Prosthetic heart valve

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an artificial heart valve which comprises a support and a valve leaflet mechanism. A plurality of bracket connecting holes are formed in the bracket; the valve leaflet mechanism comprises a plurality of connecting pieces and artificial valve leaflets; the artificial valve leaflet is provided with a valve leaflet main body, two first connecting parts and two second connecting parts, each connecting piece penetrates out of the corresponding support connecting hole from the inner side of the support after being folded and is attached to the two sides of the periphery of the support connecting hole, every two adjacent fixing parts are connected with the two sides of the corresponding connecting piece respectively, and the arc-shaped parts can be attached to the surface of the valve leaflet main body. After the artificial valve leaflet and the support are fixed, in the open state of the artificial valve leaflet, the arc-shaped part attached to the outer wall of the artificial valve leaflet can play a role in buffering the artificial valve leaflet, and the artificial valve leaflet is protected.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an artificial heart valve. Background Art

[0002] The heart is basically divided into the left heart and the right heart by the atrioventricular septum. The left heart carries arterial blood, which enters the aorta from the left ventricle through the aortic valve. The aorta then transports fresh arterial blood to all parts of the body to provide the body with the necessary oxygen and nutrients. However, it is precisely because the aortic valve is often under high pressure that various abnormalities occur, such as stenosis and reflux. Currently, aortic valve disease has become the most common disease among structural heart valves.

[0003] For aortic valve stenosis, the native aortic valve has a hard calcified area, which can be used as a fixing site for the artificial heart valve. Currently, there are two main types of aortic stenosis replacement valves: self-expanding valve and balloon-expandable valve. Due to the strong supporting force of the balloon-expandable valve stent, the valve axial direction can be designed to be shorter, which can reduce the risk of covering the coronary sinus. The valve close to the left ventricle is not easy to touch the His bundle, which can better avoid atrioventricular conduction block.

[0004] Chinese patent application 2021111421752 discloses an artificial heart valve, which can play a good role in fixing the aortic valve, and the fatigue resistance of the leaflets has also been preliminarily verified, but there are still some problems. For example, since the heart valve stent and the artificial leaflets are fixedly connected by a clip, and the clip itself has a certain hardness, during the delivery of the artificial heart valve, or during the opening and closing of the artificial leaflets, the position where the clip contacts the artificial leaflets will form a stress point, which is easy to damage the leaflets and reduce the fatigue life of the artificial heart valve. The stent is sutured with the leaflets located inside it through multiple suture holes, and the multiple suture holes are located on a sheet-like structure. During the compression and gripping process of the artificial heart valve, it is easy to form stress points at the sheet-like structure, resulting in uneven compression and gripping, so that after the artificial heart valve is implanted in the patient's body, it cannot form the expected shape when it is opened again, which increases the difficulty of controlling the artificial heart valve and reduces its performance accordingly. Summary of the invention

[0005] In view of the above-mentioned defects of the existing heart valves, the present invention provides an artificial heart valve with a long service life and more uniform compression and gripping.

[0006] In order to solve the above technical problems, one aspect of the present invention provides an artificial heart valve, the artificial heart valve comprising a stent and a leaflet mechanism arranged in the stent;

[0007] The bracket is provided with a plurality of bracket connection holes;

[0008] The leaflet mechanism comprises:

[0009] Several connecting parts;

[0010] A plurality of artificial valve leaflets, wherein the plurality of artificial valve leaflets are connected in sequence to form a ring-like structure;

[0011] The artificial valve leaflet has:

[0012] One leaflet body;

[0013] Two first connection parts, wherein the two first connection parts are connected to two sides of the free end of the leaflet body;

[0014] Two second connection parts, each of which is connected to the upper part of the first connection part and the connection part can be folded along the first flip axis;

[0015] The first connection parts of two adjacent artificial valve leaflets are connected by the connection piece to form a ring-like structure;

[0016] The bracket connecting hole is a rectangular hole, and the support rods at the upper and lower ends of the rectangular hole are connected to the middle parts of the upper and lower ends of the rectangular hole.

[0017] Optionally, the second connecting portion includes a fixed portion and an arc-shaped portion, the connection between the fixed portion and the arc-shaped portion can be folded along a second flip axis, and a side of the arc-shaped portion away from the fixed portion is an arc-shaped structure;

[0018] After each of the connecting parts is folded in half, it passes through the corresponding stent connecting hole from the inner side of the stent and is abutted against the outer periphery of the stent connecting hole. The second connecting part is located on the inner side of the stent. After folding, the fixing parts of the two adjacent artificial leaflets are respectively connected to the two sides of the connecting part, and the arc-shaped part can be abutted against the surface of the leaflet body.

[0019] Optionally, in the artificial heart valve as described above, the fixing portion and the connecting member are connected by suturing.

[0020] Optionally, in the artificial heart valve as described above, a horizontal leaflet U-shaped groove is provided at the connection between the first connection portion and the second connection portion.

[0021] Optionally, in the artificial heart valve as described above, the outer contour of the fixed end of the leaflet body has:

[0022] A leaflet bottom arc, wherein the lower end of the leaflet bottom arc is an arc-shaped structure;

[0023] Two leaflet side arcs, the two leaflet side arcs are respectively located on both sides of the leaflet bottom arc, and the lower ends of the leaflet side arcs are also arc-shaped structures;

[0024] The slopes of the leaflet bottom arc and the leaflet side arcs on both sides are equal and smoothly connected to form the fixed end of the artificial leaflet.

[0025] Optionally, in the artificial heart valve as described above, the leaflet bottom arc is a circular arc formed by a first radius, and the two leaflet side arcs are circular arcs formed by a second radius, and the second radius: the first radius = (2-5):1.

[0026] Optionally, in the artificial heart valve as described above, the arc length of the leaflet side arc: the arc length of the leaflet bottom arc = (1.2-2):1.

[0027] Optionally, in the artificial heart valve as described above, the upper end contour of the leaflet body has an upward protrusion to form a protrusion.

[0028] Optionally, in the artificial heart valve as described above, an avoidance incision is provided on the leaflet body, and the avoidance incision is located at the connection between the leaflet body and the first connecting portion.

[0029] Optionally, in the artificial heart valve as described above, the included angle of the avoidance incision is not greater than 90°.

[0030] Optionally, in the artificial heart valve as described above, the stent is in a hollow straight cylinder-like shape, and the stent includes an inflow section and an outflow section connected to each other;

[0031] The inflow segment includes a plurality of inflow segment frame units connected end to end in sequence and a plurality of inflow segment connection areas, wherein the inflow segment frame units are hollow frame units having inflow segment meshes, and the inflow segment connection area is an area where two adjacent inflow segment frame units are connected to each other;

[0032] The outflow segment includes a plurality of outflow segment frame units connected end to end in sequence and a plurality of outflow segment connection areas, wherein the outflow segment frame unit is a hollow frame unit having an outflow segment mesh, and the outflow segment connection area is an area where two adjacent outflow segment frame units are connected to each other, and several outflow segment connection areas are provided with the bracket connection holes as bracket connection parts.

[0033] Optionally, in the artificial heart valve as described above, the width of the axial connecting rod of the stent connecting portion is smaller than the width of the other outflow section connecting areas.

[0034] Optionally, in the artificial heart valve as described above, the inflow segment mesh is a gyro-shaped mesh.

[0035] Optionally, in the artificial heart valve as described above, the outflow segment mesh is a hexagonal mesh.

[0036] Optionally, in the artificial heart valve as described above, the outflow segment frame unit comprises an outflow segment upper protrusion and an outflow segment lower protrusion, the outflow segment upper protrusion protrudes along the axial direction of the stent toward the outflow end, and the outflow segment lower protrusion protrudes along the axial direction of the stent toward a direction away from the outflow end;

[0037] The outflow section frame unit further includes an outflow section upper support rod and an outflow section lower support rod, wherein the outflow section upper support rod is connected between the outflow section upper protrusion and the outflow section connection area, and the outflow section lower support rod is connected between the outflow section lower protrusion and the outflow section connection area;

[0038] When the outflow section connection area is the bracket connection part, two adjacent upper support rods of the outflow section are connected side by side to the middle of the outflow end of the bracket connection part, and two adjacent lower support rods of the outflow section are connected side by side to the middle of the inflow end of the bracket connection part.

[0039] Optionally, in the artificial heart valve as described above, the inflow segment frame unit comprises an inflow segment upper protrusion and an inflow segment lower protrusion, the inflow segment upper protrusion protrudes along the axial direction of the stent toward the outflow end, and the inflow segment lower protrusion protrudes along the axial direction of the stent toward a direction away from the outflow end;

[0040] The inflow section frame unit also includes an inflow section upper support rod and an inflow section lower support rod, wherein the inflow section upper support rod is connected between the inflow section upper protrusion and the inflow section connection area, and the inflow section lower support rod is connected between the inflow section lower protrusion and the inflow section connection area.

[0041] Optionally, in the artificial heart valve as described above, the inner side of the top of the upper protrusion of the inflow section, the inner side of the top of the lower protrusion of the inflow section and / or the outer side of the top of the lower protrusion of the inflow section are circular arc-shaped or elliptical arc-shaped.

[0042] Optionally, in the artificial heart valve as described above, the top inner side of the upper protrusion of the outflow section, the top outer side of the upper protrusion of the outflow section and / or the top inner side of the lower protrusion of the outflow section are circular arc-shaped or elliptical arc-shaped.

[0043] Optionally, in the artificial heart valve as described above, an arc connection is formed between two adjacent upper support rods of the outflow segments, between two adjacent lower support rods of the outflow segments, between the upper support rod of the outflow segment and adjacent outflow end connection areas, and / or between the lower support rod of the outflow segment and adjacent outflow end connection areas.

[0044] Optionally, in the artificial heart valve as described above, the stent also includes at least one transition section arranged between the inflow section and the outflow section, the transition section includes a plurality of interconnected transition section frame units and a plurality of transition section connection areas, the transition section frame unit is a hollow frame unit having a transition section mesh, and the transition section connection area is an area where two adjacent transition section frame units are connected to each other.

[0045] Optionally, in the artificial heart valve as described above, the radial length of the transition segment mesh is smaller than the radial length of the inflow segment mesh and the radial length of the outflow segment mesh;

[0046] And / or, the axial length of the transition section mesh is smaller than the axial length of the inflow section mesh and the axial length of the outflow section mesh.

[0047] Optionally, in the artificial heart valve as described above, the transition section frame unit comprises an upper transition section protrusion and a lower transition section protrusion, the upper transition section protrusion protrudes along the axial direction of the stent toward the outflow end, and the lower transition section protrusion protrudes along the axial direction of the stent toward a direction away from the outflow end;

[0048] The transition section frame unit also includes a transition section upper support rod and a transition section lower support rod, the transition section upper support rod is connected between the transition section upper protrusion and the transition section connection area, and the transition section lower support rod is connected between the transition section lower support rod and the transition section connection area.

[0049] Optionally, in the artificial heart valve as described above, the transition section mesh is a gyro-shaped mesh.

[0050] Optionally, in the artificial heart valve as described above, the artificial heart valve further comprises:

[0051] an outer skirt, the outer skirt being located outside the bracket, and the upper end of the outer skirt being connected to the inflow section upper support rod of the inflow section frame unit;

[0052] An inner skirt, the inner skirt is located on the inner side of the bracket, the upper end of the inner skirt is connected to the lower support rod of the outflow section of the outflow section frame unit, the lower end of the inner skirt is connected to the lower end of the outer skirt, and an annular cavity is formed between the inner skirt and the outer skirt along the circumferential direction, and the annular cavity wraps the inflow section of the bracket.

[0053] Optionally, in the artificial heart valve as described above, the upper edge of the outer skirt wraps around the upper side of the support rod on the inflow segment.

[0054] Optionally, in the artificial heart valve as described above, the upper edge of the inner skirt wraps around the upper side of the lower support rod of the outflow section.

[0055] Optionally, in the artificial heart valve as described above, a plurality of skirt protrusions are integrally provided at the upper end of the outer skirt and the upper end of the inner skirt, and a skirt U-shaped groove is provided between two adjacent skirt protrusions.

[0056] Optionally, in the artificial heart valve as described above, the skirt protrusion is a trapezoidal protrusion that is narrow at the top and wide at the bottom.

[0057] Optionally, in the artificial heart valve as described above, the distance between two adjacent U-shaped grooves of the skirt: the width of the U-shaped groove of the skirt = (50-100):1, preferably (60-90):1.

[0058] Optionally, in the artificial heart valve as described above, a plurality of skirt cutouts are arranged on the outer skirt, and the skirt cutouts are spaced apart by a plurality of the skirt U-shaped grooves and are evenly arranged below the skirt U-shaped grooves;

[0059] When the outer skirt is arranged on the outer side of the bracket, the skirt cutout is located below the inflow section connection area.

[0060] Optionally, in the artificial heart valve as described above, the upper end of the skirt incision is connected to the skirt U-shaped groove.

[0061] Optionally, in the artificial heart valve as described above, a plurality of suture grooves are evenly arranged at the lower end of the outer skirt and the lower end of the inner skirt.

[0062] Optionally, in the artificial heart valve as described above, the circumference of the outer skirt: the circumference of the inner skirt = (1.1-1.3):1.

[0063] Optionally, in the artificial heart valve as described above, the outer skirt and the inner skirt are made of a braided structural material.

[0064] Optionally, in the artificial heart valve as described above, the weaving texture of the inner skirt is consistent with the length direction of the upper support rod of the inflow section and the length direction of the lower support rod of the inflow section.

[0065] Optionally, in the artificial heart valve as described above, the lower end of the leaflet body is connected to the inner skirt as a leaflet fixing portion.

[0066] Optionally, in the artificial heart valve as described above, a reinforcing strip edge is provided on the leaflet fixing portion, and the leaflet main body is connected to the inner skirt edge through the leaflet fixing portion and the reinforcing strip edge.

[0067] Optionally, in the artificial heart valve as described above, the stent comprises:

[0068] An inflow end, the inflow end is surrounded by a plurality of inflow segment frame units, and the inflow segment frame units are hollow frame units with inflow segment meshes;

[0069] An outflow end, the outflow end is surrounded by a plurality of outflow section frame units, the outflow section frame units are hollow frame units with outflow section meshes, the number of the outflow section frame units is less than the number of the inflow section frame units, and the outflow section frame units include a first mesh and a second mesh of different mesh sizes.

[0070] Optionally, in the artificial heart valve as described above, the stent comprises:

[0071] An inflow end, the inflow end is surrounded by a plurality of inflow segment frame units, and the inflow segment frame units are hollow frame units with inflow segment meshes;

[0072] an outflow end, the outflow end comprising a plurality of bracket connection holes fixedly connected to the leaflet mechanism, and the circumference of the bracket connection holes is not provided with an outflow section frame unit,

[0073] Or when outflow segment frame units are provided on the circumference where the support connection hole is located, the number of the outflow segment frame units is less than the number of the inflow segment frame units.

[0074] Optionally, the outflow end includes a plurality of outflow segment frame units, wherein the outflow segment frame units are hollow frame units having outflow segment meshes, and the outflow segment frame units include first meshes, and the first meshes are located on both sides of the bracket connection hole.

[0075] Optionally, the outflow section framework unit further includes a second mesh, and the first mesh and the second mesh are meshes of different sizes.

[0076] Optionally, the area of ​​the first mesh is smaller than the area of ​​the second mesh, and the number of the first mesh is greater than the number of the second mesh.

[0077] Optionally, a plurality of bracket connection holes are provided on the outflow end, and the circumference of the bracket connection holes are all connected to the first mesh.

[0078] Optionally, in the artificial heart valve as described above, when the number of the inflow segment frame units is 3N, the number of the outflow segment frame units is 3(N-1) or 3(N-2), and N is a natural number greater than 2, such as 3, 6, 7, 8, etc. In order to take into account the axial length and circumference of the artificial heart valve and avoid the artificial heart valve damaging the aortic wall or blocking the coronary artery orifice, N is preferably 4 or 5.

[0079] Optionally, in the artificial heart valve as described above, the outflow segment mesh is a first layer of mesh, the first layer of mesh includes a plurality of first meshes and a plurality of second meshes, and the axial length of the first mesh is smaller than the axial length of the second mesh.

[0080] Optionally, in the artificial heart valve as described above, when the axial length of the first mesh is H1 and the axial length of the second mesh is H2, H1:H2=(0.5-0.9):1.

[0081] Optionally, in the artificial heart valve as described above, when the circumferential arc length of the first mesh is L1 and the circumferential arc length of the second mesh is L2, L2=M*L1, M is a natural number greater than 1, and M is preferably 2 or 3.

[0082] Optionally, in the artificial heart valve as described above, two of the first meshes and one of the second meshes are arranged between two adjacent stent connection holes, the second mesh is located between the two first meshes, and the stent connection hole is arranged on the outflow segment connection area between two adjacent first meshes, wherein the outflow segment connection area is the area where two adjacent outflow segment frame units are connected to each other.

[0083] Optionally, in the artificial heart valve as described above, the width of the axial connecting rod of the stent connecting portion provided with the stent connecting hole is smaller than the width of the other outflow section connecting areas.

[0084] Optionally, in the artificial heart valve as described above, a mesh covering is provided at the first mesh, and the mesh covering is fixedly connected to the first mesh.

[0085] Optionally, in the artificial heart valve as described above, the mesh covering is fixed to the periphery of the stent.

[0086] Optionally, in the artificial heart valve as described above, the angle between the two angled support rods on the outflow end side of the first mesh is α, and the angle between the two angled support rods on the outflow end side of the second mesh is β. In order to maintain a relatively consistent clamping of the two angled support rods in the clamping state, α is designed to be β. The angle of the angled support rods is mainly used to ensure the stability of the stent. If the angle is too large, it will significantly increase the difficulty of clamping during the clamping process of the artificial heart valve. If the angle is too small, more meshes are required, affecting the clamping diameter of the heart valve. Therefore, α is preferably β = 100°-150°, such as 110°, 130°, 140°, etc., and α is more preferably β = 120°.

[0087] Optionally, in the artificial heart valve as described above, the width of the angled support rod on the outflow end side of the second mesh is D1, and the width of the angled support rod on the outflow end side of the first mesh is D2, then D1 is greater than D2, preferably D1:D2=1.1-1.3:1.

[0088] Optionally, in the artificial heart valve as described above, when the artificial heart valve is in a compressed state, the height of the outflow end of the second mesh is higher than the height of the outflow end of the first mesh.

[0089] Optionally, in the artificial heart valve as described above, a developing member is provided at the outflow end of the second mesh.

[0090] Optionally, in the artificial heart valve as described above, when the artificial heart valve is in a clamped state, two angled support rods on the outflow end side of the second mesh fit each other in the middle so that the artificial heart valve presents a teardrop-shaped structure at the distal end.

[0091] Optionally, in the artificial heart valve as described above, the width and / or height of the outflow end of the second mesh is greater than the width and / or height of the outflow end of the first mesh.

[0092] Optionally, in the artificial heart valve as described above, the outflow end of the second mesh is coated with a radiopaque development material.

[0093] Optionally, in the artificial heart valve as described above, when the artificial heart valve is placed at a target position in a human body, the end of the outflow end of the second mesh is aligned with the sinus floor of the aortic sinus in the circumferential direction.

[0094] Optionally, in the artificial heart valve as described above, a second layer of mesh is provided on the inflow end side adjacent to the first mesh, and the second layer of mesh is surrounded by a plurality of third meshes;

[0095] A third layer of mesh is provided on the inflow end side adjacent to the second mesh and the second layer of mesh, and the third layer of mesh is surrounded by a plurality of fourth meshes, so that the inflow end of the second mesh is surrounded by the support rods of the second layer of mesh and the third layer of mesh;

[0096] The inflow end side adjacent to the third layer of meshes has a fourth layer of meshes, and the fourth layer of meshes are the inflow section meshes.

[0097] Optionally, in the artificial heart valve as described above, a second layer of mesh is provided on the inflow end side adjacent to the first mesh, and the second layer of mesh is surrounded by a plurality of third meshes;

[0098] A third layer of meshes is provided on the inflow end side adjacent to the second layer of meshes, and the third layer of meshes is surrounded by a plurality of fourth meshes;

[0099] A fourth layer of mesh is provided on the inflow end side adjacent to the second mesh and the third layer of mesh, and the fourth layer of mesh is the inflow section mesh, so that the inflow end of the second mesh is surrounded by the supporting rods of the second layer of mesh, the third layer of mesh, and the fourth layer of mesh.

[0100] Optionally, in the artificial heart valve as described above, the outflow end side of the second mesh is an open structure, so that the first layer of mesh is composed of a plurality of first meshes.

[0101] The positive and progressive effects of the present invention are:

[0102] 1. When connecting two adjacent artificial leaflets, the present invention abandons the existing method of using clips, and first connects multiple artificial leaflets together through a connector to form a ring-like structure. The artificial leaflets and the stent are fixed together by connecting the connectors located on the inner and outer sides of the stent and the fixing part. With this design, after the artificial leaflets and the stent are fixed, the arc-shaped part folded on the side of the fixing part is abutted against the outer wall of the leaflet body. Usually, the arc-shaped part is made integrally with the artificial leaflet, and the arc-shaped part has good flexibility. When the artificial leaflet is in the open state, the arc-shaped part abutting against the outer wall of the artificial leaflet can provide a certain supporting force to prevent the artificial leaflet from opening completely. On the one hand, it avoids the stress concentration at the connection between the artificial leaflet and the stent, which reduces the service life of the artificial leaflet. On the other hand, the incomplete opening of the artificial leaflet can prevent the artificial leaflet from sticking to the aortic wall and blocking the coronary orifice when it is in the open state.

[0103] When the artificial valve leaflet is in a closed state, blood from the aorta impacts the artificial valve leaflet. Since the free end of the arc-shaped portion has a certain width, it can protect the artificial valve leaflet at the connection with the stent, buffer the scouring force of the blood flow on the artificial valve leaflet, and better protect the artificial valve leaflet.

[0104] In addition, the arc-shaped structural design of the arc portion is more in line with fluid mechanics. When the artificial valve leaflet is closed, the arc-shaped portion can block part of the impact of blood flow and avoid the formation of vortices between the arc-shaped portion and the main body of the artificial valve leaflet, or at least reduce the vortex and reduce the impact of blood flow on the valve leaflet and the stent. On the one hand, it improves the fatigue life of the stent, and on the other hand, it makes the artificial heart valve more stable after being implanted in the human body. This is because the stability of the artificial heart valve is one of its important indicators. It is expected that the valve can maintain its position at the time of implantation after implantation to avoid displacement or even falling off. For artificial heart valves, especially in the pre-endothelialization stage after the valve has just been implanted in the human body, a stable stent can improve the safety of the product and avoid blood impact causing the valve to shift and cause surgical failure.

[0105] 2. The main shape and / or parameter design of the leaflets, the manufactured artificial leaflets form a leaflet mechanism, and are sutured and fixed by connecting parts, which can avoid the problem of reduced leaflet strength due to holes in the artificial leaflets caused by suture.

[0106] 3. The stent connection hole connected to the leaflet mechanism on the stent is a rectangular hole. Compared with multiple circular holes, it can greatly increase the number of sutures during connection, making it easier to sew multiple sutures. On the one hand, it can make the leaflet more firmly fixed, and on the other hand, it can avoid stress concentration, which can effectively extend the service life of the leaflet. Moreover, the rectangular hole design has enough space for the connector to pass from the inside of the stent through the stent connection hole to the outside of the stent.

[0107] After the support connection hole is designed as a rectangular hole, the axial frame rods on both sides of the rectangular hole become thinner. During the expansion of the valve, the axial frame rods of the rectangular hole are likely to become stress concentration points and sag inward, thereby squeezing the artificial valve leaflets passing through the rectangular hole. In order to avoid this situation, when the support rods at the upper and lower ends of the rectangular hole are connected, the support rods are connected side by side in the middle of the upper and lower ends of the rectangular hole, so as to protect the rectangular hole during the expansion of the valve and prevent the rectangular hole from sag inward and squeezing the internal valve leaflets.

[0108] 4. The mesh of the inflow section and / or transition section of the stent adopts a gyro-shaped mesh design. The contact area (axial limit) of two adjacent gyro-shaped structures is small. After the valve is implanted in the human body and expanded, a larger expansion diameter can be achieved due to the small axial limit. The gyro-shaped structure is located in the inflow section and / or transition section of the valve. When the artificial heart valve is in a closed state, the blood flow from the aorta has a greater impact on the artificial heart valve, and the gyro-shaped structure can have a larger contact area and friction with the aortic root, which can significantly improve the impact resistance of the stent.

[0109] In addition, the gyro-shaped mesh design of the inflow segment, after the artificial heart valve expands, can make the inflow end stent retract a larger size toward the aorta due to the greater expansion, so as to prevent the inflow segment of the artificial heart valve from touching the His bundle and avoiding atrioventricular conduction block. It also reduces the axial size of the artificial heart valve after expansion, reducing the impact of the implanted artificial heart valve on the patient.

[0110] 5. The mesh of the transition section is smaller than the mesh of the outflow section and the mesh of the inflow section on its upper and lower sides. The smaller mesh can provide greater strength.

[0111] In addition, the artificial heart valve is in a folded state during the delivery process. When it is delivered to the aortic valve, a high-pressure balloon is needed to expand the stent. During the expansion process, the mesh in the middle section has a greater resistance to opening. Therefore, compared with the mesh in the inflow section and the outflow section, the mesh in the middle section expands more slowly. That is, the expansion process presents a "bone-like" shape with thick ends and a thin middle. This expansion method can ensure that the position of the artificial heart valve is relatively fixed before and after expansion, and there will be no axial displacement during the expansion process, thereby ensuring the accuracy of the valve release position.

[0112] 6. The outer skirt and the inner skirt of the present invention are designed to form an annular cavity along the circumferential direction. When the stent has a transition section, the outer periphery of the transition section is not covered with a coating. With this design, on the one hand, after the artificial heart valve is implanted in the human body, endothelialization starts from the outer skirt of the outflow section. Since the transition section and its upper and lower parts are not covered by the inner and outer skirts, a small amount of blood entering this range will form a thrombus here due to the reduced flow rate, which has a better sealing effect. On the other hand, not covering the transition section with a coating can reduce the diameter of the transition section in the collapsed state, which is convenient for transportation.

[0113] 7. The outer skirt and the inner skirt of the present invention are provided with skirt U-shaped grooves to ensure that wrinkles will not appear after the inner and outer skirts wrap the support rods.

[0114] In addition, a number of narrow incisions are provided on the outer skirt, so that a small amount of blood can enter the annular cavity formed by the inner and outer skirts. Since the interior of the annular cavity is a relatively static environment, blood is more likely to form thrombi in the annular cavity, filling the gap between the outer skirt and the aortic wall that is not tightly sealed, so as to further improve the sealing performance of the artificial heart valve. Until the outer skirt is endothelialized, the narrow incisions are covered by hyperplastic tissue, and the artificial heart valve is stably fixed at the aortic root position to better prevent paravalvular leakage. The use of narrow incisions instead of notches can allow blood to enter and exit the annular cavity, but avoids the danger of thrombus overflow. On the other hand, the artificial heart valve is soaked in glutaraldehyde solution before use, and a certain amount of glutaraldehyde solution will accumulate in the annular cavity. The narrow incisions can ensure that glutaraldehyde is completely discharged in the process of cleaning the artificial heart valve before pressing and gripping.

[0115] 8. The design of the inner skirt close to the inner side of the stent can relatively limit the movement space of the inner skirt, thereby providing a stable environment for the valve leaflet, so that the artificial valve leaflet can reduce external interference in the closed state, form a closing surface according to the designed closing curve, and reduce the occurrence of reflux.

[0116] 9. During the folding process, the bracket will stretch along the axial direction of the bracket. The texture of the inner skirt is arranged in the same direction as the two support rods of the inflow section frame unit, so that the inner skirt has greater ductility during the axial stretching of the bracket, reducing the axial constraint of the bracket.

[0117] 10. In the present invention, since the number of outflow segment frame units is less than that of inflow segment frame units, the number of outflow segment meshes is less than that of inflow segment meshes, so that the outflow segment meshes have a larger hollow grid structure. While ensuring that the inflow end provides sufficient radial support, a larger hollow grid design is adopted at the local position of the outflow end, and the possibility of the artificial valve leaflet hitting the stent grid is greatly reduced. Therefore, the artificial valve leaflet can be designed to have a larger effective opening area, reducing the pressure drop caused by blood passing through the artificial heart valve, which is more ergonomic. In addition, the design of a larger hollow grid can also reduce the risk of coronary artery obstruction and provide a good coronary re-intervention channel.

[0118] 11. The present invention limits the arrangement and specifications of the first mesh and the second mesh of the first layer of mesh, so that the axial length of the stent can be minimized without blocking the coronary artery, thereby reducing the impact of the implantation of the artificial heart valve on the aortic structure.

[0119] 12. The stent connection hole connected to the leaflet mechanism is arranged on the outflow section connection area between two adjacent first mesh holes, so that both sides of the stent connection hole are protected by the first mesh holes. The first mesh holes with smaller grids can effectively prevent the invasion of calcified native leaflets to artificial leaflets, and the stent designed in this way will not cause the artificial leaflets to beat the stent, and can also well avoid the damage of the artificial leaflets to the calcified sites on the native leaflets or the aortic wall, and can design the opening area of ​​the artificial heart valve to be larger, effectively avoiding the occurrence of aortic stenosis caused by the implantation of artificial heart valves.

[0120] 13. After being compressed and gripped, the stent of the present invention has a more uniform compression shape. The shape of the mesh with stent connection holes after compression is similar to that of the mesh without stent connection holes, and there is no obvious compression tilt shape. This is because the rod width of the stent connection hole is narrower than that of other meshes, which reduces the difference between the stent connection hole and the connecting rods at other positions caused by the double support rods. Another part of the reason is that the second mesh is designed to be larger, which increases the distance between the axial struts of the second mesh in the compressed state, and further weakens the difference between the stent connection hole formed with the rectangular hole. Such an artificial heart valve is closer to the designed size and shape when it returns to the expanded state.

[0121] 14. In order to reduce the impact of native aortic calcification sites on artificial valve leaflets, a mesh coating is provided at the first mesh hole to enhance the barrier effect of the artificial heart valve on the native valve leaflets, reduce the invasion of the native valve leaflets on the artificial valve, and promote endothelialization of the outflow end. No mesh coating is provided on the second mesh hole to avoid blocking the coronary artery orifice. The mesh coating is located on the outside of the stent, so that the stent fits better with the structure at the implantation site and fills the gap between the calcification sites to avoid paravalvular leakage.

[0122] 15. The shape design of the first mesh and the second mesh, especially the angle design of the two angled support rods on the outlet side, provides sufficient support force for the bracket, and the force at the connection point of the support rod is optimal.

[0123] In order to make the first mesh and the second mesh more evenly pressed and gripped during the pressing and gripping process without biasing the mesh, the first mesh and the second mesh are designed with angled support rods of different widths.

[0124] In addition, since the outflow end is designed to have a first mesh and a second mesh structure with different heights, when the stent is in a compressed and gripped state, the height of the outflow end of the second mesh is greater than the height of the outflow end of the first mesh. The protruding design can be used as a developer of the artificial heart valve. With the assistance of the medical equipment DSA, the highly protruding second mesh will produce a marking effect, which is used to align the artificial valve leaflets and the autologous valve leaflets along the axial direction and maintain the same height as the native valve leaflets, so that the artificial heart valve has better hemodynamics.

[0125] In the gripping state, the two angled support rods at the outflow end of the second mesh fit each other in the middle, so that the distal end presents a teardrop-shaped structure. The teardrop-shaped structure of the stent can provide a stronger radial restoring force for the angled support rods, which is more conducive to the artificial heart valve returning to the expanded state when the phase transition temperature is reached. In addition, the teardrop-shaped structure itself is more conducive to being used as a developing part, and has a better developing effect under ultrasound conditions.

[0126] 16. The present invention defines an optimal positional relationship between the first layer mesh, the second layer mesh, the third layer mesh and the fourth layer mesh, so that there are no independent sharp corners at the end of the mesh inside the second layer mesh of the first layer mesh. During the process of balloon expansion of the stent, it can be avoided that the sharp corners damage the leaflets or the balloon and cause the operation failure.

[0127] 17. In the present invention, due to the different sizes of the inflow end mesh, the second mesh can also be used as a positioning device to align the native valve leaflet. Preferably, the coronary artery ostium can be controlled to be located in the middle of the second mesh, so that subsequent coronary surgical instruments can enter through the second mesh. In addition, since the artificial heart valve designed in this way can have a more precise circumferential release position, the artificial valve leaflet can be released at a position closer to the native valve leaflet, with better hemodynamic characteristics.

[0128] 18. The present invention can also omit the second mesh, and the first layer of mesh only relies on the first mesh to block the damage of the calcification site to the valve leaflet. The existence of the first mesh can also increase the contact area between the outflow end of the stent and the aortic wall. Compared with the stent whose outflow end only includes the stent connection hole, the pressure of the outflow end of the stent on the aortic wall can be greatly reduced, thereby ultimately reducing the damage to the aortic wall. BRIEF DESCRIPTION OF THE DRAWINGS

[0129] The disclosure of the present invention will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the drawings:

[0130] FIG. 1( a ) is a schematic structural diagram of an artificial valve leaflet of the present invention;

[0131] FIG1( b ) is a schematic diagram showing the connection of two adjacent artificial valve leaflets according to the present invention;

[0132] FIG1( c ) is a partial view of the connection between the valve leaflet mechanism and the stent of the present invention;

[0133] FIG. 1( d ) is a diagram showing the positional relationship between the artificial valve leaflet and the reinforced strip edge of the present invention;

[0134] FIG1( e ) is a schematic diagram of an artificial valve leaflet without a protrusion in a closed state;

[0135] FIG. 2( a ) is a schematic diagram of a structure of a bracket of the present invention;

[0136] FIG2( b ) is a front view of FIG2( a );

[0137] FIG2(c) is a partial enlarged view of FIG2(b);

[0138] FIG2( d ) is a schematic diagram of the stent deployment structure of FIG2( a );

[0139] FIG2( e ) is a schematic diagram of the sewing state of the inner skirt of the present invention;

[0140] FIG3( a ) is a schematic diagram of an unfolded structure of the outer skirt of the present invention;

[0141] FIG3( b ) is a partial enlarged view of point A in FIG3( a );

[0142] FIG3(c) is a partial enlarged view of point B in FIG3(a);

[0143] FIG4( a ) is a schematic diagram of an unfolded structure of the inner skirt of the present invention;

[0144] FIG4( b ) is a schematic diagram of another unfolded structure of the inner skirt of the present invention;

[0145] Figure 5 A schematic diagram of an artificial heart valve provided by the present invention;

[0146] FIG6( a ) is another structural stereogram of the bracket of the present invention;

[0147] FIG6(b), FIG6(c) and FIG6(d) are front views of FIG6(a) at three different angles;

[0148] FIG. 7( a ) is a schematic diagram of a stent deployment of FIG. 6( a );

[0149] FIG7( b ) is a partial enlarged view of FIG7( a );

[0150] FIG7( c ) is a schematic diagram of a stent deployment of FIG6( a );

[0151] FIG7( d ) is a partial enlarged view of FIG7( c );

[0152] Figure 8 It is a schematic diagram of another stent deployment of the present invention;

[0153] FIG9( a ) is a schematic diagram of a stent deployment after mesh coating in FIG7( a );

[0154] FIG9( b ) is a schematic diagram of another stent deployment after mesh coating according to the present invention;

[0155] FIG9( c ) is a schematic diagram of another stent deployment of the present invention;

[0156] Fig.10 A schematic diagram of a structure when other meshes are arranged in the second mesh of the present invention;

[0157] Fig.11 A compression state structural diagram of the present invention;

[0158] Figure 12(a) , 12(b) , 12(c), and 12(e) are respectively schematic diagrams of another type of stent deployment;

[0159] FIG12( d ) is a partial enlarged view of FIG12( c ). DETAILED DESCRIPTION

[0160] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0161] It should be noted that the following embodiments and features therein may be combined with each other if there is no conflict.

[0162] In the description of the present invention, it should be noted that directional words such as the terms "outside", "middle", "inside", "outside", etc., which indicate directions and positional relationships, are based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific protection scope of the present invention.

[0163] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "a number" mean two or more, unless otherwise clearly and specifically defined.

[0164] In the description of the present invention, it should be noted that the "inflow end", "outflow end", "inflow section" and "outflow section" used in the present invention are directional words, which are commonly used terms in the field of interventional medical devices, wherein the "inflow end" and "inflow section" indicate that the antegrade blood first flows into one end or a section of the interventional medical device, such as the lower end or lower section in Figure 2(b) and Figure 6(b). "Outflow end" and "outflow section" indicate that the antegrade blood flows out of one end or a section of the interventional medical device, such as the upper end or upper section in Figure 2(b) and Figure 6(b). "Axial" refers to the direction parallel to the line connecting the center of the "inflow end" and the center of the "outflow end", such as the axial direction of the stent in Figure 2(b) and Figure 6(b), that is, the up and down direction. "Radial" refers to the direction perpendicular to the above-mentioned "axial".

[0165] As shown in Fig. 1 to Fig. 4, an embodiment of an artificial heart valve provided by the present invention is shown, and the artificial heart valve comprises a stent 100 and a leaflet mechanism 200. The stent 100 is an overall annular stent that can contract or expand radially, and can be expanded by a balloon. A plurality of stent connection holes 140 are provided on the stent 100, and the leaflet mechanism 200 is connected to the inner side of the stent 100 through the stent connection holes 140.

[0166] Reference Figure 1(a) to Figure 1(d) The valve leaflet mechanism 200 includes a plurality of connectors 210 and a plurality of artificial valve leaflets 220. The plurality of artificial valve leaflets 220 are sequentially connected to form a ring-like structure. Preferably, the number of connectors 210 is equal to the number of artificial valve leaflets 220. More preferably, the number of connectors 210 and the number of artificial valve leaflets 220 are both 3. Each artificial valve leaflet 220 has a valve leaflet body 221, two first connecting portions 222 and two second connecting portions 223.

[0167] The two first connection parts 222 are connected to the two sides of the free end of the leaflet body 221, and the two second connection parts 223 are connected to the upper part of the first connection parts 222 respectively, and the connection part can be folded, that is, the second connection part 223 can be folded forward (perpendicular to the paper surface) along the first flip axis 223a. The second connection part 223 is divided into a fixed part 2231 on the left and an arcuate part 2232 on the right. The connection part between the fixed part 2231 and the arcuate part 2232 can be folded, that is, the fixed part 2231 can be folded relative to the arcuate part 2232 along the second flip axis 223b, and the second flip axis 223b divides the second connection part 223 into the fixed part 2231 and the arcuate part 2232. The side of the arcuate part 2232 away from the fixed part 2231 is an arcuate structure 2232a, that is, the right edge of the arcuate part 2232 is an arcuate structure 2232a as shown in Figure 1 (a).

[0168] When several artificial valve leaflets 220 of the same structure are connected in sequence, referring to FIG. 1( b ), the two first connection parts 222 of two adjacent artificial valve leaflets 220 are fixedly connected together by the connection member 210 , and one end of the connection member 210 covers the first connection part 222 to prevent the valve leaflet from being damaged. Several artificial valve leaflets 220 are connected in a ring shape, and after being folded in half along the axis of symmetry of the connection member, the connection member 210 is passed through the corresponding stent connection hole 140 from the inner side of the stent 100 , and the connection member 210 located on the outer side of the stent 100 is evenly divided into two parts on both sides of the stent connection hole 140 and abuts against the outer periphery of the stent 100 . As shown in FIG. 1( c ), the second connection part 223 is folded toward the outer side of the overlapping area formed by the two adjacent artificial valve leaflets 220 , the arc-shaped part abuts against the outer wall of the valve leaflet body 221 , and the fixing part 2231 is folded along the surface perpendicular to the artificial valve leaflet body and abuts against the connection member 210 on the inner side of the stent 100 . Two adjacent fixing portions 2231 are respectively connected to two sides of the connecting member 210 , and the fixed state is shown in FIG. 1( c ), thereby achieving fixation between the leaflet mechanism 200 and the stent 100 .

[0169] The present invention is fixedly connected by a fixing portion 2231 located on the inner side of the stent and a connector 210 located on the outer side of the stent. After the leaflet mechanism 200 is connected to the stent 100, the arc portion 2232 folded on the side of the fixing portion 2231 is pressed against the outer wall of the leaflet body 221. Usually, the arc portion 2232 is made integrally with the artificial leaflet 220. The arc portion 2232 has good flexibility. When the artificial leaflet 220 is in the open state, the arc portion 2232 pressed against the outer wall of the artificial leaflet 220 can provide a certain support force to prevent the artificial leaflet from being fully opened. On the one hand, it prevents the artificial leaflet from being subjected to stress concentration at the connection between the artificial leaflet and the stent, thereby reducing the service life of the artificial leaflet. On the other hand, if the artificial leaflet is not fully opened, it can prevent the artificial leaflet from sticking to the aortic wall and blocking the coronary orifice in the open state. When the artificial valve leaflet is in a closed state, the blood from the aorta impacts the artificial valve leaflet. Since the free end of the arc portion has a certain width, it can protect the artificial valve leaflet at the connection with the stent, buffer the scouring force of the blood flow on the artificial valve leaflet, and better protect the artificial valve leaflet 220. In particular, the right side of the arc portion 2232 is designed as an arc structure 2232a, which is more in line with fluid mechanics. When the artificial valve leaflet is closed, the arc portion can block the impact of part of the blood flow, avoid the formation of vortices between the arc portion and the main body of the artificial valve leaflet, or at least reduce the vortex, reduce the blood flow impact on the valve leaflet and the protection stent, on the one hand, improve the fatigue life of the stent 100, and on the other hand, make the artificial heart valve more stable after being implanted in the human body. This is because the stability of the artificial heart valve is one of its important indicators. It is expected that the valve can remain in the position at the time of implantation after implantation to avoid displacement or even shedding events. For artificial heart valves, especially in the non-endothelialization stage after the valve is just implanted in the human body, a stable stent 100 can improve the safety of the product and avoid blood impact causing the valve to shift and cause surgical failure.

[0170] In some embodiments, the leaflet mechanism 200 includes three connectors 210 and three artificial leaflets 220 , and the three artificial leaflets 220 are sequentially connected by connectors 310 to form a ring-like structure.

[0171] In some embodiments, two adjacent fixing portions 2231 are respectively connected to two sides of the connector 210 by suturing, and during suturing, the suture thread surrounds the axial frame rod of the bracket connection hole to fix the fixing portion 2231 and the connector 210 .

[0172] In some embodiments, referring to FIG. 1( a ), a horizontal leaflet U-shaped groove 224 is provided at the connection between the first connection portion 222 and the second connection portion 223, and the opening of the leaflet U-shaped groove 224 is an open structure. When the connector 210 extends from the inner side of the stent 100 through the stent connection hole 140 to the outer side of the stent 100, the first connection portion 222 connected to the connector 210 is pulled outward, and the second connection portion 223 needs to be bent so that the fixing portion 2231 is located at a position relative to the inner side of the connector 210. Through the design of the leaflet U-shaped groove 224, no matter when the connector 210 is extended or the fixing portion 2231 is bent along the leaflet U-shaped groove 224, the first connection portion 222 and the second connection portion 223 will not be damaged.

[0173] In this application, "bending" and "folding" both refer to the flipping of a component along a certain axis.

[0174] In some embodiments, referring to FIG. 1( a ), the outer contour of the fixed end of the leaflet body 221 has a leaflet bottom arc 2211 and two leaflet side arcs 2212. The lower end of the leaflet bottom arc 2211 is an arc-shaped structure. The two leaflet side arcs 2212 are respectively located on both sides of the leaflet bottom arc 2211, and the lower ends of the leaflet side arcs 2212 are also arc-shaped structures. The leaflet bottom arc 2211 and the leaflet side arcs 2212 on both sides have the same slope and are smoothly connected to form the fixed end of the artificial leaflet 220.

[0175] When an inner skirt is provided on the inner side of the stent 100, the lower end of the leaflet body 221 usually needs to be connected to the inner skirt, such as by suturing. After the lower end of the leaflet body 221 is designed as the above structure, the manufactured leaflet mechanism 200 is used in an artificial heart valve, has better performance, and can effectively avoid reflux.

[0176] In some embodiments, referring to Figure 1(d), when the lower end of the leaflet body 221 is connected to the inner skirt 400 as a leaflet fixing part, in order to avoid damage to the leaflet, a reinforcing strip edge 225 is provided on the leaflet fixing part, and the leaflet body 221 is connected to the inner skirt 400 together with the leaflet fixing part and the reinforcing strip edge 225.

[0177] In some embodiments, referring to FIG. 1( a ), the leaflet bottom arc 2211 is an arc formed by a first radius R1 , and the two leaflet side arcs 2212 are arc formed by a second radius R2 , then R2:R1=(2-5):1.

[0178] In some embodiments, referring to FIG. 1( a ), the arc length of the leaflet side arc 2212 is L2, and the arc length of the leaflet bottom arc 2211 is L1, then L2:L1=(1.2-2):1, such as 1.3:1, 1.5:1, 1.8:1, and so on.

[0179] In some embodiments, referring to FIG. 1( a ), the upper end profile of the leaflet body 221 has an upward protrusion, forming a protrusion 2213 .

[0180] As shown in FIG. 1( a ), the free end of the leaflet body 221 protrudes upward as a free edge to form a protrusion 2213. The design of the protrusion 2213 can increase the contact area between the artificial leaflets 220 when the artificial heart valve is in a closed state, and the protrusion can fill the gap formed in the middle when the artificial leaflets 220 are closed, which can ensure that the artificial leaflets 220 have a better fit and effectively avoid the occurrence of reflux. This is because, especially for the ball-expanded valve stent, due to its strong supporting force, when the artificial leaflets 220 are in a closed state, its outflow end is still against the aortic wall, or only moves slightly radially toward the central axis of the aorta, and the middle part of the multiple artificial leaflets 220 will form a triangular gap 229 as shown in FIG. 1( e ). The existence of the triangular gap 229 will cause reflux in the artificial heart valve, and the design of the protrusion 2213 can increase the fit of the artificial leaflets 220 in the closed state to avoid reflux.

[0181] In some embodiments, referring to FIG. 1( a ), two avoidance cutouts 226 are provided on the leaflet body 221 , and the avoidance cutouts 226 are located at the connection between the leaflet body 221 and the first connection portion 222 .

[0182] As shown in FIG. 1( a ), the avoidance cutout 226 is a triangular-shaped structure, so that an angle is formed between the leaflet body 221 and the first connecting portion 222 .

[0183] Since the connector 210 needs to extend from the inside of the stent 100 through the stent connection hole 140 to the outside of the stent 100, when extending, if there is no avoidance cutout 226, the connection between the leaflet body 221 and the first connection portion 222 will be wrinkled and may accumulate in the stent connection hole 140 or on the side, affecting the extension of the connector 210 and its connection with the fixing portion 2231. Therefore, in this embodiment, an avoidance cutout 226 is designed at the connection between the leaflet body 221 and the first connection portion 222 to avoid the above problem.

[0184] In some embodiments, referring to FIG. 1( a ), the angle α of the avoidance incision 226 is no greater than 90°, such as 85°, 80°, 75°, 70°, etc., which can ensure that the leaflet body 221 fits the inner side of the stent 100 , and allow sufficient suturing space for the first connecting portion 222 and the connecting piece 210 .

[0185] In some embodiments, the present embodiment further improves the bracket 100, especially the hole shape of the bracket connecting hole 140. Referring to FIG. 2(c), the bracket connecting hole 140 of the present embodiment is a rectangular hole.

[0186] The stent connection hole 140 is a rectangular hole. Compared with multiple circular holes, the number of sutures used during connection can be greatly increased, making it easier to sew multiple sutures. On the one hand, the leaflets can be more firmly fixed, and on the other hand, stress concentration can be avoided, which can effectively extend the service life of the leaflets. Moreover, the rectangular hole design has enough space for the connector 210 to pass from the inside of the stent 100 through the stent connection hole 140 and out of the outside of the stent 100.

[0187] In some embodiments, the rectangular hole is preferably a waist-shaped hole, so that the inner walls at the upper and lower ends of the rectangular hole are arc-shaped surfaces to avoid wear of the connector 210.

[0188] In some embodiments, reference Figure 2(a) to Figure 2(d) The stent 100 is in a hollow straight cylinder-like shape, and includes an inflow section 110 and an outflow section 120 that are connected to each other.

[0189] The inflow segment 110 includes a plurality of inflow segment frame units 111 connected end to end and a plurality of inflow segment connection areas 112 . The inflow segment frame unit 111 is a hollow frame unit having an inflow segment mesh 113 . The inflow segment connection area 112 is an area where two adjacent inflow segment frame units 111 are connected to each other.

[0190] The outflow section 120 includes a plurality of outflow section frame units 121 connected end to end in sequence and a plurality of outflow section connection areas 122. The outflow section frame unit 121 is a hollow frame unit having an outflow section mesh 123. The outflow section connection area 122 is an area where two adjacent outflow section frame units 121 are connected to each other. Part of the outflow section connection area 122 is provided with a bracket connection hole 140 as a bracket connection portion 122a.

[0191] 2( a ), when the leaflet mechanism 200 has three artificial leaflets 220 , three of the outflow segment connection region 122 are provided with stent connection holes 140 as stent connection portions 122 a , and the three stent connection portions 122 a are evenly arranged along the circumferential direction.

[0192] In some embodiments, two radially adjacent inflow segment frame units 111 share frame units and connection regions, and two radially adjacent outflow segment frame units 121 share frame units and connection regions.

[0193] In some embodiments, when the outflow end of the inflow segment 110 is axially adjacent to the inflow end of the outflow segment 120, that is, the stent 100 only has the inflow segment 110 and the outflow segment 120, the inflow segment frame unit 111 shares adjacent frame units and connection areas with its axially adjacent outflow segment frame unit 121.

[0194] In some embodiments, the inflow segment mesh 113 is a gyro-shaped mesh.

[0195] The gyro-shaped mesh design has a smaller contact area (axial limit) between two adjacent gyro-shaped structures. After the valve is implanted in the human body and expanded, it can reach a larger expansion diameter due to the small axial limit. The gyro-shaped structure is located in the inflow section of the valve. When the artificial heart valve is in a closed state, the blood flow from the aorta has a greater impact on the artificial heart valve, and the gyro-shaped structure can have a larger contact area and friction with the aortic root, which can significantly improve the impact resistance of the stent. In addition, the gyro-shaped mesh design of the inflow section, after the artificial heart valve expands, the gyro-shaped design can make the inflow end stent retract a larger size toward the aorta due to the larger expansion, so as to avoid the inflow section of the artificial heart valve touching the His bundle and avoid atrioventricular conduction block. It also reduces the axial size of the artificial heart valve after expansion, reducing the impact on the patient caused by the implantation of the artificial heart valve.

[0196] In some embodiments, the outflow segment mesh 123 is a hexagonal mesh.

[0197] In some embodiments, referring to Figure 2(b), the outflow segment frame unit 121 includes an outflow segment upper protrusion 1211 and an outflow segment lower protrusion 1212, the outflow segment upper protrusion 1211 protrudes along the axial direction of the bracket 100 toward the outflow end, and the outflow segment lower protrusion 1212 protrudes along the axial direction of the bracket 100 toward the direction away from the outflow end.

[0198] The outflow section frame unit 121 also includes an outflow section upper support rod 1213 and an outflow section lower support rod 1214, the outflow section upper support rod 1213 is connected between the outflow section upper protrusion 1211 and the outflow section connecting area 122, and the outflow section lower support rod 1214 is connected between the outflow section lower protrusion 1212 and the outflow section connecting area 122.

[0199] Referring to Figure 2(c), when the outflow section connection area 122 is the bracket connection part 122a, the two adjacent outflow section upper support rods 1213 are connected side by side at the middle of the outflow end of the bracket connection part 122a, and the two adjacent outflow section lower support rods 1214 are connected side by side at the middle of the inflow end of the bracket connection part 122a.

[0200] The outflow section frame unit 121 of the present embodiment is composed of an outflow section upper protrusion 1211, an outflow section upper support rod 1213, an outflow section connection area 122, an outflow section lower support rod 1214, an outflow section lower protrusion 1212, another outflow section lower support rod 1214, another outflow section connection area 122 and another outflow section upper support rod 1213 connected in sequence to form a hollow frame unit with an inflow section mesh 113. The outflow section upper support rod 1213, the outflow section connection area 122 and the outflow section lower support rod 1214 are shared between two radially adjacent outflow section frame units 121.

[0201] After the stent connection hole 140 is designed as a rectangular hole, the width of the axial frame rods on both sides of the rectangular hole on the stent connection part 122a becomes thinner. During the expansion of the valve, the axial frame rods of the rectangular hole are likely to become stress concentration points and sag inward, thereby squeezing the artificial valve leaflets 220 passing through the rectangular hole. In order to avoid this situation, in this embodiment, when the support rods at the upper and lower ends of the rectangular hole are connected, they are connected side by side in the middle of the upper and lower ends of the rectangular hole, so that during the expansion of the valve, the rectangular hole as a whole can be used as a stress support point to protect the rectangular hole and prevent the axial rods of the rectangular hole from sag inward and squeeze the valve leaflets passing through the rectangular hole. In some embodiments, referring to Figure 2(c), the width of the axial connecting rod 122a1 of the stent connection part 122a is smaller than the width of other outflow section connection areas 122. The rectangular structure of the stent connection part 122a is equivalent to the two axial connecting rods 122a1 working together to play a supporting role. Reducing the width of the axial connecting rod 122a1 of the stent connection part 122a can, on the one hand, minimize the contraction diameter of the valve in the contraction state, and on the other hand, maintain the support strength of the stent connection part 122a and other outflow section connection areas 122 to be approximately equal.

[0202] In some embodiments, referring to Figure 2(b), the inflow segment frame unit 111 includes an inflow segment upper protrusion 1111 and an inflow segment lower protrusion 1112, the inflow segment upper protrusion 1111 protrudes along the axial direction of the bracket 100 toward the outflow end, and the inflow segment lower protrusion 1112 protrudes along the axial direction of the bracket 100 toward the direction away from the outflow end.

[0203] The inflow section frame unit 111 also includes an inflow section upper support rod 1113 and an inflow section lower support rod 1114, wherein the inflow section upper support rod 1113 is connected between the inflow section upper protrusion 1111 and the inflow section connecting area 112, and the inflow section lower support rod 1114 is connected between the inflow section lower protrusion 1112 and the inflow section connecting area 112.

[0204] The inflow section frame unit 111 of the present embodiment is composed of an inflow section upper protrusion 1111, an inflow section upper support rod 1113, an inflow section connection area 112, an inflow section lower support rod 1114, an inflow section lower protrusion 1112, another inflow section lower support rod 1114, another inflow section connection area 112 and another inflow section upper support rod 1113 connected in sequence to form a hollow frame unit with an inflow section mesh 113. The inflow section upper support rod 1113, the inflow section connection area 112 and the inflow section lower support rod 1114 between two radially adjacent inflow section frame units 111.

[0205] In some embodiments, when the outflow end of the inflow segment 110 is axially adjacent to the inflow end of the outflow segment 120, that is, when the stent 100 has only the inflow segment 110 and the outflow segment 120, the inflow segment upper support rod 1113 of the inflow segment frame unit 111 is shared with the outflow segment lower support rod 1214 of the axially adjacent outflow segment frame unit 121. The inflow segment connection area 112 is shared with the outflow segment lower protrusion 1212 of the axially adjacent outflow segment frame unit 121.

[0206] In some embodiments, the top inner side of the inflow section upper protrusion 1111, the top inner side of the inflow section lower protrusion 1112 and / or the top outer side of the inflow section lower protrusion 1112 are in the shape of a circular arc or an elliptical arc.

[0207] In some embodiments, the top inner side of the upper protrusion 1211 of the outflow segment, the top outer side of the upper protrusion 1211 of the outflow segment and / or the top inner side of the lower protrusion 1212 of the outflow segment are circular arc-shaped or elliptical arc-shaped. When the artificial heart valve is in a contracted state, due to the existence of the circular arc or the elliptical arc, the adjacent upper support rods 1113 or the adjacent lower support rods 1114 of the inflow segment will not be tightly attached together, and the upper support rods 1113 or the lower support rods 1114 form a certain angle with the central axis of the valve, thereby providing a force arm for the subsequent radial expansion of the balloon, thereby avoiding the problem of the artificial heart valve being unable to expand or swell during surgery.

[0208] In some embodiments, an arc connection is formed between two adjacent outflow section upper support rods 1213, between two adjacent outflow section lower support rods 1214, between the outflow section upper support rod 1213 and the adjacent outflow end connection area, and / or between the outflow section lower support rod 1214 and the adjacent outflow end connection area.

[0209] The arc-shaped improvements are made at the joints and end corners of the stent 100, so that the stent 100 is not easily damaged during the radial contraction or expansion process, and the radial diameter after contraction is smaller.

[0210] In some embodiments, reference Figure 2(a) to Figure 2(d)The stent 100 also includes at least one transition section 130 arranged between the inflow section 110 and the outflow section 120. The transition section 130 includes a plurality of interconnected transition section frame units 131 and a plurality of transition section connection areas 132. The transition section frame unit 131 is a hollow frame unit having a transition section mesh 133. The transition section connection area 132 is an area where two adjacent transition section frame units 131 are connected to each other.

[0211] In some embodiments, two radially adjacent transition segment frame units 131 share frame units and connection areas.

[0212] In some embodiments, the transition section frame unit 131 and its axially adjacent outflow section frame unit 121 share adjacent frame units and connection areas. The transition section frame unit 131 and its axially adjacent inflow section frame unit 111 share adjacent frame units and connection areas.

[0213] In some embodiments, the axial length of the inflow segment mesh 113 and the axial length of the outflow segment mesh 123 are greater than the axial length of the transition segment mesh 133. With this design, the inflow segment has a larger axial length. First, the contact area between the inflow segment mesh 113 and the aortic root can be increased. Second, during the expansion process of the artificial heart valve, the size of the expanded mesh can be selected according to the structure of the patient's aortic root, which has higher universality. For patients with softer aortic roots, such an inflow end mesh structure can also have a larger retraction amount. Third, the axial length of the inflow end mesh 113 is increased, and the coverage range of the outer skirt is relatively larger, which can provide a larger sealing skirt and has a better anti-valvular leakage effect.

[0214] In addition, the artificial heart valve is in a folded state during the delivery process. When it is delivered to the aortic valve, a high-pressure balloon is required to expand the stent. During the expansion process, the transition segment mesh 133 has a greater resistance to opening. Therefore, compared with the outflow segment mesh 123 of the outflow segment and the inflow segment mesh 113 of the inflow segment, the transition segment mesh 133 expands more slowly, that is, the expansion process presents a "bone-like" shape with thick ends and a thin middle part. This expansion method can ensure that the position of the artificial heart valve is relatively fixed before and after expansion, and no axial displacement will occur during the expansion process, thereby ensuring the accuracy of the valve release position.

[0215] In some embodiments, referring to Figure 2(b), the transition section frame unit 131 includes a transition section upper protrusion 1311 and a transition section lower protrusion 1312, the transition section upper protrusion 1311 protrudes along the axial direction of the bracket 100 toward the outflow end, and the transition section lower protrusion 1312 protrudes along the axial direction of the bracket 100 toward the direction away from the outflow end.

[0216] The transition section frame unit 131 also includes a transition section upper support rod 1313 and a transition section lower support rod 1314. The transition section upper support rod 1313 is connected between the transition section upper protrusion 1311 and the transition section connection area 132, and the transition section lower support rod 1314 is connected between the transition section lower support rod 1314 and the transition section connection area 132.

[0217] The transition section frame unit 131 of the present embodiment is composed of a transition section upper protrusion 1311, a transition section upper support rod 1313, a transition section connection area 132, a transition section lower support rod 1314, a transition section lower protrusion 1312, another transition section lower support rod 1314, another transition section connection area 132 and another transition section upper support rod 1313 connected in sequence to form a hollow frame unit with a transition section mesh 133. The transition section upper support rod 1313, the transition section connection area 132 and the transition section lower support rod 1314 are shared between two radially adjacent transition section frame units 131.

[0218] In some embodiments, the transition section mesh 133 is a gyro-shaped mesh.

[0219] In some embodiments, when a transition section 130 is provided between the inflow section 110 and the outflow section 120, the transition section upper support rod 1313 of the transition section frame unit 131 is shared with the outflow section lower support rod 1214 of the axially adjacent outflow section frame unit 121. The transition section lower support rod 1314 of the transition section frame unit 131 is shared with the inflow section upper support rod 1113 of the axially adjacent inflow section frame unit 111. The transition section connection area 132 is shared with the outflow section lower protrusion 1212 of the axially adjacent outflow section frame unit 121 and the inflow section upper protrusion 1111 of the axially adjacent inflow section frame unit 111.

[0220] In some embodiments, referring to FIG. 2( b ), two layers of transition sections 130 are disposed between the inflow section 110 and the outflow section 120 , and two axially adjacent layers of transition sections 130 share a transition section frame unit 131 and a transition section connection region 132 .

[0221] The transition section 130 at the outflow end side has a transition section upper support rod 1313 of a transition section frame unit 131 shared with an outflow section lower support rod 1214 of an axially adjacent outflow section frame unit 121. The transition section connection area 132 is shared with an outflow section lower protrusion 1212 of an axially adjacent outflow section frame unit 121.

[0222] The transition section 130 at the inflow end side has a transition section lower support rod 1314 of a transition section frame unit 131 shared with an inflow section upper support rod 1113 of an axially adjacent inflow section frame unit 111. The transition section connection area 132 is shared with an inflow section upper protrusion 1111 of an axially adjacent inflow section frame unit 111.

[0223] When two layers of transition sections 130 are provided, the stent 100 is shown in FIG2(b), and the stent 100 has four layers of mesh from the inflow end to the outflow end, namely, one layer of inflow section mesh 113, two layers of transition section mesh 133, and one layer of outflow section mesh 123. Optionally, the apertures of the two layers of transition section mesh 133 in the middle are smaller than the upper and lower layers of mesh.

[0224] In some embodiments, reference Figure 3(a) to Figure 4(b) The artificial heart valve of this embodiment also includes an outer skirt 300 and an inner skirt 400 .

[0225] The outer skirt 300 is located outside the bracket 100, and the upper end of the outer skirt 300 is connected to the inflow section upper support rod 1113 of the inflow section frame unit 111. For example, as shown in FIG2(b), the second support rod from the bottom.

[0226] The inner skirt 400 is located on the inner side of the stent 100, and the upper end of the inner skirt 400 is connected to the lower support rod 1214 of the outflow section of the outflow section frame unit 121, for example, on the fourth support rod from the bottom as shown in FIG2(b), the inner skirt 400 wraps around from the inner side of the stent 100 to the outer edge of the upper end surface 1214a of the fourth support rod, as shown in FIG2(a) and FIG2(e). With the design of the inner skirt 400, after the artificial heart valve is expanded, the upper edge of the inner skirt contacts the aortic wall, which enables faster endothelialization and improves the fixation speed of the artificial heart valve.

[0227] The lower end of the inner skirt 400 is connected to the lower end of the outer skirt 300 , and an annular cavity is formed between the inner skirt 400 and the outer skirt 300 along the circumferential direction, and the annular cavity wraps the inflow section of the stent 100 therein.

[0228] When the stent 100 has a transition section 130, the periphery of the transition section 130 is not covered with a film. This design, on the one hand, after the artificial heart valve is implanted in the human body, endothelialization starts from the lower support rod 1214 and the outer skirt 300 of the outflow section. Since the transition section 130 and its upper and lower parts are not covered by the inner and outer skirts, a small amount of blood entering this range will form a thrombus here due to the reduced flow rate, which has a better sealing effect. On the other hand, not covering the transition section 130 with a film can reduce the diameter of the transition section in the collapsed state, which is convenient for transportation.

[0229] In some embodiments, the outer skirt 300 wraps around the upper end surface 1113a of the upper support rod 1113 from the inflow end of the stent 100 to the upper edge, such as Figure 5 The inner side of the support rod 1113 on the inflow section is not wrapped by the outer skirt 300, which can minimize the diameter of the stent 100 in the collapsed state.

[0230] In some embodiments, the upper edge of the inner skirt 400 wraps around the upper side of the outflow section lower support rod 1214. The outer side of the outflow section lower support rod 1214 is not wrapped by the inner skirt 400, which can minimize the diameter of the stent 100 in the collapsed state.

[0231] In some embodiments, referring to FIG. 3( a ) and FIG. 3( b ), a plurality of skirt protrusions 310 are integrally provided at the upper end of the outer skirt 300 , and a skirt U-shaped groove 320 is provided between two adjacent skirt protrusions 310 .

[0232] 4( a ) and 4 ( b ), a plurality of skirt protrusions 410 are integrally provided at the upper end of the inner skirt 400 , and a skirt U-shaped groove 420 is provided between two adjacent skirt protrusions 410 .

[0233] In this embodiment, both the outer skirt 300 and the inner skirt 400 are provided with skirt U-shaped grooves to ensure that wrinkles will not appear after the inner and outer skirts wrap the support rod.

[0234] In some embodiments, the skirt protrusion is a trapezoidal protrusion that is narrow at the top and wide at the bottom, so as to better wrap the upper end surface of the support rod without wrinkles after wrapping.

[0235] In some embodiments, referring to FIG. 3( b ), taking the outer skirt 300 as an example, the distance between two adjacent skirt U-shaped grooves 320 is L3, and the width of the skirt U-shaped groove 320 is L4, then L3:L4=(50-100):1, preferably (60-90):1.

[0236] The inner skirt 400 has the same structure as described above.

[0237] 3( b ), the outer skirt 300 is provided with a plurality of skirt cutouts 330, and the skirt cutouts 330 are evenly arranged below the skirt U-shaped grooves 320 at intervals of a plurality of skirt U-shaped grooves 320. When the outer skirt 300 is arranged outside the bracket 100, the skirt cutouts 330 are located below the inflow section connection area 112.

[0238] The skirt incision 330 is a narrow incision. The design of the skirt incision 330 allows a small amount of blood to enter the annular cavity formed by the inner and outer skirts. Since the interior of the annular cavity is a relatively static environment, blood is more likely to form thrombi in the annular cavity, filling the gap between the outer skirt 300 and the aortic wall that is not tightly sealed, so as to further improve the sealing performance of the artificial heart valve. Until the outer skirt 300 is endothelialized, the narrow incision is covered by the proliferating tissue, and the artificial heart valve is stably fixed at the aortic root position to better prevent paravalvular leakage. The use of a narrow incision instead of a notch allows blood to enter and exit the annular cavity, but avoids the danger of thrombus overflow. On the other hand, the artificial heart valve is soaked in a glutaraldehyde solution before use, and a certain amount of glutaraldehyde solution will accumulate in the annular cavity. The narrow incision can ensure that the glutaraldehyde is completely discharged during the cleaning process of the artificial heart valve before pressing and gripping.

[0239] In some embodiments, referring to FIG. 3( b ), an adjacent skirt U-shaped groove 320 is provided between two adjacent skirt cutouts 330 .

[0240] In some embodiments, the skirt cutout 330 is disposed directly below the corresponding skirt U-shaped groove 320 .

[0241] In some embodiments, the upper end of the skirt incision 330 is connected to the skirt U-shaped groove 320. After suturing, this place is more likely to bulge outward. The skirt incision 330 is set here, and the skirt incision 330 is not easily covered, which makes it easier for blood to enter the annular cavity from the skirt incision 330.

[0242] In some embodiments, referring to FIG. 3( c ), a plurality of suture grooves 340 are disposed at the lower end of the outer skirt 300. A plurality of suture grooves 340 are evenly disposed at the lower end of the inner skirt 400. When sew the inner and outer skirts, the suture grooves 340 can be used as positioning members to relatively determine the positions of the inner and outer skirts, so as to improve the suture operation efficiency of the inner and outer skirts.

[0243] In some embodiments, referring to FIG. 3( a ), the circumference of the outer skirt 300 is L5 , and referring to FIG. 4( a ), the circumference of the inner skirt 400 is L6 , then L5 : L6 = (1.1 −1.3):1.

[0244] The circumference of the outer skirt 300 is designed to be greater than the circumference of the inner skirt 400, so that the inner skirt 400 is close to the inner side of the stent 100, relatively limiting the movement space of the inner skirt 400, thereby providing a stable environment for the leaflet, allowing the artificial leaflet to reduce external interference in the closed state, forming a closed surface according to the designed closed curve, and reducing the occurrence of reflux.

[0245] In some embodiments, the outer skirt 300 and the inner skirt 400 are both made of a woven structural material.

[0246] In some embodiments, referring to FIG. 4( b ), the weaving texture of the inner skirt 400 is consistent with the length direction of the upper support rod 1113 of the inflow section and the length direction of the lower support rod 1114 of the inflow section.

[0247] During the folding process, the stent 100 will be stretched along the axial direction of the stent 100. The texture of the inner skirt 400 is arranged in the same direction as the two support rods of the inflow section frame unit 111, so that the inner skirt 400 has greater ductility during the axial stretching of the stent 100, reducing the axial constraint of the stent.

[0248] Since the outer skirt 300 has sufficient axial dimensions, it will not restrict the axial extension of the stent, so there is no requirement for the braiding direction. In order to facilitate suturing and increase the strength of the outer skirt 300, the braiding wire direction can be selected to extend in the axial and / or radial direction.

[0249] In some embodiments, the inner skirt 400 is sutured into a cylindrical shape at both ends and then sutured to the inner side of the stent 100 , and the lower end of the leaflet body 221 is sutured to the inner skirt 400 as a leaflet fixing portion.

[0250] In some embodiments, reference Figure 6(a) to Figure 6(d) The stent 100 of the present invention includes an inflow end and an outflow end. The inflow end is surrounded by a plurality of inflow segment frame units 111, which are hollow frame units having inflow segment meshes 113. The outflow end is surrounded by a plurality of outflow segment frame units 121, which are hollow frame units having outflow segment meshes 123. The number of outflow segment frame units 121 is less than the number of inflow segment frame units 111, and the outflow segment frame units 121 include first meshes 511 and second meshes 512 of different mesh sizes.

[0251] In the present invention, since the number of outflow segment frame units 121 is less than the number of inflow segment frame units 111, the number of outflow segment meshes 123 is less than the number of inflow segment meshes 113, so that the outflow segment meshes 123 have a larger hollow grid structure. While ensuring that the inflow end provides sufficient radial support, a larger hollow grid design is adopted at the local position of the outflow end, and the possibility of the artificial valve leaflet hitting the stent grid is greatly reduced. Therefore, the artificial valve leaflet can be designed to have a larger effective opening area, reducing the pressure drop caused by blood passing through the artificial heart valve, which is more ergonomic. In addition, the design of a larger hollow grid can also reduce the risk of coronary artery obstruction and provide a good coronary re-intervention channel.

[0252] In some embodiments, the area of ​​the first mesh 511 is smaller than the area of ​​the second mesh 512 , and the number of the first mesh 511 is greater than the number of the second mesh 512 .

[0253] In some embodiments, when the number of inflow segment frame units 111 is 3N, the inflow end of the stent 100 is surrounded by 3N inflow segment frame units 111, and the number of outflow segment frame units 121 is preferably 3 (N-1) or 3 (N-2), and the outflow end of the stent 100 is surrounded by 3 (N-1) or 3 (N-2) outflow segment frame units 121. N is a natural number greater than 2, such as 3, 6, 7, 8, etc. In order to take into account the axial length and circumference of the artificial heart valve and avoid the artificial heart valve damaging the aortic wall or blocking the coronary artery orifice, N is preferably 4 or 5.

[0254] That is, when the number of the inflow segment meshes 113 is 3N, the number of the outflow segment meshes 123 is 3(N-1) or 3(N-2), where N is a natural number greater than 2.

[0255] like Figure 6(a) to Figure 7(c) As shown, N is 4, the number of the inflow segment frame units 111 is 12, and the number of the outflow segment frame units 121 is 9.

[0256] In some embodiments, Figure 8 As shown, N is 5, the number of the inflow segment frame units 111 is 3*5=15, and the number of the outflow segment frame units 121 is less than the number of the inflow segment frame units 111. At this time, the number of the outflow segment frame units 121 is 3*(5-2)=9.

[0257] In some embodiments, reference Figure 6(b) to Figure 9(a) The outflow section mesh 123 is a first layer of meshes, and the first layer of meshes includes a plurality of first meshes 511 and a plurality of second meshes 512 . The axial length of the first mesh 511 is smaller than the axial length of the second mesh 512 .

[0258] As shown in Fig. 6(c), the axial length of the first mesh 511 is H1, and the axial length of the second mesh 512 is H2, then H1<H2. As shown in Fig. 6(d), H2-H1=ΔH, where ΔH is a value greater than zero.

[0259] Preferably, H1:H2=(0.5-0.9):1, such as 0.6:1, 0.7:1, 0.8:1 and so on.

[0260] The design that the axial length of the first mesh 511 is smaller than the axial length of the second mesh 512 can minimize the axial length of the stent without blocking the coronary artery, thereby reducing the impact of the implantation of the artificial heart valve on the aortic structure.

[0261] In some embodiments, referring to FIG. 7( a ), when the circumferential arc length of the first mesh 511 is L1 and the circumferential arc length of the second mesh 512 is L2 , L2 = M*L1 , where M is a natural number greater than 1, and M is preferably 2 or 3.

[0262] As shown in Figure 7(a), when N = 4, L2 = 2*L1;

[0263] like Figure 8 As shown, when N=5, L2′=3*L1′, wherein L2′ is the circumferential arc length of the second mesh 512 when N is 5, and L1′ is the circumferential arc length of the first mesh 511 when N is 5.

[0264] In some embodiments, reference Figure 6(a) to Figure 8 The stent 100 is provided with a plurality of stent connection holes 140 for connecting with the valve leaflet mechanism. Two first meshes 511 and one second mesh 512 are provided between two adjacent stent connection holes 140, and the second mesh 512 is located between the two first meshes 511. The stent connection hole 140 is provided on the outflow section connection area 122 between the two adjacent first meshes 511, and the outflow section connection area 122 is the area where two adjacent outflow section frame units 121 are connected to each other. The stent connection holes 140 are connected to the first meshes 511 in the circumferential direction. This is because the artificial valve leaflet is fixedly connected to the stent through the stent connection holes 140. After the artificial heart valve is implanted in the patient's body, when the artificial valve leaflet is closed, the artificial valve leaflet is subjected to reverse impact from the aortic blood flow. The stent connection hole 140 is a position directly connected to the artificial valve leaflet and is subjected to greater tension. Therefore, it is necessary to design a relatively smaller mesh, such as the first mesh 511, here to improve the radial stability of the stent. In addition, during the opening and closing process of the artificial valve leaflet, the artificial valve leaflet near the stent connection hole 140 is always closest to the stent frame, and is therefore more susceptible to invasion by calcification sites on the native valve leaflet. The design of the first mesh 511 can effectively prevent the calcified native valve leaflet from invading the valve leaflet mechanism and prevent the artificial valve leaflet from being damaged.

[0265] The number of the second meshes 512 is selected to be equal to the number of aortic valve leaflets. For example, if most patients have 3 aortic valve leaflets, the number of the second meshes 512 is selected to be 3. Of course, it is not ruled out that some patients have 2 aortic valve leaflets. In this case, the number of the second meshes 512 can also be designed to be 2.

[0266] At this time, referring to Figures 6(a) and 6(b), the outflow end includes a plurality of outflow segment frame units 121 and a plurality of outflow segment connection areas 122 connected end to end in sequence, the outflow segment frame unit 121 is a hollow frame unit having an outflow segment mesh 123, the outflow segment connection area 122 is an area where two adjacent outflow segment frame units 121 are connected to each other, and a portion of the outflow segment connection area 122 is provided with a bracket connection hole 140 as a bracket connection portion 122a.

[0267] The stent connection hole 140 connected to the leaflet mechanism is arranged on the outflow section connection area 122 between two adjacent first mesh holes 511, so that both sides of the stent connection hole 140 are protected by the first mesh holes 511, and the first mesh holes 511 with smaller grids can effectively prevent the calcified native leaflets from invading the artificial leaflets of the leaflet mechanism, and because the radial movement amplitude of the artificial leaflets near the stent connection hole 140 is small during the opening and closing process of the artificial leaflets, the first mesh holes 511 with smaller mesh sizes are designed on both sides of the stent connection hole 140, so that the leaflet area can be designed to be larger. Such a design can, on the one hand, increase the opening area of ​​the artificial heart valve, and on the other hand, can also ensure that the artificial leaflets are fully fitted when closed to prevent the occurrence of regurgitation in the valve. In addition, while ensuring that there is no situation where the artificial leaflets beat the stent 100, it can also well avoid the damage of the artificial leaflets by the calcified sites on the native leaflets or the aortic wall, and effectively avoid the restenosis of the aorta caused by the implantation of the artificial heart valve.

[0268] In some embodiments, referring to Figures 6(a) and 6(b), the inflow end includes a plurality of inflow segment frame units 111 connected end to end and a plurality of inflow segment connection areas 112, the inflow segment frame unit 111 is a hollow frame unit having an inflow segment mesh 113, and the inflow segment connection area 112 is an area where two adjacent inflow segment frame units 111 are connected to each other.

[0269] In some embodiments, referring to FIG. 6( b ), the width of the axial connecting rod 122 a 1 of the support connecting portion 122 a is smaller than the width of other outflow segment connecting regions 122 .

[0270] In some embodiments, reference Fig.11 After being compressed, the stent 100 has a more uniform compression shape. The shape of the mesh with stent connection holes after compression in the present invention is similar to the mesh without stent connection holes 140, and there is no obvious compression tilt shape. This is because the rod width of the stent connection hole is narrower than that of other mesh designs, which reduces the difference between the stent connection hole and the connection rods at other positions caused by the double support rods. Another part of the reason is that the second mesh 512 is designed to be larger, which increases the distance between the axial struts of the second mesh 512 in the compressed state, and further weakens the difference between the stent connection hole 140 formed by the rectangular hole. Such an artificial heart valve is closer to the designed size and shape when it is restored to the expanded state.

[0271] In some embodiments, referring to FIG. 9( a ), in order to reduce the influence of native aortic calcification sites on artificial valve leaflets, a mesh covering 6 is provided at the first mesh 511 , and the mesh covering 6 is fixedly connected to the first mesh 511 to enhance the barrier effect of the artificial heart valve on the native valve leaflets, reduce the invasion of the native valve leaflets on the artificial valve, and promote endothelialization of the outflow end.

[0272] The second mesh 512 is not covered with a mesh film to avoid blocking the coronary artery ostium, and at the same time, it can provide a larger movement space for the artificial valve leaflet and increase the opening area of ​​the artificial heart valve. The coating of other layers of mesh can use the coating technology in the prior art, which will not be repeated here.

[0273] In some embodiments, the mesh covering is located at the periphery of the stent 100. Preferably, the mesh covering is fixedly connected to the stent 100, such as by suturing or bonding, so as to better fit the structure at the implantation site and fill the gaps between the calcification sites to avoid paravalvular leakage.

[0274] In some embodiments, referring to FIG. 7( a) and FIG. 7( b), the angle between the two angled support rods on the outflow end side of the first mesh 511 is α, and the angle between the two angled support rods on the outflow end side of the second mesh 512 is β. The design of the two angles is that the artificial heart valve can be pressed to the designed size during the pressing process, and on the other hand, when the artificial heart valve in the pressed state is delivered to the target position of the patient, it can be smoothly expanded to the designed shape and size, so the size of the angles α and β is not particularly limited. However, in order to avoid interference between the angled support rods of the first mesh 511 and the second mesh 512 due to different angles during the pressing and expanding process, it is preferably designed to be α=β.

[0275] As described in the above embodiments, the angle of the angled support rod is mainly used to ensure the stability of the stent. If the angle is too large, the difficulty of crimping the artificial heart valve during the crimping process will be significantly increased. If the angle is too small, more meshes are required, which affects the crimping diameter of the heart valve. In addition, the axial length of the mesh is too large, which correspondingly increases the axial size of the stent. Therefore, in order to balance the stability of the stent, the supporting force and the crimping process, α=β=100°-150° is preferred, such as 110°, 130°, 140°, etc., and α=β=120° is more preferred. This is because when the angle α=β=120°, the force at the connection point of the support rod is optimal.

[0276] In some embodiments, in order to make the first mesh 511 and the second mesh 512 more evenly clamped during the clamping process and avoid bias, the width of the angled support rod on the outflow end side of the second mesh 512 is D1, and the width of the angled support rod on the outflow end side of the first mesh 511 is D2, then D1 is greater than D2, preferably D1:D2=1.1-1.3:1, such as 1.15:1, 1.2:1, 1.25:1 and so on.

[0277] In some embodiments, reference Fig.11 When the stent 100 is in the clamped state, the height of the outflow end of the second mesh 512 is higher than the height of the outflow end of the first mesh 511 .

[0278] In some embodiments, a developing member is disposed at the outflow end of the second mesh 512 .

[0279] When the height of the outflow end of the second mesh 512 is higher than the height of the outflow end of the first mesh 511, the protruding design can serve as a developer of the artificial heart valve. With the assistance of the medical device DSA, the highly protruding second mesh 512 will produce a marking effect, which is used to align the artificial valve leaflets and the autologous valve leaflets in the axial and circumferential directions, maintaining the same height as the native valve leaflets and a higher degree of overlap, so that the artificial heart valve has better hemodynamics.

[0280] In some embodiments, reference Fig.11 When the stent 100 is in a compressed state, the two angled support rods on the outflow end side of the second mesh 512 fit each other in the middle, so that the stent 100 presents a teardrop-shaped structure 512a at the distal end.

[0281] The teardrop-shaped structure 512a of the stent 100 can provide a stronger radial restoring force for the angled support rods, which is more conducive to the artificial heart valve returning to the expanded state when the phase transition temperature is reached. In addition, the teardrop-shaped structure 512a itself is more conducive to being used as a developing component and has a better developing effect under ultrasound conditions.

[0282] In some embodiments, in order to enhance the development effect, the width and / or height of the end point at the outflow end of the second mesh 512 can be increased, that is, the width and / or height of the outflow end of the second mesh 512 is greater than the width and / or height of the outflow end of the first mesh 511.

[0283] As shown in FIG. 7( d ), the width of the end points A1 and A2 of the second mesh 512 toward the outflow end is greater than the width of the end points B1 and B2 of the outflow end of the first mesh 511 ;

[0284] Or, the height of the outflow ends A1 and A2 of the second mesh 512 is greater than the height of the outflow ends B1 and B2 of the first mesh 511;

[0285] Alternatively, the width and height of the outflow ends A1 and A2 of the second mesh 512 are greater than the width and height of the outflow ends B1 and B2 of the first mesh 511 .

[0286] In some embodiments, the outflow end of the second mesh 512 is coated with a radiopaque developing material to enhance the developing performance of the outflow end.

[0287] In some embodiments, when the stent 100 is placed at the target position in the human body, the end of the outflow end of the second mesh 512 is aligned with the bottom of the aortic sinus in the circumferential direction, so that the coronary artery opening will be located in the middle of the second mesh 512, which can better avoid blockage of the coronary artery opening.

[0288] In some embodiments, reference Figure 6(b) to Figure 7(d) The inflow end side adjacent to the proximal end of the first mesh 511 has a second layer of mesh, which is surrounded by a plurality of third meshes 521; the inflow end side adjacent to the second mesh 512 and the second layer of mesh has a third layer of mesh, which is surrounded by a plurality of fourth meshes 531. In order to avoid the appearance of a sharp point in the second mesh 512 and puncture the balloon or leaflet during the expansion process, the third mesh 521 inside the second mesh 512 is missing, so that the inflow end of the second mesh 512 is surrounded by the supporting rods of the second and third layers of mesh; the inflow end side adjacent to the third layer of mesh has a fourth layer of mesh, which is the inflow segment mesh 113.

[0289] That is, in the above design of this embodiment, the second layer of meshes adjacent to the first mesh 511 is surrounded by a plurality of third meshes 521, and no third mesh 521 is provided inside the second mesh 512, that is, there is no independent mesh end sharp corner inside the second mesh 512. In order to illustrate the hazards of designing a sharp corner inside the second mesh 512, the following is shown. Fig.10 The artificial heart valve shown has sharp corners at the end of the mesh (the inner leaflet is not shown), Fig.10 In the comparative example shown, due to the presence of the sharp corner 540 in the second mesh 521, during the process of the stent 100 being expanded by the balloon, the sharp corner 540 is not subjected to the pulling force of other components and is less likely to be pulled inward when the other parts of the stent have expanded in order to maintain the original gripping state, that is, the sharp corner 540 becomes a protrusion toward the balloon, making it easier to puncture the balloon, damage the leaflets, or damage the mesh covering on the stent. In this embodiment, there is no independent sharp corner design at the end of the mesh inside the second mesh 512, which can avoid the sharp corner damaging the leaflets or balloon and causing the failure of the operation.

[0290] In some embodiments, reference Figure 8The inflow end side adjacent to the first mesh 511 has a second layer of mesh, which is surrounded by a plurality of third meshes 521; the inflow end side adjacent to the second layer of mesh has a third layer of mesh, which is surrounded by a plurality of fourth meshes 531; the inflow end side adjacent to the second mesh 512 and the third layer of mesh has a fourth layer of mesh, which is the inflow section mesh 113, so that the inflow end of the second mesh 512 is surrounded by the support rods of the second mesh, the third mesh, and the fourth mesh.

[0291] In the above design of this embodiment, in order to avoid the formation of independent sharp corners inside the second mesh 512, the second layer of mesh needs to lack two third meshes 521 in the second mesh, and the third layer of mesh needs to lack one fourth mesh 531 in the second mesh. At this time, the second mesh 512 has a larger hollow grid structure. This embodiment is suitable for scenarios where the radial support force of the stent 100 does not need to be very large and the effective opening area of ​​the valve needs to be larger.

[0292] In some embodiments, referring to FIG. 9( b ), the outflow end side of the second mesh 512 is an open structure, so that the first layer of meshes is composed of a plurality of first meshes 511 . In this embodiment, the third mesh 521 is missing.

[0293] In some embodiments, referring to Figure 9(c), in this embodiment, the first layer of mesh is composed of several groups of first meshes 511, such as 3 groups, and the number of groups of first meshes 511 is the same as the number of bracket connecting holes 140, that is, the first layer of mesh is only arranged on the left and right sides of the bracket connecting hole 140, and in order to provide a better support effect, the third mesh 521 of the bracket is not missing, and a plurality of adjacent third meshes 521 are connected in sequence to form a ring.

[0294] With respect to the embodiments shown in FIG. 9( b) and FIG. 9( c), in order to ensure that the first meshes 511 can expand according to a predetermined shape after being pressed and gripped when the outflow end of the stent is composed of only a plurality of first meshes 511 that are not formed into a ring, the outflow end (upper part) of the first mesh 511 can be designed to have a thinner rod width to facilitate expansion.

[0295] The supporting force of the artificial heart valve mainly relies on the inflow end. Therefore, in this embodiment, the second mesh 512 is omitted, and the first layer of mesh only relies on the first mesh to block the damage of the calcification site to the valve leaflet. The existence of the first mesh can also increase the contact area between the outflow end of the stent and the aortic wall. Compared with the stent whose outflow end only includes the stent connection hole 140, the pressure of the outflow end of the stent on the aortic wall can be greatly reduced, thereby ultimately reducing the damage to the aortic wall.

[0296] In some embodiments, the present invention is used Figure 6(a) to Figure 11When the stent 100 is shown, the structure of the leaflet mechanism 200 and the connection relationship between it and the stent 100, the structure of the outer skirt 300 and the connection relationship between it and the stent 100, and the structure of the inner skirt 400 and the connection relationship between it and the stent 100 are similar to Figure 2(a) to Figure 5 The embodiments corresponding to the stent are the same, that is, the above-mentioned embodiments of the leaflet mechanism 200, the outer skirt 300, and the inner skirt 400 of the present invention are still applicable to Figure 6(a) to Figure 11 The bracket 100 is shown.

[0297] For example, the outer skirt 300 is located outside the bracket 100, and the upper end of the outer skirt 300 is connected to the inflow section upper support rod 1113 of the inflow section frame unit 111. For example, the second support rod from the bottom as shown in FIG6(b).

[0298] The inner skirt 400 is located on the inner side of the bracket 100, and the upper end of the inner skirt 400 is connected to the lower support rod 1214 of the outflow section of the outflow section frame unit 121, for example, on the fourth support rod from the bottom as shown in Figure 2(b), the inner skirt 400 wraps around from the inner side of the bracket 100 to the outer edge of the upper end surface 1214a of the fourth support rod.

[0299] In some embodiments, the present invention is used Figure 12(a) , 12(b) In the stent 100 shown, the outflow end is only provided with a plurality of stent connection holes 140, but no outflow section frame unit is provided. The number of stent connection holes 140 is preferably equal to the number of leaflets. For example, most patients have 3-leaf heart valves, and the number of stent connection holes 140 is 3.

[0300] There is no support for the outflow segment frame unit at the outflow end. After being sutured with the leaflet mechanism, the distal end of the leaflet is located above the frame unit. When the leaflet closes or opens with the expansion or contraction of the heart, the leaflet will not be affected by the support rods of the frame unit, that is, the leaflet will not hit the support rods of the frame unit. Therefore, the leaflet can be designed with a larger opening area to reduce the transvalvular pressure difference when blood passes through the artificial heart valve.

[0301] In order to improve the support strength of the stent, the axial height of the stent can be increased by increasing the number of mesh layers, for example, the number of mesh layers is 3, 4, 5, and so on.

[0302] The number of mesh layers shown in Figure 12(b) is 4. The layer of mesh adjacent to the bracket connecting hole 140 at the outflow end is defined as the second layer of mesh. At this time, the second layer of mesh and the inflow end are defined as the fifth layer of mesh. In this embodiment, the shapes of the second layer of mesh and the fifth layer of mesh are designed to be the same. This is only one embodiment. The two layers of mesh can also be designed to be other same or different shapes.

[0303] In order to improve the stability of the artificial heart valve during the expansion process, such as balloon expansion, and prevent the support connection hole 140 and the second layer of mesh from rotating due to the small contact area, the contact area between the support connection hole 140 and the second layer of mesh can also be increased, as shown in Figure 12 (c). The difference from Figure 12 (b) is that the support connection hole 140 in Figure 12 (b) is a rectangular hole with basically the same width from top to bottom, connected through the top of the second layer of mesh. While the inner hole of the support connection hole 140 in Figure 12 (c) still maintains a rectangular structure, the outside of the support connection hole 140 is a structure that gradually widens from the outflow end to the inflow end (from top to bottom) to increase the contact area between the support connection hole 140 and the third mesh 521 in the second layer of mesh. Preferably, the outer periphery of the inflow end of the support connection hole 140 is tangent to the upper surface of the third mesh 521, as shown in Figure 12 (d), the two are tangent at point I, which can make the transition of the contact surface more gentle and avoid stress concentration.

[0304] In addition, in order to avoid the influence of the uniformity of the artificial heart valve structure due to the excessive thickness in the middle of the connection between the stent connection hole 140 and the third mesh 521, an adjustment hole 601 can be added to the inner adjacent part of the stent connection hole 140 and the third mesh, as shown in FIG12(d), in which there are two adjustment holes 601 in a symmetrical half-moon shape. It should be noted that the shape of the adjustment holes 601 is not limited to a half-moon shape, and the number is not limited to 2, as long as the purpose of improving the uniformity of the artificial heart valve structure can be met. For example, it can be designed to be a plurality of circles, triangles, diamonds, etc.

[0305] In other embodiments, in order to improve the contact stability between the stent connecting hole 140 and the third mesh 521, the stent connecting hole 140 can also be designed inside the first mesh 511, as shown in Figure 12(e). In this embodiment, the first mesh 511 is an approximately circular structure. Such a design can make the artificial heart valve easier to expand after being implanted in the patient's target position, and after expansion, it has stronger radial support for the native aortic valve or the aortic wall.

[0306] In order not to affect the crimping of the artificial heart valve and reduce the constraint of the stent connection hole 140 on the axial deformation of the artificial heart valve, only one end of the stent connection hole 140 is connected to the first mesh 511. In this embodiment, the outflow end of the stent connection hole 140 is connected to the inner side of the first mesh 511, which can minimize the crimping constraint force on the third mesh 521. Further, in the crimping state, the length of the stent connection hole 140 does not exceed 1 / 2 of the axial length of the first mesh 511, so as to further reduce the influence of the crimping on the third mesh and improve the uniformity of the stent in the crimping state.

[0307] This application mainly uses a balloon-expandable stent as an example for explanation. However, the shapes of the artificial valve leaflets and stents disclosed in this application are not limited to the use of balloon-expandable artificial heart valves, but are also applicable to self-expanding artificial heart valves made of nickel-titanium alloy or other materials.

[0308] The present invention is described in detail above in conjunction with the embodiments of the accompanying drawings. A person skilled in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not be construed as limiting the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. An artificial heart valve, comprising a stent and a leaflet mechanism arranged in the stent, wherein the stent is provided with a plurality of stent connection holes; It is characterized in that The leaflet mechanism comprises: Several connecting parts; A plurality of artificial valve leaflets, wherein the plurality of artificial valve leaflets are connected in sequence to form a ring-like structure; The artificial valve leaflet has: One leaflet body; Two first connection parts, wherein the two first connection parts are connected to two sides of the free end of the leaflet body; Two second connection parts, each of which is connected to the upper part of the first connection part and the connection part can be folded along the first flip axis; The first connection parts of two adjacent artificial valve leaflets are connected by the connection piece to form a ring-like structure; The bracket connecting hole is a rectangular hole, and the support rods at the upper and lower ends of the rectangular hole are connected to the middle parts of the upper and lower ends of the rectangular hole.

2. The artificial heart valve according to claim 1, characterized in that: The second connecting portion includes a fixed portion and an arc-shaped portion, the connection between the fixed portion and the arc-shaped portion can be folded along a second flip axis, and a side of the arc-shaped portion away from the fixed portion is an arc-shaped structure; After each of the connecting parts is folded in half, it passes through the corresponding stent connecting hole from the inner side of the stent and is abutted against the outer periphery of the stent connecting hole. The second connecting part is located on the inner side of the stent. After folding, the fixing parts of the two adjacent artificial leaflets are respectively connected to the two sides of the connecting part, and the arc-shaped part can be abutted against the surface of the leaflet body.

3. The artificial heart valve according to claim 2, characterized in that: The fixing portion and the connecting piece are connected by suturing.

4. The artificial heart valve according to claim 1, characterized in that: A horizontal leaflet U-shaped groove is provided at the connection between the first connection part and the second connection part.

5. The artificial heart valve according to claim 1, characterized in that: The outer contour of the fixed end of the leaflet body has: A leaflet bottom arc, wherein the lower end of the leaflet bottom arc is an arc-shaped structure; Two leaflet side arcs, the two leaflet side arcs are respectively located on both sides of the leaflet bottom arc, and the lower ends of the leaflet side arcs are also arc-shaped structures; The slopes of the leaflet bottom arc and the leaflet side arcs on both sides are equal and smoothly connected to form the fixed end of the artificial leaflet.

6. The artificial heart valve according to claim 5, characterized in that: The leaflet bottom arc is a circular arc formed by a first radius, and the two leaflet side arcs are circular arcs formed by a second radius, wherein the second radius: the first radius = (2-5): 1; And / or, the arc length of the side arc of the leaflet: the arc length of the bottom arc of the leaflet = (1.2-2):

1.

7. The artificial heart valve according to claim 1, characterized in that: The stent is in a hollow straight cylinder-like shape, and comprises an inflow section and an outflow section connected to each other; The inflow segment includes a plurality of inflow segment frame units connected end to end in sequence and a plurality of inflow segment connection areas, wherein the inflow segment frame units are hollow frame units having inflow segment meshes, and the inflow segment connection area is an area where two adjacent inflow segment frame units are connected to each other; And / or, the outflow segment includes a plurality of outflow segment frame units connected end to end in sequence and a plurality of outflow segment connection areas, the outflow segment frame unit is a hollow frame unit having an outflow segment mesh, the outflow segment connection area is an area where two adjacent outflow segment frame units are connected to each other, and several outflow segment connection areas are provided with the bracket connection holes as bracket connection parts.

8. The artificial heart valve according to claim 7, characterized in that: The width of the axial connecting rod of the bracket connecting hole is smaller than the width of the other outflow section connecting areas; And / or, the mesh of the inflow section is a gyro-shaped mesh; And / or, the mesh of the outflow section is a hexagonal mesh.

9. The artificial heart valve according to claim 7, characterized in that: The outflow section frame unit comprises an outflow section upper protrusion and an outflow section lower protrusion, wherein the outflow section upper protrusion protrudes along the axial direction of the bracket toward the outflow end, and the outflow section lower protrusion protrudes along the axial direction of the bracket toward a direction away from the outflow end; The outflow section frame unit further includes an outflow section upper support rod and an outflow section lower support rod, wherein the outflow section upper support rod is connected between the outflow section upper protrusion and the outflow section connection area, and the outflow section lower support rod is connected between the outflow section lower protrusion and the outflow section connection area; When the outflow section connection area is the bracket connection part, two adjacent upper support rods of the outflow section are connected side by side to the middle of the outflow end of the bracket connection part, and two adjacent lower support rods of the outflow section are connected side by side to the middle of the inflow end of the bracket connection part; and / or The inflow section frame unit comprises an inflow section upper protrusion and an inflow section lower protrusion, wherein the inflow section upper protrusion protrudes along the axial direction of the bracket toward the outflow end, and the inflow section lower protrusion protrudes along the axial direction of the bracket toward a direction away from the outflow end; The inflow section frame unit also includes an inflow section upper support rod and an inflow section lower support rod, wherein the inflow section upper support rod is connected between the inflow section upper protrusion and the inflow section connection area, and the inflow section lower support rod is connected between the inflow section lower protrusion and the inflow section connection area.

10. The artificial heart valve according to claim 9, characterized in that: The artificial heart valve further comprises: an outer skirt, the outer skirt being located outside the bracket, and the upper end of the outer skirt being connected to the inflow section upper support rod of the inflow section frame unit; An inner skirt, the inner skirt is located on the inner side of the bracket, the upper end of the inner skirt is connected to the lower support rod of the outflow section of the outflow section frame unit, the lower end of the inner skirt is connected to the lower end of the outer skirt, and an annular cavity is formed between the inner skirt and the outer skirt along the circumferential direction, and the annular cavity wraps the inflow section of the bracket.

11. The artificial heart valve according to claim 10, characterized in that: The upper edge of the outer skirt wraps around the upper side of the support rod on the inflow section; And / or the upper edge of the inner skirt wraps around the upper side of the lower support rod of the outflow section.

12. The artificial heart valve according to claim 10, characterized in that: The upper end of the outer skirt and the upper end of the inner skirt are integrally provided with a plurality of skirt protrusions, and a skirt U-shaped groove is provided between two adjacent skirt protrusions; The skirt raised portion is preferably a trapezoidal raised portion that is narrow at the top and wide at the bottom; and / or The outer skirt is provided with a plurality of skirt cutouts, the skirt cutouts are spaced apart from a plurality of the skirt U-shaped grooves and are evenly arranged below the skirt U-shaped grooves; When the outer skirt is arranged on the outer side of the bracket, the skirt cutout is located below the inflow section connection area.

13. The artificial heart valve according to claim 10, characterized in that: The circumference of the outer skirt: the circumference of the inner skirt = (1.1-1.3):1.

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