Sealing skirt for heart valve, heart valve, and preparation methods

Abstract

Disclosed in the present invention are a sealing skirt for a heart valve, a heart valve, and preparation methods. The sealing skirt can be arranged on the outer side of a valve frame in the circumferential direction of the valve frame. The sealing skirt comprises a sealing skirt body and at least one sealing part arranged on the outer side of the sealing skirt body in an annular configuration. One edge of the sealing part is sealedly connected to the sealing skirt body in the circumferential direction of the sealing skirt, and the other edge of the sealing part is connected to the sealing skirt body at a plurality of spaced positions in the circumferential direction of the sealing skirt, so that the sealing part obtained has a plurality of pouch-shaped structures, which are open towards the same side and consecutively arranged, in the circumferential direction of the sealing skirt; and under the action of regurgitant blood of the heart, the pouch-shaped structures can be expanded towards the side distant from the valve frame. When regurgitation occurs, the pouch-shaped structures can be expanded under the action of the pressure of regurgitant blood of the heart, and then a better sealing fit effect can be achieved between the expanded pouch-shaped structures and the human heart valve annulus, thereby well solving the problem of perivalvular leakage.

Description

Sealing skirt for heart valve, heart valve and preparation method TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a sealing skirt for a heart valve, a heart valve and a preparation method. BACKGROUND

[0002] Transcatheter valve implantation is currently the main method for valve replacement treatment. It involves compressing and loading a valve into a delivery catheter, sending the valve to the desired implantation site through the delivery catheter, and then releasing the valve from the delivery catheter to achieve valve implantation.

[0003] Due to differences in the original structure of the human body at the valve implantation site, such as irregular structure in the circumferential direction of the human valve ring, the outer periphery of the valve often cannot form an effective sealing fit with the human valve ring, resulting in leakage around the valve, i.e., so-called paravalvular leakage, which affects the performance of the valve and the effect of implantation and use. SUMMARY

[0004] The purpose of the present application is to provide a sealing skirt for a heart valve, a heart valve and a preparation method to solve the problem of paravalvular leakage of the heart valve.

[0005] The present application is achieved by the following technical solutions:

[0006] The sealing skirt for a heart valve can be arranged on the outside of the valve frame in the circumferential direction of the valve frame. The sealing skirt comprises a sealing skirt body and at least one sealing part arranged around the outside of the sealing skirt body. One edge of the sealing part is sealingly connected to the sealing skirt body in the circumferential direction of the sealing skirt. The other edge of the sealing part is connected to the sealing skirt body at multiple spaced positions in the circumferential direction of the sealing skirt. The resulting sealing part has a plurality of pocket-like structures that open to the same side in the circumferential direction of the sealing skirt and are arranged in sequence. The pocket-like structures can be expanded away from the valve frame under the action of heart regurgitant blood.

[0007] In some embodiments, the sealing part is a multi-layered structure.

[0008] In some embodiments, the sealing part is a layered structure arranged in sequence between layers.

[0009] In some embodiments, the sealing part is obtained by folding the sealing skirt body at a certain position towards one end of the sealing skirt, and connecting the free end of the folded part to the sealing skirt body at multiple positions in the circumferential direction of the sealing skirt.

[0010] In some embodiments, the sealing part is obtained by folding the sealing skirt body at a position to form a laminated sheet structure, then folding the sealing skirt body at the position, and connecting the free end of the folded part to the sealing skirt body at multiple positions along the circumference of the sealing skirt.

[0011] In some embodiments, the sealing skirt comprises multiple sealing parts arranged along the axial direction of the sealing skirt, and the openings of the pockets on each sealing part are arranged towards the same direction.

[0012] In some embodiments, the pockets of adjacent sealing parts are arranged in an interlaced manner, such that the opening of each pocket of one sealing part is located at the joint position of two adjacent pockets of another sealing part along the axial direction of the sealing skirt.

[0013] In another aspect, the application also provides a method for preparing a sealing skirt, comprising: sealing connecting one edge of a sealing part to the sealing skirt body, and connecting the other edge of the sealing part to the sealing skirt body at multiple mutually spaced positions, to form a sealing part with multiple pockets arranged along the same side and sequentially connected on the sealing skirt body, and the pockets of the sealing part can be expanded away from the frame side under the action of the regurgitant blood.

[0014] In some embodiments, the sealing part is obtained by folding the sealing skirt body at a position to form a laminated sheet structure, then folding the sealing skirt body at the position, and connecting the free end of the folded part to the sealing skirt body at multiple positions along the circumference of the sealing skirt.

[0015] In some embodiments, the sealing part is obtained by folding the sealing skirt body at a position to form a laminated sheet structure, then folding the sealing skirt body at the position, and connecting the free end of the folded part to the sealing skirt body at multiple positions along the circumference of the sealing skirt.

[0016] In some embodiments, multiple sealing parts are formed on the sealing skirt body along the axial direction of the sealing skirt.

[0017] In another aspect, the application also provides a heart valve comprising a frame and the sealing skirt for heart valve as described above, and the opening of the pocket of the sealing part is arranged towards the direction of the regurgitant blood after the heart valve is implanted.

[0018] In another aspect, the application also provides a method for preparing a heart valve, comprising: preparing the sealing skirt by using the method described above, and connecting the prepared sealing skirt to the frame.

[0019] In another aspect, the application also provides a method for preparing a heart valve, comprising:

[0020] Sewing the sealing skirt body to the frame along the circumference of the frame;

[0021] One edge of the sealing part is connected with the sealing skirt body by sealing connection, and the other edge of the sealing part is connected with the sealing skirt body or the sealing skirt body and the valve frame by sewing at multiple spaced positions, so that the sealing part with multiple pocket structures opening to the same side and arranged in sequence is formed on the sealing skirt body, and the pocket structures of the sealing part can be expanded away from the valve frame under the action of the heart regurgitant blood;

[0022] And / or, multiple sealing parts are formed on the sealing skirt body along the axial direction of the sealing skirt.

[0023] In some embodiments, the sealing skirt body is folded at a position, and the free end of the folded part is connected with the sealing skirt body or the sealing skirt body and the valve frame by sewing at multiple positions to obtain the sealing part.

[0024] In some embodiments, comprising:

[0025] The sealing skirt body is folded to form a laminated sheet structure at a position, and then folded, and the free end of the folded part is connected with the sealing skirt body or the sealing skirt body and the valve frame by sewing at multiple positions to obtain the sealing part.

[0026] Compared with the prior art, the present application has the following advantages and beneficial effects:

[0027] The sealing part is arranged on the sealing skirt, and is arranged in the form of multiple pocket structures in sequence in the circumferential direction. Due to the good continuity of each pocket structure of the sealing part in the circumferential direction, the sealing skirt can form a good sealing fit with the human valve ring at each position in the circumferential direction. When regurgitation occurs, the pocket structure can be expanded under the pressure of the heart regurgitant blood, and a good sealing fit can be formed between the expanded pocket structure and the human valve ring, thereby solving the problem of paravalvular leakage.

[0028] The sealing skirt in the present application can be integrally sewn from a piece of material, which is convenient to manufacture, and the prepared sealing skirt can have good integrity, and the connection of the sealing skirt on the heart valve is facilitated, thereby facilitating the preparation of the heart valve.

[0029] The sealing part of the sealing skirt in the present application adopts a multi-layer laminated structure, so that the structure at the position of the sealing part is more fluffy, which helps to form a better sealing fit between the sealing part and the human valve ring, and the leakage prevention effect is better.

[0030] Multiple sealing parts are arranged on the sealing skirt, and the adjacent sealing parts are arranged in an interleaved manner, so that the sealing parts form a fish scale structure on the sealing skirt, and a good sealing effect can be obtained at each position in the circumferential direction of the sealing skirt. BRIEF DESCRIPTION OF DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings in the embodiments will be briefly introduced as follows. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be considered as limiting the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0032] Fig. 1 is a schematic diagram of a heart valve structure according to an embodiment of the present application.

[0033] Fig. 2 is a front view of a partial structure of a sealing skirt according to an embodiment of the present application.

[0034] Fig. 3 is a schematic diagram of a cross section along A-A in Fig. 2.

[0035] Fig. 4 is a schematic diagram of a cross section along B-B in Fig. 2.

[0036] Fig. 5 is a schematic diagram of an operation in a preparation process of a sealing skirt according to an embodiment of the present application.

[0037] Fig. 6 is a schematic diagram of a cross section along C-C in Fig. 5.

[0038] In the drawings: 10, valve frame; 20, sealing skirt, 21, sealing skirt body, 22, sealing part, 221, connection point, 222, pocket structure, 223, combination part. DETAILED DESCRIPTION

[0039] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some of the embodiments of the present application, but not all the embodiments.

[0040] Referring to Fig. 1, for example, a heart valve structure, a sealing skirt is arranged on the outer periphery of the valve frame, so that when the valve is implanted, the sealing skirt and the human valve annulus form a sealing fit to solve the problem of paravalvular leakage. Generally, the valve frame is a regular annular structure in the circumferential direction. Although the elasticity of the valve frame can adapt to the structure of the human valve annulus to some extent, which helps the fit between the outer periphery of the sealing skirt and the human valve annulus, due to the irregular structure of the human valve annulus, the sealing skirt often cannot form effective sealing fit with the human valve annulus at each position in the circumferential direction, which leads to the problem of paravalvular leakage.

[0041] In order to obtain better sealing fit effect, in some embodiments, the structure of the heart valve sealing skirt is designed. Referring to Fig. 1, the sealing skirt 20 includes a sealing skirt body 21 arranged on the valve frame 10 in a circumferential cladding manner and one or more sealing parts 22 arranged around the outside of the sealing skirt body.

[0042] Herein, the expressions of circumferential and circumferentially arranged are described in reference to the installation state of the sealing skirt on the valve frame, in reference to the annular valve frame structure, "circumferential" refers to the circumferential direction of the valve frame, and "circumferentially arranged" refers to being arranged at least one circle around the valve frame; similarly, the "axial" mentioned later refers to the axial direction of the valve frame.

[0043] Referring to FIG. 1 and FIG. 2, one edge of the sealing part 22 is sealingly connected with the sealing skirt body 21 in the sealing skirt circumferential direction, and the other edge of the sealing part 22 is connected with the sealing skirt body 21 at multiple mutually spaced positions in the sealing skirt circumferential direction. The sealing part obtained by this connection mode is a plurality of pocket-shaped structures 222 opening to the same side and arranged in sequence in the sealing skirt circumferential direction, and the formed pocket-shaped structure 222 can be expanded to the side away from the sealing skirt body (i.e. away from the valve frame) under the action of the heart regurgitant blood.

[0044] It is easy to understand that the edge of the opening end of the pocket-shaped structure is relaxed in the free state, and the edge length is generally greater than the straight line distance between the two end points, so that it can be better expanded when subjected to the action of blood pressure.

[0045] The sealing skirt body and the sealing part can be made of the same material, which generally has a certain flexibility and deformation ability, so that it can deform when subjected to external force, and can form a good fit with the human valve annulus.

[0046] The valve structure with such a sealing skirt can, after being implanted, when regurgitation occurs, the pocket-shaped structure can be expanded under the pressure of the heart regurgitant blood, so that the sealing part can better adapt to various irregular human valve annulus structures, and at this time, the sealing skirt and the human valve annulus can achieve better sealing fit effect, and the problem of paravalvular leakage is well solved.

[0047] Referring to FIG. 2, FIG. 5 and FIG. 6, the sealing part 22 of this structure is equivalent to an annular pocket, but is divided into a plurality of small pocket-shaped structures arranged in sequence by the connection of a plurality of interval arranged connection points 221 at the opening end of the annular pocket.

[0048] Therefore, the characteristic of the sealing part in the sealing skirt is that the sealing part is arranged as a plurality of pocket-shaped structures in the circumferential direction, and by using the continuity of the structure, there is no leakage point at each position in the entire circumferential direction, and a good sealing fit can be formed between the human valve annulus at each position.

[0049] It is easily conceivable that the sealing part can adopt a sheet material, and the sheet material is connected with the sealing skirt body at one edge thereof, such as a stitching connection, an adhesive connection, etc., so that the sealing part can form a good seal with the sealing skirt body at the position. Then, the other edge of the sheet material is connected with the sealing skirt body at multiple positions, and the sheet material is connected to the sealing skirt body through a stitching at each connection point. Since the multiple connection points are spaced apart at a certain distance, a pocket-shaped structure as shown in FIG. 2 is formed between two adjacent points. At this time, the sealing skirt body forms multiple pocket-shaped structures which are continuously arranged and open to the same side in the circumferential direction.

[0050] In some embodiments, the sealing part 22 can be obtained by folding the sealing skirt body at a position towards the one end of the sealing skirt, and then connecting the free end of the folded part with the sealing skirt body at multiple positions in the circumferential direction of the sealing skirt. At this time, one edge of the obtained sealing part is directly obtained by folding, so that the connection operation at the position can be reduced during manufacturing. Since the entire sealing part adopts an integrated structure, the sealing property at the position can be good, and the sealing skirt has better integrity, and the sealing skirt is easier and more convenient to manufacture.

[0051] In some embodiments, the folded part of the sealing part described above can be provided as a multi-layer stacked structure. For example, a matching sheet material is added on the folded part after folding to form a multi-layer stacked structure, or the folded part is folded multiple times to obtain a stacked structure in which the layers are continuously arranged in sequence. Then, the free edge of the folded part of the stacked structure is connected to the sealing skirt body through a stitching at multiple connection points. At this time, the obtained sealing part can form a fluffy effect in the radial direction, so that the sealing part can better cooperate with the human annulus.

[0052] In some embodiments, referring to FIGS. 5 and 6, the sealing part 22 can be obtained by folding the sealing skirt body at a position to form a stacked sheet structure, folding the stacked sheet structure towards the one end of the sealing skirt, and then connecting the free end of the folded part with the sealing skirt body at multiple positions in the circumferential direction of the sealing skirt. At this time, the obtained sealing part is a two-layer continuous stacked structure, which can make the sealing part have a good fluffy effect. In addition, this way can facilitate the formation of multiple continuous sealing parts of this structure at multiple positions on one sealing skirt body during the manufacturing of the sealing skirt, so that the sealing skirt has good integrity, as shown in FIG. 5.

[0053] The sealing part with the above structure on the sealing skirt can well solve the problem of paravalvular leakage. When multiple sealing parts are arranged on the sealing skirt and the sealing parts are arranged in sequence in the axial direction of the sealing skirt, it is easy to understand that the arrangement of multiple sealing parts can better prevent paravalvular leakage caused by backflow. Of course, the openings of the pocket-shaped structures on each sealing part on the sealing skirt are arranged in the same direction.

[0054] For example, in the structure shown in FIG. 2, when the open end of the sealing part 22 is connected by a suture between each connection point 221 and the sealing skirt body 21 in this connection manner, a pocket-shaped structure 222 is formed between the two adjacent connection points 221. At the position on the sealing part 22 corresponding to the two connection points, the position is directly connected with the sealing skirt body, and a joint part 223 that fits the sealing skirt body is formed at this position, that is, the joint part 223 is formed on both sides of each pocket-shaped structure 222 on the sealing part 22. As known from the foregoing description, the sealing part as a whole forms a ring-shaped pocket structure on the sealing skirt body. Under the action of backflow pressure, when the pocket-shaped structure is stretched away from the sealing skirt body (i.e., away from the valve frame), the joint part position is also stretched away from the sealing skirt body (i.e., away from the valve frame), but the stretching deformation of the joint part is smaller than that of the pocket-shaped structure.

[0055] That is, the joint part position of the sealing part on each connection point can play a certain sealing role, but the sealing effect at this position is poorer than that of the pocket-shaped structure. The arrangement of multiple sealing parts 22 on the sealing skirt 20 can solve the sealing problem of the sealing part at this position to some extent. In order to achieve better results, in some embodiments, the pocket-shaped structures 222 of the sealing parts arranged adjacent in the axial direction of the sealing skirt are arranged in a staggered manner, so that the openings of each pocket-shaped structure 222 of one sealing part are located at the joint positions of two adjacent pocket-shaped structures 222 on another sealing part in the axial direction of the sealing skirt. As shown in FIG. 2, each connection point 221 of adjacent sealing parts is arranged in a staggered manner in the axial direction of the sealing skirt, and each connection point 221 on one sealing part is located at the position between two connection points 221 on another sealing part. At this time, the sealing parts form a fish scale-like structure on the sealing skirt. In the axial direction of the sealing skirt, each pocket-shaped structure 222 of one sealing part is located at a position corresponding to the joint part 223 on another sealing part, so that good sealing effect can be achieved at each position on the sealing skirt in the circumferential direction.

[0056] On the other hand, the present application also relates to a preparation method of the sealing skirt in the above embodiments for the preparation of the sealing skirt.

[0057] Based on the different structures of the sealing skirt, in some embodiments, one edge of the sealing part is sealingly connected to the sealing skirt body, and the other edge of the sealing part is connected to the sealing skirt body at multiple spaced positions, thereby forming the sealing part with multiple pockets opening to the same side and arranged in sequence on the sealing skirt body, and the pockets of the sealing part can be expanded to the side away from the sealing skirt body (i.e. away from the valve frame) under the action of the heart regurgitant blood.

[0058] In some embodiments, the sealing skirt body can be folded at a position, and the free end of the folded part is connected to the sealing skirt body at multiple positions to obtain the sealing part.

[0059] In some embodiments, referring to FIGS. 3, 4, 5 and 6, the sealing skirt body can be pulled out to the outside and folded to form a laminated sheet structure, and then folded at a position, and the free end of the folded part is connected to the sealing skirt body at multiple positions to obtain the sealing part.

[0060] In this embodiment, the above manufacturing method can be further used to form multiple sealing parts arranged in sequence on the sealing skirt body in the axial direction of the sealing skirt when the sealing skirt is prepared.

[0061] In the manufacturing method of the above embodiments, the connection between the opening end of the pocket structure on the sealing part and the sealing skirt body can be connected by a suture, and the connection points of each sealing part are staggered, and at this time, the sealing part can form a fish scale structure on the sealing skirt body as shown in FIG. 2.

[0062] Based on the sealing skirt structure in the above embodiments, the present application also relates to a heart valve. In some embodiments, referring to FIG. 1, the heart valve includes a valve frame and the sealing skirt in the above embodiments, and after the heart valve is implanted, the opening of the pocket structure of the sealing part is arranged towards the direction of the heart regurgitant blood. Taking the mitral valve shown in FIG. 1 as an example, when the valve leaflets are opened, the end where the blood flows in is the inflow end, and the end where the blood flows out is the outflow end; the heart regurgitation refers to the blood flowing from the outflow end to the inflow end, and therefore, in order to prevent the regurgitation, the opening of the pocket structure is arranged towards the outflow end of the valve.

[0063] Of course, in other embodiments, the heart valve is not limited to the mitral valve shown in FIG. 1, but can also be other types of artificial valves, such as a tricuspid valve.

[0064] The foregoing has clearly described the embodiments that can be specifically adopted in the preparation method of the sealing skirt. It needs to be further explained here that in the preparation of the heart valve, the sealing skirt can be first prepared, the sealing part is prepared on the sealing skirt, and then the prepared sealing skirt is sewn to the frame, or the sealing skirt is sewn to the frame at the same time, and the sealing part is formed on the sealing skirt.

[0065] In some embodiments, the method for preparing a heart valve comprises:

[0066] The sealing skirt body is circumferentially sewn to the frame;

[0067] One edge of the sealing part is sealingly connected to the sealing skirt body, and the other edge of the sealing part is connected to the sealing skirt body or to the sealing skirt body and the frame at multiple spaced positions by sewing thread, thereby forming the sealing part with multiple pockets arranged in sequence and opening to the same side on the sealing skirt body, and the pockets of the sealing part can be expanded away from the sealing skirt body (i.e. away from the frame) under the action of the regurgitant blood in the heart.

[0068] In this embodiment, multiple sealing parts arranged in sequence can be formed on the sealing skirt body in the axial direction of the sealing skirt when the sealing skirt is prepared.

[0069] In some embodiments, when the heart valve is prepared, the sealing skirt body is folded at a position, and the free end of the folded part is sewn to the sealing skirt body or to the sealing skirt body and the frame at multiple positions to obtain the sealing part.

[0070] In this embodiment, multiple sealing parts arranged in sequence can be formed on the sealing skirt body in the axial direction of the sealing skirt when the sealing skirt is prepared.

[0071] In some embodiments, when the heart valve is prepared,

[0072] The sealing skirt body is pulled out and folded to form a laminated sheet structure at a position, and then the free end of the folded part is sewn to the sealing skirt body or to the sealing skirt body and the frame at multiple positions to obtain the sealing part;

[0073] In this embodiment, multiple sealing parts arranged in sequence can be formed on the sealing skirt body in the axial direction of the sealing skirt when the sealing skirt is prepared.

[0074] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present application is usually placed, and are only used to facilitate the description of the present application and simplify the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0075] In addition, the terms "horizontal", "vertical" and the like in the description of the present application do not mean that the components must be absolutely horizontal or vertical, but can be slightly inclined. For example, "horizontal" only means that it is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0076] In the description of the present application, it should also be noted that unless otherwise explicitly specified and limited, the terms "provided", "mounted", "connected", "linked" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication between the two elements inside. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0077] The above is only the preferred embodiment of the present application, and does not limit the present application in any form. Any simple modification or equivalent change made according to the technical essence of the present application to the above embodiments falls within the scope of protection of the present application.

Claims

1. A sealing skirt for a heart valve, characterized in that, The sealing skirt can be arranged outside the frame in the circumferential direction of the frame, and the sealing skirt comprises a sealing skirt body and at least one sealing part arranged outside the sealing skirt body, one side of the sealing part is sealingly connected with the sealing skirt body in the circumferential direction of the sealing skirt, and the other side of the sealing part is connected with the sealing skirt body at a plurality of mutually spaced positions in the circumferential direction of the sealing skirt, so that the obtained sealing part has a plurality of pocket structures which are sequentially and continuously arranged and open to the same side in the circumferential direction of the sealing skirt, and the pocket structures can be expanded away from the frame under the action of the blood refluxed by the heart.

2. The sealing skirt for a heart valve of claim 1, characterized in that, The sealing part is a multi-layered structure.

3. The sealing skirt for a heart valve of claim 2, wherein, The sealing part is a layered structure in which each layer is sequentially and continuously arranged.

4. The sealing skirt for a heart valve of claim 1, wherein, The sealing part is obtained by folding the sealing skirt body at a position towards one end of the sealing skirt, and connecting the free end of the folded part with the sealing skirt body at a plurality of positions in the circumferential direction of the sealing skirt.

5. The sealing skirt for a heart valve of claim 1, wherein, The sealing part is obtained by folding the sealing skirt body at a position to form a layered sheet structure, folding the sheet structure towards one end of the sealing skirt, and connecting the free end of the folded part with the sealing skirt body at a plurality of positions in the circumferential direction of the sealing skirt.

6. The sealing skirt for a heart valve according to any one of claims 1-5, characterized in that, The sealing skirt comprises a plurality of sealing parts which are sequentially arranged in the axial direction of the sealing skirt, and the openings of the pocket structures on each sealing part are arranged towards the same direction.

7. The sealing skirt for a heart valve of claim 6, characterized in that, The pocket structures of adjacent sealing parts are arranged in a staggered manner, so that in the axial direction of the sealing skirt, the openings of the pocket structures of one sealing part are located at the joint positions of two adjacent pocket structures of another sealing part.

8. A method of making a sealing skirt, characterized in that, One side of the sealing part is sealingly connected with the sealing skirt body on the sealing skirt body, and the other side of the sealing part is connected with the sealing skirt body at a plurality of mutually spaced positions, so that a sealing part having a plurality of pocket structures which are sequentially and continuously arranged and open to the same side is formed on the sealing skirt body, and the pocket structures of the sealing part can be expanded away from the frame under the action of the blood refluxed by the heart.

9. The method of claim 8, wherein, The sealing part is obtained by folding the sealing skirt body at a position, and connecting the free end of the folded part with the sealing skirt body at a plurality of positions.

10. The method of claim 8, wherein The sealing part is obtained by folding the sealing skirt body at a position to form a layered sheet structure, and connecting the free end of the folded part with the sealing skirt body at a plurality of positions.

11. The method of claim 8 or 9 or 10, wherein A plurality of sealing parts are formed on the sealing skirt body in the axial direction of the sealing skirt.

12. A heart valve, characterized by The sealing skirt comprises a frame and the sealing skirt for a heart valve according to any one of claims 1-7, and after the heart valve is implanted, the openings of the pocket structures of the sealing part are arranged towards the direction of the blood refluxed by the heart.

13. A method of making a heart valve, characterized by, The sealing skirt is prepared by the preparation method according to any one of claims 8-11, and then the prepared sealing skirt is connected to the frame.

14. A method of making a heart valve, characterized by, The sealing skirt body is connected to the frame in the circumferential direction of the frame by sewing; ​ One edge of the sealing part is connected with the sealing skirt body, and the other edge of the sealing part is connected with the sealing skirt body or the sealing skirt body and the valve frame at multiple spaced positions by sewing thread, thereby forming the sealing part with multiple pockets opening to the same side and arranged in sequence on the sealing skirt body, and the pockets of the sealing part can be opened away from the valve frame under the action of the heart regurgitant blood. And / or, multiple sealing parts are formed on the sealing skirt body along the axial direction of the sealing skirt.

15. The method of claim 14, wherein the heart valve is prepared by, The sealing skirt body is folded at a position, and the free end of the folded part is sutured to the sealing skirt body or the sealing skirt body and the valve frame at multiple positions to obtain the sealing part.

16. The method of claim 14, wherein the heart valve is prepared by, Comprise: The sealing skirt body is folded to form a laminated sheet structure at a position, and then folded, and the free end of the folded part is sutured to the sealing skirt body or the sealing skirt body and the valve frame at multiple positions to obtain the sealing part.

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