Valve prosthesis and preparation method thereof

Abstract

The invention relates to the technical field of medical instruments, and provides a valve prosthesis and a preparation method thereof.The valve prosthesis comprises a valve frame and a flexible leakage-proof part arranged on the valve frame; the direction, where blood can flow, of the valve prosthesis is defined as the vertical direction, the valve frame comprises a positioning part which can be positioned on the upper side of a human heart valve ring, and the flexible leakage-proof piece comprises a containing part which can be filled with blood and is located on the lower side of the positioning part after being filled with the blood. The containing part comprises an inward extending section extending inwards in the radial direction of the valve frame and an edge part located on the edge of the inward extending section, at least part of the edge part extends outwards in the radial direction of the valve frame to form an outward extending section, and the outward extending section is located on the upper side of the inward extending section. According to the technical scheme, the problem of perivalvular leakage is solved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve prosthesis and a preparation method thereof. Background Art

[0002] Mitral stenosis or regurgitation is one of the common valvular diseases. Due to congenital abnormalities or acquired lesions, the mitral valve cannot close completely when the left ventricle contracts, causing part of the blood flowing from the left atrium to flow back into the left atrium, causing a series of pathological changes and clinical symptoms of the heart. In severe cases, it can lead to heart failure or even death.

[0003] The tissue structure of the mitral valve and annulus in the human heart is asymmetric and there are individual differences. It is difficult for the mitral valve replacement stent to maintain good wall adhesion in the presence of large differences, resulting in the problem of paravalvular leakage in the mitral valve replacement stent. Summary of the Invention

[0004] The technical problem to be solved by the present application is to provide a valve prosthesis and a preparation method thereof for solving the problem of paravalvular leakage.

[0005] In order to solve the above technical problems, this application adopts the following technical solutions: In a first aspect, the present application provides a valve prosthesis, comprising: a valve frame and a flexible leak-proof part arranged on the valve frame; the direction along which blood can flow through the valve prosthesis is defined as the up and down direction, the valve frame comprises a positioning portion that can be positioned on the upper side of the human heart valve ring, the flexible leak-proof part comprises a accommodating portion that can be filled with blood and is located on the lower side of the positioning portion after being filled with blood, the accommodating portion comprises an inward extending section extending inward along the radial direction of the valve frame and an edge portion located at the edge of the inward extending section, at least part of the edge portion extends radially outward along the valve frame to form an outward extending section, and the outward extending section is located on the upper side of the inward extending section.

[0006] In the process of implementing the above technical solution, the valve prosthesis includes a valve frame and a flexible leak-proof member disposed on the valve frame. The direction in which the valve prosthesis can accommodate blood flow is defined as the up-down direction. The valve frame includes a positioning portion that can be positioned on the upper side of the human heart valve annulus, thereby improving the stability between the valve frame and the human heart valve annulus; the flexible leak-proof member includes a receiving portion that can be filled with blood and is located below the positioning portion after being filled with blood. On the one hand, it can solve the problem of paravalvular leakage; on the other hand, when the receiving portion is filled with blood, blood gradually thrombus is filled in the receiving portion, thereby filling the gap between the valve prosthesis and the heart valve annulus, improving the fit between the valve prosthesis and the heart valve annulus, and reducing the problem of paravalvular leakage; the receiving portion includes an inwardly extending section extending inwardly along the radial direction of the valve frame and an edge portion located at the edge of the inwardly extending section, at least a portion of the edge portion extends radially outwardly along the valve frame to form an outwardly extending section, and the outwardly extending section is located on the upper side of the inwardly extending section, so that at least a portion of the receiving portion forms a chamber structure that is raised relative to the valve frame, facilitating blood entry into the receiving portion, thereby solving the problem of paravalvular leakage.

[0007] As an embodiment, the inwardly extending section extends along the circumference of the valve frame, and the inwardly extending section is provided with at least one gap for blood to be filled into the accommodating portion.

[0008] In the process of implementing the above technical solution, the inward extending section extends radially inward along the valve frame while also extending circumferentially along the valve frame, and the inward extending section is also provided with at least one gap for blood to fill into the accommodating portion. By setting the gap, the gap is connected to the accommodating portion, thereby facilitating blood to enter the accommodating portion through the gap, gradually thrombus-forming and filling the accommodating portion, further achieving the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0009] As an embodiment, the inwardly extending section extends along the circumference of the valve frame, and the inwardly extending section is provided with at least one through hole for blood to be filled into the accommodating portion.

[0010] In the process of implementing the above technical solution, the inward extending section extends radially inward along the valve frame while also extending circumferentially along the valve frame, and the inward extending section is also provided with at least one through hole for blood to fill into the accommodation portion. By providing the through hole, the through hole is connected to the accommodation portion, thereby facilitating blood to enter the accommodation portion through the through hole, gradually thrombus-forming and filling the accommodation portion, further achieving the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0011] As an embodiment, there are multiple inwardly extending segments, and the multiple inwardly extending segments are arranged at intervals along the circumference of the valve frame, and a flow port for blood to be filled into the accommodating portion is formed between every two adjacent inwardly extending segments.

[0012] In the process of implementing the above technical solution, there are multiple inward extending sections, and the multiple inward extending sections are arranged at intervals along the circumference of the valve frame. A flow opening for blood to fill into the accommodating portion is formed between every two adjacent inward extending sections, so that the accommodating portion has multiple flow openings in the circumference, which facilitates blood to enter the accommodating portion through the multiple flow openings, gradually thrombus-forming and filling the accommodating portion, further realizing the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0013] As an embodiment, the flexible leakage-proof member includes a first skirt sewn to the positioning portion, and the edge portion is connected to the first skirt or the positioning portion.

[0014] In the process of implementing the above technical solution, the flexible leakage-proof part includes a first skirt sewn to the positioning part, and the edge part is connected to the first skirt or the positioning part. Since the positioning part is located on the edge of the valve frame, the first skirt is connected to the positioning part, which can improve the stability between the first skirt and the valve frame. At the same time, the first skirt can stop the blood flow, so that the blood enters the accommodating part to reduce the blood flow, and the blood gradually coagulates to form a thrombus, which plays a sealing role; the edge part is connected to the first skirt or the positioning part, so that the edge part after connection forms a raised structure, and the corresponding accommodating part is also a raised chamber structure, which is convenient for blood to enter.

[0015] In one embodiment, the flexible leakage-proof member includes a second skirt sewn to the positioning portion, the second skirt is located under the first skirt, and an edge of the second skirt is connected to an edge of the first skirt.

[0016] In the process of implementing the above technical solution, the flexible leakage-proof part also includes a second skirt sewn to the positioning part, and the second skirt is located on the lower side of the first skirt. The first skirt and the second skirt cooperate together as the side wall of the accommodating part to seal the blood. The edge of the second skirt is connected to the edge of the first skirt to prevent blood from flowing out from the edge of the accommodating part, and also to prevent blood from other directions from flowing into the edge of the accommodating part, thereby improving the sealing of the accommodating part.

[0017] As an embodiment, the circumference of the portion of the second skirt extending in the radial direction is greater than the circumference of the portion of the first skirt extending in the radial direction.

[0018] In the process of implementing the above technical solution, the second skirt extends along the radial direction of the valve frame, and the first skirt includes at least two parts, one part of which extends along the radial direction of the valve frame, and the other part extends along the axial direction of the valve frame. Since the circumference of the part of the second skirt extending along the radial direction of the valve frame is greater than the circumference of the part of the first skirt extending along the radial direction of the valve frame, when the outer edges of the first skirt and the second skirt are sewed, in order to ensure that the outer edges of the second skirt are connected to the outer edges of the first skirt, an arch structure will be formed between the two adjacent suture positions of the second skirt to meet the suturing of the first skirt, so that the accommodating part is also a raised chamber structure, which makes it easier for blood to enter the interior of the accommodating part, avoiding the first skirt and the second skirt from being stuck together and affecting blood entry.

[0019] As an embodiment, the inwardly extending section is a curved structure along the radial direction.

[0020] In the process of implementing the above technical solution, since the inward extending section is a curved structure along the radial direction, the inward extending section is a curved structure in its initial form, so as to further improve the bulging effect of the accommodating portion, thereby facilitating blood to enter the accommodating portion.

[0021] As an embodiment, a connection position between the inwardly extending section and the first skirt or the positioning portion forms a plurality of continuous curved sections, and the inwardly extending section is one of them.

[0022] In the process of implementing the above technical solution, a plurality of continuous curved sections are formed at the connection position between the inward extending section and the first skirt cloth or the positioning portion, and the inward extending section is one of the sections, so that the thickness of the connection position between the inward extending section and the first skirt cloth or the positioning portion is greater than the thickness of the outer edges of the first skirt cloth and the second skirt cloth, so that the accommodating portion forms a local raised structure at the position of the flow port or the notch, which facilitates the entry of blood into the accommodating portion.

[0023] As an embodiment, the valve frame includes a first support body and a second support body connected to each other, the positioning portion is arranged on the second support body, the flexible leakage prevention part includes a third skirt, the first support body and the second support body partially overlap and clamp the third skirt, and the third skirt partially overlaps with the first skirt in the radial direction of the valve frame.

[0024] In the process of implementing the above technical solution, the valve frame includes a first support body and a second support body connected to each other, the positioning part is arranged on the second support body, the flexible leakage-proof part includes a third skirt, the first support body and the second support body partially overlap and clamp the third skirt, providing stable support for the third skirt; the third skirt partially overlaps with the first skirt in the radial direction of the valve frame, when the first support body and the second support body cooperate to clamp the heart valve ring, the first skirt and the third skirt circumferentially block the hollow areas on the first support body and the second support body, thereby forming a leakage-proof chamber, the first skirt and the third skirt serve as side walls of the leakage-proof chamber to prevent blood from flowing through the hollow areas on the first support body and the second support body.

[0025] As an embodiment, the first support body includes several first connection parts distributed in the circumferential direction and several second connection parts distributed in the circumferential direction, the first connection parts and the second connection parts are respectively staggered in the circumferential direction of the valve frame, and the connecting line of the several first connection parts and the connecting line of the several second connection parts are respectively located at different positions in the axial direction of the valve frame; the second support body includes several third connection parts distributed in the circumferential direction and several fourth connection parts distributed in the circumferential direction, and the several third connection parts are respectively connected to the positions of the several first connection parts, and the several fourth connection parts are respectively connected to the positions of the several second connection parts.

[0026] In the process of implementing the above technical solution, the first support body includes a plurality of first connection parts distributed in the circumferential direction and a plurality of second connection parts distributed in the circumferential direction, the first connection parts and the second connection parts are staggered in the circumferential direction of the valve frame, and the ring line formed by the connection line of the plurality of first connection parts and the ring line formed by the connection line of the plurality of second connection parts are respectively located at different positions in the axial direction of the valve frame, that is, the first connection part and the second connection part are respectively at different height positions of the valve frame; the second support body includes a plurality of third connection parts distributed in the circumferential direction and a plurality of fourth connection parts distributed in the circumferential direction, and the plurality of third connection parts are respectively connected to the positions of the plurality of first connection parts, and the plurality of fourth connection parts are respectively connected to the positions of the plurality of second connection parts. The first and second connection parts are respectively connected in a corresponding manner in the circumferential direction of the valve frame, and the third and fourth connection parts are also correspondingly staggered in the circumferential direction of the valve frame. In this way, the first support body and the second support body are connected at more circumferential points at the blood outflow end, thereby improving the stability of the first support body and the second support body; and the ring line formed by the connection line of multiple first connection parts and the ring line formed by the connection line of multiple second connection parts are respectively located at different positions in the axial direction of the valve frame. When the first support body and the second support body are connected, the fixed length of the first support body and the second support body in the axial direction is correspondingly extended, thereby improving the stability of the valve frame, and the overall anti-displacement ability of the valve prosthesis will be stronger.

[0027] As an embodiment, a second connection part is provided between two adjacent first connection parts, the first support body includes multiple groups of first connection units, each group of first connection units connects any second connection part and two adjacent first connection parts; the second support body includes multiple groups of second connection units, each group of second connection units connects any fourth connection part and two adjacent third connection parts; the first connection unit and the second connection unit are connected in corresponding positions.

[0028] In the process of implementing the above technical solution, a second connection portion is provided between two adjacent first connection portions, and the first support body includes multiple groups of first connection units, each group of first connection units connects any second connection portion to two adjacent first connection portions, thereby improving the structural stability of the first support body at the blood outflow end; the second support body includes multiple groups of second connection units, each group of second connection units connects any fourth connection portion to two adjacent third connection portions, thereby improving the structural stability of the second support body at the blood outflow end; the first connection unit and the second connection unit are connected in corresponding positions, thereby increasing the connection area between the first support body and the second support body, and improving the structural stability of both. At the same time, the loop formed by the connection line of the multiple first connection portions and the loop formed by the connection line of the multiple second connection portions are respectively located at different positions in the axial direction of the valve frame, which correspondingly extends the length of the first connection unit. Similarly, the length of the second connection unit on the second support body is also extended. Accordingly, when the first connection unit and the second connection unit are connected in corresponding positions, the connection area between the first support body and the second support body is further increased, and the structural stability of both is improved.

[0029] In a second aspect, the present application provides a method for preparing the valve prosthesis according to the first aspect, comprising the following steps: S1. providing the valve frame; S2, spraying a polymer solution into nanofibers under a high-voltage electric field, and weaving the fibers into a flexible leak-proof component; S3, pre-molding at least a portion of the flexible leakage-proof member into a curved structure by heat treatment; S4. Cut the flexible leak-proof member into at least two parts, respectively configured as a first skirt and a second skirt, wherein the first skirt and the second skirt are respectively connected to the positioning portion of the petal frame; wherein the second skirt needs to be cut into a through structure and needs to be cut into a plurality of inwardly extending segments extending radially inwardly; S5. The outer edges of the first skirt and the second skirt are sewn together, and the edge portion of the edge of the inward extending section at least partially extends radially outward along the valve frame to form an outward extending section. The outward extending section is located on the upper side of the inward extending section, and the outward extending section is connected to the positioning portion or the second skirt to form a receiving portion that can be filled with blood.

[0030] In the process of implementing the above technical solution, a polymer solution is selected to be sprayed into nanofibers under a high-voltage electric field, and the fibers are woven to form a flexible leak-proof part. Then, at least a part of the flexible leak-proof part is pre-molded into a curved structure by heat treatment. In this way, when the flexible leak-proof part is connected to the valve frame, the accommodating part formed can be in a raised state, which is convenient for blood to enter the accommodating part; the flexible leak-proof part is cut into at least two parts, which are respectively configured as a first skirt and a second skirt. The first skirt and the second skirt are respectively connected to the positioning part of the valve frame to improve stability. Qualitative; wherein, the second skirt needs to be cut into a through structure, and an inward extension section extending radially inward needs to be cut out; the outer edges of the first skirt and the second skirt are sewn together, and the edge portion of the edge of the inward extension section at least partially extends radially outward along the valve frame to form an outward extension section, and the outward extension section is located on the upper side of the inward extension section, and at least part of the accommodating portion forms a chamber structure that is raised relative to the valve frame, which facilitates blood to enter the accommodating portion and solves the problem of paravalvular leakage; and the outward extension section is connected to the positioning portion or to the second skirt to form a accommodating portion that can be filled with blood.

[0031] As an embodiment, in step S2, the cutting area of ​​the second skirt is larger than the cutting area of ​​the radially extending portion of the first skirt.

[0032] In the process of implementing the above technical solution, the cut second skirt extends along the radial direction of the valve frame, and the first skirt includes at least two parts, one part extends along the radial direction of the valve frame, and the other part extends along the axial direction of the valve frame. Since the area of ​​the cut second skirt extending along the radial direction of the valve frame is larger than the area of ​​the part of the first skirt extending along the radial direction of the valve frame, when the first skirt and the second skirt are sewed together, in order to ensure that the outer edges of the second skirt are connected to the outer edges of the first skirt, an arch structure will be formed between the two adjacent suture positions of the second skirt to meet the suturing of the first skirt, so that the accommodating part is also a raised chamber structure, which makes it easier for blood to enter the interior of the accommodating part, avoiding the first skirt and the second skirt from being stuck together and affecting blood entry. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0034] Figure 1 A schematic structural diagram of a valve prosthesis provided in an embodiment of the present application; Figure 2 A schematic structural diagram of a valve prosthesis provided in another embodiment of the present application; Figure 3 Schematic diagram of the structure of the valve prosthesis provided in different embodiments of the present application; Figure 4 For this application and Figure 1 Schematic diagrams of the structure of a valve prosthesis provided by the same embodiment from different perspectives; Figure 5 for Figure 4 Schematic diagram of the cross-sectional structure; Figure 6 Schematic diagram of the effects of the first skirt and the second skirt after pre-molding provided in an embodiment of the present application; Figure 7 A schematic structural diagram of a portion of a first skirt and a second skirt provided in an embodiment of the present application; Figure 8 A schematic diagram of the effect after a portion of the first skirt is connected to the second skirt provided in an embodiment of the present application; Figure 9 A schematic diagram of a partial structure of a receiving portion provided in an embodiment of the present application; Figure 10 A schematic diagram of the partial structure of a valve prosthesis provided in an embodiment of the present application; Figure 11 Schematic diagrams of different partial structures of the valve prosthesis provided in the embodiments of the present application; Figure 12 A schematic diagram of the relative positions of the valve prosthesis and heart tissue provided in an embodiment of the present application; Figure 13 A schematic diagram of the partial structure of the relative positions of the valve prosthesis and heart tissue provided in an embodiment of the present application.

[0035] Icons: 1-valve frame; 11-first support body; 111-first connecting part; 112-second connecting part; 113-first connecting unit; 12-second support body; 121-positioning part; 122-third connecting part; 123-fourth connecting part; 124-second connecting unit; 125-support body; 2-flexible leak-proof part; 21-second skirt; 211-inward extension section; 212-circulation port; 213-outward extension section; 214-notch; 215-through hole; 22-first skirt; 221-first leak-proof part; 222-second leak-proof part; 23-third skirt; 3-leak-proof chamber; 4-heart tissue; 5-artificial valve leaflet. DETAILED DESCRIPTION

[0036] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings in the embodiments of the present application.

[0037] It should be noted that similar reference numerals and letters represent similar items in the following figures. Therefore, once an item is defined in one figure, it does not need to be further defined or explained in subsequent figures. Furthermore, in the description of this application, the term "distal end" refers to the end of the components of the delivery device that is closest to the cardiac tissue, and "proximal end" refers to the end of the delivery device that is closest to the operator. The terms "first," "second," etc. are used solely to distinguish between the descriptions and should not be understood to indicate or imply relative importance.

[0038] On the first aspect, an embodiment of the present application provides a valve prosthesis, which allows blood to enter the accommodating portion after being anchored. After entering, the blood flow rate slows down, gradually thrombi are formed and fill the accommodating portion, and further fill the gap between the valve prosthesis and the heart valve annulus, thereby improving the fit between the valve prosthesis and the heart valve annulus and reducing the problem of paravalvular leakage.

[0039] like Figures 1 to 5 As shown in Figures 9, 10, 12 and 13, the valve prosthesis includes a valve frame 1 and a flexible leak-proof member 2 arranged on the valve frame 1. The direction in which the valve prosthesis can accommodate blood circulation is defined as the up-down direction. The valve frame 1 includes a positioning portion 121 that can be positioned on the upper side of the human heart valve ring, thereby improving the stability between the valve frame 1 and the human heart valve ring; the flexible leak-proof member 2 includes a receiving portion that can be filled with blood and is located on the lower side of the positioning portion 121 after the blood is filled. On the one hand, it can solve the problem of paravalvular leakage; on the other hand, when the receiving portion is filled with blood, it gradually becomes thrombus-filled in the receiving portion, thereby achieving The invention can fill the gap between the valve prosthesis and the heart valve ring, improve the fit between the valve prosthesis and the heart valve ring, and reduce the problem of paravalvular leakage; the accommodating portion includes an inward extending section 211 extending inward along the radial direction of the valve frame 1 and an edge portion located at the edge of the inward extending section 211, at least part of the edge portion extends radially outward along the valve frame 1 to form an outward extending section 213, and the outward extending section 213 is located on the upper side of the inward extending section 211, so that at least part of the accommodating portion forms a chamber structure that is raised relative to the valve frame 1, which facilitates blood to enter the accommodating portion and solves the problem of paravalvular leakage.

[0040] Optionally, the flexible leak-proof member 2 can be made of materials such as PET and PTFE.

[0041] like Figure 1 and 12 As shown, optionally, in an embodiment of the present application, the direction in which the valve prosthesis allows blood to flow refers to: the valve frame surrounds a blood channel for blood to flow through the valve prosthesis, and the upstream and downstream directions are defined according to the direction of blood passing through the blood channel. The accommodating portion is located on the lower side of the positioning portion 121. After the valve prosthesis is inserted, the blood will flow from the upstream direction, preferentially radially to the positioning portion 121, and secondly to the accommodating portion.

[0042] like Figure 2 As shown, as an embodiment, the inward extension section 211 extends radially inwardly of the valve frame 1 while also extending circumferentially of the valve frame 1, and the inward extension section 211 is also provided with at least one notch 214 for blood to fill into the accommodating portion. By providing the notch 214, the notch 214 is connected to the accommodating portion, thereby facilitating blood to enter the accommodating portion through the notch 214, gradually thrombus-forming and filling the accommodating portion, further achieving the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0043] Optionally, a plurality of notches 214 may be provided, and the notches 214 are opened on the edge of the inwardly extending section 211 located on the inner side of the valve frame 1 .

[0044] Optionally, the accommodating portion is a portion formed after the notch 214 is provided.

[0045] like Figure 3 As shown, as an implementation method parallel to the above-mentioned embodiment, the inward extension section 211 extends radially inwardly of the valve frame 1 while also extending circumferentially of the valve frame 1, and the inward extension section 211 is also provided with at least one through hole 215 for blood to fill into the accommodation portion. By providing the through hole 215, the through hole 215 is connected to the accommodation portion, thereby facilitating blood to enter the accommodation portion through the through hole 215, gradually thrombus-forming and filling the accommodation portion, further achieving the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0046] Optionally, a plurality of through holes 215 may be provided.

[0047] Optionally, the accommodation portion is a portion formed after the through hole 215 is provided.

[0048] like Figure 1 and 7 As shown, as an implementation method parallel to the above-mentioned embodiment, there are multiple inward extending sections 211, and the multiple inward extending sections 211 are arranged at intervals along the circumference of the valve frame 1. A flow opening 212 for blood to fill into the accommodation portion is formed between every two adjacent inward extending sections 211, so that the accommodation portion has multiple flow openings 212 in the circumference, which facilitates blood to enter the accommodation portion through the multiple flow openings 212, gradually thrombus-forming and filling the accommodation portion, further realizing the filling of the gap between the valve prosthesis and the heart valve ring, improving the fit between the valve prosthesis and the heart valve ring, and reducing the problem of paravalvular leakage.

[0049] like Figure 1 As shown, optionally, a plurality of inwardly extending segments 211 are evenly spaced along the circumference of the petal frame 1 .

[0050] like Figure 1and 5 As shown, optionally, the valve frame has a double-layer structure, including a first support body 11 and a second support body 12, the second support body 12 including a positioning portion 121 extending in a radial direction, the positioning portion 121 including multiple groups of positioning bodies, multiple positioning bodies are interconnected in the circumferential direction of the valve frame, each group of positioning bodies includes two positioning rods, one end of the two positioning rods converges, and the other two ends extend radially inward and are respectively connected to the positioning rods in the two adjacent groups of positioning portions; the second support body 12 also includes a support body 125 that encloses a blood channel, the support body 125 is connected to the positioning portion 121, the support body 125 includes multiple third connection parts 122 distributed in the circumferential direction and multiple fourth connection parts 123 distributed in the circumferential direction, the third connection parts 122 and the fourth connection parts 123 are correspondingly staggered in the circumferential direction of the valve frame 1, the support body 125 also includes multiple groups of second connection units 124, each group of second connection units 124 connects any fourth connection part 123 with two adjacent third connection parts 122, thereby forming a blood channel for blood circulation.

[0051] like Figure 5 、 10 As shown in Figure 11, as an embodiment, the flexible leakage-proof part 2 includes a first skirt 22 sewn to the positioning portion 121, and the edge portion is connected to the first skirt 22 or the positioning portion 121. Since the positioning portion 121 is located on the edge of the valve frame 1, the first skirt 22 is connected to the positioning portion 121, which can improve the stability between the first skirt 22 and the valve frame 1. At the same time, the first skirt 22 can stop the blood flow, so that the blood enters the accommodating portion to reduce the blood flow, and the blood gradually coagulates to form a thrombus, which plays a sealing role; the edge portion is connected to the first skirt 22 or the positioning portion 121, so that the edge portion after connection forms a raised structure, and the corresponding accommodating portion is also a raised chamber structure, which is convenient for blood to enter.

[0052] like Figure 5 As shown, optionally, the first skirt 22 includes a first leak-proof portion 221 extending radially and a second leak-proof portion 222 extending axially along the valve frame. The first leak-proof portion 221 can be arranged on the upper side or the lower side of the positioning portion 121; in some cases, the first skirt 22 can also be sprayed onto the positioning portion 121; the second leak-proof portion 222 is connected to the support body 125 and can be arranged on the inner side or the outer side of the support body 125; in some cases, the second leak-proof portion 222 can also be sprayed onto the support body 125.

[0053] Optionally, the first leak-proof part 221 can be a circular sheet structure. The part of the first leak-proof part 221 located at the outer edge constitutes a part of the flexible leak-proof part 2 and also serves as a part of the side wall of the accommodating part; the second leak-proof part 222 can be a columnar structure.

[0054] Optionally, the first leak-proof part 221 and the second leak-proof part 222 may be connected by sewing. Of course, the first leak-proof part 221 and the second leak-proof part 222 may also be an integral part.

[0055] like Figures 1 to 3 As shown in Figure 9, as an embodiment, the flexible leakage-proof member 2 further includes a second skirt 21 sewn to the positioning portion 121. The second skirt 21 is located on the lower side of the first skirt 22. The first skirt 22 and the second skirt 21 cooperate together as the side wall of the receiving portion to seal the blood. The edge of the second skirt 21 is connected to the edge of the first skirt 22 to prevent blood from flowing out of the edge of the receiving portion, and also to prevent blood from flowing in from other directions from the edge of the receiving portion, thereby improving the sealing of the receiving portion.

[0056] Optionally, the first skirt 22 and the second skirt 21 may be located on both sides of the positioning portion 121 , or both may be located on the lower side of the positioning portion 121 . In some cases, the first skirt 22 may be sprayed onto the positioning portion 121 .

[0057] Optionally, the outer edges of the first skirt 22 and the second skirt 21 may be connected by sewing.

[0058] Optionally, the second skirt 21 is provided with an inwardly extending section 211 , and the through hole 215 is opened on the second skirt 21 .

[0059] like Figures 1 to 5 As shown, optionally, the second skirt 21 can be an annular sheet structure, including an inwardly extending section 211, and the other part is a part of the flexible leak-proof member 2, which cooperates with the first leak-proof part 221 and can serve as the side wall on the other side of the accommodating part.

[0060] like Figure 7 and 8 As shown, as an embodiment, the circumference of the portion extending in the radial direction of the second skirt 21 is greater than the circumference of the portion extending in the radial direction of the first skirt 22. The second skirt 21 extends in the radial direction of the valve frame, and the first skirt 22 includes at least two parts, one part of which extends in the radial direction of the valve frame and is the first leak-proof portion 221, and the other part extends along the axial direction of the valve frame and is connected to the second leak-proof portion 222. Therefore, when the outer edges of the first skirt 22 and the second skirt 21 are sewed together, in order to ensure that the outer edges of the second skirt 21 are connected to the outer edges of the first skirt 22, an arch structure will be formed between the two adjacent suture positions of the second skirt 21 to meet the suturing of the first skirt 22, so that the accommodating portion is also a raised chamber structure, which makes it easier for blood to enter the interior of the accommodating portion, thereby avoiding the first skirt 22 and the second skirt 21 being stuck together and affecting the entry of blood.

[0061] Optionally, the circumference of the first leakage-proof portion 221 of the first skirt 22 is smaller than the circumference of the second skirt 21 .

[0062] As an embodiment, the inward extending section 211 is a curved structure along the radial direction, so that the inward extending section 211 is a curved structure in its initial form, so as to further enhance the bulging effect of the accommodating portion, thereby facilitating blood to enter the accommodating portion.

[0063] like Figure 6 As shown, optionally, the first skirt cloth 22 and the second skirt cloth 21 can be pre-molded into a continuous curled sheet structure by heat treatment before being sewn together. In this way, after the first skirt cloth 22 and the second skirt cloth 21 are sewn together, there are multiple raised structures on the upper and lower sides of the accommodating portion, which prevents the first skirt cloth 22 and the second skirt cloth 21 from fitting together, making it easier for blood to enter the accommodating portion.

[0064] like Figure 11 As shown, as an embodiment, the connection position of the inward extending section 211 and the first skirt 22 or the positioning portion 121 forms a plurality of continuous curved sections, and the inward extending section 211 is one of the sections, so that the thickness of the connection position of the inward extending section 211 and the first skirt 22 or the positioning portion 121 is greater than the thickness of the outer edges of the first skirt 22 and the second skirt 21, so that the accommodating portion forms a local raised structure at the position of the flow port 212 or the notch 214, which facilitates the entry of blood into the accommodating portion.

[0065] like Figure 5 and 10 As shown, as an embodiment, the valve frame 1 includes a first support body 11 and a second support body 12 connected to each other, the positioning portion 121 is arranged on the second support body 12, and the flexible leakage-proof part 2 includes a third skirt 23. The first support body 11 and the second support body 12 partially overlap and clamp the third skirt 23 to provide stable support for the third skirt 23; the third skirt 23 partially overlaps with the first skirt 22 in the radial direction of the valve frame 1. When the first support body 11 and the second support body 12 cooperate to clamp the heart valve ring, the first skirt 22 and the third skirt 23 circumferentially block the hollow areas on the first support body 11 and the second support body 12, thereby forming a leakage-proof chamber 3. The first skirt 22 and the third skirt 23 serve as side walls of the leakage-proof chamber 3 to prevent blood from flowing through the hollow areas on the first support body 11 and the second support body 12.

[0066] Optionally, the third skirt 23 may be an annular sheet structure, clamped by the first support body 11 and the second support body 12 at a position extending in the radial direction, and the first leak-proof portion 221 of the first skirt 22 partially overlaps with the third skirt 23 in the radial direction of the valve frame.

[0067] Optionally, in some cases, the third skirt 23 may also include a portion extending along the axial direction of the petal frame, which may be provided on the inner side or the outer side of the support body 125 ; in some cases, it may also be sprayed onto the support body 125 .

[0068] like Figure 1 and 4 As shown, as an embodiment, the first support body 11 includes a plurality of first connection parts 111 distributed in the circumferential direction and a plurality of second connection parts 112 distributed in the circumferential direction, the first connection parts 111 and the second connection parts 112 are staggered in the circumferential direction of the petal frame 1, and the ring line formed by the connection line of the plurality of first connection parts 111 and the ring line formed by the connection line of the plurality of second connection parts 112 are respectively located at different positions in the axial direction of the petal frame 1, that is, the first connection part 111 and the second connection part 112 are respectively at different height positions of the petal frame 1; the second support body 12 includes a plurality of third connection parts 122 distributed in the circumferential direction and a plurality of fourth connection parts 123 distributed in the circumferential direction, and the plurality of third connection parts 122 are respectively connected to the plurality of first connection parts 111, and the plurality of fourth connection parts 123 are respectively connected to the plurality of second connection parts The connection parts 112 are connected in corresponding positions, the first connection part 111 and the second connection part 112 are staggered in the circumferential direction of the valve frame 1, and the third connection part 122 and the fourth connection part 123 are also staggered in the circumferential direction of the valve frame 1. In this way, the first support body 11 and the second support body 12 are connected at more circumferential points at the blood outflow end, thereby improving the stability of the first support body 11 and the second support body 12; and the ring line formed by the connection line of multiple first connection parts 111 and the ring line formed by the connection line of multiple second connection parts 112 are respectively located at different positions in the axial direction of the valve frame 1. When the first support body 11 and the second support body 12 are connected, the fixed length of the first support body 11 and the second support body 12 in the axial direction is correspondingly extended, thereby improving the stability of the valve frame 1, and the overall anti-displacement ability of the valve prosthesis will be stronger.

[0069] Optionally, the first connection portion 111 and the second connection portion 112 are staggered in the circumferential direction of the valve frame 1, which means that the vertical projections of the first connection portion 111 and the second connection portion 112 on the plane are spaced apart.

[0070] Optionally, the first connection portion 111 and the second connection portion 112 are evenly spaced apart along the circumferential direction.

[0071] like Figure 1 and 4As shown, as an embodiment, a second connection portion 112 is provided between two adjacent first connection portions 111, and the first support body 11 includes multiple groups of first connection units 113, each group of first connection units 113 connects any second connection portion 112 to two adjacent first connection portions 111, thereby improving the structural stability of the first support body 11 at the blood outflow end; the second support body 12 includes multiple groups of second connection units 124, each group of second connection units 124 connects any fourth connection portion 123 to two adjacent third connection portions 122, thereby improving the structural stability of the second support body 12 at the blood outflow end; the first connection unit 113 and the second connection unit 113 are connected. The connection units 124 are connected at corresponding positions, thereby increasing the connection area between the first support body 11 and the second support body 12, and improving the structural stability of the two. At the same time, the ring line formed by the connection line of multiple first connection parts 111 and the ring line formed by the connection line of multiple second connection parts 112 are respectively located at different positions in the axial direction of the flap frame 1, and the length of the first connection unit 113 is correspondingly extended. Similarly, the length of the second connection unit 124 is also extended on the second support body 12. Accordingly, when the first connection unit 113 and the second connection unit 124 are connected at corresponding positions, the connection area between the first support body 11 and the second support body 12 is further increased, and the structural stability of the two is improved.

[0072] In a second aspect, the present application provides a method for preparing the valve prosthesis according to the first aspect, comprising the following steps: S1, injection molding or machining the petal frame 1; S2, spraying a polymer solution into nanofibers under a high-voltage electric field, and weaving the fibers into a flexible leak-proof component; S3, pre-molding at least a portion of the flexible leakage-proof member into a curved structure by heat treatment; A polymer solution is selected and sprayed into nanofibers under a high-voltage electric field, and the fibers are woven to form a flexible leak-proof member 2. Then, at least a portion of the flexible leak-proof member 2 is pre-molded into a curved structure by heat treatment. In this way, when the flexible leak-proof member 2 is connected to the valve frame 1, the accommodation portion formed can be in a raised state, making it easier for blood to enter the accommodation portion.

[0073] S4. Cut the flexible leak-proof member into at least two parts, respectively configured as a first skirt 22 and a second skirt 21. The first skirt 22 and the second skirt 21 are respectively connected to the positioning portion 121 of the petal frame 1. The second skirt 21 needs to be cut into a through structure and needs to be cut into a plurality of inwardly extending segments 211 extending radially inward. S5. The outer edges of the first skirt 22 and the second skirt are sewn together, and the edge portion of the edge of the inward extending section 211 at least partially extends radially outward along the valve frame to form an outward extending section 213. The outward extending section 213 is located on the upper side of the inward extending section 211, and the outward extending section 213 is connected to the positioning portion or the second skirt to form a receiving portion that can be filled with blood.

[0074] The flexible leak-proof part 2 is cut into at least two parts, which are respectively configured as a first skirt 22 and a second skirt 21. The first skirt 22 and the second skirt 21 are respectively connected to the positioning part 121 of the valve frame 1 to improve stability; wherein, the second skirt 21 needs to be cut into a through structure, and an inward extension section 211 extending radially inward needs to be cut; the outer edges of the first skirt 22 and the second skirt 21 are sewed together, and the edge of the edge of the inward extension section 211 at least partially extends radially outward along the valve frame 1 to form an outward extension section 213. The outward extension section 213 is located on the upper side of the inward extension section 211, and at least part of the accommodating part forms a chamber structure that is raised relative to the valve frame 1, which facilitates blood to enter the accommodating part and solves the problem of paravalvular leakage. The outward extension section 213 is connected to the positioning part 121 or the second skirt 21 to form a accommodating part that can be filled with blood.

[0075] like Figure 7 As shown, as an embodiment, in step S2 , the cutting area of ​​the second skirt fabric 21 is larger than the cutting area of ​​the radially extending portion of the first skirt fabric 22 .

[0076] In the process of implementing the above technical solution, the cut second skirt 21 extends along the radial direction of the valve frame, and the first skirt 22 includes at least two parts, one part extends along the radial direction of the valve frame, and the other part extends along the axial direction of the valve frame. Since the area of ​​the cut second skirt 21 extending along the radial direction of the valve frame is larger than the area of ​​the part of the first skirt 22 extending along the radial direction of the valve frame, when the first skirt 22 and the second skirt 21 are sewed, in order to ensure that the outer edges of the second skirt 21 are connected to the outer edges of the first skirt 22, an arch structure will be formed between the two adjacent suture positions of the second skirt 21 to meet the suturing of the first skirt 22, so that the accommodating part is also a raised chamber structure, which makes it easier for blood to enter the interior of the accommodating part, avoiding the first skirt 22 and the second skirt 21 being stuck together and affecting the entry of blood.

[0077] The above description is merely an embodiment of the present application and is not intended to limit the scope of protection of the present application. For those skilled in the art, various modifications and variations of the present application are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

[0078] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

[0079] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

Claims

1. A valve prosthesis, characterized in that: include: A petal frame and a flexible leak-proof member provided on the petal frame; The direction along which blood can flow through the valve prosthesis is defined as the up-down direction, the valve frame includes a positioning portion that can be positioned on the upper side of the human heart valve ring, the flexible leak-proof component includes a accommodating portion that can be filled with blood and is located below the positioning portion after being filled with blood, the accommodating portion includes an inward extending segment extending inward along the radial direction of the valve frame and an edge portion located at the edge of the inward extending segment, at least a portion of the edge portion extends radially outward along the valve frame to form an outward extending segment, and the outward extending segment is located on the upper side of the inward extending segment.

2. The valve prosthesis according to claim 1, characterized in that The inwardly extending section extends along the circumference of the valve frame, and the inwardly extending section is provided with at least one gap for blood to be filled into the accommodating portion.

3. The valve prosthesis according to claim 1, characterized in that The inwardly extending section extends along the circumference of the valve frame, and the inwardly extending section is provided with at least one through hole for blood to be filled into the accommodating portion.

4. The valve prosthesis according to claim 1, characterized in that There are multiple inwardly extending sections, which are spaced apart along the circumference of the valve frame, and a flow port for blood to be filled into the accommodation portion is formed between every two adjacent inwardly extending sections.

5. The valve prosthesis according to any one of claims 1 to 4, characterized in that: The flexible leakage-proof member includes a first skirt sewn to the positioning portion, and the edge portion is connected to the first skirt or the positioning portion.

6. The valve prosthesis according to claim 5, characterized in that The flexible leakage-proof member includes a second skirt sewn to the positioning portion, the second skirt is located on the lower side of the first skirt, and an edge of the second skirt is connected to an edge of the first skirt.

7. The valve prosthesis according to claim 6, characterized in that The circumference of the portion of the second skirt extending in the radial direction is greater than the circumference of the portion of the first skirt extending in the radial direction.

8. The valve prosthesis according to claim 7, characterized in that The inwardly extending section is a curved structure along the radial direction.

9. The valve prosthesis according to claim 5, characterized in that A connection position between the inwardly extending section and the first skirt or the positioning portion forms a plurality of continuous curved sections, and the inwardly extending section is one of the sections.

10. The valve prosthesis according to claim 6, characterized in that The valve frame includes a first support body and a second support body connected to each other, the positioning portion is arranged on the second support body, the flexible leakage prevention part includes a third skirt, the first support body and the second support body partially overlap and clamp the third skirt, and the third skirt partially overlaps with the first skirt in the radial direction of the valve frame.

11. The valve prosthesis according to claim 10, characterized in that: The first support body includes a plurality of first connecting portions distributed in the circumferential direction and a plurality of second connecting portions distributed in the circumferential direction, the first connecting portions and the second connecting portions are staggered in the circumferential direction of the valve frame, and a line connecting the plurality of first connecting portions and a line connecting the plurality of second connecting portions are located at different positions in the axial direction of the valve frame; The second support body includes several third connection parts distributed in the circumferential direction and several fourth connection parts distributed in the circumferential direction, and the several third connection parts are respectively connected to the positions of the several first connection parts, and the several fourth connection parts are respectively connected to the positions of the several second connection parts.

12. The valve prosthesis according to claim 11, characterized in that A second connecting portion is provided between two adjacent first connecting portions, the first supporting body includes a plurality of groups of first connecting units, and each group of first connecting units connects any second connecting portion with two adjacent first connecting portions; The second supporting body includes a plurality of groups of second connecting units, and each group of the second connecting units connects any one of the fourth connecting portions and two adjacent third connecting portions; The first connection unit and the second connection unit are connected at corresponding positions.

13. A method for preparing the valve prosthesis according to any one of claims 1 to 12, characterized in that: The steps include: S1. providing the valve frame; S2, spraying a polymer solution into nanofibers under a high-voltage electric field, and weaving the fibers into a flexible leak-proof component; S3, pre-molding at least a portion of the flexible leakage-proof member into a curved structure by heat treatment; S4. Cut the flexible leak-proof member into at least two parts, respectively configured as a first skirt and a second skirt, wherein the first skirt and the second skirt are respectively connected to the positioning portion of the petal frame; wherein the second skirt needs to be cut into a through structure and also needs to be cut into an inwardly extending section extending radially inwardly; S5. The outer edges of the first skirt and the second skirt are sewn together, and the edge portion of the edge of the inward extending section at least partially extends radially outward along the valve frame to form an outward extending section. The outward extending section is located on the upper side of the inward extending section, and the outward extending section is connected to the positioning portion or the second skirt to form a receiving portion that can be filled with blood.

14. The method according to claim 13, characterized in that In step S2, the cutting area of ​​the second skirt is larger than the cutting area of ​​the radially extending portion of the first skirt.

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