CN113133852A - Prosthetic valve and method of making same - Google Patents

Abstract

The invention provides a prosthetic valve and a manufacturing method thereof, comprising the following steps: a support member and three leaflets; the support member includes: an annular frame and a coating layer; the annular frame is of a net structure and can deform in the radial direction; the coating layer is arranged on the inner surface of the annular frame, is of a pleated structure and can deform in the radial direction; three valve leaflets are arranged in the support component, each valve leaflet is provided with a plurality of folding parts, and all the folding parts stretch along with the radial deformation of the support component. The prosthetic valve of the present invention can be radially expanded to accommodate patient growth; when the radial expansion ratio of the valve is 0-40%, the functionality of the artificial valve can still be ensured, the operation scheme that the artificial valve needs to be replaced again in the prior art is avoided, and the pain of a patient is relieved; when the valve radial expansion ratio is greater than or equal to 40% and less than 100%, the functionality of the prosthetic valve fails, which can serve as an anchoring ring for a re-transcatheter valve replacement procedure.

Description

Prosthetic valve and method of making same

Technical Field

The invention relates to the field of medical instruments, in particular to a prosthetic valve and a manufacturing method thereof.

Background

Some congenital heart diseases can be combined with right ventricular outflow tract stenosis, the most common of which is Faluo tetrad, which accounts for about 12% -14% of the congenital heart diseases, and the right ventricular outflow tract stenosis needs to be timely surgically corrected. The currently common treatment means include a transvalvular patch dilation procedure, valved conduit replacement. Through the treatment method of surgically implanting the pulmonary valve, as the heart of a patient grows, pulmonary artery stenosis appears first after operation, the pulmonary artery stenosis symptom appears early, and the growth of the heart of an infant patient can be adapted by timely expanding the valve through the saccule, so that the right heart function of the patient is effectively protected. The pulmonary valve regurgitation is generally not caused in early stage due to the compensation of the right heart to the regurgitation, and when a patient is hospitalized again due to symptoms such as chest distress and shortness of breath, the right ventricle is easy to irreversibly hypertrophy and even the right heart failure due to long-term regurgitation, and the treatment can be remedied by secondary thoracotomy or catheter pulmonary valve replacement and other methods, but the curative effect is greatly reduced due to the fact that the right heart function of the patient is seriously affected.

Disclosure of Invention

In view of the above-mentioned shortcomings of the prior art, it is an object of the present invention to provide a prosthetic valve for solving the above-mentioned problems in the prior art.

In order to solve the above technical problem, the present invention provides a prosthetic valve comprising: a support member and three leaflets;

the support member includes: an annular frame and a coating layer;

the annular frame is of a net structure and can deform in the radial direction;

the coating layer is arranged on the inner surface of the annular frame, is of a pleated structure and can be radially deformed;

the three valve leaflets are arranged inside the support component, each valve leaflet is provided with a plurality of folding parts, all the folding parts stretch along with the radial deformation of the support component, the edge of each valve leaflet comprises a fixed edge and a free edge which are connected, and the fixed edge is connected with the support component.

Preferably, the valve radial expansion ratio of the artificial valve is 0-100%; the valve expansion difference divided by the initial valve maximum diameter multiplied by 100% equals the valve radial expansion ratio; the maximum diameter of the initial valve is the outer diameter of the artificial valve in an initial state after being assembled; the valve expansion difference is the difference of the outer diameter of the expanded artificial valve minus the maximum diameter of the initial valve;

when the valve radial expansion ratio of the artificial valve is 0-40%, the artificial valve can realize normal working function.

Further, all of the folds are provided on the leaflets extending to the fixed edge and the free edge.

Further, each of the leaflets includes a fixed lobe and a telescopic lobe connected in series, and all of the folds extend to the fixed edge and the free edge of the telescopic lobe.

Further, each of the pleats extends onto a free edge of the leaflet.

Preferably, the cladding comprises a plurality of cladding elements connected in series; the whole body of each cladding element is of a pleated structure capable of being folded into a wave shape; or each cladding element comprises a fixed cladding piece and a telescopic cladding piece which are sequentially connected, and the telescopic cladding piece is provided with a pleated structure which can be folded into a wave shape.

Preferably, the outer surface of the annular frame is provided with the coating layer.

Preferably, the net structure of the ring frame is provided with rhombic meshes, the rhombic meshes are arranged in more than two rows, and the number of the rhombic meshes is increased from top to bottom.

The invention also relates to a manufacturing method of the artificial valve, the support component is assembled after being connected with the three valve leaflets, and the outer diameter of the artificial valve is the maximum diameter of the initial valve.

The invention also relates to a manufacturing method of the artificial valve, after the supporting component is connected with the three valve leaflets, the artificial valve is crimped by using a crimping machine, the crimped artificial valve is assembled, and the outer diameter of the crimped artificial valve is the maximum diameter of the initial valve;

when the radial expansion ratio of the valve leaflets of the artificial valve is 0-40%, the valve leaflets of the artificial valve can realize normal working function;

the leaflet expansion difference divided by the initial leaflet edge diameter multiplied by 100% equals the leaflet radial expansion ratio;

the diameter of the initial valve leaflet edge is the diameter of a circular area surrounded by the fixed edges of the three valve leaflets after the artificial valve is assembled; the leaflet expansion difference value is equal to the difference value of the diameter of a circular area surrounded by the fixed edges of the three expanded leaflets minus the initial leaflet edge diameter;

dividing the difference value of the valve edges before and after crimping by the quotient of the initial leaflet edge diameter multiplied by 100% to be equal to the leaflet crimping contraction ratio, wherein the difference value of the valve edges before and after crimping is equal to the diameter of a circular area surrounded by the fixed edges of the three leaflets before crimping minus the initial leaflet edge diameter;

when the leaflet crimping contraction ratio is equal to 40%, the wrinkled part is formed on the crimped leaflet;

when the valve leaf is pressed and held with the contraction ratio less than 40%, the folded part is formed on the pressed valve leaf, and a folding part is arranged on the fixed edge of each valve leaf.

As described above, the prosthetic valve and the method for manufacturing the same according to the present invention have the following advantageous effects:

in the artificial valve, the annular frame is a mesh structure which can deform in the radial direction; the wrapping layer is provided with a pleated structure which can deform in the radial direction; each valve leaf is provided with a plurality of folding parts; the prosthetic valve of the present invention can be radially expanded to accommodate patient growth; when the radial expansion ratio of the valve is 0-40%, the functionality of the artificial valve can still be ensured, the operation scheme that the artificial valve needs to be replaced again in the prior art is avoided, and the pain of a patient is relieved; when the valve radial expansion ratio is greater than or equal to 40% and less than 100%, the functionality of the prosthetic valve fails, which can act as an anchoring ring for a re-transcatheter valve replacement, i.e., the prosthetic valve provides effective radial support for a secondarily implanted transcatheter valve in the future, while also acting as a secondarily implanted transcatheter replacement valve itself.

Drawings

Fig. 1 is a perspective view of the prosthetic valve of example 1 in an initial state.

Fig. 2 is a schematic perspective view of the valve prosthesis of example 1 after expansion and with a radial expansion ratio of less than 40%.

Fig. 3 is a schematic perspective view of the valve of example 1 after expansion and when the radial expansion of the valve reaches 100%.

Fig. 4 is an exploded perspective view of the prosthetic valve of example 1 in its initial state.

Fig. 5 is a perspective view of the ring-shaped frame of the prosthetic valve of example 1 in an initial state.

Fig. 6 is a schematic perspective view of the ring-shaped frame of the prosthetic valve of example 1 after expansion and with a radial expansion ratio of the ring-shaped frame less than 40%.

Fig. 7 is a schematic perspective view of the ring-shaped frame of the prosthetic valve of example 1 after expansion and when the ring-shaped frame has been radially expanded to 100%.

Fig. 8 is a schematic structural view showing the ring-shaped frame of the prosthetic valve of example 1 in a deployed state.

Fig. 9 is a perspective view of the coating layer of the prosthetic valve of example 1 in an initial state.

Fig. 10 is a schematic perspective view of the coating layer of the prosthetic valve of example 1 after expansion and with a radial expansion ratio of the coating layer of less than 40%.

Fig. 11 is a schematic perspective view of the cover layer of the prosthetic valve of example 1 after expansion and when the cover layer expands radially to 100%.

Fig. 12 is a perspective view of the prosthetic valve of example 1 with three leaflets in their initial state.

Fig. 13 is a schematic perspective view of the prosthetic valve of example 1 after expansion of three leaflets and when the ratio of radial expansion of the leaflets is less than 40%.

Fig. 14 is a schematic view showing the structure of a leaflet of the prosthetic valve of example 1.

Fig. 15 is a schematic view showing the structure of a leaflet of the prosthetic valve of example 2.

Fig. 16 is a schematic view showing the structure of a leaflet of the prosthetic valve of example 3.

Fig. 17 is a schematic view showing the structure of a leaflet of the prosthetic valve of example 3.

Fig. 18 is a schematic structural view of a covering member of the prosthetic valve according to example 4.

Description of the reference numerals

100 valve leaflet

110 fold part

120 fixed blade

130 telescopic vane

140 pleating part

101 fixed edge

102 free edge

200 Ring frame

300 coating layer

310 cladding element

320 pleated structure

311 fixing cover

312 Telescopic cladding

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 become apparent to those skilled in the art from the present disclosure.

Please refer to the attached drawings. It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.

As shown in fig. 1 to 14, the prosthetic valve of the present embodiment includes: a support member and threeleaflets 100;

the support member includes: aring frame 200 and acover 300;

theannular frame 200 is a net structure and can deform radially;

thecovering layer 300 is arranged on the inner surface of thering frame 200, and thecovering layer 300 is in apleated structure 320 and can be radially deformed;

threeleaflets 100 are disposed inside the support member, eachleaflet 100 is provided with a plurality offolds 110, all folds 110 are stretched with radial deformation of the support member, the edge of eachleaflet 100 comprises a fixededge 101 and afree edge 102, the fixededge 101 is connected with the support member.

Theannular frame 200, thecoating 300, and the threeleaflets 100 expand and contract in equal proportion.

The valve radial expansion ratio of the artificial valve is 0-100%; the valve expansion difference divided by the initial valve maximum diameter multiplied by 100% equals the valve radial expansion ratio; the maximum diameter of the initial valve is the outer diameter of the artificial valve in an initial state after being assembled; the valve expansion difference is the difference of the outer diameter of the expanded artificial valve minus the maximum diameter of the initial valve;

when the valve radial expansion ratio of the artificial valve is 0-40%, the artificial valve can realize normal working function.

The artificial valve is suitable for surgical implantation, the heart of a patient is opened through surgical operation and is implanted, and surgical suture is fixed at the position of the native valve ring of the pulmonary artery or above the native valve ring, so that the reverse flow of the pulmonary artery is effectively prevented.

In the prosthetic valve of the present invention, theannular frame 200 is a radially deformable mesh structure; thewrapping layer 300 is provided with apleated structure 320 which can deform radially; eachleaflet 100 is provided with a plurality offolds 110; the prosthetic valve of the present invention can be radially expanded to accommodate patient growth; because the maximum working diameter of the artificial valve is 140% of the maximum diameter of the initial valve, when the radial expansion ratio of the valve is 0-40%, the functionality of the artificial valve can be ensured, the operation scheme that the artificial valve needs to be replaced again in the prior art is avoided, and the pain of a patient is relieved; the functionality of the prosthetic valve fails when the valve radial expansion ratio is equal to or greater than 40% and equal to or less than 100%, which can act as an anchoring ring for a second transcatheter valve replacement procedure, i.e. the prosthetic valve provides effective radial support for a second, implanted transcatheter valve in the future, while also acting as a second, implanted transcatheter replacement valve itself. The artificial valve of the invention can also be combined with a pipeline to be used as a novel pipeline with valves.

The outer surface of thering frame 200 is provided with thecoating layer 300. The inner and outer surfaces of thering frame 200 are provided with the structure of thecoating layer 300, so that the structure of the supporting member is more stable.

Thecladding 300 is a complete structure or thecladding 300 comprises a plurality ofcladding elements 310 connected in sequence; in this embodiment, the covering 300 comprises a plurality of coveringelements 310 connected in sequence, and the entirety of each coveringelement 310 is apleated structure 320 capable of being folded into a wave shape. The structure is convenient to process and stretch.

In this embodiment, the twocoating layers 300 are divided into aninner coating layer 300 and anouter coating layer 300, theinner coating layer 300 is tightly attached to the inner side of thering frame 200, and theouter coating layer 300 is tightly attached to the outer layer of thering frame 200. Thecoating layer 300 is a closed circular ring formed by a plurality of waves, thecoating layer 300 can be radially expanded and deformed, and the wavypleated structure 320 gradually changes into a circular arc structure in the process of expanding thecoating layer 300. Thecoating layer 300 at the inner layer and thecoating layer 300 at the outer layer are connected with thering frame 200 by sewing threads, and the fixing feature is that thecoating layer 300 is fixed in a wave shape.

The radial expansion ratio of thecoating layer 300 is 0-100%, and the product of the difference between the outer diameter of the expandedcoating layer 300 minus the outer diameter of theinitial coating layer 300 divided by the outer diameter of theinitial coating layer 300 multiplied by 100% is equal to the radial expansion ratio of thecoating layer 300. The outer diameter of theinitial coating layer 300 is the outer diameter of thecoating layer 300 in its initial state after assembly of the prosthetic valve.

When the radial expansion ratio of thecoating layer 300 is 100%, all thepleated structures 320 are completely straightened, and thecoating layer 300 takes the shape of a circular arc.

The undulatingpleated structure 320 is such that upon expansion, the plurality of undulating structures gradually straightens out from a crimped state, with the amplitude of the undulating structures decreasing as the valve radially expands in diameter.

The material of thecoating layer 300 can be selected from polyester, polytetrafluoroethylene and other high polymer materials and animal pericardial tissues such as pig, cattle, horse, sheep and the like.

The mesh structure of thering frame 200 is provided with rhombic meshes, the rhombic meshes are arranged in more than two rows, and the number of the rhombic meshes is increased from top to bottom. Theannular frame 200 is expanded by the expansion deformation of all the diamond-shaped meshes. The expansion characteristic of theannular frame 200 is that the mesh at the bottom layer is radially expanded firstly, and when the radial expansion ratio of theannular frame 200 is 0-40%, the diamond mesh at the top layer cannot be expanded; when the equal radial expansion reaches the maximum, all the diamond meshes are expanded.

In this embodiment, the rhombic cells are arranged in three rows, and the number of the rhombic cells is increased from top to bottom in sequence to form a three-row step-shaped closed circular ring structure.

The radial expansion ratio of thering frame 200 is 0-100%, and the product of the difference between the outer diameter of thering frame 200 after expansion minus the outer diameter of thering frame 200 in the initial state divided by the outer diameter of thering frame 200 in the initial state multiplied by 100% is equal to the radial expansion ratio of thering frame 200. The outer diameter of thering frame 200 in the initial state is the outer diameter of thering frame 200 in the initial state after the assembly of the prosthetic valve.

The material of thering frame 200 may be selected from cold-processed nickel titanium, stainless steel, and other metal materials.

Eachleaflet 100 has the same shape and size, the functionality of the artificial valve is that the artificial valve can realize normal working function, and the functionality of the artificial valve means that theleaflet 100 automatically opens and closes in the contraction and relaxation process of the heart, namely, the complete opening and closing is realized under the action of blood flow.

The fixededge 101 of eachleaflet 100 is attached to the support member by a suture. The fixededge 101 of theleaflet 100 is fixed to thecovering layer 300 in the inner layer by a suture alone, or the fixededge 101 of theleaflet 100 is fixed to the support member by a suture through thecovering layer 300 in the inner layer.

When the radial expansion ratio of thevalve leaflets 100 of the artificial valve is 0-40%, the functionality of the artificial valve is satisfied, and within the range of the radial expansion ratio, the threevalve leaflets 100 can be completely closed, and blood flow cannot pass through the middle of thevalve leaflets 100. Theleaflet 100 differential expansion divided by theinitial leaflet 100edge diameter times 100% equals theleaflet 100 radial expansion ratio; when the radial expansion ratio of thevalve leaflet 100 of the artificial valve is more than or equal to 40%, the functionality of the artificial valve fails.

The difference of the expansion of theleaflets 100 is equal to the difference of the diameter of the circular area enclosed by the fixededges 101 of the threeleaflets 100 after expansion minus the diameter of the edge of theinitial leaflet 100,

the diameter of the edge of theinitial valve leaflet 100 is the diameter of a circular area surrounded by the fixededges 101 of the threevalve leaflets 100 in the initial state after the artificial valve is assembled. When manufacturing aleaflet 100 having aninitial leaflet 100 with an edge diameter of 12mm, all thefolds 110 are provided on theleaflet 100 extending to the fixededge 101 and thefree edge 102. The expansion of thefolding part 110 needs to meet the requirement that when the radial expansion ratio of thevalve leaflet 100 of the artificial valve reaches 40%, the artificial valve can realize the normal working function.

In the initial state of theleaflet 100, thefree edge 102 of theleaflet 100 is curved and the center of the threeclosed leaflets 100 is in the shape of a small vortex. When thevalve leaflets 100 of the artificial valve are expanded to the maximum size capable of realizing the normal working function of the artificial valve and threevalve leaflets 100 are in the opening state, thefree edges 102 of thevalve leaflets 100 are straightened.

In this embodiment, all thefolds 110 are provided on theleaflet 100 extending to the fixededge 101 and thefree edge 102. All of thefolds 110 form a wave-shaped structure, and the wave-shaped structure of theleaflet 100 is expanded when theleaflet 100 is expanded. The structure is convenient to process and use.

Theleaflet 100 material may be pericardial tissue of animals such as pig, cattle, horse, sheep, etc.

The invention also relates to a manufacturing method of the artificial valve, the support component is assembled after being connected with the threevalve leaflets 100, and the outer diameter of the artificial valve is the maximum diameter of the original valve.

Example 2

As shown in fig. 15, the present embodiment is different from embodiment 1 in that each of theleaflets 100 includes a fixedlobe 120 and atelescopic lobe 130 connected in series, and all of thefolds 110 extend to the fixededge 101 and thefree edge 102 of thetelescopic lobe 130. All of thecorrugations 110 form a wave-shaped structure. The fixedlobe 120 and thetelescopic lobe 130 are connected by a suture. This configuration can facilitate the placement ofleaflets 100 with various expansion ratios.

Example 3

As shown in fig. 16 and 17, the present embodiment is different from embodiment 1 in that each of thewrinkles 110 extends to thefree edge 102 of theleaflet 100.

In the manufacturing method of the artificial valve of the embodiment, after the supporting component is connected with the threevalve leaflets 100, the artificial valve is crimped by using a crimping machine, the crimped artificial valve is assembled, and the outer diameter of the crimped artificial valve is the maximum diameter of the initial valve;

when the radial expansion ratio of thevalve leaflet 100 of the artificial valve is 0-40%, thevalve leaflet 100 of the artificial valve can realize normal working function;

theleaflet 100 differential expansion divided by theinitial leaflet 100edge diameter times 100% equals theleaflet 100 radial expansion ratio;

the diameter of the edge of theinitial valve leaflet 100 is the diameter of a circular area surrounded by the fixed edges of the threevalve leaflets 100 after the artificial valve is assembled; the difference of the expansion of thevalve leaflet 100 is equal to the difference of the diameter of a circular area surrounded by the fixed edges of thevalve leaflet 100 after expansion minus the diameter of theinitial valve leaflet 100 edge;

the quotient of the difference value of the valve edges before and after crimping divided by the diameter of theinitial valve leaflet 100 edge is multiplied by 100% and equals to the ratio of the crimping contraction of thevalve leaflet 100, and the difference value of the valve edges before and after crimping equals to the diameter of a circular area enclosed by the fixed edges of the threevalve leaflets 100 before crimping minus the diameter of theinitial valve leaflet 100 edge;

when theleaflet 100 is crimped to a contraction ratio equal to 40%, the crimpedleaflet 100 has thecorrugated part 110 formed thereon; as shown in FIG. 16; namely: when manufacturing a valve leaflet with the edge diameter of theinitial valve leaflet 100 being 12mm, the diameter of a circular area surrounded by the fixed edges of the threevalve leaflets 100 before being crimped is 16.8mm, namely the crimping contraction ratio is equal to 40%, so that the normal working function of the artificial valve can be realized; so that the fixededge 101 of theleaflet 100 does not need to reserve thepleated portion 140, and the fixededge 101 of theleaflet 100 can be completely arc-sutured;

when the pinch contraction ratio of theleaflet 100 is less than 40%, the crimpedleaflet 100 forms thefolding part 110 thereon, and a fixingedge 101 of eachleaflet 100 is provided with afolding part 140, as shown in fig. 17, that is: when manufacturing a leaflet having aninitial leaflet 100 with an edge diameter of 12mm, a circular area surrounded by the fixed edges of the threeleaflets 100 before crimping has a diameter of 15mm, that is, a crimping contraction ratio of less than 40%, and thepleating part 140 corresponds to an expansion range required for compensating for the thickness of the leaflet between 15mm and 16.8 mm.

Example 4

The present embodiment is different from embodiment 1 in that each of thepacking elements 310 includes a fixedpacking 311 and atelescopic packing 312 connected in sequence, and thetelescopic packing 312 is provided with apleated structure 320 capable of being folded into a wave shape, as shown in fig. 18. Thestationary cover 311 and thetelescopic cover 312 are connected by a suture. This configuration can facilitate the placement ofcover member 310 with a variety of expansion ratios.

In conclusion, the present invention effectively overcomes various disadvantages of the prior art and has high industrial utilization value.

The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (10)

1. A prosthetic valve, comprising: a support member and three leaflets (100);

the support member includes: an annular frame (200) and a cladding (300);

the annular frame (200) is of a net structure and can deform in the radial direction;

the coating (300) is arranged on the inner surface of the annular frame (200), and a pleated structure (320) is arranged on the coating (300) and can be radially deformed;

the three valve leaflets (100) are arranged inside the support component, a plurality of fold parts (110) are arranged on each valve leaflet (100), all the fold parts (110) stretch along with the radial deformation of the support component, the edge of each valve leaflet (100) comprises a fixed edge (101) and a free edge (102) which are connected, and the fixed edge (101) is connected with the support component.

2. The prosthetic valve of claim 1, wherein:

the valve radial expansion ratio of the artificial valve is 0-100%; the valve expansion difference divided by the initial valve maximum diameter multiplied by 100% equals the valve radial expansion ratio; the maximum diameter of the initial valve is the outer diameter of the artificial valve in an initial state after being assembled; the valve expansion difference is the difference of the outer diameter of the expanded artificial valve minus the maximum diameter of the initial valve; when the valve radial expansion ratio of the artificial valve is 0-40%, the artificial valve can realize normal working function.

3. The prosthetic valve of claim 2, wherein: all the folds (110) are arranged on the leaflet (100) extending to the fixed edge (101) and the free edge (102).

4. The prosthetic valve of claim 2, wherein: each leaflet (100) comprises a fixed leaflet (120) and a telescopic leaflet (130) connected in series, all the folds (110) extending onto the fixed edge (101) and the free edge (102) of the telescopic leaflet (130).

5. The prosthetic valve of claim 2, wherein: each of the folds (110) extends onto a free edge (102) of the leaflet (100).

6. The prosthetic valve of claim 1, wherein: the cladding (300) comprises a plurality of cladding elements (310) connected in series;

the entirety of each packing element (310) is of a pleated structure (320) which can be folded into a wave shape; or each wrapping element (310) comprises a fixed wrapping piece (311) and an expansion wrapping piece (312) which are connected in sequence, and a pleated structure (320) capable of being folded into a wave shape is arranged on the expansion wrapping piece (312).

7. The prosthetic valve of claim 1, wherein: the outer surface of the annular frame (200) is provided with the coating layer (300).

8. The prosthetic valve of claim 1, wherein: the net structure of the annular frame (200) is provided with rhombic meshes, the rhombic meshes are arranged in more than two rows, and the number of the rhombic meshes is increased from top to bottom in sequence.

9. A method of manufacturing a prosthetic valve as claimed in claim 3 or 4, wherein: after the support component is connected with the three valve leaflets (100), the artificial valve is assembled, and the outer diameter of the artificial valve is the maximum diameter of the initial valve.

10. A method of manufacturing a prosthetic valve according to any one of claims 5, wherein: after the supporting component is connected with the three valve leaflets (100), the artificial valve is crimped by using a crimping machine, the crimped artificial valve is assembled, and the outer diameter of the crimped artificial valve is the maximum diameter of the initial valve;

when the radial expansion ratio of the valve leaflet (100) of the artificial valve is 0-40%, the valve leaflet (100) of the artificial valve can realize normal working function;

the leaflet (100) expansion difference divided by the initial leaflet (100) edge diameter multiplied by 100% equals the leaflet (100) radial expansion ratio;

the diameter of the edge of the initial valve leaflet (100) is the diameter of a circular area surrounded by the fixed edges of the three valve leaflets (100) after the artificial valve is assembled; the leaflet (100) expansion difference value is equal to the difference value of the diameter of a circular area surrounded by the fixed edges of the three expanded leaflets (100) minus the diameter of the edge of the initial leaflet (100);

the quotient of the difference value of the valve edges before and after crimping divided by the diameter of the initial valve leaflet (100) edge is multiplied by 100% and equals to the ratio of the crimping contraction of the valve leaflet (100), and the difference value of the valve edges before and after crimping equals to the diameter of a circular area surrounded by the fixed edges of the three valve leaflets (100) before crimping minus the diameter of the initial valve leaflet (100) edge;

when the leaflet (100) is crimped and contracted by 40%, the crimped leaflet (100) is provided with the folded part (110);

when the valve leaflet (100) is pressed and held with the contraction ratio less than 40 percent, the folded part (110) is formed on the pressed valve leaflet (100), and a folding part (140) is arranged on the fixed edge (101) of each valve leaflet (100).

Images