Edge-sealed composite fiber material, and preparation method therefor and use thereof

Abstract

Provided in the present invention are an edge-sealed composite fiber material, and a preparation method therefor and the use thereof. The edge-sealed composite fiber material of the present invention has a first filling material with a thickness of 15-80 μm on a side face thereof, and a first filling material with a width of 30-250 μm and a thickness of 15-80 μm on a surface edge thereof. The edge-sealed composite fiber material exhibits a slightly protruded and thickened edge form with a smooth surface, and the material edge is wrapped and thickened by the first filling material, such that the edge tear strength and the suture strength of the material are thoroughly enhanced. Compared with a material not subjected to an edge sealing treatment, the material is greatly improved in terms of mechanical strength, suture strength and fatigue resistance. Moreover, an originally rough cut edge is edge-sealed with the first filling material, resulting in a smooth and continuous material edge, such that after the material is implanted into a human body, adverse phenomena, such as thrombosis and calcification at the edge of the material, which are caused by continuous irritation from an irregular cut surface and biological incompatibility of internal materials can be avoided.

Description

Edge-sealed composite fiber material, preparation method and application thereof TECHNICAL FIELD

[0001] The present application relates to the technical field of medical materials, and in particular to an edge-sealed composite fiber material, a preparation method and application thereof. BACKGROUND

[0002] Fiber-reinforced composite materials have been widely used in cardiovascular implant devices, such as artificial heart valves, artificial blood vessels, vascular stents, etc. The fiber material can be formed into different mechanical properties, such as anisotropy, high elasticity, high tensile strength, rigidity, permeability, etc. through various weaving methods, to meet the use requirements of different medical devices. Meanwhile, the surface covering material can improve the compatibility of the material in the blood, avoid inflammation, thrombosis, calcification and other reactions caused by exogenous materials, and cause an impact on the performance of the device. At present, most of the materials need to be set into irregular shapes when processed into devices, so the whole composite material needs to be cut. Since the fiber material is dispersed in the composite material, the newly generated cutting surface after cutting will expose the irregular material surface. After being processed into a device, some cutting edges will still be exposed to the human body blood. Due to the irregular shape and the continuous stimulation of the internal fiber material to the implanted site, a series of inflammation, thrombosis, calcification and other reactions will occur at the cutting surface. At the same time, the local sharp cutting points of the cutting surface will cause high stress concentration, forming a weak point of the mechanical strength of the composite material, which will eventually easily lead to cracks in the composite material from the cutting point and spread to the inside of the material, causing the failure of the material.

[0003] For example, the prior art discloses a composite material for medical devices, which is cut by scissors or blades, and the shape and size of the cut material cannot be accurately controlled, which is easy to cause roughness, disconnection and openings on the cutting surface. In the heat cutting methods such as burning, laser and ultrasonic wave, the burning will cause excessive oxidation of the fiber and coating material on the cutting surface due to the high energy, which will make the material cutting surface yellow, hard and even black, and will have an uncontrollable impact on the performance of the material. The ultrasonic wave cutting is difficult to cut some high melting point fibers and coating materials at one time due to the small energy, and even if multiple cutting is used, the cutting shape and size cannot be accurately controlled due to the deformation of the material caused by heating, and some traces of heat cutting are easily left near the cutting surface, which cannot guarantee the consistency of the performance of the material edge. The laser cutting can better control the energy, but due to the complex fiber and coating structure inside the composite material, the cutting surface exposes the laminated structure, which cannot present the smoothness consistent with the surface. After being implanted into the human body and contacted with the blood, blood is easily retained in the gap between the fiber and the coating layer on the cutting surface, causing thrombosis and calcification on the surface;

[0004] For example, the prior art discloses a composite biological textile mainly composed of a polyolefin fiber woven layer and a polyurethane coating layer combined together, pulse laser cutting is adopted to melt the cutting edge, and then dipping, spraying, inkjet coating and other methods are adopted to form a coating strip edge area of at least 1 mm on the cutting edge. Generally, dipping can only be applied to materials with regular-shaped edges such as circles, rectangles, trapezoids and the like, and many instrument products have special shape requirements for materials, for example, a heart valve, in this case, direct dipping of the material will directly dissolve part of the coating on the surface of the immersed composite material, so that the performance of the composite material is affected. And due to the large coating range, it is difficult to uniformly concentrate on the strip edge area of at least 1 mm on the cutting edge, and the area close to the cutting edge of the composite material is also easily affected by the spraying to damage the surface coating. Therefore, the edge sealing method has great difficulty in actual operation to realize uniform and consistent edge sealing effect without affecting the main material.

[0005] Based on the existing edge of the composite material, it is necessary to improve the adverse phenomena such as thrombosis and calcification. SUMMARY

[0006] Therefore, the present application provides a sealed edge composite fiber material and a preparation method and application thereof to solve the defects in the prior art.

[0007] In a first aspect, the present application provides a sealed edge composite fiber material, comprising a composite fiber material substrate and a first filling material.

[0008] The first filling material is distributed on the side surface of the composite fiber material substrate corresponding to the edge portion, and completely fills or partially fills the inside of the edge portion of the composite fiber material substrate, and the first filling material is covered on the side surface of the composite fiber material substrate corresponding to the edge portion, and completely fills or partially fills the inside of the edge portion of the composite fiber material substrate to make the side surface of the composite fiber material substrate corresponding to the edge portion smooth.

[0009] The thickness of the first filling material on the side surface and the surface edge portion of the composite fiber material substrate is 15-80 μm.

[0010] The projection width of the first filling material on the surface edge portion of the composite fiber material substrate on the surface of the composite fiber material substrate is 30-250 μm.

[0011] In a second aspect, the present application further provides a preparation device of the sealed edge composite fiber material, comprising a clamp, the clamp is used to clamp the composite fiber material substrate, and then the first filling material solution is coated.

[0012] The clamp comprises a first clamp and a second clamp.

[0013] The first clamp comprises a first clamping surface;

[0014] The second clamp comprises a second clamping surface;

[0015] The first clamping surface and the second clamping surface are respectively matched with two surfaces of the composite fiber material substrate and used for clamping the two surfaces of the composite fiber material substrate, an edge portion of the first clamping surface of the first clamp is provided with a first chamfer, and an edge portion of the second clamping surface of the second clamp is provided with a second chamfer;

[0016] A gap is formed between the first chamfer and one of the two surfaces of the composite fiber material substrate and between the second chamfer and the other surface of the composite fiber material substrate.

[0017] In a third aspect, the application further provides a preparation method of the edge-sealed composite fiber material, which is prepared by using the preparation device and comprises the following steps:

[0018] The composite fiber material substrate is provided;

[0019] After the composite fiber material substrate is clamped by using the clamp, the first filling material solution is coated on the side surface of the composite fiber material substrate and in the gap, and then drying is performed to obtain the edge-sealed composite fiber material.

[0020] In a fourth aspect, the application further provides an application of the edge-sealed composite fiber material in preparation of a medical implant material.

[0021] In a fifth aspect, the application further provides an artificial heart valve, which comprises a stent and a plurality of valve leaves connected with the stent, and the valve leaves comprise the edge-sealed composite fiber material. Advantages

[0022] 1. The edge-sealed composite fiber material has a first filling material with a thickness of 15-80 μm on the side surface and a first filling material with a projection width of 30-250 μm and a thickness of 15-80 μm on the surface edge, the edge-sealed composite fiber material has a slightly protruding thickened and smooth surface edge shape, the material edge is wrapped and thickened by the first filling material, and the edge tearing strength and the suturing strength of the material are greatly enhanced; compared with the material without edge sealing treatment, the mechanical strength, the suturing strength and the fatigue resistance of the material are greatly improved; in addition, since the originally rough cutting edge is sealed by the first filling material to become a smooth and continuous material edge, the continuous irritation caused by the irregular cutting surface and the internal material biological incompatibility can be avoided after the material is implanted into the human body, and the adverse phenomena such as thrombosis and calcification of the material edge can be avoided.

[0023] 2, The preparation method of the edge-sealed composite fiber material, the main body part of the composite fiber material substrate is completely shielded by the first clamp and the second clamp, is not affected by the coating operation, and the edge part of the clamping surface of the clamp is provided with a chamfer, so that the edge part of the composite fiber material substrate is exposed, and the coating formed after the subsequent coating of the first filling material solution completely wraps the edge of the composite fiber material substrate; the edge-sealed composite fiber material obtained after sealing has a coating layer formed after the coating of the first filling material solution on the side surface, and the thickness of the coating layer can be controlled to be 15-80 μm; and the coating layer formed after the coating of the first filling material solution on the upper and lower surfaces of the edge-sealed composite fiber material has a thickness of 15-80 μm, and the projection width of the coating layer is controlled to be 30-250 μm; the composite fiber material substrate after the edge sealing operation by the method has a very accurately controlled area affected by the edge sealing operation, and compared with the existing process of cutting the edge to form a strip edge area of at least 1 mm, the main affected area of the composite fiber material substrate treated by the method is greatly reduced. In some instrument application scenarios, such as a heart valve, the valve leaflet needs a certain softness and dynamic response performance when working. The thicker and wider the strip of the composite material edge penetration is, the more difficult it is to control the uniformity of the edge sealing effect, so that the material becomes harder, and the consistency of the material performance is difficult to guarantee. In actual use, the dynamic response performance cannot be controlled. The method can control the edge sealing affected area of the composite fiber material substrate to be very small, and the softness and dynamic response performance of the overall composite fiber material substrate after edge sealing remain completely consistent with the composite fiber material substrate without edge sealing treatment, so that the consistency of the performance of the overall composite fiber material substrate after edge sealing can be guaranteed when applied to a product; compared with the material without edge sealing treatment, the mechanical strength, suturing strength and fatigue performance are greatly improved; moreover, since the originally rough cutting edge is sealed by the first filling material to become a smooth and continuous material edge, after being implanted into the human body, the irregular cutting surface and the internal material biological incompatibility can be avoided to cause continuous irritation to cause adverse phenomena such as thrombosis and calcification of the material edge. BRIEF DESCRIPTION OF DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creating any inventive labor.

[0025] Fig. 1 is a structural schematic view of the edge-sealed composite fiber material of the present application;

[0026] Fig. 2 is a thickness and projection width schematic view of the first filling material of the present application;

[0027] Fig. 3 is a schematic view of the first clamp and the second clamp clamping the composite fiber material substrate according to the present application;

[0028] Fig. 4 is a schematic view of the height and the projected width of the first chamfer according to the present application;

[0029] Fig. 5 is a schematic view of the first clamp and the second clamp clamping the composite fiber material substrate according to the present application;

[0030] Fig. 6 is a schematic view of the structure of the first clamp according to the present application;

[0031] Fig. 7 is a schematic view of the structure of the second clamp according to the present application;

[0032] Fig. 8 is a schematic view of the structure of the first clamp according to the present application;

[0033] Fig. 9 is a schematic view of the structure of the composite fiber material substrate according to the present application;

[0034] Fig. 10 is a schematic view of the structure of the positioning member according to the present application;

[0035] Fig. 11 is a schematic view of the structure of the first magnetic member according to the present application;

[0036] Fig. 12 is a schematic view of the structure of the positioning member used in cooperation with the first clamp and the second clamp according to the present application;

[0037] Fig. 13 is a schematic view of the structure of the first magnetic member and the second magnetic member used in cooperation with the first clamp and the second clamp according to the present application;

[0038] Fig. 14 is an exploded schematic view of the clamp according to the present application;

[0039] Fig. 15 is a cross-sectional SEM view of the composite fiber material substrate after laser cutting in Example 1;

[0040] Fig. 16 is a front view SEM view of the edge-sealed composite fiber material prepared in Example 1;

[0041] Fig. 17 is a side view SEM view of the edge-sealed composite fiber material prepared in Example 1;

[0042] Fig. 18 is a cross-sectional SEM view of the composite fiber material substrate after blade cutting in Example 2;

[0043] Fig. 19 is a front view SEM view of the edge-sealed composite fiber material prepared in Example 2;

[0044] Fig. 20 is a side view SEM view of the edge-sealed composite fiber material prepared in Example 2;

[0045] Fig. 21 is a cross-sectional SEM view of the composite fiber material substrate after plasma cutting in Example 3;

[0046] Figure 22 is a top view SEM of the edge-wrapped composite fiber material prepared in Example 3;

[0047] Figure 23 is a side view SEM of the edge-wrapped composite fiber material prepared in Example 3;

[0048] Figure 24 is a top view SEM of the laser-cut composite fiber material substrate of Example 1 after 200 million cycles of flex fatigue testing (TA Electroforce 3200);

[0049] Figure 25 is a top view SEM of the edge-wrapped composite fiber material prepared in Example 1 after 200 million cycles of flex fatigue testing (TA Electroforce 3200). DETAILED DESCRIPTION

[0050] In order to make the objects, technical solutions, and advantages of the embodiments of the present application clearer, the following will be combined with the accompanying drawings for the embodiments of the present application to make a clear and complete description of the technical solutions in the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. The components of the embodiments of the present application described and shown in the accompanying drawings can be arranged and designed in various different configurations.

[0051] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative work are within the scope of protection of the present application.

[0052] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

[0053] In the description of the present application, it should be understood that the positional or location relationship indicated by terms such as "upper" is based on the positional or location relationship shown in the drawings, or the positional or location relationship commonly placed when the product of the present application is used, or the positional or location relationship commonly understood by those skilled in the art, only for the convenience of describing the present application and simplifying the description, and is not intended to indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0054] In addition, the terms "first", "second", and the like are only used to distinguish description, and cannot be understood as indicating or implying relative importance.

[0055] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0056] The edge-sealed composite fiber material according to the embodiments of the present application comprises a composite fiber material substrate 1 and a first filling material 2 as shown in FIG. 1.

[0057] The first filling material 2 is distributed on the side surface of the composite fiber material substrate 1 corresponding to the edge portion of the composite fiber material substrate 1, and fills the inside of the edge portion of the composite fiber material substrate 1 completely or partially. The first filling material 2 covers the side surface of the composite fiber material substrate 1 corresponding to the edge portion of the composite fiber material substrate 1, and fills the inside of the edge portion of the composite fiber material substrate 1 completely or partially, so as to smooth the side surface of the composite fiber material substrate 1 corresponding to the edge portion of the composite fiber material substrate 1.

[0058] The thickness of the first filling material on the side surface and the edge portion of the surface of the composite fiber material substrate 1 is 15-80 μm.

[0059] The projection width of the first filling material on the edge portion of the surface of the composite fiber material substrate 1 on the surface of the composite fiber material substrate is 30-250 μm.

[0060] The edge-sealed composite fiber material includes a composite fiber material substrate 1 and a first filling material 2. Specifically, the first filling material 2 is located on the side of the composite fiber material substrate 1 and on the edge portions of the upper and lower surfaces of the composite fiber material substrate 1. Meanwhile, the first filling material 2 completely fills or partially fills the internal pores of the edge portions of the composite fiber material substrate. The first filling material 2 covers the side and surface of the composite fiber material substrate corresponding to the edge portions and completely fills or partially fills the internal pores of the edge portions of the composite fiber material substrate, so that the side and surface of the composite fiber material substrate 1 corresponding to the edge portions are smooth. Referring to FIG. 2, the thickness of the first filling material on the side of the composite fiber material substrate 1 refers to the height of the first filling material on the single side of the composite fiber material substrate 1 in the direction perpendicular to the plane on which the composite fiber material substrate 1 is located. In FIG. 2, the thickness of the first filling material on the single side of the composite fiber material substrate 1 is a, and a is 15-80 μm. The thickness of the first filling material on the edge portions of the surface of the composite fiber material substrate 1 is 15-80 μm. Here, the thickness of the first filling material refers to the length of the first filling material in the direction from the edge of the composite fiber material substrate 1 close to the edge of the composite fiber material substrate 1 far away. In FIG. 2, b is the thickness of the single surface edge portion of the composite fiber material substrate 1, and b is 15-80 μm. The projection width of the first filling material on the surface of the composite fiber material substrate 1 is c, and c is 30-250 μm.

[0061] The edge-sealed composite fiber material has a first filling material with a projection width of 30-250 μm and a thickness of 15-80 μm on the surface edge. The edge-sealed composite fiber material has a slightly protruding thickened and smooth surface edge shape. The edge of the material is wrapped and thickened by the first filling material, and the edge tearing strength and sewing strength of the material are well enhanced. Compared with the material without edge sealing treatment, the mechanical strength, sewing strength and fatigue resistance of the material are greatly improved. Moreover, since the originally rough cutting edge is sealed by the first filling material to become a smooth and continuous material edge, the irregular cutting surface and internal material biological incompatibility can be avoided after being implanted into the human body, so that the material edge does not have adverse phenomena such as thrombosis and calcification.

[0062] In some embodiments, the composite fiber material substrate 1 includes a woven fabric and a second filling material. The second filling material is distributed in the interior and surface of the woven fabric. The second filling material partially fills or completely fills the pores between the fibers of the woven fabric, and the second filling material covers the surface of the woven fabric to make the surface of the woven fabric smooth.

[0063] In some embodiments, the fibers of the woven fabric are selected from one or more of ultrahigh molecular weight polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polypropylene, polyacrylonitrile, polyamide and polyurethane.

[0064] In some embodiments, the first filler material and the second filler material are each independently selected from one or more of polyurethane elastomer, styrene elastomer, collagen, hydrogel, and preferably the first filler material and the second filler material are selected from the same material.

[0065] In some embodiments, the polyurethane elastomer has a hard segment ratio of 15% to 25%, and the polyurethane elastomer has a polysiloxane block introduced in the soft segment, and the polysiloxane block accounts for 5% to 30% of the total mass of the polyurethane. Specifically, the polyurethane elastomer can be selected from Carbothane TM , Chronoflex ® , Chronosil ® , Bionate ® , Elast-Eon TM , BioSpan ® , Carbosil ® , Pursil ® , and the like.

[0066] In some embodiments, the styrene elastomer has a hard segment ratio of 25% to 40%, and the styrene elastomer can be selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), styrene-ethylene / butylene-styrene (SEBS), and the like.

[0067] In some embodiments, the second filler material on the surface of the woven fabric has a thickness of 8 to 50 μm. Here, the thickness of the second filler material on the surface of the woven fabric refers to the thickness of the second filler material on one side of the woven fabric.

[0068] In some embodiments, the first filler material and the second filler material on the edge portion of the surface of the woven fabric have a thickness of 23 to 130 μm.

[0069] In some embodiments, the woven fabric has a thickness of 20 to 100 μm.

[0070] In the above embodiment, the thickness of the base material is the sum of the thickness of the woven fabric and the thickness of the second filling material on both surfaces of the woven fabric, i.e., the thickness of the base material = (20-100 μm) + (8-50 μm) x 2 = 36-200 μm; for the woven fabric, the sum of the thickness of the first filling material and the second filling material on the single surface edge portion of the woven fabric is (15-80 μm) + (8-50 μm) = 23-130 μm; and for the entire edge-sealed composite fiber material, the thickness of the edge portion is the sum of the thickness of the base material and the thickness of the first filling material on both surfaces, i.e., the thickness of the edge-sealed composite fiber material = (36-200 μm) + (15-80 μm) x 2 = 66-360 μm.

[0071] In some embodiments, the fiber density of the woven fabric is 10-100 dtex, and the woven structure includes plain weave, twill weave or satin weave;

[0072] When the woven structure of the woven fabric is plain weave, the warp density of the plain weave is 500-1400 strands / 10 cm, and the weft density is 300-800 strands / 10 cm;

[0073] When the woven structure of the woven fabric is twill weave, the warp density of the twill weave is 400-1000 strands / 10 cm, and the weft density is 300-750 strands / 10 cm;

[0074] When the woven structure of the woven fabric is satin weave, the warp density of the satin weave is 600-1500 strands / 10 cm, and the weft density is 300-1000 strands / 10 cm.

[0075] Based on the same inventive concept, the present application also provides a device for preparing the above-described edge-sealed composite fiber material, which comprises a clamp for clamping the base material of the composite fiber material and then coating the first filling material solution;

[0076] The clamp comprises a first clamp 3 and a second clamp 4.

[0077] The first clamp 3 comprises a first clamping surface 31.

[0078] The second clamp 4 comprises a second clamping surface 41.

[0079] The first clamping surface 31 and the second clamping surface 41 are respectively adapted to and used for clamping the two surfaces of the base material 1 of the composite fiber material, the first clamp 3 is provided with a first chamfer 32 corresponding to the edge portion of the first clamping surface, and the second clamp 4 is provided with a second chamfer 42 corresponding to the edge portion of the second clamping surface 41.

[0080] The first chamfer 32 and the second chamfer 42 form a gap 10 between one of the surfaces of the base material 1 of the composite fiber material and the other surface of the base material 1 of the composite fiber material, respectively.

[0081] Specifically, in the above embodiment, the first filling material solution is coated on the side of the composite fiber material substrate and in the gap 10, and dried to obtain an edge-sealed composite fiber material; in the above embodiment, referring to FIGS. 3-14, the two surfaces of the composite fiber material substrate 1 are clamped by the first clamp 3 and the second clamp 4, and the first chamfer 32 is arranged on the edge portion of the first clamping surface corresponding to the first clamp 3, and the second chamfer 42 is arranged on the edge portion of the second clamping surface 41 corresponding to the second clamp 4, and the first chamfer 32 and the second chamfer 42 respectively form a gap 10 with the two surfaces of the composite fiber material substrate 1, and the main body portion of the composite fiber material substrate 1 can be completely shielded by the first clamp 3 and the second clamp 4 and is not affected by the coating operation, while the edge portion of the composite fiber material substrate 1 is exposed, which facilitates the coating layer formed after the subsequent coating of the first filling material solution to completely wrap the edge of the composite fiber material substrate 1; the edge-sealed composite fiber material obtained after edge sealing has a coating layer formed after the coating of the first filling material solution on the side, and the thickness of the coating layer can be controlled to be 15-80 μm; and the edge-sealed composite fiber material has a coating layer formed after the coating of the first filling material solution on the upper and lower surfaces, and the thickness of the coating layer can be controlled to be 15-80 μm, and the projection width of the coating layer is controlled to be 30-250 μm; by using the preparation device of the present application, the area affected by the edge sealing of the composite fiber material substrate prepared can be very accurately controlled, and compared with the strip edge area of at least 1 mm cut by the existing process, the area of the main body of the composite fiber material substrate prepared by using the preparation device of the present application is greatly reduced.

[0082] In some embodiments, the projection width of the first chamfer 32 on one surface of the composite fiber material substrate 1 and the projection width of the second chamfer 42 on the other surface of the composite fiber material substrate are both 20-100 μm; specifically, referring to FIG. 4, the projection width of the first chamfer 32 on the surface of the composite fiber material substrate 1 is e, and e is 40-300 μm.

[0083] In some embodiments, the distance between the end of the first chamfer 32 away from one surface of the composite fiber material substrate 1 and the surface is 20-100 μm; and the distance between the end of the second chamfer 42 away from the other surface of the composite fiber material substrate 1 and the surface is 20-100 μm; specifically, referring to FIG. 4, the distance between the end of the first chamfer 32 away from the surface of the composite fiber material substrate 1 and the surface is d, and d is 20-100 μm; after the gap 10 is filled with the first filling material solution and dried, the thickness of the first filling material coating layer formed will shrink compared with the original thickness of the first filling material solution, and therefore, d is set to be 20-100 μm, so that the thickness of the first filling material on the edge portion of the surface of the composite fiber material substrate 1 is 15-80 μm.

[0084] In some embodiments, the clamp further comprises a positioning member 5, the positioning member 5 is provided with a positioning hole 51, the positioning hole 51 is matched with the first clamp 3, the second clamp 4 and the composite fiber material substrate 1;

[0085] The first clamp 3 is placed in the positioning hole 51, and then one surface of the composite fiber material substrate 1 is attached to the first clamping surface 31 of the first clamp 3, and then the second clamping surface 41 of the second clamp 4 is attached to the other surface of the composite fiber material substrate 1;

[0086] After the first clamp 3 and the second clamp 4 clamp the composite fiber material substrate 1, the positioning member 5 is removed, and then the first filler solution is coated.

[0087] In the above embodiment, the clamp further comprises a positioning member 5, the positioning member 5 is provided with a positioning hole 51, the positioning hole 51 is matched with the first clamp 3, the second clamp 4 and the composite fiber material substrate 1, and the first clamp 3, the second clamp 4 and the composite fiber material substrate 1 can be embedded in the positioning hole 51; before coating, the first clamp 3, the composite fiber material substrate 1 and the second clamp 4 are placed in the positioning hole 51 in sequence, and the first clamp 3, the second clamp 4 and the composite fiber material substrate 1 are positioned and aligned by the positioning member 5, so that the surface of the composite fiber material substrate 1 is accurately clamped by the first clamp 3 and the second clamp 4, and the gap 10 formed between the surface of the composite fiber material substrate 1 and the first clamp 3 and the second clamp 4 is exposed, facilitating subsequent coating of the first filler solution; further, as shown in FIG. 10, the inner wall of the positioning hole 51 is further provided with a boss 52, and the boss 52 is used to support the first clamp 3 and the second clamp 4; specifically, the first clamp 3 is embedded in the positioning hole 51, and the first clamp 3 is supported on the boss 52, and then the composite fiber material substrate 1 and the second clamp 4 are placed in the positioning hole 51 in sequence, and the boss 52 prevents the first clamp 3, the second clamp 4 and the composite fiber material substrate 1 from passing through the positioning hole 51; in practice, the boss 52 can also not be provided, and the clamp can be placed on a horizontal fixed platform to support the first clamp 3 and the second clamp 4.

[0088] In some embodiments, the clamp further comprises a fixing member, the fixing member is used to fix the first clamp 3 and the second clamp 4 after clamping the composite fiber material substrate, so as to prevent the relative position of the first clamp 3, the second clamp 4 and the composite fiber material substrate 1 from changing, thereby causing the position of the gap 10 corresponding to the composite fiber material substrate 1 to change; the fixing member comprises a first magnetic member 61 and a second magnetic member 62;

[0089] The first magnetic member 61 is attached to the side of the first clamp 3 away from the first clamping surface 31, and the second magnetic member 62 is attached to the side of the second clamp 4 away from the second clamping surface 41;

[0090] The opposite faces of the first magnetic member 61 and the second magnetic member 62 are magnetically opposite, and the first magnetic member 61 and the second magnetic member 62 attract each other to fix the first clamp 3 and the second clamp 4.

[0091] In the above embodiment, after the first clamp 3 and the second clamp 4 clamp the composite fiber material substrate 1, the first clamp 3 and the second clamp 4 are fixed by the fixing member, so that the composite fiber material substrate 1 cannot be displaced in the subsequent coating process, and the part to be coated for accurate exposure of the edge of the composite fiber material substrate is ensured; specifically, the fixing member includes the first magnetic member 61 and the second magnetic member 62, the opposite faces of the first magnetic member 61 and the second magnetic member 62 are magnetically opposite, and the first magnetic member 61 and the second magnetic member 62 attract each other to fix the first clamp 3 and the second clamp 4, so that the composite fiber material substrate 1 cannot be displaced.

[0092] In some embodiments, the first clamp 3 is provided with a first recess on the side away from the first clamping face 31, the second clamp 4 is provided with a second recess on the side away from the second clamping face 41, the first recess is matched with the shape of the first magnetic member 61, the first magnetic member 61 is located in the first recess, and the second recess is matched with the shape of the second magnetic member 62, and the second magnetic member 62 is located in the second recess.

[0093] In some embodiments, the fixing member can also adopt the following scheme, specifically, the fixing member includes a first fixing unit and a second fixing unit, and at least one of the first fixing unit and the second fixing unit is connected with a driving unit.

[0094] The first fixing unit is located on the side of the first clamp away from the first clamping face, the second fixing unit is located on the side of the second clamp away from the second clamping face, and the driving unit is used to drive the first fixing unit and the second fixing unit to move towards each other along the thickness direction of the composite fiber material substrate to fix the first clamp and the second clamp.

[0095] Specifically, in the above embodiment, the first fixing unit and the second fixing unit can both be fixed blocks without magnetism, at least one of the first fixing unit and the second fixing unit is connected with a driving unit, and the driving unit can be a mechanical driving unit or an electric driving unit, for example, the driving unit can be an electric push rod, the electric push rod is connected with the first fixing unit, the electric push rod drives the first fixing unit to move, and the first clamp and the second clamp move towards each other and move close to each other, and the first clamp and the second clamp are fixed under the clamping action of the first fixing unit and the second fixing unit.

[0096] Based on the same inventive concept, the present application also provides a preparation method of the edge-sealed composite fiber material, which is prepared by using the preparation device, and includes the following steps:

[0097] S1, providing a composite fiber material substrate;

[0098] S2, after clamping the composite fiber material substrate with the clamp, coating a first filler material solution on the side of the composite fiber material substrate and in the gap, and drying to obtain an edge-sealed composite fiber material.

[0099] In some instrument application scenarios, such as heart valves, the valve leaflets need a certain softness and dynamic response performance when working. The thicker and wider the strip of the edge penetration of the composite material, the more difficult it is to control the uniformity of the edge sealing effect, making the material become harder, and the consistency of the material performance is difficult to guarantee. In actual use, the dynamic response performance cannot be controlled. The method of the present application can control the edge sealing influence area of the composite fiber material substrate to a very small range, and the softness and dynamic response performance of the overall composite fiber material substrate after edge sealing remain completely consistent with the composite fiber material substrate without edge sealing treatment, which can ensure the consistency of the performance of the overall composite fiber material substrate after edge sealing when applied to products. In addition, the edge of the edge-sealed composite fiber material substrate is wrapped and thickened by the first filler material, which has a good enhancement on the edge tear strength and suture strength of the material. Compared with the composite fiber material substrate without edge sealing treatment, the mechanical strength, suture strength and fatigue resistance of the composite fiber material substrate are greatly improved. Moreover, since the rough cutting edge of the composite fiber material substrate is coated with the coating formed by the first filler material solution after edge sealing, it becomes a smooth and continuous material edge, which can avoid the continuous irritation caused by irregular cutting surface and internal material biological incompatibility after being implanted into the human body, resulting in adverse phenomena such as thrombosis and calcification of the material edge.

[0100] In some embodiments, the first clamp 3, the composite fiber material substrate 1, and the second clamp 4 are sequentially placed in the positioning hole 51, the first magnetic member 61 is attached to the side of the first clamp 3 away from the first clamping surface 31, and the second magnetic member 62 is attached to the side of the second clamp 4 away from the second clamping surface 41. After the first clamp 3 and the second clamp 4 are fixed, the positioning member 5 is removed, so that the edge of the composite fiber material substrate 1 can be completely exposed, and the main body of the composite fiber material substrate 1 is completely shielded and not affected by the coating operation. Subsequently, the first filler material solution can be dispersed in the gap 10 between the surface of the composite fiber material substrate 1 and the first clamp 3 and the second clamp 4 by spraying, dispensing, dipping, or other methods. The first clamp 3 and the second clamp 4 of the present application have the same structure shape, and the first magnetic member 61 and the second magnetic member 62 have the same structure shape. Before coating, the composite fiber material substrate 1 is cut according to the designed shape, which can be cut by blade cutting, laser cutting, plasma cutting, or high-pressure water gun cutting. The shape of the positioning hole 51 of the first clamp 3, the second clamp 4, and the positioning member 5 can be flexibly designed according to the shape requirement of the composite fiber material substrate 1, and has high adaptability.

[0101] In some embodiments, the first filler material solution comprises the first filler material and a solvent, and the solvent comprises at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, dimethyl sulfoxide.

[0102] In some embodiments, the first filler material is dissolved in the solvent to obtain the first filler material solution.

[0103] In some embodiments, the drying temperature is 40-70°C, and the drying time is 10-25 min.

[0104] Specifically, after the coating of the first filler material solution is completed, the first clamp 3 and the second clamp 4 are separated, the coated composite fiber material substrate center is adsorbed with a cylindrical rod and taken out along a direction perpendicular to the plane where the composite fiber material substrate is located, and then the composite fiber material substrate center is placed above the cylindrical rod and the edges are dried, to obtain a final edge-sealed composite fiber material.

[0105] In some embodiments, the coating method comprises any one of dispensing, spraying, and dipping.

[0106] In some embodiments, when the coating method is dispensing, the controlled process parameters are as follows: the mass concentration of the first filler material solution is 12-20%, the needle aperture is 0.1-0.5 mm, and the dispensing frequency is 1-3 times.

[0107] Specifically, when the edge is sealed by dispensing, a syringe needle can be used to manually control the dispensing coverage, a pneumatic dispensing machine can be used for dispensing, or a four-axis or five-axis linkage full-automatic dispensing machine can be used for full-automatic dispensing according to the shape of the material, so as to coat the gap 10 between the surface of the composite fiber material substrate 1 and the first clamp 3 and the second clamp 4 with the first filler material solution and coat the side of the composite fiber material substrate 1 with the first filler material solution, i.e., one coating and one dispensing.

[0108] In some embodiments, when the coating method is spraying, the controlled process parameters are as follows: the mass concentration of the first filler material solution is 3-8%, the atomization gas pressure is 20-80 psi, the rotation speed is 20-40 rpm, the spraying time is 15-20 s each time, and the spraying frequency is 5-20 times.

[0109] Specifically, when the edge is sealed by spraying, the edge-sealing assembly (formed after the first clamp and the second clamp clamp the composite fiber material substrate) is fixed on the rotation shaft motor and rotated at a rotation speed of 20-40 rpm, and the spraying time is controlled to be 15-20 s each time.

[0110] In some embodiments, when the coating method is dip coating, the controlled process parameters are: the mass concentration of the first filler material solution is 8-15%, the time for each dip coating is 5-10 s, and the number of dip coating is 2-5 times.

[0111] Specifically, when the edge is coated by dip coating, the edge assembly is fixed on the dip coating machine, immersed in the solution for 5-10 s, and then completely pulled out. When the solution is completely dropped, it is considered as one coating, i.e., one dip coating.

[0112] In some embodiments, after each coating, the first magnetic part and the second magnetic part are immediately taken out, then the first clamp is taken out, and the coated composite fiber material substrate is taken out along the direction perpendicular to the surface thereof by using a rod dipped in water and dried in an oven. The drying temperature is 40-70℃, and the drying time is 10-25 min. After each coating, the first magnetic part, the second magnetic part, the first clamp, and the second clamp are cleaned with a solvent to remove the first filler material solution adhered to the surface, and then cleaned with alcohol and dried to be reused.

[0113] The edge-coated composite fiber material prepared by the method of the present application has a thickened strip (i.e., a first filler material coating) with a projection width of 30-250 μm and a thickness of 15-80 μm on the surface edge. The final edge-coated composite material has a slightly protruding thickened and smooth surface edge morphology.

[0114] Based on the same inventive concept, the present application also provides an application of the above-mentioned edge-coated composite fiber material or the edge-coated composite fiber material prepared by the above-mentioned preparation method in the preparation of medical implant materials.

[0115] Specifically, the edge-coated composite fiber material of the present application can be used to prepare medical implant materials, including but not limited to artificial heart valves, artificial blood vessels, vascular stents, and other high-molecular composite membrane materials in the medical field. The edge-coated composite fiber material can improve the blood compatibility and mechanical strength of the cutting edge of the material.

[0116] In some embodiments, the shapes of the first clamp 3, the second clamp 4, and the composite fiber material substrate 1 are close to the shape of the leaflet of a heart valve. Therefore, the edge-coated composite fiber material of the present application can be used as the leaflet of a high-molecular artificial heart valve.

[0117] Based on the same inventive concept, the present application also provides an artificial heart valve, which includes a stent and a plurality of leaflets connected to the stent. The leaflets include the above-mentioned edge-coated composite fiber material.

[0118] The following further illustrates the preparation method of the edge-sealed composite fiber material of the present application with specific examples. This part further illustrates the content of the present application in combination with specific examples, but should not be understood as a limitation of the present application. If not specifically stated, the technical means adopted in the examples are the conventional means familiar to those skilled in the art. Unless specifically stated, the reagents, methods and equipment adopted in the present application are the conventional reagents, methods and equipment in the art.

[0119] Example 1

[0120] The present application provides a preparation method of an edge-sealed composite fiber material, comprising the following steps:

[0121] S1, providing a composite fiber material substrate, comprising an ultra-high molecular weight polyethylene fiber cloth and a second filler material, the second filler material being distributed inside and on the surface of the ultra-high molecular weight polyethylene fiber cloth; the ultra-high molecular weight polyethylene fiber cloth is plain woven, the yarn density is 10 dtex, the warp density is 1100 strands / 10 cm, the weft density is 600 strands / 10 cm, and the thickness is 45 μm; the second filler material is Carbosil ® , the thickness of the second filler material on the surface of the ultra-high molecular weight polyethylene fiber cloth is 12 μm; the composite fiber material substrate is formed by compounding the ultra-high molecular weight polyethylene fiber cloth and the second filler material, and is cut into a pre-designed shape by laser cutting, the shape being close to the shape of the leaflet of the heart valve;

[0122] S2, providing the clamp shown in Figure 14, placing the first clamp, the composite fiber material substrate and the second clamp in the positioning hole in sequence, then attaching the first magnetic piece to the side of the first clamp away from the first clamping surface, and attaching the second magnetic piece to the side of the second clamp away from the second clamping surface, after fixing the first clamp and the second clamp, removing the positioning piece, the composite fiber material substrate is clamped by the first clamp and the second clamp, obtaining an edge-sealing assembly; wherein the first chamfer width e is 300 μm, and the height d is 35 μm;

[0123] S3, adding Carbosil ® to N,N-dimethylacetamide to prepare a first filler material solution with a mass fraction of 18%;

[0124] S4, the first filling material solution is filled into the air-operated dispenser container, the nozzle is equipped with a needle with a hole diameter of 0.15 mm, and the edge of the sealing assembly is continuously dispensed to coat the gap between the surface of the composite fiber material substrate and the first clamp and the second clamp with the first filling material solution and coat the first filling material solution on the side of the composite fiber material substrate, then the magnet of the sealing assembly is taken out, the dispensed composite fiber material substrate is vertically adsorbed to the center surface of the composite fiber material substrate in the surface direction by using a water-dipped rod, and then taken out and placed in a 60℃ oven for drying for 20 minutes to obtain a sealed composite fiber material, the edge coating thickness a of which is 28μm, the thickness b is 28μm, and the width c is 250μm.

[0125] Example 2

[0126] The embodiment of the present application provides a preparation method of a sealed composite fiber material, comprising the following steps:

[0127] S1, providing a composite fiber material substrate, comprising a polyethylene terephthalate fiber fabric and a second filling material, the second filling material being distributed inside and on the surface of the polyethylene terephthalate fiber fabric; the polyethylene terephthalate fiber fabric is twill woven, the yarn density is 20dtex, the warp density is 800 strands / 10 cm, the weft density is 450 strands / 10 cm, and the thickness is 75μm; the second filling material is Chronosil ® , the thickness of the second filling material on the surface of the polyethylene terephthalate fiber fabric is 16μm; the composite fiber material substrate is formed by the polyethylene terephthalate fiber fabric and the second filling material Chronosil ® , and is cut into a pre-designed shape close to the shape of the leaflet of the heart valve by a blade;

[0128] S2, providing the clamp shown in Figure 14, sequentially placing the first clamp, the composite fiber material substrate and the second clamp in the positioning hole, then attaching the first magnetic part to the side of the first clamp away from the first clamping surface, attaching the second magnetic part to the side of the second clamp away from the second clamping surface, fixing the first clamp and the second clamp, then removing the positioning part, and clamping the composite fiber material substrate by the first clamp and the second clamp to obtain a sealing assembly; wherein the first chamfer width e is 240μm, and the height d is 70μm;

[0129] S3, adding Chronosil ® to tetrahydrofuran to prepare a first filling material solution with a mass fraction of 6%;

[0130] S4, the first filling material solution is loaded into the atomizing spray device container; the center of the edge sealing assembly magnet is fixed on the rotating shaft motor to rotate, at this time the side of the composite fiber material substrate rotates along the substrate centroid, the atomizing spray head is opposite to the side of the rotating composite fiber material substrate, the atomizing gas pressure is 50 psi, the motor rotating speed is 25 rpm, the continuous spraying time is 20 seconds, after the end, the magnet of the edge sealing assembly is taken out, the sprayed composite fiber material substrate is taken out vertically to the surface direction of the substrate, the substrate center surface is adsorbed by the water-dipped rod, and then the substrate is placed into a drying oven at 50 DEG C and dried for 10 minutes;

[0131] S5, the steps S2-S4 are repeated for 10 times, and an edge sealing composite fiber material is obtained, the edge coating thickness a of which is 40 microns, the thickness b is 56 microns, and the width c is 200 microns.

[0132] Example 3

[0133] The embodiment of the application provides a preparation method of an edge sealing composite fiber material, which comprises the following steps:

[0134] S1, a composite fiber material substrate is provided, which comprises a polyamide and polyethylene terephthalate fiber blended fabric and a second filling material, the second filling material is distributed in the interior and surface of the blended fabric; the blended fabric is satin woven, the yarn density is 20 dtex, the warp density is 1000 strands / 10 cm, the weft density is 600 strands / 10 cm, and the thickness is 65 microns; the second filling material is SIBS, and the thickness of the second filling material on the surface of the blended fabric is 20 microns; the composite fiber material substrate is formed by compounding the polyamide and polyethylene terephthalate fiber blended fabric and the second filling material SIBS, and is cut into a pre-designed shape by plasma cutting, the shape is close to the shape of a leaflet of a heart valve;

[0135] S2, a clamp shown in Figure 14 is provided, the first clamp, the composite fiber material substrate and the second clamp are sequentially arranged in the positioning hole, then the first magnetic part is attached to the side of the first clamp away from the first clamping surface, the second magnetic part is attached to the side of the second clamp away from the second clamping surface, after the first clamp and the second clamp are fixed, the positioning part is removed, the composite fiber material substrate is clamped by the first clamp and the second clamp, and an edge sealing assembly is obtained; wherein the first chamfer width e is 250 microns, and the height d is 80 microns;

[0136] S3, SIBS is added to toluene to prepare a first filling material solution with a mass fraction of 12%;

[0137] S4, the first filler material solution is filled into the atomizing spray device container; the edge sealing assembly is fixed on the dip drawing machine, immersed in the first filler material solution for 10 seconds, then drawn out of the liquid surface, the magnet of the edge sealing assembly is taken out, the dipped composite fiber material substrate is taken out after the center surface of the substrate is adsorbed by the wet rod perpendicular to the surface direction of the substrate, and placed in a drying oven at 50 DEG C for 10 minutes;

[0138] S5, the steps S2-S4 are repeated, and the edge sealing composite fiber material is obtained by dipping 3 times, the edge coating thickness a is 62 μm, the thickness b is 60 μm, and the width c is 205 μm.

[0139] Performance test

[0140] Figure 15 is a cross-sectional SEM image of the composite fiber material substrate after laser cutting in Example 1. As can be seen from Figure 15, the edge of the composite fiber substrate after cutting is relatively rough and irregular.

[0141] Figure 16 is a front view SEM image of the edge sealing composite fiber material prepared in Example 1. As can be seen from Figure 16, the edge of the composite fiber substrate after the first filler material is sealed is relatively smooth and regular. Figure 17 is a side view SEM image of the edge sealing composite fiber material prepared in Example 1. As can be seen from Figure 17, the edge of the composite fiber substrate after the first filler material is sealed is thicker than before sealing, and the main body of the substrate has a relatively smooth transition zone with the edge.

[0142] Figure 18 is a cross-sectional SEM image of the composite fiber material substrate after blade cutting in Example 2. As can be seen from Figure 18, the edge of the composite fiber substrate after cutting is relatively rough and irregular.

[0143] Figure 19 is a front view SEM image of the edge sealing composite fiber material prepared in Example 2. As can be seen from Figure 19, the edge of the composite fiber substrate after the first filler material is sealed is relatively smooth and regular. Figure 20 is a side view SEM image of the edge sealing composite fiber material prepared in Example 2. As can be seen from Figure 20, the edge of the composite fiber substrate after the first filler material is sealed is thicker than before sealing, and the thickness of the first filler material gradually increases and then gradually decreases from the direction close to the main body of the substrate to the direction away from the main body of the substrate, and the first filler material as a whole is still relatively smooth.

[0144] Figure 21 is a cross-sectional SEM image of the composite fiber material substrate after plasma cutting in Example 3. As can be seen from Figure 21, the edge of the composite fiber substrate after cutting is relatively rough and irregular.

[0145] Figure 22 is a top view SEM image of the edge-coated composite fiber material prepared in Example 3. As can be seen in Figure 22, the edges of the composite fiber substrate are relatively smooth and regular after being edge-coated with the first filler material. Figure 23 is a side view SEM image of the edge-coated composite fiber material prepared in Example 3. As can be seen in Figure 23, the edges of the composite fiber substrate are thickened after being edge-coated with the first filler material, and the main body of the substrate has a relatively smooth transition zone with the edges.

[0146] Figure 24 is a top view SEM image of the laser-cut composite fiber material substrate prepared in Example 1 after 200 million cycles of the bending fatigue test (TA Electroforce 3200).

[0147] Figure 25 is a top view SEM image of the edge-coated composite fiber material prepared in Example 1 after 200 million cycles of the bending fatigue test (TA Electroforce 3200).

[0148] As can be seen in Figure 25, the edges of the edge-coated composite fiber material remain intact after 200 million cycles of the bending fatigue test; while as can be seen in Figure 24, the edges of the laser-cut composite fiber material substrate are torn and the fibers are more loose after 200 million cycles of the bending fatigue test. This indicates that the edge-coated composite fiber material prepared by the method of the present application improves the bending strength and durability of the composite material.

[0149] The laser-cut composite fiber material substrate prepared in Example 1 and the edge-coated composite fiber material prepared in Example 1 were respectively prepared into artificial heart valves, and the valves were implanted into the aortas of pigs for 140 days before being taken out for sectioning. It was found that the artificial heart valve prepared from the laser-cut composite fiber material substrate had fibrin thrombus on the leaflet tips (material edges), had a tendency of calcification, and had blocky calcification foci in the material; while the artificial heart valve prepared from the edge-coated composite fiber material prepared in Example 1 had normal leaflet tips (material edges). This indicates that the edge-coated composite fiber material prepared by the method of the present application can avoid adverse phenomena such as thrombosis and calcification.

[0150] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An edge-wrapped composite fiber material, characterized by, The composite fiber material substrate includes a composite fiber material substrate and a first filling material; The first filling material is distributed on the side surface of the composite fiber material substrate, the surface corresponding to the edge portion of the composite fiber material substrate, and the edge portion of the composite fiber material substrate is completely filled or partially filled inside, and the first filling material is covered on the side surface of the composite fiber material substrate, the surface corresponding to the edge portion of the composite fiber material substrate, and the edge portion of the composite fiber material substrate is completely filled or partially filled inside to smooth the side surface of the composite fiber material substrate, the surface corresponding to the edge portion of the composite fiber material substrate; The thickness of the first filling material on the side surface of the composite fiber material substrate and the surface edge portion is 15-80 μm; The projection width of the first filling material on the surface edge portion of the composite fiber material substrate on the surface of the composite fiber material substrate is 30-250 μm.

2. The edge-wrapped composite fiber material of claim 1, wherein, The composite fiber material substrate includes a woven fabric and a second filling material, the second filling material is distributed inside and on the surface of the woven fabric, the second filling material partially fills or completely fills the pores between the fibers of the woven fabric, and the second filling material is covered on the surface of the woven fabric to smooth the surface of the woven fabric.

3. The edge-wrapped composite fiber material of claim 2, wherein, The fibers of the woven fabric are selected from one or more of ultra-high molecular weight polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polypropylene, polyacrylonitrile, polyamide and polyurethane; And / or, the first filling material and the second filling material are each independently selected from one or more of polyurethane elastomer, styrene elastomer, collagen and hydrogel; The hard segment ratio of the polyurethane elastomer is 15%-25%, and the soft segment of the polyurethane elastomer is introduced with a polysiloxane block, and the mass ratio of the polysiloxane block in the total polyurethane is 5%-30%; The hard segment ratio of the styrene elastomer is 25%-40%; And / or, the thickness of the second filling material on the surface of the woven fabric is 8-50 μm; And / or, the thickness of the woven fabric is 20-100 μm; And / or, the fiber density of the woven fabric is 10-100 dtex, and the woven structure includes plain weave, twill or satin; When the woven structure of the woven fabric is plain weave, the warp density of the plain weave is 500-1400 strands / 10 cm, and the weft density is 300-800 strands / 10 cm; When the woven structure of the woven fabric is twill, the warp density of the twill is 400-1000 strands / 10 cm, and the weft density is 300-750 strands / 10 cm; When the woven structure of the woven fabric is satin, the warp density of the satin is 600-1500 strands / 10 cm, and the weft density is 300-1000 strands / 10 cm.

4. An apparatus for producing the edge-coated composite fiber material according to any one of claims 1 to 3, characterized by The clamp is used to clamp the composite fiber material substrate before the first filling material solution is coated; The clamp includes a first clamp and a second clamp; The first clamp includes a first clamping surface; The second clamp includes a second clamping surface; The first clamping surface and the second clamping surface are respectively matched with two surfaces of the composite fiber material substrate and used for clamping the two surfaces of the composite fiber material substrate, the first clamp is provided with a first chamfer corresponding to an edge portion of the first clamping surface, and the second clamp is provided with a second chamfer corresponding to an edge portion of the second clamping surface; The first chamfer and the other surface of the composite fiber material substrate form a gap, and the second chamfer and the other surface of the composite fiber material substrate form a gap.

5. The preparation device according to claim 4, characterized in that The projection width of the first chamfer on one surface of the composite fiber material substrate and the projection width of the second chamfer on the other surface of the composite fiber material substrate are both 20 to 100 microns. The distance between the end of the first chamfer away from one surface of the composite fiber material substrate and the surface is 20 to 100 microns. The distance between the end of the second chamfer away from the other surface of the composite fiber material substrate and the surface is 20 to 100 microns.

6. The preparation device of claim 4, wherein The clamp further comprises a positioning member, the positioning member is provided with a positioning hole, and the positioning hole is matched with the first clamp, the second clamp and the composite fiber material substrate. The first clamp is placed in the positioning hole, one surface of the composite fiber material substrate is attached to the first clamping surface of the first clamp, and the second clamping surface of the second clamp is attached to the other surface of the composite fiber material substrate.

7. A preparation device as claimed in any one of claims 4 to 6, characterized in that The clamp further comprises a fixing member, the fixing member is used for fixing the first clamp and the second clamp after clamping the composite fiber material substrate. The fixing member comprises a first magnetic member and a second magnetic member. The first magnetic member is attached to the side of the first clamp away from the first clamping surface, and the second magnetic member is attached to the side of the second clamp away from the second clamping surface. The opposite faces of the first magnetic member and the second magnetic member are magnetically opposite, and the first magnetic member and the second magnetic member are attracted to each other to fix the first clamp and the second clamp. The fixing member comprises a first fixing unit and a second fixing unit, and at least one of the first fixing unit and the second fixing unit is connected with a driving unit. The first fixing unit is located on the side of the first clamp away from the first clamping surface, the second fixing unit is located on the side of the second clamp away from the second clamping surface, and the driving unit is used for driving the first fixing unit and the second fixing unit to move towards each other along the thickness direction of the composite fiber material substrate to fix the first clamp and the second clamp.

8. A method of making an edge-coated composite fiber material, characterized by, The preparation device of claim 7 is used for preparation, comprising the following steps: Providing a composite fiber material substrate; After clamping the composite fiber material substrate by the clamp, a first filling material solution is coated on the side of the composite fiber material substrate and in the gap, and then dried to obtain an edge-sealed composite fiber material.

9. The method of producing a bound composite fiber material according to claim 8, wherein The first clamp is placed in the positioning hole, one surface of the composite fiber material substrate is attached to the first clamping surface of the first clamp, and the second clamping surface of the second clamp is attached to the other surface of the composite fiber material substrate. After the first clamp and the second clamp clamp the composite fiber material substrate, the positioning member is removed, and then the first filling material solution is coated.

10. The method for preparing the edge-sealing composite fiber material as described in claim 8, characterized in that, The first filling material solution comprises a first filling material and a solvent, and the solvent comprises at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone and dimethyl sulfoxide; And / or, the drying temperature is 40-70℃, and the drying time is 10-25min; And / or, the coating method comprises any one of dispensing, spraying and dipping; When the coating method is dispensing, the controlled process parameters are: the mass concentration of the first filling material solution is 12-20%, the needle hole diameter is 0.1mm-0.5mm, and the dispensing frequency is 1-3 times; When the coating method is spraying, the controlled process parameters are: the mass concentration of the first filling material solution is 3-8%, the atomization gas pressure is 20-80psi, the rotation speed is 20-40rpm, the spraying time is 15-20s each time, and the spraying frequency is 5-20 times; When the coating method is dipping, the controlled process parameters are: the mass concentration of the first filling material solution is 8-15%, the dipping time is 5-10s each time, and the dipping frequency is 2-5 times.

11. Use of the edge-sealed composite fiber material according to any one of claims 1-3 in the preparation of a medical implant material.

12. A prosthetic heart valve, comprising: The stent comprises a plurality of leaflets connected to the stent, and the leaflets comprise the edge-sealed composite fiber material according to any one of claims 1-3.

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