Heart valve stent and heart valve prosthesis

Abstract

Provided are a heart valve stent (100) and a heart valve prosthesis (1000). The heart valve stent (100) comprises a stent body (10) and a first positioning part (20) and a second positioning part (30) used for positioning relative to heart tissues. The stent body (10) has defined therein a flow channel for blood to flow, and an upstream direction and a downstream direction are defined according to a direction (X) in which the blood flows through the flow channel. The first positioning part (20) and the second positioning part (30) are both located at the upstream end of the flow channel, and the first positioning part (20) and the second positioning part (30) both extend radially outward from the stent body (10), wherein the second positioning part (30) is located on the upstream side of the first positioning part (20); along the circumferential direction of the flow channel, the first positioning part (20) and the second positioning part (30) at least partially overlap, and along the axial direction of the flow channel, the first positioning part (20) is spaced apart from the second positioning part (30). The heart valve stent (100) exhibits high stability and good heart tissue anchoring performance.

Description

Heart valve stent and heart valve prosthesis

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application number 202410307689.6, filed with the Patent Office of China on March 18, 2024, entitled “A Heart Valve Stent and Heart Valve Prosthesis”. The entire contents of the above application are incorporated by reference into this application. Technical Field

[0003] The present application relates to the field of medical technology, and in particular to a heart valve stent and a heart valve prosthesis. Background Art

[0004] Heart valves, located between the atria and ventricles, and between the ventricles and aorta, act as one-way valves, helping blood flow in one direction. The human body has four valves: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased (e.g., stenosis or incomplete closure), they can affect blood flow, leading to abnormal heart function and ultimately heart failure.

[0005] At present, when a valve is diseased, valve replacement surgery is often used for treatment, that is, replacing the valve with an artificial mechanical valve or a biological valve. However, the existing heart valve stents are easily detached under the influence of blood flow after implantation, and the stability of the installation and fixation is poor, which affects the service life of the artificial heart valve and increases the risk of the patient having to replace the valve again.

[0006] Summary of the Invention

[0007] The embodiments of the present application provide a heart valve stent and a heart valve prosthesis with high installation stability and strong anchoring performance to the heart valve.

[0008] An embodiment of the present application provides a heart valve stent, which includes a stent body and a first positioning portion and a second positioning portion for positioning relative to heart tissue. The stent body defines a flow channel for blood circulation, and the upstream and downstream directions are defined according to the direction of blood passing through the flow channel. The first positioning portion and the second positioning portion are both located at the upstream end of the flow channel, and the first positioning portion and the second positioning portion both extend radially outward from the stent body; wherein the second positioning portion is located on the upstream side of the first positioning portion, and along the circumference of the flow channel, the first positioning portion and the second positioning portion at least partially overlap, and along the axial direction of the flow channel, the first positioning portion and the second positioning portion are spaced apart.

[0009] In this embodiment, a heart valve stent body defines a flow channel for blood circulation in the middle portion of the stent body. A first positioning portion and a second positioning portion of the heart valve stent are both located at the upstream end of the flow channel. The first and second positioning portions abut and sandwich the stent between corresponding cardiac tissues to secure the stent, preventing displacement of the stent due to pressure exerted by blood on the valve leaflets when the valve leaflets close. This improves the stability and reliability of the stent in the cardiac tissue and extends the service life of the stent. Furthermore, the second positioning portion is located upstream of the first positioning portion, i.e., the second positioning portion abuts one side of the cardiac tissue while the second positioning portion abuts the other side of the cardiac tissue. The first and second positioning portions at least partially overlap, creating a gap between the first and second positioning portions along the axial direction of the flow channel. This allows the first and second positioning portions to be sandwiched between opposing sides of the cardiac tissue, resulting in strong anchoring stability, low rigidity, and good compliance of the second positioning portion, which minimizes impact on the conduction bundle.

[0010] In some embodiments, the extension angle of the first positioning portion or the second positioning portion in the circumferential direction is α, wherein the value of α is greater than 320°.

[0011] In some embodiments, a connecting ring is provided on the stent body, and the connecting ring is used for connection with a delivery system.

[0012] In the above embodiment, a connecting ring is formed on the stent body, which is used to connect to the delivery system so that the heart valve stent can be delivered to the target position of the heart tissue through the delivery system, thereby improving the stability and reliability of the heart valve stent delivery process; and the setting of the connecting ring can achieve full recovery of the heart valve stent.

[0013] In some embodiments, the first positioning portion includes multiple first positioning units, the multiple first positioning units are arranged along the circumferential direction, and each first positioning unit includes two first positioning rods; two first positioning rods belonging to the same first positioning unit are connected at the end away from the flow channel to form a first positioning point, and the first positioning points of the multiple first positioning units are arranged at intervals along the circumferential direction; two first positioning rods belonging to two adjacent first positioning units converge at the first node at the end close to the flow channel.

[0014] In the above embodiment, the first positioning portion includes a plurality of first positioning units, and the plurality of first positioning units are arranged along the circumferential direction. The plurality of first positioning units can cooperate with each other to achieve multi-point positioning of the heart tissue in the circumferential direction. Each first positioning unit includes two first positioning rods, and the two first positioning rods are connected at one end away from the flow channel to form a first positioning point. The first positioning points in each first positioning unit are used to achieve multi-point positioning of the corresponding position of the heart tissue. The structure is simple, the positioning stability is high, and the probability of displacement of the heart valve stent is reduced.

[0015] In some embodiments, the second positioning portion includes a plurality of second positioning units, each second positioning unit includes two second positioning rods, and the two second positioning rods converge at one end away from the flow channel to form a second positioning point; the two second positioning rods are connected to two adjacent first nodes at one end close to the flow channel; wherein the first positioning point and the second positioning point are arranged opposite to each other in the axial direction of the flow channel, and are spaced apart in the axial direction of the flow channel.

[0016] In the above embodiment, a second positioning unit is provided between two adjacent first positioning units, and the second positioning rod in the second positioning unit is connected at one end away from the flow channel to form a second positioning point, and the second positioning point is abutted against the ventricular side of the heart tissue to achieve the positioning effect.

[0017] In some embodiments, the first positioning rod includes a first axial segment and a first circumferential segment, one end of the first axial segment is connected to the first node, and the other end is connected to the first circumferential segment. In the first positioning portion, the sum of the circumferential extension angles of the first circumferential segments in each first positioning unit is the first extension angle; the second positioning rod includes a second axial segment and a second circumferential segment, one end of the second axial segment is connected to the first node, and the other end is connected to the second circumferential segment. In the second positioning portion, the sum of the circumferential extension angles of the second circumferential segments in each second positioning unit is the second extension angle; the first extension angle is not greater than the second extension angle.

[0018] In the above embodiment, the first positioning rod in the first positioning unit abuts against one side of the cardiac tissue via a first circumferential segment. The first circumferential segment is designed in an arc shape, which ensures reliable positioning and reduces pressure on the cardiac tissue, thereby minimizing damage to the cardiac tissue. Similarly, the second positioning rod in the second positioning unit abuts against the ventricular side of the cardiac tissue via a second circumferential segment. The second circumferential segment is designed in an arc shape, minimizing damage to the ventricular side of the cardiac tissue.

[0019] In some embodiments, the first circumferential segment and the second circumferential segment are designed to be arc-shaped.

[0020] In some embodiments, the stent body includes multiple support units, and the multiple support units are arranged along the circumference to form a flow channel; each support unit includes a first support rod and a second support rod for respectively connecting different artificial valve leaflets; in the same support unit, the upstream end of the first support rod and the upstream end of the second support rod are respectively connected to two adjacent first nodes, and the downstream end of the first support rod and the downstream end of the second support rod are connected to form a second node.

[0021] In the above embodiment, multiple support units serve as the skeleton of the stent body, and the central portions of the multiple support units enclose a flow channel for blood circulation. Each support unit includes a first support rod and a second support rod for connecting different leaflets, respectively. The upstream ends of the first support rod and the upstream ends of the second support rod are connected to the two first nodes, respectively, so that the multiple support units are connected to the first positioning portion and the second positioning portion as a whole.

[0022] In some embodiments, each support unit further includes a third support rod and a fourth support rod; one end of the third support rod and the fourth support rod is connected to the same second node, and the other end is respectively connected to two adjacent first nodes; a connecting ring is formed at the downstream end of the third support rod and the fourth support rod.

[0023] In the above embodiment, by connecting one end of the third and fourth support rods to the same second node and the other ends to two adjacent first nodes, the stent body achieves enhanced structural stability. Furthermore, connecting rings are formed at the downstream-most ends of the third and fourth support rods, meaning each support unit has two connecting rings. With multiple support units, the stent body comprises multiple connecting rings, which are then connected to the conveying system, providing enhanced connection stability.

[0024] In some embodiments, a first rivet is provided at the first node, in which the first positioning rod is connected to the first support rod or the second support rod at one end close to the flow channel, and the second positioning rod is connected to the third support rod or the fourth support rod at one end close to the flow channel.

[0025] In the above embodiment, the first positioning rod is connected to the first support rod or the second support rod at one end close to the flow channel, and the second positioning rod is connected to the third support rod or the fourth support rod at one end close to the flow channel. That is, the first positioning part, the second positioning part and the support unit can be connected as a whole at the intersection of the first node using the first rivet, thereby ensuring the integrity of the heart valve stent.

[0026] In some embodiments, a second rivet is provided at the second node, and in the second rivet, the first support rod is connected to the third support rod, and the second support rod is connected to the fourth support rod.

[0027] In the above embodiment, the first support rod is connected to the third support rod, and the second support rod is connected to the fourth support rod, that is, the first support rod, the second support rod, the third support rod and the fourth support rod can be connected as a whole using the second rivet, so that the integrity of the support unit is higher, thereby effectively ensuring the reliability of the connection of each support rod in each support unit.

[0028] In some embodiments, the heart valve stent is an aortic valve stent, the first positioning portion is used to be positioned at the aortic sinus, and the second positioning portion is used to be positioned at the ventricular side of the aortic valve.

[0029] In some embodiments, the heart valve stent is formed by braiding at least one filament into a shape.

[0030] In the above embodiment, the heart valve stent is woven with at least one filament, which is easy to deform for transportation through the transportation system, and when transported to the original aortic valve, the filament can quickly restore its original shape, thereby improving the reliability of the heart valve stent at the aortic valve.

[0031] In some embodiments, when the heart valve stent is woven with a plurality of filaments, two connected filaments are fixedly connected by riveting or welding.

[0032] In some embodiments, the material of the filament is memory alloy wire or nickel-titanium alloy wire.

[0033] In some embodiments, the first support rod, the second support rod, the third support rod or the fourth support rod is woven from variable diameter memory alloy wire.

[0034] In addition, an embodiment of the present application further provides a heart valve prosthesis, which includes leaflets and the aforementioned heart valve stent, wherein the leaflets are located in the flow channel of the stent body.

[0035] In some embodiments, the heart valve prosthesis includes a first skirt and a second skirt, the first skirt being connected and covering the space formed between the first support rod, the second support rod and the first positioning rod of the heart valve stent; the second skirt being arranged around the outer peripheral side of the first skirt and being sealed with the first skirt.

[0036] In some embodiments, the first skirt and the second skirt are made of biomaterials, polymers or textiles.

[0037] In some embodiments, the second skirt has an outwardly convex ring structure as a whole.

[0038] In the above embodiment, the leaflets are located in the flow channel and are connected to the heart valve stent. The opening and closing of the leaflets can control the blood circulation in the flow channel. For example, when the heart contracts, the leaflets open and the blood in the heart flows to the whole body through the aorta. At the same time, when the heart relaxes, the leaflets close in time to prevent the blood in the aorta from flowing back into the ventricle. Therefore, the sealing of the flow channel in the heart valve prosthesis is particularly important. By surrounding a first skirt in the space formed between the first support rod, the second support rod and the first positioning rod of the heart valve stent, blood can be prevented from circulating around the heart valve stent, ensuring that blood can only flow into the upstream end of the flow channel and flow out from the downstream end of the flow channel. By surrounding a second skirt on the outer peripheral side of the first skirt and sealingly connected to the first skirt, the second skirt is used to prevent blood from flowing back and avoid paravalvular leakage.

[0039] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0041] FIG1 is a schematic structural diagram of a normal heart valve in an open state;

[0042] FIG2 is a schematic structural diagram of a normal heart valve closed state;

[0043] FIG3 is a schematic structural diagram of a diseased heart valve in an open state;

[0044] FIG4 is a schematic structural diagram of a diseased heart valve in a closed state;

[0045] FIG5 is a schematic structural diagram of a heart valve stent provided in some embodiments of the present application;

[0046] FIG6 is a schematic structural diagram of a heart valve stent provided by some embodiments of the present application from another angle;

[0047] FIG7 is a schematic structural diagram of a heart valve prosthesis provided in some embodiments of the present application;

[0048] FIG8 is a schematic structural diagram of the second skirt in FIG7 ;

[0049] FIG9 is a schematic diagram of a heart valve stent positioned on an aortic valve according to some embodiments of the present application;

[0050] FIG10 is an enlarged schematic diagram of A in FIG9 ;

[0051] FIG11 is a schematic diagram of a heart valve prosthesis positioned on an aortic valve according to some embodiments of the present application.

[0052] Icons: 10-bracket body; 11-support unit; 12-first support rod; 13-second support rod; 14-third support rod; 15-fourth support rod; 16-connecting ring; 20-first positioning portion; 21-first positioning unit; 210-first positioning rod; 2101-first axial section; 2102-first circumferential section; 211-first positioning point; 30-second positioning portion; 31-second positioning unit; 310-second positioning rod; 3101-second Axial segment; 3102-second circumferential segment; 311-second positioning point; 40-first node; 41-first rivet; 50-second node; 51-second rivet; 100-heart valve stent; 200-leaflet; 300-first skirt; 400-second skirt; 401-filling port; 500-aortic valve; 501-native valve ring; 502-native valve leaflet; 503-left ventricle; 504-aorta; 1000-heart valve prosthesis. DETAILED DESCRIPTION

[0053] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0054] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for protection, but merely represents selected embodiments of the present application. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the present application without creative work are within the scope of protection of the present application.

[0055] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not require further definition or explanation in subsequent drawings.

[0056] In the description of the embodiments of this application, it should be noted that the indicated orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, or the orientations or positional relationships in which the product of this application is typically placed when in use. These are intended solely to facilitate the description of this application and simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," "third," etc., are used solely to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0057] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed" and "connected" should be understood broadly. For example, they can refer to fixed connection, detachable connection, or integral connection; they can refer to direct connection, indirect connection through an intermediate medium, or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0058] Example

[0059] Heart valves grow between the atria and ventricles, and between the ventricles and aortas, acting as one-way valves to help blood flow in one direction. The four valves of the human body are called the mitral valve, tricuspid valve, aortic valve 504 and pulmonary valve. If these valves become pathological (such as becoming narrow or incompletely closed), it will affect the flow of blood, thereby causing abnormal heart function and eventually leading to heart failure. Specifically, Figure 1 shows a schematic diagram of a normal heart valve in an open state, with the left ventricle 503 contracting, the aortic valve 500 opening, and blood flowing from the left ventricle 503 to the aorta 504. Figure 2 shows a schematic diagram of a normal heart valve in a closed state, with the left ventricle 503 dilating, the aortic valve 500 closing, and blood cannot flow from the aorta 504 to the left ventricle 503. Figure 3 illustrates a diseased heart valve in its open state, with the left ventricle 503 contracting and the aortic valve 500 opening, but the aortic valve 500 is not fully open, allowing blood to flow from the left ventricle 503 to the aorta 504. Figure 4 illustrates a diseased heart valve in its closed state, with the left ventricle 503 relaxing and the aortic valve 500 closing, but the aortic valve 500 is not fully closed, allowing blood to flow from the aorta 504 to the left ventricle 503. Therefore, when a valve is diseased, valve replacement surgery is often used for treatment, i.e., replacement with an artificial mechanical or bioprosthetic valve.

[0060] In view of this, an embodiment of the present application provides a heart valve stent 100, please refer to Figures 5 to 11, the heart valve stent 100 includes a stent body 10 and a first positioning portion 20 and a second positioning portion 30 for positioning relative to heart tissue, the stent body 10 defines a flow channel for blood circulation, and the upstream and downstream directions are defined according to the direction X of blood passing through the flow channel, the first positioning portion 20 and the second positioning portion 30 are both located at the upstream end of the flow channel, and the first positioning portion 20 and the second positioning portion 30 both extend radially outward from the stent body 10; wherein, the second positioning portion 30 is located on the upstream side of the first positioning portion 20, and along the circumference of the flow channel, the first positioning portion 20 and the second positioning portion 30 at least partially overlap, and along the axial direction of the flow channel, the first positioning portion 20 and the second positioning portion 30 are spaced apart.

[0061] In this solution, a flow channel for blood circulation is defined in the middle of the stent body 10 of the heart valve stent 100, and the first positioning portion 20 and the second positioning portion 30 in the heart valve stent 100 are both located at the upstream end of the flow channel. The first positioning portion 20 and the second positioning portion 30 are abutted and clamped on both sides of the corresponding heart tissue to fix the heart valve stent 100 and prevent the heart valve stent 100 from being displaced due to the pressure generated by the blood on the leaflets 200 when the leaflets 200 are closed, thereby improving the stability and reliability of the heart valve stent 100 in the heart tissue and extending the service life of the heart valve stent 100. In addition, the second positioning portion 30 is located on the upstream side of the first positioning portion 20, that is, the second positioning portion 30 abuts against the ventricular side of the heart tissue, and the second positioning portion 30 abuts against the other side of the heart tissue. The first positioning portion 20 and the second positioning portion 30 at least partially overlap, and the first positioning portion 20 and the second positioning portion 30 are spaced apart along the axial direction of the flow channel, so that the first positioning portion 20 and the second positioning portion 30 are respectively clamped on the opposite sides of the heart tissue, with strong anchoring stability, low rigidity and good compliance of the second positioning portion 30, and less impact on the conduction bundle.

[0062] Among them, the heart tissue can be the mitral valve, tricuspid valve, aortic 504 valve and pulmonary valve. For example, in the present embodiment, when the heart tissue is the aortic 504 valve, the first positioning portion 20 abuts against the native aortic sinus, and the second positioning portion 30 abuts against the ventricular side of the aortic valve 500.

[0063] In some embodiments, the extension angle of the first positioning portion 20 or the second positioning portion 30 in the circumferential direction is α, wherein the value of α is greater than 320°.

[0064] In this embodiment, the extension angles of the first positioning portion 20 and the second positioning portion 30 in the circumferential direction are substantially equal.

[0065] In some embodiments, the stent body 10 is provided with a connecting ring 16 for connection to a delivery system. The connecting ring 16 formed on the stent body 10 is used to connect to the delivery system, thereby facilitating delivery of the heart valve stent 100 to the target location of cardiac tissue via the delivery system. This improves the stability and reliability of the delivery process of the heart valve stent 100. Furthermore, the provision of the connecting ring 16 enables full recovery of the heart valve stent 100.

[0066] In some embodiments, the first positioning portion 20 includes a plurality of first positioning units 21, and the plurality of first positioning units 21 are arranged circumferentially, and each first positioning unit 21 includes two first positioning rods 210; the two first positioning rods 210 belonging to the same first positioning unit 21 are connected at the end away from the flow channel to form a first positioning point 211, and the first positioning points 211 of the plurality of first positioning units 21 are arranged at intervals along the circumferential direction; the two first positioning rods 210 belonging to two adjacent first positioning units 21 converge at the first node 40 at the end close to the flow channel. The first positioning portion 20 includes multiple first positioning units 21, and the multiple first positioning units 21 are arranged along the circumferential direction. The multiple first positioning units 21 can cooperate together to achieve multi-point positioning of the heart tissue in the circumferential direction. Each first positioning unit 21 includes two first positioning rods 210. The two first positioning rods 210 are connected at one end away from the flow channel to form a first positioning point 211. The first positioning points 211 in each first positioning unit 21 are used to achieve multi-point positioning of the corresponding position of the heart tissue. The structure is simple, the positioning stability is high, and the probability of displacement of the heart valve stent 100 is reduced.

[0067] The number of the first positioning units 21 may be two, three, or four. In this embodiment, the number of the first positioning units 21 is three.

[0068] In some embodiments, the second positioning portion 30 includes a plurality of second positioning units 31, each of which includes two second positioning rods 310. The two second positioning rods 310 converge at one end away from the flow channel to form a second positioning point 311. The two second positioning rods 310 are connected to two adjacent first nodes 40 at one end near the flow channel. The first positioning points 211 and the second positioning points 311 are arranged opposite each other in the axial direction of the flow channel and are spaced apart in the axial direction of the flow channel. By providing the second positioning unit 31 between two adjacent first positioning units 21, the second positioning rods 310 in the second positioning unit 31 are connected at one end away from the flow channel to form the second positioning point 311. The second positioning point 311 abuts against the ventricular side of the cardiac tissue to achieve a positioning effect.

[0069] In some embodiments, the first positioning rod 210 includes a first axial segment 2101 and a first circumferential segment 2102, one end of the first axial segment 2101 is connected to the first node 40, and the other end is connected to the first circumferential segment 2102. In the first positioning portion 20, the sum of the circumferential extension angles of the first circumferential segments 2102 in each first positioning unit 21 is the first extension angle; the second positioning rod 310 includes a second axial segment 3101 and a second circumferential segment 3102, one end of the second axial segment 3101 is connected to the first node 40, and the other end is connected to the second circumferential segment 3102. In the second positioning portion 30, the sum of the circumferential extension angles of the second circumferential segments 3102 in each second positioning unit 31 is the second extension angle; the first extension angle is not greater than the second extension angle. The first positioning rod 210 in the first positioning unit 21 abuts against one side of the cardiac tissue via a first circumferential segment 2102. The first circumferential segment 2102 is designed in an arc shape, ensuring reliable positioning and minimizing pressure on the cardiac tissue, thereby minimizing damage to the cardiac tissue. Similarly, the second positioning rod 310 in the second positioning unit 31 abuts against the ventricular side of the cardiac tissue via a second circumferential segment 3102. The second circumferential segment 3102 is designed in an arc shape, minimizing damage to the ventricular side of the cardiac tissue.

[0070] In some embodiments, the stent body 10 includes a plurality of support units 11, which are arranged circumferentially to enclose a flow channel. Each support unit 11 includes a first support rod 12 and a second support rod 13, each of which is connected to a different artificial valve leaflet 200. Within a single support unit 11, the upstream end of the first support rod 12 and the upstream end of the second support rod 13 are respectively connected to two adjacent first nodes 40, and the downstream end of the first support rod 12 and the downstream end of the second support rod 13 are connected to form a second node 50. The plurality of support units 11 serve as the skeleton of the stent body 10, and the central portions of the plurality of support units 11 enclose a flow channel for blood circulation. Each support unit 11 includes a first support rod 12 and a second support rod 13, each of which is connected to a different artificial valve leaflet 200. The upstream ends of the first support rod 12 and the upstream ends of the second support rod 13 are respectively connected to two first nodes 40, thereby integrally connecting the plurality of support units 11 to the first positioning portion 20 and the second positioning portion 30.

[0071] In some embodiments, each support unit 11 further includes a third support rod 14 and a fourth support rod 15; one end of each third support rod 14 and fourth support rod 15 is connected to the same second node 50, and the other end is connected to two adjacent first nodes 40; and a connecting ring 16 is formed at the most downstream end of each third support rod 14 and fourth support rod 15. By connecting one end of each third support rod 14 and fourth support rod 15 to the same second node 50 and the other end to two adjacent first nodes 40, the structural stability of the stent body 10 is enhanced. Furthermore, since each third support rod 14 and fourth support rod 15 has two connecting rings 16 formed at their most downstream ends, the stent body 10 has multiple connecting rings 16. Multiple support units 11 provide the stent body 10 with multiple connecting rings 16, which are used for connection to the conveying system, providing high connection stability.

[0072] In some embodiments, a first rivet 41 is provided at the first node 40. In the first rivet 41, the end of the first positioning rod 210 close to the flow channel is connected to the first support rod 12 or the second support rod 13, and the end of the second positioning rod 310 close to the flow channel is connected to the third support rod 14 or the fourth support rod 15. By connecting the end of the first positioning rod 210 close to the flow channel to the first support rod 12 or the second support rod 13, and the end of the second positioning rod 310 close to the flow channel to the third support rod 14 or the fourth support rod 15, the first rivet 41 can be used to connect the first positioning portion 20, the second positioning portion 30 and the support unit 11 as a whole at the intersection of the first node 40, thereby ensuring the integrity of the heart valve stent 100.

[0073] Among them, in the first rivet part 41, the first positioning rod 210 is connected to the first support rod 12 or the second support rod 13, and the second positioning rod 310 is connected to the third support rod 14 or the fourth support rod 15. The rods are arranged in parallel, which helps to improve the reliability of the connection of the first rivet part 41, improve the aesthetics of the product, and facilitate the contraction and expansion of the heart valve stent 100.

[0074] In some embodiments, a second rivet 51 is provided at the second node 50. In the second rivet 51, the first support rod 12 is connected to the third support rod 14, and the second support rod 13 is connected to the fourth support rod 15. By connecting the first support rod 12 to the third support rod 14, and the second support rod 13 to the fourth support rod 15, the first support rod 12, the second support rod 13, the third support rod 14, and the fourth support rod 15, that is, the second rivet 51 can be used to connect the first support rod 12, the second support rod 13, the third support rod 14, and the fourth support rod 15 into a whole, thereby enhancing the integrity of the support unit 11 and effectively ensuring the reliability of the connection between the support rods in each support unit 11.

[0075] In some embodiments, the heart valve stent 100 is an aortic valve stent, the first positioning portion 20 is used to be positioned at the aortic sinus, and the second positioning portion 30 is used to be positioned at the ventricular side of the aortic valve 500 .

[0076] In some embodiments, the heart valve stent 100 is woven and shaped from at least one filament. The heart valve stent 100 is woven from at least one filament, which facilitates deformation for delivery through a delivery system. Furthermore, when delivered to the original aortic valve 500, the filament can quickly return to its original shape, thereby improving the reliability of the heart valve stent 100 in supporting the aortic valve 500.

[0077] The heart valve stent 100 can be woven from a single filament or multiple filaments. When the heart valve stent 100 is woven from multiple filaments, the two connected filaments are fixedly connected by riveting or welding. Of course, the heart valve stent 100 can also be fixedly connected by welding or threading.

[0078] In addition, the material of the filament can be memory alloy wire or nickel-titanium alloy wire, etc. The heart valve stent 100 is woven with memory alloy wire or expanded with memory alloy mesh, and the connection parts of the memory alloy wire are connected by welding, riveting, bonding, etc.

[0079] Of course, each support rod in the support unit 11 can be made of variable diameter wire, that is, the first support rod 12, the second support rod 13, the third support rod 14 or the fourth support rod 15 can be woven with variable diameter memory alloy wire, or a memory alloy tube can be partially sleeved on the outer peripheral side of the first support rod 12, the second support rod 13, the third support rod 14 or the fourth support rod 15 to partially increase the diameter of each support rod, thereby improving the supporting force of the heart valve stent 100 and further improving the support stability.

[0080] An embodiment of the present application provides a heart valve prosthesis 1000 , which includes leaflets 200 and the aforementioned heart valve stent 100 . The leaflets 200 are located in the flow channel of the stent body 10 .

[0081] 9 to 11 , after the heart valve stent 100 or heart valve prosthesis 1000 is implanted, the heart valve stent 100 or heart valve prosthesis 1000 unfolds the native valve leaflets 502 outward, and the leaflets 200 in the heart valve prosthesis 1000 replace the native leaflets 502. The first positioning portion 20 and the second positioning portion 30 in the heart valve prosthesis 1000 abut against both sides of the native valve annulus 501.

[0082] Among them, the material of the leaflet 200 can be one of a polymer material, a biological tissue material and a tissue engineering material. Specifically, the material of the leaflet 200 can be bovine pericardium, porcine pericardium, bovine and porcine heart valves or polymer materials, etc. In the present embodiment, the material of the leaflet 200 is a polymer material. In addition, the connection method between the leaflet 200 and the heart valve stent 100 can be one of bonding, hot melting, and polymer adhesion. In the present embodiment, the leaflet 200 is coated on the surface of the heart valve stent 100 by polymer adhesion, which has greater adhesion and can avoid the damage or falling off of the leaflet 200 due to excessive stress when sewing with sutures. The leaflet 200 has higher reliability and helps to extend the service life of the product.

[0083] In some embodiments, the heart valve prosthesis 1000 includes a first skirt 300 and a second skirt 400. The first skirt 300 is connected and covers the space formed between the first support rod 12, the second support rod 13 and the first positioning rod 210 of the heart valve stent 100; the second skirt 400 is arranged around the outer peripheral side of the first skirt 300 and is sealed with the first skirt 300.

[0084] In the above embodiment, the leaflets 200 are located within the flow channel and connected to the heart valve stent 100. The opening and closing of the leaflets 200 can control blood flow in the flow channel. For example, during heart contraction, the leaflets 200 open, allowing blood in the heart to flow to the body through the aorta 504. Simultaneously, during heart diastole, the leaflets 200 close promptly to prevent blood in the aorta 504 from flowing back into the ventricle. Therefore, the sealing of the flow channel within the heart valve prosthesis 1000 is particularly important. By enclosing a first skirt 300 within the space formed between the first support rods 12 and the second support rods 13 of the heart valve stent 100 and the first positioning rod 210, blood can be prevented from flowing around the heart valve stent 100, ensuring that blood can only flow into the upstream end of the flow channel and out of the downstream end of the flow channel. A second skirt 400 is also enclosed around the outer periphery of the first skirt 300 and is sealed to the first skirt 300. The second skirt 400 is used to prevent blood from flowing back and prevent paravalvular leakage.

[0085] The first and second skirts 300 and 400 can be made of biomaterials, polymers, or textiles. The second skirt 400 is located on the outer periphery of the first skirt 300 and has an outwardly convex annular structure. The periphery of the second skirt 400 is folded downstream of the heart valve stent 100 to form a flange. When the leaflets 200 are closed, blood can only flow from the leaflets 200 to the top of the second skirt 400 and circulate from above, effectively preventing blood backflow and paravalvular leakage. A blood filling port 401 is provided at the upper edge of the second skirt 400. When filled with blood, a thrombus forms to prevent paravalvular leakage.

[0086] It should be noted that, unless there is any conflict, the features in the embodiments of this application can be combined with each other.

[0087] The above description is merely an optional embodiment of the present application and is not intended to limit the present application. Those skilled in the art will readily appreciate that various modifications and variations are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application. Industrial Applicability

[0088] The present application provides a heart valve stent and a heart valve prosthesis with high installation stability and strong anchoring performance to the heart valve.

[0089] Furthermore, it is understood that the heart valve stent and heart valve prosthesis of the present application are reproducible and can be widely used in the field of medical technology.

Claims

1. A heart valve stent, characterized in that: The invention comprises a stent body and a first positioning portion and a second positioning portion for positioning relative to cardiac tissue, the stent body defining a flow channel for blood circulation, and defining upstream and downstream directions according to the direction of blood passing through the flow channel, the first positioning portion and the second positioning portion are both located at the upstream end of the flow channel, and the first positioning portion and the second positioning portion both extend radially outward from the stent body; wherein, the second positioning portion is located on the upstream side of the first positioning portion, and along the circumference of the flow channel, the first positioning portion and the second positioning portion at least partially overlap, and along the axial direction of the flow channel, the first positioning portion and the second positioning portion are spaced apart.

2. The heart valve stent according to claim 1, characterized in that An extension angle of the first positioning portion or the second positioning portion in the circumferential direction is α, wherein the value of α is greater than 320°.

3. The heart valve stent according to claim 1, characterized in that The support body is provided with a connecting ring, and the connecting ring is used for connection with a conveying system.

4. The heart valve stent according to claim 1, characterized in that The first positioning portion includes a plurality of first positioning units, the plurality of first positioning units are arranged along the circumferential direction, and each of the first positioning units includes two first positioning rods; Two first positioning rods belonging to the same first positioning unit are connected at one end away from the flow channel to form a first positioning point, and the first positioning points of the plurality of first positioning units are arranged at intervals along the circumferential direction; Two first positioning rods belonging to two adjacent first positioning units meet at a first node at one end close to the flow channel.

5. The heart valve stent according to claim 4, characterized in that: The second positioning portion includes a plurality of second positioning units, each of the second positioning units includes two second positioning rods, and the two second positioning rods converge at one end away from the flow channel to form a second positioning point; the two second positioning rods are connected to two adjacent first nodes at one end close to the flow channel; The first positioning point and the second positioning point are arranged opposite to each other in the axial direction of the flow channel and are spaced apart from each other in the axial direction of the flow channel.

6. The heart valve stent according to claim 5, characterized in that: The first positioning rod includes a first axial segment and a first circumferential segment, one end of the first axial segment is connected to the first node, and the other end is connected to the first circumferential segment. In the first positioning portion, the sum of the circumferential extension angles of the first circumferential segments in each of the first positioning units is a first extension angle. The second positioning rod includes a second axial segment and a second circumferential segment, one end of the second axial segment is connected to the first node, and the other end is connected to the second circumferential segment. In the second positioning portion, the sum of the extension angles of the second circumferential segments in each second positioning unit in the circumferential direction is a second extension angle; the first extension angle is not greater than the The second extension angle.

7. The heart valve stent according to claim 6, characterized in that: The first circumferential segment and the second circumferential segment are designed to be arc-shaped.

8. The heart valve stent according to claim 5, characterized in that: The support body includes a plurality of support units, and the plurality of support units are arranged along the circumference to surround and form the flow channel; Each of the support units includes a first support rod and a second support rod for respectively connecting different artificial valve leaflets; in the same support unit, the upstream end of the first support rod and the upstream end of the second support rod are respectively connected to two adjacent first nodes, and the downstream end of the first support rod and the downstream end of the second support rod are connected to form a second node.

9. The heart valve stent according to claim 8, characterized in that: Each of the support units further comprises a third support rod and a fourth support rod; One end of the third support rod and the fourth support rod is connected to the same second node, and the other end is connected to two adjacent first nodes respectively; The downstream ends of the third support rod and the fourth support rod are both formed with connecting rings.

10. The heart valve stent according to claim 9, characterized in that: A first rivet is provided at the first node. In the first rivet, one end of the first positioning rod close to the flow channel is connected to the first support rod or the second support rod, and one end of the second positioning rod close to the flow channel is connected to the third support rod or the fourth support rod.

11. The heart valve stent according to claim 9, characterized in that: A second rivet is provided at the second node. In the second rivet, the first support rod is connected to the third support rod, and the second support rod is connected to the fourth support rod.

12. The heart valve stent according to any one of claims 1 to 11, characterized in that: The heart valve stent is an aortic valve stent, the first positioning portion is used to be positioned at the aortic sinus, and the second positioning portion is used to be positioned at the ventricular side of the aortic valve.

13. The heart valve stent according to any one of claims 1 to 11, characterized in that: The heart valve stent is formed by weaving at least one filamentous member into a fixed shape.

14. The heart valve stent according to claim 13, characterized in that: When the heart valve stent is woven with a plurality of filaments, two connected filaments are fixedly connected by riveting or welding.

15. The heart valve stent according to claim 13 or 14, characterized in that: The material of the filament is memory alloy wire or nickel-titanium alloy wire.

16. The heart valve stent according to any one of claims 8 to 11, characterized in that: The first support rod, the second support rod, the third support rod or the fourth support rod is braided with variable diameter memory alloy wire.

17. A heart valve prosthesis, characterized in that: It comprises a leaflet and a heart valve stent according to any one of claims 1 to 16, wherein the leaflet is located in the flow channel of the stent body.

18. The heart valve prosthesis according to claim 17, characterized in that The heart valve prosthesis comprises: a first skirt connected to and covering the space formed between the first support rod, the second support rod and the first positioning rod of the heart valve stent; The second skirt is arranged around the outer periphery of the first skirt and is sealed to the first skirt.

19. The heart valve stent according to claim 18, characterized in that: The first skirt cloth and the second skirt cloth are made of biological materials, polymers or textile fabrics.

20. The heart valve stent according to claim 18 or 19, characterized in that: The second skirt has an outwardly protruding ring structure as a whole.

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