An edge-coated composite fiber material, a method for preparing the same, and an application thereof

Abstract

The application provides an edge-sealed composite fiber material and a preparation method and application thereof. The edge-sealed composite fiber material has a first filling material with a thickness of 15-80 microns on the side surface and a first filling material with a width of 30-250 microns and a thickness of 15-80 microns on the surface edge. The edge-sealed composite fiber material presents 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 sewing strength of the material are greatly enhanced. Compared with the material without edge sealing treatment, the mechanical strength, the sewing strength and the fatigue resistance of the material are greatly improved. Furthermore, 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 continuous irritation caused by the irregular cutting surface and the internal material biological incompatibility can be avoided, and the adverse phenomena such as thrombosis and calcification of the material edge can be avoided.

Description

Technical Field

[0001] This invention relates to the field of medical materials technology, and in particular to a sealing composite fiber material, its preparation method, and its application. Background Technology

[0002] 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, meeting the needs of different medical devices. 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, which could affect device performance. Currently, most materials require irregular shapes when being processed into devices, necessitating the cutting of the entire composite material. Because the composite material contains dispersed fibers, the newly formed cut surfaces expose irregular material surfaces. Even after processing into devices, some cut edges remain exposed to the bloodstream. Due to the irregular shape and continuous stimulation of the implantation site by the internal fibers, a series of reactions such as inflammation, thrombosis, and calcification can occur at the cut surfaces. Furthermore, the sharp cut points on the cut surfaces can cause high stress concentration, creating weak points in the mechanical strength of the composite material. Ultimately, this can easily lead to cracks appearing at the cut points and spreading into the interior of the material, causing failure.

[0003] For example, existing technologies disclose a composite material for medical devices that is cut with scissors or blades. However, this method cannot precisely control the shape and size of the cut material, easily leading to roughness, fraying, and gaps on the cut surface. In thermal cutting methods such as cauterization, laser, and ultrasonic cutting, the high energy of cauterization causes excessive oxidation of the fibers and coatings on the cut surface, resulting in yellowing, hardening, or even blackening of the material, uncontrollable impacts on material properties. Ultrasonic cutting, due to its lower energy, struggles to cut some high-melting-point fibers and coatings in a single pass. Even with multiple cuts, the material deforms due to heat, making it impossible to control the accuracy of the cut shape and size, and leaving traces of thermal cutting near the cut surface, compromising the consistency of the material's edge properties. Laser cutting offers better energy control, but due to the complex fiber and coating structure within the composite material, the cut surface exposes the layered structure, making it impossible to achieve a smooth finish consistent with the surface. After implantation into the human body and contact with blood, blood can easily accumulate in the gaps between the fiber and coating layers on the cut surface, causing thrombosis and calcification.

[0004] For example, existing technology discloses a composite bio-textile, mainly composed of a polyolefin fiber woven layer and a polyurethane coating. The edges are cut and melted using a pulsed laser, and then coated with a coating strip of at least 1 mm is formed at the cut edge using methods such as dip coating, spray coating, or inkjet coating. Generally, dip coating is only suitable for materials with regular edges, such as circles, rectangles, and trapezoids. Many medical devices require materials with irregular shapes, such as heart valves. In this case, direct dip coating will dissolve part of the coating submerged in the composite material surface, affecting the composite material's performance. Spray coating and inkjet coating, due to their large coating area, make it difficult to uniformly concentrate the coating on the cut edge within a strip of at least 1 mm. The area of ​​the composite material near the cut edge is also easily affected by the spraying, damaging the surface coating. Therefore, this edge-sealing method faces significant practical difficulties in achieving uniform edges without affecting the sealing effect of the main material.

[0005] Given the current defects in composite materials, such as edge thrombosis and calcification, it is necessary to improve them. Summary of the Invention

[0006] In view of this, the present invention proposes an edge-sealing composite fiber material, its preparation method and application, in order to solve the defects of the prior art.

[0007] In a first aspect, the present invention provides an edge-sealing composite fiber material, comprising a composite fiber material substrate and a first filler material;

[0008] The first filling material is distributed on the side surface of the composite fiber material substrate, the surface corresponding to its edge portion, and completely or partially filling the interior of the edge portion of the composite fiber material substrate. The first filling material makes the side surface of the composite fiber material substrate and the surface corresponding to its edge portion smooth by covering the side surface of the composite fiber material substrate, the surface corresponding to its edge portion, and completely or partially filling the interior of the edge portion of the composite fiber material substrate.

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

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

[0011] Secondly, the present invention also provides a preparation apparatus for the edge-sealing composite fiber material, including a clamp, which is used to clamp the composite fiber material substrate and then coat it with a first filling material solution.

[0012] The clamp includes a first clamp and a second clamp;

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

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

[0015] The first clamping surface and the second clamping surface are respectively adapted to the two surfaces of the composite fiber material substrate and used to clamp the two surfaces of the composite fiber material substrate. The first clamp is provided with a first chamfer at the edge of the first clamping surface, and the second clamp is provided with a second chamfer at the edge of the second clamping surface.

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

[0017] Thirdly, the present invention also provides a method for preparing an edge-sealing composite fiber material, which is prepared using the aforementioned preparation apparatus and includes the following steps:

[0018] Provide composite fiber material substrates;

[0019] After clamping the composite fiber material substrate with the clamp, the first filling material solution is coated on the side of the composite fiber material substrate and in the gap, and then dried to obtain the edge-sealed composite fiber material.

[0020] Fourthly, the present invention also provides an application of the aforementioned edge-sealing composite fiber material in the preparation of medical implant materials.

[0021] Fifthly, the present invention also provides an artificial heart valve, including a stent and a plurality of leaflets connected to the stent, wherein the leaflets include the aforementioned sealing composite fiber material.

[0022] The beneficial effects of the edge-sealing composite fiber material and its preparation method of the present invention are as follows:

[0023] 1. The edge-sealing composite fiber material of the present invention has a first filling material with a thickness of 15-80 μm on its side and a first filling material with a projected width of 30-250 μm and a thickness of 15-80 μm on its surface edge. The edge-sealing composite fiber material exhibits a slightly protruding and thickened edge shape with a smooth surface. The edge of the material is wrapped and thickened by the first filling material, which greatly enhances the edge tear strength and suture strength of the material. Compared with the unsealed material, its mechanical strength, suture strength and fatigue resistance are greatly improved. Moreover, since the originally rough cut edge is sealed by the first filling material, it becomes a smooth and continuous material edge. After implantation into the human body, it can avoid the continuous stimulation caused by irregular cut surfaces and internal material bioincompatibility, which can lead to adverse phenomena such as thrombosis and calcification at the material edge.

[0024] 2. The preparation method of the edge-sealed composite fiber material of the present invention uses a first clamp and a second clamp to completely cover the main body of the composite fiber material substrate, so that it is not affected by the coating operation. The edges of the clamping surfaces of the clamps are chamfered, exposing the edges of the composite fiber material substrate. This facilitates the subsequent coating formed after the first filler solution is applied, allowing the coating to completely cover the edges of the composite fiber material substrate. The thickness of the coating formed on the side of the edge-sealed composite fiber material after the first filler solution is applied can be controlled between 15 and 80 μm. The thickness of the coating formed on the upper and lower surfaces of the edge-sealed composite fiber material after the first filler solution is applied can be controlled between 15 and 80 μm, and the projected width of the coating is controlled between 30 and 250 μm. Using the method of the present invention, the area affected by the edge-sealing operation of the composite fiber material substrate can be controlled very precisely. Compared with existing processes that cut edges to form strip edge areas of at least 1 mm, the method of the present invention greatly reduces the area affected by the edge-sealing operation of the composite fiber material substrate. In some medical device applications, such as heart valves, the valve leaflets require a certain degree of flexibility and dynamic response performance during operation. The thicker and wider the edge penetration strips of composite materials, the more difficult it is to control the uniformity of the edge sealing effect, making the material harder and compromising the consistency of its properties. In practical use, dynamic response performance cannot be controlled. The method of this invention can control the edge sealing effect area of ​​the composite fiber material substrate to a very small range. The softness and dynamic response performance of the sealed composite fiber material substrate remain completely consistent with those of the unsealed substrate, ensuring consistent performance when applied to products. Compared to unsealed materials, its mechanical strength, stitch strength, and fatigue performance are greatly improved. Furthermore, because the originally rough cut edges are sealed with the first filling material, they become smooth and continuous material edges. After implantation in the human body, this avoids the continuous stimulation caused by irregular cut surfaces and internal material bioincompatibility, which can lead to adverse phenomena such as thrombosis and calcification at the material edges. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a schematic diagram of the edge-sealing composite fiber material of the present invention;

[0027] Figure 2This is a schematic diagram showing the thickness and projected width of the first filling material of the present invention;

[0028] Figure 3 This is a schematic diagram of the first clamp and the second clamp of the present invention clamping the composite fiber material substrate;

[0029] Figure 4 This is a schematic diagram showing the height and projected width of the first chamfer of the present invention;

[0030] Figure 5 This is a three-dimensional schematic diagram of the first clamp and the second clamp of the present invention clamping the composite fiber material substrate;

[0031] Figure 6 This is a schematic diagram of the structure of the first clamp of the present invention;

[0032] Figure 7 This is a schematic diagram of the structure of the second clamp of the present invention;

[0033] Figure 8 This is a structural schematic diagram of another view of the first clamp of the present invention;

[0034] Figure 9 This is a schematic diagram of the structure of the composite fiber material substrate of the present invention;

[0035] Figure 10 This is a schematic diagram of the positioning component of the present invention;

[0036] Figure 11 This is a schematic diagram of the structure of the first magnetic component of the present invention;

[0037] Figure 12 This is a schematic diagram of the structure of the positioning member of the present invention used in conjunction with the first clamp and the second clamp;

[0038] Figure 13 This is a schematic diagram of the structure of the first magnetic component, the second magnetic component, and the first clamp and the second clamp of the present invention in use;

[0039] Figure 14 This is an exploded view of the clamp of the present invention;

[0040] Figure 15 This is a SEM image of the cross-section of the composite fiber material substrate in Example 1 after laser cutting;

[0041] Figure 16 This is a frontal SEM image of the edge-sealing composite fiber material prepared in Example 1;

[0042] Figure 17 The image shown is a side view SEM image of the edge-sealing composite fiber material prepared in Example 1.

[0043] Figure 18This is a SEM image of the cross-section of the composite fiber material substrate in Example 2 after it has been cut with a blade.

[0044] Figure 19 This is a frontal SEM image of the edge-sealing composite fiber material prepared in Example 2;

[0045] Figure 20 This is a side view SEM image of the edge-sealing composite fiber material prepared in Example 2;

[0046] Figure 21 This is a cross-sectional SEM image of the composite fiber material substrate in Example 3 after plasma cutting;

[0047] Figure 22 This is a frontal SEM image of the edge-sealing composite fiber material prepared in Example 3;

[0048] Figure 23 This is a side view SEM image of the edge-sealing composite fiber material prepared in Example 3;

[0049] Figure 24 The image shown is a frontal SEM image of the composite fiber material substrate after laser cutting in Example 1, which has undergone 200 million bending fatigue tests (TA Electroforce 3200).

[0050] Figure 25 The image shown is a frontal SEM image of the edge-sealing composite fiber material prepared in Example 1 after undergoing 200 million bending fatigue tests (TA Electroforce 3200). Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0052] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0053] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0054] In the description of this invention, it should be understood that the orientation or positional relationship indicated by terms such as "above" is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed when in use, or the orientation or positional relationship in which those skilled in the art are usually understood. It is only for the convenience of describing this invention and simplifying the description, and is not intended to 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, it should not be construed as a limitation of this invention.

[0055] Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0056] The technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0057] This invention provides an edge-sealing composite fiber material, such as... Figure 1 As shown, it includes a composite fiber material substrate 1 and a first filler material 2;

[0058] The first filling material 2 is distributed on the side surface of the composite fiber material substrate 1, the surface corresponding to its edge portion, and the interior of the edge portion of the composite fiber material substrate that is completely or partially filled. The first filling material 2 covers the side surface of the composite fiber material substrate, the surface corresponding to its edge portion, and the interior of the edge portion of the composite fiber material substrate that is completely or partially filled, so that the side surface of the composite fiber material substrate and the surface corresponding to its edge portion are smooth.

[0059] The thickness of the first filling material on the side and surface edge of the composite fiber material substrate 1 is 15-80 μm;

[0060] The projection width of the first filling material at the edge of the surface of the composite fiber material substrate 1 on the surface of the composite fiber material substrate is 30 to 250 μm.

[0061] The present invention relates to a sealing composite fiber material, comprising a composite fiber material substrate 1 and a first filling material 2. Specifically, the first filling material 2 is located on the side surface 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. Simultaneously, the first filling material 2 completely or partially fills the internal pores of the edge portions of the composite fiber material substrate. By covering the side surface of the composite fiber material substrate, the surface corresponding to its edge portions, and completely or partially filling the interior of the edge portions of the composite fiber material substrate, the first filling material 2 makes the side surface of the composite fiber material substrate 1 and the surface corresponding to its edge portions smooth. (Reference) Figure 2 As shown, 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 one side of the composite fiber material substrate 1 along a direction perpendicular to the plane of the composite fiber material substrate 1. Figure 2 In the composite fiber material substrate 1, the thickness of the first filling material on one side is 'a', where 'a' is 15–80 μm; the thickness of the first filling material at the edge of the surface of the composite fiber material substrate 1 is also 15–80 μm. Here, the thickness of the first filling material refers to the length of the first filling material along the plane of the composite fiber material substrate 1, from its closest point to its furthest point from the edge of the composite fiber material substrate 1. Figure 2 In this context, b represents the thickness of the edge portion of one side of the composite fiber material substrate 1, and b is 15–80 μm; the projected width of the first filling material on the surface of the composite fiber material substrate 1 is c, where c is 30–250 μm.

[0062] The edge-sealing composite fiber material of the present invention has a first filling material with a projected width of 30-250 μm and a thickness of 15-80 μm on its surface edge. The edge-sealing composite fiber material exhibits a slightly protruding and thickened edge shape with a smooth surface. The edge of the material is wrapped and thickened by the first filling material, which greatly enhances the edge tear strength and suture strength of the material. Compared with the unsealed material, its mechanical strength, suture strength and fatigue resistance are greatly improved. Moreover, since the originally rough cut edge is sealed by the first filling material, it becomes a smooth and continuous material edge. After implantation into the human body, it can avoid the continuous stimulation caused by irregular cut surfaces and internal material bioincompatibility, which can lead to adverse phenomena such as thrombosis and calcification at the material edge.

[0063] In some embodiments, the composite fiber material substrate 1 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 or completely fills the pores between the fibers of the woven fabric and makes the surface of the woven fabric smooth by covering it.

[0064] In some embodiments, the fibers used in the fabric are selected from one or more of ultra-high molecular weight polyethylene, polyethylene terephthalate, polytetrafluoroethylene, polypropylene, polyacrylonitrile, polyamide, and polyurethane.

[0065] In some embodiments, the first filler material and the second filler material are each independently selected from one or more of polyurethane elastomers, styrene elastomers, collagen, and hydrogels. Preferably, the first filler material and the second filler material are the same material.

[0066] In some embodiments, the hard segment proportion of the polyurethane elastomer is 15% to 25%, and polysiloxane blocks are introduced into the soft segments of the polyurethane elastomer, with the polysiloxane blocks accounting for 5% to 30% of the total polyurethane mass. Specifically, commercially available polyurethane elastomer materials can be selected from Carbothane. TM , Elast-Eon TM , wait.

[0067] In some embodiments, the proportion of hard segments in the styrene elastomer is 25% to 40%; commercially available styrene materials may be selected from styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene / butadiene-styrene (SIBS), styrene-ethylene / butene-styrene (SEBS), etc.

[0068] In some embodiments, the thickness of the second filling material on the fabric surface is 8 to 50 μm. Here, the thickness of the second filling material on the fabric surface refers to the thickness of the second filling material on one side of the fabric surface.

[0069] In some embodiments, the combined thickness of the first filling material and the second filling material at the edge of the fabric surface is 23–130 μm.

[0070] In some embodiments, the thickness of the woven fabric is 20–100 μm.

[0071] In the above embodiments, the thickness of the substrate 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, that is, the thickness of the substrate = (20~100μm) + (8~50μm) × 2 = 36~200μm; for the woven fabric, the sum of the thickness of the first filling material and the second filling material on the edge of one side surface is (15~80μm) + (8~50μm) = 23~130μm; for the entire edge-sealing composite fiber material, the thickness of its edge portion is the sum of the thickness of the substrate and the thickness of the first filling material on both surfaces, that is, the thickness of the edge-sealing composite fiber material = (36~200μm) + (15~80μm) × 2 = 66~360μm.

[0072] In some embodiments, the fiber density of the fabric is 10 to 100 dtex, and the weaving structure includes plain weave, twill weave, or satin weave.

[0073] When the weave structure of the fabric is plain weave, the warp density is 500-1400 strands / 10 cm and the weft density is 300-800 strands / 10 cm.

[0074] When the weave structure of the fabric is twill, the warp density is 400-1000 strands / 10 cm and the weft density is 300-750 strands / 10 cm.

[0075] When the weave structure of the fabric is satin, the warp density is 600-1500 strands / 10 cm and the weft density is 300-1000 strands / 10 cm.

[0076] Based on the same inventive concept, the present invention also provides a preparation apparatus for the above-mentioned edge-sealing composite fiber material, including a clamp, which is used to hold the composite fiber material substrate and then coat it with a first filling material solution.

[0077] The fixture includes a first fixture 3 and a second fixture 4;

[0078] The first clamp 3 includes a first clamping surface 31;

[0079] The second clamp 4 includes a second clamping surface 41;

[0080] The first clamping surface 31 and the second clamping surface 41 are respectively adapted to the two surfaces of the composite fiber material substrate 1 and used to clamp the two surfaces of the composite fiber material substrate 1. The first clamp 3 is provided with a first chamfer 32 corresponding to the edge of the first clamping surface, and the second clamp 4 is provided with a second chamfer 42 corresponding to the edge of the second clamping surface 41.

[0081] A gap 10 is formed between the first chamfer 32 and one surface of the composite fiber material substrate 1, and between the second chamfer 42 and the other surface of the composite fiber material substrate 1.

[0082] Specifically, in the above embodiments, the first filling material solution is coated on the side of the composite fiber material substrate and within the gap 10, and then dried to obtain the edge-sealing composite fiber material; in the above embodiments, refer to Figures 3-14As shown, the first clamp 3 and the second clamp 4 are used to clamp the two surfaces of the composite fiber material substrate 1. The first clamp 3 has a first chamfer 32 on the edge of the first clamping surface, and the second clamp 4 has a second chamfer 42 on the edge of the second clamping surface 41. The first chamfer 32 and the second chamfer 42 form gaps 10 with the two surfaces of the composite fiber material substrate 1, respectively. The first clamp 3 and the second clamp 4 can completely cover the main body of the composite fiber material substrate 1, so that it is not affected by the coating operation, while the edge of the composite fiber material substrate 1 is exposed, so that the coating formed after the first filling material solution is applied can completely cover the composite fiber material substrate 1. The edge of the edge-sealed composite fiber material obtained after edge sealing has a coating thickness that can be controlled between 15 and 80 μm after the side surface is coated with the first filler solution; the coating thickness that can be controlled between 15 and 80 μm on the upper and lower surfaces of the edge-sealed composite fiber material after the first filler solution is coated is also controlled between 15 and 80 μm, and the projected width of the coating is controlled between 30 and 250 μm; using the preparation device of the present invention, the area affected by the edge sealing of the prepared composite fiber material substrate can be controlled very precisely. Compared with the existing process where the cutting edge of the strip is at least 1 mm, the area affected by the edge sealing of the composite fiber material substrate prepared by the preparation device of the present invention is greatly reduced.

[0083] In some embodiments, the projected widths of the first chamfer 32 on one surface of the composite fiber material substrate 1 and the second chamfer 42 on the other surface of the composite fiber material substrate are both 20–100 μm; specifically, further refer to Figure 4 As shown, the projection width of the first chamfer 32 on the surface of the composite fiber material substrate 1 is e, where e is 40 to 300 μm.

[0084] In some embodiments, the distance between the end of the first chamfer 32 away from one of the surfaces of the composite fiber material substrate 1 and that surface is 20–100 μm; the distance between the end of the second chamfer 42 away from the other surface of the composite fiber material substrate 1 and that surface is 20–100 μm; specifically, refer to Figure 4 As shown, 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, where d is 20 to 100 μm. After the first filler material solution fills the gap 10 and then d is dried, the thickness of the first filler material coating formed will shrink compared to the original thickness of the first filler material solution. Therefore, by setting d to 20 to 100 μm, the thickness of the first filler material at the edge of the surface of the composite fiber material substrate 1 can be 15 to 80 μm.

[0085] In some embodiments, the fixture further includes a positioning member 5, which has a positioning hole 51 that is adapted to the first fixture 3, the second fixture 4, and the composite fiber material substrate 1.

[0086] Place the first clamp 3 into the positioning hole 51, then attach one surface of the composite fiber material substrate 1 to the first clamping surface 31 of the first clamp 3, and then attach the second clamping surface 41 of the second clamp 4 to the other surface of the composite fiber material substrate 1.

[0087] After the first clamp 3 and the second clamp 4 hold the composite fiber material substrate 1, the positioning piece 5 is removed, and then the first filling material solution is coated.

[0088] In the above embodiments, the fixture further includes a positioning element 5, which has a positioning hole 51. The positioning hole 51 is adapted to the first fixture 3, the second fixture 4, and the composite fiber material substrate 1. The first fixture 3, the second fixture 4, and the composite fiber material substrate 1 can be embedded in the positioning hole 51. Before coating, the first fixture 3, the composite fiber material substrate 1, and the second fixture 4 are placed sequentially in the positioning hole 51. The positioning element 5 is used to position and align the first fixture 3, the second fixture 4, and the composite fiber material substrate 1, so that the surface of the composite fiber material substrate 1 is accurately clamped by the first fixture 3 and the second fixture 4, and the gap 10 formed between the surface of the composite fiber material substrate 1 and the first fixture 3 and the second fixture 4 is exposed, which facilitates the subsequent coating of the first filling material solution. Further, referring to Figure 10 As shown, the inner wall of the positioning hole 51 is also provided with a boss 52, which 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 supported by the boss 52. Then, the composite fiber material substrate 1 and the second clamp 4 are placed in the positioning hole 51 in sequence. 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 be omitted, and the clamps can be placed on a horizontal fixed platform, with the platform supporting the first clamp 3 and the second clamp 4.

[0089] In some embodiments, the clamp further includes a fixing member for fixing 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, which would cause the position of the gap 10 corresponding to the composite fiber material substrate 1 to also change; the fixing member includes a first magnetic element 61 and a second magnetic element 62.

[0090] The first magnetic component 61 is attached to the side of the first clamp 3 away from the first clamping surface 31, and the second magnetic component 62 is attached to the side of the second clamp 4 away from the second clamping surface 41.

[0091] The opposing surfaces of the first magnetic component 61 and the second magnetic component 62 have opposite magnetic properties, and the first magnetic component 61 and the second magnetic component 62 attract each other to fix the first clamp 3 and the second clamp 4.

[0092] 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 then fixed by the fixing members. This ensures that the composite fiber material substrate 1 will not shift during the subsequent coating process, and ensures that the part of the composite fiber material substrate edge to be coated is accurately exposed. Specifically, the fixing members include a first magnetic member 61 and a second magnetic member 62. The opposing magnetic surfaces of the first magnetic member 61 and the second magnetic member 62 attract each other, thereby fixing the first clamp 3 and the second clamp 4, and thus ensuring that the composite fiber material substrate 1 will not shift.

[0093] In some embodiments, the first clamp 3 is provided with a first groove on the side away from the first clamping surface 31, and the second clamp 4 is provided with a second groove on the side away from the second clamping surface 41. The shape of the first groove and the first magnetic element 61 are adapted to each other, and the first magnetic element 61 is located in the first groove. The shape of the second groove and the second magnetic element 62 are adapted to each other, and the second magnetic element 62 is located in the second groove.

[0094] In some embodiments, the fastener may also adopt the following scheme. Specifically, the fastener 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 to a driving unit.

[0095] The first fixing unit is located on the side of the first clamp away from the first clamping surface, and the second fixing unit is located on the side of the second clamp away from the second clamping surface. The driving unit is used to drive the first fixing unit and the second fixing unit to move closer to each other along the thickness direction of the composite fiber material substrate to fix the first clamp and the second clamp.

[0096] Specifically, in the above embodiments, both the first fixing unit and the second fixing unit can be non-magnetic fixing blocks. At least one of the first fixing unit and the second fixing unit is connected to a driving unit. 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 to the first fixing unit. The electric push rod pushes the first fixing unit to move, causing the first clamp and the second clamp to move towards each other and approach each other. Under the clamping action of the first fixing unit and the second fixing unit, the first clamp and the second clamp are fixed.

[0097] Based on the same inventive concept, the present invention also provides a method for preparing the above-mentioned edge-sealing composite fiber material, which is prepared using the above-mentioned preparation apparatus and includes the following steps:

[0098] S1. Provide composite fiber material substrate;

[0099] S2. After clamping the composite fiber material substrate with a clamp, the first filling material solution is applied to the side of the composite fiber material substrate and the gaps, and then dried to obtain the edge-sealing composite fiber material.

[0100] In certain medical device applications, such as heart valves, the valve leaflets require a certain degree of flexibility and dynamic response performance during operation. The thicker and wider the edge-permeable strips of the composite material, the more difficult it is to control the uniformity of the edge-sealing effect, making the material harder and compromising the consistency of its properties. In practical use, dynamic response performance cannot be controlled. The method of this invention can control the edge-sealing effect area of ​​the composite fiber material substrate to a very small range. The flexibility and dynamic response performance of the sealed composite fiber material substrate are completely consistent with those of the unsealed substrate, ensuring the consistency of performance when applied to products. Furthermore, the edges of the sealed composite fiber material substrate are wrapped and thickened by the first filling material, significantly enhancing the edge tear strength and stitch strength. Compared to the unsealed composite fiber material substrate, its mechanical strength, stitch strength, and fatigue resistance are greatly improved. Moreover, after the rough cut edges of the composite fiber material substrate are sealed with a coating formed by the first filling material solution, they become smooth and continuous material edges. After being implanted into the human body, this can avoid the continuous stimulation caused by irregular cut surfaces and biocompatibility of internal materials, which can lead to adverse phenomena such as thrombosis and calcification at the material edges.

[0101] 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. Then, the first magnetic element 61 is attached to the side of the first clamp 3 away from the first clamping surface 31, and the second magnetic element 62 is attached to the side of the second clamp 4 away from the second clamping surface 41. After fixing the first clamp 3 and the second clamp 4, the positioning element 5 is removed, allowing the edge of the composite fiber material substrate 1 to be fully exposed, while the main body of the composite fiber material substrate 1 is completely shielded from the coating operation. Subsequently, the first filler material solution can be applied by spraying, dispensing, dipping, or other methods. The composite fiber material substrate 1 is scattered within the gap 10 formed between the surface of the composite fiber material substrate 1 and the first clamp 3 and the second clamp 4; the first clamp 3 and the second clamp 4 of the present invention have the same structural shape, and the first magnetic component 61 and the second magnetic component 62 have the same structural shape; before coating, the composite fiber material substrate 1 is cut according to the designed shape, which can be done by blade cutting, laser cutting, plasma cutting or high pressure water gun cutting, etc. The shape of the positioning hole 51 of the first clamp 3, the second clamp 4 and the positioning component 5 is flexibly designed according to the shape requirements of the composite fiber material substrate 1, and has high adaptability.

[0102] In some embodiments, the first filler material solution includes a first filler material and a solvent, wherein the solvent includes at least one of tetrahydrofuran, acetone, toluene, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, and dimethyl sulfoxide.

[0103] In some embodiments, the first filler material is dissolved in a solvent to obtain a first filler material solution.

[0104] In some embodiments, the drying temperature is 40–70°C and the drying time is 10–25 min.

[0105] Specifically, after the first filling material solution is applied, the first clamp 3 and the second clamp 4 are separated. The center of the coated composite fiber material substrate is moistened with water and adsorbed by a cylindrical rod. The substrate is then removed along a plane perpendicular to the composite fiber material substrate. The substrate is then inverted so that the center of the composite fiber material substrate is placed above the cylindrical rod and the edges are dried to obtain the final sealed composite fiber material.

[0106] In some embodiments, the coating method includes any one of dispensing, spraying, and dipping.

[0107] In some embodiments, when the coating method is dispensing, the controlled process parameters are: the mass concentration of the first filler material solution is 12-20%, the needle orifice diameter is 0.1mm-0.5mm, and the number of dispensing times is 1-3.

[0108] Specifically, during the edge sealing process, the dispensing can be manually controlled using a syringe needle, or a pneumatic dispensing machine can be used. Alternatively, a four-axis or five-axis fully automatic dispensing machine can be used to automatically dispense the adhesive according to the shape of the material. The first filling material solution is applied to the gap 10 formed between the surface of the composite fiber material substrate 1 and the first clamp 3 and the second clamp 4, and the first filling material solution is also applied to the side of the composite fiber material substrate 1. This constitutes one application, or one dispensing.

[0109] In some embodiments, when the coating method is spraying, the controlled process parameters are: the mass concentration of the first filler material solution is 3-8%, the atomizing gas pressure is 20-80 psi, the rotation speed is 20-40 rpm, the spraying time is 15-20 s, and the number of sprays is 5-20.

[0110] Specifically, during the edge sealing process, the edge sealing assembly (the first clamp and the second clamp hold the composite fiber material substrate to form the edge sealing assembly) is fixed on the rotating shaft motor and rotated at a speed of 20 to 40 rpm. Each spraying time is controlled at 15 to 20 seconds.

[0111] 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 dip coating time is 5-10s, and the number of dip coatings is 2-5.

[0112] Specifically, during the dip-coating process, the edge sealing assembly is fixed on the dip-coating lifting machine, immersed in the solution for 5 to 10 seconds, and then completely lifted out. Once the solution has completely dripped off, this is considered one coating step, or one dip-coating.

[0113] In some embodiments, after each coating is completed, the first magnetic component and the second magnetic component are immediately removed, and then the first clamp is removed. The coated composite fiber material substrate is taken out along a direction perpendicular to its surface by using a rod dipped in water and dried in an oven at a temperature of 40-70°C for 10-25 minutes. After each coating, the first magnetic component, the second magnetic component, the first clamp, and the second clamp are cleaned with solvent to remove the first filler solution adhering to the surface, and then cleaned with alcohol and dried before reuse.

[0114] The edge-sealing composite fiber material completed by the method of the present invention has a thickened strip (i.e., the first filling material coating) with a projected width of 30 to 250 μm and a thickness of 15 to 80 μm on its surface edge. The final edge-sealed composite material exhibits a slightly protruding, thickened, and smooth edge shape.

[0115] Based on the same inventive concept, the present invention also provides the application of the above-mentioned edge-sealing composite fiber material or the edge-sealing composite fiber material prepared by the above-mentioned preparation method in the preparation of medical implant materials.

[0116] Specifically, the edge-sealing composite fiber material of the present invention can be used to prepare medical implant materials, including but not limited to polymer composite membranes in the medical field such as artificial heart valves, artificial blood vessels, and vascular stents. The edge-sealing composite fiber material can improve the blood compatibility and mechanical strength of the material cutting edge.

[0117] In some embodiments, the shapes of the first clamp 3, the second clamp 4, and the composite fiber material substrate 1 are similar to the shape of the leaflets of a heart valve. Therefore, the edge-sealing composite fiber material of the present invention can be used as the leaflets of a polymer artificial heart valve.

[0118] Based on the same inventive concept, the present invention also provides an artificial heart valve, including a stent and a plurality of leaflets connected to the stent, wherein the leaflets include the aforementioned sealing composite fiber material.

[0119] The preparation method of the edge-sealing composite fiber material of the present invention is further illustrated below with specific embodiments. This section further illustrates the content of the present invention in conjunction with specific embodiments, but should not be construed as limiting the present invention. Unless otherwise specified, the technical means used in the embodiments are conventional means well known to those skilled in the art. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in the art.

[0120] Example 1

[0121] This invention provides a method for preparing an edge-sealing composite fiber material, comprising the following steps:

[0122] S1. Provide a composite fiber material substrate, including ultra-high molecular weight polyethylene (UHMWPE) fiber fabric and a second filling material, wherein the second filling material is distributed inside and on the surface of the UHMWPE fiber fabric; the UHMWPE fiber fabric is plain weave, with a yarn density of 10 dtex, a warp density of 1100 strands / 10 cm, a weft density of 600 strands / 10 cm, and a thickness of 45 μm; the second filling material is... The thickness of the second filler material on the surface of the ultra-high molecular weight polyethylene fiber fabric is 12 μm; the composite fiber material substrate is formed by combining ultra-high molecular weight polyethylene fiber fabric and the second filler material, and is cut into a pre-designed shape by laser cutting, which is close to the shape of the leaflet of the heart valve;

[0123] S2, Provide Figure 14 The fixture shown involves placing the first fixture, the composite fiber material substrate, and the second fixture sequentially into the positioning hole. Then, the first magnetic component is attached to the side of the first fixture away from the first clamping surface, and the second magnetic component is attached to the side of the second fixture away from the second clamping surface. After fixing the first and second fixtures, the positioning component is removed, and the composite fiber material substrate is clamped by the first and second fixtures to obtain the edge-sealing assembly. The first chamfer width e is 300 μm, and the height d is 35 μm.

[0124] S3, will A first filler material solution with a mass fraction of 18% was prepared by adding it to N,N-dimethylacetamide;

[0125] S4. Load the first filler material solution into the container of the pneumatic dispensing machine. Attach a 0.15mm orifice needle to the nozzle and continuously dispense the solution onto the edge of the sealing assembly. Fill the gap between the surface of the composite fiber material substrate and the first and second clamps with the first filler material solution, and also coat the side of the composite fiber material substrate with the first filler material solution. Then remove the magnet from the sealing assembly. Hold the dispensed composite fiber material substrate perpendicular to its surface direction and use a wetted rod to adhere it to the center surface of the composite fiber material substrate. Remove the substrate and place it in a 60℃ oven to dry for 20 minutes to obtain the sealing composite fiber material. The edge coating thickness a is 28μm, the thickness b is 28μm, and the width c is 250μm.

[0126] Example 2

[0127] This invention provides a method for preparing an edge-sealing composite fiber material, comprising the following steps:

[0128] S1. Provide a composite fiber material substrate, including polyethylene terephthalate (PET) fiber fabric and a second filling material, wherein the second filling material is distributed inside and on the surface of the PET fiber fabric; the PET fiber fabric is twill weave, with a yarn density of 20 dtex, a warp density of 800 strands / 10 cm, a weft density of 450 strands / 10 cm, and a thickness of 75 μm; the second filling material is... The thickness of the second filler material on the surface of the polyethylene terephthalate (PET) fiber fabric is 16 μm; the composite fiber material substrate consists of PET fiber fabric and the second filler material. The composite is formed and cut into a pre-designed shape by a blade, which closely resembles the shape of the leaflets of a heart valve;

[0129] S2, Provide Figure 14 The fixture shown involves placing the first fixture, the composite fiber material substrate, and the second fixture sequentially into the positioning hole. Then, the first magnetic component is attached to the side of the first fixture away from the first clamping surface, and the second magnetic component is attached to the side of the second fixture away from the second clamping surface. After fixing the first and second fixtures, the positioning component is removed, and the composite fiber material substrate is clamped by the first and second fixtures to obtain the edge-sealing assembly. The first chamfer width e is 240 μm, and the height d is 70 μm.

[0130] S3, will A first filling material solution with a mass fraction of 6% was prepared by adding it to tetrahydrofuran;

[0131] S4. Load the first filler material solution into the atomizing spray device container; fix the center of the edge sealing component magnet on the rotating shaft motor and rotate it. At this time, the side of the composite fiber material substrate rotates along the center of the substrate. The atomizing nozzle is facing the side of the rotating composite fiber material substrate. Set the atomizing air pressure to 50psi, the motor speed to 25rpm, and the continuous spraying time to 20 seconds. After the spraying is completed, remove the magnet of the edge sealing component. Use a wet rod to adsorb the center surface of the substrate perpendicular to its surface direction and then remove it. Place it in a 50℃ oven to dry for 10 minutes.

[0132] S5. Repeat steps S2 to S4, spraying 10 times to obtain the edge-sealing composite fiber material with an edge coating thickness a of 40 μm, a thickness b of 56 μm, and a width c of 200 μm.

[0133] Example 3

[0134] This invention provides a method for preparing an edge-sealing composite fiber material, comprising the following steps:

[0135] S1. A composite fiber material substrate is provided, comprising a polyamide and polyethylene terephthalate fiber blended fabric and a second filling material, wherein the second filling material is distributed inside and on the surface of the blended fabric; the blended fabric is satin woven with a yarn density of 20 dtex, a warp density of 1000 strands / 10 cm, a weft density of 600 strands / 10 cm, and a thickness of 65 μm; the second filling material is SIBS, and the thickness of the second filling material on the surface of the blended fabric is 20 μm; the composite fiber material substrate is formed by combining 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 of which is close to the shape of the leaflet of a heart valve;

[0136] S2, Provide Figure 14 The fixture shown places the first fixture, the composite fiber material substrate, and the second fixture sequentially into the positioning hole. Then, the first magnetic component is attached to the side of the first fixture away from the first clamping surface, and the second magnetic component is attached to the side of the second fixture away from the second clamping surface. After fixing the first and second fixtures, the positioning component is removed, and the composite fiber material substrate is clamped by the first and second fixtures to obtain the edge sealing assembly. The first chamfer width e is 250μm, and the height d is 80μm.

[0137] S3. SIBS is added to toluene to prepare a first filling material solution with a mass fraction of 12%;

[0138] S4. Load the first filler material solution into the atomizing spray device container; fix the edge sealing component on the immersion lifting machine, immerse it in the first filler material solution for 10 seconds, then lift it out of the liquid surface. After the first filler material solution has completely dripped off, remove the magnet of the edge sealing component. Use a wet rod to adsorb the center surface of the substrate perpendicular to its surface direction and then remove it. Place it in a 50°C oven to dry for 10 minutes.

[0139] S5. Repeat steps S2 to S4, dip coating 3 times to obtain the edge-sealing composite fiber material with an edge coating thickness a of 62 μm, a thickness b of 60 μm, and a width c of 205 μm.

[0140] Performance testing

[0141] Figure 15 This is a SEM image of the cross-section of the composite fiber material substrate in Example 1 after laser cutting. From... Figure 15 It can be seen that the edges of the composite fiber substrate after cutting are relatively rough and irregular.

[0142] Figure 16 This is a front-view SEM image of the edge-sealing composite fiber material prepared in Example 1. From... Figure 16 As can be seen, after the composite fiber substrate is sealed with the first filler material, its edges are relatively smooth and regular. Figure 17 This is a side-view SEM image of the edge-sealing composite fiber material prepared in Example 1. From... Figure 17 It can be seen that after the composite fiber substrate is sealed with the first filling material, it has a thicker edge than before it is sealed, and there is a relatively smooth transition area between the substrate body and the edge.

[0143] Figure 18 This is a SEM image of the cross-section of the composite fiber material substrate in Example 2 after it has been cut with a blade. From... Figure 18 It can be seen that the edges of the composite fiber substrate after cutting are relatively rough and irregular.

[0144] Figure 19 This is a front-view SEM image of the edge-sealing composite fiber material prepared in Example 2. From... Figure 19 As can be seen, after the composite fiber substrate is sealed with the first filler material, its edges are relatively smooth and regular. Figure 20 This is a side-view SEM image of the edge-sealing composite fiber material prepared in Example 2. From... Figure 20 It can be seen that after the composite fiber substrate is sealed with the first filler material, it has a thicker edge than before it is sealed. From the direction close to the substrate body to the direction far away from the substrate body, the thickness of the first filler material first gradually increases and then gradually decreases. The first filler material is still relatively smooth overall.

[0145] Figure 21This is a SEM image of the cross-section of the composite fiber material substrate in Example 3 after plasma cutting. From... Figure 21 It can be seen that the edges of the composite fiber substrate after cutting are relatively rough and irregular.

[0146] Figure 22 This is a front-view SEM image of the edge-sealing composite fiber material prepared in Example 3. From... Figure 22 As can be seen, after the composite fiber substrate is sealed with the first filler material, its edges are relatively smooth and regular. Figure 23 This is a side-view SEM image of the edge-sealing composite fiber material prepared in Example 3. From... Figure 23 It can be seen that after the composite fiber substrate is sealed with the first filling material, it has a thicker edge than before it is sealed, and there is a relatively smooth transition area between the substrate body and the edge.

[0147] Figure 24 The image shown is a frontal SEM image of the composite fiber material substrate after laser cutting in Example 1, which has undergone 200 million bending fatigue tests (TA Electroforce 3200).

[0148] Figure 25 The image shown is a frontal SEM image of the edge-sealing composite fiber material prepared in Example 1 after undergoing 200 million bending fatigue tests (TA Electroforce 3200).

[0149] from Figure 25 As can be seen, the edge-sealing composite fiber material maintained its integrity after 200 million bending fatigue tests; while from... Figure 24 As can be seen, the composite fiber material substrate after laser cutting tore at the edges after 200 million bending fatigue tests, and the fibers became more loose. This indicates that using the method of the present invention to seal the edge of the composite fiber material improves the bending strength and durability of the composite material.

[0150] Artificial heart valves were fabricated using the laser-cut composite fiber material substrate from Example 1 and the edge-sealed composite fiber material prepared in Example 1, respectively. After implantation into the porcine aorta for 140 days, tissue sections were taken. It was found that the artificial heart valve fabricated using the laser-cut composite fiber material substrate had fibrin thrombi at the leaflet tips (material edges) and showed a tendency towards calcification, with blocky calcification foci found in the material. In contrast, the artificial heart valve fabricated using the edge-sealed composite fiber material prepared in Example 1 had normal leaflet tips (material edges). This demonstrates that the edge-sealed composite fiber material prepared in this invention can avoid adverse phenomena such as thrombosis and calcification.

[0151] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A device for preparing edge-sealing composite fiber material, characterized in that, It includes a clamp for holding the composite fiber material substrate before applying a first filling material solution; 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 basically the same in shape and size as the two surfaces of the composite fiber material substrate. The first clamping surface and the second clamping surface are used to clamp the two surfaces of the composite fiber material substrate. The first clamp is provided with a first chamfer at the edge of the first clamping surface, and the second clamp is provided with a second chamfer at the edge of the second clamping surface. A gap is formed between the first chamfer and one surface of the composite fiber material substrate, and between the second chamfer and the other surface of the composite fiber material substrate.

2. The preparation apparatus according to claim 1, 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 20~100μm; The distance between the end of the first chamfer away from one of the surfaces of the composite fiber material substrate and that surface is 20~100μm; The distance between the end of the second chamfer away from the other surface of the composite fiber material substrate and the surface thereon is 20~100μm.

3. The preparation apparatus according to claim 1, characterized in that, The fixture also includes a positioning element, which has a positioning hole that is compatible with the first fixture, the second fixture, and the composite fiber material substrate. Place the first clamp into the positioning hole, then attach one surface of the composite fiber material substrate to the first clamping surface of the first clamp, and then attach the second clamping surface of the second clamp to the other surface of the composite fiber material substrate.

4. The preparation apparatus as described in claim 3, characterized in that, The clamp also includes a fixing member, which is used to fix the first clamp and the second clamp after clamping the composite fiber material substrate; The fastener includes a first magnetic component and a second magnetic component; The first magnetic element is attached to the side of the first clamp away from the first clamping surface, and the second magnetic element is attached to the side of the second clamp away from the second clamping surface; The opposing surfaces of the first and second magnetic components have opposite magnetic properties, and the first and second magnetic components attract each other to fix the first and second clamps; or, The fastener includes a first fastening unit and a second fastening unit, and at least one of the first fastening unit and the second fastening unit is connected to a driving unit. The first fixing unit is located on the side of the first clamp away from the first clamping surface, and the second fixing unit is located on the side of the second clamp away from the second clamping surface. The driving unit is used to drive the first fixing unit and the second fixing unit to move closer to each other along the thickness direction of the composite fiber material substrate to fix the first clamp and the second clamp.

5. A method for preparing an edge-sealing composite fiber material, characterized in that, The preparation is carried out using the preparation apparatus according to any one of claims 1 to 4, comprising the following steps: Provide composite fiber material substrates; After clamping the composite fiber material substrate with the clamp, the first filling material solution is coated on the side of the composite fiber material substrate and in the gap, and then dried to obtain the edge-sealed composite fiber material.

6. The method for preparing the edge-sealing composite fiber material as described in claim 5, characterized in that, Place the first clamp into the positioning hole, then attach one surface of the composite fiber material substrate to the first clamping surface of the first clamp, and then attach the second clamping surface of the second clamp to the other surface of the composite fiber material substrate. After the first and second clamps hold the composite fiber material substrate, the positioning component is removed, and then the first filling material solution is applied.

7. The method for preparing the edge-sealing composite fiber material as described in claim 5, characterized in that, The first filler material solution includes a first filler material and a solvent, wherein the solvent includes 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 includes any one of dispensing, spraying, and dip coating; When the coating method is dispensing, the controlled process parameters are: the mass concentration of the first filler material solution is 12~20%, the needle orifice diameter is 0.1mm~0.5mm, and the number of dispensing times is 1~3. When the coating method is spraying, the controlled process parameters are: the mass concentration of the first filler material solution is 3~8%, the atomizing gas pressure is 20~80psi, the rotation speed is 20~40rpm, the spraying time is 15~20s, and the number of sprays is 5~20. 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 dip coating time is 5~10s, and the number of dip coatings is 2~5.

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