CN217244963U - Kit for valve prosthesis and valve leaflets thereof - Google Patents

Abstract

The present application relates to a kit for a valve prosthesis and valve leaflets thereof. The kit comprises a valve leaflet comprising a fixation edge and a valve skirt, wherein the valve leaflet is fixedly connected with other fixation material at an offset position of the fixation edge, and visual markers are arranged on or on either or both sides of the fixation edge for establishing a positional association between the valve leaflet and the valve skirt; the valve skirt includes positioning indicia. The utility model discloses correspond visual marker and location mark, be difficult for appearing the dislocation when operation valve leaflet and valve shirt rim fixed connection, can stitch the inhomogeneous influence of valve leaf that artificial factor leads to with fixed connection in-process and fall to minimumly to improve the hemodynamic effect of valve. The utility model provides a visual marker and location mark are the nondestructive mode and realize, can improve the fatigue of lobule.

Description

Kit for valve prosthesis and valve leaflets thereof

Technical Field

The application relates to the field of medical equipment, in particular to a kit for a valve prosthesis and valve leaflets thereof.

Background

The incidence of heart valves is related to the age, and the incidence of heart valves is obviously improved along with the improvement of the average life span of Chinese population. For common valvular diseases such as aortic valve and mitral valve, surgical repair or valve replacement is usually adopted for treatment. With the development of transcatheter valve technology, there is an increasing demand for interventional prosthetic valves because interventional procedures have the advantages of less surgical trauma, faster post-operative recovery of the patient, etc., compared to traditional surgical procedures.

Interventional prosthetic valves typically include a plurality of valve leaflets that are attached to a bare stent or other support frame by valley fixation such as suturing. The opening and closing of the valve leaflets replaces the opening and closing functions of the natural leaflets to prevent the blood from flowing reversely. Therefore, high demands are made on whether the valve leaflets can perform the opening and closing functions and the fatigue resistance of the valve leaflets.

Typically, these valve leaflets are attached to the valve support structure by sutures. Due to the complex shape of the valve leaflets, existing suturing devices are not adequate, so that at present, manual suturing is mainly performed by a stitcher. The stitcher is a specially trained mechanic or experienced tailor, embroidery technician, or the like. The stitcher typically uses manual means to attach the valve leaflets, skirt and valve support structure together. Because of manual operation, it is likely that some uncontrollable variables are introduced, so that different sewing workers can make inconsistent positions of stitches, inconsistent tightness of stitches, and deviation of actual stitch trajectories from the designed trajectories when sewing the same valve and when the same sewing worker sews different valve leaflets on the same valve. By testing the fluid mechanics performance of pulsating flow, steady flow and the like of the valve, it can be found that the variables can generate negative influence on the blood flow mechanics, and the effective opening area of the valve can be reduced, the cross-valve pressure difference is increased, the backflow is increased and the like. These variables can also affect the stress/strain of the valve leaflets, leading to less than expected fatigue of the valve leaflets.

US patent application US5662705A discloses a method of manufacturing and testing tissue heart valves during open heart surgery. This solution requires the perforation of the valve leaflets to achieve positioning with the stent, which obviously results in damage to the integrity of the valve leaflets and may affect their fatigue performance.

PCT application WO2006132948a1 discloses an apparatus and method for manufacturing valve leaflets and valve prostheses including such leaflets, including using a non-contact cutting device including laser cutting or a high pressure water jet system to obtain the desired shape of the valve leaflet and creating a plurality of alignment holes in the leaflet, for example along the peripheral edge, the support structure correspondingly having a plurality of alignment holes corresponding to the alignment holes in the leaflet, then securing the leaflets to the support structure by securing one or more sutures through the leaflets and the corresponding alignment holes in the support structure, and finally manufacturing a bioprosthetic heart valve by securing a set of leaflet assemblies to the frame. Also, in this technical solution, a laser is required to perform a drilling operation on the valve leaflets, which may also damage the structure of the valve leaflets, and further affect fatigue of the valve leaflets, resulting in premature failure of the prosthetic valve.

SUMMERY OF THE UTILITY MODEL

An object of the application is to provide a valve leaflet, through with on the fixed edge of valve leaflet or, the visual marker that arbitrary side or both sides of fixed edge set up for establish position relevance between valve leaflet and other fixed materials, be difficult for appearing the dislocation when operation valve leaflet and other fixed materials fixed connection, can fall to minimumly with the inconsistent \ inhomogeneous influence in fixed connection department that artificial factor leads to among the fixed process, in order to improve the hemodynamic effect of valve, and the utility model provides a this visual marker is realized for harmless mode, and is littleer to the injury of valve leaflet, can valve improve the fatigue of leaflet. It is also an object of the present application to provide a kit for a valve prosthesis comprising, in addition to the valve leaflets described above, a valve skirt for fixed attachment to the valve leaflets. Furthermore, positioning marks matched with the visual marks are arranged on the valve skirt, so that the relative positions of the valve leaflets and the valve skirt are conveniently determined.

The application discloses a valve leaflet, the valve leaflet includes a fixed edge and a visual marker, the valve leaflet is fixedly connected with other fixing materials at the offset position of the fixed edge, the visual marker is arranged on the fixed edge or on either side or both sides of the fixed edge, and the visual marker is used for establishing position correlation between the valve leaflet and other fixing materials.

In a preferred embodiment, the valve leaflet further comprises a free portion, a base portion, a coaptation portion, wherein:

a free part located at the upper side of the base part and used for being jointed with and separated from the free parts of other valve leaflets so as to realize the flow of blood according to a desired direction;

the base part is used for connecting other fixing materials and providing support for the free part and the combined part;

the combining parts are positioned at two sides of the free part and are used for being connected with the external support part to fix the valve leaflets;

the fixed edge is located at an end of the base portion remote from the free portion.

In a preferred embodiment, the visual marker is a protruding structure located on a side of the fixed edge remote from the free portion.

In a preferred embodiment, the protruding structure is in the shape of a circular arc, square, trapezoid or ellipse.

In a preferred embodiment, the valve leaflet includes a midline, and the projecting structure is symmetrically disposed about the midline of the valve leaflet.

In a preferred embodiment, the number of protruding structures is an odd number, and is at least 3.

In a preferred embodiment, the visual marker is an ink layer located on the fixed edge on a side thereof adjacent to the free portion, or on the fixed edge.

In a preferred embodiment, the free portion comprises a first upper edge, which is located at the end remote from the base portion, and which is straight or curved.

In a preferred embodiment, the valve leaflet comprises a midline, the free portion is shaped symmetrically about the midline, the free portion further comprises a protrusion disposed on a side of the first upper edge remote from the base, and the protrusion is disposed at the midline.

In a preferred embodiment, the valve leaflets are fixedly connected to the other fixing material at an offset of 0.3mm to 1mm inside the fixing edge.

The application also discloses a valve skirt which comprises positioning marks used for being matched with the visual markers to determine the relative positions of the valve leaflets and the valve skirt.

In a preferred example, the valve skirt comprises an upper connecting part, a lower connecting part, a left connecting part, a right connecting part and a flow blocking part defined by the upper connecting part, the lower connecting part, the left connecting part and the right connecting part,

the upper connecting part and the lower connecting part are used for connecting the valve skirt and the supporting piece,

the left connecting part and the right connecting part are used for being connected with each other so as to wind the valve skirt on the surface of the support part,

the flow blocking part is used for preventing paravalvular leakage and can fix valve leaflets,

the positioning mark is arranged on the flow blocking part.

In a preferred embodiment, the positioning mark is an ink layer, or a suture pre-implanted, pre-sutured to the valve skirt.

In a preferred embodiment, the upper connecting portion includes a skirt upper edge, the lower connecting portion includes a skirt lower edge,

the shape of the upper edge of the skirt edge of the upper connecting part and the shape of the lower edge of the skirt edge of the lower connecting part are matched with the shape of the connecting part of the supporting part;

the left connecting part comprises a left edge of the skirt, the right connecting part comprises a right edge of the skirt,

the shape of the skirt left edge and the skirt right edge is linear, and the linear skirt left edge and the linear skirt right edge are parallel to the axis of the support part or form a certain angle.

In a preferred embodiment, the valve skirt and the valve leaflets are fixedly connected by sutures,

the valve skirt further comprises suture marks for indicating the extending direction of the suture stitches of the suture thread.

The utility model has the advantages that:

1) through the visual marker that sets up on the valve leaflet and the location mark one-to-one that sets up on the valve shirt rim for the workman is difficult for appearing the dislocation when sewing up, can sew up the valve leaflet that the in-process human factor leads to and sew up inconsistent \ inhomogeneous influence and reduce to minimum, with the hemodynamics effect that improves the valve.

2) The utility model discloses used visual marker, location mark and suture mark are the harmless mode and realize, and is littleer to the injury of leaflet and shirt rim, can improve the fatigue of leaflet.

3) The utility model discloses simple easy learning is favorable to extensive popularization, improves the uniformity of production efficiency and product.

The present specification describes a number of technical features distributed throughout the various technical aspects, and if all possible combinations of technical features (i.e. technical aspects) of the present specification are listed, the description is made excessively long. In order to avoid this problem, the respective technical features disclosed in the above-mentioned utility model of the present application, the respective technical features disclosed in the following embodiments and examples, and the respective technical features disclosed in the drawings may be freely combined with each other to constitute various new technical solutions (which should be regarded as having been described in the present specification) unless such a combination of the technical features is technically impossible. For example, in one example, the feature a + B + C is disclosed, in another example, the feature a + B + D + E is disclosed, and the features C and D are equivalent technical means for the same purpose, and technically only one feature is used, but not simultaneously employed, and the feature E can be technically combined with the feature C, then the solution of a + B + C + D should not be considered as being described because the technology is not feasible, and the solution of a + B + C + E should be considered as being described.

Drawings

Fig. 1 is a schematic view of a valve leaflet including a projecting structure according to one embodiment of the present invention;

fig. 2 is a schematic view of a valve leaflet with a curved upper edge of the free portion according to an embodiment of the present invention;

FIG. 3 is a schematic view of a valve leaflet having a bulge at the midline according to one embodiment of the present invention;

FIG. 4 is a schematic view of a valve leaflet including an ink layer in an embodiment of the present invention;

fig. 5 is a schematic view of a valve skirt according to another embodiment of the present invention;

FIG. 6 is a schematic view of a valve skirt with positioning marks according to another embodiment of the present invention;

fig. 7 is a schematic view of a suturing correspondence between a valve leaflet and a valve skirt according to another embodiment of the present invention.

Wherein, 100-valve leaflet; 110-a free portion; 120-a junction; 130-a base; 131-a second lower edge; 132-protrusion; 133-sewing edges; 140-a bump; 150-ink layer; 200-valve skirt; 210-an upper connection; 220-lower connection; 230-left connecting portion; 240-right connection; 250-a flow-impeding portion; 252-a location marker; 251-suture marker.

Detailed Description

The present inventors have made intensive studies and developed a kit for a valve prosthesis and valve leaflets thereof. Compared with the prior art, the utility model discloses in, the valve leaflet includes visual marker, and this visual marker sets up on the fixed edge or, arbitrary side or both sides of fixed edge for establish the position relevance between valve leaflet and other fixed materials, be difficult for appearing the dislocation when operation valve leaflet and other fixed materials fixed connection, can be with the inconsistent influence of fixed connection department that the human factor leads to among the fixed process inhomogeneous to fall to minimumly, in order to improve the hemodynamic effect of valve, and the utility model provides a this visual marker realizes for harmless mode, and is littleer to the injury of valve leaflet, can improve the fatigue of leaflet. On this basis, the utility model discloses still provide the external member for valve prosthesis, this external member for valve prosthesis includes in addition to above-mentioned valve leaflet, still includes and is used for with the fixed valve shirt rim that connects of valve leaflet. Furthermore, positioning marks matched with the visual marks are arranged on the valve skirt, so that the relative positions of the valve leaflets and the valve skirt are conveniently determined.

For the purpose of making the present application, technical solutions and advantages more apparent, embodiments of the present application will be described in further detail below with reference to the accompanying drawings.

The utility model provides a valve leaflet, including fixed edge and visual marker, this valve leaflet is in fixed edge's skew position department and other biomaterial fixed connection, and this visual marker sets up on fixed edge or, sews up any side or both sides of limit, and visual marker is used for establishing the position between valve leaflet and other fixed materials and is related.

Examples

As shown in fig. 1, one embodiment of the present invention provides a valve leaflet 100 comprising: free portion 110, base portion 130, and engaging portion 120. Wherein the free portion 110 is used for apposition (coaptation) and separation with free portions of other valve leaflets to achieve a desired direction of blood flow; a base 130 for attaching other securing materials (e.g., skirts, bare stents) and providing support for the free portion 110 and the engaging portion 120; the junctions 120 are used for connection with a support of the valve leaflets (e.g., a bare stent) to secure the valve leaflets, prevent valve leaflet migration, and improve valve leaflet fatigue.

In the present embodiment, the free portion 110 is located on the upper side of the base portion 130; the two coupling portions 120 are respectively located at both sides of the free portion 110. Specifically, the free portion 110 includes a first upper edge, a first lower edge, a first left edge, and a first right edge. The free portion 110 is connected to the base portion 130 at a first lower edge, and is connected to a combining portion 120 at a first left edge and a first right edge, respectively, and an end where the first upper edge is located is a free end. As shown in fig. 1-2, the first upper edge of the free portion 110 is linear or curved, such as circular arc, oval. Preferably, the valve leaflet 100 further comprises a midline about which the shape of the free portion is symmetrical. More preferably, as shown in fig. 3, a protrusion 140 is provided at an outer side (i.e., a side away from the base 130) of the first upper edge of the free portion 110, and the protrusion 140 is provided at a center line. Because the free portion 110 bends at the midline when apposing, the fatigue strength can be enhanced by adding a protrusion structure, and the protrusion 140 can improve the mitral valve central regurgitation. The upper and lower sides are only used for convenience of explaining the relative position relationship of the components of the valve leaflet and do not limit the present invention.

In the present embodiment, the connecting portion 120 is elongated, such as rectangular, trapezoidal, or oval. Illustratively, the support member is a bare stent. The bare stent includes a plurality of lattice cells, each of which is composed of a plurality of wave bars. The grid cells are in wave shape, diamond shape, rectangle, hexagon, etc. Wherein, a fixing groove which is radially penetrated is arranged on the partial wave rod. The combining part 120 of the valve leaflet 100 is coupled to the wave bar by bio-glue, suture, etc. after being inserted into the fixing groove. In other embodiments, the commissures 120 of the valve leaflets 100 are superimposed and attached to the commissures of the other valve leaflets by biological glue, sutures, or the like, and then the commissures of both valve leaflets are inserted together into the fixation slots and the commissures are attached to the struts. In other embodiments, for some prostheses, a buffer (such as bovine pericardium, porcine pericardium, PET mesh, etc.) is further provided between the combining portion 120 and the fixing groove to prevent the valve leaflets from being easily damaged due to too large rigidity change between the valve leaflets and the bare stent. Therefore, the joint part 120 is also connected to the buffer member by bio-glue, suture, etc. after being overlapped, and then inserted into the fixing groove.

In the present embodiment, the base 130 is located at the lower side of the free portion 110, and includes a second upper edge and a second lower edge. The base portion 130 is connected to the free portion 110 at a second upper edge, near which the valve leaflets are fixedly connected to other biological material, such as a valve skirt. Therefore, in the present embodiment, the second lower edge is the fixed edge. The second lower edge 131 of the base 130 is generally rounded or oval. In order to facilitate alignment with the corresponding portions of the other fixation material, the valve leaflets are further provided with visual markers, which can be provided on the second lower edge 131, on either side of the second lower edge 131, or on both sides of the second lower edge 131. Here, the visible marker refers to a marker that can be directly observed by the human eye, and not observed by means of a detection device such as X-ray, fluorescence, or the like.

In the example shown in fig. 1, the visual marker is a protruding structure 132. Specifically, the protruding structure 132 is disposed outside the second lower edge 131, i.e., on a side away from the free portion 110. The protruding structure 132 is shaped as a circular arc, a square, a trapezoid, an ellipse, or the like. There are at least 3 protruding structures 132. For example, as shown in fig. 1, the number of the projection structures 132 is 7. Preferably, the projection structures 132 are symmetrically disposed about a midline of the valve leaflet 100. More preferably, the projection structures 132 are an odd number and are symmetrically arranged about the midline of the valve leaflet 100.

In an alternative example, the visual marker is an ink layer 150. As shown in fig. 4, the ink layer 150 is disposed inside the second lower edge 131, i.e., on a side close to the free portion 110. The number of the ink layers 150 is at least 3. Preferably, the ink layer 150 is symmetrically disposed about the midline of the valve leaflet 100. More preferably, the ink layer 150 is an odd number and is symmetrically disposed about the midline of the valve leaflet 100. The ink layer 150 may also be disposed on the second lower edge 131.

Obviously, the visual marker may also be a combination of multiple markers, for example, the visual marker includes a protruding structure 132 disposed outside the second lower edge 131 and an ink layer 150 disposed inside the second lower edge 131.

In this embodiment, the valve leaflet 100 is fixedly attached to the valve skirt by a suture inside the second lower edge 131. Illustratively, the valve leaflet 100 is sutured to the valve skirt at a position offset 0.3mm-1mm inboard of the second lower edge 131 (i.e., the side near the free portion 110).

In this embodiment, the valve leaflet may be made of a biomaterial or a polymer material. For example, the biological material may be bovine pericardium, porcine pericardium, and the like. The polymer material may be any one or more of Polytetrafluoroethylene (PTFE), Polyurethane (PU), and Polypropylene (PP). Valve leaflets can be prepared by means of laser cutting, clipping, cutting dies and the like.

As shown in fig. 5, another embodiment of the present invention also provides a kit for a valve prosthesis, the kit comprising, in addition to the valve leaflets described above, a valve skirt 200 fixedly attached to the valve leaflets at an offset position from the fixation edges. A valve skirt 200, comprising: an upper connection portion 210, a lower connection portion 220, a left connection portion 230, a right connection portion 240, and a choke portion 250 defined by the upper connection portion 210, the lower connection portion 220, the left connection portion 230, and the right connection portion 240.

Specifically, the upper and lower attachment portions 210, 220 are used to attach the valve skirt 200 to a support, such as a bare stent. The upper connecting portion 210 includes a skirt upper edge, and the lower link portion 220 includes a skirt lower edge. Preferably, the shape of the upper edge of the skirt of the upper connecting portion 210 and the shape of the lower edge of the skirt of the lower connecting portion 220 match the shape of the connecting portion of the support member. For example, the support is a stent comprising a plurality of repeating units, such as diamonds, hexagons, undulations. Accordingly, the upper edge of the skirt of the upper connecting portion 210 and the lower edge of the skirt of the lower connecting portion 220 have a triangular shape, a wave shape, and the like.

The left and right connecting portions 230, 240 are used to connect with each other to wrap the valve skirt around the surface of the support. For example, the valve skirt is disposed on the inner wall of the stent. The left connecting portion 230 includes a skirt left edge and the right connecting portion 240 includes a skirt right edge, the skirt left edge and the skirt right edge being shaped to match. For example, the shape of the left edge and the right edge of the skirt can be straight or curved. Further, the straight left and right edges of the skirt may be parallel to the axis of the support, or may be angled, such as at 45. Preferably, the left and right connection parts 230 and 240 are also used for connection with the support.

In the present embodiment, the upper connection portion 210, the lower connection portion 220, the left connection portion 230, and the right connection portion 240 are located around the choke portion 250. The flow blocking portion 250 serves to prevent paravalvular leakage and may secure the valve leaflets. The valve skirt 200 also includes positioning indicia 252. The positioning indicia 252 are used to cooperate with visual markers to determine the relative position of the valve leaflets and the valve skirt. In this embodiment, the second lower edges 131 of the valve leaflets are secured to the resistive portions 250. Accordingly, the positioning mark 252 is also provided to the flow blocking portion 250. The number of positioning marks 252 corresponds to the number of visual markers, and the positions correspond to the visual markers one by one.

In this embodiment, the positioning mark 252 may be an ink layer, i.e., dyed with surgical ink, or a suture thread, which is pre-embedded and pre-stitched.

Exemplarily, as shown in fig. 6 and 7, the visual markers are 7 protrusions 132 disposed outside the second lower edge 131 of the valve leaflet 100, and the protrusions 132 are symmetrical about the midline of the valve leaflet 100. Accordingly, the valve skirt 200 is fixedly attached to the three valve leaflets. In each region of fixed attachment, the valve skirt 200 comprises 7 symmetrically arranged ink layers. During sewing, the bulges 132 of the valve leaflets are easily separated from the ink layer, namely, the valve leaflets can be easily separated without tools, so that the valve leaflets and the valve skirt are temporarily fixedly connected. For example, the valve leaflets and valve skirt are attached by sutures, which are slipbuckled. For another example, the low-viscosity glue is used between the valve leaflet and the valve skirt to bond the projection of the valve leaflet and the ink layer, so that the same technical effect can be achieved.

Further, the valve skirt 200 is fixedly connected to the valve leaflets by sutures. The valve skirt 200 also includes suture markers 251, the suture markers 251 indicating the direction in which the suture stitches of the suture extend. In this embodiment, the stitching marker 251 may be an ink layer dyed by surgical ink, or a stitching thread pre-embedded or pre-stitched by a stitching thread.

Exemplarily, after the easily separable connection between the protrusions 132 of the valve leaflets 100 and the ink layer is completed, a stable relationship between the valve leaflets and the valve skirt is formed, and then the valve leaflets 100 and the valve skirt 200 are sutured with reference to the suture mark lines 251; after the sewing is completed, the above-mentioned easily separable connection relation is removed.

Also, in this embodiment, the material of the valve skirt 200 may be a biological material or a polymer material. For example, the biological material may be bovine pericardium, porcine pericardium, and the like. The high molecular material can be any one or more of PTFE, PU and PP. The valve skirt 200 may be prepared by laser cutting, clipping, knife molding, and the like.

It is noted that, in the disclosure, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element. In this application, if a reference is made to performing an action based on an element, it is meant to refer to performing the action based on at least the element, including two cases: performing the action based only on the element, and performing the action based on the element and other elements. The expression of a plurality of, a plurality of and the like includes 2, 2 and more than 2, more than 2 and more than 2.

This specification includes combinations of the various embodiments described herein. Separate references to embodiments (e.g., "one embodiment" or "some embodiments" or "preferred embodiments") do not necessarily refer to the same embodiments; however, these embodiments are not mutually exclusive, unless indicated as mutually exclusive or as would be apparent to one of ordinary skill in the art. It should be noted that the term "or" is used in this specification in a non-exclusive sense unless the context clearly dictates otherwise.

All documents mentioned in this application are to be considered as being incorporated in their entirety into the disclosure of this application so as to be subject to modification as necessary. Further, it should be understood that various changes or modifications can be made to the present application by those skilled in the art after reading the contents of the present application, and these equivalents also fall within the scope of the claims of the present application.

Claims (15)

1. A valve leaflet characterized in that it comprises a fixation edge to which it is fixedly connected at an offset position of the fixation edge with a further fixation material, and a visual marker provided on or on either or both sides of the fixation edge for establishing a positional association between the valve leaflet and the further fixation material.

2. A valve leaflet according to claim 1 further comprising a free portion, a base portion, a coaptation portion, wherein:

the free part is positioned at the upper side of the base part and is used for being jointed with and separated from the free parts of other valve leaflets so as to realize the flow of blood according to the expected direction;

the base part is used for being fixedly connected with other fixing materials and providing support for the free part and the combining part;

the combining parts are positioned at two sides of the free part and are used for being connected with an external support to fix valve leaflets;

the fixed edge is located at an end of the base portion remote from the free portion.

3. A valve leaflet according to claim 2 wherein the visual marker is a protruding structure on the side of the fixation edge remote from the free portion.

4. The valve leaflet of claim 3, wherein the projecting structure has a circular arc shape, a square shape, a trapezoid shape, or an oval shape.

5. A valve leaflet according to claim 3 wherein the valve leaflet comprises a midline and the projecting structure is symmetrically disposed about the midline of the valve leaflet.

6. A valve leaflet according to claim 5 wherein the number of projecting structures is an odd number and is at least 3.

7. A valve leaflet according to claim 2 wherein the visual marker is an ink layer on the side of the fixed edge adjacent the free portion or on the fixed edge.

8. A valve leaflet according to claim 2, wherein the free portion comprises a first upper edge, which is straight or curved, at an end remote from the base portion.

9. A valve leaflet according to claim 8, wherein the valve leaflet comprises a midline, the free portion is shaped symmetrically about the midline, the free portion further comprises a protrusion disposed on a side of the first upper edge remote from the base, and the protrusion is disposed at the midline.

10. A valve leaflet according to claim 1, characterized in that the valve leaflet is fixedly connected with other fixing material at an offset of 0.3-1 mm inside the fixing edge.

11. A kit for a valve prosthesis comprising the valve leaflet of any one of claims 1-10 and a valve skirt fixedly attached to the valve leaflet at a location offset from the fixation edge, the valve skirt comprising positioning indicia for cooperating with visual markers to determine the relative position of the valve leaflet and the valve skirt.

12. The kit for a valve prosthesis of claim 11,

the valve skirt comprises an upper connecting part, a lower connecting part, a left connecting part, a right connecting part and a flow blocking part limited by the upper connecting part, the lower connecting part, the left connecting part and the right connecting part,

the upper connecting part and the lower connecting part are used for connecting the valve skirt and the support part,

the left connecting part and the right connecting part are used for being connected with each other so as to wind the valve skirt on the surface of the support part,

the flow blocking part is used for preventing paravalvular leakage and can fix valve leaflets,

the positioning mark is disposed on the flow choking portion.

13. The kit for a valve prosthesis of claim 11,

the positioning mark is an ink layer or a suture line which is embedded in advance and sewed on the skirt edge of the valve.

14. The kit for a valve prosthesis of claim 12,

the upper connecting part comprises a skirt upper edge, the lower connecting part comprises a skirt lower edge,

the shape of the upper edge of the skirt of the upper connecting part and the shape of the lower edge of the skirt of the lower connecting part are matched with the shape of the connecting part of the supporting part;

the left connecting part comprises a skirt left edge, the right connecting part comprises a skirt right edge,

the shape of the skirt left edge and the skirt right edge is straight, and the straight skirt left edge and the straight skirt right edge are parallel to the axis of the support or form a certain angle.

15. The kit for a valve prosthesis of claim 12,

the valve skirt and the valve leaflets are fixedly connected through sutures,

the valve skirt further comprises suture marks for indicating the extending direction of the suture stitches of the suture thread.

Images