artificial heart valves

Abstract

The present invention belongs to the field of medical device technology, and specifically relates to an artificial heart valve, including a stent and a leaflet mechanism; the stent is provided with a plurality of stent connection holes; the leaflet mechanism includes: a plurality of connectors and an artificial leaflet; the artificial leaflet has: a leaflet body, two first connection parts, and two second connection parts, each connector folded in half passes through the corresponding stent connection hole from the inside of the stent and rests on both sides of the outer periphery of the stent connection hole, two adjacent fixing parts are respectively connected to the two sides of the connector, and the arc-shaped part can rest on the surface of the leaflet body. In the present invention, after the artificial leaflet is fixed to the stent, when the artificial leaflet is in the open state, the arc-shaped part resting on the outer wall of the artificial leaflet can play the role of buffering the artificial leaflet and protecting the artificial leaflet.

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 and right sides of the heart by the atrioventricular septum. The blood passing through the left side of the heart is 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 often bears high pressure that various abnormalities occur, such as stenosis and regurgitation. At present, 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 that can serve as a fixing site for the artificial heart valve. Currently, there are two main types of aortic stenosis replacement valves: self-expanding valves and balloon-expandable valves. Due to the strong support force of the balloon-expandable valve stent, the valve axial direction can be designed into a shorter structure, which can reduce the risk of coverage of 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 that can effectively fix the aortic valve, and the fatigue resistance of the leaflets has also been preliminarily verified. However, some problems still exist. For example, since the heart valve stent and the artificial valve leaflets are fixedly connected by a clip, and the clip itself has a certain hardness, stress points will be formed at the contact point between the clip and the artificial valve leaflet during the delivery of the artificial heart valve or the opening and closing of the artificial valve leaflet, which can easily damage the leaflet and reduce the fatigue life of the artificial heart valve. The stent is sutured to the leaflet located inside it through multiple suture holes, and the multiple suture holes are located on a sheet-like structure. During the compression and gripping of the artificial heart valve, stress points are easily formed at the sheet-like structure, resulting in uneven compression and gripping. 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 correspondingly reduces its performance. 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, which includes 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 sequentially connected to form a ring-like structure;

[0011] The artificial valve leaflet has:

[0012] One leaflet body;

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

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

[0015] The first connecting portions of two adjacent artificial valve leaflets are connected by the connecting 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 comprises a fixed portion and an arc-shaped portion, wherein 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 connecting piece is folded in half, it passes through the corresponding stent connecting hole from the inner side of the stent and is affixed to the outer periphery of the stent connecting hole. The second connecting portion is located on the inner side of the stent. After folding, the fixing portions of the two adjacent artificial leaflets are respectively connected to the two sides of the connecting piece, and the arc-shaped portion can be affixed to 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 connecting portion and the second connecting 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 an arc formed by a first radius, and the two leaflet side arcs are an arc 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 section includes a plurality of inflow section frame units connected end to end and a plurality of inflow section connection areas, wherein the inflow section frame units are hollow frame units having inflow section meshes, and the inflow section connection areas are areas where two adjacent inflow section frame units are connected to each other;

[0032] The outflow segment includes a plurality of outflow segment frame units connected end to end and a plurality of outflow segment connection areas. The outflow segment frame unit is a hollow frame unit with an outflow segment mesh. The outflow segment connection area is an area where two adjacent outflow segment frame units are connected to each other. 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 segment 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 includes an outflow segment upper protrusion and an outflow segment lower protrusion, the outflow segment upper protrusion protrudes toward the outflow end along the axial direction of the stent, and the outflow segment lower protrusion protrudes away from the outflow end along the axial direction of the stent;

[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 includes 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, 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, there is an arc connection between two adjacent upper support rods of the outflow segment, between two adjacent lower support rods of the outflow segment, between the upper support rod of the outflow segment and the adjacent outflow end connection area, and / or between the lower support rod of the outflow segment and the adjacent outflow end connection area.

[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 mesh of the transition section is smaller than the axial length of the mesh of the inflow section and the axial length of the mesh of the outflow section.

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

[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 provided 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 outside 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 provided 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 being surrounded by a plurality of inflow segment frame units, the inflow segment frame units being hollow frame units having 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 being surrounded by a plurality of inflow segment frame units, the inflow segment frame units being hollow frame units having inflow segment meshes;

[0072] An outflow end, the outflow end includes 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 segment frame unit,

[0073] Or when outflow segment frame units are provided on the circumference where the bracket 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, each of which is a hollow frame unit having an outflow segment mesh. Each of the outflow segment frame units includes a first mesh located on both sides of the bracket connection hole.

[0075] Optionally, the outflow section frame 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 first meshes and one second mesh 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 the 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 segment 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 relatively consistent gripping of the two angled support rods in the gripping 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 gripping difficulty during the gripping process of the artificial heart valve. If the angle is too small, more meshes are required, affecting the gripping diameter of the heart valve. Therefore, it is preferred that α=β=100°-150°, such as 110°, 130°, 140°, etc., and more preferably α=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, the two angled support rods on the outflow end side of the second mesh fit together 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 is the inflow section mesh.

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

[0099] There is a fourth layer of mesh 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 support 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 progress effect of the present invention is:

[0102] 1. When connecting two adjacent artificial leaflets, the present invention abandons the existing method of using clips, and instead first connects multiple artificial leaflets together through connectors to form a ring-like structure. The artificial leaflets are fixed to the stent 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 are fixed to the stent, the arc-shaped part folded on the side of the fixing part abuts against the outer wall of the leaflet body. Usually, the arc-shaped part is made integrally with the artificial leaflet, and the flexibility of the arc-shaped part is good. 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 fully opening. 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 abutting against the aortic wall and blocking the coronary orifice when 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 portion can block part of the impact 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 stent, on the one hand, improve the fatigue life of the stent, and on the other hand, make the artificial heart valve more stable after implantation in the human body. This is because the stability of the artificial heart valve is one of its important indicators, and it is expected that the valve can maintain the 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 valve displacement and resulting in surgical failure.

[0105] 2. The main shape and / or parameter design of the leaflet is such that the artificial leaflet is formed into a leaflet structure and is sutured and fixed by connectors, thereby avoiding the problem of reduced leaflet strength due to holes in the artificial leaflet caused by suture.

[0106] 3. The stent connection holes connecting the valve leaflets are rectangular. Compared to multiple circular holes, this greatly increases the number of suture loops required during connection, making multiple suture loops easier to sew. This not only secures the valve leaflets more firmly, but also avoids stress concentration, effectively extending the life of the leaflets. Furthermore, the rectangular hole design provides ample space for the connector to pass from the inside of the stent through the stent connection holes and out of the stent.

[0107] When the stent connection hole is designed as a rectangular hole, the axial border rods on both sides of the rectangular hole become narrower. During the valve expansion process, the axial border 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. To avoid this, the present invention connects the support rods at the upper and lower ends of the rectangular hole side by side and connects them in the middle of the upper and lower ends of the rectangular hole. This protects the rectangular hole during the valve expansion process and prevents the rectangular hole from sag inward and squeezing the internal 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 limitation) 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 limitation. 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] Furthermore, the gyroscopic mesh design of the inflow segment allows the inflow stent to retract further toward the aorta after the prosthetic valve expands. This prevents the inflow segment of the prosthetic valve from contacting the His bundle and potentially preventing atrioventricular block. This also reduces the axial size of the expanded prosthetic valve, minimizing the impact of the implant 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 delivery. When it is delivered to the aortic valve, a high-pressure balloon is required to expand the stent. During the expansion process, the mesh in the middle section has 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 and inner skirts of the present invention are designed to form an annular cavity along the circumference. When a stent has a transition section, the outer periphery of the transition section is not covered with a membrane. This design, on the one hand, allows the prosthetic heart valve to undergo endothelialization starting at the outer skirt of the outflow section after implantation. Since the transition section and its upper and lower portions are not covered by the inner and outer skirts, any small amount of blood that enters this area will form a thrombus there due to the reduced flow rate, thus achieving a better sealing effect. Furthermore, not covering the transition section with a membrane reduces its diameter in the collapsed state, facilitating delivery.

[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. On the one hand, 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 and the narrow incisions are covered by hyperplastic tissue, 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 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 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 during the cleaning process of the artificial heart valve before pressing and gripping.

[0115] 8. The design of the inner skirt closely attached 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. Because the number of outflow segment frame units is smaller than that of the inflow segment frame units, the present invention also utilizes a larger openwork mesh structure. While ensuring sufficient radial support at the inflow end, the larger openwork mesh design at the localized outflow end significantly reduces the likelihood of the prosthetic valve leaflets colliding with the stent mesh. This allows the prosthetic valve leaflets to be designed with a larger effective opening area, minimizing the pressure drop caused by blood passing through the prosthetic heart valve and providing a more ergonomic design. Furthermore, the larger openwork mesh design reduces the risk of coronary artery obstruction and provides a favorable channel for coronary reintervention.

[0118] 11. The present invention limits the arrangement and specifications of the first mesh and the second mesh of the first layer, 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 set on the outflow section connection area between two adjacent first mesh holes. In this way, the stent connection hole is protected by the first mesh holes on both sides. The first mesh holes with smaller grids can effectively prevent the invasion of calcified native leaflets into artificial leaflets. In addition, the stent designed in this way will not cause the artificial leaflets to beat against 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. The opening area of ​​the artificial heart valve can be designed to be larger, effectively avoiding the occurrence of aortic stenosis caused by the implantation of the artificial heart valve.

[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 the compression shape 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 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 is designed to be larger, which increases the distance between the axial struts of the second mesh in the compressed state, further weakening the difference between the stent connection hole formed by 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. To mitigate the impact of native aortic calcification sites on the prosthetic valve leaflets, a mesh covering is placed at the first mesh opening. This enhances the barrier between the prosthetic heart valve and the native leaflets, reduces invasion of the native leaflets into the prosthetic valve, and promotes endothelialization of the outflow port. No mesh covering is placed on the second mesh opening to avoid obstruction of the coronary artery ostium. The mesh covering is located on the outside of the stent, ensuring a better fit at the implant site and filling gaps between calcification sites to prevent 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 ensure that the first mesh and the second mesh are pressed more evenly during the pressing process and to avoid bias, 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 be a first mesh and a second mesh structure with different heights, when the stent is in a compressed 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 leaflet and the autologous valve leaflet along the axial direction, maintaining the same height as the native valve leaflet, so that the artificial heart valve has better hemodynamics.

[0125] In the compressed state, the two angled struts at the outflow end of the second mesh mesh fit together in the middle, creating a teardrop-like structure at the distal end. This teardrop-like structure provides stronger radial restoring force for the angled struts, facilitating the artificial heart valve's return to its expanded state upon reaching the phase transition temperature. Furthermore, the teardrop-like structure itself facilitates imaging, resulting in superior ultrasound imaging.

[0126] 16. The present invention defines an optimal positional relationship for the first layer of mesh, the second layer of mesh, the third layer of mesh and the fourth layer of mesh, so that there are no independent sharp corners at the end of the mesh inside the second layer of mesh of the first layer. During the process of stent expansion through the balloon, it can avoid 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 to position the valve, aligning it with the native valve leaflets. Preferably, the coronary ostium can be positioned in the middle of the second mesh, facilitating the entry of subsequent coronary surgical instruments through the second mesh. Furthermore, because this design allows for a more precise circumferential release position for the artificial heart valve, the artificial leaflets can be released closer to the native leaflets, resulting in better hemodynamic characteristics.

[0128] 18. The present invention can also omit the second mesh. The first layer of mesh only relies on the first mesh to block the damage to the valve leaflet caused by the calcification site. 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, and ultimately reduce 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 for illustrative purposes only and are not intended to limit the scope of protection of the present invention. In the drawings:

[0130] FIG1( a ) is a schematic structural diagram of an artificial valve leaflet according to 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 leaflet mechanism and the stent of the present invention;

[0133] FIG1(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] FIG2( a ) is a schematic structural diagram of a stent according to the present invention;

[0136] Figure 2(b) is a front view of Figure 2(a);

[0137] Figure 2(c) is a partial enlarged view of Figure 2(b);

[0138] Figure 2(d) is a schematic diagram of the stent deployment structure of Figure 2(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 expanded structure of the outer skirt of the present invention;

[0141] Figure 3(b) is a partial enlarged view of point A in Figure 3(a);

[0142] Figure 3(c) is a partial enlarged view of point B in Figure 3(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 perspective view of the bracket of the present invention;

[0147] Figure 6(b), Figure 6(c) and Figure 6(d) are front views of Figure 6(a) from three different angles;

[0148] FIG7( a ) is a schematic diagram of the stent deployment of FIG6( a );

[0149] Figure 7(b) is a partial enlarged view of Figure 7(a);

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

[0151] Figure 7(d) is a partial enlarged view of Figure 7(c);

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

[0153] FIG9( a ) is a schematic diagram of the deployment of a stent 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 according to the present invention;

[0156] Figure 10 A schematic diagram of a structure in which other meshes are arranged within the second mesh of the present invention;

[0157] Figure 11 A compression state structure diagram of the present invention;

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

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

[0160] The following describes the embodiments of the present invention through specific examples. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different perspectives and applications without departing from the spirit of the present invention.

[0161] It should be noted that, unless there is any conflict, the following embodiments and features therein may be combined with each other.

[0162] In the description of the present invention, it should be noted that, for directional words, such as the terms "outside", "middle", "inside", "outside", etc., the directions and positional relationships indicated are based on the directions or positional relationships shown in the accompanying 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 scope of protection of the present invention.

[0163] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Therefore, the terms "first" and "second" may explicitly or implicitly refer to one or more of these features. Throughout the description of the present invention, "several" and "a number" mean two or more, unless otherwise 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 "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 Figures 1-4 , an embodiment of an artificial heart valve provided by the present invention comprises a stent 100 and a leaflet mechanism 200. The stent 100 is an annular stent that can contract or expand radially and can be expanded by a balloon. The stent 100 is provided with a plurality of stent connection holes 140, through which the leaflet mechanism 200 is connected to the inner side of the stent 100.

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

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

[0168] When multiple artificial valve leaflets 220 of the same structure are connected in sequence, as shown in Figure 1(b), the two first connecting portions 222 of two adjacent artificial valve leaflets 220 are fixedly connected together by a connector 210. One end of the connector 210 covers the first connecting portion 222 to prevent damage to the leaflets. The artificial valve leaflets 220 are connected in a ring shape. After being folded in half along the axis of symmetry of the connector, the connector 210 is passed through the corresponding stent connection hole 140 on the inner side of the stent 100. The connector 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 Figure 1(c), the second connecting portion 223 is folded outward from the overlapping area formed by the two adjacent artificial valve leaflets 220, with the arcuate portion abutting the outer wall of the leaflet body 221. The fixing portion 2231 is folded along a surface perpendicular to the artificial valve body, abutting against the connector 210 on the inner side of the stent 100. The two adjacent fixing portions 2231 are respectively connected to the two sides of the connecting member 210 . The fixed state is shown in FIG1( 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 abuts 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 abutting against the outer wall of the artificial leaflet 220 can provide a certain support force to prevent the artificial leaflet from fully opening. On the one hand, it prevents the portion where the artificial leaflet is connected to the stent from being subjected to stress concentration, thereby reducing the service life of the artificial leaflet. On the other hand, the incomplete opening of the artificial leaflet can prevent the artificial leaflet from abutting against the aortic wall and blocking the coronary ostium when in the open state. When the artificial valve leaflet is closed, blood from the aorta impacts the artificial valve leaflet. Because the free end of the curved portion has a certain width, it can protect the artificial valve leaflet at the connection with the stent, buffer the impact of blood flow on the artificial valve leaflet, and better protect the artificial valve leaflet 220. In particular, the right side of the curved portion 2232 is designed with an arc structure 2232a, which is more in line with fluid mechanics. When the artificial valve leaflet is closed, the curved portion can block some of the impact of blood flow, preventing the formation of vortices between the curved portion and the main body of the artificial valve leaflet, or at least reducing vortices, reducing the impact of blood flow on the leaflet and protecting the stent. On the one hand, it improves the fatigue life of the stent 100, and on the other hand, it makes the artificial heart valve more stable after implantation. This is because the stability of the artificial heart valve is one of its important indicators. It is expected that the valve will remain in the implanted position after implantation to avoid displacement or even dislodgement. For artificial heart valves, especially in the pre-endothelialization stage after implantation, a stable stent 100 can improve product safety and prevent blood impact from causing valve displacement and leading to surgical failure.

[0170] In some embodiments, the leaflet mechanism 200 includes three connectors 210 and three artificial leaflets 220 . 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 both sides of the connector 210 by suturing. During suturing, the suture thread surrounds the axial border rod of the bracket connection hole to fix the fixing portion 2231 and the connector 210.

[0172] In some embodiments, referring to FIG1( 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. 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, it drives the first connection portion 222 connected to the connector 210 to be pulled outward, and the second connection portion 223 needs to be bent so that the fixing portion 2231 is located relative to the inner side of the connector 210. Due to the design of the leaflet U-shaped groove 224, no damage will be caused to the first connection portion 222 and the second connection portion 223, whether the connector 210 is extended or the fixing portion 2231 is bent along the leaflet U-shaped groove 224.

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

[0174] In some embodiments, referring to FIG1( a ), the outer contour of the fixed end of the leaflet body 221 comprises a leaflet base arc 2211 and two leaflet side arcs 2212 . The lower end of the leaflet base arc 2211 is an arc-shaped structure. The two leaflet side arcs 2212 are located on either side of the leaflet base arc 2211, and the lower ends of the leaflet side arcs 2212 are also arc-shaped structures. The leaflet base arc 2211 and the leaflet side arcs 2212 on both sides have the same slope and smoothly connect 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 the 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 FIG1( a ), the leaflet bottom arc 2211 is an arc formed by a first radius R1 , and the two leaflet side arcs 2212 are arcs formed by a second radius R2 , then R2 : R1 = (2-5):1.

[0178] In some embodiments, referring to FIG1( 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 FIG1(a), the free end of the leaflet body 221 is raised upward as a free edge to form a raised portion 2213. The design of the raised portion 2213 can increase the contact area between the artificial valve leaflets 220 when the artificial heart valve is in the closed state, and the raised portion can fill the gap formed in the middle of the artificial valve leaflets 220 when the artificial valve leaflets 220 are closed, which can ensure that the artificial valve leaflets 220 have a better fit and effectively avoid the occurrence of reflux. This is because, especially for the ball-shaped valve stent, due to its strong supporting force, when the artificial valve leaflets 220 are in the closed state, their outflow ends are still attached to the aortic wall, or only move slightly radially toward the central axis of the aorta. The middle part of the multiple artificial valve leaflets 220 will form a triangular gap 229 as shown in FIG1(e). The existence of the triangular gap 229 can cause reflux in the artificial heart valve. The design of the raised portion 2213 can increase the fit of the artificial valve leaflets 220 in the closed state and avoid reflux.

[0181] In some embodiments, referring to FIG. 1( a ), two avoidance cuts 226 are provided on the leaflet body 221 , and the avoidance cuts 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, such 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, if there is no avoidance cutout 226 during extension, the connection between the leaflet body 221 and the first connection portion 222 will wrinkle and may accumulate inside or on the side of the stent connection hole 140, 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 Figure 1(a), the angle α of the avoidance incision 226 is no more than 90°, such as 85°, 80°, 75°, 70°, etc., which can not only ensure that the leaflet body 221 fits closely with the inner side of the stent 100, but also allow the first connecting portion 222 and the connecting member 210 to have sufficient suturing space.

[0185] In some embodiments, this 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 this embodiment is a rectangular hole.

[0186] The rectangular hole 140 of the stent connection hole significantly increases the number of suture loops required during connection, compared to multiple circular holes. This makes it easier to sew multiple loops of suture. This not only secures the leaflets more securely, but also prevents stress concentration, effectively extending the life of the leaflets. Furthermore, the rectangular hole design provides ample space for the connector 210 to pass from the inside of the stent 100 through the stent connection hole 140 and out 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 on the connecting piece 210.

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

[0189] The inflow section 110 includes a plurality of inflow section frame units 111 connected end to end and a plurality of inflow section connection areas 112. The inflow section frame unit 111 is a hollow frame unit having an inflow section mesh 113. The inflow section connection area 112 is an area where two adjacent inflow section 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 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 part 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 a frame unit and a connection area, and two radially adjacent outflow segment frame units 121 share a frame unit and a connection area.

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

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

[0195] The gyro-shaped mesh design reduces the contact area (axial limitation) between two adjacent gyro-shaped structures. After the valve is implanted in the human body and expanded, the axial limitation is reduced, allowing for a larger expansion diameter. The gyro-shaped structure is located in the inflow section of the valve. When the artificial heart valve is in the closed state, the blood flow from the aorta has a greater impact on the artificial heart valve. The gyro-shaped structure has a larger contact area and friction with the aortic root, significantly improving the impact resistance of the stent. In addition, the gyro-shaped mesh design of the inflow section allows the inflow end stent to retract a larger size toward the aorta after the artificial heart valve expands, preventing the inflow section of the artificial heart valve from touching the His bundle and thus preventing 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 section 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 toward the outflow end along the axial direction of the bracket 100, 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 connection area 122, and the outflow section lower support rod 1214 is connected between the outflow section lower protrusion 1212 and the outflow section connection 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 to 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 to the middle of the inflow end of the bracket connection part 122a.

[0200] The outflow section frame unit 121 of this 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, which are connected in sequence to form a hollow frame unit with an inflow section mesh 113. Two radially adjacent outflow section frame units 121 share the outflow section upper support rod 1213, outflow section connection area 122, and outflow section lower support rod 1214.

[0201] After the stent connection hole 140 is designed as a rectangular hole, the width of the axial border rods on both sides of the rectangular hole on the stent connection part 122a becomes thinner. During the expansion of the valve, the axial border rods of the rectangular hole easily 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 and 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 squeezing the 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 the other outflow section connection areas 122. The rectangular structure of the stent connecting portion 122a acts as two axial connecting rods 122a1 that work together to provide support. Reducing the width of the axial connecting rods 122a1 of the stent connecting portion 122a can, on the one hand, minimize the contracted diameter of the valve, thereby minimizing the contracted diameter. On the other hand, it can maintain approximately the same support strength between the stent connecting portion 122a and the other outflow connection regions 122.

[0202] In some embodiments, referring to Figure 2(b), the inflow segment frame unit 111 includes an upper inflow segment protrusion 1111 and a lower inflow segment protrusion 1112, the upper inflow segment protrusion 1111 protrudes along the axial direction of the bracket 100 toward the outflow end, and the lower inflow segment 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. The inflow section upper support rod 1113 is connected between the inflow section upper protrusion 1111 and the inflow section connection area 112, and the inflow section lower support rod 1114 is connected between the inflow section lower protrusion 1112 and the inflow section connection area 112.

[0204] The inflow section frame unit 111 of this 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, which are 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 are located 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 only has 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 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, 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 inflate during surgery.

[0208] In some embodiments, there is an arc connection 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 to 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 section frame units 131 share a common frame unit and a connection area.

[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 mesh size after expansion 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 transportation. When it is transported to the aortic valve, a high-pressure balloon is required to expand the stent. During the expansion process, the transition section mesh 133 has a greater resistance to opening. Therefore, compared with the outflow section mesh 123 of the outflow section and the inflow section mesh 113 of the inflow section, the transition section 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 there will be no axial displacement 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 toward the outflow end along the axial direction of the bracket 100, 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 this 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, which are connected in sequence to form a hollow frame unit with a transition section mesh 133. Two radially adjacent transition section frame units 131 share the transition section upper support rod 1313, transition section connection area 132, and transition section lower support rod 1314.

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

[0219] In some embodiments, when a transition section 130 is disposed 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 connecting region 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 provided between the inflow section 110 and the outflow section 120 , and the 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 on the outflow end side has its transition section upper support rod 1313 of the transition section frame unit 131 shared with the outflow section lower support rod 1214 of its axially adjacent outflow section frame unit 121. The transition section connection area 132 is shared with the outflow section lower protrusion 1212 of its axially adjacent outflow section frame unit 121.

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

[0223] When two layers of transition sections 130 are provided, the stent 100, as shown in FIG2( b ), 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 middle two layers of transition section mesh 133 are smaller than those of 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 further 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 Figure 2 (b), it is connected to 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 face 1214a of the fourth support rod, as shown in FIG2(a) and FIG2(e). With such a 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 .

[0228] When the stent 100 includes a transition section 130, the outer periphery of the transition section 130 is not covered with a membrane. This design, on the one hand, allows the prosthetic heart valve to undergo endothelialization starting from the lower support rod 1214 and outer skirt 300 of the outflow section after implantation. Since the transition section 130 and its upper and lower portions are not covered by the inner and outer skirts, any small amount of blood that enters this area will form a thrombus there due to the reduced flow rate, thus achieving a better sealing effect. On the other hand, not covering the transition section 130 with a membrane reduces its diameter in the collapsed state, facilitating delivery.

[0229] In some embodiments, the outer skirt 300 wraps from the inflow end of the bracket 100 to the upper end surface 1113a of the upper support rod 1113 at the upper edge, as shown in FIG. 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 are not formed after the inner and outer skirts wrap around 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.

[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, which are evenly spaced apart from a plurality of skirt U-shaped grooves 320 and arranged below the skirt U-shaped grooves 320. When the outer skirt 300 is disposed 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 thrombosis in the annular cavity, filling the gap between the outer skirt 300 and the aortic wall that is not tightly sealed, thereby further improving the sealing performance of the artificial heart valve. Until the outer skirt 300 is endothelialized and the narrow incision is covered by proliferating tissue, 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 risk of thrombosis 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 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 cutouts 330 are disposed directly below the corresponding skirt U-shaped grooves 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. By setting the skirt incision 330 here, the skirt incision 330 is not easily covered, and it is easier for blood to enter the annular cavity from the skirt incision 330.

[0242] In some embodiments, referring to FIG3(c), a plurality of suture grooves 340 are provided at the lower end of the outer skirt 300. A plurality of suture grooves 340 are also uniformly provided at the lower end of the inner skirt 400. When sewing the inner and outer skirts, the suture grooves 340 serve as positioning elements, relatively determining the positions of the inner and outer skirts, thereby improving the efficiency of the suture operation.

[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, so that the artificial leaflet can reduce external interference in the closed state, form a closed surface according to the designed closed curve, and reduce 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 bracket 100 will be stretched along the axial direction of the bracket 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 bracket 100, reducing the axial constraint of the bracket.

[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 part.

[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 frame units 111, each of which is a hollow frame unit having an inflow mesh 113. The outflow end is surrounded by a plurality of outflow frame units 121, each of which is a hollow frame unit having an outflow mesh 123. The number of outflow frame units 121 is less than the number of inflow frame units 111, and the outflow frame units 121 include a first mesh 511 and a second mesh 512 of different mesh sizes.

[0251] Because the number of outflow segment frame units 121 is smaller than the number of inflow segment frame units 111, the number of outflow segment meshes 123 is smaller than the number of inflow segment meshes 113. This results in a larger hollow grid structure for the outflow segment meshes 123. While ensuring sufficient radial support at the inflow end, the use of a larger hollow grid design at a localized location on the outflow end significantly reduces the likelihood of the artificial valve leaflets colliding with the stent grid. This allows the artificial valve leaflets to be designed with a larger effective opening area, reducing the pressure drop caused by blood passing through the artificial heart valve and achieving a more ergonomic design. Furthermore, the larger hollow grid design can reduce the risk of coronary artery obstruction and provide a favorable channel for coronary reintervention.

[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 Figures 6(a) to 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, as 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 mesh, and the first layer of mesh 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 FIG6(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 FIG6(d), H2-H1=ΔH, where ΔH is a value greater than 0.

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

[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 Figures 6(a) to 8 The stent 100 is provided with a plurality of stent connection holes 140 for connecting to the leaflet mechanism. Two first mesh holes 511 and a second mesh hole 512 are provided between two adjacent stent connection holes 140. The second mesh hole 512 is located between the two first mesh holes 511. The stent connection hole 140 is provided on the outflow segment connection area 122 between the two adjacent first mesh holes 511. The outflow segment connection area 122 is the area where two adjacent outflow segment frame units 121 are connected to each other. The stent connection holes 140 are all connected to the first mesh holes 511 in the circumferential direction. This is because the artificial valve leaflets are 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 leaflets are closed, the artificial valve leaflets are subjected to reverse impact from the aortic blood flow. As the position directly connected to the artificial valve leaflets, the stent connection holes 140 are subjected to greater tension. Therefore, it is necessary to design a relatively smaller mesh, such as the first mesh hole 511, 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. The outflow segment frame unit 121 is a hollow frame unit with 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. Part of the outflow segment connection area 122 is provided with a bracket connection hole 140 as a bracket connection part 122a.

[0267] The stent connection hole 140 connected to the leaflet mechanism is set on the outflow section connection area 122 between two adjacent first mesh holes 511. In this way, the stent connection hole 140 is protected by the first mesh holes 511 on both sides. The first mesh holes 511 with smaller grids can effectively prevent the calcified native leaflets from invading the artificial leaflets of the leaflet mechanism. In addition, since the radial movement amplitude of the artificial leaflets near the stent connection hole 140 is small during the opening and closing 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, ensure that the artificial leaflets are fully fitted when closed, preventing the occurrence of regurgitation in the valve. In addition, while ensuring that the artificial leaflets do not hit the stent 100, it can also effectively avoid damage to the artificial leaflets by the calcified sites on the native leaflets or the aortic wall, effectively avoiding the occurrence of aortic restenosis 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 bracket connecting portion 122 a is smaller than the width of the other outflow segment connecting regions 122 .

[0270] In some embodiments, reference Figure 11 After being compressed, the stent 100 has a more uniform compression shape. The shape of the mesh with stent connection holes after compression is similar to the mesh without stent connection holes 140 in the present invention, and there is no obvious compression tilt. 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, further weakening 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 returns to the expanded state.

[0271] In some embodiments, referring to FIG9(a), in order to reduce the influence of the native aortic calcification site on the artificial valve leaflet, 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 blocking effect of the artificial heart valve on the native valve leaflet, reduce the invasion of the native valve leaflet on the artificial valve, and promote endothelialization of the outflow end.

[0272] No mesh covering is provided on the second mesh 512 to avoid obstructing the coronary artery ostium. This also provides a larger movement space for the artificial valve leaflets, thereby increasing the opening area of ​​the artificial heart valve. The covering of the other mesh layers can be done using existing covering technologies, which will not be described in detail here.

[0273] In some embodiments, the mesh covering is located on 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 Figures 7(a) and 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, on the one hand, to ensure that the artificial heart valve can be compressed to the designed size during the compression and gripping process, and on the other hand, to ensure that the artificial heart valve in the compressed state can be smoothly expanded to the designed shape and size when it is delivered to the patient's target position. Therefore, the sizes of the angles α and β are 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 the different angles during the compression and expansion process, it is preferably designed so that α = β.

[0275] As described in the aforementioned embodiment, the angle of the angled support rods is primarily used to ensure the stability of the stent. If the angle is too large, the difficulty of crimping the artificial heart valve will be significantly increased. If the angle is too small, more meshes will be required, affecting the crimping diameter of the heart valve. Furthermore, if the axial length of the mesh is too large, the axial size of the stent will be increased accordingly. Therefore, to balance stent stability, support force, and crimping process, α = β = 100°-150°, such as 110°, 130°, 140°, etc., is preferred, with α = β = 120° being more preferred. This is because when the angle α = β = 120°, the force applied to the support rod connection point is optimal.

[0276] In some embodiments, in order to ensure that the first mesh 511 and the second mesh 512 are pressed more evenly during the pressing process and that bias does not occur, 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 Figure 11 When the stent 100 is in the gripping 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 provided at the outflow end of the second mesh 512 .

[0279] When the outflow end height of the second mesh 512 is higher than the outflow end height 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 leaflets and the native leaflets in the axial and circumferential directions, maintaining the same height as the native leaflets and a higher degree of overlap, so that the artificial heart valve has better hemodynamics.

[0280] In some embodiments, reference Figure 11 When the stent 100 is in the gripping state, the two angled support rods on the outflow end side of the second mesh 512 fit together 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 provides a stronger radial restoring force for the angled support rods, further facilitating the artificial heart valve's return to its expanded state upon reaching the phase transition temperature. Furthermore, the teardrop-shaped structure 512a itself is more suitable for imaging, providing superior imaging quality 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 FIG7( 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] Alternatively, the heights of the outflow ends A1 and A2 of the second mesh 512 are greater than the heights 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, and the second layer of mesh 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, and the third layer of mesh 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, resulting in the inflow end of the second mesh 512 being surrounded by the support 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, and the fourth layer of mesh 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 there is no third mesh 521 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. Figure 10 The artificial heart valve shown has sharp corners at the end of the mesh (the inner leaflets are not shown). Figure 10 In the comparative example shown, due to the presence of sharp corners 540 within the second mesh 521, during balloon expansion of the stent 100, the sharp corners 540, unable to withstand the pull of other components, tend to be retracted inwards to maintain their original gripping state when the rest of the stent has expanded. In other words, the sharp corners 540 become protrusions toward the balloon, making it more likely to puncture the balloon, damage the valve leaflets, or damage the mesh covering on the stent. In contrast, the present embodiment does not have a separate sharp corner design at the end of the mesh within the second mesh 512, thus preventing the sharp corners from damaging the valve leaflets or balloon, potentially leading to surgical failure.

[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 layer of mesh, the third layer of mesh, and the fourth layer of mesh.

[0291] In the above design of this embodiment, to avoid forming independent sharp corners within the second mesh 512, the second mesh layer needs to lack two third meshes 521 within the second mesh, and the third mesh layer needs to lack one fourth mesh 531 within the second mesh. In this case, 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 is not required to be very large, but the effective opening area of ​​the valve is required 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 mesh 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 connection holes 140, that is, the first layer of mesh is only set on the left and right sides of the bracket connection hole 140, and in order to provide a better support effect, the third mesh 521 of the bracket is not missing, and multiple adjacent third meshes 521 are connected in sequence to form a ring.

[0294] For the embodiments shown in Figures 9(b) and 9(c), in order to ensure that the first meshes 511 can expand according to a predetermined shape after being squeezed when the outflow end of the stent is composed of only a plurality of first meshes 511 that are not arranged in a ring shape, 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 presence 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 Figures 6(a) to 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 those in FIG. Figures 2(a) to 5 The embodiments corresponding to the stent are the same, that is, the above embodiments of the leaflet mechanism 200, the outer skirt 300, and the inner skirt 400 of the present invention are still applicable to Figures 6(a) to 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, as shown in Figure 6 (b), it is connected to the second support rod from the bottom.

[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 end 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 Figure 12(a) 、 12(b) In the stent 100 shown, the outflow end is only provided with a plurality of stent connection holes 140, and no outflow segment frame unit is provided. The number of stent connection holes 140 is preferably equal to the number of leaflets. For example, for most patients with a three-leaflet heart valve, the number of stent connection holes 140 is three.

[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 rod of the frame unit, that is, the leaflet will not hit the support rod 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 can be 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 connection 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. These two layers of mesh can also be designed to have other identical or different shapes.

[0303] In order to improve the stability of the artificial heart valve during expansion, such as during balloon expansion, and to prevent rotation between the stent connection hole 140 and the second layer of mesh due to the small contact area, the contact area between the stent connection hole 140 and the second layer of mesh can also be increased. As shown in FIG12(c), the difference from FIG12(b) is that the stent connection hole 140 in FIG12(b) is a rectangular hole with substantially the same width from top to bottom, connected through the top of the second layer of mesh. In FIG12(c), the inner hole of the stent connection hole 140 still maintains a rectangular structure, but the outer surface of the stent connection hole 140 is constructed to gradually widen from the outflow end to the inflow end (from top to bottom) to increase the contact area between the stent connection hole 140 and the third mesh 521 in the second layer of mesh. Preferably, the outer periphery of the inflow end of the stent connection hole 140 is tangent to the upper surface of the third mesh 521. As shown in FIG12(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, to prevent the uniformity of the artificial heart valve structure from being affected by excessive thickness in the middle portion where the stent connection hole 140 and the third mesh 521 are connected, additional adjustment holes 601 may be provided in the adjacent portion inside the stent connection hole 140 and the third mesh, as shown in FIG12( d ). In this figure, there are two symmetrical half-moon-shaped adjustment holes 601. It should be noted that the shape of the adjustment holes 601 is not limited to half-moon, and the number is not limited to two, as long as the purpose of improving the uniformity of the artificial heart valve structure is achieved. For example, multiple circular, triangular, diamond-shaped, etc. shapes may be designed.

[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 aortic wall.

[0306] To avoid affecting the crimping of the prosthetic heart valve and reduce the effect of the stent connection hole 140 on the axial deformation of the prosthetic 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. This minimizes the crimping force on the third mesh 521. Furthermore, 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, further reducing the impact of crimping on the third mesh and improving 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 has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. An artificial heart valve, comprising a stent and a leaflet mechanism disposed within the stent, wherein the stent is provided with a plurality of stent connection holes; It is characterized by: The leaflet mechanism comprises: Several connecting parts; A plurality of artificial valve leaflets, wherein the plurality of artificial valve leaflets are sequentially connected to form a ring-like structure; The artificial valve leaflet has: One leaflet body; Two first connecting portions, the two first connecting portions being connected to two sides of the free end of the leaflet body; Two second connecting parts, each of the second connecting parts is connected to the upper part of the first connecting part and the connecting part can be folded along the first flip axis; The first connecting portions of two adjacent artificial valve leaflets are connected by the connecting piece to form a ring-like structure; The bracket connection hole is a rectangular hole, and the support rods at the upper and lower ends of the rectangular hole are connected to the middle of the upper and lower ends of the rectangular hole; The bracket comprises: an inflow section, wherein the inflow section is surrounded by a plurality of inflow section frame units, and the inflow section frame units are hollow frame units having inflow section meshes; An outflow section, the outflow section includes 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, The number of the outflow section frame units is less than the number of the inflow section frame units; The inflow section includes a plurality of inflow section frame units connected end to end and a plurality of inflow section connection areas. The inflow section frame unit is a hollow frame unit with an inflow section mesh. The inflow section connection area is an area where two adjacent inflow section frame units are connected to each other. The outflow segment includes a plurality of outflow segment frame units connected end to end and a plurality of outflow segment connection areas. The outflow segment frame units are hollow frame units with outflow segment meshes. The outflow segment connection areas are areas where two adjacent outflow segment frame units are connected to each other. Some of the outflow segment connection areas are provided with bracket connection holes as bracket connection parts. The outflow section includes a plurality of outflow section frame units, each of which is a hollow frame unit having an outflow section mesh. The outflow section frame unit includes a first mesh located on both sides of the bracket connection hole. The outflow section frame unit further includes a second mesh, wherein the first mesh and the second mesh are meshes of different sizes; 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; The circumference of the bracket connection holes are all connected to the first mesh; Adjacent outflow segment frame units are connected through the outflow segment connection area, and the width of the axial connecting rod of the bracket connection part with the bracket connection hole is smaller than the width of other outflow segment connection areas; the bracket only includes one layer of inflow segment mesh and one layer of outflow segment mesh.

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

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

4. The artificial heart valve according to claim 1, wherein A horizontal leaflet U-shaped groove is provided at the connection between the first connection portion and the second connection portion.

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

1.

7. The artificial heart valve according to claim 1, wherein 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 section includes a plurality of inflow section frame units connected end to end and a plurality of inflow section connection areas, wherein the inflow section frame units are hollow frame units having inflow section meshes, and the inflow section connection areas are areas where two adjacent inflow section frame units are connected to each other; And / or, the outflow segment includes a plurality of outflow segment frame units connected end to end and a plurality of outflow segment connection areas, the outflow segment frame unit is a hollow frame unit with 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, wherein 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, wherein: The outflow section frame unit includes an outflow section upper protrusion and an outflow section lower protrusion, wherein the outflow section upper protrusion protrudes toward the outflow end along the axial direction of the bracket, and the outflow section lower protrusion protrudes away from the outflow end along the axial direction of the bracket; 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 includes 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, 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, wherein 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, wherein 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, wherein 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 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 outside of the bracket, the skirt cutout is located below the inflow section connection area.

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

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