Valve stent and valve prosthesis

Abstract

The valve stent comprises at least three wave rings arranged in the axial direction, each wave ring comprises a plurality of wave rods connected in the circumferential direction, an included angle is formed between every two adjacent wave rods, and the connecting structure of any two adjacent wave rings is of a grid structure; the at least three wave rings comprise a first wave ring, a second wave ring and a third wave ring which are sequentially connected in the first direction, and the first direction is the direction from the inflow end to the outflow end of the valve stent; at least one vacant wave trough of the second wave ring exists between two adjacent wave crests of the first wave ring, and the vacant wave trough of the second wave ring is turned outwards in the direction away from the axis of the valve support. In the process that the valve stent is implanted into a lesion position to be released, the vacant trough of the second wave ring is turned outwards, so that the vacant trough expands towards the outer side of the valve stent relative to other parts of the valve stent, the vacant trough can be immediately hung on a valve ring of an aortic valve after being released, and the anchoring stability of the valve stent is enhanced.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to valve stents and valve prostheses. Background Art

[0002] There are four valves in the human heart, including the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. They all act as one-way valves. During blood circulation, as the heart rhythmically contracts and relaxes, the heart valves also rhythmically open and close, allowing blood to pass smoothly through the valve orifice and preventing backflow, so that blood circulates in the body in a certain direction to maintain the normal function of the circulatory system. When the heart valve becomes inflamed, it will cause damage to the structure, fibrosis, adhesion, shortening, myxomatous degeneration, ischemic necrosis, calcium deposition. In addition, congenital developmental malformations, etc. will also cause valve lesions, affecting normal blood circulation, which is medically called heart valve disease.

[0003] Cardiac valve interventional surgery is a rapidly developing medical technology in recent years. Its principle is to implant a valve prosthesis into the position of the native valve and replace it through a minimally invasive form via the apex of the heart or blood vessels, ultimately achieving the purpose of treating patients. This surgery has the characteristics of small trauma, fast recovery, and low risk, and is particularly suitable for elderly patients with heart valves. Transcatheter aortic valve implantation is a type of cardiac valve interventional treatment method for aortic valve diseases, which is mainly used to treat aortic valve stenosis and aortic valve insufficiency heart valve diseases.

[0004] Currently, there are mainly two major categories of aortic valve stent systems that have been put into clinical use. One is a balloon-expandable valve stent formed by a non-memory alloy as the main structure of the stent and relying on the balloon expansion method for release; the other is a self-expanding valve stent formed by a shape memory metal material, which uses the self-expansion characteristics of the metal material for in-vivo release and is stably anchored in the lesion area.

[0005] For self-expanding valve stents, the traditional transcatheter release method is as follows: the delivery system restricts the outflow tract of the stent through a mechanical connection method, and during the release process, it is released one by one from the inflow tract to the outflow tract. This release process will form a conical opening at the inflow tract end. When the degree of calcification at the lesion site is light and the degree of fibrosis of the valve leaf is heavy, it is not easy for the stent to form an anchor immediately after contacting the valve annulus, so slippage will occur during the stent release process and the anchoring effect is poor. And during the operation, the doctor needs to use circumferential positioning based on extremely high operation experience combined with the anchoring structure of the stent itself to accurately place the anchoring structure of the stent itself into the sinus. Such an operation not only increases the operation difficulty of the operator but also may have the risk of inaccurate placement. Summary of the Invention

[0006] Based on this, it is necessary to provide a valve stent and a valve prosthesis to solve the technical problems in the prior art that the valve stent is not easily anchored immediately during the release process, is prone to slipping off, and is difficult to position and operate.

[0007] A valve stent, the valve stent includes at least three wave rings arranged axially, each wave ring includes a plurality of wave rods connected circumferentially, and an included angle is provided between adjacent wave rods, and the connection structure between any two adjacent wave rings is a grid structure;

[0008] Among the at least three wave rings, there are a first wave ring, a second wave ring and a third wave ring connected in sequence in a first direction, and the first direction is the direction from the inflow end to the outflow end of the valve stent; there is at least one vacant trough of the second wave ring between adjacent wave peaks of the first wave ring, and the vacant trough of the second wave ring turns outwards in a direction away from the axis of the valve stent.

[0009] In one embodiment, the number of troughs of the second wave ring is greater than the number of wave peaks of the first wave ring, the wave peaks of the first wave ring are connected to a part of the troughs of the second wave ring, and the other part of the troughs of the second wave ring are vacant troughs.

[0010] In one embodiment, the number of wave peaks of the first wave ring is half of the number of troughs of the second wave ring; between any two adjacent vacant troughs, there is a trough of the second wave ring connected to the wave peak of the first wave ring.

[0011] In one embodiment, the wave peaks of the first wave ring and a part of the troughs of the second wave ring are connected by a connecting rod, and the connecting rod is parallel to the axis direction of the valve stent.

[0012] In one embodiment, the two wave rods connected to any vacant trough in the second wave ring turn outwards in a direction away from the axis of the valve stent.

[0013] In one embodiment, the outward turning angle of the vacant trough of the second wave ring is greater than or equal to 1° and less than or equal to 90°.

[0014] In one embodiment, among any two adjacent wave rings on one side of the first wave ring in the first direction, the trough of the wave ring closer to the outflow end of the valve stent is connected to the wave peak of the wave ring closer to the inflow end of the valve stent.

[0015] In one embodiment, there are two adjacent wave rings on one side of the first wave ring in the first direction; among the two adjacent wave rings, the trough of the wave ring closer to the outflow end of the valve stent and the wave peak of the wave ring closer to the inflow end of the valve stent are connected by an axial connecting rod, and the axial connecting rod is parallel to the axis direction of the valve stent.

[0016] In one embodiment, the trough of the wave ring at the outflow end of the valve stent is connected to the peak of the adjacent wave ring through the axial connecting rod.

[0017] In one embodiment, among any two adjacent wave rings between the wave ring at the outflow end of the valve stent and the first wave ring, the trough of the wave ring close to the outflow end of the valve stent is directly connected to the peak of the wave ring close to the inflow end of the valve stent.

[0018] One embodiment of the present application provides a valve prosthesis, including the valve stent described in any one of the above embodiments and leaflets connected to the valve stent.

[0019] During the process of releasing the above-mentioned valve stent and valve prosthesis at the diseased position, due to the eversion of the empty trough of the second wave ring, the empty trough expands outward relative to other parts of the valve stent, so that the empty trough can be immediately hooked on the valve annulus of the aortic valve after release, enhancing the anchoring stability of the valve stent, and accurate positioning can be achieved without circumferential positioning operation, reducing the operation difficulty and the learning curve of the operator. Each wave ring of the valve stent abuts against the corresponding position in the diseased area. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic structural diagram of a valve stent according to an embodiment.

[0021] Figure 2 It is a schematic diagram of releasing a valve stent to a diseased area according to another embodiment.

[0022] Explanation of the reference numerals in the drawings: 101, peak; 102, trough; 103, wave rod; 110, first wave ring; 120, second wave ring; 130, third wave ring; 140, fourth wave ring; 200, connecting rod; 300, axial connecting rod. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0023] To make the above objects, features and advantages of the present application more obvious and understandable, the following will describe the specific embodiments of the present application in detail with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0024] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the present application.

[0025] In addition, if there are terms such as "first" and "second", these terms are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of the present application, if there is a term "plurality", the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0026] In the present application, unless otherwise clearly specified and limited, if there are terms such as "mounted", "connected", "connected to", "fixed", etc., these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0027] In the present application, unless otherwise clearly specified and limited, if there is a description such as a first feature being "above" or "below" a second feature, the meaning can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over", and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or simply means that the first feature has a higher horizontal height than the second feature. The first feature being "below", "under", and "beneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower horizontal height than the second feature.

[0028] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there can be an intermediate element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If present, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0029] Please refer to Figure 1 , an embodiment of the present application provides a valve stent. The valve stent includes at least three wave rings connected in sequence along the axis. Each wave ring includes a plurality of wave rods 103 connected end to end in sequence along the circumference, and the adjacent wave rods 103 are arranged at an angle (such as an acute angle, an obtuse angle or a right angle), so that the wave ring has a plurality of wave peaks 101 and wave valleys 102 alternately arranged in sequence along the circumference. The connection structure between any two adjacent wave rings is a grid structure. It should be noted that in this application, along the blood flow direction in the valve stent, the wave peak 101 of a single wave ring is located downstream of the wave valley 102, that is, the wave peak 101 faces the blood outflow side of the valve stent, and the wave valley 102 faces the blood inflow side of the valve stent.

[0030] Among the at least three wave rings, there are a first wave ring 110, a second wave ring 120 and a third wave ring 130 connected in sequence along the first direction. The first direction is the direction from the inflow end of the valve stent to the outflow end, that is, the blood flow direction in the valve stent. That is, along the blood flow direction in the valve stent, the second wave ring 120 is located downstream of the first wave ring 110, and the second wave ring 120 is located on the side of the first wave ring 110 close to the outflow end of the valve stent.

[0031] There is at least one vacant wave valley 102 of the second wave ring 120 between two adjacent wave peaks 101 of the first wave ring 110, and the vacant wave valley 102 of the second wave ring 120 turns outwards in the direction away from the axis of the valve stent. As Figure 1 shown, the wave valley 102 is the connection node at one end of two adjacent wave rods 103 close to the blood inflow side of the valve stent. The so-called "vacant" wave valley 102 means that in addition to being the connection node at one end of two adjacent wave rods 103 close to the blood inflow side of the valve stent, it is not connected to any other structure on the stent, so it is not restricted by any other structure on the stent. The vacant wave valley 102 can be considered as a free node.

[0032] During the process of releasing the above-mentioned valve stent at the diseased location, since the empty wave troughs 102 of the second wave ring 120 turn outwards, the empty wave troughs 102 expand towards the outside of the valve stent relative to other parts of the valve stent. As a result, after the empty wave troughs 102 are released, they can immediately hang on the valve annulus of the aortic valve, enhancing the anchoring stability of the valve stent, and accurate positioning can be achieved without circumferential positioning operation, reducing the operation difficulty and the learning curve of the operator. Each wave ring of the valve stent abuts against the corresponding position in the diseased area. Specifically, the second wave ring 120 abuts against the lower part of the valve annulus, and the first wave ring 110 abuts against the tissue below the valve annulus and above the left ventricular outflow tract. The third wave ring 130 abuts against the aortic wall below the STJ (sinotubular junction) and above the valve annulus.

[0033] The anchoring of the valve stent in the prior art is achieved by the outflow end of the valve stent adopting a corolla type or a design that can adapt to the ascending aorta structure. The ascending aorta anatomical structure is at a relatively high position in the aortic root anatomical structure, so the height of the valve stent will be made very high. However, the valve stent of the present application relies on the empty wave troughs 102 to hang on the valve annulus of the aortic valve, enhancing the anchoring effect of the valve stent, without the need to make the valve stent too high, solving the risk that the excessive height of the valve stent blocks the coronary ostium. Moreover, reducing the height of the valve stent is beneficial to improving the coaxiality between the valve stent and the valve annulus.

[0034] The valve stent of the embodiment of the present application can be made of plastic metal materials, such as stainless steel and cobalt-chromium alloy, or shape memory metal materials, such as nitinol. When the valve stent is made of plastic metal materials, balloon-expandable release is required, and the empty wave troughs 102 of the second wave ring 120 expand preferentially compared with other parts of the valve stent, improving the anchoring effect of the valve stent. When the valve stent is made of shape memory metal materials, it needs to be released gradually from the inflow end to the outflow end by means of transcatheter release.

[0035] It should be noted that the connection structure between two adjacent wave rings can refer to the connection structure formed by directly connecting two adjacent wave rings (i.e., not connected through an intermediate member). For example, in Figure 1 the shown embodiment, the second wave ring 120 and the third wave ring 130 are not connected through an intermediate member, but are directly connected to form a grid structure approximately in the shape of a rhombus. The connection structure between two adjacent wave rings can also refer to the connection structure formed by connecting two adjacent wave rings through an intermediate member. For example, in Figure 1 the shown embodiment, the third wave ring 130 and the fourth wave ring 140 are connected by an axial connecting rod 300 to form a grid structure approximately in the shape of a hexagon.

[0036] As Figure 1 and Figure 2 shown, the wave rod 103 can be a straight rod or a rod with a certain curvature, and the outer shape of the wave rod 103 can be flexibly designed.

[0037] In one embodiment, the second wave ring 120 has a total of 12 wave troughs 102, of which 6 wave troughs 102 are vacant, and the first wave ring 110 has a total of 6 wave peaks 101.

[0038] In other embodiments, the number of wave troughs of the second wave ring and the number of wave peaks of the first wave ring can also be other numbers.

[0039] As Figure 1 shown, in one embodiment, the side of the second wave ring 120 close to the inflow end of the valve stent has only one wave ring, that is, the first wave ring 110. That is to say, sorting the wave rings along the blood flow direction in the valve stent, the first wave ring 110 is the first wave ring of the valve stent, which is convenient for processing.

[0040] In other embodiments, the side of the second wave ring close to the inflow end of the valve stent can also have two, three or more wave rings. That is to say, sorting the wave rings along the blood flow direction in the valve stent, the first wave ring can be the second wave ring or the third wave ring, etc. of the valve stent.

[0041] Please refer to Figure 1 , in one embodiment, the number of wave troughs 102 of the second wave ring 120 is greater than the number of wave peaks 101 of the first wave ring 110. The wave peaks 101 of the first wave ring 110 are connected to a part of the wave troughs 102 of the second wave ring 120, and the other part of the wave troughs 102 of the second wave ring 120 are vacant wave troughs 102.

[0042] Since the wave peaks 101 of the first wave ring 110 are connected to a part of the wave troughs 102 of the second wave ring 120, it is convenient for the first wave ring 110 to be connected to the second wave ring 120, and the connection between the two is reliable. And the other part of the wave troughs 102 of the second wave ring 120 are vacant, which is convenient for hanging on the annulus of the aortic valve.

[0043] Preferably, the wave peaks 101 of the first wave ring 110 are connected to a part of the wave troughs 102 of the second wave ring 120 in a one-to-one correspondence.

[0044] In addition, since the number of wave troughs 102 of the second wave ring 120 is greater than the number of wave peaks 101 of the first wave ring 110, therefore, the number of wave rods of the first wave ring 110 is less than the number of wave rods of the second wave ring 120. The relatively small number of wave rods of the first wave ring 110 can form a relatively sparse grid structure composed of the second wave ring 120 and the first wave ring 110, so as to reduce the number of wave rods in contact with the left ventricular outflow tract by the valve stent, effectively reduce or avoid the extrusion of the valve stent on the tissue, and further reduce the occurrence of conduction block.

[0045] In other embodiments, the wave crest of the first wave ring may also be connected to the wave crest of the second wave ring, or connected to the wave rod of the second wave ring, so that all the wave troughs of the second wave ring can be left empty.

[0046] Please refer to Figure 1 In one embodiment, the number of the wave crests 101 of the first wave ring 110 is half the number of the wave troughs 102 of the second wave ring 120. In the second wave ring 120, there is a wave trough 102 of the second wave ring 120 connected to the wave crest 101 of the first wave ring 110 between any two adjacent vacant wave troughs 102. That is to say, the wave troughs 102 of the second wave ring 120 connected to the wave crest 101 of the first wave ring 110 and the wave troughs 102 of the vacant second wave ring 120 are arranged alternately in sequence. In this way, the number of the wave troughs 102 of the second wave ring 120 connected to the wave crest 101 of the first wave ring 110 and the wave troughs 102 of the vacant second wave ring 120 are the same, and are evenly arranged along the circumference of the valve stent. Since the wave troughs 102 of the second wave ring 120 connected to the wave crest 101 of the first wave ring 110 are evenly arranged along the circumference of the valve stent, the connection between the first wave ring 110 and the second wave ring 120 can be reliable and stable. Since the wave valleys 102 of the idle second wave ring 120 are evenly arranged along the circumference of the valve stent, the valve stent is subjected to balanced force in the circumferential direction when it is hung on the valve ring, and the positioning effect is good.

[0047] In other embodiments, the number of wave peaks of the first wave ring may also be other numbers, for example, greater than half of the number of wave troughs of the second wave ring or less than half of the number of wave troughs of the second wave ring.

[0048] Please refer to Figure 1 In one embodiment, the eversion angle of the vacant trough 102 of the second wave ring 120 is greater than or equal to 1° and less than or equal to 90°. A suitable eversion angle is conducive to the vacant trough 102 of the second wave ring 120 being reliably attached to the valve ring of the aortic valve.

[0049] Please refer to Figure 1 In one embodiment, in the second wave ring 120, two wave rods 103 connected by any vacant wave valley 102 are turned outward in a direction away from the axis of the valve stent.

[0050] As described above, the trough 102 is the connection node at one end of two adjacent wave rods 103 close to the blood inflow side of the valve stent. In this embodiment, the two wave rods 103 connected by any vacant trough 102, that is, the connection nodes, are the two adjacent wave rods 103 of the vacant trough 102. The two adjacent wave rods 103 turn outwards in the direction away from the axis of the valve stent, so that the side of the two adjacent wave rods 103 away from the axis of the valve stent forms a concave surface, and the concave surface defines a recessed space, which can accommodate the valve annulus, thereby enabling the valve stent to better adapt to the shape of the valve annulus, preventing the valve stent from moving up or down, and enhancing the anchoring stability.

[0051] Please refer to Figure 2 , in one embodiment, the wave crest 101 of the first wave ring 110 is connected to a part of the troughs 102 of the second wave ring 120 by connecting rods 200, and the connecting rods 200 are parallel to the axis direction of the valve stent. In this way, the two connecting rods 200 arranged at intervals and the two wave rods 103 of the first wave ring 110 located between them form a structure approximately in the shape of a U, which is beneficial to enhancing the stability of the grid structure formed by the first wave ring 110 and the second wave ring 120.

[0052] Preferably, the wave crest 101 of the first wave ring 110 is connected to a part of the troughs 102 of the second wave ring 120 by the connecting rods 200 in a one-to-one correspondence.

[0053] In other embodiments, some of the wave crests 101 of the first wave ring 110 can also be directly connected to the troughs 102 of the second wave ring 120 (that is, not connected through intermediate members such as connecting rods).

[0054] In one embodiment, among any two adjacent wave rings on one side of the first wave ring in the first direction, the trough of the wave ring close to the outflow end of the valve stent is connected to the wave crest of the wave ring close to the inflow end of the valve stent. In this way, a stable hexagonal or rhombic grid structure is formed between any two adjacent wave rings on one side of the first wave ring in the first direction, and each grid of the grid structure is tightly connected in the circumferential direction, so as to enhance the radial supporting force of the valve stent, further prevent the valve stent from sliding, and effectively ensure the valve orifice area.

[0055] Preferably, among any two adjacent wave rings on one side of the first wave ring in the first direction, the trough of the wave ring close to the outflow end of the valve stent is connected to the wave crest of the wave ring close to the inflow end of the valve stent in a one-to-one correspondence. Of course, among any two adjacent wave rings on one side of the first wave ring in the first direction, some of the troughs of the wave ring close to the outflow end of the valve stent may not be connected to the wave crests of the wave ring close to the inflow end of the valve stent.

[0056] As Figure 1As shown, in one embodiment, there are a total of 3 corrugations on one side of the first direction of the first corrugation ring 110 of the valve stent, namely the second corrugation ring 120, the third corrugation ring 130, and the fourth corrugation ring 140. Among the adjacent third corrugation ring 130 and fourth corrugation ring 140, the wave crest 101 of the third corrugation ring 130 is connected to the wave trough 102 of the fourth corrugation ring 140 in a one-to-one correspondence. Among the adjacent third corrugation ring 130 and second corrugation ring 120, the wave trough 102 of the third corrugation ring 130 is connected to the wave crest 101 of the second corrugation ring 120 in a one-to-one correspondence.

[0057] In other embodiments, there may be four, five, or more corrugations on the side of the first corrugation ring close to the outflow end of the valve stent.

[0058] Please refer to Figure 1 , in one embodiment, the valve stent has two adjacent corrugations on one side of the first direction of the first corrugation ring 110. Among these two adjacent corrugations, the wave trough of the corrugation ring close to the outflow end of the valve stent is connected to the wave crest of the corrugation ring close to the inflow end of the valve stent in a one-to-one correspondence through an axial connecting rod 300, and the axial connecting rod 300 is parallel to the axis direction of the valve stent. In this way, these two adjacent corrugations and the axial connecting rod 300 form a generally hexagonal grid structure. Since the connection of the axial connecting rod 300 extends the axial spacing between these two adjacent corrugations, the mesh opening of this grid structure is larger, and thus a large and unobstructed surgical access channel can be reserved for later PCI (Percutaneous Coronary Intervention), improving the success rate of PCI after TAVR (Transcatheter Aortic Valve Replacement). Moreover, each grid of the generally hexagonal grid structure is tightly connected circumferentially, which can enhance the radial supporting force of the valve stent, further prevent the valve stent from sliding, and effectively ensure the valve orifice area.

[0059] In this embodiment, there are a total of 3 corrugations on the side of the first corrugation ring 110 close to the outflow end of the valve stent, namely the second corrugation ring 120, the third corrugation ring 130, and the fourth corrugation ring 140. Among them, between the adjacent third corrugation ring 130 and fourth corrugation ring 140, the wave crest 101 of the third corrugation ring 130 is connected to the wave trough 102 of the fourth corrugation ring 140 in a one-to-one correspondence through an axial connecting rod 300. In this way, the connection structure of the third corrugation ring 130, the fourth corrugation ring 140, and the axial connecting rod 300 forms a generally hexagonal grid structure.

[0060] Please refer to Figure 1 , in one embodiment, the wave trough 102 of the corrugation ring at the outflow end of the valve stent is connected to the wave crest 101 of the adjacent corrugation ring through an axial connecting rod 300. In this way, a generally hexagonal grid structure can be located at the outflow end of the valve stent, which is convenient for reserving a large and unobstructed surgical access channel for later PCI (Percutaneous Coronary Intervention).

[0061] InFigure 1 In the illustrated embodiment, the wave ring at the outflow end of the valve stent, i.e., the fourth wave ring 140, is connected to the wave peak 101 of the adjacent wave ring (i.e., the third wave ring 130) through the axial connecting rod 300 in a one-to-one correspondence at the wave valley 102 of the fourth wave ring 140.

[0062] In other embodiments, on one side of the first wave ring near the outflow end of the valve stent, there may also be only two wave rings, i.e., the second wave ring and the third wave ring, and the wave peaks of the second wave ring and the wave valleys of the third wave ring are connected through the axial connecting rod in a one-to-one correspondence. On one side of the first wave ring near the outflow end of the valve stent, there may also be four or more wave rings. It is also possible that among any two adjacent wave rings, the wave valleys of the wave ring near the outflow end of the valve stent and the wave peaks of the wave ring near the inflow end of the valve stent are connected through the axial connecting rod in a one-to-one correspondence.

[0063] In one embodiment, a leaflet connection structure (not shown) is provided on the axial connecting rod 300 to facilitate connecting the leaflets to the valve stent. Moreover, when the valve stent is made of a shape memory metal material, under the pulling action of the leaflets, the valve stent can bear part of the pulling deformation of the leaflets, thereby improving the leaflet life. The leaflet connection structure is, for example, a leaflet fixing hole, etc.

[0064] In one embodiment, among any two adjacent wave rings between the wave ring at the outflow end of the valve stent and the first wave ring 110, the wave valley of the wave ring near the outflow end of the valve stent and the wave peak of the wave ring near the inflow end of the valve stent are directly connected (i.e., not connected through an intermediate member such as the axial connecting rod 300), thereby forming a grid structure approximately in the shape of a rhombus. Each grid of the grid structure approximately in the shape of a rhombus is tightly connected circumferentially, thereby enhancing the radial supporting force of the valve stent, further preventing the valve stent from sliding, and effectively ensuring the orifice area.

[0065] Preferably, among any two adjacent wave rings between the wave ring at the outflow end of the valve stent and the first wave ring 110, the wave valley of the wave ring near the outflow end of the valve stent and the wave peak of the wave ring near the inflow end of the valve stent are directly connected in a one-to-one correspondence.

[0066] In other embodiments, among any two adjacent wave rings between the wave ring at the outflow end of the valve stent and the first wave ring, some wave valleys of the wave ring near the outflow end of the valve stent and some wave peaks of the wave ring near the inflow end of the valve stent may also be indirectly connected through an intermediate member such as a connecting rod.

[0067] In Figure 1In the illustrated embodiment, the wave ring at the outflow end of the valve stent, i.e., the fourth wave ring 140, and there are two wave rings between the fourth wave ring 140 and the first wave ring 110, namely the second wave ring 120 and the third wave ring 130. The trough 102 of the third wave ring 130 is directly connected to the peak 101 of the second wave ring 120.

[0068] In other embodiments, there may also be four or more wave rings on the side of the first wave ring close to the outflow end of the valve stent. At this time, there may also be three or more wave rings between the wave ring at the outflow end of the valve stent and the first wave ring 110, so as to form more generally rhombic meshes.

[0069] An embodiment of the present application also provides a valve prosthesis, including the valve stent of any one of the above embodiments and leaflets connected to the valve stent.

[0070] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification.

[0071] The above-described embodiments only represent several implementation manners of the present application. Their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A valve stent, characterized in that, The valve stent includes at least three wave rings arranged axially. Each wave ring includes a plurality of wave rods connected circumferentially, and an included angle is formed between adjacent wave rods. The connection structure between any two adjacent wave rings is a grid structure; Among the at least three wave rings, there are a first wave ring, a second wave ring, and a third wave ring connected in sequence in a first direction. The first direction is the direction from the inflow end to the outflow end of the valve stent; there is at least one valley of the second wave ring vacant between two adjacent peaks of the first wave ring, and the vacant valley of the second wave ring turns outwards in a direction away from the axis of the valve stent.

2. The valve stent according to claim 1, wherein, The number of valleys of the second wave ring is greater than the number of peaks of the first wave ring. The peaks of the first wave ring are connected to a part of the valleys of the second wave ring, and the other part of the valleys of the second wave ring are vacant valleys.

3. The valve stent according to claim 2, wherein, The number of peaks of the first wave ring is half of the number of valleys of the second wave ring; between any two adjacent vacant valleys, there is a valley of the second wave ring connected to the peak of the first wave ring.

4. The valve stent according to claim 2, wherein The peaks of the first wave ring and a part of the valleys of the second wave ring are connected by a connecting rod, and the connecting rod is parallel to the axis direction of the valve stent.

5. The valve stent according to claim 1, characterized in that, For any two wave rods connected to a vacant valley in the second wave ring, they turn outwards in a direction away from the axis of the valve stent.

6. The valve stent according to claim 1, characterized in that, The outward turning angle of the vacant valley of the second wave ring is greater than or equal to 1° and less than or equal to 90°.

7. The valve stent according to claim 1, characterized in that, Among any two adjacent wave rings on one side of the first wave ring in the first direction, the valley of the wave ring closer to the outflow end of the valve stent is connected to the peak of the wave ring closer to the inflow end of the valve stent.

8. The valve stent according to claim 1, characterized in that, On one side of the first wave ring in the first direction, there are two adjacent wave rings; among the two adjacent wave rings, the valley of the wave ring closer to the outflow end of the valve stent and the peak of the wave ring closer to the inflow end of the valve stent are connected by an axial connecting rod, and the axial connecting rod is parallel to the axis direction of the valve stent.

9. The valve stent according to claim 8, wherein, Between the valley of the wave ring at the outflow end of the valve stent and the peak of the adjacent wave ring, they are connected by the axial connecting rod.

10. The valve stent according to claim 1, characterized in that, Among any two adjacent wave rings between the wave ring at the outflow end of the valve stent and the first wave ring, the valley of the wave ring closer to the outflow end of the valve stent is directly connected to the peak of the wave ring closer to the inflow end of the valve stent.

11. A valve prosthesis, characterized in that, It includes the valve stent according to any one of claims 1 to 10 and leaflets connected to the valve stent.

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