A prosthetic heart valve

Abstract

The application is a divisional application of the original application with the application number 2022105409207. The present application relates to an artificial heart valve, which comprises a valve support, a first sealing membrane, a second sealing membrane and a valve leaflet. The first sealing membrane is attached to the outer side of the valve support and can contact blood and gradually absorb liquid and expand with the extension of the implantation time of the valve support, thereby reducing paravalvular leakage. The second sealing membrane is arranged on the outer side of the first sealing membrane and can also expand to some extent after the first sealing membrane absorbs liquid and expands, thereby increasing the friction between the second sealing membrane and the native valve leaflet. The valve leaflet is arranged inside the valve support and is used to control the one-way flow of blood. The present application sets the first sealing membrane and the second sealing membrane, so that the artificial heart valve can better match the native tissue after implantation, thereby effectively preventing the occurrence of paravalvular leakage.

Description

[0001] This application is a divisional application. The original application was filed on May 17, 2022, with application number 2022105409207. The invention is titled: An artificial heart valve. Technical Field

[0002] This invention relates to the field of medical devices for cardiac surgery, and more particularly to an artificial heart valve. Background Technology

[0003] The heart consists of four chambers: the left and right atria, and the left and right ventricles. Each chamber has valves that control the flow of blood in one direction. The mitral valve is located between the left atrium and left ventricle. During ventricular systole, the mitral valve tightly closes the atrioventricular orifice, preventing blood from flowing back into the left atrium. The tricuspid valve is located between the right atrium and right ventricle. When the right ventricle systole, the pressure of blood within the ventricle forces the tricuspid valve to close, preventing blood from flowing back into the right atrium. The aortic valve is located between the left ventricle and the aorta. Its function is to open during ventricular systole to allow blood to flow into the aorta and close during diastole to prevent blood from flowing back into the left ventricle.

[0004] A properly functioning mitral, tricuspid, or aortic valve ensures proper blood circulation during the cardiac cycle. However, when the valve leaflets fail to make complete contact (engagement) due to disease, aortic regurgitation (AR), mitral regurgitation (MR), or tricuspid regurgitation (TR) occurs. On the other hand, abnormal cardiac structures can also cause regurgitation, and these two processes can work synergistically to accelerate abnormal cardiac function.

[0005] Currently, standard treatment for valvular regurgitation usually requires surgical intervention. Standard surgical repair or replacement procedures involve open-heart surgery, cardiopulmonary bypass, and cardiac arrest. Due to the invasive nature of these surgeries, death, stroke, bleeding, respiratory problems, kidney problems, and other complications are common. Therefore, patients often refuse or are deemed unsuitable for traditional open surgery due to the high risks.

[0006] In recent years, the successful advancement of aortic valve replacement surgery has spurred exploration into the treatment of regurgitation via transcatheter mitral / tricuspid valve replacement. Summary of the Invention

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

[0008] The present invention adopts the following technical solution:

[0009] An artificial heart valve, comprising:

[0010] - Valve stent;

[0011] - First sealing membrane, the first sealing membrane is attached to the outside of the valve stent. The first sealing membrane can come into contact with blood and gradually absorbs fluid and expands as the valve stent is implanted for a longer period of time, in order to reduce paravalvular leakage;

[0012] - The second sealing membrane is disposed outside 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.

[0013] - Leaflets, which are located inside the valve stent, are used to control the unidirectional flow of blood.

[0014] As a preferred technical solution, the valve stent is cylindrical and can expand and compress radially, and is equipped with an inflow section and an outflow section, both of which include several interconnected polygonal mesh structures.

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

[0016] As a preferred technical solution, the inflow section is configured to have a 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 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.

[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 cylindrical.

[0020] As a preferred technical solution, the upper edge of the first sealing membrane is folded inward in an 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, the annular cavity is provided with an elastic membrane material, a biocompatible sponge material, or a fiber aggregate.

[0022] As a preferred technical solution, 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.

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

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

[0025] As a preferred technical solution, the first sealing membrane includes a hydrophilic swelling material, which can absorb liquid and swell after contact with blood.

[0026] As a preferred technical solution, the second sealing membrane includes a biocompatible fabric that allows blood to pass through.

[0027] The technical solution adopted in this invention can achieve the following beneficial effects:

[0028] (1) The present invention provides an artificial heart valve. In a preferred embodiment of the present invention, a first sealing membrane is sutured to the outside of the inflow segment of the valve stent, and a second sealing membrane is sutured to the outside of the first sealing membrane. The upper edge of the first sealing membrane is higher than the inflow segment and folded inward to form a roughly cylindrical structure. The first sealing membrane is preferably a hydrophilic swelling material, while the second sealing membrane allows blood to pass through. When the artificial heart valve is implanted into the native tissue, the first sealing membrane has excellent water-proof performance on the one hand, which can prevent blood from seeping out of the valve and effectively prevent paravalvular leakage. On the other hand, as the artificial heart valve is implanted in the human body for a longer period of time, the first sealing membrane can gradually increase the gap between the artificial heart valve and the surrounding native tissue by utilizing its swelling characteristics, further preventing the occurrence of paravalvular leakage. In addition, after the first sealing membrane absorbs liquid and swells, the second sealing membrane can also expand to a certain extent with its expansion to further increase the friction between it and the native valve leaflet.

[0029] (2) In a preferred embodiment, the outwardly folded portion of the first sealing membrane is arc-shaped and there is an annular cavity between it and the valve stent. An elastic material, a sponge-like material, or a fiber composite is provided in the annular cavity so that the folded area of ​​the first sealing membrane can collapse or recover. During the delivery of the valve stent, the cavity collapses to ensure smooth delivery. After the valve stent is released, the cavity expands to increase the volume of the folded area, so that the inflow section can better fit the original valve annulus and enhance the fixation effect. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0031] Figure 1This is a schematic diagram of the valve stent structure in a preferred embodiment of the present invention as disclosed in Embodiment 1;

[0032] Figure 2 This is a schematic diagram of the structure of an artificial heart valve in a preferred embodiment of the present invention, as disclosed in Embodiment 1 of the present invention;

[0033] Figure 3 This is a three-dimensional view of an artificial heart valve in a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0034] Figure 4 This is a bottom view of an artificial heart valve in a preferred embodiment of the present invention, as disclosed in Embodiment 1.

[0035] Figure 5 This is a cross-sectional view of an artificial heart valve in a preferred embodiment of Embodiment 2 of the present invention.

[0036] Explanation of reference numerals in the attached figures:

[0037] Valve stent 1, inflow section 11, outflow section 12, first sealing membrane 2, second sealing membrane 3, leaflet 4, annular cavity 5. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0039] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0040] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0041] To address the problems existing in the prior art, this application provides an artificial heart valve, the main structure of which includes a valve stent, a first sealing membrane, a second sealing membrane, and valve leaflets; the first sealing membrane is attached to the outside of the valve stent, and can come into contact with blood, and gradually absorbs fluid and expands as the valve stent is implanted, in order to reduce paravalvular leakage; the second sealing membrane is disposed outside the first sealing membrane, and after the first sealing membrane absorbs fluid and expands, the second sealing membrane can also expand to a certain extent, in order to increase the friction between it and the original valve leaflets; the valve leaflets are disposed inside the valve stent, in order to control the unidirectional flow of blood.

[0042] Example 1

[0043] The artificial heart valve provided in this embodiment can be used within native tissue. Preferably, this embodiment 1 provides an artificial heart valve to solve the technical problems existing in the prior art. Figures 1-4 The aforementioned artificial heart valve includes a valve stent 1, a first sealing membrane 2, a second sealing membrane 3, and a leaflet 4.

[0044] refer to Figure 1 Optionally, the valve stent 1 is a self-expanding stent, a balloon-expandable stent, or a mechanically expandable stent, etc. Preferably, the valve stent 1 is a self-expanding stent. In a preferred embodiment, the valve stent 1 is made of metal or polymer material, such as nickel-titanium alloy memory material or other memory polymer materials or alloys. In this embodiment, the nickel-titanium alloy memory material, etc., is processed to form several interconnected polygonal grid structures. Optionally, the above processing methods include but are not limited to weaving, laser cutting, welding, riveting, threaded connection, etc.

[0045] In a more preferred embodiment, the valve stent 1 is a balloon-expandable stent; the valve stent 1 is made of materials such as medical stainless steel and cobalt-chromium alloy, and is pre-treated by methods such as weaving, welding, riveting, and threading to form several interconnected polygonal grid structures.

[0046] Preferably, the main body of the valve stent 1 has a cylindrical or similar cylindrical structure. Correspondingly, the main body of the valve stent 1 can expand and compress radially to ensure that it is compressed when delivered in the blood vessel, and then opens by self-expansion or balloon dilation after reaching the original valve annulus.

[0047] Preferably, the valve stent 1 includes an inflow segment 11 and an outflow segment 12. According to the direction of blood flow, the outflow segment 12 is located downstream of the inflow segment 11. The inflow segment 11 corresponds to the portion of blood flowing into the valve stent 1 after implantation of the artificial heart valve, and the outflow segment 12 corresponds to the portion of blood flowing out of the valve stent 1 after implantation of the artificial heart valve. Those skilled in the art should understand that when the valve stent 1 is a self-expanding stent, the inflow segment 11 has a higher elastic coefficient than the outflow segment 12, and after implantation into the native tissue, it can undergo elastic deformation at least in the radial and axial directions to conform to the change in the shape of the native valve annulus. If the valve stent 1 is a balloon-expandable stent, its expansion and opening process is a plastic deformation, and neither the inflow segment 11 nor the outflow segment 12 undergoes elastic recoil.

[0048] In a preferred embodiment, both the inflow section 11 and the outflow section 12 of the valve stent 1 include several interconnected polygonal mesh structures. Adjacent mesh structures are connected by elastic wave rods or nodes. The polygonal mesh is preferably rhomboid, but pentagonal, hexagonal, or other units that can form a closed shape can also be selected. 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 lateral elastic deformation. The outflow section 12 can provide stronger resistance to deformation to prevent the valve stent 1 from shifting during the cardiac cycle.

[0049] Preferably, the grid structure at the free ends of the inflow section 11 and the outflow section 12 is continuously and completely distributed in the circumferential direction, so as not to affect the radial support force and avoid unwanted displacement of the valve stent 1 after implantation of the mitral valve.

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

[0051] Preferably, multiple leaflets 4 are sewn onto the frame support of the valve stent 1, and the multiple leaflets 4 are completely wrapped inside the first sealing membrane 2. When the leaflets 4 are closed, the returning blood is completely confined within the space formed by the first sealing membrane 2, the second sealing membrane 3 and the closed leaflets 4.

[0052] Preferably, the lower edge of the first sealing membrane 2 is sewn to the lower edge of the outer side of the inflow section 11. Since the lower edge of the inflow section 11 is formed by the edge of the grid structure, it is generally continuous wavy or sawtooth and forms a ring. In order to better fit the first sealing membrane 2 with the inflow section 11, the lower edge of the first sealing membrane 2 has the same shape as the lower edge of the inflow section 11, which is also continuous wavy or sawtooth.

[0053] Preferably, the upper edge of the first sealing membrane 2 covers the upper edge of the inflow segment 11, and its length extends beyond the valve stent 1. The extended portion is folded inward along the inflow segment 11 of the valve stent 1 and sewn to the upper part of the inner side of the inflow segment 11, such as... Figures 3-4 Preferably, since the upper edge of the inflow section 11 is formed by the edge of a mesh structure, it is in a continuous wavy or sawtooth shape. When the first sealing membrane 2 is folded inward, it no longer perfectly matches the shape of the upper edge of the inflow section 11, but folds inward directly in a cylindrical shape, that is, the upper edge after folding is a continuous ring. In particular, after the first sealing membrane 2 is folded inward, the suture between the upper edge of the first sealing membrane 2 and the valve support 1 is more secure. At the same time, due to the increased thickness of the folded area, this part can better fit with the original valve annulus, which can not only better position the original tissue, but also further prevent paravalvular leakage.

[0054] Specifically, the inward folding size of the first sealing membrane 2 can be adaptively changed according to the patient's condition. Preferably, the thickness of the first sealing membrane 2 is 0.3-1 mm, and its inward folding length is 4-6 mm, to ensure that the folded area can fit onto the original valve annulus and prevent paravalvular leakage.

[0055] In a preferred embodiment, the first sealing membrane 2 is made of a biocompatible hydrophilic swelling material, which is required to absorb liquid and swell upon contact with blood, so that the artificial heart valve can better fit the native tissue.

[0056] Preferably, the first sealing membrane 2 is made of a bio-hydrogel material. Bio-hydrogel is a type of highly hydrophilic three-dimensional network structure gel that swells rapidly in water and can retain a large volume of water without dissolving in this swollen state. By controlling the production process, the bio-hydrogel can expand 2-3 times. As the valve stent 1 is implanted in the human body for a longer period of time, on the one hand, the bio-hydrogel utilizes its own liquid absorption and expansion properties, and the cylindrical structure formed by the first sealing membrane 2 at the folded edge of the valve stent 1 can gradually fill the gap between the valve stent 1 and the original tissue, preventing paravalvular leakage. On the other hand, given the excellent water-proof properties of the bio-hydrogel, it can effectively prevent blood from seeping out of the artificial heart valve, further preventing paravalvular leakage. In other aspects, because the bio-hydrogel is relatively soft, it can act as a buffer layer to prevent tearing and damage to the original valve leaflets.

[0057] refer to Figures 2-3Preferably, the second sealing membrane 3 is sewn to the outer surface of the first sealing membrane 2; the second sealing membrane 3 covers at least the entire area corresponding to the outer side of the inflow section 11 of the valve stent 1; preferably, the lower edge of the second sealing membrane 3 has the same shape as the lower edge of the inflow section 11, forming a continuous wavy or sawtooth shape; the upper edge of the second sealing membrane 3 is cylindrical.

[0058] Preferably, the second sealing membrane 3 is made of biocompatible fabric and has a certain degree of 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 membrane 3 can not only increase the friction between the second sealing membrane and the original leaflet after the valve stent 1 is inserted to enhance the fixation effect, but also expand to a certain extent as the first sealing membrane 2 absorbs liquid and expands.

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

[0060] Preferably, the valve stent 1 also has multiple imaging points. After the artificial heart valve is implanted into the human body, doctors usually need to use the imaging points set on the implanted valve stent 1 to determine whether the implantation position is accurate. Moreover, since the heart valve is a three-dimensional structure, it is usually necessary to determine whether its spatial position is accurate. Therefore, it is necessary to use the position of multiple imaging points to determine whether its spatial position is accurate.

[0061] In this embodiment, during the surgical placement of the aforementioned artificial heart valve, the valve stent 1 is delivered to the valve annulus via a balloon catheter or guiding catheter, and the valve stent 1 is opened and released by self-expansion or balloon dilation.

[0062] Because the outermost layer of the valve stent 1 is provided with a second sealing membrane 3, it can provide greater friction and strengthen the fixation effect; because the first sealing membrane 2 is made of bio-hydrogel, it gradually expands as the valve stent 1 is implanted, further tightening the gap between the valve stent 1 and the original leaflet, and strengthening the fixation of the valve; and the cylindrical structure formed by the first sealing membrane 2 at the folded edge of the valve stent 1 can further fill the gap between it and the original tissue, effectively preventing paravalvular leakage. At the same time, the bio-hydrogel is relatively soft and can act as a buffer layer to prevent tearing and damage to the original leaflet.

[0063] Example 2

[0064] refer to Figure 5In this embodiment, an artificial heart valve is provided, the structure of which includes a valve stent 1, a first sealing membrane 2, a second sealing membrane 3, and a leaflet 4.

[0065] In this embodiment, the structure of the valve stent 1 is the same as that in Embodiment 1, and will not be described again here; preferably, the first sealing film 2 is attached to the outer side of the valve stent 1; the leaflet 4 is sewn to the inner side of the valve stent 1; and the second sealing film 3 is sewn to the outer surface of the first sealing film 2.

[0066] Preferably, the lower edge of the first sealing membrane 2 is sewn to the lower edge of the inner side of the inflow section 11, the upper edge of the first sealing membrane 2 covers the upper edge of the inflow section 11, and its length exceeds that of the valve stent 1. The extended part is folded inward along the inflow section 11 of the valve stent 1, covering a part of the upper end of the inflow section 11.

[0067] In a preferred embodiment, the first sealing membrane 2, before passing over the top of the valve stent 1, covers the outer side of the upper end of the inflow section 11 in a generally arc-shaped or semi-circular form. 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. Figure 5 As shown.

[0068] Preferably, an elastic membrane material or a biocompatible sponge material, such as a TPU film, chitinous porous body, or collagen sponge PLGA, 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. After the valve stent 1 expands and is fixed, the annular cavity 5 slowly recovers. Due to the presence of this cavity, the thickness / volume of the folded area is further increased, so that the inflow section 11 of the valve stent 1 fits more tightly with the native tissue.

[0069] In another preferred embodiment, the first sealing membrane 2 is approximately arc-shaped or semi-circular before passing over the top of the valve stent 1. After passing over the top of the valve stent 1 and folding over, the end of the first sealing membrane 2 is fixed to the first sealing membrane 2 on the outside of the valve stent 1 by means of adhesive or other methods. The annular cavity 5 formed between the two is filled with a certain volume of fiber composite, such as diene elastic fiber, polyether ester elastic fiber or composite elastic fiber, 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 composite, it can fit well with the outer surface of the inflow section 11 during the delivery of the valve stent 1, ensuring smooth delivery. After the valve stent 1 is released, it can slowly expand and gradually fit with the original tissue.

[0070] Specifically, the size of the annular cavity formed by folding the first sealing membrane 2 inward can be adaptively changed according to the patient's condition. 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 Example 1 above, and will not be repeated here.

[0072] Preferably, the structure of the second sealing membrane 3 is the same as that in Embodiment 1 above, and will not be described again here.

[0073] In this embodiment 2, during the surgical placement of the aforementioned artificial heart valve, the valve stent 1 is delivered via a balloon catheter or guiding catheter. At this time, the annular cavity 5 formed by the inward folding of the valve stent 1 and the first sealing membrane 2 is in a collapsed state. Upon reaching the valve annulus, the valve stent 1 is opened and released by self-expansion or balloon dilation, at which point the annular cavity also returns to its original volume. The expanded annular cavity 5 can fit onto the valve annulus, allowing the valve stent 1 to better conform to the valve annulus and facilitating better positioning of the artificial heart valve. The second sealing membrane 3 is located on the outermost side of the valve stent 1, which can increase the friction between the valve stent 1 and the valve annulus after placement, thereby strengthening the fixation effect.

[0074] Since the first sealing membrane 2 is made of bio-hydrogel, it gradually expands as the valve stent 1 is implanted, further tightening the gap between the valve stent 1 and the original leaflet and strengthening the valve fixation. The cylindrical structure formed by the first sealing membrane 2 at the folded edge of the valve stent 1 can further fill the gap between it and the original tissue, effectively preventing paravalvular leakage. At the same time, the bio-hydrogel is relatively soft and can act as a buffer layer to prevent tearing and damage to the original leaflet.

[0075] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

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 membrane matches the shape of the first sealing membrane 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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