A polymeric heart valve and a method of making the same

Abstract

The present application relates to the technical fields of bionic valve material, and particularly relates to a high-molecular heart valve and a preparation method thereof, which comprises an outer auxiliary sheet and an inner auxiliary sheet, the outer auxiliary sheet is arranged on the outer side of the valve leaf, and the outer auxiliary sheet is divided into outer fan blades at the lower end and outer rib strips at the upper end; the inner auxiliary sheet is arranged on the inner side of the valve leaf, and the inner auxiliary sheet is divided into inner fan blades at the upper end and inner rib strips at the lower end; the upper end of the inner fan blades is in contact and fit with each other when the valve leaf is closed, and the lower end of the inner fan blades has a separated and unfolded part; the valve leaf is connected through the outer auxiliary sheet and the inner auxiliary sheet in the middle, the outer fan blades are connected to the mounting seat through the outer fan blades at the bottom end, so that the outer fan blades can obtain a smaller bending angle under stress, thereby enabling the outer fan blades to quickly respond to the blood pump movement, and solving the problems that the artificial heart valve is subjected to a large fatigue impact and bending for a long time and is easy to be damaged.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of bionic valve materials, and particularly relates to a high-molecular heart valve and a preparation method thereof. BACKGROUND

[0002] For valvular heart disease, artificial heart valve replacement is currently the most effective treatment method. Existing artificial valves are mainly divided into mechanical valves and biological valves. Mechanical valves have good durability, but can cause changes in hemodynamics and side effects such as thrombosis, and patients need to take anticoagulant drugs for life to prevent thrombosis. However, long-term use of anticoagulant drugs can cause side effects such as uncontrolled bleeding, gastrointestinal reactions, adverse mood and allergies, thereby reducing the quality of life. Biological valves are usually prepared by glutaraldehyde cross-linked pig or bovine pericardium, and have good biocompatibility. When blood flows through the valve, it shows central flow, which can simulate the physiological blood flow form, and the tissue strength after glutaraldehyde treatment is higher and the immunogenicity is lower.

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

[0004] In view of the above, in order to overcome the above technical problems, the present application designs a high-molecular heart valve and a preparation method thereof, which solves the above technical problems. SUMMARY

[0005] The technical purpose to be achieved by the present application is to increase the blood flow force by means of the auxiliary sheet, while avoiding direct action on the valve leaflet, thereby realizing the movement of the auxiliary heart valve and preventing long-term fatigue work of the heart valve.

[0006] In order to achieve the above technical purpose, the present application provides the following technical scheme:

[0007] The application provides a high polymer heart valve, which comprises valve leaves, a support frame and a mounting seat, the valve leaves are connected to the support frame, and the mounting seat is arranged at the bottom end of the support frame. The application further comprises an outer auxiliary sheet and an inner auxiliary sheet, the outer auxiliary sheet is arranged on the outer side of the valve leaves, the outer auxiliary sheet comprises outer fan blades at the lower end and outer ribs at the upper end, the inner auxiliary sheet is arranged on the inner side of the valve leaves, the inner auxiliary sheet comprises inner fan blades at the upper end and inner ribs at the lower end, the upper ends of the inner fan blades are in contact with each other when the valve leaves are closed, the lower ends of the inner fan blades have separated and unfolded parts, the lower ends of the outer auxiliary sheet are connected to the mounting seat, and the outer auxiliary sheet moves through the rapid resetting movement of the outer fan blades and then moves the inner auxiliary sheet on the inner side through the outer ribs.

[0008] The application divides the heart valve into two valve leaves, connects the valve leaves through the outer auxiliary sheet and the inner auxiliary sheet in the middle, connects the outer fan blades at the bottom end of the outer auxiliary sheet to the mounting seat, so that the outer fan blades can have a smaller bending angle under stress, and the outer fan blades can quickly respond to the blood pumping movement, so that the outer fan blades move quickly to pull the inner auxiliary sheet, thereby realizing the movement of the auxiliary heart valve and preventing the heart valve from working for a long time.

[0009] The hardness of the outer auxiliary sheet and the inner auxiliary sheet is not less than the hardness of the valve leaves, and the mounting seat is provided with an arc-shaped groove corresponding to the outer auxiliary sheet. The movement of the heart valve depends on the blood pumping movement, and the impact force of the blood flow on the valve leaves can make the valve leaves unfold, therefore, the hardness of the valve leaves needs to meet the requirements of softness and deformability, but this greatly reduces the strength of the valve leaves. Therefore, the valve leaves are divided and the auxiliary sheets in the middle are arranged.

[0010] The valve leaves comprise a connecting layer on the outer side and a contact layer on the inner side, the connecting layer is a dense textile material, and the contact layer is a smooth biological coating.

[0011] The connecting layer is made of a textile material, thereby obtaining an outer side with strong connecting and fixing capacity, the connecting layer needs to connect the outer ribs in the middle and the support frames on the two sides, and the contact layer of the biological coating should as much as possible reduce the damage caused by the blood flow impact and concentrate the impact force of the blood on the inner fan blades in the middle.

[0012] The outer fan blades are fan-shaped with a wide lower end and a narrow upper end, the inner side of the outer fan blades is connected to the connecting layer, and the two sides of the outer ribs are connected to the valve leaves; the inner side of the inner fan blades in the middle is connected to the outer ribs, and the inner ribs extend downward along the valve leaves and are connected to the mounting seat.

[0013] The close combination of the outer fan leaf and the connecting layer enhances the stability of the structure, ensuring the reliability of the valve in a high-pressure environment. The connection design of the inner fan leaf and the outer rib enables the valve to effectively transmit pressure, and the design of the inner rib extending downward to the mounting seat increases the strength and durability of the entire system.

[0014] The thickened inner side of the outer rib is provided with a connecting strip, and connecting holes are formed through the two sides of the connecting strip. The connecting holes are aligned with the valve leaves on both sides.

[0015] The thickened inner side of the outer rib provides additional support, making the rib have higher bending resistance when bearing blood flow, preventing the valve from deforming due to long-term stress during use. The thickened design of the connecting strip strengthens the overall structure and improves the durability and stability of the heart valve.

[0016] The center of the connecting strip is provided with a positioning strip, which is slidingly installed in the connecting strip, and the valve leaf is connected to the connecting strip through the connecting line thereon.

[0017] The connecting holes ensure that the valve leaf and the connecting strip can be accurately aligned, which helps to achieve uniform force transmission when the valve leaf moves, reduces local stress concentration, thereby reducing the risk of valve leaf tearing or excessive wear, so that the valve can open and close more smoothly during operation, effectively improving the overall performance of the heart valve.

[0018] The connecting lines on the valve leaves on both sides pass through the connecting holes and are connected to the positioning strip, and the positioning strip is provided with equally spaced indentations. Through the thickened connecting strip and the accurately aligned connecting hole, the mechanical strength, durability and operation convenience of the valve are improved.

[0019] A preparation method of a high-molecular heart valve, comprising:

[0020] S1, preparing a connecting layer of the valve leaf: weaving a polytetrafluoroethylene filament into a connecting layer according to the shape of the valve leaf, and reserving excess connecting lines at the edges;

[0021] S2, preparing a contact layer of the valve leaf: sewing a biological valve material on the inner side surface of the connecting layer, and then applying a biological material on the sewn biological valve material to form a smooth contact layer on the inner side;

[0022] S3, fixing and sewing two valve leaves on both sides of a single-piece valve to a support frame, and connecting the inner side center of the valve leaf to the outer rib through the connecting lines at the edges of the connecting layer;

[0023] S4, embedding multiple groups of mounting seats to form a complete heart valve.

[0024] The beneficial effects of the present application are as follows:

[0025] 1. The present application divides the heart valve into two valve leaflets, and then connects the valve leaflets through the middle outer auxiliary sheet and inner auxiliary sheet, the outer auxiliary sheet is connected with the outer fan blade through the bottom end of the mounting seat, so that the outer fan blade can obtain a smaller bending angle under stress, thereby the outer fan blade quickly responds to the blood pumping movement, so that the outer fan blade moves through the quick traction of the inner auxiliary sheet, thereby realizing the movement of the auxiliary heart valve, and preventing the long-term fatigue work of the heart valve.

[0026] 2. The present application is characterized in that the inner fan blade is arranged at the upper end of the inner auxiliary sheet, thereby increasing the contact stress area of the inner side of the valve leaflet with blood, and the inner fan blade is distributed at the middle position, cooperating with the smooth valve leaflet contact layer, so that the blood can be smoothly flowed and sensitively pumped, and at the same time, the blood can also act on the inner fan blade in time, thereby pushing away the valve leaflet, and since the blood acting force first acts on the inner fan blade, the fatigue impact damage of the valve leaflet is avoided. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the specific embodiments or prior art description will be briefly introduced as follows. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0028] The above and other aspects of the present application will now be described in greater detail with reference to the accompanying drawings, which are presented solely for the purpose of illustration and are therefore not intended to limit the present application, and by way of example only, and wherein:

[0029] Figure 1 is a schematic diagram of the overall structure of the present application;

[0030] Figure 2 is a top plan view of the overall structure of the present application;

[0031] Figure 3 is a schematic diagram of the outer side structure of the valve leaflet of the present application;

[0032] Figure 4 is a front view of the outer side of the valve leaflet of the present application;

[0033] Figure 5 is a schematic diagram of the inner side mechanism of the valve leaflet of the present application;

[0034] Figure 6 is a front view of the inner side of the valve leaflet of the present application;

[0035] Figure 7 is a schematic diagram of the structure of the connecting hole of the present application;

[0036] Figure 8 is a schematic diagram of the mounting relationship between the valve leaflet and the positioning strip of the present application;

[0037] Figure 9 is an enlarged view of A of the present application Figure 3

[0038] Figure 10 is an enlarged view of B of the present application Figure 8

[0039] Figure 11 is a flow chart of the method of the present application.

[0040] In the figure: 1, valve leaf; 11, outer auxiliary sheet; 111, outer fan blade; 112, outer rib; 113, connecting strip; 114, connecting hole; 12, inner auxiliary sheet; 121, inner fan blade; 122, inner rib; 13, connecting layer; 14, contact layer; 15, connecting line; 2, support frame; 3, mounting seat; 31, arc-shaped groove; 4, positioning strip. DETAILED DESCRIPTION

[0041] In order to better understand the above technical solutions, the above technical solutions will be described in detail below in combination with the drawings in the specification and specific embodiments.

[0042] As shown in Figures 1-10 , the present application provides a high polymer heart valve, which comprises valve leaf 1, support frame 2 and mounting seat 3, the valve leaf 1 is connected to the support frame 2, and the bottom end of the support frame 2 is provided with the mounting seat 3. It also comprises outer auxiliary sheet 11 and inner auxiliary sheet 12, 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 outer fan blade 111 at the lower end and 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 inner fan blade 121 at the upper end and inner rib 122 at the lower end; the upper end of the inner fan blade 121 is in contact and fitted with each other when the valve leaf 1 is closed, and the lower end of the inner fan blade 121 has a part that is separated and unfolded; the lower end of the outer auxiliary sheet 11 is connected with the mounting seat 3, and the outer auxiliary sheet 11 moves through the local rapid resetting movement of the outer fan blade 111, and then drags the inner auxiliary sheet 12 on the inner side to move through the outer rib 112.

[0043] The present application divides the heart valve into left and right valve leaf 1, and then connects the valve leaf 1 through the outer auxiliary sheet 11 and the inner auxiliary sheet 12 in the middle, the outer fan blade 111 at the bottom end of the outer auxiliary sheet 11 is connected with the mounting seat 3, so that the outer fan blade 111 can obtain a smaller bending angle under stress, thereby enabling the outer fan blade 111 to quickly respond to the blood pump movement, so that the outer fan blade 111 moves by quickly dragging the inner auxiliary sheet 12, thereby realizing the movement of the auxiliary heart valve and preventing the heart valve from working for a long time.

[0044] ​​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 slot 31 corresponding to the outer auxiliary sheet 11. The inner auxiliary sheet 12 with greater hardness can cope with the impact force of the internal blood flow, and the outer auxiliary sheet 11 can also quickly bend at a small stress angle, thereby driving the two valve leaves 1 to bend.

[0045] As shown in Figures 3-6 , the valve leaf 1 includes 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.

[0046] The connecting layer 13 is woven by textile material to obtain an outer side with strong connection and fixing capacity. The connecting layer 13 needs to connect the outer rib 112 in the middle and the support frame 2 on both sides. If the strength of the connecting layer 13 is not enough, it is easy to cause the artificial valve to fall off or tear during blood flow. Therefore, the connecting layer 13 needs to be densely woven. The contact layer 14 of the biological coating should as much as possible reduce the damage caused by blood flow impact, and concentrate the impact force of the blood on the inner fan blade 121 in the middle.

[0047] As shown in Figure 3 and Figure 4 , the outer fan blade 111 is a fan shape with a wide lower end and a narrow upper end, the inner side of the outer fan blade 111 is connected with the connecting layer 13, and the two sides of the outer rib 112 are connected with the valve leaf 1; the inner side of the inner fan blade 121 is connected with the outer rib 112 in the middle, and the inner rib 122 extends downward along the valve leaf 1 and is connected with the mounting seat 3.

[0048] The shape of the outer fan blade 111 (fan shape with wide lower end and narrow upper end) can optimize the stress distribution, so that the valve has better flowability and response speed in blood flow, and the risk of bending under stress is reduced, thereby ensuring that the valve can quickly and smoothly move when opening and closing, thereby improving the durability of the valve.

[0049] Secondly, the close combination of the outer fan blade 111 and the connecting layer 13 enhances the stability of the structure and ensures the reliability of the valve in a high-pressure environment. The connection design of the inner fan blade 121 and the outer rib 112 enables the valve to effectively transmit pressure, and the design of the inner rib 122 extending downward to the mounting seat 3 increases the strength and durability of the entire system.

[0050] As shown in Figure 5 and Figure 7 , the inner side of the outer rib 112 is thickened to provide a connecting strip 113, the two sides of the connecting strip 113 are provided with through connecting holes 114, and the connecting holes 114 are aligned with the two valve leaves 1.

[0051] The thickening of the inner side of the outer rib 112 provides additional support, enabling the rib to have higher bending resistance when subjected to blood flow, preventing the valve from deforming due to long-term stress during use. The thickening design of the connecting strip 113 strengthens the overall structure, improving the durability and stability of the heart valve.

[0052] The through connecting hole 114 provides a fixed point for the mutual connection of the valve leaflet 1 and the connecting strip 113, facilitating accurate connection of the components during assembly. This design not only facilitates accurate positioning during production, but also facilitates maintenance and replacement later, improving the convenience and reliability of overall use.

[0053] As shown in Figures 8-10 , the connecting strip 113 is provided with a positioning strip 4 at the center, which is slidingly installed in the connecting strip 113, and the valve leaflet 1 is connected to the connecting strip 113 through the connecting line 15 thereon. The connecting hole 114 ensures that the valve leaflet 1 and the connecting strip 113 can be accurately aligned, facilitating uniform force transmission when the valve leaflet 1 moves, reducing local stress concentration, thereby reducing the risk of valve leaflet 1 tearing or excessive wear, allowing the valve to open and close more smoothly during operation, effectively improving the overall performance of the heart valve.

[0054] As shown in Figure 8 and Figure 10 , the connecting lines 15 on the two sides of the valve leaflet 1 pass through the connecting holes 114 and are connected to the positioning strip 4, and the positioning strip 4 is provided with equally spaced notches. The positioning strip 4 is connected to the two sides of the valve leaflet 1 through the connecting lines 15, and in order to prevent the connections from rubbing against each other, equally spaced notches are provided on the positioning strip 4, so that the connecting lines 15 are sequentially limited at the notch positions, and the connecting lines 15 are more compact and stable.

[0055] As shown in Figure 11 , a preparation method of a high-molecular heart valve, comprising:

[0056] S1, preparing a connecting layer 13 of the valve leaflet 1: weaving polytetrafluoroethylene filaments into a connecting layer 13 according to the shape of the valve leaflet 1, and reserving excess connecting lines 15 at the edges;

[0057] S2, preparing a contact layer 14 of the valve leaflet 1: sewing biological valve material on the inner side surface of the connecting layer 13, and then applying biological material on the sewn biological valve material to form a smooth contact layer 14 on the inner side;

[0058] S3, fix the two valve leaflets 1 constituting a single valve on both sides and sew them 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;

[0059] S4. Engage multiple groups of mounting seats 3 to form a complete heart valve.

[0060] 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 multiple sets of mutually interlocking mounting seats 3, which simplifies the installation process and improves production efficiency.

[0061] Although the present disclosure has been described in detail above using general descriptions and specific embodiments, it will be apparent to those skilled in the art that modifications or improvements may be made based on the embodiments of the present disclosure. Therefore, such modifications or improvements, as long as they do not depart from the spirit of the present disclosure, are within the scope of protection claimed by the present disclosure.

[0062] The foregoing description is merely an excerpt from the disclosure, which 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. Rather, the scope of the invention is to be determined entirely by the appended claims, which are to be construed in accordance with established doctrines of claim interpretation.

Claims

1. A high polymer heart valve, comprising valve leaflets (1), a support frame (2) and a mounting seat (3), the valve leaflets (1) being connected to the support frame (2), and the mounting seat (3) being mounted at the bottom end of the support frame (2); characterized in that, It also includes an outer auxiliary sheet (11) and an inner auxiliary sheet (12), the valve leaflet (1) includes 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; a single valve leaflet (1) is divided into two pieces, which are connected by the outer auxiliary sheet (11) and the inner auxiliary sheet (12) in the middle. The outer auxiliary sheet (11) is arranged on the outer side of the valve leaflet (1), and the outer auxiliary sheet (11) is divided into an outer fan blade (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 leaflet (1), and the inner auxiliary sheet (12) is divided into an inner fan blade (121) at the upper end and an inner rib (122) at the lower end; the upper end of the inner fan blade (121) is in contact with each other when the valve leaflet (1) is closed, and the lower end of the inner fan blade (121) has a part that is separated and expanded; the lower end of the outer auxiliary sheet (11) is connected with the mounting seat (3), and the inner side of the outer rib (112) is thickened to be provided with a connecting strip (113), and the center of the connecting strip (113) is provided with a positioning strip (4), the positioning strip (4) is slidably installed in the connecting strip (113), and the valve leaflet (1) is connected with the connecting strip (113) through the connecting line (15) thereon; the outer auxiliary sheet (11) moves through the local quick reset movement of the outer fan blade (111), and then drags the inner auxiliary sheet (12) on the inner side to move through the outer rib (112).

2. The polymeric heart valve of claim 1, wherein: The hardness of the outer auxiliary sheet (11) and the inner auxiliary sheet (12) is not less than the hardness of the valve leaflet (1), and the mounting seat (3) is provided with an arc-shaped groove (31) corresponding to the outer auxiliary sheet (11).

3. The polymeric heart valve of claim 1, wherein: The outer fan blade (111) is a fan shape with a wide lower end and a narrow upper end, the inner side of the outer fan blade (111) is connected with the connecting layer (13), and the two sides of the outer rib (112) are connected with the valve leaflet (1); the inner side of the inner fan blade (121) is connected with the outer rib (112) in the middle, and the inner rib (122) extends downward along the valve leaflet (1) and is connected with the mounting seat (3).

4. The polymeric heart valve of claim 3, wherein: The two sides of the connecting strip (113) are provided with through connecting holes (114), and the connecting holes (114) are aligned with the left and right two pieces of the valve leaflet (1).

5. The polymeric heart valve of claim 4, wherein: The connecting lines (15) on the left and right two pieces of the valve leaflet (1) pass through the connecting holes (114) and are connected with each other on the positioning strip (4), and the positioning strip (4) is provided with equally spaced recesses.

6. A method of making a polymeric heart valve according to any one of claims 1 to 5, characterized in that: It includes: S1, preparing the connecting layer (13) of the valve leaflet (1): weaving polytetrafluoroethylene filaments into the connecting layer (13) according to the shape of the valve leaflet (1), and reserving excess connecting lines (15) at the edges; S2, preparing the contact layer (14) of the valve leaflet (1): sewing biological valve material on the inner side surface of the connecting layer (13), and then applying biological material on the sewn biological valve material to form a smooth inner contact layer (14); S3, the two pieces of the left and right fixed sewing of the composition single valve leaflet (1) are fixed on the support frame (2), and the inner side center of the valve leaflet (1) is connected with the outer rib (112) through the connecting line (15) of the edge of the connecting layer (13); S4, the mounting seat (3) is embedded with each other to form a complete heart valve.

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