Artificial heart valve

Abstract

The application is a divisional application, and the application number of the original application is 2022105409207. The invention relates to an artificial heart valve which comprises a valve support, a first sealing film, a second sealing film and a valve leaf.The first sealing film is attached to the outer side of the valve support, can make contact with blood, gradually absorbs liquid and expands along with prolonging of the implantation time of the valve support and is used for reducing perivalvular leakage; the second sealing film is arranged on the outer side of the first sealing film, and after the first sealing film absorbs liquid and expands, the second sealing film can also expand to a certain degree and is used for increasing the friction force between the second sealing film and the native valve leaflet; the valve leaflet is arranged in the valve support and used for controlling one-way flow of blood. The first sealing film and the second sealing film are arranged, so that the artificial heart valve can be better matched with a native tissue after being implanted, and perivalvular leakage is effectively prevented.

Description

[0001] This application is a divisional application, the original application date is May 17, 2022, the original application number is 2022105409207, The invention name is: A kind of artificial heart valve. TECHNICAL FIELD

[0002] The present application relates to the field of medical devices for cardiac surgery, in particular to an artificial heart valve. BACKGROUND

[0003] The heart comprises four pumping chambers, the left and right atria and the left and right ventricles, each of which has a valve that controls its one-way outflow. The mitral valve is located between the left atrium and the left ventricle, and when the ventricle contracts, the mitral valve tightly closes the atrioventricular orifice to prevent blood from flowing back into the left atrium. The tricuspid valve is located between the right atrium and the right ventricle, and when the right ventricle contracts, it squeezes the blood in the chamber to impact the tricuspid valve to close it, preventing blood from flowing back into the right atrium. The valve located between the left ventricle and the aorta is the aortic valve, which functions to open during ventricular systole to allow blood to flow into the aorta, and to close during diastole to prevent aortic blood from flowing back into the left ventricle.

[0004] A properly functioning mitral, tricuspid or aortic valve ensures correct blood circulation during the cardiac cycle, but when the leaflets of the valve cannot achieve complete contact (coaptation) due to disease, aortic regurgitation (AR), mitral regurgitation (MR) or tricuspid regurgitation (TR) occurs. On the other hand, abnormal heart structure can also be the cause of regurgitation, and the two processes can accelerate abnormal heart function due to "synergy".

[0005] Currently, standard heart valve regurgitation treatment usually requires surgical intervention, and standard surgical repair or replacement requires thoracotomy, use of cardiopulmonary bypass, and cardiac arrest. Due to the invasive nature of these surgical procedures, death, stroke, bleeding, respiratory problems, kidney problems, and other complications are common, so patients often refuse or are judged to be unsuitable for traditional open surgery due to high risk.

[0006] In recent years, the success of aortic valve replacement has spurred the exploration of transcatheter mitral / tricuspid valve replacement for the treatment of regurgitation. SUMMARY

[0007] The present application discloses an artificial heart valve, which aims to solve the technical problems existing in the prior art.

[0008] The present application adopts the following technical scheme:

[0009] An artificial heart valve comprises:

[0010] - a valve stent;

[0011] - a first sealing membrane, the first sealing membrane is attached to the outer side of the valve stent, the first sealing membrane can be in contact with blood and gradually absorbs liquid to expand with the extension of the implantation time of the valve stent, for reducing paravalvular leakage;

[0012] - a second sealing membrane, the second sealing membrane is arranged on the outer side of the first sealing membrane, after the first sealing membrane absorbs liquid to expand, the second sealing membrane can also expand with the expansion of the first sealing membrane, for increasing the friction force with the native leaflet;

[0013] - a leaflet, the leaflet is arranged inside the valve stent, for controlling the unidirectional flow of blood.

[0014] As a preferred technical solution, the valve stent is cylindrical and can be radially expanded and compressed, and is provided with an inflow section and an outflow section, both of which include a plurality of polygonal mesh structures connected to each other.

[0015] As a preferred technical solution, the adjacent polygonal mesh structures are connected through elastic wave rods or nodes, and the polygonal mesh is configured as a rhombus, a pentagon, a hexagon or other units that can form a closed shape.

[0016] As a preferred technical solution, the inflow section is configured to have denser mesh structure than the outflow section.

[0017] As a preferred technical solution, the valve stent is configured as a self-expanding stent, a balloon-expandable stent or a mechanically-expandable stent.

[0018] As a preferred technical solution, the lower edge of the first sealing membrane is sewn to the lower edge on the outer side of the inflow section, and the shape of the lower edge of the first sealing membrane matches the shape of the lower edge of the inflow section; the upper edge of the first sealing membrane is folded inward from the upper edge of the inflow section and is sewn to the upper part on the inner side of the inflow section.

[0019] As a preferred technical solution, the first sealing membrane covers the upper edge of the inflow section, and the first sealing membrane covering the upper edge of the inflow section is in a cylindrical shape.

[0020] As a preferred technical solution, the upper edge of the first sealing membrane is folded inward in a circular arc shape, and an annular cavity is formed between the folded area of the first sealing membrane and the upper edge of the inflow section.

[0021] As a preferred technical solution, an elastic membrane material, a sponge-like material with biocompatibility or a fiber assembly is arranged in the annular cavity.

[0022] As a preferred technical solution, the thickness of the first sealing membrane is 0.3-1mm; and the length of the upper edge of the first sealing membrane folded inward is 4-6mm.

[0023] As a preferred technical solution, the second sealing film covers at least the whole area corresponding to the outer surface of the inflow section.

[0024] As a preferred technical solution, the lower edge of the second sealing film matches the shape of the first sealing film and / or the lower edge of the inflow section.

[0025] As a preferred technical solution, the first sealing film comprises a hydrophilic swelling material which can swell after contacting with blood.

[0026] As a preferred technical solution, the second sealing film comprises a biocompatible fabric which allows blood to permeate.

[0027] The technical solution adopted by the present application can achieve the following beneficial effects:

[0028] (1) The present application provides an artificial heart valve. In a preferred technical solution of the present application, a first sealing film is sewn on the outer side of the inflow section of the valve support, and a second sealing film is further sewn on the outside of the first sealing film. The upper edge of the first sealing film is higher than the inflow section and is inwardly folded to form a generally cylindrical structure. The first sealing film is preferably a hydrophilic swelling material, and the second sealing film allows blood to permeate. After the artificial heart valve is implanted into the native tissue, the first sealing film has excellent water permeation prevention performance on one hand, which can prevent blood from permeating out of the valve and effectively prevent paravalvular leakage. On the other hand, as the time of implanting the artificial heart valve into the human body prolongs, the first sealing film can gradually increase the gap between the artificial heart valve and the surrounding native tissue by using its swelling property, thereby further preventing paravalvular leakage. In addition, after the first sealing film swells by absorbing liquid, the second sealing film can also expand to some extent with the swelling of the first sealing film, so as to further increase the friction force between the second sealing film and the native leaflet.

[0029] (2) In a preferred solution, the outwardly folded part of the first sealing film is in the shape of a circular arc, and there is an annular cavity between the first sealing film and the valve support. An elastic material, a sponge-like material or a fiber composite is arranged in the annular cavity, so that the folded area of the first sealing film can collapse or recover. During the process of transporting the valve support, the cavity collapses to ensure smooth transportation, and after the valve support is released, the cavity expands to increase the volume of the folded area, so that the inflow section can better fit the native annulus, thereby enhancing the fixation effect. BRIEF DESCRIPTION OF DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required to be used in the embodiment description will be briefly introduced as follows, which constitutes a part of the present application. The schematic embodiments of the present application and the description and explanation thereof do not constitute an improper limitation on the present application. In the drawings:

[0031] Figure 1A structure diagram of the valve support in a preferred embodiment disclosed in Embodiment 1 of the present application;

[0032] Figure 2 A structure diagram of the artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present application;

[0033] Figure 3 A perspective view of the artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present application;

[0034] Figure 4 A bottom view of the artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present application;

[0035] Figure 5 A sectional view of the artificial heart valve in a preferred embodiment disclosed in Embodiment 2 of the present application.

[0036] Explanation of reference numerals:

[0037] Valve support 1, inflow section 11, outflow section 12, first sealing membrane 2, second sealing membrane 3, valve leaflet 4, annular cavity 5. DETAILED DESCRIPTION

[0038] In order to make the objectives, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be described below in conjunction with specific embodiments of the present application and corresponding drawings. In the description of the present application, it should be noted that the term “or” is generally used in the sense of including “and / or”, unless the context clearly indicates otherwise.

[0039] In the description of the present application, it should be noted that, unless otherwise explicitly specified and limited, the terms “mounting”, “connection”, “connecting” should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integrally connected; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. In addition, in the description of the present application, the terms “first”, “second” and the like are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0040] Obviously, the described embodiments are only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without making creative efforts fall within the scope of protection of the present application.

[0041] To solve the problems in the prior art, the embodiment of the present application provides an artificial heart valve, and the main structure comprises a valve support, a first sealing film, a second sealing film and a valve leaflet; the first sealing film is attached to the outer side of the valve support, the first sealing film can be in contact with blood and gradually absorbs liquid and expands with the extension of the implantation time of the valve support, so as to reduce paravalvular leakage; the second sealing film is arranged on the outer side of the first sealing film, and after the first sealing film absorbs liquid and expands, the second sealing film can also expand to a certain extent, so as to increase the friction between the second sealing film and the native valve leaflet; the valve leaflet is arranged inside the valve support and is used for controlling the one-way flow of blood.

[0042] Example 1

[0043] The artificial heart valve provided in the embodiment can be used in a native tissue, preferably, the artificial heart valve provided in the embodiment 1 is used to solve the technical problems in the prior art. Figures 1-4 The artificial heart valve comprises a valve support 1, a first sealing film 2, a second sealing film 3 and a valve leaflet 4.

[0044] Reference Figure 1 Optionally, the valve support 1 is a self-expanding stent, a balloon-expandable stent or a mechanical-expandable stent, preferably, the valve support 1 is a self-expanding stent; in a preferred embodiment, the valve support 1 is made of metal or high polymer material, such as nickel-titanium alloy memory material or other memory high polymer material or alloy, in the embodiment, the nickel-titanium alloy memory material and the like are processed to form a plurality of polygonal grid structures connected to each other; optionally, the processing mode comprises but is not limited to braiding, laser cutting, welding, rivet connection, threaded connection and the like.

[0045] In a more preferred embodiment, the valve support 1 is a balloon-expandable stent; the valve support 1 is made of medical stainless steel and cobalt-chromium alloy and the like, and a plurality of polygonal grid structures connected to each other are formed by processing in the modes of braiding, welding, rivet connection, threaded connection and the like.

[0046] Preferably, the main body profile of the valve support 1 is in a cylindrical structure or a similar cylindrical structure, and correspondingly, the main body of the valve support 1 can be radially expanded and compressed, so as to ensure that it is in a compressed state when being transported in a blood vessel, and is opened by self-expansion or balloon expansion after reaching the native valve annulus.

[0047] Preferably, the valve stent 1 comprises an inflow section 11 and an outflow section 12, the outflow section 12 is downstream of the inflow section 11 according to the direction of blood flow, the inflow section 11 corresponds to the part of the blood flow into the valve stent 1 after the artificial heart valve is implanted, and the outflow section 12 corresponds to the part of the blood flow out of the valve stent 1 after the artificial heart valve is implanted. Those skilled in the art should understand that when the valve stent 1 is a self-expanding stent, the inflow section 11 has a higher elastic coefficient than the outflow section 12, and can at least elastically deform in the radial and axial directions after being implanted in the native tissue to adapt to the changes in the native valve annulus shape; if the valve stent 1 is a balloon-expandable stent, the process of expanding and opening is plastic deformation, and neither the inflow section 11 nor the outflow section 12 elastically shrinks.

[0048] In a preferred embodiment, the inflow section 11 and the outflow section 12 of the valve stent 1 each comprise a plurality of polygonal mesh structures connected to each other, adjacent mesh structures are connected by wave rods or nodes with a certain elasticity, wherein the polygonal mesh is preferably a rhombus, and can also be a pentagon, a hexagon, or other units that can form a closed shape; in a preferred embodiment, the inflow section 11 has a denser mesh structure than the outflow section 12 to provide more directional elastic deformation, such as axial elastic deformation, radial elastic deformation, and transverse elastic deformation; and the outflow section 12 can provide stronger deformation resistance to prevent the valve stent 1 from shifting during the cardiac cycle.

[0049] Preferably, the mesh structures at the free ends of the inflow section 11 and the outflow section 12 are continuously and completely distributed in the circumferential direction, so as not to affect the radial support force and avoid the undesired shifting of the valve stent 1 after being implanted in the mitral valve.

[0050] As Figures 2-4 In a preferred embodiment, the first sealing membrane 2 is attached to the outer side of the valve stent 1, and the first sealing membrane 2 is sutured to the valve stent 1; the valve leaflets 4 are sutured to the inner side of the valve stent 1 to control the one-way flow of blood; and the second sealing membrane 3 is sutured to the outer surface of the first sealing membrane 2.

[0051] Preferably, a plurality of valve leaflets 4 are sutured to the frame struts of the valve stent 1, and the plurality of valve leaflets 4 are completely wrapped in the first sealing membrane 2, and when the valve leaflets 4 are closed, the backflow of blood is completely restricted in the space formed by the first sealing membrane 2, the second sealing membrane 3, and the closed valve leaflets 4.

[0052] Preferably, the lower edge of the first sealing membrane 2 is sutured to the lower edge of the outer side of the inflow section 11, and since the lower edge of the inflow section 11 is composed of the edges of the mesh structure, it is generally in a continuous wave shape or a zigzag shape and surrounds a ring. In order to better adapt the first sealing membrane 2 to the inflow section 11, the lower edge of the first sealing membrane 2 is the same shape as the lower edge of the inflow section 11, that is, in a continuous wave shape or a zigzag shape.

[0053] Preferably, the upper edge of the first sealing film 2 covers the upper edge of the inflow section 11, and the length protrudes above the valve stent 1, the protruding part is folded inward along the inflow section 11 of the valve stent 1, and is sutured to the upper part inside the inflow section 11, as shown in Figures 3-4 ; Preferably, since the upper edge of the inflow section 11 is composed of the edge of the mesh structure, it is in a continuous wavy or zigzag shape, when the first sealing film 2 is folded inward, it no longer completely matches the shape of the upper edge of the inflow section 11, but is directly folded inward in a cylindrical shape, that is, the upper edge after folding is in a continuous circular ring shape. In particular, after folding inward, the first sealing film 2 makes the suture of the upper edge of the first sealing film 2 to the valve stent 1 more secure, and at the same time, due to the increased thickness of the folding area, the part can better fit the native annulus, not only better positioning the native tissue, but also further preventing paravalvular leakage.

[0054] In particular, for different patients, the size of the inward folding of the first sealing film 2 can be adaptively changed according to the patient's condition. Preferably, the thickness of the first sealing film 2 is 0.3-1mm, and the length of the inward folding is 4-6mm, to ensure that the folding area can be clamped on the native annulus to prevent paravalvular leakage.

[0055] In a preferred embodiment, the first sealing film 2 is made of a biocompatible hydrophilic swelling material, which requires swelling after contact with blood to make the artificial heart valve better fit the native tissue.

[0056] Preferably, the first sealing film 2 is made of a biological hydrogel material, which is a kind of three-dimensional network structure gel with extremely high water affinity. It quickly swells in water and can hold a large volume of water without dissolving in this swollen state. By controlling the production process, the biological hydrogel can be expanded by 2-3 times; With the extension of the time of implanting the valve stent 1 into the human body, on the one hand, the biological hydrogel uses its liquid absorption and swelling properties, and the cylindrical structure formed by the first sealing film 2 at the folding place of the upper edge of the valve stent 1 can gradually fill the gap between the valve stent 1 and the native tissue, preventing paravalvular leakage; On the other hand, given the excellent water permeability of biological hydrogel, it can effectively prevent blood from penetrating out of the artificial heart valve, further preventing paravalvular leakage; In other aspects, due to the softness of biological hydrogel, it can act as a buffer layer to prevent native leaflets from tearing and damaging.

[0057] Reference Figures 2-3Preferably, the second sealing film 3 is sutured to the outer surface of the first sealing film 2; the second sealing film 3 covers at least the entire area corresponding to the outer surface of the inflow section 11 of the valve stent 1; preferably, the lower edge of the second sealing film 3 is in the same shape as the lower edge of the inflow section 11, and is in a continuous wavy or zigzag shape; and the upper edge of the second sealing film 3 is in a cylindrical shape.

[0058] Preferably, the second sealing film 3 is made of a biocompatible fabric, and has a certain elasticity. The biocompatible fabric is preferably, but not limited to, any one or a combination of at least two of PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), e-PTFE or PU (polyurethane). The second sealing film 3 not only increases the friction between the valve stent 1 and the native leaflet after the valve stent 1 is implanted, to enhance the fixation effect, but also expands to a certain extent when the first sealing film 2 swells after absorbing liquid.

[0059] In the present embodiment, it should be noted that, when the first sealing film 2, the second sealing film 3 and the leaflet 4 are sutured, the sutures are all connected and fixed to the frame struts of the valve stent 1, rather than other structures.

[0060] Preferably, the valve stent 1 further has a plurality of visualization points. After the artificial heart valve is implanted in the human body, the doctor usually needs to determine whether the implantation position is accurate by the visualization points provided on the implanted valve stent 1. Moreover, since the heart valve is a three-dimensional structure, it is usually necessary to determine whether the spatial position is accurate, and therefore the spatial position needs to be determined by the positions of the plurality of visualization points.

[0061] In the present embodiment, when the artificial heart valve is implanted in surgery, the valve stent 1 is delivered to the annulus by a balloon catheter or a guide catheter, and is opened and released by self-expansion or balloon expansion.

[0062] Since the valve stent 1 has the second sealing film 3 on the outermost layer, it can provide greater friction and enhance the fixation effect; since the first sealing film 2 is made of a bio-hydrogel material, it gradually swells as the implantation time of the valve stent 1 is prolonged, further tightening the gap between the valve stent 1 and the native leaflet, and enhancing the fixation of the valve; and the cylindrical structure formed by the upper edge of the first sealing film 2 being folded on the valve stent 1 can further fill the gap between the valve stent 1 and the native tissue, effectively preventing paravalvular leakage, and the bio-hydrogel material has a soft texture, which can act as a buffer layer to prevent the native leaflet from being torn and damaged.

[0063] Example 2

[0064] Reference Figure 5In the present embodiment, a prosthetic heart valve is provided, which comprises a valve stent 1, a first sealing membrane 2, a second sealing membrane 3 and valve leaflets 4.

[0065] In the present embodiment, the valve stent 1 has the same structure as that of the embodiment 1, which will not be described again. Preferably, the first sealing membrane 2 is attached to the outer side of the valve stent 1; the valve leaflets 4 are sutured to the inner side of the valve stent 1; and the second sealing membrane 3 is sutured to the outer side of the first sealing membrane 2.

[0066] Preferably, the lower edge of the first sealing membrane 2 is sutured to the lower edge of the inflow section 11, the upper edge of the first sealing membrane 2 covers the upper edge of the inflow section 11, and the length protrudes beyond the valve stent 1, the protruding part is folded inward along the inflow section 11 of the valve stent 1, and covers part of the area at the upper end of the inflow section 11.

[0067] In a preferred embodiment, the first sealing membrane 2 is in a substantially circular arc or semicircular shape before passing over the top end of the valve stent 1, and covers the outer side of the upper end of the inflow section 11, that is, there is an annular cavity 5 between the folded area of the first sealing membrane 2 and the outer side of the upper end of the inflow section 11, as shown in Figure 5 .

[0068] Preferably, a flexible membrane material or a sponge-like material with biocompatibility, such as a TPU film or a chitin porous body, a collagen sponge PLGA, etc., is attached to the inner side of the annular cavity 5, so that the annular cavity 5 of the first sealing membrane 2 can collapse or recover; during the delivery of the valve stent 1, the annular cavity 5 collapses to ensure that the valve stent 1 can smoothly reach the native tissue and be released, and after the valve stent 1 expands and is fixed, the annular cavity 5 slowly recovers, and due to the existence of the cavity, the thickness / volume of the folded area is further increased, so that the inflow section 11 of the valve stent 1 is more closely attached to the native tissue.

[0069] In another preferred embodiment, the first sealing membrane 2 is in a substantially circular arc or semicircular shape before passing over the top end of the valve stent 1, and after passing over the top end of the valve stent 1 and being folded, the end of the first sealing membrane 2 is fixed to the outer side of the first sealing membrane 2 of the valve stent 1 by means of adhesion or the like, and a certain volume of fiber complex, such as diene-based elastic fiber, polyether ester elastic fiber or composite elastic fiber, etc., is filled in the annular cavity 5 formed between the two, so that the folded area of the first sealing membrane 2 can collapse or recover; those skilled in the art should understand that due to the bulkiness, elasticity and high elastic recovery rate of the fiber aggregate, the valve stent 1 can be better attached to the outer surface of the inflow section 11 during the delivery process, to ensure smooth delivery, and after the valve stent 1 is released, it can slowly expand and gradually attach to the native tissue.

[0070] In particular, the size of the annular cavity formed by the inward folding of the first sealing membrane 2 can be adapted to the patient's condition for different patients. Preferably, the width of the annular cavity 5 is 4-6 mm.

[0071] Preferably, the first sealing membrane 2 is made of a bio-hydrogel material, as described in Embodiment 1 above, which will not be repeated here.

[0072] Preferably, the second sealing membrane 3 has the same structure as described in Embodiment 1 above, which will not be repeated here.

[0073] In this embodiment 2, when the artificial heart valve is surgically implanted, the valve stent 1 is delivered through a balloon catheter or a guide catheter, at this time the valve stent 1 and the annular cavity 5 formed by the inward folding of the first sealing membrane 2 are in a collapsed state, and when it reaches the annulus, it is opened by self-expansion or balloon expansion and released, at this time the annular cavity also restores to the original volume; the expanded annular cavity 5 can be clamped above the annulus, so that the valve stent 1 can better fit the annulus, and also facilitate the better positioning of the artificial heart valve; and the second sealing membrane 3 is arranged at the outermost side of the valve stent 1, which can increase the friction between the valve stent 1 and the annulus after the valve stent 1 is implanted, to enhance the fixation effect.

[0074] Since the first sealing membrane 2 is made of a bio-hydrogel material, it gradually expands as the implantation time of the valve stent 1 is prolonged, further tightening the gap between the valve stent 1 and the native leaflet, and strengthening the fixation of the valve; and the cylindrical structure formed by the upward folding of the first sealing membrane 2 at the edge of the valve stent 1 can further fill the gap between the native tissue, effectively preventing paravalvular leakage, and the bio-hydrogel material is relatively soft, which can act as a buffer layer to prevent the native leaflet from tearing and damaging.

[0075] The embodiments of the application are described above in conjunction with the accompanying drawings, but the application is not limited to the specific embodiments described above, which are merely illustrative and not limiting, and those of ordinary skill in the art can make many forms under the inspiration of the application without departing from the purpose of the application and the scope protected by the claims.

Claims

1. An artificial heart valve, characterized in that, include: - Valve stent; - A first sealing membrane, which is attached to the outside of the valve stent, is able to come into contact with blood and gradually absorbs fluid and expands as the valve stent is implanted, in order to reduce paravalvular leakage; - A second sealing membrane is disposed on the outside of the first sealing membrane. After the first sealing membrane absorbs liquid and expands, the second sealing membrane can also expand to a certain extent as it expands, thereby increasing the frictional force between it and the original leaflet. - Leaflet, which is disposed inside the valve stent and is used to control the unidirectional flow of blood.

2. The artificial heart valve according to claim 1, characterized in that, The valve stent is cylindrical and can expand and compress radially. It is equipped with an inflow section and an outflow section, both of which include several interconnected polygonal mesh structures.

3. The artificial heart valve according to claim 2, characterized in that, Adjacent polygonal mesh structures are connected by flexible wave rods or nodes, and the polygonal meshes are configured as rhomboid, pentagonal, hexagonal or other units that can form closed shapes.

4. The artificial heart valve according to claim 2, characterized in that, The inflow section is configured to have a denser mesh structure than the outflow section.

5. The artificial heart valve according to claim 2, characterized in that, The valve stent is configured as a self-expanding stent, a balloon-expandable stent, or a mechanically expandable stent.

6. The artificial heart valve according to claim 2, characterized in that, The lower edge of the first sealing film is sewn to the lower edge of the outside of the inflow section, and the shape of the lower edge of the first sealing film matches the lower edge of the inflow section; the upper edge of the first sealing film is folded inward from the upper edge of the inflow section and sewn to the upper part of the inside of the inflow section.

7. The artificial heart valve according to claim 6, characterized in that, The first sealing film covers the upper edge of the inflow section, and the first sealing film covering the upper edge of the inflow section is cylindrical.

8. The artificial heart valve according to claim 6, characterized in that, The upper edge of the first sealing film is folded inward in an arc shape, and an annular cavity is formed between the folded area of ​​the first sealing film and the upper edge of the inflow section.

9. The artificial heart valve according to claim 8, characterized in that, The annular cavity is provided with an elastic membrane material, a biocompatible sponge material, or a fiber aggregate.

10. The artificial heart valve according to claim 6, characterized in that, The thickness of the first sealing film is 0.3-1mm; the length of the upper edge of the first sealing film folded inward is 4-6mm.

11. The artificial heart valve according to claim 2, characterized in that, The second sealing membrane covers at least the entire area corresponding to the outer surface of the inflow section.

12. The artificial heart valve according to claim 11, characterized in that, The lower edge of the second sealing film matches the shape of the first sealing film and / or the lower edge of the inflow section.

13. The artificial heart valve according to claim 1, characterized in that, The first sealing membrane includes a hydrophilic swelling material, which can absorb liquid and swell upon contact with blood.

14. The artificial heart valve according to claim 1, characterized in that, The second sealing membrane includes a biocompatible fabric that allows blood to pass through.

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