valve prosthesis

Abstract

This invention provides a valve prosthesis, comprising: a valve stent, leaflets, and a leaflet connector; the valve stent has a support rod; the leaflet connector includes a folded portion and a connecting portion, the folded portion being used to fold and accommodate the support rod; the connecting portion extends from both ends of the folded portion, and the connecting portion connects to the leaflet, such that the leaflet is connected to the support rod through the leaflet connector. This design improves the leaflet closure and the connection stability between the leaflet and the valve stent, thereby enhancing the overall stability of the valve prosthesis under complex operating conditions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve prosthesis. Background Technology

[0002] With increasing life expectancy and an aging population, the incidence of valvular heart disease is rising. According to statistics, 2% to 7% of people over 65 years of age have valvular disease. In Europe and America, valvular disease ranks third after coronary heart disease and hypertension. An artificial heart valve (Heart Valve Prothesis) is an implantable organ that replaces the natural heart valves (including the aortic valve, pulmonary valve, tricuspid valve, and mitral valve), allowing blood to flow in one direction and functioning like a natural heart valve. When heart valve disease is severe and valve function cannot be restored or improved by valve separation or repair surgery, artificial heart valve replacement surgery is necessary.

[0003] Interventional heart valve replacement surgery is a minimally invasive procedure that uses a delivery system to place a prosthetic valve at the lesion site. Due to the complexity of the native valve structure, designing an artificial valve is very challenging. Artificial valves can be, for example, aortic, pulmonary, tricuspid, or mitral valves. Taking the mitral valve as an example, its characteristics are: 1. The mitral valve annulus has a large area, making leaflet closure difficult: The prosthetic valve requires a certain contact area after leaflet closure. Sufficient leaflet contact area is necessary to effectively prevent blood backflow and large transvalvular pressure gradients. Transvalvular pressure gradient is the most important hemodynamic parameter for evaluating the function of an artificial heart valve. The larger the transvalvular pressure gradient, the greater the velocity gradient of blood flow, and the greater the resulting shear stress. 1. If shear stress exceeds the threshold for damaging blood components, it can cause hemolysis or sub-hemolysis, and even damage to vascular endothelial cells. 2. Poor stability of the connection between leaflet and stent: Compared to surgical procedures, interventional valves generally use self-expanding or bulb-expanding stents, which have relatively poor mechanical properties. This affects the connection between the leaflet and stent, thus affecting the stability of the valve. Some designs enhance the connection between the leaflet and stent by adding auxiliary structures to the stent, which can cause stress concentration on the leaflet and, in severe cases, damage to the leaflet. Some designs increase the connection strength between the leaflet and stent by changing the original structure of the stent, which can adversely affect the mechanical properties of the stent itself. 3. Due to the complex internal environment, the structural stability requirements of artificial valves are high: The original annulus of the mitral valve is saddle-shaped, and its systolic and diastolic morphology is uneven, so the working condition of the artificial valve in the body is unstable. In addition, there are many other structures near the original mitral valve structure, such as papillary muscles, chordae tendineae, and ventricular walls, which can affect the morphology and range of motion of the artificial valve in the body.

[0004] Therefore, improving the mitral valve leaflet closure, the connection stability between the leaflet and the stent, and the stability of the mitral valve prosthesis under complex working conditions are urgent problems to be solved in the field of interventional mitral valve surgery. Summary of the Invention

[0005] The purpose of this invention is to provide a valve prosthesis that solves the problems of high difficulty in leaflet closure, poor connection stability between leaflet and stent, and poor stability of valve prostheses under complex working conditions in current valve prostheses.

[0006] To address the aforementioned technical problems, the present invention provides a valve prosthesis, comprising: a valve stent, a leaflet, and a leaflet connector; the valve stent has a support rod; the leaflet connector includes a folded portion and a connecting portion, the folded portion being used to fold and accommodate the support rod; the connecting portion extends from both ends of the folded portion, and the connecting portion is connected to the leaflet, such that the leaflet is connected to the support rod through the leaflet connector.

[0007] Optionally, the leaflet connector includes a flexible sheet structure made of pericardial tissue and / or a polymer braid.

[0008] Optionally, when the flexible sheet structure is made of the pericardial tissue and the polymer braid, the pericardial tissue and the polymer braid are stacked, or the pericardial tissue is wrapped around the polymer braid.

[0009] Optionally, the leaflet connector includes a rigid structure, the rigid structure having a U-shaped cross-section along the direction accommodating the support rod.

[0010] Optionally, the valve stent adopts an integrally molded structure, the stent rod includes a straight rod, and the folded portion is disposed on the straight rod.

[0011] Optionally, the support rod includes a locking portion for locking and fixing the position of the leaflet connector.

[0012] Optionally, the engaging portion is a protrusion that extends along the circumferential extension direction of the valve stent.

[0013] Optionally, the leaflet includes a leaflet body and a leaflet mating portion, the leaflet mating portion is connected to the leaflet body, the leaflet mating portion is disposed between the connecting portions that extend from both ends of the folded portion, and the connecting portion is stitched to the leaflet mating portion.

[0014] Optionally, the folded portion of each valve connector accommodates one of the support rods, and the connecting portion connects two adjacent leaflets.

[0015] Optionally, the valve prosthesis includes three of the valve connectors.

[0016] The valve prosthesis provided by this invention includes: a valve stent, leaflets, and a leaflet connector; the valve stent has a support rod; the leaflet connector includes a folded portion and a connecting portion, the folded portion being used to fold and accommodate the support rod; the connecting portion extends from both ends of the folded portion, and the connecting portion is connected to the leaflet, so that the leaflet is connected to the support rod through the leaflet connector. This design improves the leaflet closure and the connection stability between the leaflet and the valve stent, thereby improving the overall stability of the valve prosthesis under complex working conditions. Furthermore, it avoids calcification of the leaflets due to stress concentration, reducing the risk of leaflet stress concentration and damage. Attached Figure Description

[0017] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0018] Figure 1 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention.

[0019] Figure 2 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention from another angle.

[0020] Figure 3 for Figure 1 A partial enlarged view of the leaflet connector.

[0021] Figure 4 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention from another angle.

[0022] Figure 5 This is a schematic diagram of a leaflet connector according to an embodiment of the present invention.

[0023] Figure 6 This is a schematic diagram of another leaflet connector according to an embodiment of the present invention.

[0024] Figure 7 This is a schematic diagram of a support rod according to an embodiment of the present invention.

[0025] Figure 8 This is a schematic diagram of the flattening of the petals according to an embodiment of the present invention.

[0026] Figure 9 This is a schematic diagram of another type of petal tiling according to an embodiment of the present invention.

[0027] In the attached image:

[0028] 1-Valve stent, 11-Inflow tract, 12-Transition segment, 13-Outflow tract, 14-Stent strut, 141-Clamping part, 142-Straight strut;

[0029] 2-Leaflet, 21-Leaflet body, 22-Leaflet constriction;

[0030] 3-Leaf connecting piece, 31-Folding part, 32-Connecting part, 321-First connecting part, 322-Second connecting part. Detailed Implementation

[0031] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to 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, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0032] Unless otherwise specified, the terms "valve," "artificial valve," and "valve prosthesis" as used in this specification refer to an artificial valve prosthesis, which includes at least a stent, leaflets, and the connection between the two, and if a skirt is present, the skirt is also included. The term "leaflet" as used herein refers to the collection of all leaflets on an artificial valve prosthesis. The term "blade" as used herein refers to one of the "leaflets." The terms "inner," "outer," "upper," "lower," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation. The term "axial" as used herein refers to the direction in which the axis of the stent lies. As used herein, the singular forms "a," "an," and "the" include the plural objects unless otherwise expressly indicated. As used herein, the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated. The term "several" is generally used to include "at least one," and the term "at least two" is generally used to include "two or more." Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature. The terms "installed," "connected," and "joined" should be interpreted broadly; for example, they may refer to a fixed connection, a detachable connection, or an integral part; they may be a direct connection or an indirect connection through an intermediate medium; they may refer to the internal communication of two elements or the interaction between two elements. Moreover, as used in this invention, the placement of one element on another element generally only indicates a connection, coupling, cooperation, or transmission relationship between the two elements, and this connection, coupling, cooperation, or transmission between the two elements may be direct or indirect through an intermediate element, and should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element may be located arbitrarily inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. For those skilled in the art, the specific meanings of the above terms in this invention can be understood according to the specific circumstances. Furthermore, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, some technical features well-known in the art have not been described to avoid confusion with the invention.

[0033] This invention provides a valve prosthesis comprising: a valve stent, leaflets, and a leaflet connector; the valve stent has a support rod; the leaflet connector includes a folded portion and a connecting portion, the folded portion being used to fold and accommodate the support rod; the connecting portion extends from both ends of the folded portion, and the connecting portion connects to the leaflet, so that the leaflet is connected to the support rod through the leaflet connector. This configuration improves the leaflet closure and the connection stability between the leaflet and the valve stent, thereby improving the overall stability of the valve prosthesis under complex operating conditions. Furthermore, it avoids calcification of the leaflet due to stress concentration, reducing the risk of leaflet stress concentration and damage.

[0034] The following description refers to the accompanying drawings.

[0035] Please refer to Figures 1 to 9 , Figure 1 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention; Figure 2 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention from another angle; Figure 3 for Figure 1 A partial enlarged view of the leaflet connector; Figure 4 This is a schematic diagram of a valve prosthesis according to an embodiment of the present invention from another angle; Figure 5 This is a schematic diagram of a leaflet connector according to an embodiment of the present invention; Figure 6 This is a schematic diagram of another leaflet connector according to an embodiment of the present invention; Figure 7 This is a schematic diagram of a support rod according to an embodiment of the present invention; Figure 8 This is a schematic diagram of the flattening of the petals according to an embodiment of the present invention; Figure 9 This is a schematic diagram of another type of petal tiling according to an embodiment of the present invention.

[0036] This embodiment provides a valve prosthesis that can be applied to the mitral valve, as well as other valves besides the mitral valve, such as the aortic valve, pulmonary valve, or tricuspid valve. The valve prosthesis includes: a valve stent 1, valve leaflets 2, and valve leaflet connectors 3.

[0037] like Figure 1As shown, the valve stent 1 has a stent rod 14. The valve stent 1 has three parts: an inflow channel 11, an outflow channel 13, and a transition section 12. The inflow channel 11, transition section 12, and outflow channel 13 are connected sequentially in the axial direction. According to the direction of blood flow, the outflow channel 13 is located downstream of the inflow channel 11. The inflow channel 11 corresponds to the part of the valve stent 1 where blood flows into the valve stent 1 during valve prosthesis operation, and the outflow channel 13 corresponds to the part of the valve stent 1 where blood flows out of the valve stent 1 during valve prosthesis operation. The valve stent 1 includes grid units, which are formed by connecting the stent rods 14. The grid units can be rhomboid or other suitable shapes, such as pentagons, hexagons, etc., that can form closed-shape units. The valve stent 1 is made of shape memory alloy material, preferably nickel-titanium metal. The valve prosthesis also includes a skirt. The leaflets 2 are disposed on the inner side of the valve stent 1 and the skirt, and are fixed to the valve stent 1 and the skirt by suturing. The leaflet 2 is generally made of biological materials or polymer materials, preferably biological materials, and more preferably bovine or porcine pericardium. The leaflet 2 comprises at least two leaflets, preferably three, evenly distributed circumferentially on the valve stent 1. After the valve prosthesis is implanted in the human body, the leaflets 2 act as a one-way valve by opening and closing. Specifically, when the leaflet 2 is open, blood from the left atrium can flow into the left ventricle; when the leaflet 2 is closed, blood from the left ventricle cannot flow into the left atrium. The skirt is generally made of polymer material, which prevents paravalvular leakage and promotes endothelialization after valve implantation, improving the stability of the valve prosthesis. The skirt can be a single piece or a multi-piece combination structure, and its shape can be adjusted according to requirements; this embodiment does not impose any particular limitations on this.

[0038] The leaflet connector 3 includes a folded portion 31 and a connecting portion 32. The folded portion 31 is used to fold and accommodate the support rod 14, so that the support rod 14 can be wrapped around the opposite corner of the folded portion 31, thereby enabling a stable connection between the folded portion 31 and the support rod 14. The connecting portion 32 extends from both ends of the folded portion 31 and connects to the leaflet 2, so that the leaflet 2 is connected to the support rod 14 through the leaflet connector 3. In the current technology, the leaflet 2 needs to be directly connected to the valve support 1 by sutures. On the one hand, the sutures are prone to breakage, and on the other hand, the stress received at the leaflet suture is also very large, which inevitably leads to calcification of the leaflet during use. For example, the connecting portion 32 is divided into a first connecting portion 321 and a second connecting portion 322, which extend from both ends of the folded portion 31, respectively. This configuration offers the following advantages: 1) The leaflet connector 3 serves as the connection medium between the leaflet 2 and the valve stent 1. The leaflet 2 is not directly connected to the valve stent 1, avoiding the direct wrapping of sutures around the valve stent 1 and preventing structural failure caused by the interaction between the leaflet 2 and the valve stent 1 under stress. This improves the connection stability between the leaflet 2 and the valve stent 1. 2) The leaflet connector 3 is directly connected to the valve stent 1. The leaflet connector 3 bears the main stress when the leaflet 2 is open or closed, preventing calcification caused by stress concentration in the leaflet 2 and reducing the risk of stress concentration and damage to the leaflet 2. 3) The leaflet connector 3 can adjust its size according to the length of the stent rod 14 it is to be connected to, improving the overall fit of the valve stent 1. 4) The shape and size of the leaflet connector 3 can be adjusted by design to control the opening or closing shape of the leaflet 2. More specifically, the connection height between two adjacent leaflets 2 can be controlled by changing the height of the leaflet connector 3, thereby controlling the closing shape of the leaflet 2. The connection area of ​​the leaflet 2 can be controlled by the area and shape, thereby controlling the opening shape of the leaflet 2.

[0039] Preferred, such as Figure 5As shown, the leaflet connector 3 includes a flexible sheet structure made of pericardial tissue and / or a polymer braid. The flexible sheet structure means that the leaflet connector 3 can be bent during installation, forming a U-shape. This U-shaped sheet structure wraps around the support rod 14, thus connecting the leaflet connector 3 to the support rod 14. The pericardial tissue is, for example, bovine or porcine pericardial material, which improves the biocompatibility of the valve prosthesis and its compatibility with the leaflet. The leaflet 2 is preferably pericardial tissue, and the leaflet 2 and the leaflet connector 3 are made of the same material with similar hardness and toughness, preventing damage to the leaflet. The polymer braid is, for example, a woven soft fabric, which has higher strength than pericardial tissue, improving the connection strength between the leaflet connector 3 and the valve stent 1. The size of the flexible sheet structure can be set according to actual needs. For example, the flexible sheet structure can be cut into the required shape, such as rectangle, circle, ellipse or trapezoid, as long as it can be folded in half.

[0040] Preferred, such as Figure 5As shown, when the flexible sheet structure is made of the pericardial tissue and the polymer braid, the pericardial tissue and the polymer braid are stacked and sutured or stacked and bonded, or the pericardial tissue covers the polymer braid. For example, preferably, the stack of the pericardial tissue and the polymer braid has three layers. These three layers are preferably sutured. In other embodiments, these three layers can also be bonded. More preferably, the stacking is achieved by suture or bonding to achieve a tight bond between the pericardial tissue and the polymer braid. The bonding is achieved, for example, with bio-adhesive. The polymer braid is disposed in the middle layer, and the pericardial tissue is disposed in the outer layer. Alternatively, in the flexible sheet structure, the pericardial tissue completely covers the polymer braid, for example, in a core-shell structure, where the polymer braid is located in the core of the core-shell structure, i.e., inside the pericardial tissue; and the pericardial tissue is located in the shell of the core-shell structure, i.e., outside the polymer braid. This design allows the leaflet connector 3 to possess both the strength of a polymer braid and the biocompatibility of pericardial tissue. It avoids the problem of fiber breakage in the polymer braid due to long-term use, which can cause connection failure between the leaflet connector 3 and the valve stent 1 when using polymer braid alone. It also avoids the problem of pericardial tissue, which is highly elastic and less prone to deformation, ensuring that the relative positions of adjacent leaflets 2 remain unchanged. This improves the structural stability of the leaflet closure area and the closure shape of leaflet 2, preventing valvular regurgitation or stress concentration in leaflet 2, thereby enhancing the stability of the valve stent and maintaining the long-term opening and closing function of the valve, resulting in better valve durability. Furthermore, the pericardial tissue is located externally and directly connects to the leaflet 2, improving the biocompatibility between the leaflet connector 3 and the leaflet 2.

[0041] Preferred, such as Figure 6 As shown, the leaflet connector 3 includes a rigid structure that provides stronger structural strength and improves connection strength. The rigid structure has a U-shaped cross-section along the direction accommodating the support rod. More specifically, the rigid structure has a U-shaped cross-section along the radial direction of the valve stent. The rigid structure is, for example, a polymer sheet or metal sheet of a certain thickness, obtained by bending. The folded portion 31 is secured to the stent, and the connecting portion 32 preferably clamps two adjacent leaflets 2. More preferably, holes can be drilled in the connecting portion 32 of the polymer sheet or metal sheet, allowing the leaflet connector 3 to be sewn together with the leaflets 2, thereby connecting the valve stent 1 and the leaflets 2 together.

[0042] Preferred, such as Figure 7As shown, the valve stent adopts a one-piece molded structure. The stent rod 14 includes a straight rod 142, and the folded portion 31 is disposed on the straight rod 142. The straight rod 142 is, for example, a straight rod extending along the axial direction of the valve stent. Compared with a curved rod, the straight rod 142 can reduce the additional stress brought by the stent rod 14 when connected with the leaflet connector 3, and increase the connection strength of the leaflet connector 3. In an exemplary embodiment, the valve stent includes a one-piece straight rod design. The one-piece straight rod design does not require adding additional structures to the grid stent structure, such as openings or grooves, and will not affect the overall mechanical performance of the stent. Furthermore, not adding additional structures reduces the stent width at this location, thereby reducing the circumferential volume of the stent and significantly reducing the profile value of the valve stent 1. The number of straight rods 142 is not less than the number of leaflet connectors 3. The straight rod 142 is preferably 4-10 mm in length and less than 2 mm in width. Furthermore, the leaflet connector 3 is provided at the straight rod 142, which can ensure that the folded part 31 of the leaflet connector 3 is subjected to uniform force, thus ensuring the connection stability of the leaflet connector 3.

[0043] Preferred, such as Figure 8 As shown, the support rod 14 includes a locking portion 141 for locking and fixing the position of the leaflet connector 3, preventing the leaflet connector 3 from moving or slipping on the support rod 14. For example, preferably, the locking portion 141 is a protrusion extending along the circumferential direction of the valve support 1. The protrusion can lock the upper and / or lower ends of the folded portion of the leaflet connector 3. The protrusion, in accordance with the size of the leaflet connector 3, prevents the leaflet connector 3 from moving on the straight rod, thereby preventing displacement of the leaflet connector 3 on the support rod 1. This effectively controls the adjacent leaflets 2 to maintain a consistent shape whether open or closed, avoiding damage to the closing or opening function caused by unevenness between adjacent leaflets 2, improving the positional stability of the leaflets 2, and improving the stability of the valve in motion. Of course, in other embodiments, the protrusion of the locking portion 141 can also extend radially along the valve support 1. Of course, the engaging part 141 can also be a barb, which inserts into the leaflet connector 13 to achieve connection. The engaging part 141 can also be other structures with relatively high friction, such as a fine thread structure.

[0044] Preferred, such as Figures 8 to 9As shown, the leaflet 2 includes a leaflet body 21 and a leaflet mating portion 22, which is connected to the leaflet body 21. The leaflet mating portion 22 is positioned between two connecting portions 32 extending from both ends of the folded portion 31, and the connecting portions 32 are sewn together with the leaflet mating portion 22. That is, the leaflet mating portion 22 is sandwiched between the two connecting portions 32. For example, the first connecting portion 321 and the second connecting portion 322 are two connecting portions 32 extending from both ends of the folded portion 31. During sewing, the first connecting portion 321, the leaflet 2, and the second connecting portion 322 are sewn together, or they can be fixed together. For example... Figure 8 As shown, the leaflet mating portion 22 can protrude from the leaflet body 21. Its protruding shape is, for example, a sheet-like structure, which facilitates its insertion into the leaflet connector 3. The sheet-like structure is, for example, rectangular, but can also be other shapes. Alternatively, for example... Figure 9 As shown, the leaflet mating part 22 can be directly disposed on the leaflet body 21 without protruding.

[0045] Preferably, the folded portion 31 of each valve connector 3 accommodates one of the support rods 14, and the connecting portion 32 connects two adjacent leaflets 2, thereby achieving a tight connection between the two adjacent leaflets 2 and ensuring that the connection strength between the two adjacent leaflets 2 is consistent, reducing the difficulty of leaflet 2 closure and improving the stability of leaflet 2 closure.

[0046] Preferably, the valve prosthesis includes three valve connectors 3. In this embodiment, there are three leaflets 2. The three valve connectors 3 connect the three leaflets 2 in pairs, thereby improving the connection strength and stability of the leaflets 2 and ensuring the closure stability of the leaflets 2.

[0047] In summary, the valve prosthesis provided by this invention includes: a valve stent, leaflets, and a leaflet connector; the valve stent has a support rod; the leaflet connector includes a folded portion and a connecting portion, the folded portion being used to fold and accommodate the support rod; the connecting portions extend from both ends of the folded portion, and the connecting portions are connected to the leaflets, so that the leaflets are connected to the support rod through the leaflet connector. This design improves the leaflet closure and the connection stability between the leaflets and the valve stent, thereby improving the overall stability of the valve prosthesis under complex working conditions. Furthermore, it avoids calcification of the leaflets due to stress concentration, reducing the risk of leaflet stress concentration and damage.

[0048] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention, without departing from the content of the present invention, shall still fall within the scope of protection of the present invention.

Claims

1. A valve prosthesis, characterized in that, include: Valve stents, leaflets, and leaflet connectors; The valve stent has a stent rod; The leaflet connector includes a folded portion and a connecting portion. The folded portion is used to fold and accommodate the support rod. The connecting portion extends from both ends of the folded portion and is connected to the leaflet, so that the leaflet is connected to the support rod through the leaflet connector. The connecting portion connects two adjacent leaflets.

2. The valve prosthesis according to claim 1, characterized in that, The leaflet connector includes a flexible sheet structure made of pericardial tissue and / or a polymer braid.

3. The valve prosthesis according to claim 2, characterized in that, When the flexible sheet structure is made of the pericardial tissue and the polymer braid, the pericardial tissue and the polymer braid are stacked and sutured or stacked and bonded together, or the pericardial tissue is wrapped around the polymer braid.

4. The valve prosthesis according to claim 1, characterized in that, The leaflet connector includes a rigid structure, the rigid structure having a U-shaped cross-section along the direction accommodating the support rod.

5. The valve prosthesis according to claim 1, characterized in that, The valve stent adopts an integral molding structure, and the stent rod includes a straight rod, with the folded portion disposed on the straight rod.

6. The valve prosthesis according to claim 1, characterized in that, The support rod includes a locking part for locking and fixing the position of the leaflet connector.

7. The valve prosthesis according to claim 6, characterized in that, The engaging portion is a protrusion that extends along the circumferential extension direction of the valve stent.

8. The valve prosthesis according to claim 1, characterized in that, The leaflet includes a leaflet body and a leaflet mating portion. The leaflet mating portion is connected to the leaflet body. The leaflet mating portion is disposed between the connecting portions that extend from both ends of the folded portion. The connecting portion is stitched to the leaflet mating portion.

9. The valve prosthesis according to claim 1, characterized in that, Each of the leaflet connectors has a folded portion that accommodates one of the support rods.

10. The valve prosthesis according to any one of claims 1-9, characterized in that, The valve prosthesis includes three of the leaflet connectors.

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