A bionic textile-based meniscus scaffold and its preparation method

Abstract

The present invention belongs to the technical field of medical devices and discloses a bionic textile-based meniscus scaffold and a preparation method thereof, comprising a hydrogel and a fiber skeleton composited therewith, wherein the fiber skeleton comprises an upper bottom surface fabric, a lower bottom surface fabric, spacer wires and an aggregate; the upper bottom surface fabric, the lower bottom surface fabric and the spacer wires together constitute the spacer fabric, the spacer fabric is semilunar in shape, and the thickness increases from the inner periphery to the outer periphery; the aggregate is composed of a plurality of fiber bundles bent into an arc shape and having the same bending direction, the aggregate is semilunar in shape, and the arrangement density of the fiber bundles in the cross section increases from the inner to the outer side; the preparation method comprises: first constructing the upper bottom surface fabric and the lower bottom surface fabric, then preparing the aggregate supported by a support rod, then combining the upper bottom surface fabric, the lower bottom surface fabric and the aggregate supported by the support rod, then inserting the spacer wires, and then withdrawing the support rod to obtain the fiber skeleton, and then placing the fiber skeleton, the hydrogel substrate and water into a meniscus scaffold mold and then heating, precooling, freeze-drying and annealing.

Description

Technical Field

[0001] The 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 tibia (e.g. Figure 1 The meniscus, shown in (a), bears over 70% of the body's weight and is crucial for maintaining knee function. However, meniscal injuries are common, with an increasing incidence and a younger age trend. Because meniscectomy is difficult to perform on its own, it is widely used. However, postoperative meniscectomy can exacerbate joint damage and may ultimately require complete knee replacement.

[0003] To solve this problem, artificial meniscus transplantation has been used in clinical practice. However, allogeneic transplants have defects such as insufficient sources. Existing synthetic artificial meniscus scaffolds have a high clinical failure rate due to structural homogeneity, and can still cause cartilage degeneration after implantation. Studies have shown that meniscus injury and abnormal increase in contact stress after transplantation are the key causes of cartilage degeneration and osteoarthritis. In the microenvironment of the joint cavity, the natural meniscus exhibits significant mechanical anisotropy due to its special collagen fiber arrangement and interwoven linkage between fibers, which 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 compression modulus begins to deform. Through the shear stretching of the anisotropic collagen fiber skeleton and the interaction of proteoglycans, the axial compressive stress is transferred to a high-load circumferential tensile strain. Stress dispersion and transmission are achieved through mechanical transduction to limit further compression of the meniscus, while reducing the peak and average pressures of the medial tibial cartilage (such as Figure 1 (shown in (b)).

[0004] To replicate this biomechanical function, researchers have used 3D printing, melt electrospinning, and other technologies to construct anisotropic meniscus scaffolds, some of which also incorporate functional molecules or seed cells. For example, in the paper (3DPrinted High-Strength Supramolecular Polymer Hydrogel-Cushioned Radially and Circumferentially Oriented Meniscus Substitute. Advanced Functional Materials. 2022, 32: 2200360.), 3D printing was used to construct an axially and circumferentially oriented PCL fiber scaffold, which was then composited with poly (N-acryloylglycinamide) hydrogel to optimize compression resistance, resulting in an artificial meniscus with a low compressive modulus and a high tensile modulus. The literature (Bioprinting of Structurally Organized Meniscal Tissuewithin Anisotropic Melt Electrowritten Scaffolds. Acta Biomaterialia. 2023,158: 216-227.) constructed anisotropic scaffolds with elongated pores by melt electrowriting, and constructed a meniscus scaffold by a layer-by-layer stacking method. In addition, the literature (Harnessing Electrospun Nanofibers to RecapitulateHierarchical Fibrous Structures of Meniscus. Journal of Biomedical MaterialsResearch Part B Applied Biomaterials. 2021, 109(2): 201-213.) constructed a heterogeneous ultrastructured nanofiber scaffold by electrospinning, in which the fiber bundles formed by nanoyarns were arranged along the circumference of the scaffold, making the scaffold exhibit mechanical anisotropy. However, existing scaffolds generally adopt a stacking structure and lack the interlacing and linkage of fibers in three-dimensional space, which makes it impossible to transfer axial stress to the circumferential direction, resulting in abnormal mechanical stimulation, making it difficult to effectively regulate the mechanical microenvironment, and making it difficult to ensure long-term cartilage protection effects and clinical translation potential.

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

[0006] The purpose 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] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] A bionic textile-based meniscus scaffold, comprising a hydrogel and a fiber skeleton composited therewith;

[0009] The fiber skeleton comprises an upper base fabric, a lower base fabric, spacer yarns and an aggregate;

[0010] The upper bottom fabric, the lower bottom fabric and the spacer yarn together constitute the spacer fabric, which is in a half-moon shape and has a thickness that increases from the inner periphery to the outer periphery.

[0011] The aggregate is composed of multiple fiber bundles bent into an arc with the same bending direction. The aggregate is crescent-shaped, 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, and the aggregate is divided into three length segments, with the middle length segment being located between the upper base fabric and the lower base fabric and interspersed with spacer yarns;

[0013] The bionic textile-based meniscus scaffold is designed with an imitation meniscus structure as a whole, which can simulate the mechanical response characteristics of the natural meniscus, that is, it can transfer axial compressive stress to circumferential tensile strain to achieve stress dispersion. The upper and lower bottom fabrics simulate the dense collagen fiber layer on the surface of the natural meniscus, the spacer wire simulates the rolled belt fiber 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 the preferred technical solution:

[0015] In the biomimetic textile-based meniscus scaffold described above, the two end segments of the assembly are located outside the spacer fabric. These end segments serve as root structures and can be fixed to the tibial plateau through bone tunnels. The lengths of the two end segments are 10-100 mm. This design avoids the use of sutures to sew the scaffold to the joint capsule, thereby preventing stress concentration at the suture site and avoiding tearing of the meniscus scaffold due to suture shearing.

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

[0017] In the bionic textile-based meniscus scaffold as described above, the spacer wire is medical-grade polyurethane fiber with a diameter of 1-10 μm, a tensile modulus of 10-300 MPa, and the spacer wire is C-shaped, V-shaped, X-shaped, or IXI-shaped.

[0018] The bionic textile-based meniscus scaffold as described above has an inner circumferential thickness of 1-2 mm, an outer circumferential thickness of 3-5 mm, a circumferential length of 20-80 mm, and a radial width of 5-15 mm, and can be customized to the same size as the meniscus.

[0019] In the bionic textile-based meniscus scaffold as described above, 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] As described above, the biomimetic textile-based meniscus scaffold has a hydrogel water content of ≥70wt%, a compression modulus of 0.1-1MPa, an energy dissipation rate of 60-80%, and a friction coefficient of <0.1, which is similar to that of cartilage.

[0021] A biomimetic textile-based meniscus scaffold as described in any of the above items, wherein the biomimetic textile-based meniscus scaffold has a circumferential tensile modulus of 200-300 MPa and a radial tensile modulus of 1-10 MPa, thereby showing that it has anisotropy; radial force is provided by the hydrogel, the spacer wire, the upper base fabric and the lower base fabric; the low radial tensile modulus allows deformation to trigger stress transduction;

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

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

[0024] After fixing the biomimetic textile-based meniscus scaffold in a simulated physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was ≤0.1MPa at a strain of 10%. After the strain exceeded 10%, the compression modulus increased with the increase of strain. The compression modulus at a strain of 80% was >200MPa. The coupling coefficient was 30%-60% at a strain of 10%, 61%-80% at a strain of 30%, and 81%-95% at a strain of 80%. In other words, more than 80% of the compressive stress was converted into circumferential tension. This shows that it has efficient stress transduction properties and can convert compressive force into tensile force in the fibers. Specifically, the aggregate runs through the entire scaffold and can more effectively disperse stress through stretching when subjected to stress, achieving high mechanical load-bearing capacity without the problem of stress concentration in the sutured part as occurs with 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) Using a warp knitting machine to construct an upper base fabric and a lower base fabric, both of which are half-moon shaped;

[0027] (b) Preparation of an aggregate supported by support rods, which 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 so that their bending directions are the same and the spacing increases from the inside to the outside, inserting 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 being the same as the bending direction of the upper bottom fabric and the lower bottom fabric, and the ends of the assembly supported by the support rods being exposed from between the upper bottom fabric and the lower bottom fabric;

[0029] (d) reciprocatingly inserting the spacer yarns from the upper base fabric and the lower base fabric through the tuck structure through the aggregate supported by the support rod, and then removing the support rod to obtain a fiber skeleton;

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

[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, which provide strong tensile shear force for the scaffold through tight weaving. The aggregate is like the steel bars in a building, which can withstand large circumferential stress and give the scaffold a high load-bearing capacity. The spacer wire starts from the upper surface of the fabric, passes through the aggregate to the lower surface, and then passes back to the upper surface from the lower surface, connecting the various parts in series like threading a needle. Its function is consistent with the rolled elastic fiber of the natural meniscus, realizing the overall interlacing and linkage of the fiber scaffold. Hydrogel is poured into it, similar to cement reinforcement of a building, further integrating the various components of the scaffold, providing the scaffold with a flexible buffering function and a surface with a low friction coefficient. This structural design enables the scaffold to achieve the same biomechanical function as the natural meniscus: it shows flexibility in the initial stage of force, and then provides high load-bearing capacity, effectively converting the compressive stress it receives into tensile stress of the lower fiber.

[0032] Beneficial effects:

[0033] (1) The present invention uses a textile method to construct a three-dimensional anisotropic skeleton with a root structure. This unique structure gives the scaffold two major advantages: in the initial stage of femoral compression, the scaffold wraps around the femur with its low modulus properties, effectively avoiding stress concentration; at the same time, it can quickly and efficiently transfer the compressive force to the circumference, achieving high load-bearing capacity through the stretching of the aggregate. This can not only reduce mechanical stimulation and protect cartilage tissue, but also solve the problem of cartilage wear and osteoarthritis easily caused by the current meniscus scaffold implantation.

[0034] (2) The bionic textile-based meniscus scaffold of the present invention has a simple molding method, a single component, good biocompatibility and stability, and exhibits 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 Schematic diagram of the meniscus structure; in the figure, a is the anatomical structure of the knee meniscus, and b is the stress transduction characteristics of the natural meniscus after axial compression;

[0037] Figure 2 Schematic diagram of the preparation process of the biomimetic textile-based meniscus scaffold of the present invention; in the figure, a is a schematic diagram of the upper and lower base fabrics after construction, b is a schematic diagram of the assembly supported by the support rods inserted between the upper and lower base fabrics, c is a schematic diagram of the spacer wires reciprocatingly interlaced between the upper and lower base fabrics, and d is a schematic diagram of the fiber skeleton and the hydrogel substrate after composite;

[0038] Figure 3is a schematic diagram of a cross section of the assembly of the present invention;

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

[0040] Figure 5 Schematic diagram of a meniscus stent mold according to the present invention;

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

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

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

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

[0045] Figure 10 Schematic diagram of cartilage degeneration scores after 6 months of animal experiments using the biomimetic textile-based meniscus scaffold prepared in Example 4 of the present invention, a commercial Actifit® control group, and different conditions; in the figure, the sham surgery group shows the cartilage degeneration score after only exposing the joint cavity without treating the meniscus in the joint cavity; the resection group shows the cartilage degeneration score after complete meniscus resection in the joint cavity without meniscus filling; the Actifit® control group shows the cartilage degeneration score after complete meniscus resection and filling with commercial Actifit® (manufacturer: Orteq, the Netherlands); and the biomimetic textile-based meniscus scaffold shows the cartilage degeneration score after complete meniscus resection and filling with the biomimetic textile-based meniscus scaffold prepared in Example 4;

[0046] Among them, 1-1 is the upper bottom surface fabric, 1-2 is the aggregate, 1-3 is the root structure, 1-4 is the spacer wire, 1-5 is the hydrogel, 2 is the support rod, 3 is the peripheral aggregate, and 4 is the inner peripheral aggregate. DETAILED DESCRIPTION

[0047] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, 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 fall equally within the scope limited by the appended claims of the application.

[0048] In order to ensure that the properties of the materials used in each embodiment and comparative example are fully disclosed, the manufacturers and brands of the materials are indicated. Products of other manufacturers and brands that meet the requirements of the present invention are also feasible.

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

[0050] Water content of hydrogel: The hydrogel in each example was used as a sample, and the water content was measured according to GB / T 6284-2006.

[0051] Compression modulus of hydrogel: The hydrogel in each example was used as a sample, and the compression modulus was measured according to GB / T 1041-2008.

[0052] Energy dissipation rate of the hydrogel: The hydrogel in each example was used as a sample, and then the energy dissipation rate was measured according to the ASTM D4065 cyclic compression test.

[0053] Friction coefficient of hydrogel: The hydrogel in each example was used as a sample, and the friction coefficient was measured according to ASTM D1894-2014.

[0054] Tensile modulus of polyurethane fiber: The spacer yarns in each example were used as samples, and the tensile modulus was measured according to GB / T3923.1-2013 standard.

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

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

[0057] Peripheral tensile modulus and internal tensile modulus: The inner and outer peripheries of the bionic textile-based meniscus scaffolds prepared in each embodiment were first cut open and used as samples respectively. The samples were then tested in accordance with the GB / T 3923.1-2013 standard, and the peripheral tensile modulus and internal tensile modulus of the samples were calculated based on the obtained stress-strain curves.

[0058] Hoop stress: The biomimetic textile-based meniscus scaffolds prepared in each embodiment were used as samples, and then a customized meniscus scaffold fixture was used to perform an extrusion test with physiological fixation under artificial joint fluid conditions. The maximum extrusion force was measured, and finally the hoop stress was calculated based on the test data. The calculation formula is: hoop stress = peak force / sample cross-sectional area; wherein, the loading rate is 5 mm / min.

[0059] Compression modulus: The biomimetic textile-based meniscus scaffold prepared in each embodiment was used as a sample, and then the restricted compression test clause in ASTM F2346 was referred to and improved in combination with ISO 604. The radial expansion of the specimen was restricted by a fixture, and the stress-strain curve was measured. The compression modulus of the sample at 10% and 80% strain was calculated based on the obtained curve. The compression modulus of the sample at 10% strain refers to the linear regression slope of the stress-strain curve in the 5%-10% strain range, and the compression modulus of 80% strain refers to the tangent modulus of the stress-strain curve in the 75%-80% strain range.

[0060] Compression-tension coupling coefficient: The bionic textile-based meniscus scaffolds prepared in each embodiment were used as samples. The axial compressive stress increment (Δσ_compression) and the circumferential tensile stress increment (Δσ_tension) were simultaneously measured using a customized biaxial loading device in accordance with the ISO 10328 standard. The coupling coefficient η of the sample at strains of 10%, 30%, and 80% was calculated based on the measurement results to characterize the stress transduction efficiency. The coupling coefficient was calculated as follows: η = Δσ_tension / Δσ_compression × 100%.

[0061] Example 1

[0062] A method for preparing a bionic textile-based meniscus scaffold, such as Figure 2 As shown, the steps are as follows:

[0063] (1) Preparation of raw materials;

[0064] Hydrogel matrix: PVA with a molecular weight of 145,000 Da;

[0065] Medical-grade ultra-high molecular weight polyethylene fiber bundles: manufactured by Honeywell, USA, brand name Spectra® 1000;

[0066] Spacer yarn: medical grade polyurethane fiber, tensile modulus is 10MPa;

[0067] (2) First, the surface and bottom base fabric structures were designed as warp fleece structures using warp knitting CAD (WKCAD) drawing software. Then, medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 10 μm) were used to construct the upper base fabric 1-1 and the lower base fabric using a warp knitting machine. Both of them were half-moon shaped.

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

[0069] (3) A plurality of medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 20 μm) are placed in a mold. The shape of the mold cavity is the same as that of a meniscus. A positioning column array is fixed in the mold cavity. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc shape under the guidance of the positioning column array and the bending direction is the same. Then, a plurality of support rods are inserted 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 fibers / cm² to 71 fibers / cm² from the inside to the outside. Then, the mold is placed in an oven and preheated to 120°C and kept warm for 5 minutes. Then, it is cooled to 80°C at a cooling rate of 2°C / min. Then, it is rapidly cooled to 25°C by spraying deionized water and demolded 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 and the spacing increases from the inside to the outside, then insert the assembly supported by the support rod between the upper bottom fabric 1-1 and the lower bottom fabric. The bending direction of the assembly supported by the support rod is the same as the bending direction of the upper bottom fabric 1-1 and the lower bottom fabric. Both ends of the assembly supported by the support rod are exposed from between the upper bottom fabric 1-1 and the lower bottom fabric, and the exposed length is 10 mm.

[0071] (5) After the spacer yarns 1-4 (customized to a diameter of 1 μm) are reciprocated through the upper bottom fabric 1-1 and the lower bottom fabric through the loop structure and the aggregate supported by the support rod, the support rod is pulled out to obtain a fiber skeleton;

[0072] (6) Place the fiber skeleton, hydrogel matrix and water into the Figure 5 In the meniscus scaffold mold shown, the hydrogel matrix is ​​first heated to 120°C in a high-pressure steam cooker to completely dissolve the hydrogel matrix, and then pre-cooled, freeze-dried, and annealed in sequence to obtain a biomimetic textile-based meniscus scaffold; among them, the freeze-drying time is 16 hours, the annealing temperature is 60°C, and the annealing time is 0.5 hours.

[0073] The final biomimetic textile-based meniscus scaffold (such as Figure 2 、 Figure 3 ) is composed of hydrogels 1-5 and a fiber skeleton composited therewith;

[0074] Hydrogel 1-5 has a water content of 80 wt %, a compression modulus of 0.1 MPa, an energy dissipation rate of 80%, and a friction coefficient of 0.05;

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

[0076] The upper bottom fabric 1-1, the lower bottom fabric and the spacer yarns 1-4 together constitute a spacer fabric. The spacer fabric is crescent-shaped, 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] like Figure 4 As shown in middle e, the spacer wire is C-type;

[0078] The biomimetic textile-based meniscus scaffold has a circumferential tensile modulus of 200 MPa, a radial tensile modulus of 1 MPa, an outer tensile modulus of 200 MPa, an inner tensile modulus of 10 MPa, and a hoop stress of 201 MPa.

[0079] After fixing the bionic textile-based meniscus scaffold to simulate the physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was 0.05 MPa when the strain was 10%. When the strain was greater than 10%, the compression modulus increased with the increase of strain. The compression modulus was 201 MPa when the strain was 80%. The compression-stretch coupling coefficient was 30% when the strain was 10%, 61% when the strain was 30%, and 81% when the strain was 80%.

[0080] Example 2

[0081] A method for preparing a bionic textile-based meniscus scaffold comprises the following steps:

[0082] (1) Preparation of raw materials;

[0083] Hydrogel matrix: PVA with a molecular weight of 145,000 Da;

[0084] Medical-grade ultra-high molecular weight polyethylene fiber bundles: manufactured by Jiangsu Jiujiujiu Technology Co., Ltd., brand JJF®-UHMWPE-MD01;

[0085] Spacer yarn: medical grade polyurethane fiber, tensile modulus is 20MPa;

[0086] (2) First, the surface and bottom fabric structures were designed as warp fleece using warp knitting CAD (WKCAD) drawing software. Then, medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 12 μm) were used to construct the upper and lower base fabrics using a warp knitting machine. Both fabrics were half-moon shaped.

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

[0088] (3) A plurality of medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 23 μm) are placed in a mold. The shape of the mold cavity is the same as that of a meniscus. A positioning column array is fixed in the mold cavity. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc shape under the guidance of the positioning column array and the bending direction is the same. Then, a plurality of support rods are inserted 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 fibers / cm² to 80 fibers / cm² from the inside to the outside. Then, the mold is placed in an oven and preheated to 122°C and kept warm for 6 minutes. Then, it is cooled to 80°C at a cooling rate of 2°C / min. Then, it is rapidly cooled to 25°C by spraying deionized water and demolded 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 and the spacing increases from the inside to the outside, then insert 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 is the same as the bending direction of the upper bottom fabric and the lower bottom fabric. Both ends of the assembly supported by the support rod are exposed from between the upper bottom fabric and the lower bottom fabric, and the exposed length is 80 mm.

[0090] (5) After the spacer wire (customized to a diameter of 4 μm) is reciprocatedly inserted from the upper base fabric and the lower base fabric through the loop structure to the aggregate supported by the support rod, the support rod is pulled out to obtain a fiber skeleton;

[0091] (6) The fiber skeleton, hydrogel matrix and water are placed together in a meniscus scaffold mold, first heated to 120°C in a high-pressure steam cooker to completely dissolve the hydrogel matrix, and then pre-cooled, freeze-dried and annealed in sequence to obtain a biomimetic textile-based meniscus scaffold; wherein, the freeze-drying time is 24 hours, the annealing temperature is 90°C, and the annealing time is 1 hour.

[0092] The final biomimetic textile-based meniscus scaffold is composed of a hydrogel and a fiber skeleton composited with it;

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

[0094] The fiber skeleton is composed of an upper base fabric, a lower base fabric, spacer yarns and an aggregate;

[0095] The upper base fabric, the lower base fabric and the spacer yarn together constitute the spacer fabric. The spacer fabric is half-moon-shaped, and the 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] like Figure 4 As shown in middle f, the spacer wire is V-shaped;

[0097] The biomimetic textile-based meniscus scaffold has a circumferential tensile modulus of 250 MPa, a radial tensile modulus of 2 MPa, an outer tensile modulus of 210 MPa, an inner tensile modulus of 20 MPa, and a hoop stress of 210 MPa.

[0098] After fixing the bionic textile-based meniscus scaffold to simulate the physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was 0.06 MPa when the strain was 10%. When the strain was greater than 10%, the compression modulus increased with the increase of strain. The compression modulus was 210 MPa when the strain was 80%. The compression-stretch coupling coefficient was 32% when the strain was 10%, 65% when the strain was 30%, and 82% when the strain was 80%.

[0099] Example 3

[0100] A method for preparing a bionic textile-based meniscus scaffold comprises the following steps:

[0101] (1) Preparation of raw materials;

[0102] Hydrogel matrix: PVA with a molecular weight of 145,000 Da;

[0103] Medical-grade ultra-high molecular weight polyethylene fiber bundles: manufactured by DSM of the Netherlands, brand name Purity® UG403;

[0104] Spacer yarn: medical grade polyurethane fiber, tensile modulus is 30MPa;

[0105] (2) First, the surface and bottom fabric structures were designed as warp fleece structures using warp knitting CAD (WKCAD) drawing software. Then, medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 15 μm) were used to construct the upper and lower base fabrics using a warp knitting machine. Both fabrics were half-moon shaped.

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

[0107] (3) A plurality of medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 26 μm) are placed in a mold. The shape of the mold cavity is the same as that of a meniscus. A positioning column array is fixed in the mold cavity. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc shape under the guidance of the positioning column array and the bending direction is the same. Then, a plurality of support rods are inserted 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 20 fibers / cm² to 90 fibers / cm² from the inside to the outside. Then, the mold is placed in an oven and preheated to 125°C and kept warm for 7 minutes. Then, it is cooled to 80°C at a cooling rate of 2°C / min. Then, it is rapidly cooled to 25°C by spraying deionized water and demolded 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 and the spacing increases from the inside to the outside, then insert 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 is the same as the bending direction of the upper bottom fabric and the lower bottom fabric. Both ends of the assembly supported by the support rod are exposed from between the upper bottom fabric and the lower bottom fabric, and the exposed length is 80 mm.

[0109] (5) After the spacer wire (customized to a diameter of 6 μm) is reciprocatedly inserted from the upper base fabric and the lower base fabric through the loop structure to the aggregate supported by the support rod, the support rod is pulled out to obtain the fiber skeleton;

[0110] (6) The fiber skeleton, hydrogel matrix and water are placed together in a meniscus scaffold mold, first heated to 120°C in a high-pressure steam cooker to completely dissolve the hydrogel matrix, and then pre-cooled, freeze-dried and annealed in sequence to obtain a biomimetic textile-based meniscus scaffold; wherein, the freeze-drying time is 24 hours, the annealing temperature is 90°C, and the annealing time is 1 hour.

[0111] The final biomimetic textile-based meniscus scaffold is composed of a hydrogel and a fiber skeleton composited with it;

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

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

[0114] The upper base fabric, the lower base fabric and the spacer yarn together constitute the spacer fabric. The spacer fabric is half-moon-shaped, and the thickness increases from the inner circumference to the outer circumference. The inner circumference thickness of the spacer fabric is 1.2mm, the outer circumference thickness is 4mm, the circumferential length is 60mm, and the radial width is 12mm.

[0115] like Figure 4 As shown in middle g, the spacer wire is X-shaped;

[0116] The biomimetic textile-based meniscus scaffold has a circumferential tensile modulus of 250 MPa, a radial tensile modulus of 3 MPa, an outer tensile modulus of 220 MPa, an inner tensile modulus of 30 MPa, and a hoop stress of 252 MPa.

[0117] After fixing the bionic textile-based meniscus scaffold to simulate the physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was 0.07 MPa when the strain was 10%. When the strain was greater than 10%, the compression modulus increased with the increase of strain. The compression modulus was 220 MPa when the strain was 80%. The compression-stretch coupling coefficient was 40% when the strain was 10%, 68% when the strain was 30%, and 85% when the strain was 80%.

[0118] Example 4

[0119] A method for preparing a bionic textile-based meniscus scaffold comprises the following steps:

[0120] (1) Preparation of raw materials;

[0121] Hydrogel matrix: PVA with a molecular weight of 145,000 Da;

[0122] Medical-grade ultra-high molecular weight polyethylene fiber bundles: manufactured by Honeywell, USA, brand name Spectra® 2000;

[0123] Spacer yarn: medical grade polyurethane fiber, tensile modulus is 100MPa;

[0124] (2) First, the surface and bottom fabric structures were designed as warp fleece structures using warp knitting CAD (WKCAD) drawing software. Then, medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 17 μm) were used to construct the upper and lower base fabrics using a warp knitting machine. Both fabrics were half-moon shaped.

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

[0126] (3) A plurality of medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 27 μm) are placed in a mold. The shape of the mold cavity is the same as that of a meniscus. A positioning column array is fixed in the mold cavity. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc shape under the guidance of the positioning column array and the bending direction is the same. Then, a plurality of support rods are inserted 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 30 fibers / cm² to 100 fibers / cm² from the inside to the outside. Then, the mold is placed in an oven and preheated to 130°C and kept warm for 8 minutes. Then, it is cooled to 80°C at a cooling rate of 2°C / min. Then, it is rapidly cooled to 25°C by spraying deionized water and demolded 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 and the spacing increases from the inside to the outside, then insert 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 is the same as the bending direction of the upper bottom fabric and the lower bottom fabric. Both ends of the assembly supported by the support rod are exposed from between the upper bottom fabric and the lower bottom fabric, and the exposed length is 80 mm.

[0128] (5) After the spacer wire (customized to 8 μm in diameter) is inserted back and forth from the upper and lower fabrics through the loop structure to the aggregate supported by the support rod, the support rod is removed to obtain a fiber skeleton;

[0129] (6) The fiber skeleton, hydrogel matrix and water were placed together in a meniscus scaffold mold, first heated to 120°C in a high-pressure steam cooker to completely dissolve the hydrogel matrix, and then pre-cooled, freeze-dried and annealed in sequence to obtain a biomimetic textile-based meniscus scaffold; wherein, the freeze-drying time was 24 h, the annealing temperature was 90°C, and the annealing time was 1.5 h.

[0130] The final biomimetic textile-based meniscus scaffold is composed of a hydrogel and a fiber skeleton composited with it;

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

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

[0133] The upper base fabric, the lower base fabric and the spacer yarn together constitute the spacer fabric. The spacer fabric is half-moon-shaped, and the thickness increases from the inner circumference to the outer circumference. The inner circumference thickness of the spacer fabric is 1.3mm, the outer circumference thickness is 5mm, the circumferential length is 80mm, and the radial width is 15mm.

[0134] like Figure 4As shown in middle h, the spacer filament is type IXI;

[0135] Bionic textile-based meniscus scaffolds (e.g. Figure 6 The circumferential tensile modulus of the meniscus is 250 MPa, and the radial tensile modulus is 10 MPa. The circumferential tensile modulus is much higher than the radial tensile modulus, indicating that it has the anisotropic mechanical properties of a natural meniscus.

[0136] Bionic textile-based meniscus scaffolds (e.g. Figure 7 The outer tensile modulus of the outer circumference (as shown) is 250MPa, and the inner tensile modulus is 40MPa. The outer tensile modulus is much higher than the inner tensile modulus. The inner softness can provide cushioning, while the outer high modulus can provide high load-bearing capacity. The inner softness and outer hardness structure also facilitates stress transfer.

[0137] The hoop stress of the biomimetic textile-based meniscal scaffold is 230 MPa, which is then compared with the hoop stress of a commercial scaffold (manufacturer: Orteq, Netherlands, brand: Actifit® Polyurethane Meniscal Scaffold). The results are as follows: Figure 8 As shown in the figure, it can be seen that the hoop stress of the biomimetic 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 arrangement of natural meniscus collagen, achieving efficient circumferential load-bearing. Commercial scaffolds have mechanical defects due to their disordered porous structure. Therefore, it can be shown that the biomimetic textile-based meniscus scaffold of the present invention has broken through the mechanical bottleneck of existing products and provides key support for meniscus reconstruction, thereby preventing stress concentration and wear of the cartilage caused by meniscus extrusion;

[0138] After fixing the biomimetic textile-based meniscus scaffold in a simulated physiological state, its compression modulus was measured by a constrained compression test, e.g. Figure 9 As shown in the figure, the compression modulus is 0.1 MPa when the strain is 10%. When the strain is greater than 10%, the compression modulus increases with the increase of strain. The compression modulus is 250 MPa when the strain is 80%. This is because the compression force is converted into the tensile force of the aggregate. Therefore, the meniscus scaffold has a good stress transfer function, and the initial low modulus is also conducive to protecting the contact cartilage tissue, achieving a soft and rigid effect.

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

[0140] In order to verify the effect of the bionic textile-based meniscus scaffold of the present invention and the commercial Actifit on cartilage wear under different conditions, a New Zealand white rabbit meniscectomy model was used for the experiment, and then the cartilage degeneration score was scored using the OARSI scoring standard. The results are shown in Figure 2. Figure 10As shown in the figure, 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, which is significantly lower than the 2.7 points of the Actifit® group, proving that the biomechanical properties of the bionic textile-based meniscus scaffold of the present invention are consistent with those of the natural meniscus, can better protect the cartilage, has long-term effectiveness, and can effectively delay cartilage degeneration.

[0141] Example 5

[0142] A method for preparing a bionic textile-based meniscus scaffold comprises the following steps:

[0143] (1) Preparation of raw materials;

[0144] Hydrogel matrix: PVA with a molecular weight of 145,000 Da;

[0145] Medical-grade ultra-high molecular weight polyethylene fiber bundles: manufactured by DSM of the Netherlands, brand name Purity® UG302;

[0146] Spacer yarn: medical grade polyurethane fiber, tensile modulus is 300MPa;

[0147] (2) First, the surface and bottom fabric structures were designed as warp fleece structures using warp knitting CAD (WKCAD) drawing software. Then, medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 20 μm) were used to construct the upper and lower base fabrics using a warp knitting machine. Both fabrics were half-moon shaped.

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

[0149] (3) A plurality of medical-grade ultra-high molecular weight polyethylene fiber bundles (customized to a diameter of 30 μm) are placed in a mold. The shape of the mold cavity is the same as that of a meniscus. A positioning column array is fixed in the mold cavity. Each medical-grade ultra-high molecular weight polyethylene fiber bundle is bent into an arc shape under the guidance of the positioning column array and the bending direction is the same. Then, a plurality of support rods are inserted 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 39 fibers / cm² to 120 fibers / cm² from the inside to the outside. Then, the mold is placed in an oven and preheated to 130°C and kept warm for 8 minutes. Then, it is cooled to 80°C at a cooling rate of 2°C / min. Then, it is rapidly cooled to 25°C by spraying deionized water and demolded 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 and the spacing increases from the inside to the outside, then insert 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 is the same as the bending direction of the upper bottom fabric and the lower bottom fabric. Both ends of the assembly supported by the support rod are exposed from between the upper bottom fabric and the lower bottom fabric, and the exposed length is 100 mm.

[0151] (5) After the spacer wire (customized to a diameter of 10 μm) is reciprocatedly inserted from the upper bottom fabric and the lower bottom fabric through the loop structure to the aggregate supported by the support rod, the support rod is pulled out to obtain a fiber skeleton;

[0152] (6) The fiber skeleton, hydrogel matrix and water were placed together in a meniscus scaffold mold, first heated to 120 °C in a high-pressure steam cooker to completely dissolve the hydrogel matrix, and then pre-cooled, freeze-dried and annealed in sequence to obtain a biomimetic textile-based meniscus scaffold; wherein, the freeze-drying time was 48 h, the annealing temperature was 120 °C, and the annealing time was 2 h.

[0153] The final biomimetic textile-based meniscus scaffold is composed of a hydrogel and a fiber skeleton composited with it;

[0154] The hydrogel has a water content of 70 wt%, a compression modulus of 1 MPa, an energy dissipation rate of 60%, and a friction coefficient of 0.099;

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

[0156] The upper base fabric, the lower base fabric and the spacer yarn together constitute the spacer fabric. The spacer fabric is half-moon-shaped, and the 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 wire is type IXI;

[0158] The biomimetic textile-based meniscus scaffold has a circumferential tensile modulus of 300 MPa, a radial tensile modulus of 10 MPa, an outer tensile modulus of 300 MPa, an inner tensile modulus of 100 MPa, and a hoop stress of 350 MPa.

[0159] After fixing the bionic textile-based meniscus scaffold to simulate the physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was 0.099 MPa when the strain was 10%. When the strain was greater than 10%, the compression modulus increased with the increase of strain. The compression modulus was 300 MPa when the strain was 80%. The compression-stretch coupling coefficient was 60% when the strain was 10%, 80% when the strain was 30%, and 95% when the strain was 80%.

Claims

1. A bionic textile-based meniscus scaffold, characterized in that: It includes a hydrogel (1-5) and a fiber skeleton composited therewith; The fiber skeleton comprises an upper bottom surface fabric (1-1), a lower bottom surface fabric, spacer yarns (1-4) and an aggregate (1-2); The upper bottom fabric (1-1), the lower bottom fabric and the spacer yarn (1-4) together constitute a spacer fabric, which is half-moon shaped and has a thickness that increases from the inner periphery to the outer periphery. The aggregate (1-2) is composed of a plurality of fiber bundles bent into an arc shape and having the same bending direction. The aggregate (1-2) is crescent-shaped, 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 interlaced back and forth between the upper bottom fabric (1-1) and the lower bottom fabric by the spacer yarn (1-4) through the loop structure.

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

3. The bionic textile-based meniscus scaffold according to claim 1, characterized in that: The upper base fabric (1-1) and the lower base fabric are both warp knitted fabrics made of medical grade ultra-high molecular weight polyethylene fiber bundles with a diameter of 10-20 μm, with a surface density of ≥70 fibers / cm 2 , tensile modulus ≥200MPa.

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

5. The bionic textile-based meniscus scaffold according to claim 1, characterized in that: The inner circumferential thickness of the spacer fabric is 1-2 mm, the outer circumferential 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, characterized in that: 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) is <40 fibers / cm from the inside to the outside. 2 Increase to >70 strands / cm 2 .

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

1.

8. The bionic textile-based meniscus scaffold according to any one of claims 1 to 7, characterized in that: The circumferential tensile modulus of the biomimetic textile-based meniscus scaffold is 200-300 MPa, and the radial tensile modulus is 1-10 MPa; The biomimetic textile-based meniscus scaffold has an outer tensile modulus of 200-300 MPa and an inner tensile modulus of 10-100 MPa; The hoop stress of the biomimetic textile-based meniscus scaffold is >200MPa; After fixing the bionic textile-based meniscus scaffold to simulate the physiological state, its compression modulus was measured through a constrained compression test. The compression modulus was ≤0.1MPa when the strain was 10%. When the strain was greater than 10%, the compression modulus increased with the increase of strain. When the strain was 80%, the compression modulus was >200MPa. 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%.

9. A method for preparing a biomimetic textile-based meniscus scaffold according to any one of claims 1 to 8, characterized in that: The following steps are involved: (a) An upper base fabric (1-1) and a lower base fabric are constructed using a warp knitting machine, both of which are half-moon shaped; (b) preparing an aggregate (1-2) supported by a support rod, wherein the support rod is used to control the arrangement density of the fiber bundles in the aggregate (1-2); (c) adjusting the upper bottom fabric (1-1) and the lower bottom fabric so that their bending directions are the same and the spacing increases from the inside to the outside, inserting the assembly (1-2) supported by the support rod between the upper bottom fabric (1-1) and the lower bottom fabric, the bending direction of the assembly (1-2) supported by the support rod being the same as the bending direction of the upper bottom fabric (1-1) and the lower bottom fabric, and the two ends of the assembly (1-2) supported by the support rod being exposed from between the upper bottom fabric (1-1) and the lower bottom fabric; (d) reciprocatingly inserting the spacer yarn (1-4) from the upper bottom fabric (1-1) and the lower bottom fabric through the loop structure into the aggregate (1-2) supported by the support rod, and then removing the support rod to obtain a fiber skeleton; (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.

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