CN212788787U - Artificial heart valve - Google Patents

Abstract

The utility model discloses a heart valve prosthesis, which comprises a bracket, valve leaflets, a suture film, suture lines and clamping pieces; the support comprises an outer support and an inner support, wherein the outer support is spherical and is used for being attached to and supporting the atrium; the inner support is cylindrical and is arranged inside the outer support; the valve leaf is arranged in the inner support and used for replacing the original heart valve; the sewing film is attached to the outer support and the inner support; the inner support is provided with a suture hole; the valve leaf passes through the suture hole and is sewed with the clamping piece through the suture. The utility model can fix the valve device in the heart more stably, and is not easy to shift; meanwhile, the valve is better matched with the physiological structure of the heart, and the paravalvular leakage is reduced; the damage of the valve to the ventricle and the structure under the valve is reduced, the outer layer bracket has a protection effect on the inner layer bracket and the valve leaflet, and the influence of the inner layer bracket and the valve leaflet pressed by the heart native tissue on the movement of the valve leaflet can be reduced. Thereby increasing the service time of the artificial heart valve.

Description

Artificial heart valve

Technical Field

The utility model relates to the technical field of medical equipment, in particular to an artificial heart valve.

Background

Heart valves are divided into two groups, atrioventricular (mitral, tricuspid) and semilunar (aortic, pulmonary) valves, according to their respective morphology and function. Between the right atrium and the right ventricle is the tricuspid valve, between the right ventricle and the pulmonary artery is the pulmonary valve, between the left atrium and the left ventricle is the mitral valve, and between the left ventricle and the aorta is the aortic valve. In the middle position between the aortic valve and the mitral and tricuspid valves in the transverse view of the heart, the pulmonary valve is located anteriorly superior and slightly to the left of the aortic valve. The mitral valve ring and the tricuspid valve ring are connected with each other and are separated from the diaphragm part chamber to form a fiber support of the heart, and the center of the support is a central fiber body comprising a left fiber triangle and a right fiber triangle. The right fibrous trigones constitute the mitral annulus, the tricuspid annulus, the left ventricular-aortic junction without the coronary valve, and the dense junctions between the septal compartments. The middle is penetrated by the bundle of cells. The left fibrous triangle, positioned anterior to left, is located between the left ventricular-aortic junction and the mitral annulus. The fibrous tape at the upper planar infundibulum portion connects the pulmonary valve to the heart central skeleton. The Todaro tendon is also attached to the central fibrous body.

The mitral valve is located between the left atrium and the left ventricle, and acts as a one-way valve to ensure that blood flows from the left atrium to the left ventricle and through a certain flow. The mitral valve complex is a complex set of devices that function and dissect structures, commonly thought of as including the annulus, leaflets, chordae tendinae, and papillary muscles. The function of the mitral valve depends on the integrity of its physiological structure. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely coapt, so that the backflow of the ventricular blood flow can be completely blocked. To achieve this result, the mitral annulus is required to be of a proper size, the leaflets have a complete structure, the papillary muscle contracts and pulls the chordae tendineae to support the leaflets, the left ventricular muscle contracts and generates a proper closing force, and the ventricles are required to have normal shapes and functions. Mitral regurgitation is triggered when damage occurs to the mitral valve complex structure or to the heart.

Tricuspid regurgitation is classified into primary and secondary according to etiology. The former is caused by the damage of the structure of the tricuspid valve itself, while the latter is caused by the rise of systolic and diastolic pressure of the right ventricle, the enlargement of the tricuspid valve annulus leading to the relative insufficiency of the tricuspid valve. The causes of primary tricuspid regurgitation are rheumatic valvular heart disease, infectious endocarditis, rheumatoid arthritis, radiation therapy, trauma (such as repeated cardiac biopsies), Marfan's syndrome, tricuspid prolapse, congenital diseases such as Ebstein malformations, and appetite suppressant drugs may also cause tricuspid regurgitation. The most common cause of secondary tricuspid regurgitation is right ventricular systolic pressure rise, which is commonly seen in mitral stenosis, pulmonary stenosis and pulmonary hypertension caused by various reasons; the second is the increase of ventricular diastolic pressure, which is commonly seen in dilated heart disease, right ventricular myocardial infarction and right heart failure caused by various reasons.

The surgical trauma, risk of surgical valve replacement, and long-term and expensive rehabilitation therapy after surgery make a large number of patients reluctant to undergo surgery. Transcatheter heart valve treatment provides doctors with a novel treatment method with less trauma, less complications and quick postoperative rehabilitation.

Patent publication CN104302247A discloses a sequentially deployed prosthetic heart valve that includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. The first front ear is disposed on the front portion of the frame. The posterior tabs are located on the posterior portion of the self-expanding frame. The frame may be designed such that any portion can be sequentially expanded in any desired order. For example, a portion of the first anterior ear and a portion of the posterior ear may first partially self-expand. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may then be fully self-expanding, followed by ventricular skirt self-expansion; or the ventricular skirt may then self-expand, followed by full expansion of the posterior tab. Although some technical problems of manufacturing of atrioventricular valve stents can be solved by the technical scheme, due to the particularity of the mitral valve structure, the mitral valve is difficult to insert into the stent and is not easy to fix after being inserted, and in practical application, the mitral valve is difficult to fix, for example, in the valve in-situ fixation problem, the valve is not enough matched with a heart physiological structure, the problem of valve periphery leakage is easily caused, the problem of damage to the ventricle and the valve lower structure is solved, and part of the valve is pressed by native tissues, so that the blood flow is influenced.

SUMMERY OF THE UTILITY MODEL

The utility model aims at the defects of the prior art and provides a prosthetic heart valve which can be more stably fixed in the heart and is not easy to shift; meanwhile, the valve is better matched with the physiological structure of the heart, and the paravalvular leakage is reduced; the damage of the valve to the ventricle and the structure under the valve is reduced, the outer layer bracket has a protection effect on the inner layer bracket and the valve leaflet, and the influence of the inner layer bracket and the valve leaflet pressed by the heart native tissue on the movement of the valve leaflet can be reduced. Thereby increasing the service time of the artificial heart valve.

In order to realize the above purpose, the utility model adopts the following technical scheme:

a heart valve prosthesis comprises a stent, valve leaflets, a suture film, a suture line and a clamping piece; the support comprises an outer support and an inner support, wherein the outer support is spherical and is used for being attached to and supporting the atrium; the inner support is cylindrical and is arranged inside the outer support; the valve leaf is arranged in the inner support and used for replacing the original heart valve; the sewing film is attached to the outer support and the inner support; the inner support is provided with a suture hole; the valve leaf passes through the suture hole and is sewed with the clamping piece through the suture.

Furthermore, each layer of the bracket is of a metal net structure, a polygonal net structure or an arc net structure; the wall thickness of the bracket is 0.1mm-1 mm.

Further, the outer support and the inner support are formed in a manner of one or more of metal material weaving, memory material cutting, laser cutting and laser welding.

Further, the connection mode of the outer support and the inner support comprises one or more of sewing, anchoring and welding.

Furthermore, the diameter of the spherical supporting and connecting atrium of the external bracket is 18mm-120mm, and the diameter from the top to the bottom of the spherical supporting and connecting atrium of the external bracket is 18mm-120 mm.

Furthermore, the diameter of the inner support is 16-40mm, and the height of the inner support is 10-50 mm.

Furthermore, openings are formed in the top and the bottom of the outer support; the width of the opening at the top is 3mm-40 mm; the width of the opening at the bottom is 18mm-60 mm.

Furthermore, the bottom of the outer support or the inner support is provided with a connecting rod.

Further, the suture film comprises an outer suture film and an inner suture film, and the outer suture film is sutured at the bottom of the outer bracket through a suture line; the inner stitching membrane is stitched on the inner support through a stitching line; the sewing film is made of one or more of PET, e-PTFE, PTFE and TPU; the thickness of the sewing film is 0.01mm-1 mm.

Further, the shape of the suture hole is polygonal or circular.

Further, the valve leaf comprises a free edge, a suture ear and a suture edge; the thickness of the valve leaf is 0.08mm-0.8 mm; the material of the valve leaf is biological material and/or high molecular material.

Further, the suture ear is sutured with the clip by a suture.

Furthermore, the clamping piece is provided with clamping piece holes, and the number of the clamping piece holes is 1-10; the clamping piece is made of one or more of high polymer materials, biological materials and metal materials; the clip hole is polygonal or circular.

Furthermore, the suture is made of one or more of high polymer materials PET, e-PTFE, biological tissues and tissue engineering materials, and the diameter of the suture is 0.01mm-0.5 mm.

Compared with the prior art, the utility model discloses can make the inner support that has the valve leaflet receive more protections of outer support, the valve leaflet opens and shuts more stably. The valve device is more stably fixed in the heart and is not easy to shift; the blood flow inflow end structure of the valve is adducted, so that the damage of the valve to the atrium is reduced; the valve is better inosculated with the physiological structure of the heart, the paravalvular leakage is reduced, the influence of the valve pressed by the native tissue of the heart on the movement of the valve leaf is reduced, and the service time of the artificial heart valve is prolonged.

Drawings

FIG. 1 is a block diagram of a heart valve device according to one embodiment;

FIG. 2 is a block diagram of an external stent of a heart valve device according to one embodiment;

FIG. 3 is a block diagram of a stent of a heart valve device according to one embodiment;

fig. 4 is a structural diagram of an inner frame, a valve leaf and a tectorial membrane of a heart valve device provided by the first embodiment;

fig. 5 is a structural view of an inner frame and a valve leaflet of a heart valve device provided by the first embodiment;

fig. 6 is a diagram of a leaflet clip structure of a heart valve device according to one embodiment;

FIG. 7 is a structural view of a sewing membrane of a heart valve device provided in one embodiment;

fig. 8 is a schematic deployment view of a leaflet of a heart valve device provided in accordance with one embodiment;

FIG. 9 is a heart valve device according to one embodiment shown in a cardiac bitmap;

FIG. 10 is a schematic view of an external stent provided in the second embodiment

FIG. 11 is a schematic view of an external stent provided in the third embodiment

FIG. 12 is a schematic view of an external stent according to the fourth embodiment

FIG. 13 is a schematic view of an external bolster provided in example five;

wherein, 1, the valve; 2. an outer support; 2-1. spherical top; 2-2 spherical bottoms; 2-3, connecting rod; 2-4, the position with the largest diameter; 2-5. the top of the outer support is flat; 2-6. the top of the outer bracket is a concave top; 2-7, carrying out top capping; 3. an inner support; 3-1, sewing holes; 4. an inner sewing film; 5. an outer seam film; 6. a leaflet; 6-1, free edge; 6-2, sewing the ear; 6-3, sewing edges; 7. a clip; 7-1. clip hole; 8. a heart; 9. stents formed by laser cutting and by heat setting.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

The utility model aims to provide a prosthetic heart valve aiming at the defects of the prior art.

Example one

The present embodiment provides a prosthetic heart valve, as shown in fig. 1-8, the prosthetic heart valve 1 includes a stent, leaflets 6, a sewing film, sutures, a clip 7; the support comprises an outer support 2 and an inner support 3, wherein the outer support 2 is spherical so as to be attached and supported with the atrium; the inner support 3 is cylindrical, and the inner support 3 is arranged inside the outer support 2; the valve leaf 6 is arranged inside the inner support 3 and is used for replacing the original heart valve; the sewing film is attached to the outer bracket 2 and the inner bracket 3; the inner support 3 is provided with a suture hole 3-1; the valve leaf 6 passes through the suture hole 3-1 and is sewed with the clip 7 by suture.

As shown in fig. 1, the outer stent 2 and the inner stent 3 are formed in a manner including one or more of metal material weaving, memory material cutting, laser cutting, and laser welding; the connection mode of the outer support 2 and the inner support 3 comprises one or more of sewing, anchoring and welding.

Preferably, the stent is usually woven from a metal material (metal tube), the tube is cut by laser to obtain a cut stent, and the stent is heat-set by passing through a die to define the structure of the outer stent and the inner stent. The outer support pipe is usually a pipe with the diameter of 5mm-12mm, and the inner support pipe is usually a pipe with the diameter of 3mm-10 mm; the material is preferably a nickel titanium alloy material.

As shown in fig. 2, the external frame 2 has a spherical structure, and each layer of the external frame 2 has a metal mesh structure, a polygonal mesh structure or an arc mesh structure. The diameter of 2-4 of the spherical supporting atrium of the outer bracket 2 is 18mm-120mm, the diameter from 2-1 of the spherical top of the outer bracket to 2-2 of the spherical bottom of the outer bracket is 18mm-120mm, and the wall thickness of the outer bracket 2 is 0.1mm-1 mm.

The spherical top 2-1 of the external bracket 2 is provided with a spherical opening, the opening is a blood inflow end and is gentle to prevent the heart tissue from being punctured, and the opening width of the spherical top is 3mm-40mm, preferably 5mm-30 mm. The spherical bottom 2-2 of the outer stent 2 is also provided with a straight cylindrical opening, the opening of which is the blood flow outflow end, and one end of the opening is provided with a connecting rod 2-3, the connecting rod 2-3 is used for connecting with a delivery system of the artificial heart valve, and the opening width of the spherical bottom is 18mm-60mm, preferably 25mm-50 mm.

It should be noted that the sphere-like shape is a space structure formed by an arc structure, and actually is also a complex polygonal structure; the straight cylinder type may be a straight cylinder having a non-uniform diameter.

As shown in fig. 3, the inner frame 3 is cylindrical, and each layer of the inner frame 3 is a metal mesh structure, a polygonal mesh structure, or a circular arc mesh structure. The top and the bottom of the inner support 3 are both provided with openings, the height from the top to the bottom is 10mm-50mm, the left and right diameters of the inner support 3 are 16-40mm, and the diameter of the inner support 3 is not more than the opening width of the spherical bottom of the outer support; the wall thickness of the inner support is 0.1mm-1 mm.

The inner support 3 is provided with a sewing hole 3-1, the shape of the sewing hole 3-1 is polygonal or circular, and the number of the sewing holes is 1-10, which is used for sewing the valve leaf with the clamping piece through a sewing thread through the sewing hole 3-1.

As shown in fig. 7, the sewing film includes an outer sewing film 5 and an inner sewing film 4, and the function of the sewing film is to prevent paravalvular leakage. The outer sewing film 5 is similar to the structure of the outer side at the bottom of the outer bracket 2 and is sewn at the outer side of the bottom 2-2 of the outer bracket 2 through a sewing line; the inner sewing film 4 is similar to the cylindrical structure of the inner bracket 3 and is sewed on the inner side of the inner bracket 3 through a sewing line; the inner sewing film 4 and the outer sewing film 5 are made of one or more of PET, e-PTFE, PTFE and TPU; the thickness of the inner sewing film 4 and the thickness of the outer sewing film 5 are both 0.01mm-1 mm.

In the embodiment, the clamping piece 7 is arranged outside the inner bracket suture hole 3-1, and the clamping piece 7 is connected with the valve leaflet through a suture line; the material of the clip 7 is one or more of a high polymer material, a biological material and a metal material.

As shown in fig. 6, which is a schematic structural diagram of the clip 7, a clip hole 7-1 may be formed in the clip 7, and the clip hole 7-1 is polygonal or circular; the number of the clip holes 7-1 is 1-10, which corresponds to the number of the suture holes 3-1.

In this embodiment, the clip 7 may not have a clip hole in some cases, and the material of the clip 7 may be one or more of a polymer material and a biomaterial. When sewing, the sewing needle can directly penetrate through the clip materials to sew without needing clip holes. To ensure the sealing property. The inner support and the outer support are sewed with sewing films.

As shown in fig. 8, the leaflet 6 comprises a free edge 6-1, two suture ears 6-2, and two suture ears 6-3; the suture ears 6-2 of the valve leaflet 6 are sutured into the inner support through the suture holes 3-1 of the inner support, the suture ears 6-2 of the valve leaflet 6 are also sutured on the inner support 3 together with a part of the inner suture film 4, and the suture ears 6-2 of the valve leaflet 6 are also sutured with the clamping piece 7 through sutures. That is, the valve leaflet 6 is connected with the inner suture film, the suture hole and the gasket in sequence through the suture.

The thickness of the valve leaf is 0.08mm-0.8 mm; the material of the valve leaflet is a biological material and/or a high polymer material, and the preferable material comprises bovine pericardium, porcine valves and bovine valves.

As shown in fig. 4-5, the valve leaflet 6 is arranged inside the inner sewing film 4, the inner sewing film 4 is arranged inside the inner support 3, and the three are connected by sewing with the suture. As shown in fig. 1, the inner frame 3 is disposed inside the bottom of the outer frame 2, and the outer frame and the inner frame are connected by one or more methods such as sewing, anchoring, welding, etc.

The suture is made of one or more of high polymer materials PET, e-PTFE, biological tissue and tissue engineering material, and the diameter of the suture is 0.01mm-0.5 mm.

In this embodiment, the memory material weave is specifically described as an example:

the method comprises the steps of forming a columnar support by laser cutting of a memory material (such as a nickel-titanium alloy tube), and then performing heat setting on the columnar support, wherein the outer support is spherical, and the inner support is columnar. Becomes an external bracket and an internal bracket (as shown in figures 1 and 2). The top structure is gentle, prevents to stab the heart tissue.

After the surface treatment of the stent, another animal valve (such as pig aorta) is taken and is chemically fixed (the treatment comprises selection, fat removal, virus inactivation, calcification prevention, sterilization and the like), three best valve leaflets with the same size and shape are selected to be combined into a group, and the selected valve leaflets 6 and the inner stent 3 are sutured by an inner suturing film through a suture line to form an integrated device. The inner stent and the outer stent are sutured through the outer suturing film.

In this embodiment, the inner stent is located inside the outer stent, and the outer stent plays a role in supporting and fixing in the heart. The outer support can also protect the inner support, and the inner support type deformation is prevented from being too large during heartbeat. By doing so, the stress of the inner support can be reduced, and the inner support is not easy to break. In addition, the valve leaflets can be better opened and closed by preventing the deformation of the inner support from being overlarge during the heartbeat. Better opening and closing of the valve leaflets can better simulate the blood flow of a human body, and the valve leaflets can be opened and closed better, so that the service life of the valve leaflets can be prolonged.

In this embodiment, the use method of the integrated valve device is as follows: placing the valve device within a lumen of a delivery device and through the delivery device into the left atrium; delivering the valve device to a target location via a delivery device; when the delivery device reaches a target position, the valve device is released, so that the outer support 2 is attached to and supported on the left atrium, the space of the left atrium can be effectively occupied, the position of the valve is fixed by utilizing the radial supporting force of the outer support 2, and the valve 1 can be more stably fixed in the heart and is not easy to displace; the inner support 3 is supported and connected with the original heart mitral valve; wherein, the valve leaflet 6 is arranged inside the inner support 3 to replace the original heart mitral valve, and the delivery device is pulled out from the left atrium after the valve device is completely attached to the heart, as shown in fig. 9.

It should be noted that the integrated valve device can also be implanted through an apical puncture or a transvenous/arterial approach, which can be selected according to the actual situation.

When the integrated valve device is placed in the heart, blood flows in from the spherical top 2-1 of the outer support and flows out from the valve leaf opening.

The valve device of the embodiment is more stably fixed in the heart and is not easy to shift; the blood flow inflow end structure of the valve is adducted, so that the damage of the valve to the atrium is reduced; the knittable structure with moderate supporting force can reduce the pressure of the support structure on the atrium; the valve is better inosculated with the physiological structure of the heart, and the paravalvular leakage is reduced; the damage of the valve to the ventricle and the subvalvular structure is reduced, and the influence of the valve on the movement of the valve leaflet due to the compression of the native tissue of the heart is reduced.

Example two

The present embodiment provides a heart valve device different from the first embodiment in that:

as shown in fig. 10, the top of the external frame 2 of this embodiment is a flat top 2-5 which is completely flush with the side close to the atrium ceiling.

This embodiment is a completely flat top on the side of the outer frame near the atrial apex to avoid atrial stenosis when the atrium is contracted.

EXAMPLE III

The heart valve device provided by the embodiment is different from the first and second embodiments in that:

as shown in fig. 11, the top of the external stent 2 of this embodiment has a concave top 2-6 on the side near the top of the atrium.

This embodiment is characterized by a concave roof on the side of the outer frame near the atrial roof to avoid atrial stenosis when the atrium is contracted.

Example four

The heart valve device provided by the embodiment is different from the first, second and third embodiments in that:

as shown in fig. 12, the top of the external frame 2 of this embodiment is provided with a top cap on the side close to the atrium top. The top cap material is one or more of PET, e-PTFE, PTFE and TPU.

The embodiment is provided with a top cap 2-7 on the side of the outer frame 2 near the top of the atrium to avoid the narrow injury of the atrium when the atrium contracts. Simultaneously, the product fixation and endothelialization are facilitated.

EXAMPLE five

The heart valve device provided by the embodiment is different from the first, second, third and fourth embodiments in that:

as shown in fig. 13, the outer stent, the inner stent and the outer stent of the present embodiment are integrally formed by laser cutting and heat setting.

The outer and inner stents of the stent 9 of this embodiment are laser cut and integrally formed by heat setting. The inner stent can be pulled out of the outer stent in the delivery system, and the diameter of the delivery system is reduced after the valve is crimped. Thereby reducing damage to the vessel or body tissue by the delivery system.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications, additions and substitutions for the specific embodiments described herein may be made by those skilled in the art without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Claims (14)

1. A heart valve prosthesis is characterized by comprising a bracket, valve leaflets, a suture film, suture lines and clamping pieces; the support comprises an outer support and an inner support, wherein the outer support is spherical and is used for being attached to and supporting the atrium; the inner support is cylindrical and is arranged inside the outer support; the valve leaf is arranged in the inner support and used for replacing the original heart valve; the sewing film is attached to the outer support and the inner support; the inner support is provided with a suture hole; the valve leaf passes through the suture hole and is sewed with the clamping piece through the suture.

2. The heart valve prosthesis of claim 1, wherein each layer of the stent is a metal mesh structure, a polygonal mesh structure, or a circular arc mesh structure; the wall thickness of the bracket is 0.1mm-1 mm.

3. The prosthetic heart valve of claim 1, wherein the outer stent and the inner stent are formed in a manner that includes one or more of braiding a metal material, cutting a memory material, laser cutting, and laser welding.

4. The prosthetic heart valve of claim 1, wherein the connection of the outer stent to the inner stent comprises one or more of suturing, anchoring, and welding.

5. The prosthetic heart valve of claim 1, wherein the outer stent spherical support has a diameter of 18mm to 120mm on both sides of the atrium and a diameter of 18mm to 120mm from the top to the bottom of the outer stent spherical support.

6. The prosthetic heart valve of claim 1, wherein the inner stent has a diameter of 16-40mm and a height of 10-50 mm.

7. A prosthetic heart valve according to claim 5, wherein the outer stent is provided with openings at both the top and bottom; the width of the opening at the top is 3mm-40 mm; the width of the opening at the bottom is 18mm-60 mm.

8. A prosthetic heart valve according to claim 7, wherein the bottom of the outer or inner stent is provided with a connecting rod.

9. The heart valve prosthesis of claim 1, wherein the suture membrane comprises an outer suture membrane and an inner suture membrane, the outer suture membrane is sutured to the bottom of the outer stent by a suture thread; the inner stitching membrane is stitched on the inner support through a stitching line; the sewing film is made of one of PET, e-PTFE, PTFE and TPU; the thickness of the sewing film is 0.01mm-1 mm.

10. A prosthetic heart valve according to claim 1, wherein the suture holes are polygonal or circular in shape.

11. The prosthetic heart valve of claim 7, wherein the leaflet includes a free edge, a sewing ear, a sewing edge; the thickness of the valve leaf is 0.08mm-0.8 mm; the valve leaf is made of biological material or polymer material.

12. A prosthetic heart valve according to claim 11, wherein the sewing ear is sewn to the clip by a suture.

13. The heart valve prosthesis of claim 1, wherein the clip is provided with clip holes, the number of the clip holes being 1-10; the clamping piece is made of one of a high polymer material, a biological material and a metal material; the clip hole is polygonal or circular.

14. The heart valve prosthesis of claim 1, wherein the suture thread is made of one of PET, e-PTFE, biological tissue and tissue engineering material, and has a diameter of 0.01mm to 0.5 mm.

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