Heart valve stent and heart valve prosthesis

Abstract

The embodiment of the utility model provides a heart valve stent and a heart valve prosthesis, and belongs to the technical field of medical treatment. The heart valve stent comprises a stent body, a first positioning portion and a second positioning portion, the first positioning portion and the second positioning portion are used for positioning heart tissue, a flow channel allowing blood to flow is defined in the stent body, the upstream direction and the downstream direction are defined according to the direction of the blood passing through the flow channel, and the first positioning portion and the second positioning portion are both located at the upstream end of the flow channel. The first positioning part and the second positioning part extend outwards in the radial direction from the stent body, and the second positioning part is located on the upstream side of the first positioning part; the first positioning part comprises a plurality of first positioning units, each first positioning unit is of an elastic structure, each first positioning unit is provided with a first node close to the flow channel and a first positioning point away from the flow channel, and when the first positioning units are subjected to axial resistance, the first positioning units can contract and deform in the direction from the first positioning points to the first nodes. The heart valve stent is high in stability and small in damage to heart tissue.

Description

Technical Field

[0001] 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

[0002] Heart valves grow between the atria and ventricles, and between the ventricles and aortas, and act as one-way valves to help blood flow in one direction. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased (such as becoming narrow or incompletely closed), it will affect the movement of blood flow, causing abnormal heart function and eventually leading to heart failure.

[0003] At present, when a valve is diseased, valve replacement 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 prone to fall off due to 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 patients having to replace the valve again. Utility Model Content

[0004] The embodiments of the present application provide a heart valve stent and a heart valve prosthesis, which have high stability and strong anchoring performance to heart tissue.

[0005] In a first aspect, 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 defines 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, the first positioning portion and the second positioning portion both extend radially outward from the stent body, and the second positioning portion is located on the upstream side of the first positioning portion; the first positioning portion includes a plurality of first positioning units, the plurality of first positioning units are arranged along the circumference of the stent body, the first positioning unit is an elastic structure, the first positioning unit has a first node close to the flow channel and a first positioning point away from the flow channel, and can undergo contraction deformation in the direction from the first positioning point to the first node when the first positioning unit is subjected to axial resistance.

[0006] In this solution, a flow channel for blood circulation is defined in the middle of the stent body of the heart valve stent, so as to provide blood circulation, and the first positioning part and the second positioning part in the heart valve stent are both located at the upstream end of the flow channel, and the first positioning part and the second positioning part are abutted and clamped on both sides of the corresponding heart tissue (such as the aortic valve) to play a role in fixing the heart valve stent, and the positioning is reliable, and the phenomenon of displacement of the heart valve stent caused by the pressure generated by the blood on the valve leaflets when the valve leaflets are closed is prevented, thereby improving the stability and reliability of the heart valve stent in the heart tissue and extending the service life of the heart valve stent. In addition, the second positioning part is located on the upstream side of the first positioning part, that is, the second positioning part abuts against the ventricle side of the heart tissue, and the first positioning part abuts against the other side of the heart tissue, and the first positioning unit is an elastic structure. When there is stress between the first positioning unit and the side of the heart tissue away from the ventricle (such as the aortic sinus), the first positioning unit can undergo slight buffering deformation, reducing the probability of rigid contact between the first positioning unit and the heart tissue, and causing less damage to the heart tissue.

[0007] In some embodiments, each first positioning unit includes two first positioning rods, which are connected at one end away from the flow channel to form a first positioning point and intersect at a first node at an end close to the flow channel; the first positioning points of multiple first positioning units are arranged at intervals along the circumferential direction; each first positioning rod includes a connecting section, a first bending section and a second bending section in sequence, one end of the connecting section is connected to the first node, and the other end is connected to one end of the first bending section, the other end of the first bending section is connected to the second bending section, and the two second bending sections in the two first positioning rods intersect at the first positioning point; when the second bending section is subjected to axial resistance, it can undergo shrinkage deformation toward the first bending section and / or the connecting section.

[0008] In the above technical solution, two first positioning rods are connected at one end away from the flow channel to form a first positioning point, and the first positioning points in each first positioning unit are used to realize multi-point positioning of the corresponding position of the heart tissue, which has a simple structure and high positioning stability, and reduces the probability of displacement of the heart valve stent. In addition, by making the first positioning rod include a connecting section, a first bending section and a second bending section, when the second bending section contacts the heart tissue and there is stress, the second bending section can shrink and deform in the direction of the first bending section and / or the connecting section, which plays a buffering role on the heart tissue, thereby causing less damage to the heart tissue.

[0009] In some embodiments, the angle between the connecting section and the first bending section is α, and the value of α is 30°-90°; the angle between the first bending section and the second bending section is β, and the value of β is 10°-30°.

[0010] In some embodiments, the shape formed by two first positioning rods belonging to the same first positioning unit is heart-shaped.

[0011] In the above technical solution, the shape enclosed by the two first positioning rods is heart-shaped, and the first positioning unit is an arc-shaped structure, so that the area of ​​the end of the first positioning rod away from the flow channel in contact with the heart tissue is large, the pressure on the heart tissue is small, and the damage to the contact part of the heart tissue is correspondingly small; and when there is stress between the heart-shaped first positioning unit and the heart tissue, the first positioning unit can undergo a slight buffering deformation, thereby reducing the rigid contact between the first positioning unit and the heart tissue, causing less damage to the heart tissue.

[0012] In some embodiments, along the circumference of the flow channel, the first positioning portion and the second positioning portion are staggered.

[0013] In the above technical solution, the first positioning part and the second positioning part are respectively in contact with the two sides of the heart tissue to play the role of fixing the heart valve stent, thereby ensuring that the heart valve stent is fixed stably. By staggering the first positioning part and the second positioning part, the contact parts of the first positioning part and the second positioning part with the two sides of the heart tissue are staggered, so that the force transmission points of the first positioning part and the second positioning part to the heart tissue are staggered, thereby reducing the probability of stress concentration between the heart valve stent and the heart tissue.

[0014] In some embodiments, the second positioning portion includes multiple second positioning units, and a second positioning unit is arranged between two adjacent first positioning units; each second positioning unit includes two second positioning rods, and the two second positioning rods belonging to the same second positioning unit form a second positioning point at the end away from the flow channel, and the second positioning points and the first positioning points are alternately arranged along the circumferential direction; the two second positioning rods belonging to two adjacent second positioning units converge at two adjacent first nodes at the end close to the flow channel.

[0015] In the above technical solution, a second positioning unit is provided between two adjacent first positioning units, and two second positioning rods in the second positioning unit are connected at one end away from the flow channel to form a second positioning point. Compared with the distal end of a second positioning rod directly contacting the heart tissue, the second positioning point formed by the intersection of the distal ends of the two second positioning rods is a closed-loop structure. When the second positioning point of the closed-loop structure contacts the heart tissue, it prevents the heart tissue from being stabbed. In addition, the first positioning point and the second positioning point are alternately arranged in the circumferential direction, which increases the number of positioning points where the first positioning part and the second positioning part abut against the heart tissue, making the positioning points of the first positioning part and the second positioning part and the heart tissue more dense, and reducing the force magnitude of each positioning point.

[0016] In some embodiments, the stent body includes a plurality of support units, and the plurality of support units are circumferentially arranged to enclose and form a flow channel; each support unit includes a first support rod and a second support rod respectively used to connect different 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.

[0017] In the above technical solution, a plurality of support units serve as the skeleton of the stent body, and the middle parts of the plurality of support units are enclosed to form a flow channel for blood circulation. Each support unit includes a first support rod and a second support rod for connecting different leaflets, respectively, and the upstream ends of the first support rod and the second support rod are respectively connected to the two first nodes, so that the plurality of support units are connected to the first positioning portion and the second positioning portion as a whole.

[0018] In some embodiments, each support unit also 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.

[0019] In the above technical solution, 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, so that the structural stability of the support body is higher. A connecting ring is formed at the most downstream end of the third support rod and the fourth support rod, that is, each support unit has two connecting rings, so the multiple support units make the support body have multiple connecting rings, and the connecting rings are connected to the conveying system, and the connection stability is high.

[0020] In some embodiments, a first rivet is provided at the first node, in which the second positioning rod is connected to the first support rod or the second support rod at one end close to the flow channel, and the first positioning rod is connected to the third support rod or the fourth support rod at one end close to the flow channel.

[0021] In the above technical solution, 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 by the first rivet, thereby ensuring the integrity of the heart valve stent.

[0022] In some embodiments, a second rivet is provided at the second node, in which the first support rod is connected to the third support rod, and the second support rod is connected to the fourth support rod.

[0023] In the above technical solution, 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 by 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.

[0024] 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.

[0025] In some embodiments, the heart valve stent is formed by weaving at least one filament.

[0026] In the above technical solution, 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 supported at the aortic valve.

[0027] In a second aspect, an embodiment of the present application further provides a heart valve prosthesis, which includes valve leaflets and the aforementioned heart valve stent, wherein the valve leaflets are located in the flow channel of the stent body.

[0028] In some embodiments, the heart valve prosthesis includes a first skirt and a second skirt, the first skirt is connected and covers the space formed between the first support rod, the second support rod and the second positioning rod of the heart valve stent; the second skirt is arranged around the outer peripheral side of the first skirt and is sealed with the first skirt.

[0029] In the above technical solution, the valve leaflets are located in the flow channel and connected to the heart valve stent. The opening and closing of the valve leaflets can control the blood circulation in the flow channel. For example, when the heart contracts, the valve leaflets open to allow the blood in the heart to flow to the whole body through the aorta. At the same time, when the heart relaxes, the valve leaflets close in time to prevent the blood in the aorta from returning to flow 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 area 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 flowing from the peripheral side of 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 reflux and avoid paravalvular leakage.

[0030] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. 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 related drawings can be obtained based on these drawings without paying creative work.

[0032] Figure 1 This is a schematic diagram of the structure of a normal heart valve in an open state;

[0033] Figure 2 This is a schematic diagram of the structure of a normal heart valve in a closed state;

[0034] Figure 3 This is a schematic diagram of the structure of a diseased heart valve in an open state;

[0035] Figure 4 It is a structural schematic diagram of a diseased heart valve in a closed state;

[0036] Figure 5 A schematic diagram of the structure of a heart valve stent provided in some embodiments of the present application;

[0037] Figure 6 A schematic structural diagram of a heart valve stent provided in some embodiments of the present application from another angle;

[0038] Figure 7 A schematic diagram of the structure of a heart valve prosthesis provided in some embodiments of the present application;

[0039] Figure 8 for Figure 7 The structural diagram of the second skirt cloth;

[0040] Fig. 9 Schematic diagram of a heart valve prosthesis positioned on an aortic valve according to some embodiments of the present application.

[0041] 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-connecting section; 2102-first bending section; 2103-second bending section; 211-first positioning point; 30-second positioning portion; 31-second positioning unit; 3 10-second positioning rod; 311-second positioning point; 40-first node; 41-first rivet; 50-second node; 51-second rivet; 100-heart valve stent; 200-valve 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

[0042] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0043] 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 which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0044] 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, further definition and explanation thereof is not required in subsequent drawings.

[0045] In the description of the embodiments of the present application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0046] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0047] Example

[0048] Heart valves grow between the atria and ventricles, and between the ventricles and aortas, and act as one-way valves to help blood flow in one direction. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased (such as becoming narrow or incompletely closed), it will affect the flow of blood, causing abnormal heart function and eventually leading to heart failure. Specifically, Figure 1 As shown in FIG. 5 , a schematic diagram of a normal heart valve in an open state is shown, in which the left ventricle 503 contracts, the aortic valve 500 opens, and blood flows from the left ventricle 503 to the aorta 504. Figure 2 As shown in FIG. 5 , a schematic diagram of a normal heart valve in a closed state is shown, in which the left ventricle 503 is in diastole, the aortic valve 500 is closed, and blood cannot flow from the aorta 504 to the left ventricle 503. Figure 3 As shown in FIG. 5 , a schematic diagram of a diseased heart valve in an open state is shown, in which the left ventricle 503 contracts and the aortic valve 500 opens, but the aortic valve 500 does not open completely, and blood flows from the left ventricle 503 to the aorta 504. Figure 4 As shown, a schematic diagram of a diseased heart valve in a closed state is shown, in which the left ventricle 503 is diastolic and the aortic valve 500 is closed, but the aortic valve 500 is not completely closed, and blood can flow from the aorta 504 to the left ventricle 503. Therefore, when a valve is diseased, valve replacement is often used for treatment, that is, replacement with an artificial mechanical valve or a biological valve.

[0049] In view of this, the present application embodiment provides a heart valve stent 100, please refer to Figures 5 to 9The heart valve stent 100 includes a stent body 10 and a first positioning portion 20 and a second positioning portion 30 for positioning with heart tissue. The stent body 10 defines a flow channel for blood circulation, and defines upstream and downstream directions 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; the second positioning portion 30 is located on the upstream side of the first positioning portion 20; the first positioning portion 20 includes a plurality of first positioning units 21, and the plurality of first positioning units 21 are arranged along the circumference of the stent body 10. The first positioning unit 21 is an elastic structure, and the first positioning unit 21 has a first node 40 close to the flow channel and a first positioning point 211 away from the flow channel. When the first positioning unit 21 is subjected to axial resistance, it can undergo contraction deformation in the direction from the first positioning point 211 to the first node 40.

[0050] In the present embodiment, 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 (such as the aortic valve 500) to fix the heart valve stent 100. The positioning is reliable and the heart valve stent 100 is prevented 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. Furthermore, 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 ventricle side of the heart tissue, and the first positioning portion 20 abuts against the other side of the heart tissue. The first positioning unit 21 is an elastic structure. When stress exists between the first positioning unit 21 and the side of the heart tissue away from the ventricle (such as the aortic sinus), the first positioning unit 21 can undergo a slight buffering deformation, thereby reducing the probability of rigid contact between the first positioning unit 21 and the heart tissue, causing less damage to the heart tissue.

[0051] The first positioning unit 21 may be a variety of elastic structures. For example, the first positioning unit 21 may be a spiral spring structure or a heart-shaped structure with deformation capability.

[0052] In some embodiments, each first positioning unit 21 includes two first positioning rods 210, and the two first positioning rods 210 are connected at one end away from the flow channel to form a first positioning point 211, and intersect at a first node 40 at an end close to the flow channel; the first positioning points 211 of multiple first positioning units 21 are arranged at intervals along the circumferential direction; each first positioning rod 210 includes a connecting section 2101, a first bending section 2102 and a second bending section 2103 in sequence, one end of the connecting section 2101 is connected to the first node 40, and the other end is connected to one end of the first bending section 2102, the other end of the first bending section 2102 is connected to the second bending section 2103, and the two second bending sections 2103 in the two first positioning rods 210 intersect at the first positioning point 211; when the second bending section 2103 is subjected to axial resistance, it can undergo shrinkage deformation toward the first bending section 2102 and / or the connecting section 2101.

[0053] The two first positioning rods 210 are connected at one end away from the flow channel to form a first positioning point 211, and the first positioning points 211 in each first positioning unit 21 are used to realize multi-point positioning of the corresponding position of the heart tissue, which has a simple structure and high positioning stability, and reduces the probability of displacement of the heart valve stent 100. In addition, by providing the first positioning rod 210 with a connecting section 2101, a first bending section 2102, and a second bending section 2103, when the second bending section 2103 contacts the heart tissue and there is stress, the second bending section 2103 can shrink and deform in the direction of the first bending section 2102 and / or the connecting section 2101, which has a buffering effect on the heart tissue, thereby causing less damage to the heart tissue.

[0054] There are angles between the connecting section 2101 and the first bending section 2102 and between the first bending section 2102 and the second bending section 2103 , and the specific values ​​of the angles may be determined according to actual conditions.

[0055] Optionally, the angle between the connecting section 2101 and the first bending section 2102 is α, and the value of α is 30°-90°; the angle between the first bending section 2102 and the second bending section 2103 is β, and the value of β is 10°-30°.

[0056] The shape formed by the two first positioning rods 210 belonging to the same first positioning unit 21 can be a variety of shapes. For example, the shape formed by the two first positioning rods 210 can be an inverted isosceles trapezoid or a heart shape, etc., depending on the actual situation.

[0057] In some embodiments, the shape enclosed by the two first positioning rods 210 belonging to the same first positioning unit 21 is heart-shaped. By making the shape enclosed by the two first positioning rods 210 heart-shaped, the first positioning unit 21 is an arc-shaped structure, so that the area of ​​the end of the first positioning rod 210 away from the flow channel in contact with the heart tissue is large, the pressure on the heart tissue is small, and the corresponding damage to the contact part of the heart tissue is small; and when there is stress between the heart-shaped first positioning unit 21 and the heart tissue, the first positioning unit 21 can undergo slight buffering deformation, reducing the rigid contact between the first positioning unit 21 and the heart tissue, and causing less damage to the heart tissue.

[0058] In some embodiments, the first positioning portion 20 and the second positioning portion 30 are staggered along the circumference of the flow channel. The first positioning portion 20 and the second positioning portion 30 are respectively in contact with the two sides of the heart tissue to fix the heart valve stent 100, thereby ensuring that the heart valve stent 100 is fixed and stable. By staggering the first positioning portion 20 and the second positioning portion 30, the contact parts of the first positioning portion 20 and the second positioning portion 30 with the two sides of the heart tissue are staggered, and the force transmission points of the first positioning portion 20 and the second positioning portion 30 to the heart tissue are staggered, thereby reducing the probability of stress concentration between the heart valve stent 100 and the heart tissue.

[0059] In some embodiments, the second positioning portion 30 includes a plurality of second positioning units 31, and a second positioning unit 31 is arranged between two adjacent first positioning units 21; each second positioning unit 31 includes two second positioning rods 310, and the two second positioning rods 310 belonging to the same second positioning unit 31 form a second positioning point 311 at the end away from the flow channel, and the second positioning points 311 and the first positioning points 211 are alternately arranged along the circumferential direction; the two second positioning rods 310 belonging to two adjacent second positioning units 31 converge at two adjacent first nodes 40 at the end close to the flow channel.

[0060] By arranging a second positioning unit 31 between two adjacent first positioning units 21, two second positioning rods 310 in the second positioning unit 31 are connected at one end away from the flow channel to form a second positioning point 311. Compared with the distal end of a second positioning rod 310 directly contacting the heart tissue, the second positioning point 311 formed by the intersection of the distal ends of the two second positioning rods 310 is a closed loop structure. When the second positioning point 311 of the closed loop structure contacts the heart tissue, it prevents the heart tissue from being stabbed. In addition, the first positioning point 211 and the second positioning point 311 are alternately arranged in the circumferential direction, which increases the number of positioning points where the first positioning part 20 and the second positioning part 30 abut against the heart tissue, making the positioning points of the first positioning part 20 and the second positioning part 30 and the heart tissue more dense, and reducing the force magnitude of each positioning point.

[0061] In some embodiments, the stent body 10 includes a plurality of support units 11, which are arranged circumferentially to enclose and form a flow channel; each support unit 11 includes a first support rod 12 and a second support rod 13 for connecting different leaflets 200 respectively; in the same 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 middle parts of the plurality of support units 11 are enclosed to form a flow channel for blood circulation. Each support unit 11 includes a first support rod 12 and a second support rod 13 for connecting different leaflets 200 respectively, and the upstream end of the first support rod 12 and the upstream end of the second support rod 13 are respectively connected to two first nodes 40, so that the plurality of support units 11 are connected to the first positioning portion 20 and the second positioning portion 30 as a whole.

[0062] In some embodiments, each support unit 11 further includes a third support rod 14 and a fourth support rod 15; one end of the third support rod 14 and the fourth support rod 15 is connected to the same second node 50, and the other end is respectively connected to two adjacent first nodes 40; a connecting ring 16 is formed at the most downstream end of the third support rod 14 and the fourth support rod 15. By connecting one end of the third support rod 14 and the fourth support rod 15 to the same second node 50, and the other end is respectively connected to two adjacent first nodes 40, the structural stability of the support body 10 is higher. And the most downstream end of the third support rod 14 and the fourth support rod 15 is formed with a connecting ring 16, that is, each support unit 11 has two connecting rings 16, then multiple support units 11 make the support body 10 have multiple connecting rings 16, and the connecting ring 16 can be connected to the conveying system, and the connection stability is high.

[0063] In some embodiments, a first rivet 41 is provided at the first node 40, in which the first rivet 41 has an end of the first positioning rod 210 close to the flow channel connected to the first support rod 12 or the second support rod 13, and an end of the second positioning rod 310 close to the flow channel connected to the third support rod 14 or the fourth support rod 15. 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, that is, the first rivet 41 can be used to connect the first positioning portion 20, the second positioning portion 30 and the support unit 11 at the intersection of the first node 40 as a whole, thereby ensuring the integrity of the heart valve stent 100.

[0064] 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.

[0065] In some embodiments, a second rivet 51 is provided at the second node 50, and 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. 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, that is, the first support rod 12, the second support rod 13, the third support rod 14 and the fourth support rod 15 can be connected as a whole by using the second rivet 51, so that the integrity of the support unit 11 is higher, thereby effectively ensuring the reliability of the connection of each support rod in each support unit 11.

[0066] In this embodiment, the heart tissue is an aortic valve, and the heart valve stent 100 is an aortic valve stent. The first positioning portion 20 is used to be positioned at the aortic sinus of the heart tissue, and the second positioning portion 30 is used to be positioned at the ventricular side of the heart valve.

[0067] In some embodiments, the heart valve stent 100 is woven and shaped by at least one filament. The heart valve stent 100 is woven and shaped by at least one filament, which is easy to deform for delivery through a delivery system, and when delivered to the original aortic valve 500, the filament can quickly restore its original shape, thereby improving the reliability of the heart valve stent 100 supporting the aortic valve 500.

[0068] The heart valve stent 100 can be woven from one thread-like member or multiple thread-like members. When the heart valve stent 100 is woven from multiple thread-like members, two connected thread-like members are fixedly connected by riveting or welding. Of course, the heart valve stent 100 can also be fixedly connected by welding or threaded connection.

[0069] 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.

[0070] 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 is 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.

[0071] The present application also provides a heart valve prosthesis 1000, see Figure 7 and Figure 8 The heart valve prosthesis 1000 includes a valve leaflet 200 and a heart valve stent 100 , and the valve leaflet 200 is located in the flow channel of the stent body 10 .

[0072] After the heart valve prosthesis 1000 is implanted, Fig. 9 As shown, the heart valve prosthesis 1000 expands the native valve leaflets 502 outward, and the valve leaflets 200 in the heart valve prosthesis 1000 replace the native valve 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 ring 501.

[0073] 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 a polymer material, 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 damage or falling off of the leaflet 200 due to excessive stress when sewing with sutures. The reliability of the leaflet 200 is higher, which helps to extend the service life of the product.

[0074] In some embodiments, see Figure 7 and Figure 8The 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 and connected to the first skirt 300. The valve leaf 200 is located in the flow channel and connected to the heart valve stent 100. The opening and closing of the valve leaf 200 can control the blood flow in the flow channel. For example, when the heart contracts, the valve leaf 200 opens to allow the blood in the heart to flow to the whole body through the aorta 504. At the same time, when the heart relaxes, the valve leaf 200 closes in time to prevent the blood in the aorta 504 from returning to the side of the ventricle. Therefore, the sealing of the flow channel in the heart valve prosthesis 1000 is particularly important. By surrounding the first skirt 300 in 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, 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 flow out from the downstream end of the flow channel. By surrounding the outer peripheral side of the first skirt 300 with a second skirt 400 that is sealed and connected to the first skirt 300, the second skirt 400 is used to prevent blood from flowing back and avoid paravalvular leakage.

[0075] The materials of the first skirt 300 and the second skirt 400 can be biomaterials, polymers or textiles. The second skirt 400 is located on the outer peripheral side of the first skirt 300. The second skirt 400 presents an outwardly protruding annular structure as a whole. The peripheral side of the second skirt 400 is folded toward the downstream direction of the heart valve stent 100 to form a flange. When the leaflet 200 is closed, blood can only flow from the leaflet 200 to the top of the second skirt 400 and circulate from the top of the second skirt 400, thereby effectively preventing blood reflux and avoiding paravalvular leakage. A blood filling port 401 is provided at the upper edge of the second skirt 400. After blood is filled, a thrombus is formed to prevent paravalvular leakage.

[0076] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0077] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A heart valve stent, characterized in that: It includes a stent body and a first positioning portion and a second positioning portion for positioning relative to cardiac tissue, the stent body defines a flow channel for blood circulation, and 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, the first positioning portion and the second positioning portion both extend radially outward from the stent body, and the second positioning portion is located at the upstream side of the first positioning portion; the first positioning portion includes a plurality of first positioning units, and the plurality of first positioning units are arranged along the circumference of the stent body, the first positioning unit is an elastic structure, the first positioning unit has a first node close to the flow channel and a first positioning point away from the flow channel, and can undergo contraction deformation in the direction from the first positioning point to the first node when the first positioning unit is subjected to axial resistance.

2. The heart valve stent according to claim 1, characterized in that: Each of the first positioning units includes two first positioning rods, the two first positioning rods are connected at one end away from the flow channel to form the first positioning point, and meet at the first node at one end close to the flow channel; The first positioning points of the plurality of first positioning units are arranged at intervals along the circumferential direction; Each of the first positioning rods includes a connecting section, a first bending section and a second bending section in sequence, one end of the connecting section is connected to the first node, and the other end is connected to one end of the first bending section, the other end of the first bending section is connected to the second bending section, and the two second bending sections in the two first positioning rods intersect at the first positioning point; when the second bending section is subjected to axial resistance, it can shrink and deform toward the first bending section and / or the connecting section.

3. The heart valve stent according to claim 2, characterized in that: The angle between the connecting section and the first bending section is α, and the value of α is 30°-90°; the angle between the first bending section and the second bending section is β, and the value of β is 10°-30°.

4. The heart valve stent according to claim 2, characterized in that: The shape enclosed by the two first positioning rods belonging to the same first positioning unit is heart-shaped.

5. The heart valve stent according to claim 2, characterized in that: Along the circumferential direction of the flow channel, the first positioning portion and the second positioning portion are staggered and distributed.

6. The heart valve stent according to claim 5, characterized in that: The second positioning portion includes a plurality of second positioning units, and one second positioning unit is disposed between two adjacent first positioning units; Each of the second positioning units includes two second positioning rods, and the two second positioning rods belonging to the same second positioning unit form a second positioning point at an end away from the flow channel, and the second positioning point and the first positioning point are alternately arranged along the circumferential direction; Two second positioning rods belonging to two adjacent second positioning units meet at two adjacent first nodes at one end close to the flow channel.

7. The heart valve stent according to claim 6, characterized in that: The support body includes a plurality of support units, and the plurality of support units are arranged along the circumferential direction to surround and form the flow channel; Each of the support units includes a first support rod and a second support rod respectively used to connect different 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.

8. The heart valve stent according to claim 7, 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; A connecting ring is formed at the downstream end of each of the third supporting rod and the fourth supporting rod.

9. The heart valve stent according to claim 8, characterized in that: A first rivet is provided at the first node, in which an end of the second positioning rod close to the flow channel is connected to the first support rod or the second support rod, and an end of the first positioning rod close to the flow channel is connected to the third support rod or the fourth support rod.

10. The heart valve stent according to claim 8, characterized in that: A second rivet is provided at the second node, in which the first support rod is connected to the third support rod, and the second support rod is connected to the fourth support rod.

11. The heart valve stent according to any one of claims 1 to 10, 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.

12. The heart valve stent according to any one of claims 1 to 10, characterized in that: The heart valve stent is formed by weaving and shaping at least one filamentous member.

13. A heart valve prosthesis, characterized in that: It comprises a leaflet and a heart valve stent according to any one of claims 1 to 12, wherein the leaflet is located in the flow channel of the stent body.

14. The heart valve prosthesis according to claim 13, characterized in that: The heart valve prosthesis comprises: A first skirt is connected and covers the space formed between the first support rod, the second support rod and the second positioning rod of the heart valve stent; The second skirt cloth is disposed around the outer peripheral side of the first skirt cloth and is sealed and connected to the first skirt cloth.

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