CN116999208A

CN116999208A - valve prosthesis

Info

Publication number: CN116999208A
Application number: CN202210468878.2A
Authority: CN
Inventors: 邱尧; 刘世红; 陈国明
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2022-04-29
Filing date: 2022-04-29
Publication date: 2023-11-07
Also published as: CN118593194A; WO2023206708A1

Abstract

The present invention provides a valve prosthesis comprising: valve stents, leaflets, and leaflet connectors; the valve support is provided with a bracket rod; the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces. By the arrangement, the closure degree of the valve leaflet is improved, the connection stability between the valve leaflet and the valve support is improved, and the overall stability of the valve prosthesis is improved under a complex working condition.

Description

Valve prosthesis

Technical Field

The invention relates to the technical field of medical appliances, in particular to a valve prosthesis.

Background

With the prolongation of human life and aging of the population, the incidence of heart valve disease is increasing. According to literature statistics, valve diseases exist in 2% -7% of the elderly aged over 65 years. In European and American countries, valve disease is located in the third place after coronary heart disease and hypertension. The prosthetic heart valve (Heart Valve Prothesis) is an artificial organ implantable in the heart to replace heart valves (including aortic, pulmonary, tricuspid and mitral valves) and to allow unidirectional blood flow and function as a natural heart valve. When heart valve pathology is severe and valve function cannot be restored or improved by valve detachment or repair, then prosthetic heart valve replacement is necessary.

Interventional heart valve replacement is a minimally invasive procedure controlled by a delivery system to place a valve prosthesis at a lesion site. Due to the complexity of the structure of the native valve, the design difficulty of the prosthetic valve is great, and the prosthetic valve may be, for example, an aortic valve, a pulmonary valve, a tricuspid valve, a mitral valve, or the like. The characteristics of the mitral valve will be described by taking the mitral valve as an example: 1. the area of the mitral valve annulus is large, and the closing difficulty of the valve leaflet is high: the prosthetic valve prosthesis has certain requirements on the contact area of the valve leaflets after closing, and the sufficient contact area of the valve leaflets can effectively prevent blood backflow and large valve-crossing pressure difference. The valve-crossing pressure difference is the most important hemodynamic parameter for evaluating the function of the artificial heart valve, and the larger the valve-crossing pressure difference is, the larger the velocity gradient of blood flow is, and the larger the shear stress generated by the valve-crossing pressure difference is. If the shear stress exceeds a threshold value causing damage to blood components, hemolysis or sub-hemolysis is caused, and even damage to vascular endothelial cells, 2, poor connection stability of the valve leaflet and the stent is caused: compared with surgical operation, the artificial valve for interventional operation generally adopts a self-expanding or ball-expanding stent, and the mechanical property of the stent is relatively poor, which can influence the connection between the valve leaflet and the stent, thereby influencing the stability of the valve. Some designs enhance the attachment of the leaflet to the stent by adding to the attachment structure of the stent, which can cause stress concentrations in the leaflet and, in severe cases, the valve She Shousun. Some designs increase the strength of the attachment of the leaflet to the stent by changing the original structure of the stent, which can adversely affect the mechanical properties of the stent itself. 3. Because of the complex in vivo environment, the requirement on the structural stability of the artificial valve is high: the native mitral valve annulus is saddle-shaped and has unbalanced systolic and diastolic morphology, so the prosthetic valve is unstable in vivo. In addition, there are many other structures in the vicinity of the native mitral valve structure, such as papillary muscles, chordae tendineae, ventricular walls, etc., which can affect the morphology and range of motion of the prosthetic valve in the body.

Therefore, improving the mitral valve leaflet closure, the connection stability of the leaflet and the stent, and improving the stability of the mitral valve prosthesis under complex working conditions are the challenges to be solved in the field of interventional mitral valves.

Disclosure of Invention

The invention aims to provide a valve prosthesis to solve the problems of high valve leaflet closing difficulty, poor connection stability of valve leaflets and a bracket and poor valve prosthesis stability under complex working conditions in the existing valve prosthesis.

To solve the above technical problems, the present invention provides a valve prosthesis, comprising: valve stents, leaflets, and leaflet connectors; the valve support is provided with a bracket rod; the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces.

Optionally, the leaflet attachment comprises a flexible sheet-like structure made of pericardial tissue and/or a polymeric braid.

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 coated outside the polymer braid.

Optionally, the leaflet attachment comprises a rigid structure, and the cross section of the rigid structure along the direction of accommodating the support rod is in a U shape.

Optionally, the valve support adopts the integrated into one piece structure, the support pole includes the straight-bar, the fifty percent discount portion set up in on the straight-bar.

Optionally, the bracket rod includes a clamping portion for clamping and fixing the position of the leaflet connecting piece.

Optionally, the engaging portion is a protrusion, and the protrusion extends along a circumferential extending direction of the valve support.

Optionally, the leaflet includes a leaflet She Benti and a leaflet folding portion, the leaflet folding portion is connected with the leaflet She Benti, the leaflet folding portion is disposed between the connecting portions that extend along two ends of the folding portion, and the connecting portions are connected with the leaflet folding portion in a sewing manner.

Optionally, the folded portion of each valve connector accommodates one of the stent rods, and the connecting portion connects two adjacent valve leaflets.

Optionally, the valve prosthesis comprises three of the valve connectors.

In one embodiment of the present invention, a valve prosthesis comprises: valve stents, leaflets, and leaflet connectors; the valve support is provided with a bracket rod; the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces. By the arrangement, the closure degree of the valve leaflet is improved, the connection stability between the valve leaflet and the valve support is improved, and the overall stability of the valve prosthesis is improved under a complex working condition. In addition, calcification of the valve leaflet due to stress concentration is avoided, and risk of the valve She Yingli concentration and damage to the valve leaflet is reduced.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

fig. 1 is a schematic view of a valve prosthesis according to an embodiment of the present invention.

Fig. 2 is a schematic view of a valve prosthesis according to an embodiment of the present invention at another angle.

Fig. 3 is an enlarged view of a portion of the leaflet attachment of fig. 1.

Fig. 4 is a schematic view of a valve prosthesis according to an embodiment of the present invention at another angle.

Fig. 5 is a schematic view of a leaflet attachment of an embodiment of the present invention.

FIG. 6 is a schematic view of another leaflet attachment member according to an embodiment of the present invention

Fig. 7 is a schematic view of a bracket bar according to an embodiment of the present invention.

Fig. 8 is a schematic illustration of a tiling of leaflets of an embodiment of the present invention.

Fig. 9 is a schematic illustration of tiling of another leaflet of an embodiment of the present invention.

In the accompanying drawings:

1-valve support, 11-inflow channel, 12-transition section, 13-outflow channel, 14-support rod, 141-clamping part and 142-straight rod;

2-leaflet, 21-leaflet She Benti, 22-leaflet coaptation;

3-leaflet attachment, 31-doubled over portion, 32-attachment portion, 321-first attachment portion, 322-second attachment portion.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

Unless otherwise specified, "valve," "prosthetic valve," "valve prosthesis" as used herein refer to a prosthetic valve prosthesis that includes at least a stent, a leaflet, and a connection therebetween, and if provided, a skirt. As used herein, "leaflet" refers to the collection of all leaflets on a prosthetic valve prosthesis. As used herein, a "leaflet" refers to one of the "leaflets". The terms "inner", "outer", "upper", "lower" and the like are used herein for illustrative purposes only and are not meant to be the only embodiments, and "axial" as used herein refers to the direction in which the axis of the stent is located. As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "plurality" is generally employed in its sense including "at least one," the term "at least two" is generally employed in its sense including "two or more,

furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", "a third" may include either explicitly or implicitly one or at least two of such features, and the terms "mounted", "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art that the invention may be practiced without one or more of these details. In other instances, well-known features have not been described in detail in order to avoid obscuring the invention.

An embodiment of the present invention provides a valve prosthesis, including: valve stents, leaflets, and leaflet connectors; the valve support is provided with a bracket rod; the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces. By the arrangement, the closure degree of the valve leaflet is improved, the connection stability between the valve leaflet and the valve support is improved, and the overall stability of the valve prosthesis is improved under a complex working condition. In addition, calcification of the valve leaflet due to stress concentration is avoided, and risk of the valve She Yingli concentration and damage to the valve leaflet is reduced.

The following description refers to the accompanying drawings.

Referring to fig. 1 to 9, fig. 1 is a schematic view of a valve prosthesis according to an embodiment of the present invention; FIG. 2 is a schematic view of a valve prosthesis according to an embodiment of the present invention at another angle; FIG. 3 is an enlarged view of a portion of the leaflet attachment of FIG. 1; FIG. 4 is a schematic view of a valve prosthesis according to an embodiment of the present invention at another angle;

FIG. 5 is a schematic view of a leaflet attachment of an embodiment of the present invention; FIG. 6 is a schematic view of another leaflet attachment of an embodiment of the present invention; FIG. 7 is a schematic view of a bracket bar according to an embodiment of the present invention; FIG. 8 is a schematic illustration of tiling of leaflets in accordance with an embodiment of the present invention; fig. 9 is a schematic illustration of tiling of another leaflet of an embodiment of the present invention.

The present embodiment provides a valve prosthesis that may be applied to a mitral valve, but may also be applied to other valves than a mitral valve, such as an aortic valve, a pulmonary valve, or a tricuspid valve, among others. The valve prosthesis comprises: a valve holder 1, leaflets 2 and leaflet attachment pieces 3.

As shown in fig. 1, the valve stent 1 has a stent rod 14. The valve holder 1 has three parts, an inflow channel 11, an outflow channel 13 and a transition piece 12, respectively, the inflow channel 11, the transition piece 12 and the outflow channel 13 being connected in series in the axial direction, the outflow channel 13 being located downstream of the inflow channel 11, depending on the direction of the blood flow. The inflow channel 11 corresponds to the part of the blood flowing into the valve holder 1 during operation of the valve prosthesis, and the outflow channel 13 corresponds to the part of the blood flowing out of the valve holder 1 during operation of the valve prosthesis. The valve stent 1 comprises a grid cell formed by the stent struts 14 connected. Wherein the grid cells may be diamond-shaped or other suitable shapes, such as pentagonal, hexagonal, etc. cells that may form a closed shape. The valve stent 1 is made of a shape memory alloy material, preferably a nickel titanium metal material. The valve prosthesis further comprises a skirt. The valve leaflet 2 is arranged on the inner side of the valve holder 1 and the skirt and is fixed on the valve holder 1 and the skirt by means of stitching. The material of the leaflet 2 is typically a biomaterial or a polymeric material, preferably a biomaterial, more preferably bovine pericardium or porcine pericardium material. The leaflets 2 comprise at least two, preferably 3, leaflets 2, distributed evenly in the circumferential direction of the valve holder 1. After the valve prosthesis is implanted in a human body, the valve leaflet 2 functions as a one-way valve by opening and closing, specifically, when the valve leaflet 2 is opened, blood of the left atrium can flow into the left ventricle, and when the valve leaflet 2 is closed, blood of the left ventricle cannot flow into the left atrium. The skirt edge 3 is made of a high polymer material generally, and the skirt edge 3 can prevent the perivalvular leakage; is favorable for endothelialization after valve implantation and improves the stability of valve prosthesis. The skirt 3 may have a one-piece structure or a multi-piece structure, and the shape thereof may be adjusted as required, and the present embodiment is not particularly limited.

The leaflet attachment 3 includes a folded portion 31 and a connecting portion 32, where the folded portion 31 is configured to fold in half and accommodate the stent rod 14, so that the stent rod 14 can be wrapped in the opposite corner of the folded portion 31, and further the folded portion 31 and the stent rod 14 can be stably connected. The two ends of the doubling-up part 31 are respectively provided with the connecting parts 32 in an extending way, and the connecting parts 32 are connected with the valve leaves 2, so that the valve leaves 2 are connected with the bracket rod 1 through the valve leaf connecting pieces 3. Since in the current technology, the leaflet 2 needs to be directly connected to the valve support 1 by suture winding, on one hand, the suture is easy to break, and on the other hand, the stress received by the suture of the leaflet is also large, and the leaflet is inevitably calcified during use. For example, the connecting portion 32 is divided into a first connecting portion 321 and a second connecting portion 322, and the first connecting portion 321 and the second connecting portion 322 are respectively provided along two ends of the folded portion 31. So set up, have following beneficial effect: 1) The valve leaflet connecting piece 3 is used as a connecting medium of the valve leaflet 2 and the valve support 1, the valve leaflet 2 is not directly connected with the valve support 1, the suture is prevented from being directly wound on the valve support 1, structural failure caused by interaction between the valve leaflet 2 and the valve support 1 when the valve leaflet 2 is stressed is avoided, and the connection stability between the valve leaflet 2 and the valve support 1 is improved. 2) The valve leaflet connector 3 is directly connected with the valve support 1, and the valve leaflet connector 3 bears main stress when the valve leaflet 2 is opened or closed, so that calcification phenomenon of the valve leaflet 2 caused by stress concentration is avoided, and the risks of stress concentration of the valve leaflet 2 and damage to the valve leaflet 2 are reduced. 3) The leaflet connecting piece 4 can adjust the size of the leaflet connecting piece according to the length size of the bracket rod 14 to be connected, so that the overall matching degree of the valve bracket 3 is improved. 4) The shape and size of the leaflet attachment 4 can be adjusted by design to control the opening or closing form of the leaflet 2, more specifically, the height of the leaflet attachment 4 can be changed to control the connecting height of two adjacent leaflets 2, so as to control the closing form of the leaflet 2, and the area and shape can be used to control the connecting area of the leaflet 2, so as to control the opening form of the leaflet 2.

Preferably, as shown in fig. 5, the leaflet attachment 3 comprises a flexible sheet-like structure made of pericardial tissue and/or polymer braid. The flexible sheet structure indicates that the leaflet connecting piece 3 can be bent during installation connection, the bent flexible sheet structure can form a U-shaped structure, and the U-shaped sheet structure bypasses the support rod 14 to wrap the support rod 14 therein, so that the leaflet connecting piece 3 is connected with the support rod 14. The pericardial tissue is, for example, bovine pericardium or porcine pericardium material, thereby improving the biocompatibility of the valve prosthesis and its compatibility with the valve leaflets. The valve leaflet 2 is preferably pericardial tissue, the valve leaflet 2 and the valve leaflet connecting piece 4 are made of the same material, and the hardness and toughness of the material are the same, so that the valve leaflet is not damaged. The polymer braid is, for example, a braided soft cloth, has higher strength than pericardial tissue, and can improve the connection strength between the leaflet connector 3 and the valve stent 1. The dimensions of the flexible sheet structure may be set according to actual requirements, for example, the flexible sheet structure may be cut into a desired shape, for example, a rectangle, a circle, an ellipse, a trapezoid, or the like, as long as the flexible sheet structure can be folded in half.

Preferably, as shown in fig. 5, when the flexible sheet structure is made of the pericardial tissue and the polymer braid, the pericardial tissue is laminated and sewed or laminated and bonded with the polymer braid, or the pericardial tissue is coated outside the polymer braid. For example, it is preferable that the laminate of the pericardial tissue and the polymer braid has three layers. The three layers are preferably arranged by stitching. In other embodiments, the three layers may also be adhesively disposed. More preferably, the arrangement of the lamination layer realizes the tight combination of the pericardial tissue and the polymer braiding body through stitching or bonding. The bonding is achieved, for example, with a biological glue. The polymer braid is arranged in the middle interlayer, and the pericardium tissue is arranged in the outer interlayer. Or, in the flexible sheet structure, the pericardial tissue is completely covered outside the polymer braid, for example, the polymer braid is arranged in a core-shell structure, and the polymer braid is positioned at the core part of the core-shell structure, namely, is positioned in the pericardial tissue; the pericardial tissue is positioned on the shell part of the core-shell structure, namely, the outside of the polymer braid. Thus, the valve leaflet connector 1 has the strength of a high molecular braiding body and the biocompatibility of pericardial tissues. The valve support can avoid the problem that when the polymer braiding body is singly used, the connection failure of the valve leaflet connecting piece 3 and the valve support 1 is caused by the rupture of fibrous tissues when the polymer braiding body is used for a long time. And when the pericardial tissue is independently used, the pericardial tissue is not easy to deform because of larger elasticity, the relative positions between adjacent valve leaflets 2 are not changed, the stability of the structure of the valve leaflet closure part and the closed state of the valve leaflets 2 are improved, the valve regurgitation or the stress concentration of the valve leaflets 2 is avoided, the stability of the valve support is improved, the long-term opening and closing functionality of the valve is maintained, and better valve durability is brought. Furthermore, the pericardial tissue is provided at the outside, which is directly connected with the leaflet 2, improving the compatibility between the leaflet connector 3 and the leaflet 2.

Preferably, as shown in fig. 6, the leaflet attachment member 3 includes a rigid structure that provides a stronger structural strength and increases the attachment strength. The cross section of the hard structure along the direction of accommodating the bracket rod is U-shaped. More specifically, the cross section of the hard structure along the radial direction of the valve bracket is U-shaped. The rigid structure is, for example, a polymer rigid sheet or a metal rigid sheet having a certain thickness, and is obtained by bending, the folded portion 31 is clamped on the bracket, and the connecting portion 32 preferably clamps the two adjacent valve leaflets 2. More preferably, holes may be perforated in the connecting portion 32 of the polymer hard sheet or the metal hard sheet, so that the leaflet connector 3 and the leaflet 2 are sutured together, and the valve stent 1 and the leaflet 2 are connected together.

Preferably, as shown in fig. 7, the valve support is in an integrally formed structure, the support 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 support, and compared with a curved rod, the straight rod 142 can reduce the extra stress brought by the support rod 14 when being connected with the leaflet connecting piece 3, and increase the connection strength of the leaflet connecting piece 3. In an exemplary embodiment, the valve stent comprises a straight rod with an integrated design, and the design of the integrated straight rod does not need to add additional structures, such as holes, grooves and the like, on the grid stent structure, so that the overall mechanical performance of the stent is not affected, and the width of the stent at the position is reduced without adding additional structures, thereby achieving the purpose of reducing the circumferential volume of the stent, and further significantly reducing the profile value of the valve stent 1. The number of the straight rods 142 is not less than the number of the leaflet connectors 3. The straight bar 142 is preferably 4-10mm in length and less than 2mm in width. And, the straight rod 142 is provided with the valve leaflet connector 3, so that the stress on the folded part 31 of the valve leaflet connector 3 is even, and the connection stability of the valve leaflet connector 3 is ensured.

Preferably, as shown in fig. 8, the support rod 14 includes an engaging portion 141 for engaging and fixing the position of the leaflet attachment member 3, so as to prevent the leaflet attachment member 3 from moving or slipping on the support rod 14. For example, the engaging portion 141 is preferably a protrusion extending in the circumferential extending direction of the valve holder 1. The bulge can block the upper end and/or the lower extreme of the fifty percent discount portion of valve leaf connecting piece 3, the size of protruding cooperation valve leaf connecting piece 3 avoids valve leaf connecting piece 3 to remove on the straight-bar, and then prevents that valve leaf connecting piece 3 from taking place the displacement on cradling piece 1, can effectively control and keep consistent form when opening or closing between the adjacent valve leaf 2, avoids because the closed or open function damage that the condition that has the height to be uneven of two adjacent valve leaves 2 caused, has improved the stability in the position of valve leaf 2 to the stability under the motion state has been improved. Of course, in other embodiments, the protrusion of the engaging portion 141 may also extend along the radial direction of the valve holder 1. Of course, the engagement portion 141 could also be a barb that penetrates into the leaflet attachment piece 13 to effect attachment. The engaging portion 141 may have another structure with relatively high friction, for example, a fine screw structure.

Preferably, as shown in fig. 8 to 9, the leaflet 2 includes a leaflet She Benti and a leaflet coaptation portion 22, and the leaflet coaptation portion 22 is connected to the leaflet body 21. The leaflet coaptation portion 22 is configured to be disposed between two connecting portions 32 extending along two ends of the folded portion 31, and the connecting portions 32 are connected with the leaflet coaptation portion 22 by stitching. That is, the leaflet coaptation section 22 is sandwiched between the two connecting sections 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. When the first connecting portion 321, the leaflet 2 and the second connecting portion 322 are sewn together, they may be fixed together. For example, as shown in fig. 8, the leaflet coaptation portion 22 may protrude from the leaflet body 21. The protruding shape is for example a sheet-like structure, which is for example rectangular sheet-like, but other shapes are possible, which is convenient for being clipped into the leaflet attachment 3. As shown in fig. 9, for example, the leaflet coaptation portion 22 may be directly disposed on the leaflet She Benti without protruding.

Preferably, the folded part 31 of each valve connecting piece 3 accommodates one support rod 14, and the connecting part 32 connects two adjacent valve leaflets 2, so that the two adjacent valve leaflets 2 are tightly connected, the connection strength between the two adjacent valve leaflets 2 is consistent, the closing difficulty of the valve leaflets 2 is reduced, and the closing stability of the valve leaflets 2 is improved.

Preferably, the valve prosthesis comprises three of the valve connectors 3. In this embodiment, the number of the valve leaflets 2 is three, and in the three valve leaflets 2, the three valve connectors 3 connect the three valve leaflets 2 in pairs, so that the connection strength and the connection stability of the valve leaflets 2 are improved, and the closure stability of the valve leaflets 2 is ensured.

In summary, in the valve prosthesis provided by the present invention, the valve prosthesis includes: valve stents, leaflets, and leaflet connectors; the valve support is provided with a bracket rod; the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces. By the arrangement, the closure degree of the valve leaflet is improved, the connection stability between the valve leaflet and the valve support is improved, and the overall stability of the valve prosthesis is improved under a complex working condition. In addition, calcification of the valve leaflet due to stress concentration is avoided, and risk of the valve She Yingli concentration and damage to the valve leaflet is reduced.

It should also be appreciated that while the present invention has been disclosed in the context of a preferred embodiment, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A valve prosthesis, comprising: valve stents, leaflets, and leaflet connectors;

the valve support is provided with a bracket rod;

the valve leaflet connecting piece comprises a folding part and a connecting part, wherein the folding part is used for folding and arranging and accommodating the bracket rod; the two ends of the doubling-over part are respectively provided with the connecting parts in an extending mode, and the connecting parts are connected with the valve leaves, so that the valve leaves are connected with the support rods through the valve leaf connecting pieces.

2. The valve prosthesis of claim 1, wherein the leaflet attachment comprises a flexible sheet-like structure made of pericardial tissue and/or a polymer braid.

3. The valve prosthesis of claim 2, wherein when the flexible sheet structure is made of the pericardial tissue and the polymer braid, the pericardial tissue is layered with the polymer braid in a stitched or layered adhesive arrangement, or the pericardial tissue is wrapped outside the polymer braid.

4. The valve prosthesis of claim 1, wherein the leaflet attachment comprises a rigid structure having a U-shaped cross-section along a direction that accommodates the stent rod.

5. The valve prosthesis of claim 1, wherein the valve stent is of an integrally molded construction, the stent stem comprises a straight stem, and the doubled-over portion is disposed on the straight stem.

6. The valve prosthesis of claim 1, wherein the stent stem comprises a snap-fit portion for snap-securing the position of the leaflet attachment.

7. The valve prosthesis of claim 6, wherein the engagement portion is a protrusion extending in a circumferential extension direction of the valve stent.

8. The valve prosthesis of claim 1, wherein the leaflet includes a flap She Benti and a leaflet apposition portion connected to the flap She Benti, the leaflet apposition portion being disposed between the connection portions extending along each of the two ends of the apposition portion, the connection portions being sutured to the leaflet apposition portion.

9. The valve prosthesis of claim 1, wherein the doubled-over portion of each valve connector accommodates one of the stent struts and the connector connects two adjacent leaflets.

10. The valve prosthesis of any one of claims 1-9, wherein the valve prosthesis comprises three of the valve connectors.