pressed by the native annulus on the inflow side to deform toward the valve annulus to be able to fit with the native annulus throughout the cardiac cycle, and the inner stent 2 is not deformed, so that the valve prosthesis leaflets can have good hemodynamic performance.

Referring to fig. 17-18, the inner stent 2 is designed to be expandable or self-expanding. The inner stent 2 may be manufactured from a memory alloy, such as nitinol. Other biocompatible metallic materials may also be used for fabrication. The outer stent 1 may also be manufactured from a memory alloy, such as nitinol or other biocompatible metallic material. The inner and outer brackets 1 may be integrally manufactured or may be sewn by connection. In this example by sewing. In some inventive examples, the annular structure 20 of the outer stent 1 may vary with the variation of the annulus of the cardiac cycle, designed as a D-shaped structure or saddle-shaped to conform to the variation of the annulus, particularly for the mitral valve. In some embodiments, the prosthetic device is cut from a memory alloy tubular material or braided from a wire-like material, with good flexibility.

The inner stent 2 and the outer stent 1 are composed of a plurality of diamond-shaped lattice cells, and the valve body 60 is sewed in the inner stent 2. In this embodiment, the valve body is a biological tissue leaflet, and the biological valve tissue shown in fig. 19 comprises bovine pericardium or porcine pericardium, and is composed of three independent valves or three valves formed integrally.

Referring to fig. 24, to enable release of the valve prosthesis within the heart, the valve prosthesis is first compression loaded into a suitable sheath 80. The valve prosthesis body is compressed into the sheath 80 and the clip 40 is reverse-stretched into the sheath 80 by a pull wire 90 or other similar wire depending on the number of anchoring features of the valve prosthesis. In some examples, the distal ends of these pull wires 90 or wires are connected to the valve prosthesis by a loop, and the proximal ends control the recoil and recoil of the clip 40 by manipulating the handles. As shown in fig. 26, the valve prosthesis loaded into the sheath 80 is then delivered transapically. When the valve prosthesis is delivered to the intended atrial side, the sheath 80 is retracted by manipulating the delivery handle to enable the valve prosthesis to be gradually exposed and deployed. In some self-expanding examples, the valve prosthesis is partially deployed once the valve prosthesis is advanced stepwise to expose. While in the expandable example, a balloon is required to expand the deployment.

Continuing with the valve prosthesis interventional procedures of figures (a) - (j), the deployed valve prosthesis may be released based on the characteristics of the native valve. For example, in the mitral valve prosthesis example, the valve prosthesis includes two anterior and posterior clamps 40. When a point sheath 80 is withdrawn and the valve prosthesis is advanced out gradually, the atrial-side portion of the valve prosthesis has been deployed, the relative positions of the native leaflets and the valve prosthesis can be identified by ultrasound guidance, and can be adjusted so that the anterior-posterior clamp 40 mates with the native leaflets. When the positions are mated, the sheath 80 is again withdrawn to progressively expose the valve prosthesis, with the atrial portion of the valve prosthesis deployed against the annulus portion and the native annulus device until the clip 40 is exposed out of the sheath and the withdrawal of the sheath ceases. At this point, the valve prosthesis has been anchored well at the native annulus. The clip 40 is then controlled by the pull wire 90 or wire to capture the native leaflet and release the clip 40 for rebound. If the capture is not good, the reverse fold can also be pulled back and the capture can be re-performed. Once the valve prosthesis release position is satisfactory and the clips 40 are successfully mated, the valve prosthesis eventually releases after the pull wire or wire is detached, the two clips 40 capture the native anterior and posterior leaflet between the prosthetic stent and the anchoring component, the barbs 50 or raised structures are supported under the native annulus, the clips 40 are supported on the leaflet fibrous structure, and the prosthetic device anchoring is stable. Finally, the delivery sheath 80 is fully withdrawn, completing the implantation procedure.

While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following claims be interpreted as including the preferred embodiments and all such alterations and modifications as fall within the scope of the invention.

It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A valve prosthesis device comprising selectively distributed barbs, comprising an outer stent and an inner stent; the outer support comprises a disc-shaped structure which is unfolded at the atrial side, an annular structure which is matched with the annular side, and a conical structure which is unfolded at the ventricular side; the outer support ring structure is externally selectively provided with barbs or protrusions for anchoring the prosthesis to the heart's congenital annulus; the rebounding clamping pieces are distributed on the circumferential side of the outer bracket 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.

2. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the barbs or protrusions are distributed at intermediate locations of the tricuspid valve leaflet;

or at the anterior leaflet A2 and posterior leaflet P1, P3 of the mitral valve.

3. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the tapered structure deployed on the ventricular side comprises split structures of different taper.

4. The selectively distributed barb-containing valve prosthesis device of claim 3, wherein the split structures of different tapers are distributed at 60 ° -120 °; wherein the split structure of the prosthetic device adapted to the mitral valve is 120 deg. distributed.

5. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the atrial-side deployed disc-like structure is a circular structure or a contoured structure;

the annular structure of the side of the valve ring is a circular structure or a special-shaped structure.

6. The selectively distributed barb-containing valve prosthesis device of claim 5, wherein the contoured structure is a D-like or saddle-like structure.

7. The selectively distributed barb-containing valve prosthesis device of claim 1, further comprising an ultrasonically identifiable visualization structure on the disc-like structure of the atrial side portion.

8. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the inner and outer stents are fabricated from a memory alloy or biocompatible metallic material, wherein the inner stent is expandable or self-expanding.

9. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the outer stent is cut from a memory alloy tubular material or braided from a filamentary material and the inner stent is cut from a memory alloy tubular material.

10. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the inner and outer stents are integrally manufactured or joined and sutured.

11. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the outer stent and the inner stent are coated with a biocompatible material to prevent leakage of blood flow from between the prosthesis and the native annulus.

12. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the clip has a loop-shaped structure formed from a wire weave or a flat cut.

13. The selectively distributed barb-containing valve prosthesis device of claim 12, wherein the clip has a braided flexible material applied thereto.

14. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the mitral valve-fitting prosthesis device comprises two clamps, an anterior anchoring component for capturing the native anterior leaflet and the fixation prosthesis, and a posterior anchoring component for capturing the native posterior leaflet and the fixation prosthesis; the prosthetic device adapted to the tricuspid valve comprises three clamps, one for capturing the native anterior leaflet and the immobilized prosthesis, the posterior clamp for capturing the native posterior leaflet and the immobilized prosthesis, and the other for capturing the native septal leaflet and the immobilized prosthesis.

15. The selectively distributed barb-containing valve prosthesis device of claim 1, wherein the valve body is a biological tissue leaflet comprising bovine pericardium or porcine pericardium.