Hernia repair patch and method of making same

Abstract

The application provides a hernia repair patch and a preparation method thereof, and relates to the technical field of medical materials.The hernia repair patch comprises a multilayer structure or a single layer structure, and the outer layer of the multilayer structure has a pore size structure of 50-300 mu m.The hernia repair patch is provided with the multilayer structure, the pore size structure on the outer layer is convenient for tissue cell adhesion and nutrient substance flow, and thus can effectively promote rapid tissue growth.In addition, the hernia repair patch can be prepared from various degradable biomaterials, has good mechanical properties, and has the technical effect that the hernia repair patch is absorbable in the body.

Description

Technical Field

[0001] This invention relates to the field of medical materials technology, and in particular to a hernia repair patch and its preparation method. Background Technology

[0002] A hernia, also known as a hernia, occurs when a part of the body's tissue or organ leaves its original location and protrudes into another area through a gap, defect, or weak point in the body. Types include umbilical hernias, direct inguinal hernias, indirect inguinal hernias, incisional hernias, recurrent hernias after surgery, linea alba hernias, and femoral hernias. Hernias are often caused by coughing, sneezing, excessive exertion, obesity, straining during bowel movements, pregnancy in women, excessive crying in children, and age-related deterioration of the abdominal wall.

[0003] Currently, the common treatment for hernias is hernia mesh repair, which involves covering the defect and repairing the hernia ring with a mesh material. However, existing hernia repair meshes have poor affinity with cell tissues, which is not conducive to cell adhesion and growth.

[0004] Therefore, it is both necessary and urgent to research and develop a hernia repair patch that facilitates cell and tissue attachment and growth.

[0005] In view of this, the present invention is hereby proposed. Summary of the Invention

[0006] The first objective of this invention is to provide a hernia repair patch with a multi-layer structure. By adopting a multi-layer structure, the outer layer of the hernia repair patch has a porous structure that facilitates the attachment of tissue cells and the flow of nutrients, thereby effectively promoting rapid tissue growth.

[0007] The second objective of this invention is to provide a method for preparing a hernia repair patch.

[0008] The present invention provides a hernia repair patch, wherein the hernia repair patch has a multi-layer structure, and the outer layer of the multi-layer structure has a pore size structure of 50-300μm.

[0009] Furthermore, the multi-layer structure of the hernia repair patch includes a double-layer or triple-layer structure;

[0010] Alternatively, the hernia repair patch may also include a single-layer structure.

[0011] Furthermore, the total thickness of the single-layer hernia repair patch is 0.05-1.5 mm; the pore size is 0-75 μm.

[0012] Preferably, the double-layer hernia repair patch comprises an inner layer and an outer layer; the total thickness of the double-layer hernia repair patch is 0.05-1.5 mm; the outer layer has a thickness of 0.05-1.4 mm and a pore size of 50-300 μm; the inner layer has a thickness of 0.05-1.4 mm and a pore size of 0-50 μm.

[0013] Preferably, the three-layer hernia repair patch comprises an inner layer, an outer layer, and an outermost layer; the outermost layer of the three-layer hernia repair patch has a thickness of 0.05-1.4 mm and a pore size of 300-500 μm; the outer layer has a thickness of 0.05-1.4 mm and a pore size of 50-300 μm; and the inner layer has a thickness of 0.05-1.4 mm and a pore size of 0-50 μm.

[0014] Furthermore, the outer layer of the double-layer hernia repair patch has a guide growth structure;

[0015] And / or, the outermost layer of the three-layer hernia repair patch has a guide growth structure.

[0016] Furthermore, the guide growth structure is a groove structure with the outer edge pointing towards the center.

[0017] Furthermore, the hernia repair patch is primarily made of biodegradable biomaterials;

[0018] Preferably, the biodegradable biomaterial includes at least one of polylactic acid, polycaprolactone, polyhydroxyalkanoates, polybutylene succinate, polybutylene terephthalate, polyvinyl alcohol, and polycarbonate.

[0019] Preferably, the hernia repair patch includes any one of the following shapes: circular, elliptical, square, rectangular, hexagonal, or octagonal.

[0020] The present invention provides a method for preparing the above-mentioned hernia repair patch, the method comprising the following steps:

[0021] (a) Dissolve the biodegradable biomaterial in a non-alcoholic polar solvent to prepare a solution A with a concentration of 3%-70% (w / v); then add a porogen and stir until the porogen is evenly distributed to obtain a tableting solution;

[0022] (b) The preparation solution is evenly coated on the surface of a smooth preparation fixture and left to stand; then the fixture is demolded, the solvent is removed, and the fixture is dried to obtain a hernia repair patch.

[0023] Optionally, step (b) is repeated 1 to 2 times on the surface of the hernia repair patch to obtain a multi-layered hernia repair patch.

[0024] Preferably, the outer layer of the double-layer hernia repair patch, or the outermost layer of the triple-layer hernia repair patch, is made by electrospinning.

[0025] Furthermore, the non-alcoholic polar solvent includes at least one of tetrahydrofuran, dichloroethane, dimethyl ether, or N,N-dimethylformamide.

[0026] Furthermore, the pore-forming agent includes at least one of sodium chloride, sucrose, gelatin balls, monosodium glutamate, modified cellulose, urea, polyethylene glycol, and polyvinylpyrrolidone.

[0027] Furthermore, when preparing a double-layer hernia repair patch, the outer layer of the double-layer hernia repair patch is made by electrospinning;

[0028] Alternatively, when preparing a three-layer hernia repair patch, the outermost layer of the three-layer hernia repair patch is made by electrospinning.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] The hernia repair patch provided by this invention has a multi-layer structure, and the outer layer of the multi-layer structure has a pore size of 50-300 μm. By employing a multi-layer structure, the pore size of the outer layer of the hernia repair patch facilitates tissue cell attachment and nutrient flow, thereby effectively promoting rapid tissue growth.

[0031] The present invention provides a method for preparing a hernia repair patch, the method comprising: dissolving a biodegradable biomaterial in a non-alcoholic polar solvent to obtain solution A; subsequently adding a pore-forming agent and stirring until the pore-forming agent is evenly distributed to obtain a patch preparation solution; uniformly coating the patch preparation solution onto the surface of a smooth patch preparation fixture and allowing it to stand; subsequently demolding and removing the solvent, drying, and obtaining the hernia repair patch; the above preparation method has the advantages of simple preparation process and easy operation. Attached Figure Description

[0032] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of the single-layer hernia repair patch structure provided in Embodiment 1 of the present invention;

[0034] Figure 2 This is a schematic diagram of the double-layer hernia repair patch structure provided in Embodiment 1 of the present invention. Detailed Implementation

[0035] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0036] According to one aspect of the present invention, a hernia repair patch is provided, wherein the hernia repair patch has a multilayer structure, and the outer layer of the multilayer structure has a pore size structure of 50 to 300 μm.

[0037] The hernia repair patch provided by this invention has a multi-layer structure, and the outer layer of the multi-layer structure has a pore size of 50-300 μm. By employing a multi-layer structure, the pore size of the outer layer of the hernia repair patch facilitates tissue cell attachment and nutrient flow, thereby effectively promoting rapid tissue growth.

[0038] In a preferred embodiment of the present invention, the multi-layer structure of the hernia repair patch includes a single-layer, double-layer, or triple-layer structure. Wherein:

[0039] (I) Single-layer hernia repair patch:

[0040] It is in sheet form, with one side smooth (anti-sticking side) and the other side rough (growth-promoting side).

[0041] Total thickness: 0.05-1.5mm; pore size: 0-75μm.

[0042] (II) Double-layer hernia repair patch:

[0043] Sheet-like, two-layer structure. Total thickness: 0.05-1.5mm;

[0044] Outer layer (growth-promoting layer), thickness: 0.05-1.4 mm, pore size: 50-300 μm. Function of the outer layer: promotes rapid tissue growth. (Large pore size facilitates tissue cell attachment and nutrient flow.)

[0045] The inner layer (anti-adhesion layer) is the side of the hernia repair patch that contacts the organ, with a thickness of 0.05-1.4 mm. Its function is to provide excellent anti-adhesion protection for the hernia repair patch. It has a pore size of 0-50 μm (its dense structure prevents the ingrowth of fibroblasts, muscle cells, and vascular tissue cells, thus preventing adhesion).

[0046] (III) Three-layer hernia repair patch:

[0047] Sheet-like, three-layer structure. Based on the double-layer structure of 1.2, an additional layer—the outermost layer—is added. Total thickness: 0.05-2mm;

[0048] Outer layer, thickness: 0.05-1.4 mm, pore size: 50-300 μm; function of the outer layer: to promote rapid tissue growth (large pore size facilitates tissue cell attachment and nutrient flow);

[0049] The inner layer (anti-adhesion layer) is the side of the hernia repair patch that contacts the organ, with a thickness of 0.05-1.4 mm. Its function is to provide excellent anti-adhesion protection for the hernia repair patch. The pore size is 0-50 μm.

[0050] In addition to the two layers, an outermost layer is added, with a thickness of 0.05-1.4 mm and a pore size of 300-500 μm (the larger pore size facilitates tissue cell attachment and nutrient flow). A growth-guiding structure may also be provided in the outermost layer.

[0051] (iv) Reduce the thickness of the above three-layer structure to make it more suitable for use while ensuring mechanical properties. Adjust the thickness and pore size of the three layers. Total thickness: 0.05-1.5.

[0052] Outermost layer: Thickness: 0.05-1.3mm, pore size: 200-500μm, the outermost layer may have a guided growth structure.

[0053] Outer layer, thickness: 0.05-1.3mm, pore size: 50-200μm;

[0054] The inner layer (anti-adhesion layer) is the side of the hernia repair patch that contacts the organ. Its thickness is 0.05-1.4 mm. The function of the inner layer is to provide excellent anti-adhesion protection for the hernia repair patch. The pore size is 0-50 μm.

[0055] In a preferred embodiment of the present invention, the outer layer of the double-layer hernia repair patch has a guide growth structure;

[0056] And / or, the outermost layer of the three-layer hernia repair patch has a guide growth structure.

[0057] In a preferred embodiment of the present invention, the guide growth structure is a groove structure with the outer edge pointing towards the center.

[0058] In a preferred embodiment of the present invention, the hernia repair patch is mainly made of biodegradable biomaterials;

[0059] Preferably, the biodegradable biomaterial includes at least one of polylactic acid, polycaprolactone, polyhydroxyalkanoates, polybutylene succinate, polybutylene terephthalate, polyvinyl alcohol, and polycarbonate.

[0060] Preferably, the hernia repair patch includes any one of the following shapes: circular, elliptical, square, rectangular, hexagonal, or octagonal.

[0061] According to one aspect of the present invention, a method for preparing the above-mentioned hernia repair patch, the method comprising the following steps:

[0062] (a) Dissolve the biodegradable biomaterial in a non-alcoholic polar solvent to prepare a solution A with a concentration of 3%-70% (w / v); then add a porogen and stir until the porogen is evenly distributed to obtain a tableting solution;

[0063] (b) The preparation solution is evenly coated on the surface of a smooth preparation fixture and left to stand; then the fixture is demolded, the solvent is removed, and the fixture is dried to obtain a hernia repair patch.

[0064] Optionally, repeat step (b) once to obtain a single-layer hernia repair patch; or repeat step (b) twice to obtain a double-layer hernia repair patch.

[0065] The present invention provides a method for preparing a hernia repair patch, the method comprising: dissolving a biodegradable biomaterial in a non-alcoholic polar solvent to obtain solution A; subsequently adding a pore-forming agent and stirring until the pore-forming agent is evenly distributed to obtain a patch preparation solution; uniformly coating the patch preparation solution onto the surface of a smooth patch preparation fixture and allowing it to stand; subsequently demolding and removing the solvent, drying, and obtaining the hernia repair patch; the above preparation method has the advantages of simple preparation process and easy operation.

[0066] Optionally, repeat step (b) once to obtain a single-layer hernia repair patch; or repeat step (b) twice to obtain a double-layer hernia repair patch.

[0067] In a preferred embodiment of the present invention, the non-alcoholic polar solvent includes at least one of tetrahydrofuran, dichloroethane, dimethyl ether, or N,N-dimethylformamide.

[0068] It should be noted that different biodegradable materials used to fabricate nerve repair conduits require different preferred non-alcoholic polar solvents. Through experimental screening and comparison, tetrahydrofuran (THF) is the preferred solvent for fabricating nerve repair conduits using polyurethane biodegradable materials.

[0069] Note: The non-alcoholic polar solvents refer to polar solvents other than alcohols.

[0070] In a preferred embodiment of the present invention, the pore-forming agent includes at least one of sodium chloride, sucrose, gelatin balls, monosodium glutamate, modified cellulose, urea, polyethylene glycol, and polyvinylpyrrolidone.

[0071] In a preferred embodiment of the present invention, when preparing a double-layer hernia repair patch, the outer layer of the double-layer hernia repair patch is made by electrospinning;

[0072] Alternatively, when preparing a three-layer hernia repair patch, the outermost layer of the three-layer hernia repair patch is made by electrospinning.

[0073] Preferably, the preparation method includes: first, using electrospinning to prepare the outermost layer, or the middle layer + outermost layer; then, using an ultra-thin protective sleeve (with a sealed bottom) made of glass or ceramic to cover the outermost layer, or the middle layer + outermost layer; then, placing it in the inner layer preparation solution; using a casting method to attach the inner layer to the protective sleeve; after the inner layer is formed, removing the protective sleeve and pressing it together.

[0074] Specifically, the preparation method of the hernia repair patch includes the following steps:

[0075] (I) Preparation of tableting solution:

[0076] Biodegradable biomaterials are dissolved in a non-alcoholic polar solvent to prepare a biodegradable biomaterial solution with a concentration of 3%-70% (w / v). A porogen is then added and stirred until the porogen is evenly distributed, thus obtaining the tableting solution.

[0077] The pore-forming agents are sodium chloride, sucrose, or gelatin balls, monosodium glutamate, modified cellulose, urea, polyethylene glycol, and polyvinylpyrrolidone.

[0078] (1) Single-layer case:

[0079] 1) No pore-forming agent added:

[0080] 2) Add porogen: The concentration of the porogen should be controlled within the range of 0-50% (w / v). The particle size of the porogen should be controlled within the range of 0-74 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0081] (2) The case of two layers:

[0082] Outer layer (growth promoting layer): The concentration of the porogen is controlled within the range of 0-500% (w / v). The particle size of the porogen is controlled within the range of 49-299 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0083] Inner layer: The concentration of the porogen is controlled within the range of 0-50% (w / v). The particle size of the porogen is controlled within the range of 0-49 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0084] (3) Three-layer case:

[0085] 1) Add a layer to the double layer of 1.2.

[0086] Outermost layer: The concentration of the porogen is controlled within the range of 0-500% (w / v). The particle size of the porogen is controlled within the range of 299-499 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0087] Outer layer: The concentration of the porogen is controlled within the range of 0-500% (w / v). The particle size of the porogen is controlled within the range of 49-299 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0088] Inner layer (anti-blocking layer): The concentration of the porogen is controlled within the range of 0-50% (w / v). The particle size of the porogen is controlled within the range of 0-49μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0089] 2) Based on the double-layer structure in 1), reduce the total thickness.

[0090] Outermost layer: The concentration of the porogen is controlled within the range of 10-500% (w / v). The particle size of the porogen is controlled within the range of 199-499 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0091] Outer layer: The concentration of the porogen is controlled within the range of 10-300% (w / v). The particle size of the porogen is controlled within the range of 49-199 μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0092] Inner layer (anti-blocking layer): The concentration of the porogen is controlled within the range of 0-50% (w / v). The particle size of the porogen is controlled within the range of 0-49μm. (When in solid state, the porogen will expand and contract within a certain temperature range, especially sucrose.)

[0093] (II) Production:

[0094] The preparation solution is evenly coated onto the smooth surface of the preparation fixture and left to stand. During this standing period, the non-alcoholic polar solvents in the preparation solution adhering to the surface of the preparation fixture continuously evaporate, and the initial hernia repair patch gradually takes shape.

[0095] (1) Fabrication of a single-layer hernia repair patch: A biodegradable biomaterial solution is evenly coated onto the surface of a smooth patch-making fixture and left to stand. While standing, stripes or protrusions are pressed onto the unformed hernia repair patch to increase the roughness of the surface.

[0096] (2) Fabrication of a double-layer hernia repair patch: The solution for fabricating the outer and inner layers is applied sequentially to the surface of a smooth patch fabrication fixture according to the thickness requirements of each layer.

[0097] (3) Fabrication of a three-layer hernia repair patch: The solutions for fabricating the outermost, outermost, and innermost layers are applied sequentially to the surface of a smooth patch fabrication fixture according to the thickness requirements of each layer.

[0098] (III) Demolding:

[0099] The initial hernia repair patch is peeled off from the aforementioned patch-making fixture.

[0100] It can be peeled off directly (to facilitate easier peeling, raised or striped structures can be provided on the surface of the fixture); it can also be peeled off after soaking in glucose solution, pure water, water for injection or physiological saline; it can also be easily peeled off with a mold release agent such as polytetrafluoroethylene.

[0101] (iv) Solvent removal:

[0102] Immerse the initial hernia repair patch in glucose solution, pure water, water for injection, or physiological saline until the non-alcoholic polar solvent is removed.

[0103] During the removal of non-alcoholic polar solvents, porogens are also partially or completely removed. If only partially removed, some porogens may remain in the initial hernia repair patch, but this does not affect the patch's use in the human body. The total amount of residual non-alcoholic polar solvents is ≤0.1%.

[0104] (V) Drying:

[0105] The initial hernia repair patch was dried until the residual moisture in the initial nerve repair conduit was ≤0.5% for easy storage.

[0106] (vi) Post-processing:

[0107] Remove any rough edges or uneven thickness from the dried initial hernia repair patch. Ensure it is free of air bubbles, damage, foreign objects, and of uniform thickness, then cut it to the required size; this is the finished hernia repair patch.

[0108] The technical advantages of the single-layer, double-layer, and triple-layer hernia repair patches in this application can also be summarized as follows:

[0109] 1. Single-layer structure: The porous structure on the outer surface of the hernia repair patch facilitates the flow and exchange of nutrients, thus promoting rapid tissue growth. Simultaneously, the porous or non-porous structure on the inner surface prevents adhesion. In other words, in this single-layer structure, one side is smooth, preventing adhesion, while the other side is rough, promoting growth. Cells adhere more easily to the rough surface, facilitating growth.

[0110] 2. The structural advantages of a double layer over a single layer: The larger pores of the outer layer not only facilitate the attachment and rapid growth of tissue cells, but also make it easier for oxygen and nutrients to flow, further promoting growth; the inner layer structure can prevent adhesion.

[0111] 3. Advantages of a three-layer structure over a two-layer structure: The added outermost layer further increases the size of the external pores, which is conducive to the attachment and rapid growth of tissue cells.

[0112] 4. Using the hernia repair patch preparation method involved in this invention, various biodegradable biomaterials can be used to prepare hernia repair patches with good mechanical properties and absorbability in vivo.

[0113] It should be noted that the outer surface of the hernia repair patch in this application is also provided with a groove-like growth guiding structure to guide tissue growth and facilitate the directional and rapid growth of tissue.

[0114] Meanwhile, it should be noted that, through testing and verification, the mechanical performance parameters of the hernia repair patch of this application all meet the following requirements: longitudinal and transverse tensile strength should be ≥5MPa, suture strength should be ≥5N, burst strength should be ≥20KPa, and tear strength should be ≥5N.

[0115] Example 1:

[0116] Figure 1 This is a schematic diagram of the single-layer hernia repair patch structure obtained in this embodiment.

[0117] A method for preparing a single-layer hernia repair patch using a casting method includes the following steps:

[0118] (1) Solution preparation: Dissolve the polyurethane material in tetrahydrofuran (THF) solvent to prepare 100 mL of a 35% (w / v) polyurethane solution. Add 25% (w / v) sodium chloride particles that have been ground and sieved, with a particle size of 25 μm. Stir until the sodium chloride particles are evenly distributed to obtain the tableting solution.

[0119] (2) Slide preparation: The slide preparation solution is evenly coated on the surface of a smooth slide preparation fixture and left to stand.

[0120] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0121] (3) Demolding: Soak the above-mentioned preparation fixture in water until the initial hernia repair patch is peeled off from the preparation fixture.

[0122] (4) Solvent removal: Immerse the initial hernia repair patch in water until the total amount of residual solvent in the initial hernia repair patch is ≤0.1%.

[0123] (5) Drying: Dry the initial hernia repair patch until the residual moisture content in the initial hernia repair patch is ≤0.5% for easy storage.

[0124] (6) Post-processing: Remove any rough edges or uneven thickness from the dried initial hernia repair patch. Ensure it is free of bubbles, damage, foreign matter, and of uniform thickness, and cut it to the required size. Sterilize with cobalt-60 gamma irradiation, package, and store; this is the finished hernia repair patch.

[0125] The hernia repair patch prepared in this embodiment was subjected to performance testing. The specific testing methods are as follows:

[0126] Moisture Residue Test Method: Before testing, the hernia repair patch sample was placed in a drying device to dry. Then, the micro moisture meter was adjusted to the test parameters to measure the moisture content of the dry hernia repair patch. After the system finished measuring the sample analysis, the experimental data was recorded, and the next sample was tested.

[0127] Porosity testing method: Cut the dry hernia repair patch to the specified size as required, and use measuring tools such as a thickness gauge and density balance to measure parameters such as the length, width, thickness and mass of the sample. Then, determine the sample mass using the hexadecane absorption method, and finally obtain the porosity experimental value using the porosity formula.

[0128] Solvent residue test method: Use a gas chromatograph and select appropriate mobile phase, aqueous phase, injection temperature, and headspace sampler conditions according to product requirements. Weigh the dry hernia repair patch sample, dissolve it in the solvent to prepare the test solution. Then adjust the injection conditions for detection.

[0129] Thickness testing method: First, use a measuring tool to cut a high-quality dry hernia repair patch sample, then use a thickness gauge to test the sample thickness. Repeat the measurement multiple times and take the average value.

[0130] Tensile strength testing method: First, cut the dry hernia repair patch sample to be tested into multiple specimens of appropriate width, with flat edges, parallel sides, and no visible defects. Then, turn on the tensile testing machine, set the parameters, and conduct the tensile test. Data processing is then performed.

[0131] Suture strength test method: First, cut the dry hernia repair patch sample to be tested into multiple specimens with appropriate width, flat edges, parallel sides and no visible defects. Then, use sutures of selected specifications to sew one end of the sample to be tested with two stitches and tie a knot to fix it. Suture multiple patch specimens in the same way, and use a thickness gauge to test the thickness of each sample. Then, use a tensile testing machine to clamp the sample to be tested and perform suture strength test on the suture joint to obtain test data.

[0132] Bursting strength test method: First, cut the dry hernia repair patch sample to be tested into multiple square specimens with appropriate width, flat edges, parallel sides and no visible defects, and test the thickness of each specimen with a thickness gauge. Then, turn on the tensile testing machine, clamp the sample to be tested and perform the bursting strength test to obtain the test data.

[0133] Tear strength testing method: First, cut the dry hernia repair patch sample to be tested into multiple samples with appropriate width, smooth edges, parallel sides, and no visible defects. Then, measure the mass of each sample using a thickness gauge. Next, cut along the center of the sample with a cutter to prepare a trouser-shaped sample. The cutting edge of the cutter must be...

[0134] Keep the blade sharp, without any burrs or nicks. Turn on the tensile testing machine, clamp the sample to be tested, and perform a tear strength test to obtain the test data.

[0135] The specific test results are shown in the table below:

[0136] Table: Test results of single-layer hernia repair mesh:

[0137]

[0138] Example 2

[0139] Figure 2 This is a schematic diagram of the double-layer hernia repair patch structure obtained in this embodiment.

[0140] A method for preparing a double-layer hernia repair patch using a casting method includes the following steps:

[0141] (1) Dissolving polyurethane material: Dissolve polyurethane material in tetrahydrofuran (THF) to prepare 100 mL each of 35% (w / v) and 35% (w / v) polyurethane solutions.

[0142] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0143] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 150 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0144] (4) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0145] (5) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth patch preparation jig surface, and let it stand for 30 minutes.

[0146] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0147] (6) Demolding: Soak the above-mentioned preparation fixture in water until the initial hernia repair patch is peeled off from the above-mentioned preparation fixture.

[0148] (7) Solvent removal: Immerse the initial hernia repair patch in water until the total amount of residual solvent in the initial hernia repair patch is ≤0.1%.

[0149] (8) Drying: Dry the initial hernia repair patch until the residual moisture content in the initial hernia repair patch is ≤0.5% for easy storage.

[0150] (9) Post-processing: Remove any rough edges or uneven thickness from the dried initial hernia repair patch. Ensure it is free of bubbles, damage, foreign matter, and of uniform thickness, and cut it to the required size. Sterilize with cobalt-60 gamma irradiation, package, and store; this is the finished hernia repair patch.

[0151] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0152] Table: Test Results of Double-Layer Hernia Repair Mesh

[0153]

[0154] Example 3

[0155] A method for preparing a three-layer hernia repair patch using a casting method includes the following steps:

[0156] (1) Dissolving polyurethane material: Dissolve polyurethane material in tetrahydrofuran (THF) to prepare 100 mL of polyurethane solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0157] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0158] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0159] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0160] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0161] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0162] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0163] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0164] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0165] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0166] Table: Test Results of Three-Layer Hernia Repair Mesh

[0167]

[0168]

[0169] Example 4: Examples of fabricating hernia repair patches using different biodegradable materials:

[0170] (I) 4-1: Preparation of a three-layer hernia repair patch using polylactic acid biodegradable material:

[0171] (1) Dissolving polylactic acid material: Dissolve polylactic acid material in dimethyl ether (DME) solvent to prepare 100 mL each of polyurethane solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0172] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polylactic acid material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0173] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polylactic acid material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0174] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polylactic acid material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0175] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0176] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0177] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0178] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0179] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0180] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0181] Table: Test results of hernia repair patches prepared using polylactic acid materials:

[0182]

[0183] (II) 4-2: Preparation of a three-layer hernia repair patch using polyhydroxyalkanoate biodegradable material

[0184] (1) Dissolving polyhydroxyalkanoate material: Dissolve polyhydroxyalkanoate material in DME solvent to prepare 100 mL each of polyurethane solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0185] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyhydroxyalkanoate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0186] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polyhydroxyalkanoate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0187] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyhydroxyalkanoate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0188] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0189] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0190] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0191] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0192] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0193] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0194] Table: Test results of hernia repair patches prepared using polyhydroxyalkanoates:

[0195]

[0196] (III) 4-3: Preparation of a three-layer hernia repair patch using polybutylene succinate biodegradable material:

[0197] (1) Dissolving polybutylene succinate material: Dissolve polybutylene succinate material in DME solvent to prepare 100 mL of polybutylene succinate solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0198] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polybutylene succinate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0199] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polybutylene succinate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0200] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polybutylene succinate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0201] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0202] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0203] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0204] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0205] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0206] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0207] Table: Test results of hernia repair patches prepared with polybutylene succinate:

[0208]

[0209]

[0210] (iv) 4-4: Preparation of a three-layer hernia repair patch using poly(butylene terephthalate)-adipate-butylene glycol biodegradable material

[0211] (1) Dissolving poly(terephthalic acid-adipate-butylene glycol) material: Dissolve the poly(terephthalic acid-adipate-butylene glycol) material in DME solvent to prepare 100 mL of poly(terephthalic acid-adipate-butylene glycol) solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0212] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% poly(butylene terephthalate) terephthalate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0213] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% poly(terephthalic acid-adipic acid-butylene glycol) material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0214] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% poly(terephthalic acid-adipic acid-butylene glycol) material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0215] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0216] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0217] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0218] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0219] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0220] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0221] Table: Test results of hernia repair patches prepared with polybutylene terephthalate (PET-butylene adipate):

[0222]

[0223] (V) 4-5: Preparation of a three-layer hernia repair patch using polyvinyl alcohol biodegradable material

[0224] (1) Dissolving polyvinyl alcohol material: Dissolve polyvinyl alcohol material in DME solvent to prepare 100 mL of polyvinyl alcohol solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0225] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyvinyl alcohol material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0226] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polyvinyl alcohol material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0227] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyvinyl alcohol material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0228] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0229] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0230] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0231] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0232] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0233] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0234] Table: Test results of hernia repair patches prepared using polyvinyl alcohol:

[0235]

[0236]

[0237] (vi) 4-6: Preparation of a three-layer hernia repair patch using polycarbonate biodegradable material

[0238] (1) Dissolving polycarbonate material: Dissolve the polycarbonate material in DME solvent to prepare 100 mL of polycarbonate solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0239] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polycarbonate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0240] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polycarbonate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0241] (4) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polycarbonate material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0242] (5) Preparation of inner hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0243] (6) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0244] (7) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes.

[0245] During the settling process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0246] (8) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0247] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0248] Table: Test results of hernia repair patches prepared using polycarbonate materials:

[0249]

[0250] Example 5: Preparation of a single-layer hernia repair patch using polyurethane biodegradable material (with different concentrations of non-alcohol polar solvent).

[0251] (1) Solution preparation: Dissolve the polyurethane biodegradable biomaterial in the tetrahydrofuran solvents shown in the table below to prepare 100 mL of polyurethane solutions with concentrations of 5% (w / v), 10% (w / v), 15% (w / v), and 20% (w / v), respectively.

[0252] Then add 25% (w / v) sodium chloride particles that have been ground and sieved, with a particle size of 25 μm, and stir until the sodium chloride particles are evenly distributed to obtain the tableting solution.

[0253] (2) Slide preparation: The slide preparation solution is evenly coated on the surface of a smooth slide preparation fixture and left to stand.

[0254] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0255] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0256] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0257] Table: Comparative experimental results of different solvent concentrations:

[0258]

[0259]

[0260] Example 6: Preparation of a single-layer hernia repair patch using polyurethane biodegradable material (with different porogen concentrations)

[0261] (1) Solution preparation: The polyurethane biodegradable biomaterials were dissolved in the tetrahydrofuran solvents shown in the table below to prepare 100 mL of polyurethane solution with a concentration of 35% (w / v).

[0262] Then add ground and sieved sodium chloride particles with concentrations of 0% (w / v), 10% (w / v), 40% (w / v), and 60% (w / v), with a particle size of 25μm. Stir until the sodium chloride particles are evenly distributed to prepare various tube-making solutions for making multiple hernia repair patches.

[0263] (2) Slide preparation: The slide preparation solution is evenly coated on the surface of a smooth slide preparation fixture and left to stand.

[0264] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0265] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0266] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0267] Table: Comparative experimental results of different porogen concentrations:

[0268]

[0269]

[0270] Example 7: A single-layer hernia repair patch was prepared using a biodegradable polyurethane material.

[0271] (1) Solution preparation: Dissolve the polyurethane biodegradable biomaterial in the tetrahydrofuran solvent shown in the table below to prepare 100 mL of polyurethane solution with a concentration of 35% (w / v).

[0272] Then add 25% (w / v) sodium chloride particles that have been ground and sieved, with particle sizes controlled at 1-10 μm, 10-50 μm, 50-100 μm, and 100-200 μm. Stir until the sodium chloride particles are evenly distributed to prepare various tube-making solutions for making multiple hernia repair patches.

[0273] (2) Slide preparation: The slide preparation solution is evenly coated on the surface of a smooth slide preparation fixture and left to stand.

[0274] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0275] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0276] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0277] Table: Comparative test results of different porogen particle sizes:

[0278]

[0279]

[0280] Example 8: Preparation of a single-layer hernia repair patch using polyurethane biodegradable material

[0281] (1) Solution preparation: Dissolve the polyurethane biodegradable biomaterial in the tetrahydrofuran solvent shown in the table below to prepare 100 mL of polyurethane solutions with concentrations of 35% (w / v), 35% (w / v), 35% (w / v), 35% (w / v), and 35% (w / v), respectively.

[0282] Then add 25% (w / v) sodium chloride particles that have been ground and sieved, with a particle size controlled at 25 μm. Stir until the sodium chloride particles are evenly distributed to prepare various tube-making solutions for making multiple hernia repair patches.

[0283] (2) Patch preparation: The patch preparation solutions of different concentrations are uniformly coated on the surface of a smooth patch preparation fixture in sequence, and left to stand to obtain multiple single-layer hernia repair patches of different thicknesses.

[0284] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0285] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0286] The hernia repair patch prepared in this embodiment was subjected to performance testing, and the specific testing method was the same as in Example 1. The specific test results are shown in the table below:

[0287] Table: Comparative test results of different thicknesses:

[0288]

[0289] Example 9

[0290] To illustrate the significant effect of the structure of the hernia repair patch of the present invention on promoting rapid tissue growth, the following embodiments are provided, along with comparative experiments:

[0291] (I) 9-1: Preparation of a single-layer sheet structure, a non-porous hernia repair patch:

[0292] (1) Solution preparation: Polyurethane biodegradable biomaterials were dissolved in tetrahydrofuran solvent to prepare 100 mL of polyurethane solution with a concentration of 35% (w / v).

[0293] (2) Slide preparation: The above-mentioned slide preparation solutions of different concentrations are uniformly coated on the surface of a smooth slide preparation fixture and left to stand.

[0294] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0295] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0296] (II) 9-2: Preparation of a single-layer sheet structure, a perforated hernia repair patch:

[0297] (1) Solution preparation: Polyurethane biodegradable biomaterials were dissolved in tetrahydrofuran solvent to prepare 100 mL of polyurethane solution with a concentration of 35% (w / v).

[0298] Next, add 25% (w / v) sodium chloride particles that have been ground and sieved, with a particle size controlled at 25 μm. Stir until the sodium chloride particles are evenly distributed to prepare the tableting solution.

[0299] (2) Patch preparation: The patch preparation solutions of different concentrations are uniformly coated on the surface of a smooth patch preparation fixture in sequence, and left to stand to obtain multiple single-layer hernia repair patches of different thicknesses.

[0300] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0301] (3) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0302] (III) 9-3: Preparation of a hernia repair patch with a double-layer structure, the outer layer having large pores and the inner layer having small pores:

[0303] (1) Dissolving polyurethane material: Dissolve polyurethane material in tetrahydrofuran (THF) to prepare 100 mL each of 35% (w / v) and 35% (w / v) polyurethane solutions.

[0304] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0305] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 150 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0306] (4) Preparation of microporous inner layer hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0307] (5) Preparation of macroporous outer layer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth patch preparation jig surface, and let it stand for 30 minutes.

[0308] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0309] (6) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0310] (iv) 9-4: Preparation of a three-layer patch structure, with a large pore in the outermost layer, and pores in the outer and inner layers:

[0311] (1) Dissolving polyurethane material: Dissolve polyurethane material in tetrahydrofuran (THF) to prepare 100 mL of polyurethane solutions with concentrations of 35% (w / v), 35% (w / v), and 35% (w / v).

[0312] (2) Preparation of solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25 μm. The concentration of sodium chloride is 25% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 1.

[0313] (3) Preparation of solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100 μm. The concentration of sodium chloride is 150% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 2.

[0314] (3) Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The concentration of sodium chloride is 250% (w / v). Add it to the prepared 35% polyurethane material solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3.

[0315] (4) Preparation of microporous inner layer hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes.

[0316] (5) Preparation of the hernia repair patch in the intermediate layer: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth surface of the patch preparation jig, and let it stand for 30 minutes.

[0317] (6) Preparation of macroporous outer layer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 3 evenly on the smooth patch preparation jig surface, and let it stand for 30 minutes.

[0318] During the settling process, the tetrahydrofuran solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape.

[0319] (7) Demolding, solvent removal, drying, and post-treatment steps: same as in Example 1.

[0320] The hernia repair patches prepared according to methods 9-1, 9-2, 9-3, and 9-4 were subjected to efficacy tests, as detailed below:

[0321] In the same formulation, the thicker the hernia repair patch, the better its mechanical properties. At the same thickness, the salt-free hernia repair patch exhibits the best mechanical properties. Lower salt content results in lower porosity and smaller particle size, leading to better mechanical properties; higher salt content results in higher porosity and larger particle size, leading to poorer mechanical properties. A thicker layer with lower salt content and smaller salt particles generally exhibits better mechanical properties and lower porosity.

[0322] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing a hernia repair patch, characterized in that, The preparation method of the hernia repair patch includes the following steps: (1) Dissolve the biodegradable biomaterial in a non-alcoholic polar solvent to prepare a solution A with a concentration of 35% (w / v); (2) Then add the porogen and stir until the porogen is evenly distributed to prepare solution 1, solution 2 and solution 3, as follows: Preparation of Solution 1: Grind sodium chloride and sieve out sodium chloride particles with a size of 25μm. The sodium chloride concentration is 25% (w / v). Add it to the prepared 35% biodegradable biomaterial solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare Solution 1. Preparation of Solution 2: Grind sodium chloride and sieve out sodium chloride particles with a size of 100μm. The sodium chloride concentration is 150% (w / v). Add it to the prepared 35% biodegradable biomaterial solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare Solution 2. Preparation of solution 3: Grind sodium chloride and sieve out sodium chloride particles with a size of 250 μm. The sodium chloride concentration is 250% (w / v). Add it to the prepared 35% biodegradable biomaterial solution and stir magnetically until the sodium chloride is evenly dispersed in the solution to prepare solution 3. (3) Preparation of inner layer hernia repair patch: Coat the patch preparation solution 1 evenly on the surface of the smooth patch preparation fixture and let it stand for 30 minutes; (4) Preparation of outer hernia repair patch: Place the jig horizontally after standing for 30 minutes in the above steps, coat the patch preparation solution 2 evenly on the smooth patch preparation jig surface, and let it stand for 30 minutes; (5) Preparation of the outermost hernia repair patch: Place the fixture horizontally after standing for 30 minutes in the above steps, and evenly coat the patch preparation solution 3 on the smooth surface of the patch preparation fixture, and let it stand for 30 minutes; During the standing process, the solvent in the preparation solution adhering to the surface of the preparation fixture continuously evaporates, and the initial hernia repair patch gradually takes shape. (6) Perform the steps of demolding, solvent removal, drying, and post-treatment in sequence to obtain a three-layer hernia repair patch; The three-layer hernia repair patch comprises an inner layer, an outer layer, and an outermost layer; the outermost layer of the three-layer hernia repair patch has a thickness of 0.05-1.4 mm and a pore size of 300-500 μm; the outer layer has a thickness of 0.05-1.4 mm and a pore size of 50-300 μm; and the inner layer has a thickness of 0.05-1.4 mm and a pore size of 0-50 μm. The biodegradable biomaterial is one of the following: polyurethane, polylactic acid, polycaprolactone, polyhydroxyalkanoates, polybutylene succinate, polybutylene terephthalate, polyvinyl alcohol, and polycarbonate.

2. The method for preparing the hernia repair patch according to claim 1, characterized in that, The outermost layer of the three-layer hernia repair patch has a growth-guiding structure.

3. The method for preparing the hernia repair patch according to claim 2, characterized in that, The guide growth structure is a groove structure with the outer edge pointing towards the center.

4. The method for preparing the hernia repair patch according to claim 1, characterized in that, The hernia repair patch can be any one of the following shapes: round, oval, square, rectangular, hexagonal, or octagonal.

5. The method for preparing the hernia repair patch according to claim 1, characterized in that, The non-alcoholic polar solvent includes at least one of tetrahydrofuran, dichloroethane, dimethyl ether, or N,N-dimethylformamide.

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