Scleral patch materials and methods of making and using the same

Abstract

This invention discloses a scleral patch material, its preparation method, and its application, relating to the field of medical device technology. The scleral patch material has a multi-layered structure, with a core of a fiber-reinforced polymer film and 1-3 layers of nanofiber films on both sides. The fiber-reinforced polymer film comprises a thermoplastic elastomer polymer material and reinforcing fibers; the weight ratio of the reinforcing fibers to the thermoplastic elastomer polymer material is 5%-30 wt%. The nanofiber film is prepared by spinning the thermoplastic elastomer polymer material. The nanofiber film is placed on the fiber-reinforced polymer film and hot-pressed under multiple gradient temperature conditions below the melting point of the thermoplastic elastomer polymer material, resulting in a gradient density distribution of the scleral patch material from the core to the surface. This invention meets the requirements for patch materials in scleral reinforcement surgery in terms of mechanical properties and biocompatibility.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a scleral patch material, its preparation method, and its application. Background Technology

[0002] Posterior scleral reinforcement (PSR), a surgical intervention for controlling the progression of pathological myopia, is primarily used in clinical practice for children and adolescents with rapidly elongating axial lengths, as well as patients with high myopia. This procedure uses biocompatible materials such as medical-grade silicone sponge, allogeneic sclera, or autologous fascia lata as reinforcement media. These materials are implanted and fixed to the scleral surface at the posterior pole of the eyeball, achieving mechanical reinforcement and biofusion of the scleral structure in this area. Its core mechanism lies in two aspects: firstly, through physical support and scar healing response, it inhibits local expansion of the posterior pole sclera and the overall progressive elongation of the axial length, thereby reducing myopia refractive error to some extent; secondly, postoperative changes in the local microenvironment can induce neovascularization, significantly improving blood perfusion of the choroid and retina, thereby activating the metabolic function of photoreceptor cells, enhancing retinal bioelectrical activity, and ultimately improving visual sensitivity. Based on the aforementioned mechanism of action, posterior scleral reinforcement surgery is particularly suitable for controlling the progressive elongation of the axial length in patients with high myopia. For adolescents with high myopia whose axial length exceeds 26 mm and whose annual rate of myopia progression is higher than 1.00 D, this surgery has significant clinical intervention value. By delaying further axial elongation, this procedure not only helps stabilize the refractive state but may also reduce the risk of pathological myopia-related complications such as posterior staphyloma, macular schisis, and choroidal atrophy, thereby improving long-term visual prognosis.

[0003] However, the scleral patch materials currently used in clinical practice are mainly biological materials, such as allogeneic sclera, dura mater, or animal pericardium. These materials pose risks of immunogenicity and viral transmission, and are easily absorbed by enzymes after implantation, leading to a decrease in mechanical strength and failing to achieve lifelong stable reinforcement. On the other hand, some non-biological materials, such as silicone sponge, have poor biocompatibility and insufficient mechanical strength, making them prone to creep and other problems. Summary of the Invention

[0004] To address the technical problems existing in the prior art, embodiments of the present invention provide a scleral patch material, its preparation method, and its application. The technical solution is as follows:

[0005] A scleral patch material, wherein the scleral patch material has a multi-layer structure, the core being a fiber-reinforced polymer film, and the two outer layers being 1-3 layers of nanofiber film;

[0006] The fiber-reinforced polymer film comprises: a thermoplastic elastomer polymer material and reinforcing fibers; the weight ratio of the reinforcing fibers to the thermoplastic elastomer polymer material is 5%-30 wt%.

[0007] The nanofiber film is prepared by using a thermoplastic elastomer polymer material through a spinning process.

[0008] The nanofiber film is placed on the fiber-reinforced polymer film and hot-pressed under multiple gradient temperatures below the melting point of the thermoplastic elastomer polymer material, so that the density of the scleral patch material is gradient-distributed from the core to the surface. The multiple gradient temperatures include at least one of 20-30°C or 40-60°C below the melting point of the thermoplastic elastomer polymer material.

[0009] Optionally, the thermoplastic elastomer polymer material includes at least one of thermoplastic polyurethane (TPU) and SEBS;

[0010] And / or, the reinforcing fiber includes at least one of nylon fiber, carbon fiber or spandex fiber;

[0011] And / or, the length of the reinforcing fiber is 1-10 mm;

[0012] And / or, the weight ratio of the reinforcing fiber to the thermoplastic elastomer polymer material is 10%-25 wt%;

[0013] And / or, the thickness of the fiber-reinforced polymer film is 100-200 μm.

[0014] Optionally, the spinning process includes at least one of electrospinning or air spinning;

[0015] And / or, the diameter of the nanofibers in the nanofiber film is 50-500 nm;

[0016] And / or, the thickness of the nanofiber film is 50-150 μm.

[0017] Optionally, the thickness of the scleral patch material is 400-800 μm;

[0018] And / or, the thickness of the scleral patch material is 600 μm.

[0019] The method for preparing the scleral patch material includes:

[0020] (1) Preparation of fiber-reinforced polymer film: The reinforcing fiber is used as the fiber reinforcing phase and dispersed in a solution of thermoplastic elastomer polymer material. The resulting solution is uniformly coated into a mold to prepare the fiber-reinforced polymer film.

[0021] (2) Preparation of nanofiber films: Thermoplastic elastomer polymer materials are dissolved in organic solvents and prepared into nanofiber films by spinning process;

[0022] (3) First-stage hot pressing: The nanofiber film is placed on both sides of the fiber-reinforced polymer film and hot-pressed at a temperature 20-30°C lower than the melting point of the thermoplastic elastomer polymer material;

[0023] (4) Secondary hot pressing: The nanofiber film is placed on both sides of the composite film prepared after primary hot pressing, and then hot pressed at a temperature 40-60°C lower than the melting point of the thermoplastic elastomer polymer material to obtain the scleral patch material.

[0024] Optionally, in step (1), the concentration of the reinforcing fiber in the thermoplastic elastomer polymer solution is 1-10 wt%.

[0025] And / or, in step (1), the organic solvent in the solution of the thermoplastic elastomer polymer is selected from at least one of n-hexane, N,N-dimethylformamide, and hexafluoroisopropanol;

[0026] And / or, in step (1), the obtained solution is uniformly coated onto the mold by spin coating or casting.

[0027] Optionally, in step (2), the organic solvent is selected from at least one of n-hexane, N,N-dimethylformamide, and hexafluoroisopropanol;

[0028] And / or, in step (2), the spinning process includes at least one of electrospinning or air spinning.

[0029] Optionally, in step (3), the first-stage hot pressing time is 15-30 min;

[0030] And / or, in step (4), the secondary hot pressing time is 15-30 min.

[0031] The application of the scleral patch material in the preparation of a kit for posterior scleral reinforcement surgery.

[0032] A kit for posterior scleral reinforcement surgery, comprising the aforementioned scleral patch material.

[0033] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0034] This invention employs a graded, layer-by-layer composite process using gradient hot pressing to combine a reinforcing film and a nanofiber film. This provides the final composite material with superior mechanical properties, ensuring effective mechanical support and creep resistance during clinical use. Simultaneously, the outer nanofiber film layer provides a nanofiber structure for tissue cell ingrowth, enhancing the overall biocompatibility of the material. By implementing this patent, the requirements for patch materials in scleral reinforcement surgery can be met in terms of both mechanical properties and biocompatibility, providing a novel patch material for post-scleral reinforcement surgery. Attached Figure Description

[0035] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying 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.

[0036] Figure 1 This is a diagram of the nylon fiber reinforced TPU film (core film) provided in Embodiment 1 of the present invention;

[0037] Figure 2 This is a diagram of the TPU nanofiber film prepared by the air spinning process provided in Example 1 of this invention;

[0038] Figure 3 This is a diagram of the composite TPU composite scleral patch material prepared by graded hot pressing according to Embodiment 1 of the present invention;

[0039] Figure 4 This is a mechanical tensile curve of the composite TPU composite scleral patch material prepared by graded hot pressing provided in Experimental Example 1 of this invention;

[0040] Figure 5 This is a diagram showing the cell culture and proliferation experiment results of the composite TPU composite scleral patch material prepared by graded hot pressing according to Experimental Example 2 of the present invention. Detailed Implementation

[0041] The technical solution of the present invention will now be described with reference to the accompanying drawings.

[0042] In embodiments of the present invention, words such as "exemplarily," "for example," etc., are used to indicate that something is an example, illustration, or description. Any embodiment or design described as "exemplary" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of the word "exemplary" is intended to present the concept in a concrete manner. Furthermore, in embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one.

[0043] To address the limitations of biological sources for scleral patch materials used in clinical posterior scleral reinforcement surgery, as well as the insufficient mechanical properties and poor biocompatibility of synthetic polymer materials, this invention proposes a graded composite scleral patch material and its preparation method. This patch material is a composite film, with a high-strength composite film core and an outer nanofiber structure to improve biocompatibility for cell growth and infiltration. Specifically, the core reinforcement film is further enhanced with internal fibers (nylon, carbon, or spandex fibers, etc.) to improve its tensile strength and creep resistance. The outer layer is a nanofiber film material prepared using a spinning process. This nanofiber structure has good biocompatibility and can promote the migration and growth of fibroblasts into the patch material.

[0044] The multilayer structure is achieved through hot pressing at multiple gradient temperatures. The gradient hot pressing process involves first hot pressing at a temperature 20-30°C below the melting point of the thermoplastic elastomer polymer, and then hot pressing at a temperature 40-60°C below the melting point of the thermoplastic elastomer polymer. This results in a denser fiber film applied first and a relatively looser fiber film applied later.

[0045] For example, the implementation method is as follows: First, wrap a layer of nanofiber film on both sides of the core strengthening film and then hot-press it for 15-30 min at a temperature 20-30℃ lower than the melting point of the thermoplastic polymer; Second, after cooling the composite film after the previous hot pressing, re-coat both sides with nanofiber film prepared by spinning process and then hot-press it for 15-30 min at a temperature 40-60℃ lower than the melting point of the thermoplastic polymer; Through this gradient temperature layer-by-layer hot pressing method, the transition between the internally toughened film and the external nanofiber film can be achieved, realizing the preparation of high-strength gradient film material.

[0046] The scleral patch prepared using this invention has good mechanical properties, can be sutured to tissues, and has anti-creep ability for long-term implantation. Furthermore, the patch material prepared by graded hot pressing at different gradient temperatures ensures the bonding force between different layers and also ensures that the surface layer has a nanofiber structure, which can induce fibroblast ingrowth and improve the biocompatibility of the material.

[0047] In a preferred embodiment of the present invention, a polymer fiber reinforcing phase is first thoroughly mixed into a solution of thermoplastic elastomer polymer material. After thorough mixing, a core-reinforced polymer film is prepared by spin coating or casting. Then, the thermoplastic elastomer polymer material is dissolved in a solvent and air-spun to obtain an elastomer polymer nanofiber film. Finally, the elastomer polymer nanofiber film is hot-pressed onto the core-reinforced polymer film using a graded, multi-gradient temperature hot-pressing method, thus preparing a gradient structure material with high internal strength and a nanofiber structure on the surface. This invention can achieve the preparation of a film material with high internal strength and a nanofiber structure on the outer surface. Furthermore, this film material exhibits good overall flexibility and excellent creep resistance, meeting the requirements for patch materials in scleral reinforcement surgery in terms of mechanical properties and biocompatibility, providing a new patch material for post-scleral reinforcement surgery.

[0048] In another preferred embodiment of the present invention, a method for preparing a graded composite scleral patch material is provided. This involves dissolving a non-degradable thermoplastic elastomer polymer (thermoplastic polyurethane (TPU), SEBS, etc.) in an organic solvent, adding reinforcing fibers (nylon fibers, carbon fibers, or spandex fibers, etc.) and mixing thoroughly. A uniformly thick reinforcing film is then prepared as the core by casting or spin coating. Further, the non-degradable thermoplastic elastomer polymer is dissolved in an organic solvent and then spun into a nanofiber film using a spinning process (air spinning or electrospinning). Finally, the nanofiber film is hot-pressed onto both sides of the core film under multiple temperature gradients below the melting point of the thermoplastic elastomer. The final product is a material with an internal reinforcing polymer film and a surface nanofiber structure, exhibiting a gradient distribution from the core to the surface.

[0049] The preparation method of the graded composite scleral patch material as described above includes the following steps:

[0050] (1) Preparation of fiber-reinforced core film: Nylon fibers, carbon fibers or spandex fibers with a length of millimeters are used as fiber reinforcement phases and are uniformly dispersed in the polymer solution of thermoplastic elastomer at a concentration of 1-10%wt. Then, the solution is uniformly coated onto a flat mold by spin coating or casting. After the solvent has fully evaporated, a fiber-reinforced thermoplastic elastic polymer film with a thickness of 50-150 μm is prepared as the core film.

[0051] (2) Preparation of thermoplastic elastomer polymer nanofiber films: The thermoplastic elastomer polymer is fully dissolved in an organic solvent, and nanofiber films with a thickness of 50-150 μm are prepared by electrospinning or air spinning.

[0052] (3) Composite primary hot pressing: After wrapping a layer of nanofiber film on both sides of the core reinforcing film, hot press for 15-30 min at a temperature 20-30℃ lower than the melting point of the thermoplastic polymer. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0053] (4) Composite secondary hot pressing: The composite film prepared after the first-stage hot pressing is coated with nanofiber film on both sides again, and then hot-pressed for 15-30 min at a temperature 40-60℃ lower than the melting point of the thermoplastic polymer. Finally, a high-strength gradient film material is obtained with a final film thickness of 400-800 μm.

[0054] Furthermore, the density of the nanofiber film varies depending on the temperature at which it is hot-pressed; the lower the temperature, the more porous the structure.

[0055] Furthermore, in a graded composite scleral patch material, the selected polymer matrix material is a thermoplastic elastomer polymer material, such as thermoplastic TPU and SEBS.

[0056] Furthermore, a graded composite scleral patch material contains a core reinforcing film, which is reinforced with internal fibers (nylon fibers, carbon fibers, or spandex fibers, etc.) to further improve its tensile strength and creep resistance.

[0057] Furthermore, a graded composite scleral patch material has an outer layer of nanofiber film material prepared by spinning process. This nanofiber structure has good biocompatibility and can promote the migration and growth of fibroblasts into the patch material.

[0058] Furthermore, a graded composite scleral patch material is developed, with a multi-layer structure achieved through hot pressing at multiple gradient temperatures layer by layer.

[0059] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0060] Unless otherwise specified, the experimental methods described in the following embodiments are conventional experimental methods well known to those skilled in the art, and are performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Where specific conditions are not specified in the experimental methods, they are generally operated under conventional conditions.

[0061] Unless otherwise specified, all materials and reagents described in the following examples are commercially available.

[0062] Example 1: Nylon fiber reinforced thermoplastic polyurethane (TPU) composite scleral patch material

[0063] The preparation steps are as follows:

[0064] 1) Preparation of fiber-reinforced core film: Nylon fibers with a fiber length of 6 mm (Yuanyang New Materials, 8 mm) were uniformly dispersed at a concentration of 5% wt into a 30% N,N-dimethylformamide solution of TPU (BASF, 120A). The solution was then uniformly coated onto a flat mold by casting. After the solvent was fully evaporated, a fiber-reinforced TPU core film with a thickness of 100 μm was prepared.

[0065] 2) Preparation of TPU nanofiber film by air spinning: 30% TPU N,N-dimethylformamide solution was selected and air spinning was carried out at a rate of 5 ml / h to obtain a film with a thickness of 100 μm.

[0066] 3) Composite primary hot pressing: After wrapping a layer of nanofiber film around both sides of the core reinforcing film, hot press at 120℃ for 15 min. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0067] 4) Composite secondary hot pressing: The composite film prepared after the primary hot pressing is coated with nanofiber films on both sides again, and then hot-pressed at 100℃ for 15 min. The final result is a high-strength gradient film material with a final film thickness of approximately 450 μm.

[0068] Experimental results:

[0069] See the experimental results. Figures 1 to 3 .from Figures 1 to 3 It can be seen that the fiber-reinforced TPU film has a certain smoothness and is relatively dense overall; the TPU nanofiber film obtained by air spinning has a long fiber nonwoven structure; finally, after the nanofiber film is hot-pressed onto the fiber-reinforced film, the air-spun nanofiber film and the internal fiber-reinforced film are well bonded and there is no delamination, while the fiber structure is still visible on the surface.

[0070] Example 2: Carbon fiber reinforced thermoplastic polyurethane (TPU) composite scleral patch material

[0071] The preparation steps are as follows:

[0072] 1) Preparation of fiber-reinforced core film: Carbon fiber (Toray Industries, Japan, 6 mm) was uniformly dispersed in a 30% wt solution of TPU in N,N-dimethylformamide. The solution was then uniformly coated onto a flat mold by casting. After the solvent was fully evaporated, a fiber-reinforced TPU core film with a thickness of 100 μm was prepared.

[0073] 2) Preparation of TPU nanofiber film by air spinning: 30% TPU N,N-dimethylformamide solution was selected and air spinning was carried out at a rate of 5 ml / h to obtain a film with a thickness of 100 μm.

[0074] 3) Composite primary hot pressing: After wrapping a layer of nanofiber film around both sides of the core reinforcing film, hot press at 120℃ for 15 min. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0075] 4) Composite secondary hot pressing: The composite film prepared after the primary hot pressing is coated with nanofiber films on both sides again, and then hot-pressed at 100℃ for 15 min. The final result is a high-strength gradient film material with a final film thickness of approximately 450 μm.

[0076] Example 3: Nylon fiber reinforced thermoplastic SEBS composite scleral patch material

[0077] The preparation steps are as follows:

[0078] 1) Preparation of fiber-reinforced core film: Nylon fibers with a fiber length of 6 mm were uniformly dispersed in a 6% wt hexane solution of SEBS (Asahi Kasei Corporation, H1221, Japan) at a concentration of 5% wt. The solution was then uniformly coated onto a flat mold by casting. After the solvent was fully evaporated, a fiber-reinforced SEBS core film with a thickness of 100 μm was prepared.

[0079] 2) Preparation of SEBS nanofiber films by air spinning: A 5% SEBS n-hexane solution was used to perform air spinning at a rate of 5 ml / h to obtain a film with a thickness of 100 μm.

[0080] 3) Composite primary hot pressing: After wrapping a layer of nanofiber film around both sides of the core reinforcing film, hot press at 120℃ for 15 min. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0081] 4) Composite secondary hot pressing: The composite film prepared after the primary hot pressing is coated with nanofiber films on both sides again, and then hot-pressed at 100℃ for 15 min. The final result is a high-strength gradient film material with a final film thickness of approximately 450 μm.

[0082] Example 4: Carbon fiber reinforced thermoplastic SEBS composite scleral patch material

[0083] The preparation steps are as follows:

[0084] 1) Preparation of fiber-reinforced core film: Carbon fiber is uniformly dispersed in a 6% hexane solution of SEBS at a concentration of 1%wt. Then, the solution is uniformly coated onto a flat mold by casting. After the solvent has fully evaporated, a fiber-reinforced SEBS core film with a thickness of 100 μm is prepared.

[0085] 2) Preparation of SEBS nanofiber films by air spinning: A 5% SEBS n-hexane solution was used to perform air spinning at a rate of 5 ml / h to obtain a film with a thickness of 100 μm.

[0086] 3) Composite primary hot pressing: After wrapping a layer of nanofiber film around both sides of the core reinforcing film, hot press at 120℃ for 15 min. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0087] 4) Composite secondary hot pressing: The composite film prepared after the primary hot pressing is coated with nanofiber films on both sides again, and then hot-pressed at 100℃ for 15 min. The final result is a high-strength gradient film material with a final film thickness of 450 μm.

[0088] Example 5: Aramid fiber reinforced thermoplastic SEBS composite scleral patch material

[0089] The preparation steps are as follows:

[0090] 1) Preparation of fiber-reinforced core film: Aramid fibers with a fiber length of 6 mm are uniformly dispersed in a 6% wt SEBS n-hexane solution at a concentration of 5% wt. The solution is then uniformly coated onto a flat mold by casting. After the solvent has fully evaporated, a fiber-reinforced SEBS core film with a thickness of 100 μm is prepared.

[0091] 2) Preparation of SEBS nanofiber films by air spinning: A 5% SEBS n-hexane solution was used to perform air spinning at a rate of 5 ml / h to obtain a film with a thickness of 100 μm.

[0092] 3) Composite primary hot pressing: After wrapping a layer of nanofiber film around both sides of the core reinforcing film, hot press at 120℃ for 15 min. This ensures good adhesion between the nanofiber film and the core reinforcing film;

[0093] 4) Composite secondary hot pressing: The composite film prepared after the primary hot pressing is coated with nanofiber films on both sides again, and then hot-pressed at 100℃ for 15 min. The final result is a high-strength gradient film material with a final film thickness of approximately 450 μm.

[0094] Experimental Example 1

[0095] The following tests are conducted using the materials from Examples 1-3 as examples. However, those skilled in the art will understand, or it can be verified through simple experiments, that other embodiments of the present invention can achieve the same or similar technical effects, and will not be described in detail here.

[0096] The composite TPU composite scleral patch material prepared using the graded hot-pressing process of this invention was subjected to mechanical tensile testing. Specific methods and procedures can be found in GB / T 1040.3-2006, "Determination of Tensile Properties of Films and Sheets". The testing equipment was a microcomputer-controlled electronic universal testing machine (model UTM6103) purchased from Shenzhen Sansi Zongheng Technology Co., Ltd. The testing speed was 10 mm / min. Test parameters are shown in Table 1.

[0097] Table 1

[0098]

[0099] Experimental results:

[0100] Mechanical tensile curve as shown Figure 4 As shown in Table 2, the mechanical properties determined based on the mechanical tensile curve are shown below.

[0101] Table 2

[0102]

[0103] Among them, samples 1-3 are samples prepared under the conditions of Examples 1-3, and the results of mechanical tensile tests were obtained.

[0104] As can be seen from Table 1, the composite scleral patch material prepared using the technical solution provided in this patent has good tensile properties and can meet the clinical mechanical requirements for scleral patch materials.

[0105] Experimental Example 2

[0106] The scleral patch material made of composite TPU was obtained using the preparation conditions of Example 1, and cell proliferation culture experiments were conducted. The specific experimental steps are as follows:

[0107] (1) A 6mm diameter punch was used to punch the composite TPU scleral patch material to obtain a 6mm diameter disc to fit the cell culture of a 96-well plate.

[0108] (2) The round pieces of TPU scleral patch material obtained by stamping are cleaned with deionized water, dried in an oven at 80°C for 2 hours, and then placed in a clean bench for overnight ultraviolet light sterilization.

[0109] (3) Place the sterilized sample in a 96-well plate and wash it three times with PBS solution for use in cell culture;

[0110] (4) The cultured L929 cells were cultured at 1×10 4Cells were seeded onto the surface of the sample at a rate of 3 cells per well, while a blank 96-well plate was used as a control group. At each time point, the number of samples was set to 3.

[0111] (5) The cell count of samples cultured for 1 day, 3 days and 5 days was determined using the CCK-8 kit purchased from Tongren Chemical.

[0112] Experimental results:

[0113] Experimental results are as follows Figure 5 As shown. From Figure 5 As can be seen from the cell proliferation culture results, the composite TPU scleral patch material prepared using this patent has good biocompatibility, and L929 cells have a good proliferation effect on the material surface.

[0114] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A scleral patch material, characterized in that, The scleral patch material has a multi-layer structure, with a core of fiber-reinforced polymer film and 1-3 layers of nanofiber film on both sides. The fiber-reinforced polymer film comprises: a thermoplastic elastomer polymer material and reinforcing fibers; the weight ratio of the reinforcing fibers to the thermoplastic elastomer polymer material is 5%-30 wt%. The nanofiber film is prepared by using a thermoplastic elastomer polymer material through a spinning process. The nanofiber film is placed on the fiber-reinforced polymer film and hot-pressed under multiple gradient temperatures below the melting point of the thermoplastic elastomer polymer material, so that the density of the scleral patch material is gradient-distributed from the core to the surface. The multiple gradient temperatures include at least one of 20-30°C or 40-60°C below the melting point of the thermoplastic elastomer polymer material.

2. The scleral patch material according to claim 1, characterized in that, The thermoplastic elastomer polymer material includes at least one of thermoplastic polyurethane (TPU) and SEBS; And / or, the reinforcing fiber includes at least one of nylon fiber, carbon fiber or spandex fiber; And / or, the length of the reinforcing fiber is 1-10 mm; And / or, the weight ratio of the reinforcing fiber to the thermoplastic elastomer polymer material is 10%-25 wt%; And / or, the thickness of the fiber-reinforced polymer film is 100-200 μm.

3. The scleral patch material according to claim 1, characterized in that, The spinning process includes at least one of electrospinning or air spinning; And / or, the diameter of the nanofibers in the nanofiber film is 50-500 nm; And / or, the thickness of the nanofiber film is 50-150 μm.

4. The scleral patch material according to claim 1, characterized in that, The thickness of the scleral patch material is 400-800 μm; And / or, the thickness of the scleral patch material is 600 μm.

5. The method for preparing the scleral patch material according to any one of claims 1-4, characterized in that, The preparation method includes: (1) Preparation of fiber-reinforced polymer film: The reinforcing fiber is used as the fiber reinforcing phase and dispersed in a solution of thermoplastic elastomer polymer material. The resulting solution is uniformly coated into a mold to prepare the fiber-reinforced polymer film. (2) Preparation of nanofiber films: Thermoplastic elastomer polymer materials are dissolved in organic solvents and prepared into nanofiber films by spinning process; (3) First-stage hot pressing: The nanofiber film is placed on both sides of the fiber-reinforced polymer film and hot-pressed at a temperature 20-30°C lower than the melting point of the thermoplastic elastomer polymer material; (4) Secondary hot pressing: The nanofiber film is placed on both sides of the composite film prepared after primary hot pressing, and then hot pressed at a temperature 40-60°C lower than the melting point of the thermoplastic elastomer polymer material to obtain the scleral patch material.

6. The preparation method according to claim 5, characterized in that, In step (1), the concentration of the reinforcing fiber in the thermoplastic elastomer polymer solution is 1-10 wt%. And / or, in step (1), the organic solvent in the solution of the thermoplastic elastomer polymer is selected from at least one of n-hexane, N,N-dimethylformamide, and hexafluoroisopropanol; And / or, in step (1), the obtained solution is uniformly coated onto the mold by spin coating or casting.

7. The preparation method according to claim 5, characterized in that, In step (2), the organic solvent is selected from at least one of n-hexane, N,N-dimethylformamide, and hexafluoroisopropanol; And / or, in step (2), the spinning process includes at least one of electrospinning or air spinning.

8. The preparation method according to claim 5, characterized in that, In step (3), the first-stage hot pressing time is 15-30 min; And / or, in step (4), the secondary hot pressing time is 15-30 min.

9. The use of the scleral patch material according to any one of claims 1-4 in the preparation of a kit for posterior scleral reinforcement.

10. A kit for posterior scleral reinforcement surgery, characterized in that, It includes the scleral patch material according to any one of claims 1-4.

Images