TWI765500B - Tissue scaffold for use in tendon and/or ligament - Google Patents

Abstract

The present disclosure provides a tissue scaffold for use in tendon and/or ligament, wherein the tissue scaffold comprises a textile formed by interweaving warp yarns and weft yarns, and the warp yarns comprises fibers having a special-shaped cross-sectional structure, and the textile comprises: a main area with the bioactive substances formed on the surface of its fiber; and a fixed area containing the bioceramic material weft. With the advantages of stimulating tissue proliferation and inducing tissue repair, the tissue scaffold has the ability of improving tissue regeneration and bone healing, and thus can be beneficial to the reconstruction behavior of tendon and/or ligament tissue.

Description

Tissue scaffolds for tendons and/or ligaments

The present disclosure relates to a scaffold for tissue engineering, and more particularly, to a tissue scaffold for tendon and/or ligament injury.

Tendon or ligament tear or rupture injury is a common clinical sports injury, especially when the injury occurs on the cruciate ligament in the knee joint, due to its biological environment and limited blood supply, the ligament tissue is There is no natural healing ability after fracture, and reconstruction works are required through surgery.

Regarding the reconstruction of tendon or ligament, it can be divided into autograft, allograft and artificial graft according to the type of repair material. Although autografts have good reconstruction effects and no immune rejection, they have problems such as complications in the donor area; while allografts are not only expensive, but also have risks of immune rejection and disease transmission. Recently, artificial grafts have gradually attracted the attention of the medical community due to their convenient materials, no risk of disease transmission, and high mechanical strength. However, artificial grafts only have mechanical load-bearing effects, not biological activity and tissue induction, which are not conducive to tendons. The bone interface heals, and the cells and tissues on the surface of the artificial ligament cannot grow normally to form normal tendon or ligament tissue. After long-term use, the artificial graft is prone to problems such as fatigue, wear and tear, which leads to instability of the knee joint, and the worn fragments are also likely to cause iatrogenic diseases such as hydrops in the joint cavity.

In view of this, it is necessary to propose a biologically active and tissue-inducing tissue scaffold to solve the problems of fatigue, wear, fracture and poor stability of existing artificial grafts after long-term use.

The present disclosure provides a tissue scaffold for tendons and/or ligaments, comprising a fabric body interlaced by warp yarns and weft yarns, wherein the warp yarns include a plurality of fibers with a special-shaped cross-sectional structure, and the weave system includes: a main body area with a bioactive substance on the fiber surface of the main body area, the bioactive substance can be further impregnated into the pores of the main body area; and a fixed area, wherein the fixed area is formed on both sides of the main body area, and The weft yarn contains bioceramic material.

According to the present disclosure, through the unique design of the texture structure, and the corresponding bioactive materials are combined according to the tissue scaffold segments, more cell attachment areas and a good proliferation environment are provided, and the activity of tissue cells and bone is effectively improved. and proliferative ability, and it is beneficial to the reconstruction behavior of tendon and/or ligament tissue, and it has practical application prospects.

The following describes the implementation of the present disclosure through specific embodiments, and those skilled in the art can easily understand the advantages and effects of the present disclosure from the content disclosed in this specification. The present disclosure can also be implemented or applied by other different embodiments, and various details in this specification can also be given different modifications and changes based on different viewpoints and applications without departing from the spirit disclosed in the present disclosure. Furthermore, all ranges and values herein are inclusive and combinable. Any value or point falling within a range described herein, eg, any integer, can be taken as a minimum or maximum value to derive a lower range, etc.

According to the present disclosure, a tissue scaffold for tendons and/or ligaments is provided. As shown in FIG. 1 , the tissue scaffold 1 is composed of a fabric formed by interlacing warp yarns 101 and weft yarns 110 and 120. . The warp yarn 101 includes a plurality of fibers with a special-shaped cross-sectional structure, the plurality of fibers constitute the warp yarn, and the weaving system includes: a main body area 11, and a biologically active substance is formed on the surface of the fibers, and the biologically active substance can be combined Further impregnation into the pores of the main body region 11 ; and forming the fixing regions 121 and 122 on both sides of the main body region and containing the bioceramic material weft yarn 120 .

As used herein, the "warp" refers to the yarn that extends along the length of the loom during weaving, serves as the main support structure in the fabric, and is tied to the direction of tension when performing the stretching action of tendons and/or ligaments. Again, as shown in FIG. 1 , the warp yarns 101 of the main body region 11 and the fixing regions 121 and 122 of the tissue scaffold of the present disclosure are integrally formed; yarns perpendicular to each other.

The warp yarns and weft yarns are formed by twisting and pulling a plurality of fibers. In a specific embodiment, the warp yarns in the tissue scaffold of the present disclosure are twisted and reach 200 to 800 Denier. The weft yarn is twisted to 50 to 100 Denier.

In this article, the "texture" is woven by warp and weft in an interlaced and or mutually perpendicular manner, and the interlaced points formed therefrom can be arranged continuously or discontinuously, and can be selected periodically or not. The rules change the position of its interweaving point.

In a specific embodiment, the size of the tissue mesh of the tissue scaffold of the present disclosure is 0.1 to 1 mm, and the tissue mesh provides sufficient growth space for cells, and provides gas exchange and nutrients required for cell growth. Metabolism and other transport space.

On the other hand, the weaving system of the present disclosure is not limited to a single-layer weave structure, but also includes a multi-layer upper and lower weave structure. In a specific embodiment, the thickness or diameter of the fabric is 1.0 to 10 mm.

In the tissue scaffold of the present disclosure, the texture material can be a polymer material or a polymer composite material, wherein the polymer composite material includes other fillers, such as carbon fiber, in addition to the polymer material. Molecular materials are selected in consideration of mechanical properties, stability, wear resistance and biocompatibility of their applications, but are not limited to their types.

In a specific embodiment, the polymer material can be polyethylene terephthalate, polyethylene, polytetrafluoroethylene, polyurethane, polycaprolactone, polylactic acid, polyglycolic acid, One of polyetheretherketone, polyetherketoneketone and other materials, or a mixture or copolymer thereof. Among them, the polyethylene system may include ultra-high molecular weight polyethylene.

In another embodiment, the fabric material is polyethylene terephthalate.

In this article, the "special-shaped cross-sectional structure" refers to a fibrous structure with a non-circular cross-section, which has a high fiber surface area and has the effect of improving the adhesion of tissue cells. In a specific embodiment, the warp fibers of the present disclosure may have an H-shaped cross-section, an S-shaped cross-section, a W-shaped cross-section, a Y-shaped cross-section, or a cross-shaped cross-section.

In the tissue scaffold of the present disclosure, the thickness of the fibers of the fabric corresponds to the overall surface area thereof, thereby affecting the surface properties and mechanical properties of the fabric. In a specific embodiment, the long axis diameter of the fibers with a special-shaped cross-sectional structure contained in the warp yarn is 15 to 50 microns, and the diameter of the fibers constituting the weft yarns of the fabric is 20 to 50 microns; in another specific embodiment In an embodiment, the warp yarns contain fibers with a profiled cross-sectional structure with a fineness of 1.5 to 50 denier, and the weft fibers constituting the fabric have a fineness of 40 to 100 denier. 2, which illustrates a practical embodiment of the tissue scaffold of the present disclosure. The "main body area" 11 refers to the part of the body that is exposed outside the bone, and the "fixation area" 121, 122 refers to implanted bone, such as for connection with proto-tendon and/or ligament tissue. The textured part of the bone.

In order to further induce tendon and/or ligament tissue repair, there is a bioactive substance on the fiber surface of the main body area. Wherein, the biologically active substance is collagen.

In a specific embodiment, the modification of the tissue scaffold containing biologically active substances of the present disclosure is prepared by the following steps: providing a reaction solution containing biologically active substances; and The bulk region is contacted with the reaction solution.

In addition to containing biologically active substances, the "reaction solution" includes a solvent and a pH adjuster.

The above-mentioned biologically active substances are, for example, collagen, gelatin, fibroin and the like.

In another embodiment, the bioactive substance contains collagen, and the collagen accounts for 0.5 to 5 wt % of the total weight of the main body region.

In other embodiments, the weight ratio of the collagen to the total weight of the main body region may be 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 or 4.5 wt %, and not limited to This is limited.

In a specific embodiment, in the reaction solution, the biologically active substance is collagen, the solvent is an aqueous acetic acid solution with pH≤3.0, and the pH adjuster is phosphate buffered saline and sodium hydroxide , the specific preparation method includes: dissolving 0.1 g of the collagen powder in 60 ml of acetic acid aqueous solution, adding 1 g of the main body area of the texture, then adding 40 ml of phosphate buffered saline and adjusting the pH value with sodium hydroxide 7.5, allowing the collagen to form on the surface of the fibers in the bulk region.

In another embodiment, the solid content of the collagen dissolved in the acetic acid is 0.01 to 0.1 wt %, and the reaction temperature of the main body region and the reaction solution is 20 to 40 ^° C, and the reaction time is 24 to 24 °C. 48 hours.

Besides, the modified main body region of the present disclosure can further contain other substances that stimulate cell proliferation, such as gelatin, silk protein, keratin and the like.

Regarding the above-mentioned fixed area weft yarns, in order to effectively improve the healing ability of the bone interface, bioceramic materials are added therein. In one embodiment, the bioceramic material is calcium phosphate, calcium sulfate, bioglass or a combination thereof; in one embodiment, the calcium phosphate can be hydroxyapatite or tricalcium phosphate.

In another embodiment, the bioceramic material is hydroxyapatite, and the average particle size thereof is 10 to 200 nanometers.

In an embodiment, the bioceramic material is present in the weft yarns of the fixed area, and the bioceramic material accounts for 1 to 4 wt % of the total weight of the weft yarns of the fixed area. In another embodiment, the bioceramic material accounts for more than 1 wt % to 4 wt % of the total weight of the fixed area weft yarns. When the weight ratio of the bioceramic material is too low, the bone growth cannot be improved. If the weight ratio of the bioceramic material is too high, the fibers are easily broken during spinning.

In other embodiments, the weight ratio of the bioceramic material to the total weight of the weft yarns in the fixed area may be 1.5, 2.0, 2.5, 3.0 or 3.5 wt %, but not limited thereto.

On the other hand, the weft yarn containing the bioceramic material and the weft yarn not containing the bioceramic material can be selected in the fixed area of the present disclosure at the same time, or each weft yarn contains the bioceramic material. In an embodiment, the number ratio of the weft yarns containing the bioceramic material to the weft yarns not containing the bioceramic material is 1:9 to 10:0; in another embodiment, the fixed area of the present disclosure The weft yarn containing the bioceramic material can be used alone.

The weft fibers in the fixed region containing the bioceramic material of the tissue scaffold of the present disclosure are prepared by the following steps: providing a masterbatch incorporating a bioceramic material; and Spinning is performed with this master batch.

In a specific embodiment, the master batch comprises the above-mentioned texture material and bioceramic material, and the content of the bioceramic material accounts for 1 to 4 wt % of the master batch.

In addition to the above-mentioned texture material and bio-ceramic material, the master batch includes a dispersant. The dispersant can be a polyester polymer material, and the content of the dispersant is 0.1 to 2 wt % of the master batch.

In a specific embodiment, the specific preparation method of the master batch includes: kneading and granulating polyethylene terephthalate, hydroxyapatite and polyester dispersant to form the master batch.

The present disclosure is further described in detail below through specific embodiments, but the scope of the present disclosure is not limited by the description of the embodiments.

Example 1 : Preparation of tissue scaffolds

Preparation of warp yarn: Polyethylene terephthalate is hot melt spinning at above 270°C through a special-shaped cross-section spinning nozzle to obtain semi-stretched yarns, and then stretched at a temperature of 100 to 200 °C to obtain fully-stretched yarns.

Preparation of weft yarn: The preparation method of weft yarn is the same as the preparation method of warp yarn above, but the special-shaped section spinning nozzle is adjusted to a circular one.

When preparing weft yarns containing bioceramics, use masterbatches mixed with bioceramics instead, wherein, the preparation method of masterbatches mixed with bioceramics is prepared by the following steps: mixing polyethylene terephthalate, average particle size The hydroxyapatite with a diameter of 60 nm and the polyester dispersant are mixed and granulated to form a masterbatch mixed with 2% by weight of the bioceramic material.

Fabric preparation: According to the main body area and fixed area of the fabric body shown in Figure 1, the warp and weft yarns are selected for interlaced weaving, and the main body area is brought into contact with the reaction solution containing biologically active substances.

Regarding the above-mentioned reaction solution, collagen is used as the biologically active substance. In addition to containing the biologically active substance, the reaction solution also includes a solvent and a pH adjuster, wherein the solvent is an aqueous acetic acid solution with pH≦3.0, and the pH adjustor The ingredients are phosphate buffered saline and sodium hydroxide, and the specific modification method is prepared by the following steps: dissolve 0.1 g of the collagen powder in 60 ml of acetic acid aqueous solution, add 1 g of the main body area of the texture to the , and then add 40 ml of phosphate buffered saline and adjust the pH to 7.5 with sodium hydroxide. After 48 hours of reaction at a reaction temperature of 20 to 40 ^° C, the collagen is formed on the surface of the fiber in the main body region.

Finally, the tissue body of the tissue scaffold prepared above was cut into an appropriate size, and the following cell tests and analysis were performed: (1) Determination of the number of cell proliferation and cell attachment rate: First, the tissue body of the main body area of this example (with an area of 1 cm) was taken. ² ) Put it in a 48-well dish, drop a small amount of cell suspension (20 μl) on its surface, let it stand for 2 hours in a 37 ^o C temperature incubator, add 0.8 ml of bone marrow mesenchymal stem cell culture medium, without sticking At this point, the cells will be taken away from the surface of the tissue fibers by the culture medium; after overnight culture, the tissue with attached cells is transferred to a new 48-well dish, added with 0.3 ml PrestoBlue and incubated at 37 ^o C temperature. In this case, the PrestoBlue is reduced to pink after the action of nicotinamide adenine dinucleotide (NADH) dehydrogenase in the mitochondria, which can transmit fluorescence (Ex/Em: 560 nm/590 nm) to detect the number of reacting cells; after 1 hour of reaction, remove 100 ul of the reactant and move it to a 96-well plate for analysis, and detect its fluorescence reading (Ex/Em: 560 nm/590 nm), and according to the standard curve , the number of cells attached to the fiber surface was quantified by interpolation, and the results of the number of cell proliferation and the rate of cell attachment were recorded in Figure 3 and Figure 4, respectively. 3 and 4, it can be seen that the tissue scaffold of this embodiment has the effect of significantly enhancing the cell proliferation ability and cell adhesion due to the warp fibers with a special-shaped cross-sectional structure and the surface modification of the main body region of the texture. (2) Determination of ALP activity of osteogenic enzymes: The ALP activity of osteogenic enzymes was determined by using mesenchymal stem cells (MSCs), wherein the cell seeding density was 5× ^{10 4} /cm ² , and the bone differentiation medium was α-MEM containing 10% fetal bovine Serum (FBS), ascorbic acid (50 μg/ml), dexamethasone (0.1 μM), β-sugar phosphate (10 mM); while the control medium was α-MEM, containing 10% FBS, collected on the seventh and day 14 samples were analyzed, and the osteogenic enzyme ALP activity was measured with the pNPP alkaline phosphatase assay kit (SensoLyte ® ) and Microplate reader (Biotek, Synergy™ H1). (dish) The results of the ALP activity of the osteogenic enzyme were used as a control. It is obvious that the tissue scaffold of this example contains bioceramic materials, thereby enhancing the effect of the ALP activity of the osteogenic enzyme, indicating that the tissue scaffold of the present disclosure can effectively promote bone regeneration. (3) Determination of bone differentiation ability: calcium deposition analysis was performed using mesenchymal stem cells (MSC), wherein the cell seeding density was 5× ^{10 4} /cm ² , and the bone differentiation medium was α-MEM, containing 10% fetal bovine serum (FBS), Ascorbic acid (50 μg/ml), dexamethasone (0.1 μM), β-sugar phosphate (10 mM); while the control medium was α-MEM with 10% FBS, collected on days 7, 14 and 21 Samples were analyzed and cell samples were treated with culture medium and stained with alizarin red to assess calcium deposition on days 7, 14 and 21 and recorded in FIG. 6 . It can be seen from the results in FIG. 6 that the tissue scaffold of this example contains bioceramic materials, and its calcium deposition is significantly increased, indicating that the tissue scaffold of the present disclosure has the ability to promote the bone differentiation of mesenchymal stem cells.

Next, the tissue scaffolds prepared above were subjected to subsequent animal experiments.

Animal experiment of ligament reconstruction surgery: New Zealand white rabbits were used as the animal model of Medial Collateral Ligament (MCL) reconstruction surgery. 0.5 ml/kg) for anesthesia, open the knee joint of the hind limb with a scalpel, drill a bone tunnel in the femur and tibia respectively, and then pass the tissue scaffold through the bone tunnel at the tibial end, and then penetrate into the bone tunnel at the femoral end and the tibial end. The femur is fixed with a metal button, and the femoral end is fixed with a metal bone nail. Finally, the removed layers of tissue and skin are sutured to complete the operation.

Finally, the following analyses of the tissue scaffolds were performed 1 or 3 months after implantation in animals as described above: (1) Scanning electron microscope observation: Scanning electron microscope (QUANTA 400F/Thermo Scientific™) was used to observe the tissue growth on the cross-section and surface of the tissue scaffold implanted in the animal experiment for 3 months. It can be seen from Fig. 7A that fibroblasts are observed on the fiber surface of the tissue scaffold of the present embodiment; as can be seen from Fig. 7B and Fig. 7C, collagen fibers and soft tissue are distributed inside and on the surface of the tissue scaffold, forming a tissue network with a rope-like structure. The tissue scaffolds of this embodiment are tightly wrapped, showing that the tissue scaffolds of this embodiment have excellent biocompatibility and biological activity, and can induce the regeneration of tendon and ligament tissues (fibroblasts and collagen fibers). (2) Observation of tissue sections: paraffin-embedded tissue sections were then stained with hematoxylin-eosin and Masson's trichrome to observe the tissue growth of the tissue scaffolds implanted in animal experiments for 3 months. In both the xylin-eosin staining (Fig. 8A) and Masson's trichrome staining (Fig. 8B), it can be seen that the periphery and the inner space of the tissue scaffold of this embodiment are filled with new cells and collagen fibers. The tissue scaffold has the effect of promoting the regeneration of tendon and ligament tissue (cells and collagen fibers) (that is, ligamentation of the tissue scaffold). (3) Micro-computed tomography (micro-CT): Micro-computed tomography (Bruker micro-CT, Kontich, Belgium) was used to analyze the fixation of the tissue scaffolds in the bone tunnel 3 months after implantation in animal experiments. It can be seen from 9A and 9B that the tissue scaffold fixed in the bone tunnel of this embodiment has formed new bone, and it is obvious that the tissue scaffold of this embodiment has the ability to heal the interface between the implant and the bone (that is, the ability of osseointegration). (4) Biomechanical test: use a tensile testing machine (INSTRON 3400) to measure the mechanical strength of the tissue scaffold fixed to the bone tunnel, first cut off the metal buckle that fixes the specimen on the tibia, and then move the specimen to the test stage And fix, test its tissue scaffold after implantation in animal experiments for 1 month and 3 months, and finally pull out the tibia or the final fracture force, as can be seen from Figure 10, because the tissue scaffold of this example has a unique texture structure It is designed and has excellent osseointegration ability, so it can withstand large tensile tension, thereby improving the mechanical properties of its tissue scaffold.

Example 2 to 5 : Different cross-sectional structures of warp fibers

The preparation method of the tissue scaffold is the same as that in Example 1, except that the cross-sectional structures of the warp fibers are changed to be H-shaped, S-shaped, W-shaped and cross-shaped; then, the prepared tissue scaffolds are Cell proliferation number determination and cell attachment rate analysis were performed and recorded in Figures 3 and 4 .

Example 6 : Different concentrations of bioceramic materials

The preparation method of the tissue scaffold was the same as that in Example 1, except that the content of bioceramic material was changed to 4%; then, the prepared tissue scaffold was subjected to osteogenesis enzyme activity analysis, and recorded in FIG. 5 .

Comparative example 1

The preparation method of the tissue scaffold is the same as that of Example 1, except that the cross-sectional structure of the warp fibers is changed to a circular cross-section; then, the tissue scaffolds prepared are subjected to cell proliferation quantity determination and cell adhesion rate analysis, and recorded in 3 and 4.

Comparative example 2

The preparation method of the tissue scaffold is the same as that in Example 1, except that the surface of the tissue body in the main body area is not modified; then, the tissue scaffolds prepared are subjected to the determination of the number of cells proliferating and the analysis of the cell adhesion rate, and recorded in Figure 3 and Figure 4.

Comparative example 3 to 7

The preparation method of the tissue scaffold is the same as that of Comparative Example 2, except that the cross-sectional structure of the warp fibers is changed into a circular cross-section, an H-shaped cross-section, an S-shaped cross-section, a W-shaped cross-section and a cross-shaped cross-section. The prepared tissue scaffolds were subjected to the determination of the number of cells proliferating and the analysis of the cell attachment rate, which were recorded in Fig. 3 and Fig. 4 .

Comparative example 8

The preparation method of the tissue scaffold was the same as that of Example 1, except that the bioceramic material was not added; then, the prepared tissue scaffold was subjected to osteogenesis enzyme activity analysis, which was recorded in FIG. 5 .

Comparative example 9

The preparation method of the tissue scaffold was the same as that of Example 1, except that the content of the bioceramic material was adjusted to 1%; then, the prepared tissue scaffold was subjected to osteogenesis enzyme activity analysis, which was recorded in FIG. 5 .

Comparative example 10

Carry out the animal test of the ligament reconstruction surgery of above-mentioned embodiment 1 with commercially available tissue scaffolds (Orthomed, LCA60NEF), then, the above-mentioned tissue scaffolds are subjected to analysis such as surface observation, tissue sectioning, micron-level computed tomography and biomechanical testing, and Recorded in Figures 7D-7E, Figures 8C-8D, Figures 9C-9D, and Figure 10.

To sum up, the present disclosure is to combine the corresponding bioactive materials according to different sections of the tissue scaffold to induce the regeneration of the tendon or ligament tissue and improve the osseointegration ability, and then gradually form the tendon or ligament tissue similar to autologous, The problems of fatigue, wear, fracture and poor stability of the existing artificial graft after long-term use are solved.

The above-mentioned embodiments are only illustrative, and are not intended to limit the present disclosure. Any person skilled in the art can modify and change the above embodiments without departing from the spirit and scope of the present disclosure. Therefore, the protection scope of the right of the present disclosure is defined by the scope of the patent application attached to the present disclosure, and shall be included in the technical content of this disclosure as long as the effect and implementation purpose of the present disclosure are not affected.

1: Tissue scaffold 11: Main body area 101: Warp 110, 120: weft yarn 121, 122: Fixed area

Embodiments of the present disclosure are described by way of illustrative reference to the accompanying drawings: 1 is a schematic structural diagram of the tissue scaffold of the present disclosure; 2 is a schematic diagram of the actual use state of the tissue scaffold of the present disclosure; 3 is a graph comparing the number of cells proliferating in the tissue scaffolds of the disclosed examples and comparative examples, wherein, from left to right, each group of examples and comparative examples are D1, D3, and D7, respectively, and D1, D3, and D7 represent respectively The number of cells after 1, 3 and 7 days of culture on the surface of tissue fibers; FIG. 4 is a graph comparing the cell attachment rates of the tissue scaffolds of the disclosed embodiment and the comparative example; FIG. 5 is a graph showing the comparison of the ALP activities of the osteogenic enzyme on the 7th and 14th days of cell culture of the tissue scaffolds of the disclosed examples and the comparative examples, wherein the groups on the 7th day and the 14th day are respectively from left to right: 0%, 1%, 2%, 4% and dish, and 0% means that the surface of the fabric fiber without adding its bioceramic material is cultured in Comparative Example 8; 1% means that the content of the bioceramic material is 1% by weight of the fabric fiber Surface culture comparative example 9; 2% means that the content of bioceramic material is 2 wt% of the texture fiber surface culture Example 1; 4% means that the content of bioceramic material is 4 wt% of the texture fiber surface culture Example 6; dish means not cultured on the surface of the tissue fibers, but only the ALP activity results of the osteogenic enzyme cultured on the cell culture plate are used as a control; 6 is a graph showing the comparison of calcium deposition staining of the tissue scaffolds of the disclosed embodiment and the comparative example on the 7th day, the 14th day and the 21st day of cell culture; 7A to 7C are scanning electron microscope images of the tissue scaffolds according to the disclosed embodiments promoting tendon and ligament tissue regeneration; 7D to 7E are scanning electron microscope images of commercially available tissue scaffolds; 8A to 8B are histological sections of the tissue scaffolds stained with hematoxylin-eosin and Masson's trichrome staining, respectively; Figures 8C to 8D are respectively histological sections of commercially available tissue scaffolds stained with hematoxylin-eosin and Masson's trichrome; FIGS. 9A-9B are micro-computed tomography images of the tissue scaffolds according to the disclosed embodiments of the invention; 9C to 9D are micro-computed tomography images of commercially available tissue scaffolds; and FIG. 10 is a comparison diagram of the mechanical strength of the tissue scaffold in the bone tunnel in the first month and the third month of the disclosed embodiment and the comparative example.

1: Tissue scaffold

11: Main body area

101: Warp

110, 120: weft yarn

121, 122: Fixed area

Claims (8)

A tissue scaffold for tendons and/or ligaments, comprising a fabric body with a mesh size of 0.1 to 1 mm formed by interlaced warp yarns and weft yarns, wherein the warp yarns comprise a plurality of fibers with a special-shaped cross-sectional structure, and The weaving system includes: a main body area with a biologically active substance on its fiber surface; and a fixed area, wherein the fixed area is formed on both sides of the main body area, and the weft yarn contains a bioceramic material, wherein the bioceramic The material accounts for 1 to 4 wt % of the total weight of the weft yarns in the fixed area, and the warp yarns in the fixed area do not contain the bioceramic material. The tissue scaffold according to claim 1, wherein the long axis diameter of the fibers with a profiled cross-sectional structure contained in the warp yarns is 15 to 50 microns, and the diameters of the weft yarns constituting the fabric are 20 to 50 microns in diameter. The tissue scaffold according to claim 1, wherein the special-shaped section structure comprises an H-shaped section, an S-shaped section, a W-shaped section, a Y-shaped section or a cross-shaped section. The tissue scaffold according to claim 1, wherein the warp yarns contain fibers with a special-shaped cross-sectional structure with a fineness of 1.5 to 50 denier, and the weft yarns constituting the fabric have a fineness of 40 to 100 denier. Ni. The tissue scaffold according to claim 1, wherein the material of the fabric comprises polyethylene terephthalate, polyethylene, polytetrafluoroethylene, polyurethane or a combination thereof. The tissue scaffold of claim 1, wherein the bioactive substance contains collagen, and the collagen accounts for 0.5 to 5% by weight of the total weight of the main body region. The tissue scaffold of claim 1, wherein the bioceramic material comprises calcium phosphate, calcium sulfate, bioglass or a combination thereof. The tissue scaffold according to claim 1, wherein the bioceramic material is hydroxyapatite, and its average particle size is 10 to 200 nanometers.

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