Sealing skirt for heart valves, heart valves and their preparation methods

Abstract

This invention discloses a sealing skirt for a heart valve, a heart valve, and a method for its preparation. The sealing skirt is disposed circumferentially on the outside of the valve arch. The sealing skirt includes a sealing skirt body and at least one sealing portion surrounding the outside of the sealing skirt body. One edge of the sealing portion is sealed to the sealing skirt body circumferentially, and the other edge of the sealing portion is connected to the sealing skirt body at multiple spaced intervals along the circumferential direction of the sealing skirt. The resulting sealing portion has multiple pocket-shaped structures with openings facing the same side and arranged sequentially in the circumferential direction of the sealing skirt. These pocket-shaped structures can be expanded away from the valve arch by the action of regurgitated blood. In the event of regurgitation, the pocket-shaped structures can be expanded by the pressure of the regurgitated blood, resulting in a better sealing fit between the expanded pocket-shaped structures and the valve annulus, effectively solving the problem of paravalvular leakage.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a sealing skirt for a heart valve, a heart valve, and a method for its preparation. Background Technology

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

[0003] Due to differences in the original human structure at the valve implantation site, such as the irregularity of the circumferential structure of the human valve annulus, it is often difficult to form an effective seal between the outer periphery of the valve and the human valve annulus, resulting in leakage at the valve periphery, also known as paravalvular leakage, which affects the valve performance and the effectiveness of implantation. Summary of the Invention

[0004] The purpose of this invention is to provide a sealing skirt for heart valves, a heart valve, and a method for preparing it, so as to solve the problem of paravalvular leakage of heart valves.

[0005] This invention is achieved through the following technical solution:

[0006] A sealing skirt for a heart valve, the sealing skirt being disposed circumferentially on the outside of the valve frame, the sealing skirt including a sealing skirt body and at least one sealing portion surrounding the outside of the sealing skirt body, one side of the sealing portion being sealed to the sealing skirt body in the circumferential direction of the sealing skirt, and the other side of the sealing portion being connected to the sealing skirt body at multiple spaced intervals along the circumferential direction of the sealing skirt, such that the resulting sealing portion has multiple pocket-shaped structures with openings facing the same side and arranged sequentially in the circumferential direction of the sealing skirt, and the pocket-shaped structures can be opened away from the valve frame by the action of regurgitated blood in the heart.

[0007] In some embodiments, the sealing portion has a multi-layered structure.

[0008] In some embodiments, the sealing portion is a stacked structure in which the layers are arranged sequentially.

[0009] In some embodiments, the sealing portion is obtained by folding the sealing skirt body towards one end of the sealing skirt at a certain position, and then connecting the free end of the folded portion to the sealing skirt body at multiple positions along the circumference of the sealing skirt.

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

[0011] In some embodiments, the sealing skirt includes a plurality of sealing portions, which are arranged sequentially along the axial direction of the sealing skirt, and the openings of the pocket-shaped structures on each sealing portion are all oriented in the same direction.

[0012] In some embodiments, the pocket-shaped structures of adjacent sealing portions are staggered, such that in the axial direction of the sealing skirt, the openings of each pocket-shaped structure of one sealing portion are located exactly at the junction of two adjacent pocket-shaped structures on another sealing portion.

[0013] On the other hand, the present invention also provides a method for preparing a sealing skirt, wherein one side of the sealing part is sealed and connected to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body at multiple mutually spaced positions, and a sealing part having multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the valve frame under the action of regurgitated blood in the heart.

[0014] In some embodiments, the sealing skirt body is folded at a certain position, and the free end of the folded portion is connected to the sealing skirt body at multiple positions to obtain the sealing part.

[0015] In some embodiments, the sealing skirt body is folded at a certain position to form a layered sheet structure, and then folded over, and the free end of the folded portion is connected to the sealing skirt body at multiple positions to obtain the sealing part.

[0016] In some embodiments, a plurality of sealing portions are formed on the sealing skirt body along the sealing skirt axis.

[0017] On the other hand, the present invention also provides a heart valve, including a valve frame and a sealing skirt for the heart valve, wherein after the heart valve is implanted, the opening of the pocket-shaped structure of the sealing part is arranged in the direction of cardiac regurgitation.

[0018] On the other hand, the present invention also provides a method for preparing a heart valve, wherein a sealing skirt is prepared using the above-described preparation method, and then the prepared sealing skirt is connected to the valve frame.

[0019] On the other hand, the present invention also provides a method for preparing a heart valve, comprising:

[0020] The sealing skirt body is sewn to the valve frame along the circumference of the valve frame;

[0021] One side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple spaced positions by sutures. A sealing part with multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the valve frame under the action of regurgitated blood in the heart.

[0022] And / or, multiple sealing portions are formed on the sealing skirt body along the sealing skirt axis.

[0023] In some embodiments, the sealing skirt body is folded at a certain position, and the free end of the folded portion is sewn to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple positions to obtain the sealing part.

[0024] In some embodiments, including:

[0025] The sealing skirt body is folded at a certain position to form a layered sheet structure, then folded again, and the free end of the folded part is sewn to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple positions to obtain the sealing part.

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

[0027] This invention provides a sealing part on the sealing skirt, which is configured as a structure of multiple continuous pocket-shaped structures in the circumferential direction. Due to the good continuity of each pocket-shaped structure in the circumferential direction, the sealing skirt can form a good sealing fit with the human valve annulus at all positions in the circumferential direction. Moreover, when backflow occurs, the pocket-shaped structures can be expanded under the pressure of the regurgitated blood in the heart. The expanded pocket-shaped structures can form a good sealing fit with the human valve annulus, which effectively solves the problem of paravalvular leakage.

[0028] The sealing skirt in this invention can be made from a single piece of material and sewn together, which is convenient to manufacture and the resulting sealing skirt has good integrity and facilitates its connection to the heart valve, thereby facilitating the preparation of the heart valve.

[0029] The sealing part of the sealing skirt of the present invention adopts a multi-layered structure, which makes the structure at the sealing part position more loose, which helps to form a better sealing fit between the sealing part and the human body valve ring, and the leakage prevention effect is better.

[0030] The present invention provides a sealing skirt with multiple sealing parts, and the adjacent sealing parts are arranged in an alternating manner. The sealing parts form a fish scale-like structure on the sealing skirt, so that the sealing skirt can achieve a good sealing effect at all positions in the circumference. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the heart valve structure in an embodiment of the present invention.

[0033] Figure 2 This is a front view of a partial structure of the sealing skirt in an embodiment of the present invention.

[0034] Figure 3 for Figure 2 Schematic diagram of the AA-direction section.

[0035] Figure 4 for Figure 2 Schematic diagram of the BB-direction section.

[0036] Figure 5 This is a schematic diagram illustrating the sealing skirt preparation process in an embodiment of the present invention.

[0037] Figure 6 for Figure 5 Schematic diagram of the cross section at point CC.

[0038] in:

[0039] 10. Petal frame;

[0040] 20. Sealing skirt; 21. Sealing skirt body; 22. Sealing part; 221. Connection point; 222. Pocket structure; 223. Joint. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0042] Reference Figure 1Taking this heart valve structure as an example, a sealing skirt is placed on the outer periphery of the valve frame. This allows the sealing skirt to form a tight seal with the human valve annulus during valve implantation, thus solving the problem of paravalvular leakage. Normally, 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, facilitating the fit between the outer periphery of the sealing skirt and the human valve annulus, the irregularity of the human valve annulus structure often makes it difficult for the sealing skirt to form an effective seal with the human valve annulus at all circumferential positions. This leads to the problem of paravalvular leakage.

[0043] To achieve a better sealing fit, in some embodiments, the structure of the heart valve sealing skirt is designed with reference to... Figure 1 The sealing skirt 20 includes a sealing skirt body 21 that covers the petiole frame 10 circumferentially and one or more sealing portions 22 that surround the outside of the sealing skirt body.

[0044] The descriptions of circumferential and surrounding settings here are based on the installation state of the sealing skirt on the petiole frame, with the reference being a ring-shaped petiole frame structure. "Circumferential" refers to the direction along the circumference of the petiole frame, and "surrounding" setting means setting it around the petiole frame at least once in the circumferential direction. Similarly, "axial" mentioned later refers to the direction along the axis of the petiole frame.

[0045] Reference Figure 1 and Figure 2 One side of the sealing part 22 is sealed and connected to the sealing skirt body 21 in the circumferential direction of the sealing skirt. The other side of the sealing part 22 is connected to the sealing skirt body 21 at multiple spaced positions along the circumferential direction of the sealing skirt. The sealing part obtained by this connection method has multiple pocket-shaped structures 222 with openings facing the same side and arranged sequentially in the circumferential direction of the sealing skirt. The formed pocket-shaped structures 222 can be opened away from the sealing skirt body (i.e. away from the valve frame) under the action of the regurgitated blood in the heart.

[0046] It is easy to understand that the side of this pocket-shaped structure at the open end is relaxed in a free state, and its side length is generally greater than the straight-line distance between its two ends, so that it can be better stretched when subjected to blood pressure.

[0047] The sealing skirt body and the sealing part can be made of the same material. This material usually has a certain degree of flexibility and deformation ability, so that it can deform when subjected to external force, so that it can form a good fit with the human body valve annulus.

[0048] When a valve structure with this type of sealing skirt is implanted and regurgitation occurs, the pocket-shaped structure can be expanded under the pressure of the regurgitated blood in the heart, allowing the sealing part to better adapt to various irregular human valve annulus structures. At this time, the sealing skirt and the human valve annulus can achieve a better sealing fit, which effectively solves the problem of paravalvular leakage.

[0049] Reference Figure 2 , Figure 5 and Figure 6 The sealing part 22 of this structure is equivalent to an annular pocket, except that the opening end of the annular pocket is connected by multiple spaced connection points 221, which divide it into multiple small pocket-shaped structures arranged in sequence.

[0050] Therefore, the sealing part in this sealing skirt is also characterized by being set as multiple pocket-shaped structures that are continuous in the circumferential direction. By utilizing this continuous structural feature, there will be no leakage points at any position in the entire circumferential direction, and a good sealing fit can be formed with the human body valve ring at each position.

[0051] It's easy to imagine that this sealing part could be made of sheet material. One edge of the sheet is connected to the sealing skirt body, for example, by sewing or bonding, so that the sealing part can form a good seal with the sealing skirt body at that location. Then, the other edge of the sheet is connected to the sealing skirt body at multiple locations, and at each connection point, the sheet is connected to the sealing skirt body with stitches. Since the connection points are spaced a certain distance apart, a seal is formed between adjacent points. Figure 2 The pocket-shaped structure shown in the figure has multiple pocket-shaped structures with openings facing the same side and arranged continuously on the sealing skirt body in the circumferential direction.

[0052] In some embodiments, the sealing portion 22 can be obtained by folding the sealing skirt body towards one end of the sealing skirt at a certain position, and then connecting the free end of the folded portion to the sealing skirt body at multiple positions along the circumference of the sealing skirt. In this case, since one edge of the resulting sealing portion is directly obtained by folding, the connection operation at that position can be reduced during manufacturing. Furthermore, since the entire sealing portion adopts an integral structure, it can have good sealing performance at that position, and the sealing skirt has better overall integrity. The manufacturing of the sealing skirt is simpler and more convenient.

[0053] In some embodiments, the folded portion of the sealing part can be configured as a multi-layered structure; for example, after folding, a matching sheet is added to the folded portion to form a multi-layered structure, or the folded portion is folded multiple times to obtain a layered structure in which each layer is arranged sequentially, and then the free edge of the folded portion of the layered structure is connected to the sealing skirt body at multiple connection points by stitches. At this time, the sealing part can form a fluffy effect in the radial direction, which can make the sealing part and the human body valve ring fit better.

[0054] In some embodiments, refer to Figure 5 and Figure 6 The sealing part 22 can be obtained by folding the sealing skirt body at a certain position to form a layered sheet structure, then folding it towards one end of the sealing skirt, and then connecting the free end of the folded part to the sealing skirt body at multiple positions along the circumference of the sealing skirt. The resulting sealing part is a two-layer continuous layered structure, which gives the sealing part a good fluffy effect. Furthermore, this method allows for the easy formation of multiple continuous sealing parts of this structure at multiple positions on a single sealing skirt body during the manufacturing of the sealing skirt, giving the sealing skirt good integrity, such as... Figure 5 As shown.

[0055] The sealing part with the above structure on the sealing skirt can effectively solve the problem of periploidal leakage. When multiple sealing parts are set on the sealing skirt and the sealing parts are arranged sequentially along the axial direction of the sealing skirt, it is easy to understand that the arrangement of multiple sealing parts can better prevent periploidal leakage caused by backflow. Of course, the openings of the pocket-shaped structures on each sealing part on the sealing skirt are all arranged in the same direction.

[0056] by Figure 2 Taking the structure shown as an example, when the opening end of the sealing part 22 is connected to the sealing skirt body 21 at each connection point 221 using this connection method, a pocket-shaped structure 222 is formed between two adjacent connection points 221. At the positions corresponding to the two connection points on the sealing part 22, since it is directly connected to the sealing skirt body, a joint 223 that fits into the sealing skirt body is formed at this position. That is, a joint 223 is formed on both sides of each pocket-shaped structure 222 on the sealing part 22. As we know from the previous description, the sealing part as a whole forms an annular pocket structure on the sealing skirt body. Under the action of backflow pressure, when the pocket-shaped structure is opened away from the sealing skirt body (i.e., away from the valve frame), the joint position will also be opened away from the sealing skirt body (i.e., away from the valve frame) at the same time. However, the deformation caused by the opening is smaller than that of the pocket-shaped structure.

[0057] In other words, while the sealing portion at the joint position corresponding to each connection point can provide a certain sealing effect, the sealing effect at this position is somewhat worse than that at the pocket-shaped structure position. Providing multiple sealing portions 22 on the sealing skirt 20 can solve the sealing problem at this position to some extent. To achieve better results, in some embodiments, the pocket-shaped structures 222 of the sealing portions arranged adjacent to each other along the sealing skirt axial direction are staggered, so that in the axial direction of the sealing skirt, the openings of each pocket-shaped structure 222 of one sealing portion are exactly located at the joint position of two adjacent pocket-shaped structures 222 on another sealing portion. For example... Figure 2 As shown, the connection points 221 of adjacent sealing parts are staggered in the axial direction of the sealing skirt. Each connection point 221 on one sealing part is located precisely between two corresponding 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, among adjacent sealing parts, the pocket-shaped structures 222 of one sealing part are located precisely at positions corresponding to the joint portions 223 on the other sealing part. This ensures a good sealing effect at all circumferential positions on the sealing skirt.

[0058] On the other hand, the present invention also relates to a method for preparing the sealing skirt in the above embodiments, which is used for preparing the sealing skirt.

[0059] Based on the different structures that the sealing skirt can adopt, in some embodiments, one side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body at multiple spaced-apart positions. A sealing part with multiple pocket-shaped structures opening to the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the sealing skirt body (i.e. away from the valve frame) under the action of the regurgitated blood in the heart.

[0060] In some embodiments, the sealing skirt body may be folded at a certain position, and the free end of the folded portion may be connected to the sealing skirt body at multiple positions to obtain the sealing part.

[0061] In some embodiments, refer to Figure 3 , Figure 4 , Figure 5 and Figure 6 The sealing part can be obtained by pulling the sealing skirt body outward at a certain position and folding it to form a layered sheet structure, then folding it over, and connecting the free end of the folded part to the sealing skirt body at multiple positions.

[0062] In this embodiment, the above-described manufacturing method can be further used to form a plurality of sequentially arranged sealing portions on the sealing skirt body along the sealing skirt axis during the preparation of the sealing skirt.

[0063] In the preparation method of the above embodiments, the connection between the pocket-shaped structure on the sealing part and the sealing skirt body at the opening end can be achieved by stitching, and the connection points of each sealing part are staggered. In this case, the sealing part can form a shape on the sealing skirt body as shown in the image. Figure 2 The fish-scale-like structure shown.

[0064] Based on the sealing skirt structure in the above embodiments, the present invention also relates to a heart valve, wherein in some embodiments, reference is made to... Figure 1 The heart valve includes a valve frame and a sealing skirt as described in the above embodiment, and after the heart valve is implanted, the opening of the pocket-shaped structure of the sealing part is positioned towards the direction of cardiac regurgitation. Figure 1 Taking the mitral valve shown as an example, when the valve leaflets are open, the end where blood flows in is the inflow end, and the end where blood flows out is the outflow end. Cardiac regurgitation refers to blood flowing from the outflow end to the inflow end. Therefore, in order to prevent regurgitation, the opening of the pocket structure is set towards the outflow end of the valve.

[0065] Of course, in other embodiments, the heart valve is not limited to Figure 1 The mitral valve shown can also be other types of artificial valves, such as the tricuspid valve.

[0066] The specific implementation methods for preparing the sealing skirt have been clearly explained above. Here, it needs to be further explained that in the preparation of heart valves, the sealing skirt can be prepared first, and the sealing part can be prepared on the sealing skirt. Then, the prepared sealing skirt can be sewn onto the valve frame. Alternatively, the sealing skirt can be sewn directly onto the valve frame while the sealing part is formed on the sealing skirt.

[0067] In some embodiments, a method for preparing a heart valve includes:

[0068] The sealing skirt body is sewn to the valve frame along the circumference of the valve frame;

[0069] One side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple spaced positions by sutures. A sealing part with multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the sealing skirt body (i.e. away from the valve frame) under the action of regurgitated blood in the heart.

[0070] In this embodiment, during the fabrication of the sealing skirt, multiple sealing portions arranged sequentially can be formed on the sealing skirt body along the sealing skirt axis.

[0071] In some embodiments, during the fabrication of a heart valve, the sealing skirt body is folded at a certain position, and the free end of the folded portion is stitched to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple positions to obtain the sealing portion.

[0072] In this embodiment, during the fabrication of the sealing skirt, multiple sealing portions arranged sequentially can be formed on the sealing skirt body along the sealing skirt axis.

[0073] In some embodiments, during the fabrication of a heart valve,

[0074] The sealing skirt body is pulled outward at a certain position and folded to form a layered sheet structure. Then it is folded over and the free end of the folded part is sewn to the sealing skirt body or simultaneously to the sealing skirt body and the petal frame at multiple positions to obtain the sealing part.

[0075] In this embodiment, during the fabrication of the sealing skirt, multiple sealing portions arranged sequentially can be formed on the sealing skirt body along the sealing skirt axis.

[0076] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0077] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0078] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0079] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A sealing skirt for heart valves, characterized in that, The sealing skirt can be disposed on the outside of the valve arch along the circumference of the valve arch. The sealing skirt includes a sealing skirt body and at least one sealing part disposed around the outside of the sealing skirt body. One side of the sealing part is sealed to the sealing skirt body in the circumferential direction of the sealing skirt. The other side of the sealing part is connected to the sealing skirt body at multiple spaced positions along the circumferential direction of the sealing skirt, so that the resulting sealing part has multiple pocket-shaped structures with openings facing the same side and arranged sequentially in the circumferential direction of the sealing skirt. The pocket-shaped structure can be opened away from the valve arch by the action of regurgitated blood in the heart. The sealing part is obtained by folding the sealing skirt body at a certain position to form a layered sheet structure, then folding it towards one end of the sealing skirt, and connecting the free end of the folded part to the sealing skirt body at multiple positions along the circumference of the sealing skirt.

2. The sealing skirt for heart valves according to claim 1, characterized in that, The sealing part has a multi-layered structure.

3. The sealing skirt for heart valves according to claim 2, characterized in that, The sealing part is a layered structure in which each layer is arranged continuously in sequence.

4. The sealing skirt for a heart valve according to any one of claims 1-3, characterized in that, The sealing skirt includes multiple sealing parts, which are arranged sequentially along the axial direction of the sealing skirt, and the openings of the pocket-shaped structures on each sealing part are all oriented in the same direction.

5. The sealing skirt for a heart valve according to claim 4, characterized in that, The pocket-shaped structures of adjacent sealing parts are staggered, so that in the axial direction of the sealing skirt, the openings of each pocket-shaped structure of one sealing part are exactly located at the joint position of two adjacent pocket-shaped structures on another sealing part.

6. A method for preparing a sealing skirt for heart valves, characterized in that, One side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body at multiple spaced positions. A sealing part with multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body. The pocket-shaped structure of the sealing part can be opened away from the valve frame under the action of regurgitated blood from the heart. The sealing skirt body is folded at a certain position to form a layered sheet structure, and then folded again. The free end of the folded part is connected to the sealing skirt body at multiple positions to obtain the sealing part.

7. The method for preparing a sealing skirt for a heart valve according to claim 6, characterized in that, Multiple sealing sections are formed on the sealing skirt body along the axial direction of the sealing skirt.

8. A heart valve, characterized in that, It includes a valve frame and a sealing skirt for a heart valve as described in any one of claims 1-5, wherein after the heart valve is implanted, the opening of the pocket-shaped structure of the sealing part is positioned in the direction of cardiac regurgitation.

9. A method for preparing a heart valve, characterized in that, The sealing skirt is prepared using the preparation method described in claim 6 or 7, and then the prepared sealing skirt is attached to the valve frame.

10. A method for preparing a heart valve, characterized in that, include: The sealing skirt body is sewn to the valve frame along the circumference of the valve frame; One side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple spaced positions by sutures. A sealing part with multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the valve frame under the action of regurgitated blood in the heart. The sealing skirt body is folded at a certain position to form a layered sheet structure, then folded again, and the free end of the folded part is sewn to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple positions to obtain the sealing part.

11. A method for preparing a heart valve, characterized in that, include: The sealing skirt body is sewn to the valve frame along the circumference of the valve frame; One side of the sealing part is sealed to the sealing skirt body, and the other side of the sealing part is connected to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple spaced positions by sutures. A sealing part with multiple pocket-shaped structures with openings facing the same side and arranged sequentially is formed on the sealing skirt body, and the pocket-shaped structure of the sealing part can be opened away from the valve frame under the action of regurgitated blood in the heart. The sealing skirt body is folded at a certain position to form a layered sheet structure, and then folded over. The free end of the folded part is then sewn to the sealing skirt body or simultaneously to the sealing skirt body and the valve frame at multiple positions to obtain the sealing part. Multiple sealing sections are formed on the sealing skirt body along the axial direction of the sealing skirt.

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