Bionic textile-based meniscus stent and preparation method thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a bionic textile-based meniscus stent and a preparation method thereof.The bionic textile-based meniscus stent comprises hydrogel and a fiber skeleton compounded with the hydrogel, and the fiber skeleton comprises an upper bottom face fabric, a lower bottom face fabric, spacer wires and aggregates; the upper bottom surface fabric, the lower bottom surface fabric and the spacer yarns jointly form a spacer fabric, the spacer fabric is semilunar, and the thickness of the spacer fabric is gradually increased from the inner periphery to the outer periphery; the aggregate is composed of a plurality of fiber bundles which are bent into an arc shape and have the same bending direction, the aggregate is semilunar, and the arrangement density of the fiber bundles in the section is gradually increased from inside to outside; the preparation method comprises the following steps: firstly, constructing an upper bottom surface fabric and a lower bottom surface fabric, then preparing an aggregate supported by the supporting rods, then combining the upper bottom surface fabric, the lower bottom surface fabric and the aggregate supported by the supporting rods, then inserting spacing filaments, and pulling away the supporting rods to obtain a fiber skeleton; and putting the fiber skeleton, the hydrogel base material and water into a meniscus bracket mold, heating, pre-cooling, freeze-drying and annealing.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and relates to a bionic textile-based meniscus scaffold and a preparation method thereof. Background Art

[0002] The meniscus is a crescent-shaped fibrocartilaginous structure located between the femur and the tibia (as shown in (a) below), which bears more than 70% of the human body weight and is crucial for maintaining knee joint function. However, meniscus injuries are common, with the incidence rate increasing year by year and showing a trend of getting younger. Due to its difficult endogenous healing, meniscectomy is widely used. However, it will exacerbate joint damage after surgery and may ultimately require total knee replacement. Figure 1

[0003] To solve this problem, artificial meniscus transplantation has been applied clinically. However, allogeneic grafts have defects such as insufficient sources, and existing synthetic artificial meniscus scaffolds have high clinical failure rates due to structural homogenization and still cause problems such as cartilage degeneration after implantation. Research shows that abnormal increase in contact stress after meniscus injury and transplantation is the key cause of cartilage degeneration and osteoarthritis. In the joint cavity microenvironment, the natural meniscus exhibits significant mechanical anisotropy by virtue of its special collagen fiber arrangement and inter-fiber interpenetration and linkage, and can transfer axial compressive stress to circumferential tensile strain to achieve stress dispersion. Specifically: the circumferential collagen fiber bundles in the meniscus are fixed to the tibial plateau. When subjected to compressive force from the femur, the natural meniscus with a low compressive modulus begins to deform. Through the shear stretching of the anisotropic collagen fiber framework and the interaction of proteoglycans, the axial compressive stress is transferred to the high-load circumferential tensile strain, and stress dispersion and transfer are achieved through mechanical transduction to limit further compression of the meniscus and at the same time reduce the peak and average pressures on the medial tibial cartilage (as shown in (b) below). Figure 1

[0004] ​​To reproduce this biomechanical function, researchers have carried out research on the construction of anisotropic meniscus scaffolds by means of technologies such as 3D printing, melt electrowriting, and electrospinning, and some have also added functional molecules or seed cells. For example, in the literature (3DPrinted High-Strength Supramolecular Polymer Hydrogel‐Cushioned Radially andCircumferentially Oriented Meniscus Substitute. Advanced FunctionalMaterials. 2022, 32: 2200360.), an artificial meniscus with a low compressive modulus and a high tensile modulus was obtained by constructing an axially and circumferentially oriented PCL fiber skeleton through 3D printing technology and compounding it with poly-N-acryloylglycinamide hydrogel to optimize the compressive resistance. In the literature (Bioprinting of Structurally Organized Meniscal Tissuewithin Anisotropic Melt Electrowritten Scaffolds. Acta Biomaterialia. 2023,158: 216-227.), an anisotropic scaffold with slender pores was constructed by melt electrowriting, and a meniscus scaffold was constructed by the method of layer-by-layer stacking. In addition, in the literature (Harnessing Electrospun Nanofibers to RecapitulateHierarchical Fibrous Structures of Meniscus. Journal of Biomedical MaterialsResearch Part B Applied Biomaterials. 2021, 109(2): 201-213.), a heterogeneous ultrastructured nanofiber scaffold was constructed by electrospinning, in which the fiber bundles formed by nano-yarns were arranged along the circumference of the scaffold, making the scaffold exhibit mechanical anisotropy. However, the existing scaffolds generally adopt a stacked structure, lacking the interpenetration and linkage of fibers in three-dimensional space, resulting in the inability to transduce axial stress to the circumferential direction, generating abnormal mechanical stimuli, and it is difficult to effectively regulate the mechanical microenvironment, and the long-term cartilage protection effect and clinical transformation potential are difficult to guarantee.

[0005] Therefore, the development of an artificial meniscus scaffold that can effectively achieve the transduction of axial stress to the circumferential direction plays an important role in promoting the development of the field of knee injury repair. Summary of the Invention

[0006] The object of the present invention is to solve the problems existing in the prior art and provide a bionic textile-based meniscus scaffold and a preparation method thereof.

[0007] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] A bionic textile-based meniscus scaffold includes a hydrogel and a fiber skeleton compounded therewith;

[0009] The fiber skeleton includes an upper bottom fabric, a lower bottom fabric, spacer filaments and an aggregate;

[0010] The upper bottom fabric, the lower bottom fabric and the spacer filaments together form a spacer fabric, the spacer fabric is in a semi-circular shape, and the thickness increases from the inner circumference to the outer circumference;

[0011] The aggregate is composed of multiple fiber bundles bent into an arc shape and having the same bending direction, the aggregate is in a semi-circular shape, and the arrangement density of the fiber bundles in the cross section increases from the inside to the outside;

[0012] The spacer fabric and the aggregate have the same bending direction, the aggregate is divided into three length segments, the middle length segment is located between the upper bottom fabric and the lower bottom fabric and is interspersed with spacer filaments;

[0013] The bionic textile-based meniscus scaffold is designed as an imitation meniscus structure as a whole, and can simulate the mechanical response characteristics of the natural meniscus, that is, it can transfer the axial compression stress to the circumferential tensile strain to achieve stress dispersion. The upper bottom fabric and the lower bottom fabric simulate the dense collagen fiber layer on the surface of the natural meniscus, the spacer filaments simulate the tie fibers in the natural meniscus, the aggregate simulates the circumferential collagen fiber bundles inside the natural meniscus, and the hydrogel simulates the hydrogel in the natural meniscus.

[0014] As a preferred technical solution:

[0015] For the bionic textile-based meniscus scaffold as described above, the two end length segments of the aggregate are located outside the spacer fabric, and the two end length segments serve as root structures and can be fixed to the tibial plateau through bone tunnels. The lengths of the two end length segments are 10-100 mm. This design avoids using sutures to suture the scaffold to the joint capsule, thereby preventing the generation of stress concentration at the suture and avoiding the tearing of the meniscus scaffold caused by suture shear.

[0016] For the bionic textile-based meniscus scaffold as described above, both the upper bottom fabric and the lower bottom fabric are warp knitted fabrics, made of medical-grade ultra-high molecular weight polyethylene fiber bundles with a diameter of 10-20 μm, the surface density is ≥70 roots / cm², and the tensile modulus is ≥200 MPa.

[0017] A bionic textile-based meniscus scaffold as described above, wherein the spacer filaments are medical-grade polyurethane fibers with a diameter of 1-10 μm, the tensile modulus of the spacer filaments is 10-300 MPa, and the spacer filaments are of C-type, V-type, X-type or IXI-type.

[0018] A bionic textile-based meniscus scaffold as described above, wherein the inner peripheral thickness of the spacer fabric is 1-2 mm, the outer peripheral thickness is 3-5 mm, the circumferential length is 20-80 mm, and the radial width is 5-15 mm, and it can be customized to the same size as the meniscus.

[0019] A bionic textile-based meniscus scaffold as described above, wherein the fiber bundles are medical-grade ultra-high molecular weight polyethylene fiber bundles with a diameter of 20-30 μm; the arrangement density of the fiber bundles in the cross-section of the aggregate increases from <40 fibers / cm² to >70 fibers / cm² from the inside to the outside.

[0020] A bionic textile-based meniscus scaffold as described above, wherein the water content of the hydrogel is ≥70 wt%, the compression modulus is 0.1-1 MPa, the energy dissipation rate is 60-80%, and the friction coefficient <0.1, which is similar to that of cartilage.

[0021] A bionic textile-based meniscus scaffold as described in any one of the above, wherein the circumferential tensile modulus of the bionic textile-based meniscus scaffold is 200-300 MPa, and the radial tensile modulus is 1-10 MPa, indicating its anisotropy; the radial mechanics is provided by the hydrogel, spacer filaments, upper bottom fabric and lower bottom fabric; the low radial tensile modulus allows deformation to trigger stress transduction;

[0022] The outer peripheral tensile modulus of the bionic textile-based meniscus scaffold is 200-300 MPa, and the inner peripheral tensile modulus is 10-100 MPa, indicating that its inner periphery is soft and the outer periphery is hard, simulating the characteristics of the natural meniscus and providing better buffering;

[0023] The circumferential stress of the bionic textile-based meniscus scaffold >200 MPa; the aggregate is directly connected to the tibial plateau (fiber bundles are directly connected), simulating the natural meniscus fiber-bone integration mechanism, greatly improving the fixation strength (i.e., circumferential stress), and its ability to resist femoral extrusion far exceeds suture fixation;

[0024] After fixing the bionic textile-based meniscus scaffold in a simulated physiological state, its compression modulus was measured by a restricted compression test. The compression modulus was ≤0.1MPa when the strain was 10%. After the strain was greater than 10%, the compression modulus increased with the increase of the strain. The compression modulus was >200MPa when the strain was 80%. The coupling coefficient was 30%-60% when the strain was 10%, 61%-80% when the strain was 30%, and 81%-95% when the strain was 80%, that is, more than 80% of the compressive stress was converted into circumferential tension. It can be seen that it has efficient stress transduction characteristics and can convert the compressive force into the tensile force of the fiber. Specifically, the aggregate runs through the entire scaffold, and when it is stressed, it can disperse the stress more effectively by stretching, achieve high mechanical bearing, and will not produce the problem of stress concentration in the suture part such as suture fixation.

[0025] The present invention also provides a method for preparing the bionic textile-based meniscus scaffold as described above, comprising the following steps:

[0026] (a) The upper base fabric and the lower base fabric are constructed by using a warp knitting machine, both of which are half-moon shaped;

[0027] (b) preparing an aggregate supported by support rods, wherein the support rods are used to control the arrangement density of fiber bundles in the aggregate;

[0028] (c) adjusting the upper bottom fabric and the lower bottom fabric to have the same bending direction and the spacing increasing from the inside to the outside, inserting the assembly supported by the support rod between the upper bottom fabric and the lower bottom fabric, the bending direction of the assembly supported by the support rod being the same as the bending direction of the upper bottom fabric and the lower bottom fabric, and the two ends of the assembly supported by the support rod being exposed from between the upper bottom fabric and the lower bottom fabric;

[0029] (d) after the spacer yarn is reciprocatedly inserted from the upper bottom fabric and the lower bottom fabric through the loop structure through the aggregate supported by the support rod, the support rod is withdrawn to obtain a fiber skeleton;

[0030] (e) The fiber skeleton, hydrogel matrix and water are placed together in a meniscus scaffold mold, first heated until the hydrogel matrix is ​​completely dissolved, and then pre-cooled, freeze-dried and annealed in sequence.

[0031] The bionic textile-based meniscus scaffold of the present invention has a three-dimensional fiber and hydrogel interlocking structure, which consists of four parts. The upper and lower bottom fabrics are like two stable foundations. Through tight weaving, they provide strong tensile shear force for the scaffold. The aggregate is like the steel bars in a building, capable of withstanding large circumferential stresses and endowing the scaffold with high load-bearing capacity. The spacer filaments start from the upper surface of the fabric, pass through the aggregate to reach the lower surface, and then return from the lower surface to the upper surface, connecting all parts in series like threading a needle. Its function is the same as that of the tie elastic fibers of the natural meniscus, realizing the overall interpenetrating linkage of the fiber scaffold. Hydrogel is poured into it, similar to cement reinforcing a building, further integrating the components of the scaffold and providing a flexible buffering function and a surface with a low friction coefficient for the scaffold. This structural design enables the scaffold to achieve the same biomechanical functions as the natural meniscus: showing flexibility in the initial stage of force application and then providing high load-bearing capacity, effectively converting the applied compressive stress into tensile stress of the lower fibers.

[0032] Advantages:

[0033] (1) The present invention adopts a textile method to construct a three-dimensional anisotropic skeleton with a root structure. This unique structure endows the scaffold with two major advantages: in the initial stage of femoral compressive force, the scaffold wraps the femur by virtue of its low modulus property, effectively avoiding stress concentration; at the same time, it can quickly and efficiently transduce the compressive force to the circumferential direction and achieve high load-bearing through the stretching of the aggregate. This can not only reduce mechanical stimulation and protect cartilage tissue but also solve the problems of easy cartilage wear and osteoarthritis caused by current meniscus scaffold implantation.

[0034] (2) The forming method of the bionic textile-based meniscus scaffold of the present invention is simple, the composition is single, it has good biocompatibility and stability, and shows outstanding clinical transformation potential.

[0035] (3) The bionic textile-based meniscus scaffold of the present invention has high strength, excellent tear resistance, and good durability, and can maintain good use effects for a long time. Description of the Drawings

[0036] Figure 1 It is a schematic diagram of the meniscus structure; in the figure, a is the anatomical structure diagram of the knee joint meniscus, and b is the stress transduction characteristic diagram of the natural meniscus under axial extrusion;

[0037] Figure 2 It is a schematic diagram of the preparation process of the bionic textile-based meniscus scaffold of the present invention; in the figure, a is the schematic diagram of the constructed upper bottom fabric and lower bottom fabric, b is the schematic diagram of inserting the aggregate supported by the support rod between the upper bottom fabric and the lower bottom fabric, c is the schematic diagram of the spacer filaments reciprocally penetrating through the upper bottom fabric and the lower bottom fabric, and d is the schematic diagram after the fiber skeleton and the hydrogel substrate are compounded;

[0038] Figure 3Schematic diagram of the cross-section of the aggregate of the present invention;

[0039] Figure 4 Different types of spacer filaments of the present invention; in the figure, e is a C-type spacer filament, f is a V-type spacer filament, g is an X-type spacer filament, and h is an IXI-type spacer filament;

[0040] Figure 5 Schematic diagram of the meniscus scaffold mold of the present invention;

[0041] Figure 6 Schematic diagram of the circumferential and radial tensile moduli of the bionic textile-based meniscus scaffold prepared in Example 4 of the present invention;

[0042] Figure 7 Schematic diagram of the tensile moduli of the outer and inner circumferences of the bionic textile-based meniscus scaffold prepared in Example 4 of the present invention;

[0043] Figure 8 Schematic diagram of the circumferential stress of the bionic textile-based meniscus scaffold prepared in Example 4 of the present invention and a commercial scaffold;

[0044] Figure 9 Schematic diagram of the tensile moduli of the bionic textile-based meniscus scaffold prepared in Example 4 of the present invention under different strains;

[0045] Figure 10 Schematic diagram of the cartilage degeneration scores after 6 months of animal experiments using the bionic textile-based meniscus scaffold prepared in Example 4 of the present invention, the commercial Actifit® control group, and under different conditions; in the figure, the sham operation group is the cartilage degeneration score after only exposing the joint cavity without treating the meniscus in the joint cavity, the resection group is the cartilage degeneration score after completely removing the meniscus in the joint cavity and not filling the meniscus, the Actifit® control group is the cartilage degeneration score after completely removing the meniscus and filling it with the commercial Actifit® (manufactured by Dutch company Orteq), and the bionic textile-based meniscus scaffold is the cartilage degeneration score after completely removing the meniscus and filling it with the bionic textile-based meniscus scaffold prepared in Example 4;

[0046] Among them, 1-1 is the upper bottom fabric, 1-2 is the aggregate, 1-3 is the root structure, 1-4 is the spacer filament, 1-5 is the hydrogel, 2 is the support rod, 3 is the outer peripheral aggregate, and 4 is the inner peripheral aggregate. Detailed implementation method

[0047] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.

[0048] To ensure that the properties of the substances used in each embodiment and comparative example are fully disclosed, the manufacturers and grades of the substances are specified. Products of other manufacturers and grades that meet the limitations of the present invention are also feasible.

[0049] The test methods for the relevant performance indicators in the following embodiments and comparative examples are as follows:

[0050] Water content of hydrogel: The hydrogels in each embodiment were used as samples respectively, and then the water content was determined with reference to the standard of GB / T 6284-2006.

[0051] Compression modulus of hydrogel: The hydrogels in each embodiment were used as samples respectively, and then the compression modulus was determined with reference to the standard of GB / T 1041-2008.

[0052] Energy dissipation rate of hydrogel: The hydrogels in each embodiment were used as samples respectively, and then the energy dissipation rate was determined with reference to the ASTM D4065 cyclic compression test.

[0053] Coefficient of friction of hydrogel: The hydrogels in each embodiment were used as samples respectively, and then the coefficient of friction was determined with reference to the standard of ASTM D1894-2014.

[0054] Tensile modulus of polyurethane fiber: The spacer filaments in each embodiment were used as samples respectively, and then the tensile modulus was determined with reference to the standard of GB / T3923.1-2013.

[0055] Tensile modulus of the upper and lower bottom fabrics: The upper and lower bottom fabrics prepared in each embodiment were used as samples respectively, and then the samples were tested with reference to the standard of GB / T 3923.1-2013, and then the tensile modulus of the samples was calculated according to the obtained stress-strain curve.

[0056] Circumferential tensile modulus and radial tensile modulus: The bionic textile-based meniscus scaffolds prepared in each embodiment were used as samples respectively, and then the samples were tested with reference to the standard of GB / T 3923.1-2013, and then the circumferential tensile modulus and radial tensile modulus of the samples were calculated according to the obtained stress-strain curve.

[0057] Peripheral tensile modulus and inner peripheral tensile modulus: First, cut the inner and outer peripheries of the bionic textile-based meniscus scaffolds prepared in each example and use them as samples respectively. Then, refer to the standard of GB / T 3923.1-2013 to test the samples, and calculate the peripheral tensile modulus and inner peripheral tensile modulus of the samples according to the obtained stress-strain curves.

[0058] Circumferential stress: Take the bionic textile-based meniscus scaffolds prepared in each example as samples respectively. Then, use a customized meniscus scaffold fixing device to conduct extrusion tests under the condition of artificial joint fluid with quasi-physiological fixation, measure the maximum extrusion force, and finally calculate the circumferential stress according to the test data. The calculation formula is: circumferential stress = peak force / sample cross-sectional area; where the loading rate is 5 mm / min.

[0059] Compression modulus: Take the bionic textile-based meniscus scaffolds prepared in each example as samples respectively. Then, refer to the limited compression test clause in ASTM F2346 and improve it in combination with ISO 604. Restrict the radial expansion of the specimen through a fixture, measure the stress-strain curve, and then calculate the compression modulus of the sample at 10% and 80% strain respectively according to the obtained curve. The compression modulus at 10% strain refers to the linear regression slope of the stress-strain curve in the 5%-10% strain interval, and the compression modulus at 80% strain refers to the tangent modulus of the stress-strain curve in the 75%-80% strain interval.

[0060] Compression-tension coupling coefficient: Take the bionic textile-based meniscus scaffolds prepared in each example as samples respectively. Then, refer to the ISO 10328 standard to synchronously measure the axial compression stress increment (Δσ_compression) and circumferential tensile stress increment (Δσ_tension) through a customized biaxial loading device. Finally, calculate the coupling coefficient η of the sample at 10%, 30%, and 80% strain respectively according to the measurement results to characterize the stress transduction efficiency. The calculation formula of the coupling coefficient is: η = Δσ_tension / Δσ_compression × 100%.

[0061] Example 1

[0062] A preparation method of a bionic textile-based meniscus scaffold is as Figure 2 shown, and the steps are as follows:

[0063] (1) Preparation of raw materials;

[0064] Hydrogel substrate: PVA with a molecular weight of 145000 Da;

[0065] Medical-grade ultra-high molecular weight polyethylene fiber bundle: The manufacturer is Honeywell in the United States, and the grade is Spectra®1000;

[0066] Spacer yarn: Medical-grade polyurethane fiber with a tensile modulus of 10 MPa;

[0067] (2) First, design the surface and bottom base fabric tissue structures as warp plush tissues through warp knitting CAD (WKCAD) drawing software. Then, use medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 10 μm) to construct the upper bottom fabric 1-1 and the lower bottom fabric through the warp knitting machine. Both are in a semi-circular shape;

[0068] The surface density of the upper bottom fabric 1-1 is 71 roots / cm², and the tensile modulus is 200 MPa; the surface density of the lower bottom fabric is 71 roots / cm², and the tensile modulus is 200 MPa;

[0069] (3) Place multiple medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 20 μm) in the mold. The shape of the inner cavity of the mold is the same as that of the meniscus. An array of positioning columns is fixed in the inner cavity of the mold. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc under the guidance of the positioning column array and has the same bending direction. Then, insert multiple support rods into the aggregate composed of all medical-grade ultra-high molecular weight polyethylene fiber bundles, so that the arrangement density of the fiber bundles in the cross-section of the aggregate increases from 10 roots / cm² to 71 roots / cm² from the inside to the outside. Then, place the mold in an oven, preheat it to 120 °C, keep it warm for 5 minutes, cool it to 80 °C at a cooling rate of 2 °C / min, and then rapidly cool it to 25 °C by spraying deionized water and demold it to obtain an aggregate supported by support rods;

[0070] (4) Adjust the upper bottom fabric 1-1 and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the aggregate supported by the support rods between the upper bottom fabric 1-1 and the lower bottom fabric. The bending direction of the aggregate supported by the support rods is the same as that of the upper bottom fabric 1-1 and the lower bottom fabric. Both ends of the aggregate supported by the support rods protrude from between the upper bottom fabric 1-1 and the lower bottom fabric, and the protruding length is 10 mm;

[0071] (5) Pass the spacer yarn 1-4 (with a customized diameter of 1 μm) through the upper bottom fabric 1-1 and the lower bottom fabric in a reciprocating manner through the loop structure and penetrate the aggregate supported by the support rods, and then remove the support rods to obtain a fiber skeleton;

[0072] (6) Put the fiber skeleton, the hydrogel substrate, and water into the meniscus bracket mold as shown in Figure 5 Heat it to 120 °C through a high-pressure steam pot to completely dissolve the hydrogel substrate, and then perform pre-cooling, freeze-drying, and annealing in sequence to obtain a bionic textile-based meniscus bracket; among them, the freeze-drying time is 16 h, the annealing temperature is 60 °C, and the annealing time is 0.5 h.

[0073] The finally obtained bionic textile-based meniscus scaffold (as shown in Figure 2 , Figure 3 ) consists of hydrogels 1-5 and a fiber skeleton composite with them;

[0074] The water content of hydrogels 1-5 is 80 wt%, the compression modulus is 0.1 MPa, the energy dissipation rate is 80%, and the friction coefficient is 0.05;

[0075] The fiber skeleton consists of an upper bottom fabric 1-1, a lower bottom fabric, spacer filaments 1-4 and an aggregate 1-2;

[0076] The upper bottom fabric 1-1, the lower bottom fabric and the spacer filaments 1-4 together form a spacer fabric. The spacer fabric is semi-circular, and its thickness increases from the inner circumference to the outer circumference. The inner circumference thickness of the spacer fabric is 1 mm, the outer circumference thickness is 3 mm, the circumferential length is 20 mm, and the radial width is 5 mm;

[0077] As shown in Figure 4 e in, the spacer filaments are C-shaped;

[0078] The circumferential tensile modulus of the bionic textile-based meniscus scaffold is 200 MPa, the radial tensile modulus is 1 MPa, the outer circumferential tensile modulus is 200 MPa, the inner circumferential tensile modulus is 10 MPa, and the circumferential stress is 201 MPa;

[0079] After fixing the bionic textile-based meniscus scaffold under simulated physiological conditions, its compression modulus is measured by a confined compression test. The compression modulus at a strain of 10% is 0.05 MPa. After the strain is greater than 10%, the compression modulus increases with the increase of the strain. The compression modulus at a strain of 80% is 201 MPa. The compression-tension coupling coefficient at a strain of 10% is 30%, the compression-tension coupling coefficient at a strain of 30% is 61%, and the compression-tension coupling coefficient at a strain of 80% is 81%.

[0080] Example 2

[0081] A preparation method of a bionic textile-based meniscus scaffold is as follows:

[0082] (1) Preparation of raw materials;

[0083] Hydrogel substrate: PVA with a molecular weight of 145000 Da;

[0084] Medical-grade ultra-high molecular weight polyethylene fiber bundle: The manufacturer is Jiangsu Jiujijiu Science and Technology Co., Ltd., and the brand is JJF®-UHMWPE-MD01;

[0085] Spacer filaments: Medical-grade polyurethane fibers with a tensile modulus of 20 MPa;

[0086] (2)First, use warp knitting CAD (WKCAD) drawing software to design the basic fabric structures of the top layer and the bottom layer as warp plush structures. Then, use medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 12 μm) to construct the upper bottom fabric and the lower bottom fabric through a warp knitting machine. Both are in a semi-circular shape;

[0087] The surface density of the upper bottom fabric is 71 roots / cm², and the tensile modulus is 200 MPa; the surface density of the lower bottom fabric is 71 roots / cm², and the tensile modulus is 200 MPa;

[0088] (3)Place multiple medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 23 μm) in a mold. The shape of the inner cavity of the mold is the same as that of the meniscus. An array of positioning columns is fixed in the inner cavity of the mold. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc under the guidance of the positioning column array and in the same bending direction. Then, insert multiple support rods into the aggregate composed of all medical-grade ultra-high molecular weight polyethylene fiber bundles, so that the arrangement density of the fiber bundles in the cross-section of the aggregate increases from 20 roots / cm² to 80 roots / cm² from the inside to the outside. Then, place the mold in an oven, preheat it to 122 °C, keep it warm for 6 min, cool it to 80 °C at a cooling rate of 2 °C / min, and then quickly cool it to 25 °C by spraying deionized water and demold it to obtain an aggregate supported by support rods;

[0089] (4)Adjust the upper bottom fabric and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the aggregate supported by support rods between the upper bottom fabric and the lower bottom fabric. The bending direction of the aggregate supported by support rods is the same as that of the upper bottom fabric and the lower bottom fabric. The two ends of the aggregate supported by support rods protrude from between the upper bottom fabric and the lower bottom fabric, and the protruding length is 80 mm;

[0090] (5)Pass the spacer yarn (with a customized diameter of 4 μm) through the upper bottom fabric and the lower bottom fabric back and forth through the tuck stitch structure to the aggregate supported by support rods, and then pull out the support rods to obtain a fiber skeleton;

[0091] (6)Put the fiber skeleton, the hydrogel substrate, and water into a meniscus stent mold. First, heat it to 120 °C by a high-pressure steam sterilizer to completely dissolve the hydrogel substrate, and then perform pre-cooling, freeze-drying, and annealing in sequence to obtain a bionic textile-based meniscus stent; among them, the freeze-drying time is 24 h, the annealing temperature is 90 °C, and the annealing time is 1 h.

[0092] The finally prepared bionic textile-based meniscus stent is composed of a hydrogel and a fiber skeleton compounded with it;

[0093] The water content of the hydrogel is 80 wt%, the compression modulus is 0.2 MPa, the energy dissipation rate is 75%, and the friction coefficient is 0.09;

[0094] The fiber skeleton is composed of an upper bottom fabric, a lower bottom fabric, spacer filaments, and an assembly;

[0095] The upper bottom fabric, the lower bottom fabric, and the spacer filaments together form a spacer fabric. The spacer fabric is in a semi-circular shape, and its thickness increases from the inner circumference to the outer circumference. The inner circumference thickness of the spacer fabric is 1.1 mm, the outer circumference thickness is 4 mm, the circumferential length is 60 mm, and the radial width is 10 mm;

[0096] As Figure 4 shown in f, the spacer filaments are V-shaped;

[0097] The circumferential tensile modulus of the bionic textile-based meniscus stent is 250 MPa, the radial tensile modulus is 2 MPa, the outer circumferential tensile modulus is 210 MPa, the inner circumferential tensile modulus is 20 MPa, and the circumferential stress is 210 MPa;

[0098] After fixing the bionic textile-based meniscus stent in a simulated physiological state, its compression modulus is measured through a confined compression test. The compression modulus at a strain of 10% is 0.06 MPa. After the strain is greater than 10%, the compression modulus increases with the increase of the strain. The compression modulus at a strain of 80% is 210 MPa. The compression-tension coupling coefficient at a strain of 10% is 32%, the compression-tension coupling coefficient at a strain of 30% is 65%, and the compression-tension coupling coefficient at a strain of 80% is 82%.

[0099] Example 3

[0100] A preparation method of a bionic textile-based meniscus stent is as follows:

[0101] (1) Preparation of raw materials;

[0102] Hydrogel substrate: PVA with a molecular weight of 145000 Da;

[0103] Medical-grade ultra-high molecular weight polyethylene fiber bundle: The manufacturer is DSM of the Netherlands, and the grade is Purity® UG403;

[0104] Spacer filaments: Medical-grade polyurethane fibers with a tensile modulus of 30 MPa;

[0105] (2) First, use warp knitting CAD (WKCAD) drawing software to design the surface layer and bottom layer basic fabric structures as warp plush tissues. Then, use medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 15 μm) to construct the upper bottom fabric and the lower bottom fabric through a warp knitting machine. Both are in a semi-circular shape;

[0106] The surface density of the upper bottom fabric is 75 threads / cm², and the tensile modulus is 250 MPa; the surface density of the lower bottom fabric is 75 threads / cm², and the tensile modulus is 250 MPa;

[0107] (3) Place multiple medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 26 μm) in a mold. The shape of the inner cavity of the mold is the same as that of the meniscus. A positioning post array is fixed in the inner cavity of the mold. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc under the guidance of the positioning post array and in the same bending direction. Then, insert multiple support rods into the aggregate composed of all medical-grade ultra-high molecular weight polyethylene fiber bundles, so that the arrangement density of the fiber bundles in the cross-section of the aggregate increases from 20 threads / cm² to 90 threads / cm² from the inside to the outside. Then, place the mold in an oven, preheat it to 125 °C, keep it warm for 7 minutes, cool it to 80 °C at a cooling rate of 2 °C / min, and then quickly cool it to 25 °C by spraying deionized water and demold it to obtain an aggregate supported by support rods;

[0108] (4) Adjust the upper bottom fabric and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the aggregate supported by support rods between the upper bottom fabric and the lower bottom fabric. The bending direction of the aggregate supported by support rods is the same as that of the upper bottom fabric and the lower bottom fabric. Both ends of the aggregate supported by support rods protrude from between the upper bottom fabric and the lower bottom fabric, and the protruding length is 80 mm;

[0109] (5) Pass the spacer filaments (with a customized diameter of 6 μm) through the upper bottom fabric and the lower bottom fabric in a reciprocating manner through the tuck stitch structure to the aggregate supported by support rods, and then remove the support rods to obtain a fiber skeleton;

[0110] (6) Put the fiber skeleton, the hydrogel substrate, and water into the meniscus stent mold. First, heat it to 120 °C by a high-pressure steam sterilizer to completely dissolve the hydrogel substrate, and then perform pre-cooling, freeze-drying, and annealing in sequence to obtain a bionic textile-based meniscus stent; among them, the freeze-drying time is 24 h, the annealing temperature is 90 °C, and the annealing time is 1 h.

[0111] The finally prepared bionic textile-based meniscus stent is composed of a hydrogel and a fiber skeleton composite with it;

[0112] The water content of the hydrogel is 75 wt%, the compression modulus is 0.3 MPa, the energy dissipation rate is 70%, and the friction coefficient is 0.08;

[0113] The fiber skeleton is composed of an upper bottom fabric, a lower bottom fabric, spacer filaments, and an aggregate;

[0114] The upper bottom fabric, the lower bottom fabric and the spacer yarns together form a spacer fabric, which is semi-circular in shape and has a thickness increasing from the inner circumference to the outer circumference; the thickness of the spacer fabric at the inner circumference is 1.2 mm, the thickness at the outer circumference is 4 mm, the circumferential length is 60 mm, and the radial width is 12 mm;

[0115] As Figure 4 shown in g, the spacer yarns are in an X shape;

[0116] The circumferential tensile modulus of the bionic textile-based meniscus scaffold is 250 MPa, the radial tensile modulus is 3 MPa, the outer circumferential tensile modulus is 220 MPa, the inner circumferential tensile modulus is 30 MPa, and the circumferential stress is 252 MPa;

[0117] After fixing the bionic textile-based meniscus scaffold in a simulated physiological state, its compression modulus is measured through a confined compression test. The compression modulus at a strain of 10% is 0.07 MPa. After the strain is greater than 10%, the compression modulus increases with the increase of the strain. The compression modulus at a strain of 80% is 220 MPa. The compression-tension coupling coefficient at a strain of 10% is 40%, the compression-tension coupling coefficient at a strain of 30% is 68%, and the compression-tension coupling coefficient at a strain of 80% is 85%.

[0118] Example 4

[0119] A preparation method of a bionic textile-based meniscus scaffold is as follows:

[0120] (1) Preparation of raw materials;

[0121] Hydrogel substrate: PVA with a molecular weight of 145000 Da;

[0122] Medical-grade ultra-high molecular weight polyethylene fiber bundles: The manufacturer is Honeywell, USA, and the grade is Spectra®2000;

[0123] Spacer yarns: Medical-grade polyurethane fibers with a tensile modulus of 100 MPa;

[0124] (2) First, use warp knitting CAD (WKCAD) drawing software to design the basic fabric structures of the surface layer and the bottom layer as warp plush tissues, and then use medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 17 μm) to construct the upper bottom fabric and the lower bottom fabric through a warp knitting machine, both of which are semi-circular in shape;

[0125] The surface density of the upper bottom fabric is 75 roots / cm², and the tensile modulus is 250 MPa; the surface density of the lower bottom fabric is 75 roots / cm², and the tensile modulus is 250 MPa;

[0126] (3) Place multiple medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 27 μm) in a mold. The shape of the inner cavity of the mold is the same as that of the meniscus. An array of positioning columns is fixed in the inner cavity of the mold. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc under the guidance of the positioning column array and in the same bending direction. Then, insert multiple support rods into the aggregate composed of all the medical-grade ultra-high molecular weight polyethylene fiber bundles, so that the arrangement density of the fiber bundles in the cross-section of the aggregate increases from 30 roots / cm² to 100 roots / cm² from the inside to the outside. Then, place the mold in an oven, preheat it to 130 °C, keep it warm for 8 min, cool it to 80 °C at a cooling rate of 2 °C / min, and then quickly cool it to 25 °C by spraying deionized water and demold it to obtain an aggregate supported by support rods;

[0127] (4) Adjust the upper bottom fabric and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the aggregate supported by the support rods between the upper bottom fabric and the lower bottom fabric. The bending direction of the aggregate supported by the support rods is the same as that of the upper bottom fabric and the lower bottom fabric. Both ends of the aggregate supported by the support rods protrude from between the upper bottom fabric and the lower bottom fabric, and the protruding length is 80 mm;

[0128] (5) Pass the spacer filaments (with a customized diameter of 8 μm) through the tuck stitch structure to reciprocally penetrate the upper bottom fabric and the lower bottom fabric and then reach the aggregate supported by the support rods. After that, pull out the support rods to obtain a fiber skeleton;

[0129] (6) Put the fiber skeleton, the hydrogel substrate, and water together into a meniscus bracket mold. First, heat it to 120 °C by a high-pressure steam boiler to completely dissolve the hydrogel substrate, and then sequentially perform precooling, freeze-drying, and annealing to obtain a bionic textile-based meniscus bracket; among them, the freeze-drying time is 24 h, the annealing temperature is 90 °C, and the annealing time is 1.5 h.

[0130] The finally prepared bionic textile-based meniscus bracket is composed of a hydrogel and a fiber skeleton composite with it;

[0131] The water content of the hydrogel is 70 wt%, the compression modulus is 1 MPa, the energy dissipation rate is 70%, and the friction coefficient is 0.07;

[0132] The fiber skeleton is composed of an upper bottom fabric, a lower bottom fabric, spacer filaments, and an aggregate;

[0133] The upper bottom fabric, the lower bottom fabric, and the spacer filaments together form a spacer fabric. The spacer fabric is in a semi-circular shape, and its thickness increases from the inner circumference to the outer circumference; the inner circumference thickness of the spacer fabric is 1.3 mm, the outer circumference thickness is 5 mm, the circumferential length is 80 mm, and the radial width is 15 mm;

[0134] As Figure 4As shown in Figure IXI, the spacer yarn is of type IXI;

[0135] The circumferential tensile modulus of the bionic textile-based meniscus scaffold (as shown in Figure 6 ) is 250 MPa, and the radial tensile modulus is 10 MPa. Its circumferential tensile modulus is much higher than the radial tensile modulus, indicating that it has the anisotropic mechanics of the natural meniscus;

[0136] The circumferential tensile modulus of the bionic textile-based meniscus scaffold (as shown in Figure 7 ) is 250 MPa, and the circumferential tensile modulus of the inner circumference is 40 MPa. Its circumferential tensile modulus of the outer circumference is much higher than that of the inner circumference. The inner circumference is soft and can buffer, and the outer circumference with high modulus can bear high loads. Moreover, the structure of soft inside and hard outside is also convenient for stress transfer;

[0137] The circumferential stress of the bionic textile-based meniscus scaffold is 230 MPa, and then its circumferential stress is compared with that of a commercial scaffold (manufacturer: Dutch company Orteq, brand: Actifit® Polyurethane Meniscal Scaffold). The results are as shown in Figure 8 . It can be seen from the figure that the circumferential stress of the bionic textile-based meniscus scaffold of the present invention is significantly higher than that of the commercial scaffold. The design of its circumferential fibers successfully replicates the collagen arrangement of the natural meniscus, realizing efficient circumferential load-bearing. However, the commercial scaffold will have mechanical defects due to its disordered porous structure. Therefore, it can be shown that the bionic textile-based meniscus scaffold of the present invention breaks through the mechanical bottleneck of existing products and provides key support for meniscus reconstruction to prevent stress concentration and wear of cartilage caused by meniscus extrusion;

[0138] After fixing the bionic textile-based meniscus scaffold in a simulated physiological state, its compression modulus is measured through a confined compression test, as shown in Figure 9 . The compression modulus at a strain of 10% is 0.1 MPa. After the strain is greater than 10%, the compression modulus increases with the increase of the strain. The compression modulus at a strain of 80% is 250 MPa. This is because the compression force is converted into the tensile force of the aggregate. Therefore, this meniscus scaffold has a good stress transfer function, and the initial low modulus is also beneficial to protecting the contacting cartilage tissue, achieving the effect of being both soft and rigid;

[0139] The compression-tension coupling coefficient at a strain of 10% is 50%, the compression-tension coupling coefficient at a strain of 30% is 70%, and the compression-tension coupling coefficient at a strain of 80% is 88%.

[0140] To verify the wear of cartilage under different conditions using the bionic textile-based meniscus scaffold of the present invention, commercial Actifit, a New Zealand white rabbit meniscectomy model is used for experiments, and then the OARSI scoring standard is used for cartilage degeneration scoring. The results are as shown in Figure 10As shown, by comparing the scoring results, it can be seen that the cartilage degeneration score of the bionic textile-based meniscus scaffold of the present invention is 1.6 points, significantly lower than 2.7 points of the Actifit® group, proving that the bionic textile-based meniscus scaffold of the present invention has biomechanical properties consistent with natural meniscus, can better protect cartilage, has long-term effectiveness, and can effectively delay cartilage degeneration.

[0141] Example 5

[0142] A preparation method of a bionic textile-based meniscus scaffold is as follows:

[0143] (1) Preparation of raw materials;

[0144] Hydrogel substrate: PVA with a molecular weight of 145000 Da;

[0145] Medical-grade ultra-high molecular weight polyethylene fiber bundle: The manufacturer is DSM of the Netherlands, and the brand is Purity® UG302;

[0146] Spacer yarn: Medical-grade polyurethane fiber with a tensile modulus of 300 MPa;

[0147] (2) First, use warp knitting CAD (WKCAD) drawing software to design the surface layer and bottom layer basic fabric tissue structures as warp plush tissues, and then use medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 20 μm) to construct the upper bottom fabric and the lower bottom fabric through a warp knitting machine, both of which are in a semi-circular shape;

[0148] The surface density of the upper bottom fabric is 80 roots / cm², and the tensile modulus is 300 MPa; the surface density of the lower bottom fabric is 80 roots / cm², and the tensile modulus is 300 MPa;

[0149] (3) Place multiple medical-grade ultra-high molecular weight polyethylene fiber bundles (with a customized diameter of 30 μm) in a mold. The shape of the inner cavity of the mold is the same as that of the meniscus. A positioning column array is fixed in the inner cavity of the mold. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc under the guidance of the positioning column array and in the same bending direction. Then, insert multiple support rods into the aggregate composed of all medical-grade ultra-high molecular weight polyethylene fiber bundles, so that the arrangement density of the fiber bundles in the cross-section of the aggregate increases from 39 roots / cm² to 120 roots / cm² from the inside to the outside. Then, preheat the mold in an oven to 130 °C and keep it warm for 8 minutes, then cool it at a cooling rate of 2 °C / min to 80 °C, and then rapidly cool it to 25 °C by spraying deionized water and then demold it to obtain an aggregate supported by support rods;

[0150] (4) Adjust the upper bottom fabric and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the assembly supported by the support rods between the upper bottom fabric and the lower bottom fabric. The bending direction of the assembly supported by the support rods is the same as that of the upper bottom fabric and the lower bottom fabric. Both ends of the assembly supported by the support rods protrude from between the upper bottom fabric and the lower bottom fabric, and the protruding length is 100 mm;

[0151] (5) Pass the spacer yarns (with a customized diameter of 10 μm) through the tuck stitch structure to reciprocally penetrate between the upper bottom fabric and the lower bottom fabric and then to the assembly supported by the support rods. After that, remove the support rods to obtain a fiber skeleton;

[0152] (6) Put the fiber skeleton, the hydrogel substrate, and water together into a meniscus scaffold mold. First, heat it to 120 °C in a high-pressure steam sterilizer to completely dissolve the hydrogel substrate, and then perform pre-cooling, freeze-drying, and annealing in sequence to obtain a bionic textile-based meniscus scaffold; among them, the freeze-drying time is 48 h, the annealing temperature is 120 °C, and the annealing time is 2 h.

[0153] The finally prepared bionic textile-based meniscus scaffold is composed of a hydrogel and a fiber skeleton composite with it;

[0154] The water content of the hydrogel is 70 wt%, the compressive modulus is 1 MPa, the energy dissipation rate is 60%, and the friction coefficient is 0.099;

[0155] The fiber skeleton is composed of an upper bottom fabric, a lower bottom fabric, spacer yarns, and an assembly;

[0156] The upper bottom fabric, the lower bottom fabric, and the spacer yarns together form a spacer fabric. The spacer fabric is in a semi-circular shape, and its thickness increases from the inner circumference to the outer circumference; the inner circumference thickness of the spacer fabric is 2 mm, the outer circumference thickness is 5 mm, the circumferential length is 80 mm, and the radial width is 15 mm;

[0157] The spacer yarns are of type IXI;

[0158] The circumferential tensile modulus of the bionic textile-based meniscus scaffold is 300 MPa, the radial tensile modulus is 10 MPa, the outer circumferential tensile modulus is 300 MPa, the inner circumferential tensile modulus is 100 MPa, and the circumferential stress is 350 MPa;

[0159] After simulating the physiological state to fix the bionic textile-based meniscus scaffold, its compressive modulus was measured through a confined compression test. The compressive modulus at a strain of 10% was 0.099 MPa. After the strain was greater than 10%, the compressive modulus increased with the increase in strain. The compressive modulus at a strain of 80% was 300 MPa. The compression-tension coupling coefficient at a strain of 10% was 60%. The compression-tension coupling coefficient at a strain of 30% was 80%. The compression-tension coupling coefficient at a strain of 80% was 95%.

Claims

1. A bionic textile-based meniscus scaffold, characterized in that, It includes a hydrogel (1-5) and a fiber framework composite with it; The fiber framework includes an upper bottom fabric (1-1), a lower bottom fabric, spacer filaments (1-4), and an aggregate (1-2); The upper bottom fabric (1-1), the lower bottom fabric, and the spacer filaments (1-4) together form a spacer fabric, which is semi-circular in shape and its thickness increases from the inner circumference to the outer circumference; The aggregate (1-2) is composed of multiple fiber bundles bent into an arc shape and having the same bending direction. The aggregate (1-2) is semi-circular in shape, and the arrangement density of the fiber bundles in the cross-section increases from the inside to the outside; The spacer fabric and the aggregate (1-2) have the same bending direction. The aggregate (1-2) is divided into three length segments. The middle length segment is located between the upper bottom fabric (1-1) and the lower bottom fabric and is penetrated by the spacer filaments (1-4).

2. The bionic textile-based meniscus stent according to claim 1, characterized in that, The two end length segments of the aggregate (1-2) are located outside the spacer fabric, and the lengths of the two end length segments are 10-100 mm.

3. The bionic textile-based meniscus scaffold according to claim 1, characterized in that, Both the upper bottom fabric (1-1) and the lower bottom fabric are warp knitted fabrics, made of medical-grade ultra-high molecular weight polyethylene fiber bundles with a diameter of 10-20 μm, the surface density ≥ 70 roots / cm², and the tensile modulus ≥ 200 MPa.

4. The bionic textile-based meniscus scaffold according to claim 1, wherein The spacer filaments (1-4) are medical-grade polyurethane fibers with a diameter of 1-10 μm. The tensile modulus of the spacer filaments (1-4) is 10-300 MPa, and the spacer filaments (1-4) are of type C, V, X, or IXI.

5. The bionic textile-based meniscus stent according to claim 1, wherein The inner circumference thickness of the spacer fabric is 1-2 mm, the outer circumference thickness is 3-5 mm, the circumferential length is 20-80 mm, and the radial width is 5-15 mm.

6. The bionic textile-based meniscus scaffold according to claim 1, wherein, The fiber bundles are medical-grade ultra-high molecular weight polyethylene fiber bundles with a diameter of 20-30 μm; the arrangement density of the fiber bundles in the cross-section of the aggregate (1-2) increases from < 40 roots / cm² to > 70 roots / cm² from the inside to the outside.

7. The bionic textile-based meniscus scaffold according to claim 1, characterized in that, The water content of the hydrogel (1-5) ≥ 70 wt%, the compression modulus is 0.1-1 MPa, the energy dissipation rate is 60-80%, and the friction coefficient < 0.

1.

8. A bionic textile-based meniscus scaffold according to any one of claims 1-7, characterized in that, The circumferential tensile modulus of the bionic textile-based meniscus scaffold is 200-300 MPa, and the radial tensile modulus is 1-10 MPa; The outer circumference tensile modulus of the bionic textile-based meniscus scaffold is 200-300 MPa, and the inner circumference tensile modulus is 10-100 MPa; The circumferential stress of the bionic textile-based meniscus scaffold > 200 MPa; After fixing the bionic textile-based meniscus scaffold in a simulated physiological state, its compression modulus is measured through a confined compression test. The compression modulus at a strain of 10% ≤ 0.1 MPa, and the compression modulus increases with the increase of the strain after the strain is greater than 10%. The compression modulus at a strain of 80% > 200 MPa, the coupling coefficient at a strain of 10% is 30%-60%, the coupling coefficient at a strain of 30% is 61%-80%, and the coupling coefficient at a strain of 80% is 81%-95%.

9. A method for preparing a bionic textile-based meniscus scaffold according to any one of claims 1-8, characterized in that, It includes the following steps: (a) Use a warp knitting machine to construct the upper bottom fabric (1-1) and the lower bottom fabric, both of which are semi-circular in shape; (b) Prepare an aggregate (1-2) supported by a support rod, and the support rod is used to control the arrangement density of the fiber bundles in the aggregate (1-2); (c)Adjust the upper bottom fabric (1-1) and the lower bottom fabric so that their bending directions are the same. After the spacing increases from the inside to the outside, insert the assembly (1-2) supported by the support rods between the upper bottom fabric (1-1) and the lower bottom fabric. The bending direction of the assembly (1-2) supported by the support rods is the same as that of the upper bottom fabric (1-1) and the lower bottom fabric. Both ends of the assembly (1-2) supported by the support rods protrude from between the upper bottom fabric (1-1) and the lower bottom fabric; (d)Pass the spacer yarn (1-4) through the tuck stitch structure to reciprocally penetrate the assembly (1-2) supported by the support rods between the upper bottom fabric (1-1) and the lower bottom fabric, and then remove the support rods to obtain a fiber skeleton; (e)Put the fiber skeleton, the hydrogel substrate, and water into the meniscus stent mold together. First, heat it until the hydrogel substrate is completely dissolved, and then perform pre-cooling, freeze-drying, and annealing in sequence.

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