Valve prosthesis and preparation method therefor

Abstract

The present application relates to the technical field of medical devices, and provides a valve prosthesis, comprising a stent and a bag body arranged on the stent. The stent comprises an extension body that can be located on one side of a cardiac valve annulus, and the side of the extension body opposite to the cardiac valve annulus is an outer side. The bag body is located on the outer side of the extension body. The bag body is provided with an opening that allows blood to enter. By means of the technical solutions of the present application, the valve prosthesis can better fit the cardiac valve annulus, thereby solving the problem of perivalvular leakage.

Description

Valve prostheses and their preparation methods

[0001] Cross-reference to related applications

[0002] This disclosure claims priority to Chinese Patent Application No. 2024111774885, entitled "Valve Prosthesis", filed with the Chinese Patent Office on August 26, 2024.

[0003] Priority is also claimed to Chinese patent application No. 2025109314411, filed with the Chinese Patent Office on July 7, 2025, entitled “Valve Prosthesis and Preparation Method Thereof”. Technical Field

[0004] This application relates to the field of medical device technology, and more specifically, to a valve prosthesis. Background Technology

[0005] 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 some of the blood flowing from the left atrium into the left ventricle to flow back into the left atrium, causing a series of pathological changes and clinical symptoms in the heart. In severe cases, it can lead to heart failure or even death.

[0006] Most existing mitral valve replacement stents are cylindrical in shape, relying on the radial support provided by the stent's own elasticity after anchoring. However, the asymmetry of the mitral valve valve and annulus tissue structure in the human heart, coupled with individual differences, makes it difficult for mitral valve replacement stents to maintain good wall apposition even with significant variations, leading to paravalvular leakage. Summary of the Invention

[0007] The technical problem to be solved by this application is to provide a valve prosthesis that improves the fit with the heart valve annulus, thereby solving the problem of paravalvular leakage.

[0008] To solve the above-mentioned technical problems, this application adopts the following technical solution:

[0009] This application provides a valve prosthesis, comprising: a stent and a pouch disposed on the stent; the stent includes an extension that can be located on one side of the heart valve annulus, the side of the extension opposite to the heart valve annulus being the outer side; the pouch is located on the outer side of the extension; wherein the pouch has an opening that allows blood to enter.

[0010] In the implementation of the above technical solution, the stent includes an extension body that can be located on one side of the heart valve annulus after anchoring, and a pocket body located outside the extension body. When the stent is installed in place, the pocket body is between the extension body and the heart valve annulus, and the pocket body has an opening that allows blood to enter. In this way, after the valve prosthesis is anchored, blood will enter the pocket body through the opening, gradually thrombosis and fill the pocket body, further filling the gap between the stent and the heart valve annulus, improving the fit between the valve prosthesis and the heart valve annulus, and reducing the problem of paravalvular leakage.

[0011] Furthermore, the material used in this application to fill the space between the extension body and the heart valve annulus is a pouch, which has good fit and can accommodate different amounts of blood depending on the size of the gap between the stent and the heart valve annulus, thus improving the adaptability of the stent.

[0012] In one embodiment, the extension includes a plurality of first positioning units arranged circumferentially along the support; the bag body is located on the outer side of the plurality of first positioning units.

[0013] In the implementation of the above technical solution, multiple first positioning units are arranged along the circumference of the stent to improve the stability between the stent and the heart valve annulus; at the same time, the bag is located outside the multiple first positioning units, so that the bag is in an unfolded state and has a ring structure. After the valve prosthesis is anchored, when there is a gap between the valve prosthesis and the heart valve annulus, it is convenient for blood to enter the bag.

[0014] In one implementation, each of the first positioning units includes two first positioning rods, and the two first positioning rods in the same first positioning unit form a first connection point; the bag body is located outside the plurality of first connection points.

[0015] In the implementation of the above technical solution, two first positioning rods in the same first positioning unit are connected to form a first connection point, so that multiple first connection points are formed in the circumference of the stent, thereby improving the stability between the stent and the heart valve annulus; at the same time, the bag body is located outside the multiple first connection points, so that the bag body extends in the radial direction of the extension body, extending the length of the bag body in the radial direction, increasing the area of ​​the bag body that can seal the gap, and further reducing the problem of paravalvular leakage.

[0016] In one implementation, two adjacent first positioning rods in two adjacent first positioning units meet at a first node at one end facing downstream, and the bag body is located outside the first node.

[0017] In the implementation of the above technical solution, the two adjacent first positioning rods in the two adjacent first positioning units meet at the first node at the end facing downstream, thereby improving the stability of the support structure. In addition, the bag body is located outside the multiple first nodes, which also increases the coverage area of ​​the bag body and reduces the problem of periocular leakage.

[0018] In one embodiment, the bag body includes a first layer and a second layer, the first layer being connected to the support, and the second layer having a free edge portion; the free edge portion forms an opening in the bag body.

[0019] In the implementation of the above technical solution, the bag body is configured as a first layer and a second layer. The second layer is located outside the first layer along the radial direction of the support. The first layer is connected to the support to satisfy the stability between the bag body and the support. The second layer has a free edge, thereby forming an opening in the bag body to facilitate blood entering the bag body.

[0020] In one implementation, the free edge portion is located at the opposite end of the position where the second layer connects to the first layer, and the free edge portion is the entire edge of the second layer.

[0021] In the implementation of the above technical solution, the free edge is located at the relative edge of the connection between the second layer and the first layer, and the free edge is located at the entire edge of the second layer, which facilitates blood to enter the bag from all sides and reduces the problem of perivalvular leakage.

[0022] In one embodiment, the stent includes a support body connected to the extension body. The support body defines a flow channel for blood circulation. The extension body also includes a plurality of second positioning units arranged circumferentially along the support body. Each second positioning unit includes two second positioning rods. The two second positioning rods in the same second positioning unit are connected at the end away from the flow channel to form a second connection point. The first layer is connected to the second connection point.

[0023] In the implementation of the above technical solution, the stent includes a supporting body connected to an extension body. The supporting body encloses a flow channel for blood circulation. The extension body also includes multiple second positioning units arranged circumferentially along the supporting body. Each second positioning unit includes two second positioning rods. The two second positioning rods in the same second positioning unit are connected at the end away from the flow channel to form a second connection point, thereby improving the stability between the stent and the heart valve annulus. The first layer is also connected to the second connection point, further improving the stability between the bag and the stent and facilitating blood entry into the bag.

[0024] In one embodiment, the stent includes a support body connected to the extension body, the support body defining a flow channel for blood circulation, the extension body extending outward in a radial direction along the support body, and the bag body connected to the support body.

[0025] In the implementation of the above technical solution, the bag body is connected to the supporting body. Since the bag body has a free edge, it can be located outside the extension body so that blood can enter the bag body.

[0026] In one embodiment, the bag body is a polymer film or textile fabric.

[0027] In the implementation of the above technical solution, the bag body is a polymer membrane or textile fabric, which is convenient to sew or bond with the support. At the same time, the polymer membrane or textile fabric can also stop blood flow, allowing blood to enter the bag body to reduce blood flow and gradually coagulate to form a thrombus, thus playing a blocking role.

[0028] In one embodiment, the support body includes a plurality of first support units, each first support unit including a first support rod and a second support rod, and two second positioning rods in the same second positioning unit are respectively connected to the first support rod and the second support rod in two adjacent first support units.

[0029] In the implementation of the above technical solution, the support body includes multiple first support units, each first support unit includes a first support rod and a second support rod, and the two second positioning rods in the same second positioning unit are respectively connected to the first support rod and the second support rod in two adjacent first support units, so that the stent is hollow, which facilitates blood flow; at the same time, it also improves the stability of the stent.

[0030] In one implementation, the upstream ends of the first support rod and the second support rod are connected to form a third connection point; in two adjacent first support units, the downstream end of the second support rod in one first support unit meets the downstream end of the first support rod in the other first support unit at the third node.

[0031] In the implementation of the above technical solution, the upstream ends of the first support rod and the second support rod are connected to form a third connection point, thereby improving the structural stability of the support; in two adjacent first support units, the downstream end of the second support rod in one first support unit meets the downstream end of the first support rod in the other first support unit at the third node, thereby improving the structural stability of the support.

[0032] In one embodiment, the support body further includes multiple arc-shaped third support rods, with a first support unit spaced between two adjacent third support rods, and both ends of each third support rod are connected to the third node.

[0033] In the implementation of the above technical solution, the third support rod is set as an arc-shaped structure to facilitate the expansion or contraction of the support. Two adjacent third support rods are spaced apart by a first support unit, and both ends of each third support rod are connected to the third node to improve the stability of the support.

[0034] In one embodiment, the support body further includes a plurality of second support units, which are arranged circumferentially along the bracket; each second support unit includes a fourth support rod and a fifth support rod, the ends of the fourth support rod and the fifth support rod facing downstream are connected to form a fourth node; in two adjacent second support units, the upstream end of the fourth support rod in one second support unit and the upstream end of the fifth support rod in the other second support unit are respectively connected to the two ends of the third support rod.

[0035] In the implementation of the above scheme, the supporting body also includes multiple second supporting units. These multiple second supporting units are arranged along the circumference of the support, making the support a hollow structure. At the same time, each second supporting unit includes a fourth supporting rod and a fifth supporting rod. The downstream ends of the fourth and fifth supporting rods are connected to form a fourth node. In two adjacent second supporting units, the upstream end of the fourth supporting rod in one second supporting unit and the upstream end of the fifth supporting rod in the other second supporting unit are respectively connected to the two ends of the third supporting rod, which also improves the overall structural stability of the support.

[0036] In one embodiment, the stent further includes an abutment configured to abut against cardiac tissue, the abutment including a connecting portion located radially outward of the support body and connected to the support body; the support body is provided with a first connecting hole, and the connecting portion is provided with a second connecting hole; the valve prosthesis further includes a first connector for passing through the first connecting hole and the second connecting hole, and a second connector configured to connect the first connecting hole and the third support rod.

[0037] In the implementation of the above scheme, by setting an abutment body, which can cooperate with the extension body to abut against the inner and outer sides of the heart valve annulus respectively, the stability between the stent and the heart valve annulus is improved. The abutment body includes a connecting part located radially outside the support body and connected to the support body. The support body is provided with a first connecting hole, and the connecting part is provided with a second connecting hole, which facilitates the connection of the abutment body and the support body by the first connector, thereby improving the structural strength of the stent. The second connector can connect the first connecting hole and the third support rod together, further improving the structural stability of the stent. On the other hand, by setting an extension body, and the extension body being located radially outside the support body, and by adopting a double-layer stent structure, when releasing the valve prosthesis, the abutment body can be released first. At this time, the support body is not yet fully released. The position of the abutment body can be adjusted according to the actual situation, so that the abutment point of the abutment body is positioned on the inner side of the heart valve annulus, and then the support body is released to complete the release of the stent. In this way, after the sheath enters the target position before releasing the abutment, it is not necessary to precisely position the sheath before releasing the valve prosthesis. It is only necessary to release the abutment into the ventricular region inside the heart valve annulus. After releasing the abutment, the position of the sheath is finely adjusted so that the abutment point is positioned inside the heart valve annulus. Then the support body can be released directly. This improves the accuracy of positioning the first connection point and the abutment point on the outside and inside of the heart valve annulus, reduces the positioning difficulty of valve prosthesis release, and improves the convenience of operation.

[0038] In one embodiment, the abutment body further includes a plurality of first abutment units configured to abut against heart tissue, the plurality of first abutment units being arranged circumferentially along the support body; each first abutment unit includes two first abutment rods, the two first abutment rods in the same first abutment unit being connected at the edge of the abutment body to form an abutment point configured to abut against heart tissue; the two adjacent first abutment rods in two adjacent first abutment units converge at a fifth node at one end facing downstream.

[0039] In the implementation of the above scheme, the abutment body also includes multiple first abutment units configured to abut against the heart tissue. The multiple first abutment units are arranged circumferentially along the support body to improve the stability between the stent and the heart tissue. Each first abutment unit includes two first abutment rods. The two first abutment rods in the same first abutment unit are connected at the edge of the abutment body to form an abutment point configured to abut against the heart tissue, realizing multi-point positioning of the abutment body and the heart tissue. The structure is simple and the positioning stability is high.

[0040] This application provides a valve prosthesis, comprising: a valve frame and a flexible leak-proof component disposed on the valve frame; the direction in which blood can flow through the valve prosthesis is defined as the up-down direction, the valve frame including a positioning portion that can be positioned on the upper side of the human heart valve annulus, the flexible leak-proof component including a receiving portion that can be filled with blood and is located below the positioning portion after being filled with blood, the receiving portion including an inwardly extending segment extending inwardly along the radial direction of the valve frame and an edge portion located at the edge of the inwardly extending segment, at least a portion of the edge portion extending outwardly along the radial direction of the valve frame to form an outwardly extending segment, the outwardly extending segment being located above the inwardly extending segment.

[0041] In the implementation of the above technical solution, the valve prosthesis includes a valve frame and a flexible leak-proof component disposed on the valve frame. The direction of blood flow in the valve prosthesis is defined as the up-down direction. The valve frame includes a positioning part 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 component includes a receiving part that can be filled with blood and is located below the positioning part after being filled with blood. On the one hand, it can solve the problem of paravalvular leakage. On the other hand, when the receiving part is filled with blood, it gradually thrombusies and fills the receiving part, 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 part includes an inwardly extending section that extends inward along the radial direction of the valve frame and an edge part located at the edge of the inwardly extending section. At least a portion of the edge part extends outward along the radial direction of the valve frame to form an outwardly extending section. The outwardly extending section is located above the inwardly extending section, thereby forming a chamber structure that is raised relative to the valve frame, which facilitates the entry of blood into the receiving part and solves the problem of paravalvular leakage.

[0042] In one embodiment, the inwardly extending segment extends circumferentially along the valve frame, and the inwardly extending segment has at least one notch for blood to fill the receiving portion.

[0043] In the implementation of the above technical solution, the inward extension segment extends radially inward along the valve frame and also extends circumferentially along the valve frame. The inward extension segment also has at least one notch that allows blood to fill the receiving part. By setting the notch, the notch is connected to the receiving part, so that blood can easily enter the receiving part through the notch and gradually thrombose and fill the receiving part. This further realizes the filling of the gap between the valve prosthesis and the heart valve annulus, improves the fit between the valve prosthesis and the heart valve annulus, and reduces the problem of paravalvular leakage.

[0044] Alternatively, the inwardly extending section extends circumferentially along the valve frame, and the inwardly extending section has at least one through-hole for blood to fill the receiving portion.

[0045] In the implementation of the above technical solution, the inward extension section extends radially inward along the valve frame and also extends circumferentially along the valve frame. The inward extension section also has at least one through hole that allows blood to fill the receiving part. By setting the through hole, the through hole is connected to the receiving part, so that blood can easily enter the receiving part through the through hole, gradually thrombosis and fill the receiving part, further realizing the filling of 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.

[0046] Alternatively, there may be multiple inwardly extending segments, which are spaced apart circumferentially along the valve frame, with a flow port for blood to fill the receiving portion formed between every two adjacent inwardly extending segments.

[0047] In the implementation of the above technical solution, there are multiple inward extension segments, which are spaced apart circumferentially along the valve frame. A flow port for blood to fill the receiving part is formed between every two adjacent inward extension segments, so that there are multiple flow ports in the circumference of the receiving part. This allows blood to enter the receiving part through multiple flow ports, gradually thrombosis and filling the receiving part. This further fills the gap between the valve prosthesis and the heart valve annulus, improves the fit between the valve prosthesis and the heart valve annulus, and reduces the problem of paravalvular leakage.

[0048] In one embodiment, the flexible leak-proof component includes a first skirt fabric sewn to the positioning portion, and the edge portion is connected to the first skirt fabric or the positioning portion.

[0049] In the implementation of the above technical solution, the flexible leak-proof component includes a first skirt sewn onto the positioning part, and an edge portion connected to the first skirt or the positioning part. Since the positioning part is located on the edge of the valve frame, the connection between the first skirt and the positioning part can improve the stability between the first skirt and the valve frame. At the same time, the first skirt can stop the flow of blood, allowing blood to enter the receiving part and reduce the flow of blood, so that the blood gradually coagulates to form a thrombus, thus playing a sealing role. The edge portion is connected to the first skirt or the positioning part, so that the connected edge portion forms a raised structure, and the corresponding receiving part is also a raised chamber structure, which facilitates the entry of blood.

[0050] In one embodiment, the flexible leak-proof component includes a second skirt fabric sewn to the positioning portion, the second skirt fabric being located below the first skirt fabric, and the edge of the second skirt fabric being connected to the edge of the first skirt fabric.

[0051] In the implementation of the above technical solution, the flexible leak-proof component also includes a second skirt fabric sewn to the positioning part. The second skirt fabric is located below the first skirt fabric. The first skirt fabric and the second skirt fabric work together to serve as the side wall of the receiving part, which plays a role in blocking blood. The edge of the second skirt fabric is connected to the edge of the first skirt fabric to prevent blood from flowing out from the edge of the receiving part, and also to prevent blood from flowing in from other directions from the edge of the receiving part, thereby improving the sealing of the receiving part.

[0052] In one embodiment, the perimeter of the radially extending portion of the second skirt fabric is greater than the perimeter of the radially extending portion of the first skirt fabric.

[0053] In the implementation of 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 sewn together, in order to ensure that the outer edges of the second skirt are connected to the outer edges of the first skirt, an arched structure will be formed between two adjacent sewing positions of the second skirt to satisfy the sewing of the first skirt. This makes the receiving part a raised chamber structure, making it easier for blood to enter the receiving part and preventing the first skirt and the second skirt from sticking together and affecting blood entry.

[0054] In one embodiment, the inwardly extending section has a curved structure in the radial direction.

[0055] In the implementation of the above technical solution, since the inward extension section is a curved structure in the radial direction, the inward extension section is a curved structure in its initial form, so as to further improve the bulging effect of the receiving part, thereby facilitating the entry of blood into the receiving part.

[0056] In one embodiment, the inwardly extending section forms multiple continuous curved sections at the connection position with the first skirt fabric or the positioning part, and the inwardly extending section is one of these sections.

[0057] In the implementation of the above technical solution, the connection position between the inward extension section and the first skirt or the positioning part forms multiple continuous curved sections, and the inward extension section is one of them. This makes the thickness of the connection position between the inward extension section and the first skirt or the positioning part greater than the thickness of the outer edges of the first skirt and the second skirt. This makes the receiving part form a locally raised structure at the flow port or notch, which facilitates the entry of blood into the receiving part.

[0058] In one embodiment, the petal frame includes a first support body and a second support body connected to each other, the positioning part is disposed on the second support body, and the flexible leak-proof component 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 petal frame.

[0059] In the implementation of 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 disposed on the second support body. The flexible leak-proof component 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 and the first skirt partially overlap radially with each other on the valve frame. When the first support body and the second support body cooperate to clamp the heart valve annulus, the first skirt and the third skirt seal the hollow areas on the first support body and the second support body circumferentially, thereby forming a leak-proof chamber. The first skirt and the third skirt serve as the side walls of the leak-proof chamber, preventing blood from flowing through the hollow areas on the first support body and the second support body.

[0060] In one embodiment, the first support includes a plurality of first connecting portions distributed circumferentially and a plurality of second connecting portions distributed circumferentially, the first connecting portions and the second connecting portions being staggered circumferentially on the petiole frame, and the lines connecting the plurality of first connecting portions and the lines connecting the plurality of second connecting portions being located at different positions along the axial direction of the petiole frame; the second support includes a plurality of third connecting portions distributed circumferentially and a plurality of fourth connecting portions distributed circumferentially, the plurality of third connecting portions being connected to the plurality of first connecting portions in corresponding positions, and the plurality of fourth connecting portions being connected to the plurality of second connecting portions in corresponding positions.

[0061] In the implementation of the above technical solution, the first support includes a plurality of first connecting parts distributed circumferentially and a plurality of second connecting parts distributed circumferentially. The first connecting parts and the second connecting parts are staggered circumferentially on the petiole frame, and the loop formed by the lines connecting the plurality of first connecting parts and the loop formed by the lines connecting the plurality of second connecting parts are located at different positions on the axial direction of the petiole frame, that is, the first connecting parts and the second connecting parts are located at different heights on the petiole frame. The second support includes a plurality of third connecting parts distributed circumferentially and a plurality of fourth connecting parts distributed circumferentially. The plurality of third connecting parts are respectively connected to the plurality of first connecting parts at corresponding positions, and the plurality of fourth connecting parts are respectively connected to the plurality of second connecting parts. The valve prosthesis is connected in corresponding positions. The first and second connecting parts are offset circumferentially on the valve frame, and the third and fourth connecting parts are also offset circumferentially on the valve frame. In this way, the first and second supports achieve more circumferential point connections at the blood outflow end, improving the stability of the first and second supports. Furthermore, the loops formed by the lines connecting multiple first connecting parts and the loops formed by the lines connecting multiple second connecting parts are located at different positions on the valve frame axis. When the first and second supports are connected, the fixed length of the first and second supports in the axial direction is correspondingly extended, improving the stability of the valve frame and making the overall anti-displacement ability of the valve prosthesis stronger.

[0062] In one embodiment, a second connecting part is provided between two adjacent first connecting parts. The first support includes multiple sets of first connecting units, each set of first connecting units connecting any second connecting part to two adjacent first connecting parts. The second support includes multiple sets of second connecting units, each set of second connecting units connecting any fourth connecting part to two adjacent third connecting parts. The first connecting units and the second connecting units are connected in corresponding positions.

[0063] In the implementation of the above technical solution, a second connecting part is provided between two adjacent first connecting parts. The first support body includes multiple sets of first connecting units. Each set of first connecting units connects any second connecting part to two adjacent first connecting parts, thereby improving the structural stability of the first support body at the blood outflow end. The second support body includes multiple sets of second connecting units. Each set of second connecting units connects any fourth connecting part to two adjacent third connecting parts, thereby improving the structural stability of the second support body at the blood outflow end. The first connecting units and the second connecting units are connected in corresponding positions, thereby increasing the connection area between the first support body and the second support body and improving their structural stability. At the same time, the loop formed by the lines connecting multiple first connecting parts and the loop formed by the lines connecting multiple second connecting parts are located at different positions along the valve frame axis, which also correspondingly extends the length of the first connecting unit. Similarly, the length of the second connecting unit on the second support body is also extended. Accordingly, when the first connecting unit and the second connecting unit are connected in corresponding positions, the connection area between the first support body and the second support body is further increased, improving their structural stability.

[0064] This application provides a method for preparing the valve prosthesis described in the first aspect, comprising the following steps:

[0065] S1. Provide the valve frame;

[0066] S2. Select a polymer solution and spray it into nanofibers under a high voltage electric field, then weave the fibers to form a flexible leak-proof component;

[0067] S3. At least a portion of the flexible leak-proof component is pre-molded into a curved structure by heat treatment;

[0068] S4. Cut the flexible leak-proof component 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 petal frame. The second skirt needs to be cut into a through structure and also needs to be cut into multiple radially inwardly extending segments.

[0069] S5. The outer edges of the first skirt fabric and the second skirt fabric are sewn together. At least part of the edge of the inward extension section extends radially outward along the valve frame to form an outward extension section. The outward extension section is located above the inward extension section, and the outward extension section is connected to the positioning part or the second skirt fabric to form a receiving part that can be filled with blood.

[0070] In the implementation of the above technical solution, a polymer solution is sprayed into nanofibers under a high-voltage electric field. These fibers are then woven to form a flexible leak-proof component. At least a portion of the flexible leak-proof component is pre-molded into a curved structure through heat treatment. This allows the receiving portion formed when the flexible leak-proof component is connected to the valve frame to be raised, facilitating blood entry into the receiving portion. The flexible leak-proof component is cut into at least two parts, respectively configured as a first skirt and a second skirt. The first and second skirts are respectively connected to the positioning portion of the valve frame, improving stability. Qualitatively, the second skirt needs to be cut into a through-structure, and an inwardly extending section extending radially inward needs to be cut out; the outer edges of the first and second skirts are sewn together, and at least part of the edge of the inwardly extending section extends radially outward along the valve frame to form an outwardly extending section. The outwardly extending section is located above the inwardly extending section, and at least part of the receiving part forms a chamber structure that is raised relative to the valve frame, which facilitates blood entry into the receiving part and solves the problem of paravalvular leakage; and the outwardly extending section is connected to the positioning part or the second skirt to form a receiving part that can be filled with blood.

[0071] In one embodiment, in step S2, the cutting area of ​​the second skirt fabric is greater than the cutting area of ​​the radially extended portion of the first skirt fabric.

[0072] In the implementation of the above technical solution, the cut second skirt extends along the radial direction of the valve frame, while the first skirt includes at least two parts, one part extending along the radial direction of the valve frame and the other part extending 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 first skirt extending along the radial direction of the valve frame, when the first and second skirts are sewn together, in order to ensure that the outer edges of the second skirt are connected to the outer edges of the first skirt, an arched structure will be formed between two adjacent sewing positions of the second skirt to satisfy the sewing of the first skirt. This makes the receiving part a raised chamber structure, allowing blood to enter the receiving part more easily and preventing the first and second skirts from sticking together and affecting blood entry. Attached Figure Description

[0073] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0074] Figure 1 is a schematic diagram of the valve prosthesis provided in an embodiment of this application;

[0075] Figure 2 is a schematic diagram of the valve prosthesis provided in the embodiment of this application from different perspectives;

[0076] Figure 3 is a structural schematic diagram of the valve prosthesis provided in the embodiment of this application from another perspective;

[0077] Figure 4 is a structural schematic diagram of the valve prosthesis provided in an embodiment of this application from another perspective;

[0078] Figure 5 is a partial view of the structure of the valve prosthesis after release according to an embodiment of this application;

[0079] Figure 6 is a cross-sectional structural diagram of the valve prosthesis provided in the embodiment of this application;

[0080] Figure 7 is a structural schematic diagram of another valve prosthesis provided in an embodiment of this application;

[0081] Figure 8 is a structural schematic diagram of a valve prosthesis provided in another embodiment of this application;

[0082] Figure 9 is a schematic diagram of the structure of the valve prosthesis provided in different embodiments of this application;

[0083] Figure 10 is a structural schematic diagram of the valve prosthesis provided in this application and Figure 7 is a schematic diagram of the same embodiment provided in the same application from different perspectives;

[0084] Figure 11 is a schematic cross-sectional view of the structure in Figure 10;

[0085] Figure 12 is a schematic diagram of the effect of the first skirt fabric and the second skirt fabric after pre-plasticizing according to the embodiment of this application;

[0086] Figure 13 is a partial structural diagram of the first skirt fabric and the second skirt fabric provided in the embodiment of this application;

[0087] Figure 14 is a schematic diagram showing the effect of connecting a portion of the first skirt fabric with the second skirt fabric according to an embodiment of this application;

[0088] Figure 15 is a partial structural schematic diagram of the receiving portion provided in an embodiment of this application;

[0089] Figure 16 is a partial structural schematic diagram of the valve prosthesis provided in an embodiment of this application;

[0090] Figure 17 is a schematic diagram of different partial structures of the valve prosthesis provided in the embodiments of this application;

[0091] Figure 18 is a schematic diagram showing the relative position of the valve prosthesis and heart tissue provided in the embodiments of this application;

[0092] Figure 19 is a partial structural diagram showing the relative position of the valve prosthesis and heart tissue provided in the embodiment of this application.

[0093] Icons: 1-Extension; 11-First Positioning Unit; 111-First Positioning Rod; 112-First Connection Point; 113-First Node; 12-Second Positioning Unit; 121-Second Positioning Rod; 122-Second Connection Point; 123-Second Node; 13-First Support Unit; 131-First Support Rod; 132-Second Support Rod; 133-Third Connection Point; 134-Third Node; 135-Third Support Rod; 14-Second Support Unit; 141-Fourth Support Rod; 142-Fifth Support Rod; 143-Fourth Node; 2-Abutting Body; 21-Connecting Part; 211-Second Connecting Hole; 22-First Abutting Unit; 221-First Abutting Rod; 222-Abutting Point; 223-Fifth Node; 3-Bag Body; 31-Opening; 32-First Layer; 33-Second Layer;

[0094] In another embodiment, the icons in the aforementioned embodiments are not used consecutively, and the labels in Figures 7 to 19 related to this embodiment are renumbered: 1-valve frame; 11-first support; 111-first connecting part; 112-second connecting part; 113-first connecting unit; 12-second support; 121-positioning part; 122-third connecting part; 123-fourth connecting part; 124-second connecting unit; 125-support body; 2-flexible leak-proof component; 21-second skirt; 211-inward extension section; 212-flow 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 Implementation

[0095] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0096] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are configured only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0097] As shown in Figures 1, 2, 5, and 6, this application provides a valve prosthesis including a stent and a pocket 3 disposed on the stent. The stent includes an extension 1 that can be anchored to one side of the heart valve annulus. The pocket 3 is located outside the extension 1. When the stent is installed, the pocket 3 is between the extension 1 and the heart valve annulus, and the pocket 3 has an opening 31 that allows blood to enter. In this way, after the valve prosthesis is anchored, blood will enter into the pocket 3 through the opening 31, the flow rate will slow down, and blood will gradually thrombose and fill the pocket 3. This will further fill the gap between the stent and the heart valve annulus, improve the fit between the valve prosthesis and the heart valve annulus, and reduce the problem of paravalvular leakage.

[0098] Optionally, the outer side of the extension body 1 refers to the outer surface of the extension body 1, that is, the outer peripheral side of the extension body 1 located radially outward.

[0099] Optionally, the pocket 3 is filled between the extension body 1 and the heart valve annulus, which has good fit. Depending on the size of the gap between the stent and the heart valve annulus, different amounts of blood can be injected, thus improving the adaptability of the stent.

[0100] Optionally, the opening 31 of the bag body 3 can be formed in a circumferential circle, or several openings 31 can be spaced out along the circumferential circle.

[0101] Optionally, the bag 3 can be sewn onto the stent, or in some cases, it can be covered onto the surface of the stent by means of a film.

[0102] Optionally, the material of the bag body 3 can be a polymer film or non-woven fabric.

[0103] Optionally, a portion of the bag body 3 can be fixed to the support body instead of the outside of the extension body 1, and the bag body 3 has a free edge. Therefore, the bag body 3 can be located on the outside of the extension body 1 even if it is not fixed to the outside of the extension body 1. Of course, as a preferred embodiment, the bag body 3 can be fixed to the outside of both the support body and the extension body 1 to improve the stability between the bag body 3 and the support.

[0104] Optionally, the direction of blood flow can be defined as upstream and downstream, with the upstream direction being the outer side of the heart valve annulus and the downstream direction being the inner side of the heart valve annulus.

[0105] As shown in Figures 1 and 5, in one embodiment, the extension body 1 includes multiple first positioning units 11, which are arranged circumferentially along the stent to achieve multi-point positioning of the stent and improve the stability between the stent and the heart valve annulus. At the same time, the bag body 3 is located outside the multiple first positioning units 11, so that the bag body 3 is in an unfolded state and has a ring structure. After the valve prosthesis is anchored, when there is a gap between the valve prosthesis and the heart valve annulus, it is convenient for blood to enter the bag body 3.

[0106] Optionally, the bag body 3 can be connected to multiple first positioning units 11 to improve the stability between the bag body 3 and the extension body 1.

[0107] As shown in Figure 1, in one embodiment, each first positioning unit 11 includes two first positioning rods 111. The two first positioning rods 111 in the same first positioning unit 11 are connected to form a first connection point 112, so that the stent has multiple first connection points 112 in the circumferential direction, which improves the stability between the stent and the heart valve annulus. At the same time, the bag body 3 is located outside the multiple first connection points 112, so that the bag body 3 extends in the radial direction of the extension body 1, extending the radial length of the bag body 3, increasing the area that the bag body 3 can seal the gap, and further reducing the problem of paravalvular leakage.

[0108] Optionally, the bag body 3 can be connected to multiple first connection points 112, which improves the stability between the bag body 3 and the extension body 1, and also reduces the free state of the bag body 3 at the first connection point 112, making it easier for blood to enter the bag body 3 and form a thrombus.

[0109] Optionally, the bag body 3 can be connected to a section of the extension body 1 or to the entire extension body 1.

[0110] As shown in Figure 1, in one embodiment, two adjacent first positioning rods 111 in two adjacent first positioning units 11 converge at the first node 113 at one end facing downstream, thereby improving the stability of the support structure. In addition, the bag body 3 is located outside the multiple first nodes 113, which also increases the coverage area of ​​the bag body 3 and reduces the problem of periocular leakage.

[0111] Optionally, the bag body 3 can be connected to the first node 113, which improves the stability between the bag body 3 and the support.

[0112] As shown in Figures 2, 5 and 6, in one embodiment, the bag body 3 is configured as a first layer 32 and a second layer 33, wherein the second layer 33 is located outside the first layer 32 along the radial direction of the support, the first layer 32 is connected to the support to satisfy the stability between the bag body 3 and the support, and the second layer 33 has a free edge portion, thereby forming an opening 31 in the bag body 3 to facilitate blood entering the bag body 3.

[0113] Optionally, the first layer 32 is connected to the first node 113, the first connection point 112, and the first positioning unit 11. The first layer 32 and the second layer 33 can be two independent layered structures, that is, the first layer 32 is sewn to the second layer 33 at the opposite edge of the free edge of the second layer 33, and the connecting edge of the first layer 32 and the second layer 33 can also be connected to multiple first connection points 112. Of course, the bag body 3 can also be integrally formed, that is, the first layer 32 and the second layer 33 are a whole structure.

[0114] In one implementation, the free edge portion is located at the opposite edge of the connection between the second layer 33 and the first layer 32, and the free edge portion is located at the entire edge of the second layer 33, thereby facilitating blood to enter the bag body 3 from all sides and reducing the problem of perivalvular leakage.

[0115] Optionally, if the bag body 3 is a one-piece structure, the free edge of the second layer 33 is located at the opposite edge where the second layer 33 and the first layer 32 form a bent edge; if the first layer 32 and the second layer 33 are two independent structures, the free edge is located at the opposite edge where the first layer 32 and the second layer 33 are connected.

[0116] As shown in Figure 3, in one embodiment, the stent includes a support body connected to an extension body 1. The support body encloses a flow channel for blood circulation. The extension body 1 also includes multiple second positioning units 12, which are arranged circumferentially along the support body. Each second positioning unit 12 includes two second positioning rods 121. The two second positioning rods 121 in the same second positioning unit 12 are connected at the end away from the flow channel to form a second connection point 122, thereby improving the stability between the stent and the heart valve annulus. The first layer 32 is connected to the second connection point 122, further improving the stability between the bag body 3 and the stent, and also facilitating blood entry into the bag body 3.

[0117] Optionally, the first connection point 112 protrudes from the second connection point 122 in a direction away from the flow channel. On the one hand, this allows the stent to form multiple support points that contact the heart tissue in the radial direction, thereby improving the stability of the stent and the heart tissue. On the other hand, it can also allow the bag body 3 to have multiple connection positions in the radial direction, thereby improving the stability between the bag body 3 and the stent.

[0118] As a parallel implementation, the stent also includes a support body connected to the extension body 1, and a bag body 3 connected to the support body. Since the bag body 3 has a free edge, in this embodiment, unlike other embodiments, the bag body 3 only needs to be connected to the support body and not to the extension body 1, so that the bag body 3 can be located outside the extension body 1 to allow blood to enter the bag body 3.

[0119] Optionally, the support body and the extension body 1 are integrally formed to meet the structural strength requirements of the bracket.

[0120] In one implementation, the bag body 3 is made of polymer film or textile fabric, which is convenient to sew or bond with the support. At the same time, the polymer film or textile fabric can also stop blood flow, allowing blood to enter the bag body 3 to reduce blood flow and gradually coagulate to form a thrombus, thus playing a sealing role.

[0121] As shown in Figure 3, in one embodiment, the support body includes multiple first support units 13. Each first support unit 13 includes a first support rod 131 and a second support rod 132. The two second positioning rods 121 in the same second positioning unit 12 are respectively connected to the first support rod 131 and the second support rod 132 in two adjacent first support units 13, so that the stent is hollow, which facilitates blood flow and also improves the stability of the stent.

[0122] As shown in Figure 3, optionally, the two first positioning rods 111 of the first positioning unit 11 and the two second positioning rods 121 of the second positioning unit 12 in the same extending direction meet at the second node 123 at one end facing the downstream direction, thereby further improving the structural strength of the support.

[0123] As shown in Figure 3, in one embodiment, the upstream ends of the first support rod 131 and the second support rod 132 are connected to form a third connection point 133, thereby improving the structural stability of the support; in two adjacent first support units 13, the downstream end of the second support rod 132 in one first support unit 13 meets the downstream end of the first support rod 131 in the other first support unit 13 at a third node 134, thereby improving the structural stability of the support.

[0124] As shown in Figure 4, in one embodiment, the third support rod 135 is set into an arc-shaped structure to facilitate the expansion or contraction of the support. Two adjacent third support rods 135 are spaced apart by a first support unit 13, and both ends of each third support rod 135 are connected to the third node 134 to improve the stability of the support.

[0125] As shown in Figure 4, in one embodiment, the support body also includes multiple second support units 14. The multiple second support units 14 are arranged along the circumference of the support, making the support a hollow structure. At the same time, each second support unit 14 includes a fourth support rod 141 and a fifth support rod 142. The downstream ends of the fourth support rod 141 and the fifth support rod 142 are connected to form a fourth node 143. In two adjacent second support units 14, the upstream end of the fourth support rod 141 in one second support unit 14 and the upstream end of the fifth support rod 142 in the other second support unit 14 are respectively connected to the two ends of the third support rod 135, which also improves the overall structural stability of the support.

[0126] As shown in Figures 1, 2, and 6, in one embodiment, the stent further includes an abutment 2 configured to abut against the heart tissue. By providing the abutment 2, it can cooperate with the extension 1 to abut against the inner and outer sides of the heart valve annulus, respectively, improving the stability between the stent and the heart valve annulus. The abutment 2 includes a connecting portion 21 located radially outward of the support body and connected to the support body. The support body is provided with a first connecting hole, and the connecting portion 21 is provided with a second connecting hole 211, facilitating the connection of the abutment 2 and the support body by a first connector, thereby improving the stability of the stent. Structural strength; the second connector can connect the first connecting hole and the third support rod 135 together, further improving the structural stability of the stent; on the other hand, by setting the extension body 1, and the extension body 1 being located on the radial outer side of the support body, by adopting a double-layer stent structure, when releasing the valve prosthesis, the abutment body 2 can be released first. At this time, the support body is not yet fully released. The position of the abutment body 2 can be adjusted according to the actual situation, so that the abutment point 222 of the abutment body 2 is positioned on the inner side of the heart valve annulus, and then the support body is released to complete the release of the stent. In this way, after the sheath enters the target position before releasing the abutment 2, it is not necessary to precisely locate the position of the sheath before releasing the valve prosthesis. It is only necessary to release the abutment 2 into the ventricular region inside the heart valve annulus. After releasing the abutment 2, the position of the sheath is finely adjusted so that the abutment point 222 of the abutment 2 is located inside the heart valve annulus. Then the support body can be released directly. This improves the accuracy of locating the first connection point 112 and the abutment point 222 on the outside and inside of the heart valve annulus, reduces the positioning difficulty of valve prosthesis release, and improves the convenience of operation.

[0127] Optionally, the connection between the supporting body and the abutment 2 can be either rigid or flexible. For example, the first connector can be a rivet or screw, which passes through the first connecting hole and the second connecting hole 211 to rigidly connect the supporting body and the abutment 2; or, the first connector can be a pull wire or a soft rope, which passes through the first connecting hole and the second connecting hole 211 and is knotted to flexibly connect the supporting body and the abutment 2. Of course, the specific first connector can be determined according to the actual situation.

[0128] Optionally, the second connector can be a pull wire or a soft rope, which can pass through the first connecting hole and be wrapped around the third support rod 135 to achieve the connection between the support body and the third support rod 135.

[0129] Optionally, an abutment 2 can be provided on the radially outer side of the support body, which can also serve to clamp the first layer 32.

[0130] Optionally, in some cases, the first layer 32 may also be connected to the abutment 2.

[0131] As shown in Figures 1, 2, and 5, in one embodiment, the abutment body 2 further includes a plurality of first abutment units 22 configured to abut against the heart tissue. The plurality of first abutment units 22 are arranged circumferentially along the support body to improve the stability between the stent and the heart tissue. Each first abutment unit 22 includes two first abutment rods 221. The two first abutment rods 221 in the same first abutment unit 22 are connected at the edge of the abutment body 2 to form an abutment point 222 configured to abut against the heart tissue, thereby realizing multi-point positioning of the abutment body 2 and the heart tissue. The structure is simple and the positioning stability is high.

[0132] Optionally, the abutment 2 can be abutted against the inside of the heart valve annulus.

[0133] Optionally, two adjacent first abutting rods 221 in two adjacent first abutting units 22 converge at the fifth node 223 in the downstream direction. The abutting body 2 also includes a second abutting unit, which includes two second abutting rods. The edge of the first layer 32 can be fixed to the second abutting rods to improve the stability between the bag body 3 and the support. The ends of the two second abutting rods in the upstream direction converge at the fifth node 223, and the ends in the downstream direction converge to form a connecting part 21.

[0134] In addition, this application provides another type of valve prosthesis. After anchoring, blood can enter the receiving portion of the prosthesis. Upon entry, the blood flow slows down, gradually thrombotic and filling the receiving portion, further 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 paravalvular leakage. It should be noted that in this embodiment, the icons from the previous embodiments are not used consecutively, and the labels in Figures 7 to 19 related to this embodiment are renumbered.

[0135] As shown in Figures 7 to 11, 15, 16, 18, and 19, the valve prosthesis includes a valve frame 1 and a flexible leak-proof component 2 disposed on the valve frame 1. The direction of blood flow in the valve prosthesis is defined as the vertical direction. The valve frame 1 includes a positioning part 121 that can be positioned on the upper side of the human heart valve annulus, thereby improving the stability between the valve frame 1 and the human heart valve annulus. The flexible leak-proof component 2 includes a receiving part that can be filled with blood and is located below the positioning part 121 after being filled with blood. On the one hand, it can solve the problem of paravalvular leakage; on the other hand, when the receiving part is filled with blood, it gradually thrombusies and fills the receiving part. The internal structure fills 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 paravalvular leakage. The receiving portion includes an inwardly extending segment 211 extending inward along the radial direction of the valve frame 1 and an edge portion located at the edge of the inwardly extending segment 211. At least a portion of the edge portion extends outward along the radial direction of the valve frame 1 to form an outwardly extending segment 213. The outwardly extending segment 213 is located above the inwardly extending segment 211, thereby forming at least a portion of the receiving portion into a chamber structure that is raised relative to the valve frame 1, facilitating blood entry into the receiving portion and solving the problem of paravalvular leakage.

[0136] Optionally, the flexible leak-proof component 2 can be made of materials such as PET and PTFE.

[0137] As shown in Figures 7 and 18, optionally, in the embodiments of this application, the direction in which the valve prosthesis can accommodate blood flow refers to: the valve frame enclosing a blood channel that allows blood to flow through the valve prosthesis, and the upstream and downstream directions are defined according to the direction of blood flow through the blood channel. The receiving part is located below the positioning part 121 because after the valve prosthesis is inserted, the blood will flow from the upstream direction, preferentially radially to the positioning part 121, and secondarily to the receiving part.

[0138] As shown in Figure 8, in one embodiment, the inwardly extending segment 211 extends radially inward along the valve frame 1 and also extends circumferentially along the valve frame 1. The inwardly extending segment 211 also has at least one notch 214 that allows blood to fill into the receiving part. By providing the notch 214, the notch 214 is connected to the receiving part, thereby facilitating blood to enter the receiving part through the notch 214, gradually thrombosis and filling the receiving part, further realizing the filling of 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.

[0139] Optionally, multiple notches 214 can be provided, and the notches 214 are opened on the edge of the inward extension 211 located inside the petal frame 1.

[0140] Optionally, the receiving portion is the part formed after the notch 214 is provided.

[0141] As shown in Figure 9, as an implementation method parallel to the above embodiment, the inwardly extending segment 211 extends radially inward along the valve frame 1 and also extends circumferentially along the valve frame 1. The inwardly extending segment 211 is also provided with at least one through hole 215 that allows blood to fill the receiving part. By providing the through hole 215, the through hole 215 is connected to the receiving part, thereby facilitating blood to enter the receiving part through the through hole 215, gradually thrombosis and filling the receiving part, further realizing the filling of 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.

[0142] Optionally, multiple through holes 215 can be provided.

[0143] Optionally, the receiving portion is the part formed after the through hole 215 is provided.

[0144] As shown in Figures 7 and 13, as an implementation method parallel to the above embodiments, there are multiple inwardly extending segments 211. These multiple inwardly extending segments 211 are arranged at intervals along the circumference of the valve frame 1. A flow port 212 for blood to fill the receiving part is formed between every two adjacent inwardly extending segments 211, so that there are multiple flow ports 212 in the circumference of the receiving part. This facilitates blood to enter the receiving part through multiple flow ports 212, gradually thrombosis and filling the receiving part. This further achieves the filling of the gap between the valve prosthesis and the heart valve annulus, improves the fit between the valve prosthesis and the heart valve annulus, and reduces the problem of paravalvular leakage.

[0145] As shown in Figure 7, optionally, multiple inwardly extending segments 211 are arranged at uniform intervals along the circumference of the petal frame 1.

[0146] As shown in Figures 7 and 11, 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 includes a positioning part 121 extending in the radial direction. The positioning part 121 includes multiple sets of positioning bodies, which are interconnected in the circumferential direction of the valve frame. Each set of positioning bodies includes two positioning rods, one end of which converges, and the other two ends extend radially inward and are respectively connected to the positioning rods in the two adjacent sets of positioning parts. The second support body 12 also includes a support body that encloses the blood passage. 125, the support body 125 is connected to the positioning part 121. The support body 125 includes a plurality of third connecting parts 122 distributed in the circumferential direction and a plurality of fourth connecting parts 123 distributed in the circumferential direction. The third connecting parts 122 and the fourth connecting parts 123 are staggered in the circumferential direction of the valve frame 1. The support body 125 also includes a plurality of sets of second connecting units 124. Each set of second connecting units 124 connects any fourth connecting part 123 to two adjacent third connecting parts 122, thereby forming a blood channel for blood flow.

[0147] As shown in Figures 11, 16, and 17, in one embodiment, the flexible leak-proof component 2 includes a first skirt 22 sewn onto the positioning part 121. The edge portion is connected to the first skirt 22 or the positioning part 121. Since the positioning part 121 is located on the edge of the valve frame 1, the connection between the first skirt 22 and the positioning part 121 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 flow of blood, allowing blood to enter the receiving part and reduce the flow of blood, so that the blood gradually coagulates to form a thrombus, thus playing a sealing role. The edge portion is connected to the first skirt 22 or the positioning part 121, so that the connected edge portion forms a raised structure, and the corresponding receiving part is also a raised chamber structure, which facilitates the entry of blood.

[0148] As shown in Figure 11, optionally, the first skirt fabric 22 includes a first leak-proof part 221 extending radially and a second leak-proof part 222 extending axially along the petal frame. The first leak-proof part 221 can be disposed on the upper side or the lower side of the positioning part 121; in some cases, the first skirt fabric 22 can also be sprayed onto the positioning part 121. The second leak-proof part 222 is connected to the support body 125 and can be disposed on the inner side or the outer side of the support body 125; in some cases, the second leak-proof part 222 can also be sprayed onto the support body 125.

[0149] Optionally, the first leak-proof part 221 can be a circular sheet structure, and the portion of the first leak-proof part 221 located at the outer edge constitutes part of the flexible leak-proof member 2 and also serves as part of the side wall of the receiving part; the second leak-proof part 222 can be a columnar structure.

[0150] Optionally, the first leak-proof part 221 and the second leak-proof part 222 can be connected by stitching. Of course, the first leak-proof part 221 and the second leak-proof part 222 can also be a single piece.

[0151] As shown in Figures 7 to 9 and 15, in one embodiment, the flexible leak-proof component 2 also includes a second skirt fabric 21 sewn onto the positioning part 121. The second skirt fabric 21 is located below the first skirt fabric 22. The first skirt fabric 22 and the second skirt fabric 21 work together to form the side wall of the receiving part, which plays a role in blocking blood. The edge of the second skirt fabric 21 is connected to the edge of the first skirt fabric 22 to prevent blood from flowing out from the edge of the receiving part, and also to prevent blood from flowing in from other directions from the edge of the receiving part, thereby improving the sealing of the receiving part.

[0152] Optionally, the first skirt fabric 22 and the second skirt fabric 21 can be located on both sides of the positioning part 121, or they can both be located on the lower side of the positioning part 121. In some cases, the first skirt fabric 22 can also be sprayed onto the positioning part 121.

[0153] Optionally, the outer edges of the first skirt fabric 22 and the second skirt fabric 21 can be connected by sewing.

[0154] Optionally, the second skirt fabric 21 is provided with an inwardly extending section 211; and a through hole 215 is formed on the second skirt fabric 21.

[0155] As shown in Figures 7 to 11, optionally, the second skirt fabric 21 can be an annular sheet structure, including an inwardly extending section 211, and the other part is part of the flexible leak-proof member 2, which cooperates with the first leak-proof part 221 and can serve as a side wall on the other side of the receiving part.

[0156] As shown in Figures 13 and 14, in one embodiment, the circumference of the radially extending portion of the second skirt 21 is greater than the circumference of the radially extending portion of the first skirt 22. The second skirt 21 extends radially along the valve frame, and the first skirt 22 includes at least two parts, one of which extends radially along the valve frame as the first leak-proof portion 221, and the other part extends axially along the valve frame as the second leak-proof portion 222. Therefore, during the sewing process of the outer edges of the first skirt 22 and the second skirt 21, 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 arched structure is formed between two adjacent sewing positions of the second skirt 21 to satisfy the sewing of the first skirt 22. This makes the receiving portion a raised chamber structure, allowing blood to enter the receiving portion more easily and preventing the first skirt 22 and the second skirt 21 from sticking together and affecting blood entry.

[0157] Optionally, the perimeter of the first leak-proof part 221 of the first skirt fabric 22 is smaller than the perimeter of the second skirt fabric 21.

[0158] As one implementation, the inwardly extending section 211 has a curved structure in the radial direction, so that the inwardly extending section 211 is a curved structure in its initial form, in order to further improve the bulging effect of the receiving part, thereby facilitating the entry of blood into the receiving part.

[0159] As shown in Figure 12, optionally, the first skirt fabric 22 and the second skirt fabric 21 can be pre-molded into a continuous curled sheet structure by heat treatment before sewing. In this way, after the first skirt fabric 22 and the second skirt fabric 21 are sewn together, there are multiple raised structures on the upper and lower sides of the receiving part, which prevents the first skirt fabric 22 and the second skirt fabric 21 from sticking together and facilitates blood to enter the receiving part.

[0160] As shown in Figure 17, in one embodiment, the connection position of the inwardly extending section 211 with the first skirt fabric 22 or with the positioning part 121 is formed with multiple continuous curved sections, and the inwardly extending section 211 is one of these sections. This makes the thickness of the connection position of the inwardly extending section 211 with the first skirt fabric 22 or with the positioning part 121 greater than the thickness of the outer edges of the first skirt fabric 22 and the second skirt fabric 21. This results in a locally raised structure in the receiving part at the flow port 212 or the notch 214, which facilitates the entry of blood into the receiving part.

[0161] As shown in Figures 11 and 16, in one embodiment, the valve frame 1 includes a first support body 11 and a second support body 12 connected to each other. A positioning part 121 is disposed on the second support body 12. The flexible leak-proof component 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, providing stable support for the third skirt 23. The third skirt 23 and the first skirt 22 partially overlap radially in the valve frame 1. When the first support body 11 and the second support body 12 cooperate to clamp the heart valve annulus, 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 leak-proof chamber 3. The first skirt 22 and the third skirt 23 serve as the side walls of the leak-proof chamber 3, preventing blood from flowing through the hollow areas on the first support body 11 and the second support body 12.

[0162] Optionally, the third skirt fabric 23 can be an annular sheet structure, held in a radially extending position by the first support 11 and the second support 12, with the first leak-proof part 221 of the first skirt fabric 22 overlapping the radial upper part of the third skirt fabric 23 on the petal frame.

[0163] 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 disposed on the inner or outer side of the support body 125; in some cases, it may also be sprayed onto the support body 125.

[0164] As shown in Figures 7 and 10, in one embodiment, the first support 11 includes a plurality of first connecting portions 111 distributed circumferentially and a plurality of second connecting portions 112 distributed circumferentially. The first connecting portions 111 and the second connecting portions 112 are staggered circumferentially on the petiole frame 1, and the loops formed by the lines connecting the plurality of first connecting portions 111 and the loops formed by the lines connecting the plurality of second connecting portions 112 are located at different positions in the axial direction of the petiole frame 1, that is, the first connecting portions 111 and the second connecting portions 112 are located at different heights on the petiole frame 1. The second support 12 includes a plurality of third connecting portions 122 distributed circumferentially and a plurality of fourth connecting portions 123 distributed circumferentially. The plurality of third connecting portions 122 are respectively connected to the plurality of first connecting portions 111 at corresponding positions, and the plurality of fourth connecting portions 123 are respectively connected to the plurality of third connecting portions 122 at corresponding positions. The second connecting part 112 is connected accordingly. The first connecting part 111 and the second connecting part 112 are offset in the circumferential direction of the valve frame 1. The third connecting part 122 and the fourth connecting part 123 are also offset in the circumferential direction of the valve frame 1. In this way, the first support body 11 and the second support body 12 achieve more circumferential point connections at the blood outflow end, improving the stability of the first support body 11 and the second support body 12. Moreover, the loop formed by the connection of multiple first connecting parts 111 and the loop formed by the connection of multiple second connecting parts 112 are 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 also extended accordingly, improving the stability of the valve frame 1 and making the overall anti-displacement ability of the valve prosthesis stronger.

[0165] Optionally, the first connecting part 111 and the second connecting part 112 being staggered in the circumferential direction of the petal frame 1 means that the vertical projections of the first connecting part 111 and the second connecting part 112 on the plane are spaced apart.

[0166] Optionally, the first connecting portion 111 and the second connecting portion 112 are evenly spaced along the circumferential direction.

[0167] As shown in Figures 7 and 10, in one embodiment, a second connecting portion 112 is provided between two adjacent first connecting portions 111. The first support body 11 includes multiple sets of first connecting units 113, each set of first connecting units 113 connecting any second connecting portion 112 to two adjacent first connecting 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 sets of second connecting units 124, each set of second connecting units 124 connecting any fourth connecting portion 123 to two adjacent third connecting portions 122, thereby improving the structural stability of the second support body 12 at the blood outflow end; the first connecting units 113 and The second connecting unit 124 is connected at the corresponding position, thereby increasing the connection area between the first support 11 and the second support 12 and improving their structural stability. At the same time, the loop formed by the lines connecting the multiple first connecting parts 111 and the loop formed by the lines connecting the multiple second connecting parts 112 are located at different positions along the axial direction of the petal frame 1, which also correspondingly extends the length of the first connecting unit 113. Similarly, the length of the second connecting unit 124 on the second support 12 is also extended. Accordingly, when the first connecting unit 113 and the second connecting unit 124 are connected at the corresponding position, the connection area between the first support 11 and the second support 12 is further increased, improving their structural stability.

[0168] In addition, this application provides a method for preparing the valve prosthesis in the foregoing embodiments, comprising the following steps:

[0169] S1. The petal frame 1 is formed by injection molding or machining;

[0170] S2. Select a polymer solution and spray it into nanofibers under a high voltage electric field, then weave the fibers to form a flexible leak-proof component;

[0171] S3. At least a portion of the flexible leak-proof component is pre-molded into a curved structure by heat treatment;

[0172] A polymer solution is selected and sprayed into nanofibers under a high voltage electric field. The fibers are then woven to form a flexible leak-proof component 2. At least a portion of the flexible leak-proof component 2 is pre-molded into a curved structure by heat treatment. This allows the receiving portion formed when the flexible leak-proof component 2 is connected to the valve frame 1 to be in a raised state, facilitating the entry of blood into the receiving portion.

[0173] S4. Cut the flexible leak-proof component into at least two parts, which are respectively configured as a first skirt fabric 22 and a second skirt fabric 21. The first skirt fabric 22 and the second skirt fabric 21 are respectively connected to the positioning part 121 of the petal frame 1. The second skirt fabric 21 needs to be cut into a through structure and also needs to be cut into multiple radially inwardly extending segments 211.

[0174] S5. The outer edges of the first skirt fabric 22 and the second skirt fabric are sewn together. At least part of the edge of the inward extension section 211 extends radially outward along the valve frame 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 the outward extension section 213 is connected to the positioning part or to the second skirt fabric to form a receiving part that can be filled with blood.

[0175] The flexible leak-proof component 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. The second skirt 21 needs to be cut into a through structure and also needs to be cut into an inwardly extending section 211 extending radially inward. The outer edges of the first skirt 22 and the second skirt 21 are sewn together. At least part of the edge of the inwardly extending section 211 extends radially outward along the valve frame 1 to form an outwardly extending section 213. The outwardly extending section 213 is located on the upper side of the inwardly extending section 211. At least part of the receiving part forms a chamber structure that is raised relative to the valve frame 1, which facilitates blood to enter the receiving part and solves the problem of perivalvular leakage. The outwardly extending section 213 is connected to the positioning part 121 or to the second skirt 21 to form a receiving part that can be filled with blood.

[0176] As shown in Figure 13, in one embodiment, in step S2, the cutting area of ​​the second skirt fabric 21 is greater than the cutting area of ​​the radially extended portion of the first skirt fabric 22.

[0177] In the implementation of the above technical solution, the cut second skirt fabric 21 extends along the radial direction of the valve frame, and the first skirt fabric 22 includes at least two parts, one part extending along the radial direction of the valve frame and the other part extending along the axial direction of the valve frame. Since the area of ​​the cut second skirt fabric 21 extending along the radial direction of the valve frame is larger than the area of ​​the first skirt fabric 22 extending along the radial direction of the valve frame, when the first skirt fabric 22 and the second skirt fabric 21 are sewn together, in order to ensure that the outer edges of the second skirt fabric 21 are connected to the outer edges of the first skirt fabric 22, an arched structure will be formed between two adjacent sewing positions of the second skirt fabric 21 to satisfy the sewing of the first skirt fabric 22. This makes the receiving part a raised chamber structure, making it easier for blood to enter the receiving part and preventing the first skirt fabric 22 and the second skirt fabric 21 from sticking together and affecting blood entry.

[0178] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0179] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0180] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. Industrial applicability

[0181] This disclosure provides a valve prosthesis and its preparation method, which can improve the fit with the heart valve annulus, thereby solving the problem of paravalvular leakage.

Claims

1. A valve prosthesis, characterized in that, The device includes a stent and a pouch disposed on the stent; the stent includes an extension that can be located on one side of the heart valve annulus, the side of the extension opposite to the heart valve annulus being the outer side; the pouch is located on the outer side of the extension; wherein the pouch has an opening that allows blood to enter.

2. The valve prosthesis according to claim 1, characterized in that, The extension includes a plurality of first positioning units, which are arranged circumferentially along the bracket. The bag is located outside the plurality of the first positioning units.

3. The valve prosthesis according to claim 2, characterized in that, Each of the first positioning units includes two first positioning rods, and the two first positioning rods in the same first positioning unit form a first connection point; the bag body is located outside the plurality of first connection points.

4. The valve prosthesis according to claim 3, characterized in that, Two adjacent first positioning rods in two adjacent first positioning units meet at a first node at one end facing downstream, and the bag body is located outside the first node.

5. The valve prosthesis according to any one of claims 1 to 4, characterized in that, The bag body includes a first layer and a second layer, the first layer being connected to the support, and the second layer having a free edge portion; the free edge portion forms an opening in the bag body.

6. The valve prosthesis according to claim 5, characterized in that, The free edge portion is located at the opposite end of the position where the second layer connects to the first layer, and the free edge portion is the entire edge of the second layer.

7. The valve prosthesis according to claim 6, characterized in that, The stent includes a support body connected to the extension body. The support body defines a flow channel for blood circulation. The extension body also includes a plurality of second positioning units arranged circumferentially along the support body. Each second positioning unit includes two second positioning rods. The two second positioning rods in the same second positioning unit are connected at the end away from the flow channel to form a second connection point. The first layer is connected to the second connection point.

8. The valve prosthesis according to any one of claims 1 to 7, characterized in that, The stent includes a support body connected to the extension body, the support body defining a flow channel for blood circulation, the extension body extending outward in a radial direction along the support body, and the bag body connected to the support body.

9. The valve prosthesis according to any one of claims 1 to 8, characterized in that, The bag body is made of polymer film or textile fabric.

10. The valve prosthesis according to claim 7 or 8, characterized in that, The support body includes multiple first support units, each of which includes a first support rod and a second support rod. Two second positioning rods in the same second positioning unit are respectively connected to the first support rod and the second support rod in two adjacent first support units.

11. The valve prosthesis according to claim 10, characterized in that, The upstream ends of the first support rod and the second support rod are connected to form a third connection point; in two adjacent first support units, the downstream end of the second support rod in one first support unit meets the downstream end of the first support rod in the other first support unit at the third node.

12. The valve prosthesis according to claim 11, characterized in that, The supporting body also includes multiple arc-shaped third support rods, with a first support unit spaced between two adjacent third support rods, and both ends of each third support rod are connected to the third node.

13. The valve prosthesis according to claim 12, characterized in that, The supporting body further includes multiple second supporting units, which are arranged circumferentially along the bracket; each second supporting unit includes a fourth supporting rod and a fifth supporting rod, with the downstream ends of the fourth and fifth supporting rods connected to form a fourth node; in two adjacent second supporting units, the upstream end of the fourth supporting rod in one second supporting unit and the upstream end of the fifth supporting rod in the other second supporting unit respectively merge and connect with the two ends of the third supporting rod.

14. The valve prosthesis according to claim 12 or 13, characterized in that, The stent further includes an abutment configured to abut against cardiac tissue, the abutment including a connecting portion located radially outward of the support body and connected to the support body; The supporting body is provided with a first connecting hole, and the connecting part is provided with a second connecting hole; The valve prosthesis also includes a first connector for passing through the first connection hole and the second connection hole, and a second connector configured to connect the first connection hole and the third support rod.

15. The valve prosthesis according to claim 14, characterized in that, The abutment body further includes a plurality of first abutment units configured to abut against heart tissue, the plurality of first abutment units being arranged circumferentially along the support body; Each of the first abutting units includes two first abutting rods, the two first abutting rods in the same first abutting unit being connected at the edge of the abutting body to form an abutting point configured to abut against the heart tissue; the two adjacent first abutting rods in two adjacent first abutting units meet at a fifth node at one end facing downstream.

16. A valve prosthesis, characterized in that, include: A petal frame and a flexible leak-proof component disposed on the petal frame; The direction in 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 annulus. The flexible leak-proof component includes a receiving portion that can be filled with blood and is located below the positioning portion after being filled with blood. The receiving portion includes an inwardly extending segment that extends inward along the radial direction of the valve frame and an edge portion located at the edge of the inwardly extending segment. At least a portion of the edge portion extends outward along the radial direction of the valve frame to form an outwardly extending segment. The outwardly extending segment is located above the inwardly extending segment.

17. The valve prosthesis according to claim 16, characterized in that, The inwardly extending section extends circumferentially along the valve frame, and the inwardly extending section has at least one notch for blood to fill into the receiving portion; Alternatively, the inwardly extending section extends circumferentially along the valve frame, and the inwardly extending section is provided with at least one through hole for blood to fill the receiving portion; Alternatively, there may be multiple inwardly extending segments, which are spaced apart circumferentially along the valve frame, with a flow port for blood to fill the receiving portion formed between every two adjacent inwardly extending segments.

18. The valve prosthesis according to claim 16 or 17, characterized in that, The flexible leak-proof component includes a first skirt fabric sewn onto the positioning portion, and the edge portion is connected to the first skirt fabric or the positioning portion.

19. The valve prosthesis according to claim 18, characterized in that, The flexible leak-proof component includes a second skirt fabric sewn to the positioning part, the second skirt fabric being located below the first skirt fabric, and the edge of the second skirt fabric being connected to the edge of the first skirt fabric.

20. The valve prosthesis according to claim 19, characterized in that, The circumference of the radially extended portion of the second skirt fabric is greater than the circumference of the radially extended portion of the first skirt fabric.

21. The valve prosthesis according to claim 20, characterized in that, The inwardly extending section has a curved structure in the radial direction.

22. The valve prosthesis according to any one of claims 18 to 21, characterized in that, The inwardly extending section forms multiple continuous curved sections at the connection position with the first skirt fabric or the positioning part, and the inwardly extending section is one of these sections.

23. The valve prosthesis according to any one of claims 19 to 21, characterized in that, The petal frame includes a first support body and a second support body connected to each other. The positioning part is disposed on the second support body. The flexible leak-proof component includes a third skirt. The first support body and the second support body partially overlap and clamp the third skirt. The third skirt and the first skirt partially overlap in the radial direction of the petal frame.

24. The valve prosthesis according to claim 23, characterized in that, The first support 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 respectively offset in the circumferential direction of the petiole frame, and the line connecting the plurality of first connecting portions and the line connecting the plurality of second connecting portions are respectively located at different positions in the axial direction of the petiole frame. The second support includes a plurality of third connecting parts distributed in the circumferential direction and a plurality of fourth connecting parts distributed in the circumferential direction, wherein the plurality of third connecting parts are respectively connected to the plurality of first connecting parts in a corresponding position, and the plurality of fourth connecting parts are respectively connected to the plurality of second connecting parts in a corresponding position.

25. The valve prosthesis according to claim 24, characterized in that, A second connecting part is provided between two adjacent first connecting parts. The first support body includes multiple sets of first connecting units, and each set of first connecting units connects any second connecting part to two adjacent first connecting parts. The second support includes multiple sets of second connecting units, each set of second connecting units connecting any of the fourth connecting parts to the two adjacent third connecting parts; The first connecting unit and the second connecting unit are connected in corresponding positions.

26. A method for preparing the valve prosthesis according to any one of claims 16 to 25, characterized in that, Includes the following steps: S1. Provide the valve frame; S2. Select a polymer solution and spray it into nanofibers under a high voltage electric field, then weave the fibers to form a flexible leak-proof component; S3. At least a portion of the flexible leak-proof component is pre-molded into a curved structure by heat treatment; S4. Cut the flexible leak-proof component 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 petal frame. The second skirt needs to be cut into a through structure and also needs to be cut into an inwardly extending section that extends radially inward. S5. The outer edges of the first skirt fabric and the second skirt fabric are sewn together. At least part of the edge of the inward extension section extends radially outward along the valve frame to form an outward extension section. The outward extension section is located above the inward extension section, and the outward extension section is connected to the positioning part or the second skirt fabric to form a receiving part that can be filled with blood.

27. The method according to claim 26, characterized in that, In step S2, the cutting area of ​​the second skirt fabric is greater than the cutting area of ​​the radially extended portion of the first skirt fabric.

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