Leaflet for heart valve, and method for preparing same

Abstract

The present application relates to the technical field of heart valves. Provided are a leaflet for a heart valve, and a method for preparing same. The leaflet for a heart valve of the present application may comprise a leaflet body and a reinforcing member, wherein the leaflet body comprises a region to be reinforced, which is selected from among one or more of a commissure region, an attachment edge region and a free edge region; and the reinforcing member corresponds to the region to be reinforced in terms of area and structure, and is connected to one or two sides of the region to be reinforced. In the leaflet of the present application, the reinforcing member is arranged in the region to be reinforced of the leaflet body, thereby improving the durability of the leaflet and avoiding early rupture thereof during operation. In addition, with reinforcement by the reinforcing member, the overall stress distribution of the entire leaflet is more uniform, without affecting the performance of the material of the leaflet body, thus meeting the synchronous improvement requirements for the hydrodynamic performance and the durability of the leaflet material.

Description

A valve leaflet for a heart valve and its preparation method

[0001] This application claims priority to Chinese Patent Application No. 2024117936008, filed on December 6, 2024, entitled "A valve leaflet for a heart valve and a method for preparing the same", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of artificial heart valve technology, and in particular to a valve leaflet for a heart valve and a method for preparing the same. Background Technology

[0003] Fiber-reinforced composite materials have been widely used in cardiovascular implantable devices, such as artificial heart valves, artificial blood vessels, and vascular stents. The fiber materials can be woven using various methods to achieve different mechanical properties, such as anisotropy, high elasticity, high tensile strength, rigidity, and permeability. Simultaneously, the surface coating material can improve the material's biocompatibility in blood, avoiding reactions such as inflammation, thrombosis, and calcification caused by exogenous materials, thus meeting the needs of different medical devices. In the case of artificial heart valves, during operation, the valve leaflets move back and forth with the cardiac cycle. Within the entire leaflet material region, different locations experience varying levels of stress due to blood pressure.

[0004] Generally, the stress level of valve leaflet materials near the attachment angle and apex of the artificial valve stent is much higher than in other areas. Furthermore, under the same blood pressure and valve size parameters, the stress level in different areas of the valve leaflet material is significantly affected by the elastic modulus of the material itself. Generally, the higher the elastic modulus of the leaflet material, the greater the stress level in the leaflet area near the attachment angle and apex. Sometimes, the maximum stress level in different areas of a single leaflet can be tens or even hundreds of times higher than the minimum stress level. Therefore, to improve the durability of valve leaflet materials and prevent premature tearing during operation, simply increasing the overall strength of the material often does not yield ideal results. Sometimes, excessively high material strength leads to a large overall elastic modulus and stiffness, affecting the opening and closing pattern of the leaflet in the blood and resulting in poor valve hydrodynamic performance. At the same time, high leaflet stiffness can cause stress concentration in localized areas, especially in the attachment angle, potentially leading to earlier valve tearing and failure. Therefore, in the field of artificial heart valves, there is an urgent need for a holistic valve leaflet material structure design and manufacturing process that balances both the hydrodynamic performance and durability of the valve.

[0005] Existing technologies involve designing valve leaflets as multi-layered polymer materials. The overall structure comprises five layers from top to bottom: a first fiber layer, a filling layer, a porous sponge layer, a filling layer, and a second fiber layer. Additionally, a small amount of filling material is present on the outer sides of the upper and lower fiber layers. The overall thickness of the valve leaflet material is significant, reaching up to 300 micrometers, which negatively impacts the loading and clamping of interventional valves. Thicker leaflets require more space for clamping, necessitating larger valve delivery device dimensions and increasing the challenge of surgical approach. Furthermore, the greater thickness results in higher bending strain and stress during leaflet bending, affecting fluid dynamics. The additional shear stress generated by material bending between layers places high demands on interlayer bonding, increasing the risk of delamination and fatigue failure.

[0006] Another technology involves forming the petals using a one-piece, large jacquard weave structure. This involves setting areas with higher tightness and thickness than the petals in the attachment edge, joint, free edge, and specific areas on the belly, thus reinforcing the target area. A thin polyurethane coating is then applied to the surface. Due to the soft nature of the woven material, increasing tightness or thickness in specific areas can cause uneven tension within the weave structure. When the entire piece of fabric is removed from the machine, this uneven tension in the localized weave structure leads to curling and deformation of the fabric, making it difficult for the material to maintain the intended petal size and shape. Summary of the Invention

[0007] One objective of the first aspect of this application is to provide a leaflet for a heart valve that solves the problem that the leaflet material in the prior art has many layers and a large thickness, which leads to difficulty in compression and surgery.

[0008] The second objective of this application is to address the problem of uneven tension in existing leaflets.

[0009] Specifically, this application provides a leaflet for a heart valve, comprising:

[0010] The leaflet body includes a reinforcing region selected from one or more of the hanging angle region, the attachment edge region, and the free edge region; and

[0011] A reinforcing member, which corresponds to the area and structure of the reinforcing region, is composited on one or both sides of the reinforcing region;

[0012] After the leaflet body is combined with the reinforcing member, the thickness of the reinforcing region of the leaflet is 120μm to 300μm, and the thickness of other regions is 60μm to 120μm.

[0013] Optionally, the area of ​​the reinforcing region on one side of the leaflet body is 6.5% to 22.5% of the total area of ​​that side of the leaflet body; the outline width of the reinforcing member is 1mm to 4.5mm.

[0014] Optionally, the leaflet body includes a first fabric layer and two first polymer layers respectively disposed on both sides of the first fabric layer. The thickness of the first fabric layer is 40μm to 60μm, the thickness of the first polymer layer is 10μm to 30μm, and the thickness of the leaflet body is 60μm to 120μm.

[0015] Optionally, the structure of the first fabric layer is selected from plain weave, twill weave, or satin weave, and the linear density of the first fabric layer is 5 to 30 dtex; the warp density of the first fabric layer is 25 to 200 strands / cm, and the weft density of the first fabric layer is 15 to 100 strands / cm.

[0016] Optionally, the material of the first fabric layer is selected from one or more of polyethylene, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, and polyamide with an average molecular weight of 1000-5000 kDa.

[0017] Optionally, the material of the first polymer layer is selected from one or more of polyurethane and polystyrene polymers; wherein, the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil; and the styrene material is selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), and styrene-ethylene / butene-styrene (SEBS).

[0018] Optionally, the reinforcement includes a second fabric layer and second polymer layers located on both sides of the second fabric layer; the thickness of the second fabric layer is 40μm to 100μm, the thickness of the second polymer layer is 10μm to 40μm, and the thickness of the reinforcement is 60μm to 180μm.

[0019] Optionally, the second fabric layer has a plain weave structure, the linear density of the second fabric layer is 2 to 60 dtex, the warp density of the second fabric layer is 20 to 160 strands / cm, and the weft density of the second fabric layer is 12 to 90 strands / cm.

[0020] Optionally, the material of the second fabric layer is selected from polyethylene or polyamide with an average molecular weight of 1000-5000 kDa.

[0021] Optionally, the material of the second polymer layer is the same as that of the first polymer layer, so that when the reinforcement is attached to the leaflet body, the first polymer layer and the first polymer layer are fused together to form an integral structure.

[0022] In particular, this application also provides a method for preparing a leaflet for a heart valve. The method includes:

[0023] Prepare a leaflet body and a reinforcement, wherein the leaflet body includes a reinforcement region, the reinforcement region being selected from one or more of a hanging corner region, an attachment edge region, and a free edge region;

[0024] The reinforcement is incorporated into one or both sides of the reinforcement region of the leaflet body.

[0025] Optionally, it includes:

[0026] When the leaflet body and the reinforcement are integrally formed, the steps for preparing the leaflet body and the reinforcement include:

[0027] A first fabric layer material is selected, and a first polymer solution is coated on one side of the first fabric layer, which is then heated and cured to form the first polymer layer.

[0028] A layer of the first polymer solution is coated on the other side of the first fabric layer and then heated and cured to form the first polymer layer;

[0029] The material is cut into a shape that integrates the main body of the leaflet and the reinforcing member, thus completing the preparation.

[0030] Optionally, the step of attaching the reinforcement to one side of the leaflet body includes:

[0031] A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body;

[0032] Place the leaflet body into the groove of the positioning device;

[0033] A composite solution is provided at the location requiring reinforcement on the upper side of the leaflet body, wherein the composite solution is the same as the first polymer solution;

[0034] The reinforcing member is folded along the side of the groove of the positioning member so that the reinforcing member is placed above the composite solution of the leaflet body and is attached to the leaflet body;

[0035] After standing for 5-10 minutes, place it in an oven at 50-70℃ and dry for at least 48 hours.

[0036] Optionally, when the leaflet body and the reinforcement are separate, the steps for manufacturing the leaflet body and the reinforcement include:

[0037] First, prepare the main body of the leaflet;

[0038] The reinforcing member is then prepared.

[0039] Optionally, the step of preparing the leaflet body includes:

[0040] A first fabric layer material is selected, and a first polymer solution is coated on one side of the first fabric layer, which is then heated and cured to form the first polymer layer.

[0041] A layer of the first polymer solution is coated on the other side of the first fabric layer and then heated and cured to form the first polymer layer;

[0042] Cut the material into the shape of the main body of the petal to complete the preparation.

[0043] Optionally, the thickness of the first fabric layer is 40μm to 60μm, the thickness of the first polymer layer is 10μm to 30μm, and the thickness of the leaflet body is 60μm to 120μm;

[0044] The structure of the first fabric layer is selected from plain weave, twill weave or satin weave, the warp density of the first fabric layer is 25 to 200 strands / cm, and the weft density of the first fabric layer is 15 to 100 strands / cm.

[0045] The material of the first fabric layer is selected from one or more of ultra-high molecular weight polyethylene (average molecular weight greater than 1,000-5000 kDa), polypropylene, polyethylene terephthalate, polytetrafluoroethylene, and polyamide.

[0046] Optionally, the step of coating one side of the first fabric layer with a first polymer solution and heating and curing to form the first polymer layer includes:

[0047] A layer of the first polymer solution is applied to the first fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.4 mm to 4 mm above the surface of the first fabric layer, moves at a speed of 2 mm / s to 40 mm / s, is heated at a temperature of 50°C to 70°C, and is cured at a temperature of 50°C to 70°C for 10 min to 20 min.

[0048] Optionally, the step of coating a layer of the first polymer solution on the other side of the first fabric layer and then heating and curing it to form the first polymer layer includes:

[0049] A layer of the first polymer solution is applied to the first fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.2–2 mm above the surface of the first fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

[0050] Optionally, the first polymer solution is prepared by dissolving a first polymer in an organic solvent;

[0051] The material of the first polymer is selected from one or more of polyurethane and polystyrene polymers; the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil.

[0052] Styrene-based materials are selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), and styrene-ethylene / butene-styrene (SEBS).

[0053] The organic solvents include, but are not limited to, at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide;

[0054] The mass concentration of the first polymer solution is 5%-22%.

[0055] Optionally, the step of preparing the reinforcement includes:

[0056] A second fabric layer material is selected, and a second polymer solution is coated on one side of the second fabric layer, which is then heated and cured to form a second polymer layer; wherein, the second polymer solution is the same as the first polymer solution;

[0057] A layer of the second polymer solution is coated on the other side of the second fabric layer and then heated and cured to form a second polymer layer;

[0058] Cut into the shape of the reinforcement to complete the preparation.

[0059] Optionally, the thickness of the second fabric layer is 40 μm to 100 μm, the thickness of the second polymer layer is 10 μm to 40 μm, and the thickness of the reinforcement is 60 μm to 180 μm.

[0060] The second fabric layer has a plain weave structure, a linear density of 2 to 60 dtex, a warp density of 20 to 160 strands / cm, and a weft density of 12 to 90 strands / cm.

[0061] The material of the second fabric layer is selected from high molecular weight polyethylene and polyamide.

[0062] Optionally, the step of coating one side of the second fabric layer with a second polymer solution and heating to cure it to form the second polymer layer includes:

[0063] A layer of the second polymer solution is applied to the second fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.8–8 mm above the surface of the second fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 10–20 minutes.

[0064] Optionally, the step of coating a layer of the second polymer solution on the other side of the second fabric layer and then heating and curing it to form the second polymer layer includes:

[0065] A layer of the second polymer solution is applied to the second fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.4–4 mm above the surface of the second fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

[0066] Optionally, when the reinforcement is provided on one side of the leaflet body, the step of attaching the reinforcement to the leaflet body includes:

[0067] A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body;

[0068] Place the leaflet body into the groove of the positioning device;

[0069] A composite solution is provided at the location requiring reinforcement on the upper side of the leaflet body, wherein the composite solution is the same as the first polymer solution;

[0070] The reinforcing member is placed above the composite solution and attached to the leaflet body;

[0071] After standing for 5-10 minutes, place it in an oven at 50-70℃ and dry for at least 48 hours.

[0072] Optionally, when the reinforcement is attached to both sides of the leaflet body, after some of the reinforcement is laminated to one side of the leaflet body according to the above steps, the product is flipped over and the above steps are repeated to attach the other reinforcement to the other side of the leaflet body.

[0073] The leaflet of this design may include a leaflet body and a reinforcement. The reinforcement increases the reinforced area of ​​the leaflet body, which may include the hanging corner area, the attachment edge area, and the free edge area. This design incorporates a reinforcement at at least one location within these reinforced areas, thereby improving the leaflet's durability and preventing premature tearing during operation. Furthermore, the reinforcement results in a more uniform stress distribution across the entire leaflet without affecting the performance of the leaflet body material, thus meeting the requirement for simultaneous improvement of the leaflet material's hydrodynamic and durability properties.

[0074] The leaflet thickness of this design is low, which does not affect the loading of the interventional valve. Furthermore, the low thickness requires less space for leaflet clamping, resulting in a smaller overall size of the valve delivery device and reducing surgical difficulty. Additionally, the low leaflet thickness in this embodiment results in lower bending strain and stress during operation, minimizing the impact on the leaflet's fluid properties. Moreover, the additional shear stress generated by material bending between layers places lower requirements on interlayer bonding strength, reducing the likelihood of delamination of the composite material layers and lowering the probability of fatigue failure.

[0075] The method for preparing heart valve leaflets in this scheme involves preparing a leaflet body and a reinforcing element, and then combining the reinforcing element with the leaflet body to obtain the leaflet. The leaflet prepared using this method can be formed as a single unit, thus overcoming the problem of weak bonding and separation between material layers, suppressing slippage between the multi-layered leaflet body and the reinforcing element, especially mitigating the interlayer shear stress generated by leaflet bending during operation. The seamless fusion of multiple layers can distribute the shear stress between material layers, achieving a reinforcing effect.

[0076] The above and other objects, advantages and features of this application will become more apparent to those skilled in the art from the following detailed description of specific embodiments in conjunction with the accompanying drawings. Attached Figure Description

[0077] The following sections will describe some specific embodiments of this application in detail by way of example and not limitation, with reference to the accompanying drawings. The same reference numerals in the drawings denote the same or similar parts or components. Those skilled in the art should understand that these drawings are not necessarily drawn to scale. In the drawings:

[0078] Figure 1 is a schematic structural diagram of the leaflet body and the reinforcing member combined according to a specific embodiment of this application;

[0079] Figure 2 is a schematic structural diagram of the leaflet body and the reinforcement separated according to a specific embodiment of the present application; wherein, (a) is the leaflet body and (b) is the reinforcement;

[0080] Figure 3 is a schematic structural diagram of the leaflet body and the reinforcement separated according to another specific embodiment of the present application; wherein, (a) is the reinforcement and (b) is the leaflet body;

[0081] Figure 4 is a schematic structural diagram of the leaflet body and the reinforcing member integrally formed according to a specific embodiment of this application;

[0082] Figure 5 is a cross-sectional view of one embodiment after being cut along the cutting line AA in Figure 1;

[0083] Figure 6 is a cross-sectional view of another embodiment after being cut along the cutting line AA in Figure 1;

[0084] Figure 7 is a cross-sectional view after being cut along the cutting line BB in Figure 2;

[0085] Figure 8 is a cross-sectional view after being cut along the cutting line CC in Figure 2;

[0086] Figure 9 is a schematic flowchart of a method for preparing a leaflet for a heart valve according to a specific embodiment of this application;

[0087] Figure 10 is a schematic flowchart of the steps for preparing the leaflet body and the reinforcement according to a specific embodiment of this application;

[0088] Figure 11 is a schematic flowchart of the steps of attaching the reinforcement to one side of the leaflet body according to a specific embodiment of the present application;

[0089] Figure 12 is a schematic structural diagram of a first positioning device according to a specific embodiment of this application;

[0090] Figure 13 is a schematic structural diagram of a second positioning device according to a specific embodiment of the present application; wherein, (a) is a schematic diagram of the second positioning device; (b) is a schematic diagram of the clamping piece; and (c) is a schematic diagram of the clamping piece combined with the second positioning device.

[0091] Figure 14 is a schematic flowchart of the steps for preparing a reinforcement according to a specific embodiment of this application;

[0092] Figure 15 is a schematic flowchart of the steps of attaching the reinforcement to one side of the leaflet body according to another specific embodiment of this application;

[0093] Figure 16 is a cross-sectional scanning electron microscope image of the leaflet body prepared according to the method in Example 1;

[0094] Figure 17 is a cross-sectional scanning electron microscope image of the reinforcement prepared according to the method in Example 1;

[0095] Figure 18 is a cross-sectional scanning electron microscope image of the composite of the leaflet body and the reinforcement prepared according to the method in Example 1;

[0096] Figure 19 is a cross-sectional scanning electron microscope image of the leaflet body position when the leaflet body and the reinforcement are combined according to the method in Example 1;

[0097] Figure 20 is a photograph of the leaflet prepared according to the method in Example 1;

[0098] Figure 21 is a cross-sectional scanning electron microscope image of the leaflet body prepared according to the method in Example 2;

[0099] Figure 22 is a cross-sectional scanning electron microscope image of the reinforcement prepared according to the method in Example 2;

[0100] Figure 23 is a cross-sectional scanning electron microscope image of the composite of the leaflet body and the reinforcement prepared according to the method in Example 2;

[0101] Figure 24 is a photograph of the leaflet prepared according to the method in Example 2;

[0102] Figure 25 is a cross-sectional scanning electron microscope image of the leaflet body and the reinforcing member combined according to the method in Example 3;

[0103] Figure 26 is a photograph of the leaflet prepared according to the method in Example 3.

[0104] Explanation of reference numerals in the attached figures:

[0105] Leaflet-100; Leaflet body-110; Reinforcing member-120; Second fabric layer-121; Second polymer layer-122; Hanging corner area-111; Attachment edge area-112; Free edge area-113; First fabric layer-114; First polymer layer-115; First positioning device-200; Protrusion-210; Groove-220; Second positioning device-300; Groove-310; Clip-320. Detailed Implementation

[0106] In the description of this embodiment, it should be understood that the terms "length", "width", "height", "up", "down", "left", "right", "vertical", "horizontal", "bottom", "inner", "outer", "front", "rear", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0107] As a specific embodiment of this application, as shown in Figures 1-6, this embodiment discloses a valve leaflet 100 for a heart valve. The valve leaflet 100 may include a leaflet body 110 and a reinforcement member 120. The leaflet body 110 may include a reinforcement region, which is selected from one or more of the attachment angle region 111, the attachment edge region 112, and the free edge region 113. The reinforcement member 120 corresponds to the area and structure of the reinforcement region and is composited on one side (as shown in Figure 5) or both sides of the reinforcement region (as shown in Figure 6). After the leaflet body 110 and the reinforcement member 120 are composited, the thickness of the leaflet at the location corresponding to the reinforcement region is 120 μm to 300 μm, and the thickness of other regions is 60 μm to 120 μm.

[0108] Specifically, the leaflet 100 in this embodiment may include a leaflet body 110 and a reinforcement 120. The reinforcement 120 increases the reinforcement area of ​​the leaflet body 110, which may include a hanging corner area 111, an attachment edge area 112, and a free edge area 113. In these areas, the stress level of the leaflet 100 is much higher than that in other areas. Therefore, in this embodiment, the reinforcement 120 is composited at at least one location in these reinforcement areas to improve the durability of the leaflet 100 and prevent premature tearing of the leaflet 100 during operation. In addition, through the reinforcement of the reinforcement 120, the stress distribution of the entire leaflet 100 is more uniform without affecting the performance of the material of the leaflet body 110, thus meeting the requirement of simultaneously improving the hydrodynamic properties and durability of the leaflet 100 material.

[0109] Specifically, in this embodiment, the thickness of the leaflet 100 in the reinforced region can be 120μm to 300μm, for example, 120μm, 150μm, 200μm, 240μm, or 300μm, etc., and the specific thickness can be designed according to actual conditions. Additionally, the thickness of the leaflet 100 in other locations in this embodiment can be 60μm, 80μm, 100μm, or 120μm. The specific thickness can also be designed according to actual conditions. Specifically, the leaflet 100 in this embodiment has a low thickness, which does not affect the loading of the interventional valve. Furthermore, the low thickness requires less space during leaflet 100 loading, resulting in a smaller overall size of the valve delivery device and reducing the difficulty of manual operation. In addition, the low thickness of the leaflet 100 in this embodiment results in lower bending strain and stress during the bent working state, minimizing the impact on the fluid performance of the leaflet 100. Moreover, the additional shear stress generated between layers due to material bending requires less interlayer bonding strength, making it less likely to cause delamination between composite material layers and reducing the probability of fatigue failure.

[0110] As a specific embodiment of this application, the area of ​​the reinforcing region on one side of the leaflet body 110 is 6.5% to 22.5% of the total area of ​​that side of the leaflet body 110. The outline width of the reinforcing member 120 is 1 mm to 4.5 mm.

[0111] Specifically, in this embodiment, the reinforcing areas of the leaflet body 110 are mainly located in the hanging corner region 111, the attachment edge region 112, and the free edge region 113. Since the area with concentrated stress in these regions accounts for only 6.5% to 22.5% of the total area of ​​one side of the leaflet body 110, the reinforcing member 120 in this embodiment also occupies only 6.5% to 22.5% of the area of ​​one side of the leaflet body 110. For example, the area of ​​the reinforcing member 120 can be 6.5%, 10%, 12.5%, 15%, 18%, 20%, or 22.5%. Furthermore, the width of the reinforcing area is only 1mm to 4.5mm. Therefore, the width of the reinforcing member 120 can also be 1mm to 4.5mm. For example, the width of the reinforcing member 120 can be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm, or 4.5mm.

[0112] As a specific embodiment of this application, as shown in FIG7, the leaflet body 110 of this embodiment may include a first fabric layer 114 and two first polymer layers 115 respectively disposed on both sides of the first fabric layer 114. The thickness of the first fabric layer 114 is 40μm to 60μm, the thickness of the first polymer layer 115 is 10μm to 30μm, and the thickness of the leaflet body 110 is 60μm to 120μm.

[0113] Specifically, the structure of the first fabric layer 114 can be selected from plain weave, twill weave, or satin weave. The linear density of the first fabric layer 114 is 5–30 dtex. The warp density of the first fabric layer 114 can be 25–200 plies / cm, for example, 25 plies / cm, 50 plies / cm, 100 plies / cm, 150 plies / cm, 180 plies / cm, 200 plies / cm, 250 plies / cm, etc. The weft density of the first fabric layer 114 can be 15–100 plies / cm, for example, 15 plies / cm, 30 plies / cm, 50 plies / cm, 70 plies / cm, 90 plies / cm, or 100 plies / cm, etc.

[0114] Specifically, the material of the first fabric layer 114 can be selected from one or more of ultra-high molecular weight polyethylene (average molecular weight greater than 1,000-5000 kDa), polypropylene, polyethylene terephthalate, polytetrafluoroethylene, and polyamide.

[0115] Specifically, the material of the first polymer layer 115 may be selected from one or more of polyurethane and polystyrene polymers; wherein, the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil; and the styrene material is selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), and styrene-ethylene / butene-styrene (SEBS).

[0116] As a specific embodiment of this application, as shown in FIG8, the reinforcement 120 of this embodiment may include a second fabric layer 121 and a second polymer layer 122 located on both sides of the second fabric layer 121. The thickness of the second fabric layer 121 is 40μm to 100μm, the thickness of the second polymer layer 122 is 10μm to 40μm, and the thickness of the reinforcement 120 is 60μm to 180μm.

[0117] Specifically, in this embodiment, the second fabric layer 121 has a plain weave structure, which is relatively stable. The linear density of the second fabric layer 121 is 2–60 dtex, for example, the linear density of the second fabric layer 121 can be 2 dtex, 10 dtex, 20 dtex, 40 dtex, 50 dtex, or 60 dtex. The warp density of the second fabric layer 121 is 20–160 ply / cm, for example, the warp density can be 20 ply / cm, 40 ply / cm, 60 ply / cm, 80 ply / cm, 100 ply / cm, 120 ply / cm, or 160 ply / cm. The weft density of the second fabric layer 121 is 12–90 ply / cm. This weft density can be 12, 20, 40, 60, 80, or 90 ply / cm.

[0118] Specifically, the material of the second fabric layer 121 is selected from ultra-high molecular weight polyethylene (average molecular weight greater than 1,000-5000 kDa) and polyamide. The material of the second fabric layer 121 can be the same as or different from the material of the first fabric layer 114.

[0119] Specifically, the material of the second polymer layer 122 is the same as that of the first polymer layer 115, so that when the reinforcement 120 is attached to the leaflet body 110, the first polymer layer 115 fuses with each other to form an integral structure. Specifically, selecting the same material for the first polymer layer 115 and the second polymer layer 122 facilitates the fusion of the leaflet body 110 and the reinforcement 120, thereby preventing the leaflet body 110 and the reinforcement 120 from separating during use.

[0120] As a specific embodiment of this application, as shown in FIG9, this embodiment provides a method for preparing a valve leaflet 100 for a heart valve, the preparation method including:

[0121] Step S100: Prepare leaflet body 110 and reinforcement 120, wherein the leaflet body 110 includes a reinforcement region, which is selected from one or more of the hanging corner region 111, attachment edge region 112 and free edge region 113;

[0122] In step S200, the reinforcing member 120 is composited onto one or both sides of the reinforcing region of the leaflet body 110.

[0123] Specifically, the method for preparing the valve leaflet 100 for the heart valve in this embodiment involves preparing a valve leaflet body 110 and a reinforcing member 120, and then combining the reinforcing member 120 with the valve leaflet body 110 to obtain the valve leaflet 100. The valve leaflet 100 prepared by this method can be formed into a whole, thereby overcoming the problem of weak bonding and separation between material layers, suppressing slippage between the multi-layered valve leaflet body 110 and the reinforcing member 120, especially the interlayer shear force generated by the bending of the valve leaflet 100 during operation. The seamless fusion of multiple layers can share the shear stress between material layers, achieving a reinforcing effect.

[0124] As a specific embodiment of this application, as shown in FIG10, when the leaflet body 110 and the reinforcing member 120 are integrally formed, the steps for preparing the leaflet body 110 and the reinforcing member 120 include:

[0125] Step S110: Select the material of the first fabric layer 114, coat one side of the first fabric layer 114 with a layer of the first polymer solution, and heat and cure to form the first polymer layer 115.

[0126] Step S120: A first polymer solution is coated on the other side of the first fabric layer 114 and then heated and cured to form the first polymer layer 115.

[0127] Step S130: Cut the petal body 110 and the reinforcing member 120 into an integral shape to complete the preparation.

[0128] Specifically, in this embodiment, the integrated material of the leaflet body 110 and the reinforcement 120 is prepared by coating the two sides of the first polymer layer 115 on both sides of the first fabric layer 114 and cutting it. They are all three-layer planar composite materials with uniform stress thickness, and will not curl or deform in a relaxed state.

[0129] Specifically, the structure, shape and size of the first fabric layer 114 have been explained in detail above, and will not be repeated here.

[0130] Specifically, in this embodiment, the step of coating one side of the first fabric layer 114 with a first polymer solution and heating and curing to form the first polymer layer 115 includes:

[0131] A first polymer solution is applied to the first fabric layer 114 using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.4 mm to 4 mm above the surface of the first fabric layer 114, with a moving speed of 2 mm / s to 40 mm / s, a heating temperature of 50°C to 70°C, a curing temperature of 50°C to 70°C, and a curing time of 10 min to 20 min.

[0132] Specifically, in this embodiment, the steps of coating a first polymer solution on the other side of the first fabric layer 114 and then heating and curing it to form the first polymer layer 115 include:

[0133] A first polymer solution is applied to the first fabric layer 114 using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.2–2 mm above the surface of the first fabric layer 114, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

[0134] Specifically, in this embodiment, the first polymer solution is prepared by dissolving a first polymer in an organic solvent;

[0135] The first polymer is selected from one or more of polyurethane and polystyrene polymers; the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil.

[0136] Styrene-based materials are selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), and styrene-ethylene / butene-styrene (SEBS).

[0137] Organic solvents include, but are not limited to, at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide;

[0138] The mass concentration of the first polymer solution is 5%-22%.

[0139] As a specific embodiment of this application, as shown in FIG11, the step of attaching the reinforcement 120 to one side of the leaflet body 110 in this embodiment may include:

[0140] Step S210: A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body 110.

[0141] Step S220: Place the leaflet body 110 into the groove of the positioning device;

[0142] Step S230: A composite solution is placed at the position requiring reinforcement on the upper side of the leaflet body 110, wherein the composite solution is the same as the first polymer solution;

[0143] In step S240, the reinforcing member 120 is folded along the side of the groove of the positioning member so that the reinforcing member 120 is placed above the composite solution of the leaflet body 110 and is attached to the leaflet body 110.

[0144] Step S250: After standing for 5-10 minutes, place in an oven and dry at 50-70℃ for 48-96 hours.

[0145] Specifically, in this embodiment, the integral structure of the leaflet body 110 and the reinforcement 120 is placed in a pre-prepared positioning device. This positioning device includes a groove with the same contour shape as the quality assurance portion of the leaflet body 110, thus allowing the leaflet body 110 to be positioned within the groove and preventing movement. Furthermore, while the leaflet body 110 is placed in the groove, a composite solution is applied to the area of ​​the leaflet body 110 requiring reinforcement. This process utilizes a vision-based automatic triaxial dispensing machine to dispense the solution onto the leaflet body 110. The dispensing machine has a nozzle diameter of 0.1-1 mm, a distance of 1-2 mm from the material surface, an air pressure of 2-20 psi, and a movement speed of 0.5-10 mm / s, forming a filler film of uniform thickness at the reinforcement location of the leaflet body 110. Specifically, in this embodiment, the material of the composite solution dispensed by the dispensing machine is the same as that of the first polymer solution, so that the leaflet body 110 and the reinforcing member 120 can be seamlessly bonded together and form a fused structure after drying. The final product can overcome the problem of weak interlayer bonding and separation, and suppress the slippage between multiple layers of materials. In particular, during the operation of the leaflet 100, the interlayer shear force generated by the bending of the leaflet 100 can be shared by the seamless fusion of multiple layers, thereby achieving the effect of reinforcement.

[0146] Specifically, since the outermost material of the leaflet body 110 and the reinforcement 120 is the same, and the material of the composite solution used during the composite process is also the same as the material of the outer side of the leaflet body 110, after the leaflet body 110 is composited with the reinforcement 120, the outermost material of the leaflet body 110 and the reinforcement 120 are integrated, and the edge position of the reinforcement 120 also forms a smooth transition to the non-reinforced area.

[0147] Furthermore, as shown in Figure 12, the positioning device in this embodiment can be a first positioning device 200 adapted to the structure of a single leaflet body 110. This first positioning device 200 can have a protrusion 210 formed on the plate. The inner side of the protrusion 210 forms a groove 220, and the edge of the groove 220 is substantially consistent with the outer contour of the free edge region 113 of the single leaflet body 110 and the reinforcement 120. This ensures that the single leaflet body 110 will not move relative to the reinforcement 120 when it is placed at the first positioning device 200 and integrated with it, allowing for precise positioning and reinforcement of the final leaflet material. This first positioning device 200 is suitable for cases where the leaflet body 110 and the reinforcement 120 are not integrally formed. The groove of the first positioning device 200 has a semi-open structure, with one end open, facilitating the hanging corner region 111 to hang at the groove opening and also facilitating the removal of the leaflet 100 from the first positioning device 200.

[0148] Of course, as in other embodiments, the positioning device can be adapted to multiple connected leaflet bodies 110 structures. As shown in FIG13, the positioning device may only include a second positioning device 300 adapted to the three connected leaflet bodies 110 structures shown in FIG13(a); the positioning device may also be a second positioning device 300 adapted to the three connected leaflet bodies 110 structures and three clamping pieces 320 with the same shape as the non-positioning area of ​​the leaflet body. The second positioning device 300 is provided with a groove 310 that adapts to the shape contour when the three leaflet bodies 110 are connected to each other. Of course, the second positioning device 300 and the three clamping pieces 320 are suitable for situations where the leaflet body 110 and the reinforcement 120 are not integrally formed, and where the reinforcement 120 is integrally formed with the leaflet body 110 in the hanging corner area 111 and the attachment edge area 112.

[0149] Therefore, when the reinforcement 120 is integrally formed with the leaflet body 110 in the hanging corner area 111 and the attachment edge area 112, the three leaflet bodies 110 can be connected together and placed in the groove 310. Since the reinforcement 120 is outside the groove 310, it will be bent 90 degrees under the positioning of the groove 310 and composite onto the leaflet body 110 in the opposite direction.

[0150] In one specific embodiment, the reinforcing member 120 is located in the hanging corner area 111, and the leaflet body 110 is integrally formed with the reinforcing member 120. Therefore, the second positioning device 300 and the three clamping pieces 320 can be used to composite the leaflet body 110 with the reinforcing member 120. Specifically, after connecting the three leaflet bodies 110 together, they are placed in the groove of the second positioning device 300. Then, the three clamping pieces 320 are placed in the groove of the second positioning device 300 containing the leaflet bodies 110. Since the reinforcing member 120 is outside the groove, it will bend 90 degrees under the positioning of the groove 310 and be precisely composited onto the leaflet body 110 in the reverse direction by the contour limiting of the three clamping pieces 320. During the composite process, before the composite solution is applied, the three clamping pieces 320 can also shield the areas of the leaflet body 110 that do not need reinforcement, avoiding contamination or impact on other parts during dispensing.

[0151] Specifically, the positioning device can position the leaflet body 110 and the reinforcement 120, which can precisely control the size of the material and the consistency of the reinforcement area, thereby increasing the consistency of the performance of the final formed leaflet 100.

[0152] As another specific embodiment of this application, when the leaflet body 110 and the reinforcing member 120 are separate, the steps for preparing the leaflet body 110 and the reinforcing member 120 include:

[0153] First, prepare the main body of the leaflet 110;

[0154] Reinforcing component 120 is then prepared.

[0155] Specifically, in this embodiment, the steps for preparing the leaflet body 110 are the same as those for preparing the integrated structure of the leaflet body 110 and the reinforcing member 120, and will not be repeated here.

[0156] Specifically, as shown in Figure 14, the steps for preparing the reinforcement 120 include:

[0157] Step S310: Select the material of the second fabric layer 121, coat one side of the second fabric layer 121 with a layer of the second polymer solution, and heat to cure to form the second polymer layer 122; wherein, the second polymer solution is the same as the first polymer solution;

[0158] In step S320, a second polymer solution is coated on the other side of the second fabric layer 121 and then heated and cured to form the second polymer layer 122.

[0159] Step S330: Cut into the shape of the reinforcing member 120 to complete the preparation.

[0160] Specifically, the reinforcing member 120 in this embodiment is also a three-layer composite material, with a second polymer layer 122 formed on both sides of the second fabric layer 121. In this embodiment, the material of the second fabric layer 121 can be the same as or different from the material of the first fabric layer 114. The material of the second polymer layer 122 is the same as the material of the first polymer layer 115, ensuring that the reinforcing member 120 and the leaflet body 110 can form a fused structure after fusion. This overcomes the problem of weak interlayer bonding and separation, suppresses slippage between multiple layers, and especially mitigates the interlayer shear force generated by the bending of the leaflet 100 during operation. The seamless fusion of multiple layers can share the shear stress between the material layers, achieving a reinforcing effect.

[0161] Specifically, the structure, size and material of the second fabric layer 121 in this embodiment have been described in detail above, and will not be repeated here.

[0162] Specifically, in this embodiment, the step of coating one side of the second fabric layer 121 with a second polymer solution and heating and curing to form the second polymer layer 122 includes:

[0163] A second polymer solution is applied to the second fabric layer 121 using a scraper and then heated and cured in an oven. The scraper is positioned 0.8–8 mm above the surface of the second fabric layer 121, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 10–20 minutes.

[0164] Specifically, the step of coating a second polymer solution on the other side of the second fabric layer 121 and then heating and curing it to form the second polymer layer 122 in this embodiment includes:

[0165] A second polymer solution is applied to the second fabric layer 121 using a scraper and then heated and cured in an oven. The scraper is positioned 0.4–4 mm above the surface of the second fabric layer 121, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

[0166] As a specific embodiment of this application, as shown in FIG15, the step of attaching the reinforcement 120 to the leaflet body 110 when the reinforcement 120 is provided on one side of the leaflet body 110 includes:

[0167] Step SS210: A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body 110.

[0168] Step SS220: Place the leaflet body 110 into the groove of the positioning device;

[0169] Step SS230: A composite solution is placed at the location requiring reinforcement on the upper side of the leaflet body 110, wherein the composite solution is the same as the first polymer solution;

[0170] Step SS240: Place the reinforcing member 120 above the composite solution and attach it to the leaflet body 110;

[0171] Step SS250: After standing for 5-10 minutes, place in an oven at 50-70℃ and dry for at least 48 hours.

[0172] Specifically, the positioning device used in this embodiment can be either the first positioning device 200 described above or the second positioning device 300. When the leaflet body 110 and the reinforcing member 120 are separated in this embodiment, the leaflet body 110 is first placed in the pre-prepared positioning device, then glue is applied to the leaflet body 110 using a dispensing machine, and finally the reinforcing member 120 is laminated with the leaflet body 110. The dispensing steps and conditions of the dispensing machine are consistent with the steps and conditions for the integral molding of the leaflet body 110 and the reinforcing member 120 described above. After lamination, the reinforcing member 120 and the leaflet body 110 are seamlessly bonded together, and after drying, they form a fused structure. The final product can overcome the problem of weak interlayer bonding and separation, suppressing slippage between multiple layers of material. Especially during the operation of the leaflet 100, the interlayer shear force generated by the bending of the leaflet 100 can be distributed by the seamless fusion of multiple layers, achieving a reinforcing effect.

[0173] In another preferred embodiment, in step SS220, after the leaflet body 110 is placed in the groove of the positioning device, the leaflet body 110 can be covered by the clip 320 at this time, exposing only the area that needs to be reinforced (e.g., the hanging corner area), and then step SS230 is performed.

[0174] As another specific embodiment, in this embodiment, when the reinforcement 120 is attached to both sides of the leaflet body 110, in the step of combining the leaflet body 110 and the reinforcement 120 together, after the preparation is completed on one side according to steps SS210 to SS250, the above steps are repeated until the other reinforcement 120 is attached to the other side of the leaflet body 110.

[0175] The final material has 2 (with reinforcement 120 on one side) to 3 (with reinforcement 120 on both sides) fiber layers and 3 to 4 filler layers (the middle two layers are fused together) in the reinforced region of the leaflet body 110, with a total thickness of 120-300 micrometers. In the non-reinforced region, there is a single fiber layer and 2 filler layers, with a total thickness of 60-120 micrometers.

[0176] The reinforced composite material, serving as the leaflet 100, is sewn onto the metal framework using sutures to form an artificial valve. This artificial valve exhibits good pulsating flow performance and durability.

[0177] The following is a detailed description using specific embodiments.

[0178] Example 1:

[0179] The three-layer composite petal body 110 is made of a plain weave fabric 114 formed by mixing 10 dtex ultra-high molecular weight polyethylene fiber and 10 dtex polyethylene terephthalate fiber, with a ratio of 1:3. The warp density of the first fabric layer 114 is 1400 strands / 10 cm, and the weft density is 900 strands / 10 cm. A 18% Carbosil solution is applied to both sides to form the first polymer layer 115. During the first coating, the scraper is 0.8 mm above the fixed horizontal plane, moving at a speed of 5 mm / s, and dried in a 60°C oven for 20 min. During the second coating, the scraper is 0.6 mm above the fixed horizontal plane, moving at a speed of 5 mm / s, and dried in a 60°C oven for 48 hours. The scanning electron microscope image of the final petal body 110 cross-section after being cut into petal shape is shown in Figure 16. The thickness of the first fabric layer 114 of the final leaflet body 110 is 51 micrometers, and the thickness of the upper and lower first polymer layers 115 is 11 micrometers each, for a total thickness of 73 micrometers.

[0180] The reinforcing component 120 uses a 10-dtex ultra-high molecular weight polyethylene fiber plain weave fabric to form a second fabric layer 121. The warp density of the second fabric layer 121 is 1400 strands / 10 cm, and the weft density is 900 strands / 10 cm. A second polymer layer 122 is formed by double-sided scraping with an 18% Carbosil solution. During the first-sided scraping, the scraper is 0.8 mm above the fixed horizontal plane, the moving speed is 5 mm / s, and it is dried in a 60°C oven for 20 min. During the second-sided scraping, the scraper is 0.6 mm above the fixed horizontal plane, the moving speed is 5 mm / s, and it is dried in a 60°C oven for 48 hours. After being cut into the shape of the reinforcing area, the cross-sectional scanning electron microscope image of the reinforcing component is shown in Figure 17. The final thickness of the second fabric layer 121 of the reinforcing component 120 is 62 micrometers, and the thickness of each of the upper and lower second polymer layers 122 is 10 micrometers, for a total thickness of 82 micrometers.

[0181] The three-layer composite material of the leaflet body 110 is aligned onto the first positioning device 200. A vision-based automatic triaxial dispensing machine is used to dispense adhesive into the reinforcing area of ​​the leaflet body 110 using an 18% Carbosil solution. The dispensing machine has a 0.5mm orifice, a 1mm distance from the material surface, an air pressure of 10psi, and a movement speed of 5mm / s, forming a composite solution of uniform thickness in the reinforcing area of ​​the three-layer composite leaflet body 110. Then, the reinforcement 120 is aligned with the reinforcing area of ​​the three-layer composite leaflet body 110 via the first positioning device 200, and the composite solution seamlessly bonds the reinforcing composite material to the three-layer composite leaflet body 110. The assembly is then left to stand for 10 minutes to allow the composite solution to fully penetrate and fuse the leaflet body 110 and reinforcement 120. Finally, the entire assembly is placed horizontally in an oven and dried at 60°C for 48 hours, completing the preparation of the leaflet material.

[0182] The final leaflet material, as shown in the scanning electron microscope (SEM) image of its cross-section, is shown in Figure 18. It can be seen that the reinforcing region has two fiber layers and three filler layers, with a total thickness of 161 micrometers. Furthermore, after the reinforcing member 120 is combined with the leaflet body 110, a transition region is formed between them. In the leaflet thickness direction, the height of the transition region gradually decreases from away from the center of the leaflet 100 to near the center. The cross-sectional SEM image of the transition region between the reinforcing member 120 and the leaflet body 110 is shown in Figure 19. It can be seen from the figure that the reinforcing member 120 and the leaflet body 110 prepared by this method have a smooth transition.

[0183] Specifically, since the second polymer layer of the reinforcing member 120 is made of the same material as the first polymer layer of the leaflet body 110, and the material of the composite solution is also the same as that of the first polymer layer, the transition area between the reinforcing member and the leaflet body is relatively smooth due to the fusion and flow of the materials during the composite process, preventing the formation of protrusions caused by solution accumulation. A photograph of the final prepared leaflet is shown in Figure 20.

[0184] The three leaflet materials were sewn onto a 25mm nickel-titanium alloy support to prepare a valve, which was then subjected to pulsating flow testing. The effective opening area of ​​the valve was 2.7cm². 2 The total regurgitation percentage was 4.5%. The valve fatigue test was conducted at a frequency of 15 Hz, with over 750 million effective runs.

[0185] Example 2:

[0186] The three-layer composite petal body 110 is made of 10 dtex polyethylene terephthalate fibers woven into a plain weave fabric to form the first fabric layer 114. The warp density of the first fabric layer 114 is 1800 strands / 10 cm, and the weft density is 1000 strands / 10 cm. A 22% styrene-isoprene-styrene solution is applied to both sides to form the first polymer layer 115. During the first coating, the scraper is 0.6 mm above the fixed horizontal plane, moving at a speed of 3 mm / s, and dried in a 60°C oven for 10 minutes. During the second coating, the scraper is 0.4 mm above the fixed horizontal plane, moving at a speed of 3 mm / s, and dried in a 60°C oven for 48 hours. After being cut into the shape of a petal, the cross-sectional scanning electron microscope image of the final petal body is shown in Figure 21. The thickness of the first fabric layer 114 of the final petal body 110 is 59 micrometers, and the thickness of the upper and lower first polymer layers 115 is 14 micrometers each, with a total thickness of 87 micrometers.

[0187] The reinforcing component 120 uses 20 dtex ultra-high molecular weight polyethylene fiber plain weave fabric as the second fabric layer 121. The warp density of the second fabric layer 121 is 1100 strands / 10 cm, and the weft density is 750 strands / 10 cm. A 22% styrene-isoprene-styrene solution is used as the second polymer solution to coat both sides of the second fabric layer 121 to form a composite material. During the first coating, the scraper is 1.6 mm above the fixed horizontal plane, the moving speed is 3 mm / s, and it is dried in an oven at 60°C for 10 min. During the second coating, the scraper is 1.2 mm above the fixed horizontal plane, the moving speed is 3 mm / s, and it is dried in an oven at 60°C for 48 hours. After being cut into the shape of the reinforcing area, the scanning electron microscope image of the cross-section of the resulting reinforcing component is shown in Figure 22. The final thickness of the second fabric layer 121 is 85 micrometers, and the thickness of each of the upper and lower second polymer layers 122 is 8 micrometers, for a total thickness of 101 micrometers.

[0188] The petal-shaped main body 110 is aligned with the first positioning device 200. A vision-based automatic triaxial dispensing machine is used to dispense adhesive at the reinforcement positions of the three-layer composite material. The dispensing solution is a 22% styrene-isoprene-styrene solution. The dispensing machine has a nozzle diameter of 0.8 mm, a distance of 2 mm from the material surface, an air pressure of 15 psi, and a movement speed of 3 mm / s, forming a composite solution of uniform thickness in the reinforcement area of ​​the three-layer composite petal-shaped main body 110. Then, the reinforcement 120 is aligned with the reinforcement area of ​​the three-layer composite petal-shaped main body 110 using the reinforcement positioning device, and the petal-shaped main body 110 and reinforcement 120 are seamlessly bonded together using the composite solution. The mixture is then left to stand for 8 minutes to allow the composite solution to fully penetrate and fuse the reinforcement 120 and petal-shaped main body 110. Finally, the entire assembly is placed horizontally in an oven and dried at 60°C for 48 hours to complete the preparation of the petal-shaped material.

[0189] The final leaflet material, as shown in the scanning electron microscope (SEM) image of its cross-section, has two fiber layers and three filler layers in the reinforcement region, with a total thickness of 188 micrometers. A photograph of the final leaflet 100 is shown in Figure 24.

[0190] The three leaflet materials were sewn onto a 25mm nickel-titanium alloy support to prepare a valve, which was then subjected to pulsating flow testing. The effective opening area of ​​the valve was 2.6cm². 2 The total regurgitation percentage was 5.3%. The valve fatigue test was conducted at a frequency of 15 Hz, with over 1.2 billion effective cycles.

[0191] Example 3

[0192] The integrated fabrication process of the leaflet body 110 material and the reinforcement 120 is completely consistent with the leaflet body 110 material process in Example 1, except that the shape drawing is changed to an integrated shape of the leaflet body 110 material and the reinforcement material (as shown in Figure 4). The integrated material is then placed in the grooved substrate of the second positioning device 300, where the reinforcement material is bent at a 90° angle to the body material and rests against the side wall of the groove. Three gaskets are then placed over the leaflet material. A vision-based automatic triaxial dispensing machine is used to dispense adhesive into the reinforcement area of ​​the leaflet body 110 material exposed in the groove. The dispensing solution is an 18% Carbosil solution. The dispensing machine has a nozzle diameter of 0.5 mm, a distance of 1 mm from the material surface, an air pressure of 10 psi, and a movement speed of 5 mm / s, forming a composite solution of uniform thickness in the reinforcement area of ​​the leaflet body 110. The reinforcement 120 is then folded along the edge of the groove and bonded to the leaflet body 110 material. Subsequent penetration and drying steps are the same as in Example 1.

[0193] The final leaflet material, as shown in the scanning electron microscope (SEM) image of its cross-section, has two fiber layers and three filler layers in the reinforcement region, with a total thickness of 161 micrometers. A photograph of the final fabricated leaflet is shown in Figure 26.

[0194] The three leaflet materials were sewn onto a 23mm nickel-titanium alloy support to prepare a valve, which was then subjected to pulsating flow testing. The effective opening area of ​​the valve was 2.4cm². 2 The total regurgitation percentage was 3.8%. The valve fatigue test was conducted at a frequency of 15 Hz, with over 900 million effective cycles.

[0195] Therefore, those skilled in the art should recognize that although many exemplary embodiments of this application have been shown and described in detail herein, many other variations or modifications conforming to the principles of this application can be directly determined or derived from the disclosure of this application without departing from the spirit and scope of this application. Thus, the scope of this application should be understood and construed as covering all such other variations or modifications.

Claims

1. A leaflet for a heart valve, characterized in that, include: The leaflet body includes a reinforcing region selected from one or more of the hanging angle region, the attachment edge region, and the free edge region; and A reinforcing member, which corresponds to the area and structure of the reinforcing region, is composited on one or both sides of the reinforcing region; After the leaflet body is combined with the reinforcing member, the thickness of the leaflet reinforcing region is 120μm to 300μm, and the thickness of other regions is 60μm to 120μm.

2. The valve leaflet for a heart valve according to claim 1, characterized in that, The area of ​​the reinforcing region on one side of the leaflet body is 6.5% to 22.5% of the total area of ​​that side of the leaflet body; the outline width of the reinforcing member is 1mm to 4.5mm.

3. The valve leaflet for a heart valve according to claim 1, characterized in that, The leaflet body includes a first fabric layer and two first polymer layers respectively disposed on both sides of the first fabric layer. The thickness of the first fabric layer is 40μm to 60μm, the thickness of the first polymer layer is 10μm to 30μm, and the thickness of the leaflet body is 60μm to 120μm. The structure of the first fabric layer is selected from plain weave, twill weave, or satin weave, and the linear density of the first fabric layer is 5 to 30 dtex; the warp density of the first fabric layer is 25 to 200 strands / cm, and the weft density of the first fabric layer is 15 to 100 strands / cm. The material of the first fabric layer is selected from one or more of polyethylene, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, and polyamide.

4. The valve leaflet for a heart valve according to claim 3, characterized in that, The material of the first polymer layer is selected from one or more of polyurethane and polystyrene polymers; wherein, the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil; and the styrene material is selected from styrene-isoprene-styrene, styrene-butadiene-styrene, styrene-isoprene / butadiene-styrene, and styrene-ethylene / butene-styrene.

5. The valve leaflet for a heart valve according to claim 3, characterized in that, The reinforcement includes a second fabric layer and second polymer layers located on both sides of the second fabric layer; the thickness of the second fabric layer is 40μm to 100μm, the thickness of the second polymer layer is 10μm to 40μm, and the thickness of the reinforcement is 60μm to 180μm. The second fabric layer has a plain weave structure, a linear density of 2 to 60 dtex, a warp density of 20 to 160 strands / cm, and a weft density of 12 to 90 strands / cm. The material of the second fabric layer is selected from polyethylene and polyamide.

6. The valve leaflet for a heart valve according to claim 5, characterized in that, The material of the second polymer layer is the same as that of the first polymer layer, so that when the reinforcement is attached to the leaflet body, the first polymer layer and the first polymer layer fuse together to form an integral structure.

7. A method of making a leaflet for a heart valve, characterized by, include: Prepare a leaflet body and a reinforcement, wherein the leaflet body includes a reinforcement region, the reinforcement region being selected from one or more of a hanging corner region, an attachment edge region, and a free edge region; The reinforcement is incorporated into one or both sides of the reinforcement region of the leaflet body.

8. The method of claim 7, wherein the leaflet for a heart valve is prepared by, include: When the leaflet body and the reinforcement are integrally formed, the steps for preparing the leaflet body and the reinforcement include: A first fabric layer material is selected, and a first polymer solution is coated on one side of the first fabric layer, which is then heated and cured to form the first polymer layer. A layer of the first polymer solution is coated on the other side of the first fabric layer and then heated and cured to form the first polymer layer; The fabric treated above is cut into the shape of the leaflet body and the reinforcement as a single unit to complete the preparation.

9. The method for preparing a heart valve leaflet according to claim 8, characterized in that, The step of attaching the reinforcement to one side of the leaflet body includes: A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body; Place the leaflet body into the groove of the positioning device; A composite solution is provided at the location requiring reinforcement on the upper side of the leaflet body, wherein the composite solution is the same as the first polymer solution; The reinforcing member is folded along the side of the groove of the positioning member so that the reinforcing member is placed above the composite solution of the leaflet body and is attached to the leaflet body; After standing for 5 to 10 minutes, place it in an oven and dry at 50 to 70°C for 48 to 96 hours.

10. The method for preparing valve leaflets for heart valves according to claim 7, characterized in that, When the leaflet body and the reinforcement are separated, the steps for preparing the leaflet body and the reinforcement include: The leaflet body and the reinforcing member are prepared separately; wherein, The steps for preparing the leaflet body include: A first fabric layer material is selected, and a first polymer solution is coated on one side of the first fabric layer. The solution is then heated and cured to form a first polymer layer on one side of the first fabric layer material. A layer of the first polymer solution is coated on the other side of the first fabric layer and then heated and cured to form the first polymer layer on the other side of the first fabric layer material; Cut the material into the shape of the main body of the petal to complete the preparation.

11. The method for preparing a leaflet for a heart valve according to claim 8 or 10, characterized in that, The thickness of the first fabric layer is 40μm to 60μm, the thickness of the first polymer layer is 10μm to 30μm, and the thickness of the leaflet body is 60μm to 120μm; The structure of the first fabric layer is selected from plain weave, twill weave or satin weave, the warp density of the first fabric layer is 25 to 200 strands / cm, and the weft density of the first fabric layer is 15 to 100 strands / cm. The material of the first fabric layer is selected from one or more of polyethylene, polypropylene, polyethylene terephthalate, polytetrafluoroethylene, and polyamide.

12. The method for preparing a leaflet for a heart valve according to claim 8 or 10, characterized in that, The step of coating a first polymer solution onto one side of the first fabric layer and heating and curing it to form the first polymer layer includes: A layer of the first polymer solution is applied to the first fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.4 mm to 4 mm above the surface of the first fabric layer, moves at a speed of 2 mm / s to 40 mm / s, is heated at a temperature of 50°C to 70°C, and is cured at a temperature of 50°C to 70°C for 10 min to 20 min. The steps of coating a layer of the first polymer solution on the other side of the first fabric layer and then heating and curing it to form the first polymer layer include: A layer of the first polymer solution is applied to the first fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.2–2 mm above the surface of the first fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

13. The method for preparing valve leaflets for heart valves according to claim 8 or 10, characterized in that, The first polymer solution is prepared by dissolving a first polymer in an organic solvent; The material of the first polymer is selected from one or more of polyurethane and polystyrene polymers; the polyurethane material is selected from Carbothane, Chronoflex, Chronosil, Bionate, Elast-Eon, BioSpan, Carbosil, and Pursil. Styrene-based materials are selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), and styrene-ethylene / butene-styrene (SEBS). The organic solvents include, but are not limited to, at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide; The mass concentration of the first polymer solution is 5%-22%.

14. The method for preparing a heart valve leaflet according to claim 10, characterized in that, The steps for preparing the reinforcement include: A second fabric layer material is selected, and a second polymer solution is coated on one side of the second fabric layer, which is then heated and cured to form a second polymer layer; wherein, the second polymer solution is the same as the first polymer solution; A layer of the second polymer solution is coated on the other side of the second fabric layer and then heated and cured to form a second polymer layer; Cut into the shape of the reinforcement to complete the preparation.

15. The method for preparing a heart valve leaflet according to claim 14, characterized in that, The thickness of the second fabric layer is 40μm to 100μm, the thickness of the second polymer layer is 10μm to 40μm, and the thickness of the reinforcement is 60μm to 180μm. The second fabric layer has a plain weave structure, a linear density of 2 to 60 dtex, a warp density of 20 to 160 strands / cm, and a weft density of 12 to 90 strands / cm. The material of the second fabric layer is selected from polyethylene and polyamide.

16. The method for preparing a heart valve leaflet according to claim 14, characterized in that, The step of coating a second polymer solution onto one side of the second fabric layer and heating and curing it to form the second polymer layer includes: A layer of the second polymer solution is applied to the second fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.8–8 mm above the surface of the second fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 10–20 minutes. The steps of coating a layer of the second polymer solution on the other side of the second fabric layer and then heating and curing it to form the second polymer layer include: A layer of the second polymer solution is applied to the second fabric layer using a scraper and then heated and cured in an oven. The scraper is positioned at a height of 0.4–4 mm above the surface of the second fabric layer, moves at a speed of 2–40 mm / s, is heated at a temperature of 50–70°C, and is cured at a temperature of 50–70°C for 48–96 hours.

17. The method for preparing a heart valve leaflet according to claim 14, characterized in that, When the reinforcement is provided on one side of the leaflet body, the step of attaching the reinforcement to the leaflet body includes: A positioning device is obtained, wherein the positioning device includes a groove with at least a portion of the contour shape of the leaflet body; Place the leaflet body into the groove of the positioning device; A composite solution is provided at the location requiring reinforcement on the upper side of the leaflet body, wherein the composite solution is the same as the first polymer solution; The reinforcing member is placed above the composite solution and attached to the leaflet body; After standing for 5-10 minutes, place it in an oven and dry at 50-70℃ for 48-96 hours.

18. The method for preparing a heart valve leaflet according to claim 17, characterized in that, When the reinforcement is attached to both sides of the leaflet body, After attaching some of the reinforcements to one side of the leaflet body according to the above steps, flip the product over and repeat the above steps to attach the other reinforcements to the other side of the leaflet body.

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