An artificial heart valve

Abstract

The present invention relates to an artificial heart valve, which comprises a valve stent, a first sealing film, a second sealing film, valve leaflets and valve leaflet anchoring members. The valve stent includes an inflow section and an outflow section. The first sealing film is arranged on the outermost side of the artificial heart valve and covers at least all regions corresponding to the outer surface of the inflow section. The second sealing film is attached to the inner side of the valve stent, and its upper edge is turned outwards from the upper edge of the inflow section and covers a part of the first sealing film to reduce paravalvular leakage. The valve leaflets are arranged inside the valve stent and are used to control the one-way flow of blood. The valve leaflet anchoring members are spiral-shaped and can be wound outside the chordae tendineae of the mitral / tricuspid valve and interact with the valve stent. By providing the first sealing film and the second sealing film, the artificial heart valve of the present invention can better fit with the native tissue after being implanted into the mitral / tricuspid valve, so as to effectively prevent the occurrence of paravalvular leakage.

Description

Technical Field

[0001] The present invention relates to the field of medical devices for cardiac surgery, and particularly to an artificial heart valve. Background Art

[0002] The heart includes four pumping chambers, namely the left atrium, the right atrium, the left ventricle, and the right ventricle. Each pumping chamber has a valve that controls its unidirectional outflow. Among them, the mitral valve is located between the left atrium and the left ventricle. 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. When the right ventricle contracts, it squeezes the blood in the ventricle to impact the tricuspid valve and close it, preventing blood from flowing back into the right atrium.

[0003] A functionally perfect mitral valve or tricuspid valve can ensure correct blood circulation during the cardiac cycle. However, when the leaflets of the valve cannot achieve complete contact (engagement) due to disease, mitral regurgitation (MR) or tricuspid regurgitation (TR) will occur. On the other hand, abnormal cardiac structure may also be the cause of regurgitation, and these two processes can accelerate abnormal cardiac function due to "synergistic effects".

[0004] Currently, standard treatment for cardiac valve regurgitation usually requires surgical procedures. Standard surgical repair or replacement operations require thoracotomy, the use of cardiopulmonary bypass, and cardiac arrest. Due to the invasive nature of these surgical procedures, deaths, strokes, bleeding, respiratory problems, kidney problems, and other complications are common. Therefore, patients often refuse or are judged to be unsuitable for traditional open surgery due to the high risks.

[0005] In recent years, due to the successful advancement of aortic valve replacement, it has inspired the exploration of transcatheter mitral / tricuspid valve replacement for treating regurgitation. However, mitral / tricuspid valve replacement is much more difficult than aortic replacement in many aspects. For example, the mitral / tricuspid valve has a non-traditional circular shape in terms of spatial structure, has a more complex organizational structure (annulus, leaflets, chordae tendineae, papillary muscles), is larger than the aortic valve, and is more slender in shape. The leaflets of the mitral / tricuspid valve are soft. Compared with aortic valve stenosis or calcification, the mitral / tricuspid valve cannot provide good retention for the replacement valve. At the same time, when the ventricle contracts, the pressure in the ventricle will rise sharply. If the replacement valve fails to establish sufficient anchoring at the annulus, there will be a risk of displacement. Therefore, to effectively perform mitral / tricuspid valve replacement for treating regurgitation, not only has to withstand the large cyclic loads from the mitral / tricuspid valve, but more importantly, establish stable and firm anchoring. Summary of the Invention

[0006] The present invention discloses an artificial heart valve, aiming to solve the technical problems existing in the prior art.

[0007] The present invention adopts the following technical solutions:

[0008] An artificial heart valve, comprising:

[0009] - A valve stent, the valve stent including an inflow section and an outflow section;

[0010] - A first sealing membrane, the first sealing membrane being disposed on the outer side of the valve stent, and the first sealing membrane covering at least all regions corresponding to the outer surface of the inflow section; the first sealing membrane is used to increase the frictional force with the native leaflets;

[0011] - A second sealing membrane, the second sealing membrane being attached to the inner side of the valve stent, the upper edge of the second sealing membrane being folded outward from the upper edge of the inflow section and covering a part of the first sealing membrane, for reducing paravalvular leakage;

[0012] - Leaflets, the leaflets being disposed inside the valve stent for controlling the unidirectional flow of blood;

[0013] - Leaflet anchoring members, the leaflet anchoring members being spiral-shaped and capable of coiling around the mitral / tricuspid chordal plexus and interacting with the valve stent implanted into the mitral / tricuspid valve.

[0014] As a preferred technical solution, the valve stent is cylindrical; the valve stent includes a plurality of interconnected polygonal grid structures.

[0015] As a preferred technical solution, the first sealing membrane is made of a biocompatible fabric.

[0016] As a preferred technical solution, the upper edge of the second sealing membrane is sutured to the upper part of the inflow section; the lower edge of the second sealing membrane is sutured to the lower edge inside the inflow section, and the lower edge of the second sealing membrane matches the shape of the lower edge of the inflow section.

[0017] As a preferred technical solution, the second sealing membrane covers the upper edge of the inflow section, and the second sealing membrane covering the upper edge of the inflow section is cylindrical.

[0018] As a preferred technical solution, the upper edge of the second sealing membrane is folded outward in an arc shape, and an annular cavity is formed between the folded area of the second sealing membrane and the first sealing membrane.

[0019] As a preferred technical solution, an elastic membrane material, a biocompatible sponge material or a fiber aggregate is provided in the annular cavity.

[0020] As a preferred technical solution, the thickness of the second sealing membrane is 0.3 - 1 mm; the length of the upper edge of the second sealing membrane folded outward is 4 - 6 mm.

[0021] As a preferred technical solution, the second sealing film includes a microporous membrane for inducing the in-growth of tissue cells.

[0022] As a preferred technical solution, the microporous membrane is covered with pores, the size of the pores being configured to allow cells to grow in, and adjacent pores being connected to each other to allow the extracellular matrix generated after the cells grow in to be interconnected.

[0023] As a preferred technical solution, the diameter of the pores is 5 - 20 μm.

[0024] As a preferred technical solution, the microporous membrane includes an ePTFE microporous membrane.

[0025] As a preferred technical solution, the leaflet is sutured to the inner side of the second sealing film; the first sealing film is sutured to the outer surface of the inflow section.

[0026] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0027] (1) The present invention provides an artificial heart valve. In a preferred embodiment, a first sealing film is sutured to the outer side of the inflow section of the valve stent, and a second sealing film is sutured to the inner side of the inflow section. The upper edge of the second sealing film is higher than the inflow section and is folded outward to form a substantially cylindrical structure; the second sealing film is preferably a biocompatible polymer material and is covered with micropores. After the artificial heart valve is implanted into the annulus of the native mitral / tricuspid valve, the second sealing film can induce the rapid in-growth of cell tissue inward to form endothelialization, prevent paravalvular leakage. At the same time, the structure of its upper edge folded outward not only makes the connection between the second sealing film and the valve stent closer and more stable, but also enables the inflow section to better fit the native mitral / tricuspid valve annulus, and at the same time enables the artificial heart valve to be better positioned.

[0028] (2) In a preferred embodiment, the folded-out part of the second sealing film covers part of the first sealing film, and there is an annular cavity between the second sealing film and the first sealing film. An elastic material or fiber aggregate is provided in the annular cavity so that the folded area of the second sealing film can collapse or recover. During the process of delivering 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 native annulus and enhance the fixing effect.

[0029] (3) In a preferred embodiment of the present invention, an anchor is further provided outside the chordae tendineae plexus of the mitral / tricuspid valve. The anchor can directly cooperate with the implanted valve stent to prevent the valve stent from deforming or shifting during the contraction or relaxation of the native tissue, so as to effectively ensure the fixed position of the valve stent and reduce the risk of its displacement. Description of the Drawings

[0030] To more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. These drawings form a part of the present invention. The schematic 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 drawings:

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

[0032] Figure 2 It is a schematic structural diagram of a valve stent, leaflets, and a second sealing film in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0033] Figure 3 It is a schematic structural diagram of an artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0034] Figure 4 It is a perspective view of an artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0035] Figure 5 It is a bottom view of an artificial heart valve in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0036] Figure 6 It is a schematic structural diagram of a leaflet anchor in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0037] Figure 7 It is a schematic structural diagram of an artificial heart valve after being implanted into the mitral valve in a preferred embodiment disclosed in Embodiment 1 of the present invention;

[0038] Figure 8 It is a sectional view of an artificial heart valve in a preferred embodiment disclosed in Embodiment 2 of the present invention.

[0039] Explanation of reference numerals:

[0040] Valve stent 1, inflow section 11, outflow section 12, second sealing film 2, first sealing film 3, leaflets 4, leaflet anchor 5, native mitral valve 6, annular cavity 7. Detailed implementation manners

[0041] To make the objectives, technical solutions, and advantages of the present invention clearer, the following will clearly and completely describe the technical solutions of the present invention in conjunction with the specific embodiments and corresponding drawings of the present invention. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless otherwise clearly specified in the content.

[0042] In the description of the present invention, it should be noted that, unless otherwise clearly defined and limited, the terms "installed", "connected", and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations. In addition, in the description of this application, the terms "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0043] Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0044] To solve the problems existing in the prior art, an embodiment of the present application provides an artificial heart valve, the main structure of which includes a valve stent, a first sealing film, a second sealing film, valve leaflets, and valve leaflet anchoring members; wherein, the valve stent includes an inflow section and an outflow section; the first sealing film is arranged on the outer side of the valve stent, and the first sealing film covers at least all the areas corresponding to the outer surface of the inflow section; the first sealing film is used to increase the friction with the native valve leaflets; the second sealing film is attached to the inner side of the valve stent, the upper edge of the second sealing film is turned outwards from the upper edge of the inflow section and covers a part of the first sealing film, which is used to reduce paravalvular leakage; the valve leaflets are arranged inside the valve stent and are used to control the unidirectional flow of blood; the valve leaflet anchoring members are spiral and can be coiled outside the mitral / tricuspid chordae tendineae plexus and interact with the valve stent implanted in the mitral / tricuspid valve.

[0045] Example 1

[0046] The artificial heart valve provided by this embodiment can be used in the mitral valve or the tricuspid valve. Preferably, taking the implantation of the mitral valve as an example, Embodiment 1 of this embodiment provides an artificial heart valve to solve the technical problems existing in the prior art. According to Figures 1-7 , the above artificial heart valve includes a valve stent 1, a first sealing film 3, a second sealing film 2, and valve leaflets 4; in a preferred embodiment, the above artificial heart valve further includes a valve leaflet anchoring member 5. The valve stent 1 is positioned in the annulus of the native mitral valve 6, and the valve leaflet anchoring member 5 is spirally coiled and positioned at the chordae tendineae of the native mitral valve 6 to anchor the valve stent 1 implanted in the mitral valve and prevent the valve stent 1 from shifting during the cardiac cycle.

[0047] Refer to Figure 1, Optionally, the valve stent 1 is a self-expanding stent, a balloon-expandable stent, 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 nitinol memory material or other memory polymer materials or alloys. In this embodiment, by processing the nitinol memory material, etc., a plurality of interconnected polygonal grid structures are formed; optionally, the above processing methods include but are not limited to weaving, laser cutting, welding, riveting, threading, etc.

[0048] 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 a plurality of interconnected polygonal grid structures are pre-formed by means of weaving, welding, riveting, threading, etc.

[0049] Preferably, the main body contour of the valve stent 1 is in a cylindrical structure or a structure similar to a cylindrical shape. Correspondingly, the main body of the valve stent 1 can be radially expanded and compressed, ensuring that it is in a compressed state during delivery in the blood vessel and then opening by self-expansion or balloon expansion after reaching the annulus of the native mitral valve 6.

[0050] Preferably, the valve stent 1 includes an inflow section 11 and an outflow section 12. According to the direction of blood flow, the outflow section 12 is located downstream of the inflow section 11. The inflow section 11 corresponds to the part where blood flows into the valve stent 1 after the artificial heart valve is implanted, and the outflow section 12 corresponds to the part where blood flows out of the valve stent 1 after the artificial heart valve is implanted; specifically, the inflow section 11 is positioned at the annulus of the native mitral valve 6, and the outflow section 12 is positioned at the connection transition region between the leaflets and chordae tendineae of the native mitral valve 6. 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 modulus than the outflow section 12 and can undergo elastic deformation at least radially and axially after being implanted into the mitral valve to conform to the change in the shape of the annulus of the native mitral valve 6; if the valve stent 1 is a balloon-expandable stent, the process of its expansion and opening is plastic deformation, and neither the inflow section 11 nor the outflow section 12 exhibits elastic retraction.

[0051] In a preferred embodiment, both the inflow section 11 and the outflow section 12 of the valve stent 1 include a plurality of interconnected polygonal grid structures, and adjacent grid structures are connected by wave rods or nodes with a certain elasticity. Among them, the polygonal grid is preferably a rhombus, and pentagons, hexagons, etc. that can form closed shapes can also be selected; in a preferred embodiment, the inflow section 11 has a denser grid structure than the outflow section 12 to provide elastic deformation in more directions, such as axial elastic deformation, radial elastic deformation, and transverse elastic deformation; while the outflow section 12 can provide stronger anti-deformation ability to prevent the valve stent 1 from shifting during the cardiac cycle.

[0052] Preferably, the grid structures at the free ends of the inflow section 11 and the outflow section 12 are continuously and integrally distributed in the circumferential direction, so as not to affect the radial supporting force and avoid unexpected displacement of the valve stent 1 after implantation into the mitral valve.

[0053] Such as Figures 2-5 , in a preferred embodiment, the second sealing film 2 is attached to the inner side surface of the valve stent 1, and the second sealing film 2 is sutured to the valve stent 1; the valve leaflets 4 are sutured to the inner side of the valve stent 1 for controlling the one-way flow of blood; the first sealing film 3 is sutured to the outer surface of the inflow section 11 of the valve stent 1.

[0054] Preferably, multiple valve leaflets 4 are sewn on the frame struts of the valve stent 1, and the multiple valve leaflets 4 are completely wrapped within the second sealing film 2. When the valve leaflets 4 are closed, the reflux blood is completely restricted within the space formed by the second sealing film 2, the first sealing film 3, and the closed valve leaflets 4.

[0055] Preferably, the lower edge of the second sealing film 2 is sutured to the lower edge inside 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 in a continuous wave shape or zigzag shape and forms a loop. In order for the second sealing film 2 to better fit the inflow section 11, the lower edge of the second sealing film 2 has the same shape as the lower edge of the inflow section 11, also in a continuous wave shape or zigzag shape.

[0056] Preferably, the upper edge of the second sealing film 2 covers the upper edge of the inflow section 11, and the length extends beyond the valve stent 1. The extended part is folded outward along the inflow section 11 of the valve stent 1, covering a partial area at the upper end of the first sealing film 3, and is sutured to the upper part of the inflow section 11, such as Figure 2 ; Preferably, since the upper edge of the inflow section 11 is formed by the edge of the grid structure, it is in a continuous wave shape or zigzag shape. When the second sealing film 2 is folded outward, it no longer completely fits the shape of the upper edge of the inflow section 11, but is directly folded outward in a cylindrical shape, that is, the folded upper edge forms a continuous circular ring. In particular, after the second sealing film 2 is folded outward, the upper edge of the second sealing film 2 is more firmly sutured to the valve stent 1. At the same time, due to the increased thickness of the folded area, this part can better fit the native mitral valve 6 annulus, not only can it be better positioned in the mitral valve, but also can further prevent paravalvular leakage. In particular, for different patients, the size and / or shape of their mitral valves will be different. Those skilled in the art should understand that the size of the outward folding of the second sealing film 2 can be adaptively changed according to the patient's situation. Preferably, the length of the outward folding of the second sealing film 2 is 4 - 6 mm to ensure that the folded area can be clamped on the native mitral valve 6 annulus to prevent paravalvular leakage. Preferably, the thickness of the second sealing film 2 is 0.3 - 1 mm.

[0057] In a preferred embodiment, the second sealing membrane 2 is made of a biocompatible polymer material, and has smaller pores distributed throughout its surface. The size of the pores should be set to allow tissue cells to grow in, so that the artificial heart valve can quickly form endothelialization after being implanted into the mitral valve. Optionally, the second sealing membrane 2 is made of materials such as polyurethane, polytetrafluoroethylene, expanded polytetrafluoroethylene, alginic acid / alginate, silk protein, chitin, gelatin, collagen, hyaluronic acid, chitosan, polycaprolactone, polylactic acid, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyglycolic acid, polymethacrylic acid, polylactic acid-polyglycolic acid, carboxymethyl starch, acetate starch, carboxymethyl chitosan, carboxymethyl cellulose, polyvinyl alcohol, polyacrylamide, polyacrylic acid, and polyvinyl pyrrolidone; preferably, the second sealing membrane 2 is made of an expanded polytetrafluoroethylene (ePTFE) microporous film. Since the ePTFE microporous film is a film formed by expanding and stretching polytetrafluoroethylene as a raw material, it already has countless micropores for cells to enter, and there is no need to make pores by weaving or 3D printing. Moreover, it is light in weight and will not add extra burden after being implanted into the mitral valve.

[0058] More preferably, the diameter of the pores distributed on the second sealing membrane 2 is 5-20 μm to allow a single cell to pass through. Further, the pores provided in the structure of the second sealing membrane 2 are all interconnected to allow the extracellular matrix generated after the tissue cells grow in to be interconnected with each other, which is beneficial to the rapid growth of cell tissue after the artificial heart valve is implanted to anchor the valve stent 1 to prevent its displacement.

[0059] Reference Figures 3-5 , preferably, the first sealing membrane 3 is sutured to the outer surface of the valve stent 1, and the folded-out part of the second sealing membrane 2 covers the outside of the first sealing membrane 3; the first sealing membrane 3 at least covers all the areas corresponding to the outer side surface of the inflow section 11 of the valve stent 1; preferably, the lower edge of the first sealing membrane 3 has the same shape as the lower edge of the inflow section 11, being a continuous wavy or serrated shape; the upper edge of the first sealing membrane 3 is cylindrical.

[0060] Preferably, the first sealing membrane 3 is made of a biocompatible fabric, and the biocompatible fabric is preferably but not limited to any one or at least two combinations of PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), e-PTFE, or PU (polyurethane). The first sealing membrane 3 can increase the friction force between the valve stent 1 and the leaflets 6 of the native mitral valve after the valve stent 1 is implanted to strengthen the fixing effect.

[0061] In this embodiment, it should be noted that when the above-mentioned first sealing membrane 3, second sealing membrane 2, and leaflets 4 are sutured, the sutures are all connected and fixed to the frame struts of the valve stent 1, rather than other structures.

[0062] Preferably, there are also a plurality of radiopaque points on the valve stent 1. After the artificial heart valve is implanted into the human body, usually, doctors need to determine whether the implantation position is accurate through the radiopaque 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 its spatial position is accurate. Therefore, it is necessary to judge whether its spatial position is accurate through the positions of a plurality of radiopaque points.

[0063] Reference Figure 7 , in this embodiment, when the above artificial heart valve is surgically implanted, the valve stent 1 is delivered to the annulus of the native mitral valve 6 through a balloon catheter or a guiding catheter, and the valve stent 1 is opened and released by self-expansion or balloon dilation. Among them, since the second sealing membrane 2 is covered with micropores, it can induce the rapid ingrowth of cell tissue inward to form endothelialization, prevent paravalvular leakage. At the same time, the structure with its upper edge turned outward is engaged above the annulus of the native mitral valve 6, so that the valve stent 1 can better fit the annulus of the native mitral valve 6, which is also beneficial for the better positioning of the artificial heart valve; and the first sealing membrane 3 is arranged on the outermost side of the valve stent 1, which can increase the friction force with the annulus of the native mitral valve 6 after the valve stent 1 is implanted to strengthen the fixation effect.

[0064] When the valve stent 1 is positioned, the leaflet anchor 5 is released into the mitral chordal plexus through a delivery device. The valve stent 1 has a radially outward expanding force, while the leaflet anchor 5 has a radially inward tightening force. The two cooperate with each other to anchor the valve stent 1 to prevent it from shifting, so that the artificial heart valve fits better with the native tissue structure and is safer and more stable.

[0065] Example 2

[0066] Still taking the mitral valve implantation as an example, reference Figure 8 , in this embodiment, an artificial heart valve is provided, and its structure includes a valve stent 1, a first sealing membrane 3, a second sealing membrane 2 and leaflets 4; in a preferred embodiment, the above artificial heart valve further includes a leaflet anchor 5.

[0067] In this embodiment, the structure of the valve stent 1 is the same as that in Embodiment 1 and will not be described herein again; preferably, the first sealing membrane 3 is sutured to the outer surface of the inflow section 11 of the valve stent 1, and the second sealing membrane 2 is attached to the inner side of the valve stent 1; the leaflets 4 are sutured to the inside of the valve stent 1.

[0068] Preferably, the lower edge of the second sealing membrane 2 is sutured to the lower edge inside the inflow section 11, the upper edge of the second sealing membrane 2 covers the upper edge of the inflow section 11, and the length is higher than that of the valve stent 1. The extended part is turned outward along the inflow section 11 of the valve stent 1 to cover a partial area at the upper end of the first sealing membrane 3.

[0069] In a preferred embodiment, after bypassing the top end of the valve stent 1, the second sealing film 2 covers the outer side of the upper end of the first sealing film 3 in a substantially circular arc or semi-circular shape. That is, there is an annular cavity 7 between the folded area of the second sealing film 2 and the first sealing film 3, as Figure 8 shown.

[0070] Preferably, an elastic film-like material or a biocompatible sponge-like material, such as a TPU film, a chitin porous body, a collagen sponge PLGA, etc., is attached to the inner side of the annular cavity 7, so that the folded area of the second sealing film 2 can collapse or recover. During the process of delivering the valve stent 1, the annular cavity 7 collapses to ensure that the valve stent 1 can reach the mitral valve smoothly and be released. After the valve stent 1 expands and is fixed, the annular cavity 7 slowly recovers. Due to the existence of this cavity, the thickness / volume of the folded area is further increased, making the inflow section 11 of the valve stent 1 fit more closely with the native mitral valve 6.

[0071] In another preferred embodiment, after bypassing the top end of the valve stent 1, the second sealing film 2 is in a substantially circular arc or semi-circular shape and is fixed to the outer side of the upper end of the first sealing film 3 by heat melting or pasting. Preferably, a fiber aggregate with a certain volume, such as a diene elastic fiber, a polyether ester elastic fiber or a composite elastic fiber, etc., is filled in the annular cavity 7 between the folded area of the second sealing film 2 and the first sealing film 3, so that the folded area of the second sealing film 2 can collapse or recover. Those skilled in the art should understand that due to the bulkiness, elasticity and relatively high elastic recovery rate of the fiber aggregate, it can fit well with the outer surface of the inflow section 11 during the delivery process of the valve stent 1 to ensure the smooth delivery, and can slowly expand after the valve stent 1 is released and gradually fit with the native mitral valve 6.

[0072] Particularly, for different patients, the size and / or shape of the mitral valve will be different. Those skilled in the art should understand that the size of the annular cavity 7 formed by the outward folding of the second sealing film 2 can be adaptively changed according to the patient's condition. Preferably, the width of the first sealing film 3 covered by the annular cavity 7 is 4-6 mm.

[0073] Preferably, the second sealing film 2 is made of a biocompatible polymer material. Refer to the description in the above-mentioned Embodiment 1 and details will not be repeated here.

[0074] Preferably, the structure of the first sealing film 3 is the same as that in the above-mentioned Embodiment 1 and details will not be repeated here.

[0075] In this embodiment 2, when the above-mentioned artificial heart valve is surgically implanted, the valve stent 1 is delivered through a balloon catheter or a guide catheter. At this time, the annular cavity 7 formed by the valve stent 1 and the second sealing membrane 2 folding outward is in a collapsed state. When it reaches the annulus of the native mitral valve 6, the valve stent 1 is opened and released by self-expansion or balloon expansion, and the annular cavity 7 is also restored to its original volume.

[0076] Since the second sealing membrane 2 is covered with micropores, it can induce cell tissue to grow rapidly inward to form endothelialization and prevent paravalvular leakage. At this time, even if there is spongy material or gas in the annular cavity 7, it will not hinder the growth of tissue cells; the expanded annular cavity 7 structure can be engaged above the valve ring of the native mitral valve 6, so that the valve stent 1 can better fit the valve ring of the native mitral valve 6, and it is also beneficial for the artificial heart valve to be better positioned; and the first 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 valve ring of the native mitral valve 6 after the valve stent 1 is inserted, so as to strengthen the fixation effect.

[0077] After the valve stent 1 is positioned, the leaflet anchor 5 is released to the chordae tendineae of the mitral valve through the delivery device. The valve stent 1 has a radially outward expansion force, while the leaflet anchor 5 has a radially inward tightening force. The two cooperate with each other to anchor the valve stent 1 to prevent it from shifting, making the artificial heart valve safer and more stable when cooperating with the native tissue structure.

[0078] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. An artificial heart valve, characterized in that, Comprising: - A valve stent, the valve stent including an inflow section and an outflow section; - A first sealing membrane, the first sealing membrane being disposed outside the valve stent, the first sealing membrane at least covering all regions corresponding to the outer surface of the inflow section; the first sealing membrane is used to increase the frictional force with the native leaflets; - A second sealing membrane, the second sealing membrane being attached to the inner side of the valve stent, the upper edge of the second sealing membrane being folded outward from the upper edge of the inflow section and covering a part of the first sealing membrane, an annular cavity being formed between the folded region of the second sealing membrane and the first sealing membrane, an elastic material being provided in the annular cavity, the annular cavity being capable of collapsing during delivery and restoring after the valve stent is released, so that the thickness / volume of the folded region is further increased, and the inflow section can be more closely attached to the native annulus to reduce paravalvular leakage; - Leaflets, the leaflets being disposed inside the valve stent for controlling the unidirectional flow of blood; - Leaflet anchoring members, the leaflet anchoring members being spiral and capable of coiling outside the mitral / tricuspid chordal plexus and interacting with the valve stent implanted in the mitral / tricuspid valve.

2. The artificial heart valve according to claim 1, characterized in that, The valve stent is cylindrical; the valve stent includes a plurality of interconnected polygonal grid structures.

3. The artificial heart valve according to claim 1, wherein The first sealing membrane is made of a biocompatible fabric.

4. The artificial heart valve according to claim 1, wherein, The upper edge of the second sealing membrane is sutured to the upper part of the inflow section; the lower edge of the second sealing membrane is sutured to the lower edge inside the inflow section, and the lower edge of the second sealing membrane matches the shape of the lower edge of the inflow section.

5. The artificial heart valve according to claim 4, characterized in that, The second sealing membrane covers the upper edge of the inflow section, and the second sealing membrane covering the upper edge of the inflow section is cylindrical.

6. The artificial heart valve according to claim 4, characterized in that, The upper edge of the second sealing membrane is folded outward in an arc shape.

7. The artificial heart valve according to claim 6, wherein, An elastic membrane-like material, a biocompatible sponge-like material or a fiber aggregate is provided in the annular cavity.

8. The artificial heart valve according to claim 4, characterized in that, The thickness of the second sealing membrane is 0.3 - 1 mm; the length of the upper edge of the second sealing membrane folded outward is 4 - 6 mm.

9. The artificial heart valve according to claim 1, wherein, The second sealing membrane includes a microporous membrane for inducing the in-growth of tissue cells.

10. The artificial heart valve according to claim 9, characterized in that, The microporous membrane is covered with pores, the size of the pores being configured to allow cells to grow in, and adjacent pores being connected to allow the extracellular matrix generated after the cells grow in to be interconnected.

11. The artificial heart valve according to claim 10, characterized in that, The diameter of the pores is 5 - 20 μm.

12. The artificial heart valve according to claim 9, characterized in that, The microporous membrane includes an ePTFE microporous membrane.

13. The artificial heart valve according to claim 1, characterized in that, The leaflets are sutured to the inner side of the second sealing membrane; the first sealing membrane is sutured to the outer surface of the inflow section.

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