Valve stent and heart valve prosthesis prosthesis

Abstract

The utility model provides a valve stent and an artificial heart valve prosthesis, the artificial heart valve comprises the valve stent, the valve stent is provided with an inflow end and an outflow end which are opposite to each other, and the valve stent comprises a main stent and a plurality of clamping mechanisms which are arranged at intervals along the circumferential direction of the main stent and are connected with the outer circumferential surface of the main stent; the clamping mechanism comprises a first clamping body and a second clamping body which are arranged in the direction from the inflow end to the outflow end. The first clamping body and the second clamping body are used for clamping the native valve leaflet so that the heart valve prosthesis can be anchored in the heart, the anchoring of the heart valve prosthesis can be achieved without extruding the valve ring in the radial direction through the main support, and the situation that native tissue such as the valve ring is damaged due to radial extrusion is avoided.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical equipment, and in particular relates to a valve stent and an artificial heart valve prosthesis. Background Art

[0002] Interventional valve replacement is a minimally invasive valve replacement procedure. Its principle is to load the artificial heart valve prosthesis into the delivery system, and then use the catheter to deliver and release it to the valve in the heart that needs to be replaced, and use the artificial heart valve prosthesis to replace the original valve to improve the patient's heart function. Interventional valve replacement can treat heart valve disease without opening the chest and stopping the heart, avoiding the huge trauma caused to the patient by opening the chest and stopping the heart.

[0003] When replacing the native valve with an artificial heart valve prosthesis, the impact of the implanted artificial heart valve on the tissues surrounding the native valve should be minimized as much as possible. For example, when replacing the native tricuspid valve, the artificial heart valve should not cause damage to the Koch triangle area, the coronary sinus, and the native chordae tendineae attached to the tricuspid valve ring. In the prior art, after implantation, the artificial heart valve prosthesis is generally anchored by radially squeezing the valve ring with a stent, but this method is likely to have an adverse effect on the valve ring and other tissues. Utility Model Content

[0004] The utility model aims to provide a valve stent and an artificial heart valve prosthesis, aiming to reduce the damage of the artificial heart valve to the surrounding tissues of the native valve such as the valve ring by changing the anchoring mode of the artificial heart valve prosthesis.

[0005] To achieve the above-mentioned object, the utility model provides a valve stent having an inflow end and an outflow end opposite to each other; the valve stent comprises a main stent and a plurality of clamping mechanisms arranged at intervals along the circumference of the main stent and connected to the outer circumference of the main stent; the clamping mechanism comprises:

[0006] A first clamp and a second clamp are arranged in a direction from the inlet end to the outflow end; the first clamp includes a first part and a second part, the first part is connected to the main support and extends radially outward from the main support, and the second part is connected to an end of the first part away from the main support and extends in a direction close to the outflow end; the second clamp includes a third part and a fourth part, the third part is connected to the main support and extends radially outward from the main support, and the fourth part is connected to an end of the third part away from the main support and extends in a direction close to the inflow end; the fourth part at least partially overlaps with the second part in the axial direction of the main support, and in a natural state, the fourth part is located on a side of the second part close to the axis of the main support, and in a use state, the fourth part is located on a side of the second part away from the axis of the main support.

[0007] Optionally, in use, the ratio of the distance from the end of the second part away from the first part to the axis of the main bracket to the outer diameter of the main bracket is (1.5~2.5):1, and the ratio of the distance from the end of the fourth part away from the first part to the axis of the main bracket to the outer diameter of the main bracket is (1.5~2.5):1.

[0008] Optionally, the first clamp body includes at least one first rod, the first rod includes a first sub-rod and a second sub-rod; the first sub-rod is connected to the main support and extends radially outward from the main support, and the second sub-rod is connected to an end of the first sub-rod away from the main support and extends in a direction close to the outflow end;

[0009] When the first clamp includes multiple first rods, the first sub-rods of the multiple first rods are arranged at intervals along the circumference of the main bracket and together constitute the first part; the second sub-rods of the multiple first rods are connected to each other at the ends away from the first sub-rods and together constitute the second part.

[0010] Optionally, the second clamping body includes a plurality of second rods, each of the second rods includes a third sub-rod and a fourth sub-rod, the third sub-rod is connected to the main support and extends radially outwardly of the main support, and the fourth sub-rod is connected to an end of the third sub-rod away from the main support and extends in a direction close to the inflow end;

[0011] The third sub-rods of multiple second rods are arranged at intervals along the circumference of the main bracket and together constitute the third part, the ends of the fourth sub-rods of multiple second rods away from the third sub-rods are connected to each other, and the fourth sub-rods of multiple second rods together constitute the fourth part.

[0012] Optionally, the number of the clamping mechanisms is 2 to 6.

[0013] Optionally, the bracket also includes a skirt bracket, which is connected to the outer circumferential surface of the main bracket and includes a support portion, the support portion is located on a side of the clamping mechanism close to the inflow end, and there is a gap between the support portion and the first part of the first clamp body.

[0014] Optionally, the ratio of the maximum distance from the skirt bracket to the axis of the main bracket to the radius of the main bracket is (2.2-2.8):1.

[0015] Optionally, the support portion includes a plurality of support rods arranged at intervals along the circumference of the main support; the support rods include a fifth sub-rod and a sixth sub-rod, the fifth sub-rod is connected to the main support and extends radially outward along the main support; the sixth sub-rod is an arc-shaped structure, and the sixth sub-rod is connected to one end of the fifth sub-rod away from the main support, and extends in a direction close to the inflow end.

[0016] Optionally, the sixth sub-rod is at least partially formed into a wave-shaped structure.

[0017] Optionally, the fifth sub-rod is at least partially formed into a wavy structure, and the sixth sub-rod is at least partially formed into a wavy structure.

[0018] Optionally, the skirt bracket also includes a first joint portion, which is an annular structure and includes a plurality of first joint rods connected end to end in sequence, and two adjacent first joint rods are connected to form a second V-shaped structure with an opening toward the inflow end; a support rod is arranged at the junction of two adjacent second V-shaped structures; the first joint portion is sleeved on the outer peripheral surface of the main bracket, and the junction of two adjacent second V-shaped structures is connected to the main bracket.

[0019] Optionally, the skirt bracket also includes a second joining portion, which is an annular structure and includes a plurality of second joining rods connected end to end in sequence, and two adjacent second joining rods are connected to form a third V-shaped structure with an opening toward the axis of the main bracket; the junction of two adjacent third V-shaped structures is connected to one of the support rods.

[0020] Optionally, the outer diameter of the main support is less than or equal to 30 mm.

[0021] To achieve the above-mentioned purpose, the utility model also provides a heart valve prosthesis, including an artificial valve leaflet and a valve stent as described above, wherein the artificial valve leaflet is arranged on the inner side of the main stent and connected to the main stent.

[0022] Optionally, at least one first mesh layer and one second mesh layer are formed on the main stent; the first mesh layer includes a plurality of first meshes, and the plurality of first meshes of the same first mesh layer are arranged in sequence along the circumference of the main stent; the second mesh layer is closer to the outflow end than the first mesh layer, and the plurality of second meshes of the second mesh layer are arranged in sequence along the circumference of the main stent; in the axial direction of the main stent, the size of the second mesh is larger than the size of the first mesh; the artificial valve leaflet is arranged at the second mesh layer.

[0023] Compared with the prior art, the valve stent and artificial heart valve prosthesis of the utility model have the following advantages:

[0024] The aforementioned valve stent has a relative inflow end and outflow end; the valve stent includes a main stent and a plurality of clamping mechanisms arranged at intervals along the circumference of the main stent and connected to the outer circumferential surface of the main stent; the clamping mechanism includes a first clamp and a second clamp arranged in the direction from the inflow end to the outflow end; the first clamp includes a first part and a second part, the first part is connected to the main stent and extends radially outward from the main stent, the second part is connected to an end of the first part away from the main stent and extends in a direction close to the outflow end; the second clamp includes a third part and a fourth part, the third part is connected to the main stent, the fourth part is connected to an end of the third part away from the main stent and extends in a direction close to the inflow end; the fourth part at least partially overlaps with the second part in the axial direction of the main stent, and in a natural state, the fourth part is located on a side of the second part close to the axis of the main stent, and in a use state, the fourth part is located on a side of the second part away from the axis of the main stent. The valve stent is used in an artificial heart valve prosthesis. When the artificial heart valve prosthesis is used to replace the native valve, the artificial heart valve is anchored by clamping the native valve leaflets using a clamping mechanism. In this way, the diameter of the main stent can be designed to be smaller than the diameter of the valve ring of the native valve, so that the main stent will not squeeze the valve ring in the radial direction, and will not cause damage to the valve ring. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation on the present invention.

[0026] Figure 1 It is a structural schematic diagram of a valve stent provided by the utility model according to one embodiment;

[0027] Figure 2 1 is a schematic structural diagram of a valve stent provided by the utility model according to an embodiment. Figure 2 and Figure 1The observation direction is different;

[0028] Figure 3 It is a partial schematic diagram of a clamping mechanism of a valve stent provided by the utility model according to one embodiment;

[0029] Figure 4 This is a schematic diagram of a usage scenario of an artificial heart valve prosthesis provided by the utility model according to an embodiment;

[0030] Figure 5 It is a structural schematic diagram of a main stent of a valve stent provided by the utility model according to one embodiment;

[0031] Figure 6 1 is a schematic structural diagram of a support rod of a skirt support of a valve support provided by the utility model according to an embodiment, in which a sixth sub-rod is partially formed into a wave shape;

[0032] Figure 7 1 is a schematic structural diagram of a support rod of a skirt support of a valve support provided by the utility model according to an embodiment, wherein the fifth sub-rod is partially wavy and the sixth sub-rod is also partially wavy;

[0033] Figure 8 is a top view of a valve stent provided by the utility model according to an embodiment, and the skirt stent shown in the figure does not include the second joint portion;

[0034] Fig. 9 1 is a top view of a valve stent provided by the utility model according to an embodiment, wherein the skirt stent shown in the figure comprises a second joint portion, and the end of the support rod away from the main stent is connected to the second joint portion;

[0035] Fig.10 1 is a top view of a valve stent provided by the utility model according to an embodiment, wherein the skirt stent shown in the figure comprises a second joint portion, and the middle portion of the support rod in the figure is connected to the second joint portion;

[0036] Fig.11 The present invention is a simplified schematic diagram of an artificial heart valve prosthesis provided according to one embodiment when it is released, wherein a) is a schematic diagram when the second clamp is released, b) is a schematic diagram when the first clamp is released, and c) is a schematic diagram when the artificial heart valve prosthesis is released as a whole.

[0037] [Description of reference numerals is as follows]:

[0038] 1-artificial heart valve prosthesis, 10-valve stent, 11-inflow end, 12-outflow end, 100-main stent, 110-first mesh layer, 120-second mesh layer, 101-first mesh, 102-second mesh, 103-first stent rod, 104-second stent rod, 200-clamping mechanism, 210-first clamping body, 211-first part, 212-second part, 213-first sub-rod, 214-second Sub-rod, 220-second clamp, 221-third part, 222-fourth part, 223-third sub-rod, 224-fourth sub-rod, 300-skirt bracket, 310-support part, 311-fifth sub-rod, 312-sixth sub-rod, 320-first joint part, 321-first joint rod, 330-second joint part, 331-second joint rod, 21-artificial valve leaflet, 31-native valve leaflet, 32-valve ring, 2-sheath. DETAILED DESCRIPTION

[0039] The following describes the implementation of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific implementations, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, so the diagram only shows the components related to the present invention rather than drawing according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0040] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise of being possible to implement, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0041] As used in this specification, the singular forms "one", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, 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 or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between two elements or an interactive relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention 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 therefore cannot be understood as a limitation on the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0042] One of the purposes of the utility model is to provide a valve stent and an artificial heart valve prosthesis, wherein the artificial heart valve prosthesis comprises the valve stent. When the artificial heart valve prosthesis is implanted in the heart to replace the native valve leaflets, the artificial heart valve prosthesis can ensure that the artificial heart valve prosthesis is stably anchored and the artificial heart valve prosthesis does not radially squeeze the valve ring of the native valve leaflets, thereby reducing damage to the valve ring and other native structures caused by squeezing.

[0043] In order to make the purpose, advantages and features of the utility model clearer, the utility model is further described in detail below in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model. The same or similar reference numerals in the drawings represent the same or similar components.

[0044] Figure 1 and Figure 2 The structure diagram of the valve stent 10 provided by the embodiment of the utility model is shown. Figure 1 and Figure 2 The valve stent 10 has an opposite inflow end 11 and an outflow end 12, and includes a main stent 100 and a plurality of clamping mechanisms 200. The plurality of clamping mechanisms 200 are arranged at intervals along the circumference of the main stent 100, and each of the clamping mechanisms 200 is connected to the outer circumference of the main stent 100.

[0045] The valve stent 10 is used to prepare an artificial heart valve prosthesis 1 (such as Figure 4 As shown in FIG. 1 ), the artificial heart valve prosthesis further includes an artificial valve leaflet 21, and the artificial valve leaflet 21 is arranged on the inner side of the main stent 100. When the artificial heart valve prosthesis 1 is implanted in the human body to replace the native valve leaflet 31 (as shown in FIG. Figure 4 When the artificial heart valve prosthesis 1 is anchored, the clamping mechanism 200 is used to clamp the native valve leaflet 31. That is, compared with the prior art, the artificial heart valve prosthesis 1 provided in the embodiment of the utility model does not clamp the valve ring 32 (such as the valve ring 32 of the native valve leaflet 31) of the main stent 100. Figure 4 and Fig.11 c) to achieve anchoring of the artificial heart valve prosthesis. In this way, the outer diameter of the main stent 100 can be smaller than the diameter of the valve ring. For example, when the artificial heart valve prosthesis 1 is used to replace the native leaflet 31 of the tricuspid valve, the outer diameter of the main stent 100 can be smaller than the diameter of the tricuspid valve ring. In this way, when the artificial heart valve prosthesis 1 is implanted in the heart, the artificial heart valve prosthesis 1 will not squeeze the valve ring 32 in the radial direction, thus avoiding the situation where the valve ring 32 and the native tissue near it are damaged due to radial squeezing from the artificial heart valve prosthesis 1.

[0046] It should be understood that the number of the clamping mechanisms 200 is not less than the number of native leaflets 31, that is, the number of the clamping mechanisms 200 is more than two. In practice, the number of the clamping mechanisms 200 may be the same as the number of the native leaflets 31, so that each clamping mechanism 200 clamps one native leaflet. For example, for the tricuspid valve, in some cases, the tricuspid valve includes two native leaflets 31 due to developmental malformation, and therefore, the valve support 100 may include two clamping mechanisms 200, each clamping mechanism 200 clamps one native leaflet 31. In some cases, the tricuspid valve includes three native leaflets 31, namely the anterior leaflet, the posterior leaflet, and the septal leaflet, then the valve support 100 may include three clamping mechanisms 200, one clamping mechanism 200 clamps the anterior leaflet, one clamping mechanism 200 clamps the posterior leaflet, and one clamping mechanism 200 clamps the septal leaflet. In some cases, at least one of the native leaflets 31 in the tricuspid valve has a crack, causing it to be divided into two. In this case, it can be considered that the tricuspid valve includes more than four native leaflets 31. In this case, the valve stent 10 also correspondingly includes more than four clamping mechanisms 200.

[0047] Of course, the number of the clamping mechanisms 200 may be greater than the number of native leaflets 31, so that at least one native leaflet 31 corresponds to more than two clamping mechanisms 200. For example, in the case where the tricuspid valve includes three native leaflets 31, the valve stent 10 may include six clamping mechanisms 200, and every two clamping mechanisms 200 are arranged corresponding to one native leaflet 31. Then, during implantation, if all the clamping mechanisms 200 are clamped on the corresponding native leaflets 31, the clamping stability can be further improved, but if some of the clamping mechanisms 200 fail to clamp the native leaflets 31, for example, among the two clamping mechanisms 200 corresponding to the anterior leaflet, only one of the clamping mechanisms 200 successfully clamps the anterior leaflet, while the other clamping mechanism 200 fails to clamp the anterior leaflet, it can also ensure that the artificial heart valve prosthesis is stably anchored, that is, when the number of the clamping mechanisms 200 is greater than the number of the native leaflets 31, it is allowed that some of the clamping mechanisms 200 fail to successfully clamp the native leaflets 200. In other words, the artificial heart valve prosthesis 1 has a certain error tolerance when being released, which can reduce the difficulty of release.

[0048] It can also be understood that when the artificial heart valve prosthesis is implanted in the heart to replace the native leaflets, such as the native tricuspid valve leaflets, the artificial leaflets 21 are opened to allow blood to flow from the right atrium and the inflow end 11 to the outflow end 12 and enter the right ventricle, and when the artificial leaflets 21 are closed, the artificial heart valve prosthesis prevents blood from flowing back from the right ventricle to the right atrium. Of course, the artificial heart valve prosthesis can also be used to replace the native mitral valve leaflets. In this case, when the artificial leaflets 21 are opened, blood is allowed to flow from the left atrium and the inflow end 11 to the outflow end 12 and enter the left ventricle, and when the artificial leaflets 21 are closed, the artificial heart valve prosthesis prevents blood from flowing back from the left ventricle to the left atrium.

[0049] Next, the artificial heart valve prosthesis 1 is described in detail. It should be noted that the following only describes a preferred structure of the artificial heart valve prosthesis 1, which is not the only structure and should not constitute an improper limitation to the present invention.

[0050] Please refer to Figure 5 , the main stent 100 may have a uniform outer diameter in its axial direction. Or the outer diameter of the main stent 100 changes uniformly from one end to the other end, for example, the outer diameter of the main stent 100 gradually increases or decreases from the inflow end 11 to the outflow end 12. Alternatively, the outer diameter of the main stent 100 first increases and then decreases from the inflow section 11 to the outflow end 12 to form an hourglass shape. In addition, the valve ring 32 of the tricuspid valve is generally about 30 mm. Therefore, when the artificial heart valve body is used to replace the native tricuspid valve leaflet, the outer diameter of the main stent 100 may be less than or equal to 30 mm.

[0051] The main stent 100 can be formed by weaving wire or cutting pipe. Regardless of the forming method, a plurality of meshes are formed on the main stent 100, and the plurality of meshes are divided into a plurality of mesh layers arranged along the axial direction of the main stent 100, and two axially adjacent mesh layers partially overlap. It should be understood that each mesh layer includes a plurality of meshes 101, and all the meshes 101 of the same mesh layer are arranged in sequence along the circumference of the main stent 100.

[0052] In some embodiments, all meshes of the main stent 100 have the same size in the axial direction of the main stent 100. In other embodiments, the mesh layer is divided into a first mesh layer 110 and a second mesh layer 120, the number of the first mesh layer 110 is at least one, and the number of the second mesh layer 120 is one. For ease of description, the meshes belonging to the first mesh layer 110 are referred to as first meshes 101, and the meshes belonging to the second mesh layer 110 are referred to as second meshes 102 herein.

[0053] When there are multiple first mesh layers 110, multiple first mesh layers 110 are arranged in sequence along the axial direction of the main stent 100. All the second meshes 102 of the second mesh layer 120 are arranged along the circumferential direction of the main stent 100, and the second mesh layer 120 is closer to the outflow end 12 than all the first mesh layers 110. That is, the first mesh layer 110 and the second mesh layer 120 are arranged in the direction from the inflow end 11 to the outflow end 12. Moreover, in the axial direction of the main stent 100, the size of the second mesh 102 is larger than the size of the first mesh 101. The artificial valve leaflet 21 is arranged at the second mesh layer 120. The advantage of doing this is that the area of ​​the second mesh 102 is relatively large. When the artificial heart valve prosthesis 1 is squeezed, the artificial valve leaflet 21 is located at the second mesh 102, so that the contact area between the artificial valve leaflet 21 and the main stent 100 is smaller, thereby reducing the damage to the artificial valve leaflet 21 caused by the squeezing of the main stent 100.

[0054] In detail, the main support 100 includes a plurality of first support rods 103 and a plurality of second support rods 104. The first mesh 101 may be a rhombus, which is formed by four first support rods 103 connected end to end in sequence, and each of the first support rods 103 that enclose the first mesh 101 is inclined relative to the axis S of the main support 100. The second mesh 102 may be a hexagon, which is formed by four first support rods 103 and two second support rods 104. Among them, every two first support rods 103 are connected to form a first V-shaped structure, and the two first V-shaped structures are arranged at intervals along the axial direction of the main support 100, and the openings of the two first V-shaped structures are arranged oppositely, so that the first support rods 103 that enclose the second mesh 102 are inclined relative to the axis S of the main support 100. The two second support rods 104 extend along the axis S of the main support 100, and the two second support rods 104 are arranged opposite to each other, and the opposite ends of each second support rod 104 are connected to the two first V-shaped structures. It should be understood that the two first support rods 103 close to the first mesh layer 110 in the second mesh 102 also participate in the formation of the first mesh 101. In the artificial heart valve prosthesis 1, the artificial valve leaf 21 can be connected to the second support rod 104 by suturing. This form of the valve support 10, on the basis of facilitating the setting of the artificial valve leaf 21, also has good radial stiffness and will not be squeezed and deformed due to the rhythmic contraction of the heart.

[0055] In addition, those skilled in the art know that the artificial heart valve prosthesis is pressed and gripped in a delivery system and delivered to the heart through the delivery system. When the axial length of the main stent 100 is too large, it is not conducive to the bending control operation of the delivery system. Therefore, the axial length of the main stent 100 should be as small as possible while meeting the connection requirements of the artificial valve leaflet. Generally, the number of the first mesh layer 110 is 1 to 3.

[0056] Figure 3 A partial schematic diagram of the clamping mechanism 200 is shown. Figure 3 Combined with Figure 1 and Figure 2 , the clamping mechanism 200 includes a first clamping body 210 and a second clamping body 220 arranged in the direction from the inflow end 11 to the outflow end 12. The first clamping body 210 includes a first portion 211 and a second portion 212, wherein the first portion 211 is connected to the main support 100 and extends radially outwardly of the main support 100. The second portion 212 is connected to an end of the first portion 211 away from the main support 100 and extends in a direction close to the outflow end 12. Preferably, the second portion 212 is connected to the first portion 211 in a smooth transition. Similarly, the second clamping body 220 includes a third portion 221 and a fourth portion 222, wherein the third portion 221 is connected to the main support 100 and extends radially outwardly of the main support 100. The fourth portion 222 is connected to an end of the third portion 221 away from the main support 100, and the other end extends in a direction toward the inflow end 11. The fourth portion 222 is connected to the third portion 221 in a smooth transition.

[0057] That is, the first clamp body 210 is a bending structure that first extends outward along the radial direction of the main stent 100 and then bends toward the outflow end 12, and the second clamp body 220 is a bending structure that first extends outward along the radial direction of the main stent 100 and then bends toward the inflow end 11. Further, the fourth portion 222 and the second portion 212 at least partially overlap in the axial direction of the main stent 100, and in a natural state, the fourth portion 222 is located on a side of the second portion 212 close to the axis S of the main stent 100. When the artificial heart valve prosthesis 1 is released and switched to a use state, the fourth portion 222 is switched to a side of the second portion 212 away from the axis S of the main stent 100 by controlling the release sequence of the first clamp body 210 and the second clamp body 220, so that there is a clamping force between the fourth portion 222 and the second portion 212, and the native leaflet 31 can be stably clamped. The release sequence of the first prosthesis 210 and the second prosthesis 220 will be described in detail later. The natural state refers to the state when the first clamp 210 and the second clamp 220 are not subjected to external force.

[0058] It should be noted that the first portion 211 extends outwardly along the radial direction of the main stent 100, which means that the first portion 211 extends outwardly along the radial direction of the main stent 100, and the first portion 211 may be substantially parallel to the radial direction of the main stent 100. The same is true for the third portion 221 extending outwardly along the radial direction of the main stent 100, that is, the third portion 221 may be substantially parallel to the radial direction of the main stent 100.

[0059] The angle between the fourth portion 222 and the third portion 221 (eg Figure 3 The angle α) shown can be greater than 90°, so that when the second clamp 220 is released, a larger area of ​​the native leaflet can be held, which is convenient for the first clamp 210 to cooperate with the second clamp 220. However, after the first clamp 210 clamps the native leaflet, the native leaflet is prone to slipping. Alternatively, the angle between the fourth part 222 and the third part 221 can also be less than 90°. In this way, although it is slightly difficult to make the first clamp 210 and the second clamp 220 cooperate, as long as the first clamp 210 and the second clamp 220 clamp the native leaflet, the native leaflet is not easy to slip, so that the clamping mechanism 200 has better clamping reliability.

[0060] Preferably, the first clamp 210 and the second clamp 220 both have a certain width, where the width refers to the size of the corresponding clamp in the circumferential direction of the main stent 100. This arrangement has the advantage of making it easier for the clamping mechanism 200 to capture and clamp the native leaflet 31.

[0061] Optionally, refer to Figure 1 and Figure 2 The first clamp body 210 includes at least one first rod (not marked in the figure), and each of the first rods includes a first sub-rod 213 and a second sub-rod 214. The first sub-rod 213 is connected to the main stent 100 and extends outwardly in the radial direction of the main stent 100. The second sub-rod 214 is connected to an end of the first sub-rod 213 away from the main stent 100 and extends in a direction close to the outflow end 12. That is, the first rod body is a bent rod that first extends outwardly in the radial direction of the main stent 100 and then bends toward the outflow end 12.

[0062] In some cases, the first clamp body 210 includes one first rod, and in this case, the rigidity of the first rod is preferably less than that of the second clamp body 220, so that the first rod can be in contact with the leaflet line to increase the clamping force. In other cases, the first clamp body 210 includes more than two first rods, and in the same clamping mechanism 200, the first sub-rods 213 of the plurality of first rods are arranged at intervals along the circumference of the main stent 100, and together constitute the first part 211; the second sub-rods 214 of the plurality of first rods are connected to each other at the ends away from the first sub-rod 213, and together constitute the second part 212.

[0063] The second clamping body 220 includes a plurality of second rods (not marked in the figure), each of which includes a third sub-rod 223 and a fourth sub-rod 224. The third sub-rod 223 is connected to the main support 100 and extends radially outward from the main support 100. The fourth sub-rod 224 is connected to an end of the third sub-rod 223 away from the main support 100 and extends in a direction close to the inflow end 11. That is, the second rod body is a bent rod that first extends radially outward from the main support 100 and then bends toward the inflow end 11. In the same clamping mechanism 200, the third sub-rods 223 of the plurality of second rods are arranged at intervals along the circumference of the main support 100 and together constitute the third portion 221; the fourth sub-rods 224 of the plurality of second rods are connected to each other at the ends away from the third sub-rod 223 and together constitute the fourth portion.

[0064] In addition, in the use state, the ratio of the distance from the end of the second part away from the first part to the axis of the main stent to the outer diameter of the main stent is (1.5-2.5):1, and the ratio of the distance from the end of the fourth part away from the first part to the axis of the main stent to the outer diameter of the main stent is (1.5-2.5):1. The advantage of setting this ratio is that the ventricle will not be damaged due to the excessive size of the second clamp 220 in the radial direction of the main stent 100, and the expected anchoring effect will not be achieved due to the small size of the second clamp 220 on the main stent 100. At the same time, the sizes of the first clamp 210 and the second clamp 220 on the main stent 100 are similar, and the clamping failure will not be caused by the excessive size difference between the two.

[0065] Furthermore, the valve support 10 may also include a skirt support 300. The skirt support 300 is connected to the outer peripheral surface of the main support 100 and includes a support portion 310. The support portion 310 is located on the side of the clamping mechanism 200 close to the inflow end 11. Correspondingly, the artificial heart valve prosthesis 1 also includes a skirt (not shown in the figure), which is attached to the support portion 310 of the skirt support 300. When implanted in the heart, the support portion 310 is used to abut against the top of the valve ring 32, and paravalvular leakage can be prevented under the action of the support portion 310 and the skirt. In addition, the skirt support 300 can also perform one-way limiting on the artificial heart valve prosthesis 1 to optimize the positioning effect of the artificial heart valve prosthesis 1. The ratio of the maximum distance from the skirt stent to the axis of the main stent to the radius of the main stent is (2.2-2.8):1, so that the skirt stent 300 has a suitable size in the radial direction of the main stent 100, which can effectively block regurgitation and paravalvular leakage without causing damage to atrial tissue due to excessive size.

[0066] Furthermore, there is a gap between the support portion 310 and the first portion 211 of the first clamp body 210 , and the gap is used to accommodate the valve ring 323 to prevent the clamping mechanism 200 and the skirt support 300 from squeezing the valve ring 32 and causing damage to the valve ring 32 .

[0067] The skirt support 300 may have any suitable configuration. Figure 1 and Figure 2The support portion 310 includes a plurality of support rods (not marked in the figure), for example, 12 to 18. The plurality of support rods are arranged at intervals along the circumference of the main stent 100, and each of the support rods includes a fifth sub-rod 311 and a sixth sub-rod 312. The fifth sub-rod 311 is connected to the main stent 100, and extends radially outwardly along the main stent 100. The sixth sub-rod 312 is an arc-shaped structure, and the sixth sub-rod 312 is connected to an end of the fifth sub-rod 311 away from the main stent 100, and extends in a direction close to the inflow end 11. In use, the sixth sub-rod 312 abuts against the top of the valve ring 32.

[0068] Preferably, please refer to Figure 6 The sixth sub-rod 312 is at least partially formed into a wave-shaped structure. In this way, the rigidity of the sixth sub-rod 312 can be reduced, the pressure on the native tissue above the valve ring 32 can be reduced, and the damage to the native tissue can be reduced. Figure 7 As shown, the fifth sub-rod 311 may also be at least partially formed into a wave-shaped structure.

[0069] The support rod can be connected to the main support 100 in any suitable manner. Figure 1 , the skirt bracket 300 also includes a first joint portion 320. The first joint portion 320 includes a plurality of first joint rods 321, and the plurality of first joint rods 321 are connected end to end in sequence so that the first joint portion presents an annular structure, and two adjacent first joint rods 321 form a second V-shaped structure, and the opening of the second V-shaped structure faces the inflow end 11. The plurality of support rods are arranged at intervals along the circumference of the first joint portion, and each support rod is connected to the junction of two adjacent second V-shaped structures. When assembled with the main bracket 100, the first joint portion 320 is sleeved on the outer peripheral surface of the main bracket 100, and then the first joint portion 320 is connected to the main bracket 100 by any suitable method such as suturing and welding. In this way, the support rod is indirectly connected to the main bracket 100 through the first joint portion 320. By providing the first joint portion 320, on the one hand, the connection between the skirt support 300 and the main support 100 can be simplified, and on the other hand, the rigidity of the main support 100 can be further enhanced to prevent it from being squeezed and deformed during heart contraction.

[0070] In some implementations, such as Figure 1 , Figure 2 and Figure 8 As shown, the ends of the plurality of support rods away from the main support 100 are not connected to each other. In other implementations, such as Fig. 9As shown, the skirt support 300 also includes a second joint portion 330, and the second joint portion 330 includes a plurality of second joint rods 331, and the plurality of second joint rods 331 are connected end to end in sequence, so that the second joint portion 330 presents a ring structure. Two adjacent second joint rods 331 are connected to form a third V-shaped structure, and the opening of the third V-shaped structure faces the axis of the main support 100. The end of each support rod away from one end of the main support 100 is connected to the junction of two adjacent third V-shaped structures. By setting the second joint portion 330, the stability of the artificial heart valve prosthesis when being pressed and gripped in the delivery system can be improved, and it is not easy to become unstable. In an alternative embodiment, the middle part of each support rod, such as the midpoint position, is connected to the junction of two adjacent third V-shaped structures. Next, the implantation process of the artificial heart valve prosthesis 1 is introduced.

[0071] Please refer to Fig.11 Combined with Figure 4 The artificial heart valve prosthesis 1 is pressed and gripped in a sheath tube 2 of a delivery system. After the artificial heart valve prosthesis 1 is delivered to a predetermined position in the heart, such as the native tricuspid valve, by using the delivery system, the second clamp 220 (such as Fig.11 As shown in a) in the figure), the second prosthesis 220 is made to hold the native valve leaflet 31. Then the first clamp 210 is released, and the second portion 212 of the first clamp 210 is located inside the fourth portion 222 of the second clamp 220 (as shown in a). Fig.11 b), and clamp the native leaflet 31 together with the fourth portion 222. Finally, release the skirt support 300 so that the support portion 310 of the skirt support 300 abuts against the upper side of the valve ring 32 (as shown in FIG. Fig.11 Finally, the conveying system is withdrawn.

[0072] Although the utility model is disclosed as above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the utility model without departing from the spirit and scope of the utility model. Thus, if these modifications and variations of the utility model fall within the scope of the claims of the utility model and their equivalents, the utility model is also intended to include these modifications and variations.

Claims

1. A valve stent having an inflow end and an outflow end opposite to each other; characterized in that: The valve stent comprises a main stent and a plurality of clamping mechanisms arranged at intervals along the circumference of the main stent and connected to the outer circumference of the main stent; the clamping mechanisms comprise: A first clamp and a second clamp are arranged in a direction from the inlet end to the outflow end; the first clamp includes a first part and a second part, the first part is connected to the main support and extends radially outward from the main support, and the second part is connected to an end of the first part away from the main support and extends in a direction close to the outflow end; the second clamp includes a third part and a fourth part, the third part is connected to the main support and extends radially outward from the main support, and the fourth part is connected to an end of the third part away from the main support and extends in a direction close to the inflow end; the fourth part at least partially overlaps with the second part in the axial direction of the main support, and in a natural state, the fourth part is located on a side of the second part close to the axis of the main support, and in a use state, the fourth part is located on a side of the second part away from the axis of the main support.

2. The valve stent according to claim 1, characterized in that: When in use, the ratio of the distance from the end of the second part away from the first part to the axis of the main bracket to the outer diameter of the main bracket is (1.5~2.5):1, and the ratio of the distance from the end of the fourth part away from the first part to the axis of the main bracket to the outer diameter of the main bracket is (1.5~2.5):

1.

3. The valve stent according to claim 1, characterized in that: The first clamp body includes at least one first rod, and the first rod includes a first sub-rod and a second sub-rod; the first sub-rod is connected to the main support and extends outwardly in the radial direction of the main support, and the second sub-rod is connected to an end of the first sub-rod away from the main support and extends in a direction close to the outflow end; When the first clamp includes multiple first rods, the first sub-rods of the multiple first rods are arranged at intervals along the circumference of the main bracket and together constitute the first part; the second sub-rods of the multiple first rods are connected to each other at the ends away from the first sub-rods and together constitute the second part.

4. The valve stent according to claim 1, characterized in that: The second clamp body includes a plurality of second rods, each of the second rods includes a third sub-rod and a fourth sub-rod, the third sub-rod is connected to the main support and extends radially outwardly of the main support, and the fourth sub-rod is connected to an end of the third sub-rod away from the main support and extends in a direction close to the inflow end; The third sub-rods of multiple second rods are arranged at intervals along the circumference of the main bracket and together constitute the third part, the ends of the fourth sub-rods of multiple second rods away from the third sub-rods are connected to each other, and the fourth sub-rods of multiple second rods together constitute the fourth part.

5. The valve stent according to claim 1, characterized in that: The number of the clamping mechanisms is 2 to 6.

6. The valve stent according to claim 1, characterized in that: The bracket also includes a skirt bracket, which is connected to the outer peripheral surface of the main bracket and includes a support portion, which is located on a side of the clamping mechanism close to the inflow end, and there is a gap between the support portion and the first part of the first clamp body.

7. The valve stent according to claim 6, characterized in that: The ratio of the maximum distance between the skirt bracket and the axis of the main bracket to the radius of the main bracket is (2.2-2.8):

1.

8. The valve stent according to claim 6, characterized in that: The support portion includes a plurality of support rods arranged at intervals along the circumference of the main support; the support rods include a fifth sub-rod and a sixth sub-rod, the fifth sub-rod is connected to the main support and extends radially outward from the main support; the sixth sub-rod is an arc-shaped structure, and the sixth sub-rod is connected to an end of the fifth sub-rod away from the main support, and extends in a direction close to the inflow end.

9. The valve stent according to claim 8, characterized in that: The sixth sub-rod is at least partially formed into a wave-shaped structure.

10. The valve stent according to claim 8, characterized in that: The fifth sub-rod is at least partially formed into a wave-shaped structure, and the sixth sub-rod is at least partially formed into a wave-shaped structure.

11. The valve stent according to claim 8, characterized in that: The skirt bracket also includes a first joint portion, which is an annular structure and includes multiple first joint rods connected end to end in sequence, and two adjacent first joint rods are connected to form a second V-shaped structure with an opening facing the inflow end; a support rod is arranged at the junction of two adjacent second V-shaped structures; the first joint portion is sleeved on the outer peripheral surface of the main bracket, and the junction of two adjacent second V-shaped structures is connected to the main bracket.

12. The valve stent according to claim 8, characterized in that: The skirt bracket also includes a second joining portion, which is an annular structure and includes a plurality of second joining rods connected end to end in sequence, and two adjacent second joining rods are connected to form a third V-shaped structure with an opening toward the axis of the main bracket; the junction of two adjacent third V-shaped structures is connected to one of the support rods.

13. The valve stent according to claim 1, characterized in that: The outer diameter of the main support is less than or equal to 30 mm.

14. A heart valve prosthesis, characterized in that: The valve stent comprises an artificial valve leaflet as described in claim 1, wherein the artificial valve leaflet is arranged on the inner side of the main stent and connected to the main stent.

15. The heart valve prosthesis according to claim 14, characterized in that: At least one first mesh layer and one second mesh layer are formed on the main stent; the first mesh layer includes a plurality of first meshes, and the plurality of first meshes of the same first mesh layer are arranged in sequence along the circumference of the main stent; the second mesh layer is closer to the outflow end than the first mesh layer, and the plurality of second meshes of the second mesh layer are arranged in sequence along the circumference of the main stent; in the axial direction of the main stent, the size of the second mesh is larger than the size of the first mesh; the artificial valve leaflet is arranged at the second mesh layer.

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