Valve stent and artificial valve

Abstract

The present invention provides a valve stent and an artificial valve. The valve stent has an inflow end and an outflow end that are opposite to each other, and is provided with a plurality of annular wavy rings that are sequentially arranged from the outflow end to the inflow end in an axial direction. Each annular wavy ring comprises a plurality of grid cell units that are sequentially arranged in a circumferential direction of the valve stent. There is at least one type of grid cell unit, being a quadrilateral grid cell, and grid cell units used for suturing skirt edges and / or fixed edges of artificial valve leaflets on the valve stent are all quadrilateral grid cells. The artificial valve comprises artificial valve leaflets, skirt edges, and a valve stent. The skirt edges and / or fixed edges of the artificial valve leaflets are sutured to wavy struts in the quadrilateral grid cells. The fixed edges of the artificial valve leaflets are arranged from the outflow end to the inflow end along the wavy struts in the plurality of quadrilateral grid cells and are sutured to the wavy struts in the quadrilateral grid cells. The present invention can improve the suture firmness of the artificial valve leaflets, expand the size options of the artificial valve, and reduce the risk of damage to or failure of the skirt edges and / or the artificial valve leaflets.

Description

Valve stents and artificial valves Technical Field

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

[0002] The heart contains four chambers: the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously throughout the cardiac cycle. The valves separating the atria from the ventricles are called the atrioventricular valves. They act as one-way valves, ensuring the normal flow of blood within the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery, and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta, and from there to the pericardium. There are typically no direct connections between the ventricles or between the atria. At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after the onset of ventricular systole (ie, ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the respective atria.

[0003] When the atrioventricular valves fail, they fail to function properly, resulting in improper closure. The atrioventricular valves are complex structures, typically consisting of an annulus, leaflets, chordae tendineae, and supporting structures. Each atrium is connected to its valve by the atrial vestibule. The mitral valve has two leaflets, and the attachment or coaptation of the corresponding surfaces of the leaflets helps to close or seal the valve, preventing blood from flowing in the wrong direction. During ventricular contraction, the failure of the leaflets to seal is called malcoaptation, allowing blood to flow backward through the valve (regurgitation). Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lowered blood pressure, and reduced oxygen flow to tissues. Mitral valve insufficiency can also cause blood from the left atrium to flow back into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death. Transcatheter valve replacement surgery involves a catheter-based procedure in which a prosthetic valve is compressed outside the body into a delivery system. This is then delivered through a vascular path or transcardiac apex to the annulus, where it is released and secured to the annulus, replacing the native valve. Compared with surgical operations, transcatheter valve replacement surgery does not require extracorporeal circulation assist devices, is less invasive, and allows patients to recover faster. Postoperative hemodynamic indicators of patients can be significantly improved.

[0004] Current prosthetic valves primarily utilize two types of stents: self-expanding stents and balloon-expandable stents. Taking the balloon-expandable aortic valve as an example, to minimize access-induced damage, the prosthetic valve's compressed diameter is optimized, requiring excellent compressibility. Furthermore, the aortic anatomy varies significantly between patients and individuals, necessitating a wide range of prosthetic valve specifications. Regarding compressibility, valve stents are typically constructed of highly ductile metal materials. However, the skirt or prosthetic leaflets sutured to the stent lack sufficient elasticity. Improper stent design can lead to excessive folding or localized overstretching of the skirt or leaflets after compression, potentially damaging them. Ideally, prosthetic valves would be available in as many sizes as possible to match the aortic dimensions of each patient or individual. However, current products offer limited options. This can lead to aortic tears or insufficient valve anchoring in patients or individuals whose aortic dimensions differ significantly from the designed valve dimensions.

[0005] Therefore, for those skilled in the art, how to design an artificial valve with good compressibility, which will not cause damage to the skirt or artificial leaflets, and which can have diversified specifications, is a technical problem that needs to be solved urgently.

[0006] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0007] Summary of the Invention

[0008] In view of this, an object of the present invention is to provide a valve stent and an artificial valve with good compressibility while taking into account more specifications.

[0009] To achieve the above-mentioned purpose, the present invention provides a valve stent having relative inflow and outflow ends, wherein the valve stent is provided with a plurality of annular waves arranged in sequence along the axial direction from the outflow end to the inflow end, and each of the annular waves includes a plurality of grid units arranged in sequence along the circumference of the valve stent, and the grid units are of at least one type, one of which is a quadrilateral grid, and all the grid units on the valve stent used for suturing the skirt and / or the fixed edges of the artificial valve leaflets are the quadrilateral grids.

[0010] Optionally, an extension direction of a diagonal line of the quadrilateral grid is parallel to the axial direction of the valve support, and the quadrilateral grid is symmetrically arranged on both sides of the diagonal line.

[0011] Optionally, the quadrilateral grid is a diamond grid.

[0012] Optionally, in the quadrilateral grid, the length of two adjacent wave bars in the circumferential direction close to the outflow end is smaller than the length of two adjacent wave bars in the circumferential direction away from the outflow end.

[0013] Optionally, in the quadrilateral grid, the length of two adjacent wave bars in the circumferential direction close to the outflow end is greater than the length of two adjacent wave bars in the circumferential direction away from the outflow end.

[0014] Optionally, two adjacent wave rods in the quadrilateral grid in the axial direction are connected by an arc transition.

[0015] Optionally, the first annular wave ring of the valve stent from the outflow end to the inflow end is a bare stent segment, the grid units in the first annular wave ring are all the quadrilateral grids or all the hexagonal grids, and the grid units in all the remaining annular wave rings except the first one are all the quadrilateral grids.

[0016] Optionally, all the grid units in the first annular wave ring are quadrilateral grids, and the length of two adjacent wave rods in the quadrilateral grid in the first annular wave ring close to the outflow end and in the circumferential direction is smaller than the length of two adjacent wave rods away from the outflow end and in the circumferential direction.

[0017] Optionally, in the quadrilateral grids of all the annular wave circles except the first one, the length of two adjacent wave rods in the circumferential direction close to the outflow end is greater than the length of two adjacent wave rods in the circumferential direction away from the outflow end.

[0018] Based on the same inventive concept, the present invention also provides an artificial valve, which includes an artificial valve leaflet, a skirt and any valve stent as described above, wherein the fixed edge of the skirt and / or the artificial valve leaflet is sutured to the wave rods in the quadrilateral grid, and the fixed edge of the artificial valve leaflet is extended from the outflow end to the inflow end along the wave rods in multiple quadrilateral grids and sutured to the wave rods in the quadrilateral grid.

[0019] Compared with the prior art, the valve stent and artificial valve provided by the present invention have at least the following advantages:

[0020] In the aforementioned valve stent and artificial valve, the mesh units used to sew the skirt and / or the fixed edges of the artificial valve leaflets are all quadrilateral meshes. Furthermore, the fixed edges of the artificial valve leaflets are arranged along the wave bars within the quadrilateral meshes from the outflow end to the inflow end of the valve stent and are sutured to the wave bars within the quadrilateral meshes. This configuration not only enhances the suture security of the artificial valve leaflets but also allows for adaptive balloon expansion diameter within a certain range, increasing the specifications of the artificial valve. Furthermore, during compression and expansion, the skirt and / or artificial valve leaflets are not overstretched or squeezed, allowing them to deform more freely and be less susceptible to damage or failure. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Those skilled in the art will appreciate that the accompanying drawings are provided to better understand the present invention and do not constitute any limitation on the scope of the present invention.

[0022] FIG1 is a schematic diagram of the three-dimensional structure of a valve stent according to one embodiment of the present invention;

[0023] FIG2 is a schematic diagram of the three-dimensional structure of a valve stent according to another embodiment of the present invention;

[0024] FIG3 is a schematic diagram of a partial structure of a valve stent provided in an expanded configuration according to an embodiment of the present invention;

[0025] FIG4 is a schematic diagram of a partial structure of a valve stent in an expanded configuration according to a comparative embodiment;

[0026] FIG5 is a schematic diagram of a partial structure of the valve stent in FIG3 when it is in a compressed configuration;

[0027] FIG6 is a schematic diagram of a partial structure of the valve stent in FIG4 when it is in a compressed configuration;

[0028] FIG7 is a schematic diagram of the three-dimensional structure of a valve stent provided according to a comparative embodiment;

[0029] FIG8 is a schematic structural diagram of an annular wave ring according to an embodiment of the present invention;

[0030] FIG9 is a schematic structural diagram of an annular wave ring according to another embodiment of the present invention;

[0031] FIG10 is a schematic structural diagram of an annular wave ring according to another embodiment of the present invention;

[0032] FIG11 is a schematic structural diagram of an artificial valve leaflet according to an embodiment of the present invention.

[0033] In the attached figure:

[0034] 100-valve stent; 110-annular wave ring; 111-grid unit; 112-wave rod; 1121-oblique wave rod; 1122-axial wave rod; 1111-quadrilateral grid; 1113-hexagonal grid; 130-artificial valve leaflet; 131-fixed edge; 1311-bottom end of fixed edge; 132-free edge; 133-joint; 300-stitch; A, B1, B2-intersection. DETAILED DESCRIPTION

[0035] To make the objects, advantages, and features of the present invention more clearly apparent, the present invention is further described below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale. They are only used to conveniently and clearly assist in illustrating the purposes of the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, different drawings may need to illustrate different focuses and sometimes use different scales.

[0036] As used in the present invention, the singular forms "a", "an", and "the" include plural objects, the term "or" is generally used to include the meaning of "and / or", the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first" and "second" are used for descriptive purposes only and are not to be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features specified as "first" and "second" may explicitly or implicitly include one or at least two of the features, the terms "one end" and "the other end" generally refer to two corresponding parts, which not only include endpoints, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between two elements. In addition, as used in the present invention, "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element. It should not be understood as indicating or implying a spatial positional relationship between the two elements. That is, one element can be in any orientation, such as inside, outside, above, below, or to one side of another element, unless the content clearly indicates otherwise. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0037] The term "axial direction" described herein refers to the direction of the central axis of the valve stent or artificial valve, and "circumferential direction" refers to the direction around the central axis of the valve stent or artificial valve.

[0038] The present invention aims to provide a valve stent and artificial valve to address the problem that at least one of the existing skirt and artificial valve leaflets has limited deformation freedom during compression and expansion, making them susceptible to breakage or failure. It also aims to address the problem that existing artificial valves are limited in specifications and cannot be well matched to the aortic size of each patient or individual. The artificial valve of the present invention is preferably an artificial aortic valve.

[0039] The following description is made with reference to the accompanying drawings. It will be understood by those skilled in the art that, under the premise of no conflict, the following preferred embodiments can be freely combined and superimposed.

[0040] An embodiment of the present invention provides a valve stent 100 for an artificial valve. The valve stent 100 has a compressed configuration and an expanded configuration, and is capable of transitioning between the compressed and expanded configurations. The valve stent 100 of the present invention is a balloon-expandable stent, as shown in Figures 1 and 2. The valve stent 100 is generally a mesh-shaped annular frame, typically cut from a metal tube. This balloon-expandable stent is typically cylindrical in structure and can be expanded using a balloon.

[0041] Specifically, the valve stent 100 has an inflow end and an outflow end relative to each other. As shown in Figures 1 and 2 , the top end of the valve stent 100 is the outflow end, and the bottom end is the inflow end. The valve stent 100 is provided with a plurality of annular corrugations 110 arranged axially from the outflow end to the inflow end. Each annular corrugation 110 includes a plurality of grid cells 111 arranged circumferentially of the valve stent 100. The grid cells 111 on the same annular corrugation 110 are substantially identical in size and shape.

[0042] The present invention does not limit the number of annular corrugations 110. It should be understood that the number of annular corrugations 110 includes, but is not limited to, the four shown in the figure. For example, in other embodiments, three or more annular corrugations 110 may be used. When the prosthetic valve is implanted in the body, at least one annular corrugation 110 is positioned in contact with the native aortic valve tissue. This position facilitates the proper fit of the skirt of the prosthetic valve with the native aortic valve tissue, resulting in a better seal and significantly reducing the risk of paravalvular leak.

[0043] The grid units 111 may be of one or two types. When the grid units 111 are of one type, as shown in FIG2 , all the grid units 111 are quadrilateral grids 1111, that is, the valve stent 100 entirely adopts quadrilateral grids 1111. When the grid units 111 are of two types, as shown in FIG1 , all the grid units 111 in the first annular wave ring 110 from the outflow end to the inflow end of the valve stent 100 are hexagonal grids 1113, and all the grid units 111 in all the remaining annular wave rings 110 except the first annular wave ring 110 are quadrilateral grids 1111. The advantage of the quadrilateral grid 1111 is that it is easier to deform than the hexagonal grid 1113, which is beneficial to the compression and expansion of the valve stent 100 and more uniform deformation. In addition, the number of intersections between the wave rods 112 and the wave rods 112 in the quadrilateral grid 1111 is small, which helps the stitches 300 (see Figure 3) to move and be evenly distributed on the wave rods 112. At the same time, the length change of the quadrilateral grid 1111 after compression is small, which can reduce the movement of the stitches 300.

[0044] Preferably, the extension direction of a diagonal line of the quadrilateral grid 1111 is parallel to the axial direction of the valve stent 100, and the quadrilateral grids 1111 are symmetrically arranged on both sides of the diagonal line to ensure the performance of the valve stent 100. The quadrilateral grid 1111 described in this specification can be a parallelogram or a non-parallelogram, which is not limited by the present invention.

[0045] 1 to 3 , the present invention needs to ensure that all grid units 111 (see suture area) on the valve stent 100 used for suturing the skirt (not shown) and / or the fixed edge 131 of the artificial valve leaflet 130 are quadrilateral grids 1111 .

[0046] Those skilled in the art will appreciate that the artificial valve leaflets 130 are attached to the valve stent 100. The valve stent 100 can provide several functions for the artificial valve, including serving as the main structure of the valve, carrying the artificial valve leaflets 130 inside for support, and connecting to a delivery system. As shown in FIG11 , the artificial valve leaflets 130 are substantially symmetrical as a whole, and include a fixed edge 131, a free edge 132, and a commissure 133; both ends of the free edge 132 and the fixed edge 131 are commissures 133, that is, the commissures 133 are located between the adjacent ends of the free edge 132 and the fixed edge 131. The fixed edge 131 is substantially in the shape of an arc convex away from the free edge 132, and when the multiple artificial valve leaflets 130 are fixed to the valve stent 100, they are always in contact with each other at the commissures 133. The shape of the free edge 132 is not limited. For example, the free edge 132 bulges into an upper arc in the direction away from the fixed edge 131, or bulges into a lower arc in the direction close to the fixed edge 131, or is a straight shape. The fixed edge 131 starts from the joint 133, and the bottom end 1311 (i.e., the bottom) of the fixed edge 131 is the position closest to the inflow end. Among them, the fixed edge 131 of each artificial valve leaflet 130 needs to be sutured with the wave rod 112. When the fixed edge 131 is sutured, the spacing of the stitches 300 is uniform to ensure the tightness of the suture. The joint 133 is sutured with the stent window (usually a through hole) near the outflow end of the valve stent 100. When suturing the wave rod 112, the joint 133 minimizes the dead zone at the joint position as much as possible to reduce the risk of thrombosis. The shape of the stent window mostly matches the shape of the joint 133 to ensure the connection stability and fatigue life of the artificial valve. The joint 133 is shaped to improve the fatigue life of the valve and the stability of the connection, such as a rectangle, square, or diamond, with a more suitable shape being a rectangle. The same stent window is simultaneously connected to the joints 133 of two adjacent artificial valve leaflets 130. The artificial valve leaflets 130 dynamically switch between open and closed states. In the closed state, the free edges 132 of the artificial valve leaflets 130 are tightly closed or converged in a sealed abutment manner; in the open state, the free edges 132 of the artificial valve leaflets 130 are spread apart.

[0047] It should be noted that when the artificial valve leaflet 130 is sutured, the bottom end 1311 of its fixed edge 131 is also extended and sewn along the wave struts 112 in the quadrilateral grid 1111, without crossing the quadrilateral grid 1111. Therefore, the distance between the stitches 300 of the bottom end 1311 is small, which can ensure the normal opening and closing of the artificial valve leaflet 130. In other words, the fixed edge 131 extends along the wave struts 112 in the quadrilateral grids 1111 from the outflow end to the inflow end of the valve stent 100, so that the fixed edge 131 will not cross the hexagonal grid 1113 without being sewn, as in Figure 7. Thus, the grid cells 111 on the valve stent 100 where the skirt and / or the fixed edges 131 of the artificial valve leaflets 130 are sewn are covered with stitches 300. The stitches 300 are distributed on the wave bars 112 of the grid cells 111. Preferably, the stitches 300 are evenly distributed on the wave bars 112. The stitches 300 described herein can be the suture points between the skirt and the wave bars 112, or the suture points between the artificial valve leaflets 130 and the wave bars 112. The suture points on the same grid cell 111 are evenly distributed along the wave bars 112, and the distance between the suture points is appropriate.

[0048] Although the present application does not show the skirt, those skilled in the art can understand the skirt by referring to the prior art, and the details will not be described in detail. The skirt can be sutured on the valve stent 100 as a sealing component and sutured along the quadrilateral grid 1111. The skirt may include at least one of an inner skirt and an outer skirt. The inner skirt is arranged on the inner side of the valve stent 100, and the outer skirt is arranged on the outer side of the valve stent 100. The skirt is mainly arranged at the inflow end and covers the corresponding annular wave ring 110. The skirt can be fully wrapped around the circumference of the valve stent 100 at the inflow end of the valve stent 100, which can effectively prevent paravalvular leakage. The valve stent 100, the artificial valve leaflet 130 and the skirt are connected as a whole and to each other mainly by sutures.

[0049] In order to better understand the present invention, FIG4 also shows the situation of using a hexagonal grid 1113 to sew the skirt and the artificial valve leaflet 130. As shown in FIG4 , in the comparative embodiment, the stitches 300 are arranged along the six wave bars 112 of the hexagonal grid 1113. It can be understood that the wave bars 112 in the hexagonal grid 1113 can be further divided into oblique wave bars 1121 and axial wave bars 1122. The oblique wave bars 1121 are at an angle to the axial direction of the valve stent 100, and the axial wave bars 1122 are parallel to the axial direction of the valve stent 100. Compared with the quadrilateral grid 1111, the hexagonal grid 1113 has an axial wave bar 1122 in addition to the oblique wave bar 1121, thereby adding an extra intersection point between the oblique wave bar 1121 and the axial wave bar 1122. As shown in FIG3 , the quadrilateral grid 1111 has only one cross intersection point A on a single side. However, as shown in Figure 4, the hexagonal grid 1113 has been transformed from a single cross intersection A to two Y-shaped intersections B1 and B2. It should be understood that all intersections are nodes through which the pins 300 cannot move, and thus affect the movement of the pins 300 during compression and expansion, thereby affecting the deformation of the skirt and artificial valve leaflets 130.

[0050] The difference between the quadrilateral grid 1111 and the hexagonal grid 1113 will be further described below in conjunction with the compressed states of FIG. 5 and FIG. 6 .

[0051] Referring to Figure 5, during the compression process, the stitches 300 on the quadrilateral grid 1111 can slide on the wave bar 112 as the angle of the wave bar 112 changes, and finally the stitches 300 can be distributed more evenly on the wave bar 112. Therefore, the movement of the stitches 300 is not easily hindered, and it is not easy to cause the skirt and / or artificial valve leaflet 130 to be subjected to additional stretching or squeezing.

[0052] Conversely, referring to Figure 6, although the stitches 300 on the hexagonal grid 1113 can slide on the oblique wave bar 1121 as the angle of the oblique wave bar 1121 changes, the movement of the stitches 300 is hindered due to the addition of the intersection points B1 or B2, which will cause the skirt and / or artificial valve leaflet 130 to be subjected to additional stretching or squeezing, thereby causing the skirt and / or artificial valve leaflet material to wrinkle, overstretch, break or fail.

[0053] Therefore, the more nodes there are on the grid unit 111, the more it will hinder the movement of the stitches 300, affecting the skirt and / or artificial valve leaflet material, and easily causing the skirt and / or artificial valve leaflet material to be damaged or fail.

[0054] Furthermore, the hexagonal grid 1113 has an additional axial wave bar 1122 compared to the quadrilateral grid 1111. Consequently, the axial height of the hexagonal grid 1113 is greater than that of the quadrilateral grid 1111. Consequently, under the same crimping and deformation conditions, the hexagonal grid 1113 experiences a greater axial length variation. This increased length variation also increases the travel distance of the stitches 300, further exacerbating the stretching or squeezing of the skirt and prosthetic leaflet material.

[0055] Based on this, the present invention aims to sew the skirt and / or artificial leaflets 130 through the quadrilateral grid 1111, so that the valve stent 100 has excellent compressibility while not over-stretching or squeezing the skirt and / or artificial leaflets 130 during the compression and expansion deformation process, so that the deformation of the skirt and / or artificial leaflets 130 is freer and less likely to be damaged or fail.

[0056] Continuing with FIG7 , in the comparative embodiment, when the hexagonal grid 1113 is used to suture the fixed edge 131 of the artificial valve leaflet 130, the bottom end 1311 of the fixed edge 131 cannot be sutured along the wave bar 112 of the hexagonal grid 1113. The bottom end 1311 will be arranged across the hexagonal grid 1113. In this case, the suture area between the fixed edge 131 and the wave bar 112 is reduced, thereby reducing the suture firmness of the artificial valve leaflet 130. In addition, at the position marked C, the distance between the stitches 300 of the artificial valve leaflet 130 is large (circumferentially spanning the hexagonal grid 1113), which requires the artificial valve to be expanded to the designed size to ensure that the artificial valve leaflet 130 can function normally, thereby limiting the specifications of the artificial valve. When the hexagonal grid 1113 is used, the axial wave rod 1122 is also prone to tilting during compression, resulting in the artificial valve having to be expanded to the design specifications before the axial wave rod 1122 can restore its original shape to ensure that the artificial valve can work normally. This further limits the specifications of the artificial valve to the design specifications, and cannot have more specifications during the operation to adapt to the balloon expansion diameter, and then match the aortic size of different patients or individuals.

[0057] For example, the design diameter (i.e., design specification) of the valve stent 100 is 26 mm. When implanted into the human body, the surgeon must expand the valve stent 100 to the design diameter to ensure the normal opening and closing of the artificial valve leaflets 130. Therefore, for patients with a native valve size of 24.5 mm, the design diameter of 26 mm does not match 24.5 mm well, resulting in the risk of excessive expansion and damage to the aortic valve. Alternatively, for a native valve size exceeding 26 mm, the design diameter of 26 mm does not match the native valve size well, resulting in the problem of weak anchoring of the artificial valve.

[0058] Referring back to FIG1 , the present invention can ensure that when the valve stent 100 is close to or slightly exceeds the designed diameter expansion size, the artificial valve leaflets 130 sutured on the wave rod 112 can still open and close normally. For example, the design diameter of the valve stent 100 is 26 mm, but the valve stent 100 of the present invention can actually work normally within the range of 24 mm to 28 mm, that is, the artificial valve leaflets 130 can open and close normally within this expansion diameter range. Therefore, when implanted into the human body, the surgeon can choose the size closest to the human body's native valve (for example, 24.5 mm) for balloon expansion, which will not cause aortic tearing and can ensure the anchoring effect of the artificial valve, thereby achieving a valve stent 100 of one design specification corresponding to multiple implantation specifications.

[0059] It should also be understood that the fixed edge 131 of the artificial valve leaflet 130 extends along the wave rods 112 in the quadrilateral grid 1111 from the outflow end to the inflow end of the valve stent 100, such as the suturing path shown in Figures 1 or 2. In this case, the suturing path of the fixed edge 131 of the artificial valve leaflet 130 coincides with the path of the wave rods 112 in the quadrilateral grid 1111, which not only provides sufficient suturing area for the stitches 300 to sew, increasing the suturing firmness of the artificial valve leaflet 200, but also facilitates the design of the valve suturing plan, reduces the suturing difficulty, and also increases the specifications of the artificial valve. Therefore, the diameter of the valve stent 100 of the present invention after expansion can be greater than, equal to, or less than the designed diameter.

[0060] The present invention does not impose any restrictions on the size and shape of the quadrilateral grid 1111. The quadrilateral grid 1111 described herein includes not only the grid units 111 used for suturing the skirt and / or artificial valve leaflets 130, but may also include the grid units 111 within the first annular wave ring 110 at the outflow end. Preferred embodiments of the quadrilateral grid 1111 are further described below. It should be noted that the following description is merely an enumeration and is not exhaustive of all implementations, and should not constitute an undue limitation on the present invention.

[0061] Referring to Figure 1, in one embodiment, the first annular wave coil 110 of the valve stent 100 from the outflow end to the inflow end is a bare stent segment, which is not covered by the skirt and the artificial valve leaflet 130. The grid units 111 in the bare stent segment are all hexagonal grids 1113. In view of the fact that the first annular wave coil 110 usually corresponds to the opening position of the coronary artery, the size of the grid units 111 in the first annular wave coil 110 should be as large as possible so as not to block the coronary artery. For example, in the embodiment described in Figure 1, the first annular wave coil 110 is a bare stent segment, which all adopts hexagonal grids 1113 and has a larger grid size. Alternatively, according to the embodiment described in Figure 2, the grid units 111 in the first annular wave coil 110 are all quadrilateral grids 1111.

[0062] As shown in FIG8 , in a preferred embodiment, the length L1 of the two adjacent wave rods 112 in the quadrilateral grid 1111 near the outflow end (i.e., the upper part) and in the circumferential direction is less than the length L2 of the two adjacent wave rods 112 away from the outflow end and in the circumferential direction, that is, L1 < L2. As a result, the quadrilateral grid 1111 presents a structural form that is short at the top and long at the bottom. At the same time, this structure makes the spacing between the wave rods 112 in the upper half near the outflow end larger. When applied to the aortic valve, the annular wave ring 110 of this structure is suitable for being set at the outflow end of the valve stent 100, which can ensure that there is sufficient intervention space for the coronary artery orifice. Referring to FIG2 , specifically in one embodiment, the first annular wave ring 110 adopts a quadrilateral grid 1111, and the length L1 of the two adjacent wave rods 112 in the quadrilateral grid 1111 near the outflow end and in the circumferential direction is less than the length L2 of the two adjacent wave rods away from the outflow end and in the circumferential direction.

[0063] Preferably, the grid units 111 in all the annular wave circles 110 except the first annular wave circle 110 are all quadrilateral grids 1111 .

[0064] As shown in Figure 9, in a preferred embodiment, the length L1 of two circumferentially adjacent wave struts 112 near the outflow end of the quadrilateral grid 1111 is greater than the length L2 of two circumferentially adjacent wave struts 112 away from the outflow end, i.e., L1>L2. This creates a structure with a longer top and shorter bottom, resulting in a smaller spacing between wave struts 112 in the upper half near the outflow end. For aortic valve applications, this annular wave ring 110 is particularly suitable for placement near the inflow end or native annulus of the valve stent 100 to provide sufficient support.

[0065] In a specific embodiment, the length L1 of two adjacent wave rods 112 in the circumferential direction close to the outflow end in the quadrilateral grids 1111 of all the remaining annular wave rings 110 except the first annular wave ring 110 is greater than the length L2 of two adjacent wave rods 112 in the circumferential direction away from the outflow end, so as to enhance the supporting performance of the valve stent 100.

[0066] As shown in FIG10 , in a preferred embodiment, the quadrilateral grid 1111 is a diamond grid. Continuing to refer to FIG10 , in order to make the stitches 300 slide more smoothly on the wave rods 112, preferably, two adjacent wave rods 112 in the axial direction of the quadrilateral grid 1111 are transitionally connected by a larger arc R, so that the transition between the wave rods 112 and the wave rods 112 is longer, so as to increase the movement of the stitches 300, thereby increasing the deformation freedom of the skirt and / or artificial valve leaflets 130. It should be understood that when the valve stent 100 is compressed and expanded by a balloon, the stitches 300 need to slide on the wave rods 112 to ensure that the skirt and / or artificial valve leaflets 130 can adapt to the size of the stent after compression and expansion.

[0067] Based on the valve stent 100 of an embodiment of the present invention, the present invention also provides an artificial valve, including an artificial valve leaflet 130, a skirt and a valve stent 100, wherein the fixed edge 131 of the skirt and / or the artificial valve leaflet 130 is sutured and fixed to the wave rods 112 in the quadrilateral grid 1111, and the fixed edge 131 of the artificial valve leaflet 130 is extended from the outflow end to the inflow end along the wave rods 112 in several quadrilateral grids 1111 and is sutured to the wave rods 112 in the quadrilateral grid 1111.

[0068] Since the artificial valve provided in this application and the valve stent 100 provided in this application belong to the same inventive concept, the artificial valve provided in this application has all the advantages of the valve stent 100 provided in this application, so the beneficial effects of the artificial valve provided in this application will not be described one by one here.

[0069] In summary, the valve stent 100 provided in the embodiment of the present invention uses the quadrilateral grid 1111 to sew the skirt and / or artificial valve leaflets 130, and thus, during the compression and expansion deformation process, the skirt and / or artificial valve leaflets 130 will not be overstretched or squeezed, so that the skirt and / or artificial valve leaflets 130 can be deformed more freely and not easily damaged or failed. At the same time, an artificial valve can adapt to the balloon expansion diameter within a certain range, so that it can be expanded into multiple different specifications, which can better match the patient's heart valve size. Because the suturing area is increased, the reliability of the suturing of the artificial valve leaflets 130 is better.

[0070] It should also be noted that, as discussed herein, a "patient" or "individual" can be a human or any animal. It should be understood that the animal can be any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pets. For example, the animal can be a laboratory animal specifically selected to possess certain characteristics similar to those of humans (e.g., rats, dogs, pigs, monkeys, etc.).

[0071] The above description is only a description of the preferred embodiment of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the technical solution of the present invention.

Claims

1. A valve stent having an inflow end and an outflow end opposite to each other, characterized in that: The valve stent is provided with a plurality of annular waves arranged in sequence along the axial direction from the outflow end to the inflow end, each of the annular waves includes a plurality of grid units arranged in sequence along the circumference of the valve stent, the grid units are of at least one type, one of which is a quadrilateral grid, and all of the grid units on the valve stent used for suturing the skirt and / or the fixed edges of the artificial valve leaflets are the quadrilateral grids.

2. The valve stent according to claim 1, characterized in that: An extension direction of a diagonal line of the quadrilateral grid is parallel to the axial direction of the valve support, and the quadrilateral grid is symmetrically arranged on both sides of the diagonal line.

3. The valve stent according to claim 2, characterized in that: The quadrilateral grid is a diamond grid.

4. The valve stent according to claim 2, characterized in that: In the quadrilateral grid, the length of two adjacent wave bars in the circumferential direction close to the outflow end is smaller than the length of two adjacent wave bars in the circumferential direction far from the outflow end.

5. The valve stent according to claim 2, characterized in that: In the quadrilateral grid, the length of two adjacent wave bars in the circumferential direction close to the outflow end is greater than the length of two adjacent wave bars in the circumferential direction far from the outflow end.

6. The valve stent according to claim 2, characterized in that: In the quadrilateral grid, two adjacent wave rods in the axial direction are connected by an arc transition.

7. The valve stent according to claim 1, characterized in that: The first annular wave ring of the valve stent from the outflow end to the inflow end is a bare stent segment, the grid unit is of one type, and all the grid units in the annular wave ring are quadrilateral grids.

8. The valve stent according to claim 7, characterized in that: In the quadrilateral grid in the first annular wave ring, the length of two adjacent wave rods close to the outflow end and in the circumferential direction is smaller than the length of two adjacent wave rods far from the outflow end and in the circumferential direction.

9. The valve stent according to claim 7, characterized in that: In the quadrilateral grids of all the annular wave circles except the first one, the length of two adjacent wave rods in the circumferential direction close to the outflow end is greater than the length of two adjacent wave rods in the circumferential direction away from the outflow end.

10. The valve stent according to claim 1, characterized in that: The first annular wave ring of the valve stent from the outflow end to the inflow end is a bare stent segment, and the grid units are of two types. The grid units in the first annular wave ring are all hexagonal grids, and the grid units in all the remaining annular wave rings except the first one are all quadrilateral grids.

11. The valve stent according to claim 10, characterized in that: The wave bars in the hexagonal grid include oblique wave bars and axial wave bars. The oblique wave bars are at an angle to the axial direction of the valve support, and the axial wave bars are parallel to the axial direction of the valve support. The oblique wave bars and axial wave bars of two adjacent hexagonal grids form two Y-shaped intersections.

12. An artificial valve, characterized in that: It comprises an artificial valve leaflet, a skirt and a valve support as described in any one of claims 1 to 11, wherein the fixed edges of the skirt and / or the artificial valve leaflet are sutured to the wave bars in the quadrilateral grid, and the fixed edges of the artificial valve leaflet are extended from the outflow end to the inflow end along multiple wave bars in the quadrilateral grid and sutured to the wave bars in the quadrilateral grid.

13. The artificial valve according to claim 12, characterized in that: The stitching points on the same grid unit are evenly distributed along the wave rod.

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