Polymer heart valve and preparation method thereof

Abstract

The invention relates to the technical field of bionic valve materials, in particular to a macromolecule heart valve and a preparation method thereof.The macromolecule heart valve comprises an outer auxiliary piece and an inner auxiliary piece, the outer auxiliary piece is arranged on the outer side of a valve leaf, and the outer auxiliary piece is divided into outer fan blades at the lower end and outer ribs at the upper end; the inner auxiliary piece is arranged on the inner side of the valve leaf, and the inner auxiliary piece is divided into an inner fan blade at the upper end and an inner rib at the lower end; the upper ends of the inner fan blades make contact with each other and are attached to each other when the valve leaves are closed, and the lower ends of the inner fan blades are provided with separated and unfolded parts. The valve leaves are connected through the outer auxiliary piece and the inner auxiliary piece in the middle, the outer auxiliary piece enables the outer fan blades to obtain a small stress bending angle through the outer fan blades with the bottom ends connected with the mounting base, and therefore the outer fan blades rapidly respond to a blood pump to move; the problem that an artificial heart valve is prone to being damaged due to large fatigue impact and bending for a long time is solved.

Description

Technical Field

[0001] The invention relates to the technical field of bionic valve materials, and in particular to a polymer heart valve and a preparation method thereof. Background Art

[0002] For valvular heart disease, artificial heart valve replacement is currently the most effective treatment. Existing artificial valves are mainly divided into mechanical valves and biological valves. Mechanical valves have good durability, but may cause side effects such as hemodynamic changes and thrombosis, and patients need to take anticoagulants for life to prevent thrombosis. However, long-term use of anticoagulants may cause side effects such as difficult bleeding, gastrointestinal reactions, bad mood and allergies, thereby reducing the quality of life. Biological valves are usually prepared from pig or bovine pericardium cross-linked with glutaraldehyde and have good biocompatibility. The blood flow through the valve orifice is central flow, which can simulate the physiological blood flow form, and the tissue treated with glutaraldehyde has higher strength and lower immunogenicity.

[0003] In artificial heart valves, the impact of blood and repeated bending can cause material fatigue damage. Mechanical valves may experience cyclical stress and deformation under the impact of blood flow, which may lead to the formation of microcracks. This repeated mechanical load not only affects the function of the valve, but may also accelerate the aging and failure of the material. Biological valves face similar challenges. Although they are designed to simulate physiological flow, the dynamic characteristics of blood flow may still cause fatigue of the valve material, ultimately affecting the stability and durability of the valve.

[0004] In view of the above situation, in order to overcome the above technical problems, the present invention designs a polymer heart valve and a preparation method thereof, which solves the above technical problems. Summary of the invention

[0005] The technical purpose to be achieved by the present invention is to increase the blood flow force through the auxiliary sheet while avoiding direct action on the valve leaflets, thereby assisting the movement of the heart valve and preventing the heart valve from long-term fatigue operation.

[0006] In order to achieve the above technical objectives, the present invention provides the following technical solutions: The present invention provides a polymer heart valve, comprising valve leaflets, a support frame and a mounting seat, wherein the valve leaflets are connected to the support frame, and a mounting seat is installed at the bottom end of the support frame. It also comprises an outer auxiliary sheet and an inner auxiliary sheet, wherein the outer auxiliary sheet is arranged on the outer side of the valve leaflets, and the outer auxiliary sheet is divided into an outer leaflet at the lower end and an outer rib at the upper end; the inner auxiliary sheet is arranged on the inner side of the valve leaflets, and the inner auxiliary sheet is divided into an inner leaflet at the upper end and an inner rib at the lower end; the upper ends of the inner leaflets are in contact and fit with each other when the valve leaflets are closed, and the lower ends of the inner leaflets have a separated and unfolded part; the lower end of the outer auxiliary sheet is connected to the mounting seat, and the outer auxiliary sheet moves through the local rapid reset of the outer leaflets, and then pulls the inner auxiliary sheet to move through the outer ribs.

[0007] The present invention divides the heart valve into two left and right valve leaflets, and then connects the valve leaflets through an outer auxiliary piece and an inner auxiliary piece in the middle. The outer auxiliary piece is an outer fan leaf connected to a mounting seat through the bottom end, so that the outer fan leaf can obtain a smaller force bending angle, so that the outer fan leaf can quickly respond to the movement of the blood pump, so that the outer fan leaf can quickly pull the inner auxiliary piece to move, thereby achieving the movement of the auxiliary heart valve and preventing the heart valve from long-term fatigue operation.

[0008] The hardness of the outer auxiliary sheet and the inner auxiliary sheet is not less than the hardness of the valve leaf, and the mounting seat is provided with an arc groove corresponding to the outer auxiliary sheet. The movement of the heart valve depends on the pumping movement of the blood. The impact force of the blood flow on the valve leaf will cause the valve leaf to unfold. Therefore, the hardness of the valve leaf needs to meet the requirements of softness and deformability, but this greatly reduces the strength of the valve leaf. Therefore, the valve leaf is divided and an auxiliary sheet is set in the middle.

[0009] The valve leaflet comprises an outer connecting layer and an inner contact layer, wherein the connecting layer is a dense textile material, and the contact layer is a smooth biological coating.

[0010] The connecting layer is woven from textile materials to obtain an outer side with strong connection and fixing ability. The connecting layer needs to connect the outer ribs in the middle and the support frames on both sides. The contact layer of the biological coating surface should reduce the damage caused by blood flow impact as much as possible and concentrate the impact force of the blood on the inner fan blades in the middle.

[0011] The outer fan blade is fan-shaped with a wider lower end and a narrower upper end. The inner side of the outer fan blade is connected to the connecting layer, and the two sides of the outer rib are connected to the valve leaf. The inner middle part of the inner fan blade is connected to the outer rib, and the inner rib extends downward along the valve leaf and is connected to the mounting seat.

[0012] The close connection between the outer blades and the connection layer enhances the stability of the structure and ensures the reliability of the valve under high pressure. The connection design between the inner blades and the outer ribs enables the valve to effectively transmit pressure, and the design of the inner ribs extending downward to the mounting seat increases the strength and durability of the entire system.

[0013] The inner side of the outer rib is thickened to be provided with a connecting strip, and penetrating connecting holes are opened on both sides of the connecting strip, and the connecting holes are aligned with the valve leaves on both sides.

[0014] The thickening of the inner side of the outer ribs provides additional support, making the ribs more resistant to bending when subjected to blood flow, preventing the valve from deforming due to long-term stress during use. The thickening design of the connecting strip strengthens the overall structure and improves the durability and stability of the heart valve.

[0015] A positioning strip is arranged at the center of the connecting strip. The positioning strip is slidably installed in the connecting strip. The valve leaflets are connected to the connecting strip via connecting lines thereon.

[0016] The connecting holes ensure that the valve leaflets and the connecting strips can be precisely aligned, which helps to achieve uniform force transmission when the valve leaflets move, reduce local stress concentration, and thus reduce the risk of valve leaflet tearing or excessive wear, allowing the valve to open and close more smoothly during operation, effectively improving the overall performance of the heart valve.

[0017] The connection lines on the valve leaves on both sides pass through the connection holes and are interlaced and connected to the positioning strips, and the positioning strips are provided with equally spaced indentations. The mechanical strength, durability and operational convenience of the valve are improved by the thickened connection strips and the precisely aligned connection holes.

[0018] A method for preparing a polymer heart valve, comprising: S1. Preparing a connecting layer of the valve leaflets: weaving polytetrafluoroethylene filaments according to the shape of the valve leaflets to form a connecting layer, and leaving extra connecting lines at the edge; S2. preparing a contact layer of the valve leaflets: sewing a biological valve material on the inner surface of the connecting layer, and then applying biological material on the sewn biological valve material to form a smooth contact layer on the inner side; S3, fixing and sewing the two valve leaflets constituting a single valve on both sides to the support frame, and connecting the inner center of the valve leaflet to the outer rib through a connecting line at the edge of the connecting layer; S4. Engage multiple groups of mounting seats together to form a complete heart valve.

[0019] The beneficial effects of the present invention are as follows: 1. The present invention divides the heart valve into two left and right valve leaflets, and then connects the valve leaflets through the outer auxiliary sheet and the inner auxiliary sheet in the middle. The outer auxiliary sheet is an outer fan blade connected to the mounting seat through the bottom end, so that the outer fan blade can obtain a smaller force bending angle, so that the outer fan blade can quickly respond to the movement of the blood pump, so that the outer fan blade can quickly pull the inner auxiliary sheet to move, thereby achieving the movement of the auxiliary heart valve and preventing the heart valve from long-term fatigue operation.

[0020] 2. The present invention increases the contact force area between the inner side of the valve leaflet and the blood by disposing the inner leaflet at the upper end of the inner auxiliary piece. At the same time, the inner leaflet is distributed in the middle position, and cooperates with the smooth valve leaflet contact layer, so that the blood can act on the inner leaflet in time while flowing smoothly and being pumped sensitively, thereby pushing the valve leaflet open. Since the force of the blood first acts on the inner leaflet, fatigue impact damage to the valve leaflet is avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0022] The above and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 It is a top plan view of the overall structure of the present invention; Figure 3 is a schematic diagram of the outer structure of the valve leaflet of the present invention; Figure 4 is a front view schematic diagram of the outer side of the valve leaflet of the present invention; Figure 5 is a schematic diagram of the inner structure of the valve leaflet of the present invention; Figure 6 is a front view schematic diagram of the inner side of the valve leaflet of the present invention; Figure 7 It is a structural schematic diagram of the connection hole of the present invention; Figure 8 It is a schematic diagram of the installation relationship between the valve leaf and the positioning strip of the present invention; Fig. 9 The present invention Figure 3 A magnified view of point A; Fig.10 The present invention Figure 8 The enlarged view of point B; Fig.11 It is a flow chart of the method of the present invention.

[0023] In the figure: 1. valve leaf; 11. outer auxiliary plate; 111. outer fan blade; 112. outer rib; 113. connecting strip; 114. connecting hole; 12. inner auxiliary plate; 121. inner fan blade; 122. inner rib; 13. connecting layer; 14. contact layer; 15. connecting line; 2. support frame; 3. mounting seat; 31. arc groove; 4. positioning strip. DETAILED DESCRIPTION

[0024] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0025] like Figure 1-10 As shown, a polymer heart valve provided by the present invention comprises a valve leaf 1, a support frame 2 and a mounting seat 3, wherein the valve leaf 1 is connected to the support frame 2, and the mounting seat 3 is installed at the bottom end of the support frame 2. It also comprises an outer auxiliary sheet 11 and an inner auxiliary sheet 12, wherein the outer auxiliary sheet 11 is arranged on the outer side of the valve leaf 1, and the outer auxiliary sheet 11 is divided into an outer leaf 111 at the lower end and an outer rib 112 at the upper end; the inner auxiliary sheet 12 is arranged on the inner side of the valve leaf 1, and the inner auxiliary sheet 12 is divided into an inner leaf 121 at the upper end and an inner rib 122 at the lower end; the upper ends of the inner leaf 121 are in contact with each other when the valve leaf 1 is closed, and the lower ends of the inner leaf 121 have a separated and unfolded part; the lower end of the outer auxiliary sheet 11 is connected to the mounting seat 3, and the outer auxiliary sheet 11 is moved by the local rapid reset movement of the outer leaf 111, and then the inner auxiliary sheet 12 is pulled to move by the outer rib 112.

[0026] The present invention divides the heart valve into two left and right valve leaflets 1, and then connects the valve leaflets 1 through the outer auxiliary piece 11 and the inner auxiliary piece 12 in the middle. The outer auxiliary piece 11 has an outer fan leaf 111 connected to the mounting seat 3 through the bottom end, so that the outer fan leaf 111 can obtain a smaller force bending angle, so that the outer fan leaf 111 can quickly respond to the movement of the blood pump, so that the outer fan leaf 111 can quickly pull the inner auxiliary piece 12 to move, thereby achieving the movement of the auxiliary heart valve and preventing the heart valve from long-term fatigue operation.

[0027] The hardness of the outer auxiliary sheet 11 and the inner auxiliary sheet 12 is not less than that of the valve leaf 1, and the mounting seat 3 is provided with an arc groove 31 corresponding to the outer auxiliary sheet 11. The inner auxiliary sheet 12 with greater hardness responds to the impact of the internal blood flow, and while achieving rapid response and bending, the outer auxiliary sheet 11 can also bend quickly when the force angle is small, thereby driving the valve leafs 1 on both sides to bend.

[0028] like Figure 3-6 As shown, the valve leaflet 1 comprises an outer connecting layer 13 and an inner contact layer 14 , wherein the connecting layer 13 is a dense textile material, and the contact layer 14 is a smooth biological coating.

[0029] The connecting layer 13 is woven by textile materials to obtain an outer side with strong connection and fixing ability. The connecting layer 13 needs to connect the outer ribs 112 in the middle and the support frames 2 on both sides. Once the strength of the connecting layer 13 is insufficient, it is easy to cause the artificial valve to fall off or tear during blood flow. Therefore, the connecting layer 13 needs to be woven more densely; and the contact layer 14 on the biological coating surface should reduce the damage caused by blood flow impact as much as possible, and concentrate the impact force of the blood on the inner fan blades 121 in the middle.

[0030] like Figure 3 and Figure 4 As shown, the outer fan blade 111 is fan-shaped with a wider lower end and a narrow upper end. The inner side of the outer fan blade 111 is connected to the connecting layer 13, and the outer ribs 112 are connected to the valve leaf 1 on both sides; the inner middle part of the inner fan blade 121 is connected to the outer rib 112, and the inner rib 122 extends downward along the valve leaf 1 and is connected to the mounting seat 3.

[0031] The shape of the outer blades 111 (a fan-shaped shape that is wider at the bottom and narrower at the top) can optimize the force distribution, allowing the valve to have better fluidity and response speed in blood flow, reducing the risk of bending due to force, thereby ensuring that the valve can move quickly and smoothly when opening and closing, thereby improving the durability of the valve.

[0032] Secondly, the close connection between the outer blades 111 and the connection layer 13 enhances the stability of the structure and ensures the reliability of the valve under high pressure. The connection design between the inner blades 121 and the outer ribs 112 enables the valve to effectively transmit pressure, and the design of the inner ribs 122 extending downward to the mounting seat 3 increases the strength and durability of the entire system.

[0033] like Figure 5 and Figure 7 As shown, the inner side of the outer rib 112 is thickened to be provided with a connecting strip 113 , and penetrating connecting holes 114 are opened on both sides of the connecting strip 113 , and the connecting holes 114 are aligned with the valve leaflets 1 on both sides.

[0034] The inner thickening of the outer rib 112 provides additional support, making the rib more resistant to bending when subjected to blood flow, and preventing the valve from deforming due to long-term stress during use. The thickening design of the connecting strip 113 strengthens the overall structure and improves the durability and stability of the heart valve.

[0035] The through connection hole 114 provides a fixing point for the valve leaf 1 and the connection strip 113 to be connected to each other, which is conducive to ensuring the accurate connection of each component during the assembly process. This design is not only conducive to accurate positioning during the production process, but also convenient for later maintenance and replacement, improving the overall convenience and reliability of use.

[0036] like Figure 8-Figure 10 As shown, a positioning strip 4 is provided at the center of the connecting strip 113, and the positioning strip 4 is slidably installed in the connecting strip 113, and the valve leaf 1 is connected to the connecting strip 113 via the connecting line 15 thereon. The connecting hole 114 ensures that the valve leaf 1 and the connecting strip 113 can be accurately aligned, which helps to achieve uniform force transmission when the valve leaf 1 moves, reduces local stress concentration, and thus reduces the risk of tearing or excessive wear of the valve leaf 1, so that the valve can open and close more smoothly during operation, effectively improving the overall performance of the heart valve.

[0037] like Figure 8 and Fig.10 As shown, the connection lines 15 on the valve leaflets 1 on both sides pass through the connection holes 114 and are interlaced and connected to the positioning strip 4, and the positioning strip 4 is provided with equally spaced indentations. The positioning strip 4 is connected to the valve leaflets 1 on both sides through the connection lines 15. In order to prevent the connection from being squeezed and rubbed against each other, equally spaced indentations are provided on the positioning strip 4, so that the connection lines 15 are sequentially limited at the indentation positions, and the connection lines 15 are more compact and stable.

[0038] like Fig.11 As shown, a method for preparing a polymer heart valve comprises: S1, preparing the connection layer 13 of the valve leaf 1: weaving polytetrafluoroethylene filaments according to the shape of the valve leaf 1 to form the connection layer 13, and reserving excess connection lines 15 at the edge; S2, preparing the contact layer 14 of the valve leaflet 1: sewing the biological valve material on the inner surface of the connecting layer 13, and then applying the biological material on the sewn biological valve material to form a smooth contact layer 14 on the inner side; S3, fix and sew the two valve leaflets 1 constituting a single valve on both sides to the support frame 2, and connect the inner center of the valve leaflet 1 to the outer rib 112 through the connecting line 15 at the edge of the connecting layer 13; S4, embedding multiple groups of mounting seats 3 with each other to form a complete heart valve.

[0039] The present invention improves the durability of the artificial valve by simplifying the preparation process and optimizing the valve structure. First, the connection layer 13 woven with polytetrafluoroethylene filaments not only provides the necessary strength and stability, but also ensures the durability of the valve. Secondly, the biomaterial sewing and coating process of the contact layer 14 forms a smooth inner contact surface, which can effectively reduce friction, enhance biocompatibility, and reduce the risk of thrombosis. Subsequently, the valve leaf 1 is fixed to the support frame 2 and connected to the outer rib 112 by a connecting line 15, ensuring the overall structural stability of the valve. Finally, a complete valve is formed by a plurality of sets of mutually interlocking mounting seats 3, which simplifies the installation process and improves production efficiency.

[0040] Although the present disclosure has been described in detail above with general descriptions and specific implementation methods, it is obvious to those skilled in the art that some modifications or improvements may be made based on the embodiments of the present disclosure. Therefore, these modifications or improvements made without departing from the spirit of the present disclosure are within the scope of protection claimed by the present disclosure.

[0041] The foregoing is merely an excerpt from the disclosure that these modifications may be made to the invention in light of the above detailed description. The terms used in the appended claims should not be construed to limit the invention to the specific embodiments disclosed in the specification. Instead, the scope of the invention will be determined entirely by the appended claims, which will be interpreted in accordance with established principles of claim interpretation.

Claims

1. A polymer heart valve, comprising a valve leaf (1), a support frame (2) and a mounting seat (3), wherein the valve leaf (1) is connected to the support frame (2), and the mounting seat (3) is installed at the bottom end of the support frame (2); characterized in that: The invention also comprises an outer auxiliary sheet (11) and an inner auxiliary sheet (12), wherein the outer auxiliary sheet (11) is arranged on the outer side of the valve leaf (1), and the outer auxiliary sheet (11) is divided into an outer leaf (111) at the lower end and an outer rib (112) at the upper end; the inner auxiliary sheet (12) is arranged on the inner side of the valve leaf (1), and the inner auxiliary sheet (12) is divided into an inner leaf (121) at the upper end and an inner rib (122) at the lower end; the upper ends of the inner leaf (121) are in contact with each other when the valve leaf (1) is closed, and the lower ends of the inner leaf (121) have a separated and unfolded portion; the lower end of the outer auxiliary sheet (11) is connected to the mounting seat (3), and the outer auxiliary sheet (11) is moved by the local rapid reset movement of the outer leaf (111), and then the inner auxiliary sheet (12) is pulled by the outer rib (112) to move.

2. A polymer heart valve according to claim 1, characterized in that: The hardness of the outer auxiliary sheet (11) and the inner auxiliary sheet (12) is not less than the hardness of the valve leaf (1), and the mounting seat (3) is provided with an arc-shaped groove (31) corresponding to the outer auxiliary sheet (11).

3. A polymer heart valve according to claim 1, characterized in that: The valve leaf (1) comprises an outer connecting layer (13) and an inner contact layer (14); the connecting layer (13) is a dense textile material, and the contact layer (14) is a smooth biological coating.

4. A polymer heart valve according to claim 3, characterized in that: The outer fan blade (111) is fan-shaped with a wider lower end and a narrower upper end; the inner side of the outer fan blade (111) is connected to the connecting layer (13); the two sides of the outer rib (112) are connected to the valve leaf (1); the inner middle part of the inner fan blade (121) is connected to the outer rib (112); the inner rib (122) extends downward along the valve leaf (1) and is connected to the mounting seat (3).

5. A polymer heart valve according to claim 4, characterized in that: The inner side of the outer rib (112) is thickened to be provided with a connecting strip (113), and penetrating connecting holes (114) are provided on both sides of the connecting strip (113), and the connecting holes (114) are aligned with the valve leaves (1) on both sides.

6. A polymer heart valve according to claim 5, characterized in that: A positioning strip (4) is provided at the center of the connecting strip (113), and the positioning strip (4) is slidably mounted in the connecting strip (113). The valve leaf (1) is connected to the connecting strip (113) via a connecting line (15) thereon.

7. A polymer heart valve according to claim 6, characterized in that: The connection lines (15) on the valve leaves (1) on both sides pass through the connection holes (114) and are interlacedly connected to the positioning strip (4), and the positioning strip (4) is provided with indentations at equal intervals.

8. A method for preparing a polymer heart valve according to any one of claims 1 to 7, characterized in that: include: S1. Preparing a connecting layer (13) of the valve leaf (1): weaving polytetrafluoroethylene filaments according to the shape of the valve leaf (1) to form a connecting layer (13), and leaving extra connecting lines (15) at the edge; S2, preparing the contact layer (14) of the valve leaflet (1): sewing a biological valve material on the inner surface of the connecting layer (13), and then applying a biological material on the sewn biological valve material to form a smooth inner contact layer (14); S3, fixing and sewing the two valve leaves (1) constituting a single valve on both sides to the support frame (2), and connecting the inner center of the valve leaf (1) to the outer rib (112) through a connecting line (15) at the edge of the connecting layer (13); S4, multiple groups of mounting seats (3) are interlocked to form a complete heart valve.

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