JP2022104790A - Tissue scaffold for use in tendon and/or ligament - Google Patents

Abstract

To propose a tissue scaffold with a biological activity and tissue induction to improve fatigue, abrasion, fracture and poor stability of existing artificial grafts after long-term use.SOLUTION: A tissue scaffold for use in a tendon and/or ligament is provided, which includes a weave formed by interlacing warp yarns and weft yarns, where the warp yarns include a plurality of fibers with an alternative shaped cross section structure. The weave includes a main body area with a bioactive component formed on the fiber surface, and a fixed area with weft yarn including a bio-ceramic material. The tissue scaffold prepared in the present disclosure has characteristics of stimulating growth of tissues and inducing tissue repair, effectively improving an ability of tissue regeneration and bone healing, and is beneficial to reconstruction of the tendon and/or ligament.SELECTED DRAWING: Figure 1

Description

The present disclosure relates to scaffolds for use in tissue engineering, in particular tissue scaffolds for use in tendon and / or ligament injuries.

Tears or ruptures of tendons or ligaments, especially injuries that occur in the cruciate ligament of the knee joint, are common clinical sports injuries. Ligamentous tissue, due to its biological environment and limited blood supply, is incapable of healing spontaneously after rupture and must be surgically reconstructed.

Reconstruction of tendons and ligaments can be divided into autologous transplants, allogeneic transplants, and artificial transplants, depending on the type of repair material. Autologous transplants have a good reconstructive effect and do not have immune rejection, but have problems such as complications at the donor site. Allogeneic transplants are not only costly, but also at risk of immune rejection and disease transmission. On the other hand, artificial transplants have been attracting more and more attention in the medical community in recent years because of their convenient material acquisition, no risk of disease transmission, and high mechanical strength. However, the artificial implant has only a mechanical load-bearing effect and no biological activity and tissue induction suitable for healing the tendon / ligament and bone interface. In addition, the cells and tissues on the surface of the artificial ligament are difficult to grow to form normal tendon or ligament tissue. After long-term use, artificial implants are prone to fatigue, wear and fractures, which can lead to instability of the knee joint, and worn debris causes medical damage such as water accumulation in the joint cavity. It will be easier.

Therefore, it is necessary to propose a tissue scaffold with biological activity and tissue inducibility in order to improve fatigue, wear, tearing, and loss of stability of existing artificial implants after long-term use.

The present disclosure includes a woven fabric formed by interweaving warps and wefts, wherein the warps contain tissue scans for use in tendons and / or ligaments, including multiple fibers with alternative shaped cross-sectional structures. Provide a fold. The woven fabric includes a main body area and a fixed area, and the main body has a bioactive component on the fiber surface of the main body, and the bioactive component is a fine particle of the main body. The pores can be further impregnated, the fixing portions are formed on both sides of the body portion, and the wefts include a bioceramic material.

According to the present disclosure, through the design of a unique woven structure, by combining the corresponding bioactive materials respectively according to the section of tissue scaffold, more cell adhesion regions and a better growth environment are provided, soft tissue and bone. Effectively enhances tissue activity and proliferative capacity. This can be provided for the reconstruction of tendon and / or ligament tissue and has the prospect of its application.

The embodiments of the present disclosure will be described by reference to the drawings as an example.

It is a schematic diagram of the tissue scaffold by an exemplary embodiment. It is a schematic diagram of the actual use state of the tissue scaffold by an exemplary embodiment. It is a comparative figure of the number of proliferating cells of the tissue scaffold between the Example and the comparative example. Each group of Examples and Comparative Examples is D1, D3 and D7 from left to right, respectively, where D1, D3 and D7 are the number of cells cultured on the fiber surface of the fabric for 1, 3 and 7 days, respectively. Is shown. It is a comparative figure of the cell adhesion rate of the tissue scaffold of the Example and the comparative example by this disclosure. It is a comparative diagram of the bone-forming enzyme ALP activity on the 7th day and the 14th day of the cell culture of the tissue scaffold of the example and the comparative example. The 7th and 14th day groups are 0%, 1%, 2%, 4% and dish from left to right. 0% indicates the surface culture of the woven fiber to which the bioceramic material is not added in Comparative Example 8. 1% indicates the surface culture of the woven fiber containing 1% by weight of the bioceramic material in Comparative Example 9. 2% indicates surface culture of woven fibers containing 2% by weight bioceramic material in Example 1. 4% indicates surface culture of woven fibers containing 4% by weight bioceramic material in Example 6. Dish, as a control, means the result of bone-forming enzyme ALP activity, which is not cultured on the surface of the woven fiber and is cultured only on the cell culture plate. It is a comparative figure of the calcium deposition staining of the tissue scaffold on the 7th day, the 14th day and the 21st day of the cell culture of the example and the comparative example by this disclosure. FIG. 6 is a scanning electron micrograph of tendon and ligament tissue regeneration promoted by the tissue scaffold of the examples according to the present disclosure. FIG. 6 is a scanning electron micrograph of tendon and ligament tissue regeneration promoted by the tissue scaffold of the examples according to the present disclosure. FIG. 3 is a scanning electron micrograph of tendon and ligament tissue regeneration promoted by the tissue scaffold of the examples according to the present disclosure. It is a scanning electron microscope image of a commercially available tissue scaffold. It is a scanning electron microscope image of a commercially available tissue scaffold. Tissue sections stained with hematoxylin eosin and Masson's trichrome of the tissue scaffold of the examples according to the present disclosure, respectively. Tissue sections stained with hematoxylin eosin and Masson's trichrome of the tissue scaffold of the examples according to the present disclosure, respectively. Tissue sections stained with commercially available hematoxylin / eosin and Masson's trichrome, respectively. Tissue sections stained with commercially available hematoxylin / eosin and Masson's trichrome, respectively. It is a microcomputer tomographic image of the osseointegration ability promoted by the tissue scaffold of the embodiment according to the present disclosure. It is a microcomputer tomographic image of the osseointegration ability promoted by the tissue scaffold of the embodiment according to the present disclosure. It is a microcomputer tomographic image of a commercially available scaffold. It is a microcomputer tomographic image of a commercially available scaffold. It is a comparative figure of the mechanical strength of the tissue scaffold in the bone tunnel in the 1st month and the 3rd month of the Example and the comparative example by this disclosure.

Hereinafter, the technical contents of the present invention will be described with reference to specific embodiments. Those skilled in the art can easily understand the advantages and effects of the present invention by the contents described in the present specification. Also, this disclosure may be enforced or applied in other different forms, and the various details of this specification may differ, with different modifications and changes, without departing from the scope disclosed in this disclosure. It can also be based on viewpoints and applications. In addition, all ranges and values described herein are inclusive and can be combined. Any value or point within the range described herein, eg, any integer, can be used as the minimum or maximum value to derive lower ranges and the like.

The present disclosure provides tissue scaffolds for use in tendons and / or ligaments. As shown in FIG. 1, the tissue scaffold 1 is composed of a woven fabric formed by interweaving warp 101 and warp 110 and 120. The warp 101 includes a plurality of fibers having a cross-sectional structure having an alternative shape, and the plurality of fibers constitute the warp. The woven fabric includes a main body 11 and fixing portions 121 and 122, the main body 11 contains a bioactive component on the surface thereof, and the bioactive component may be further impregnated into the pores of the main body 11. good. Further, the fixing portions 121 and 122 include the bioceramic material weft 120 and are formed on both sides of the main body portion.

As used herein, the term "warp" refers to a yarn that stretches between woven fabrics along the length of the loom and is used as the main support structure for the woven fabric, in the direction of the ligaments and / or. It is the same as the direction of tension when performing the stretching action of the ligament. Further, as shown in FIG. 1, the fixing portions 121 and 122 of the tissue scaffold of the present disclosure and the warp 101 of the main body portion 11 are integrally formed. On the other hand, the term "warp and weft" refers to a thread interwoven with or perpendicular to a warp.

The warp and weft described above are formed by twisting and pulling a plurality of fibers. In certain embodiments, the warps in the tissue scaffolds of the present disclosure are twisted up to 200-800 denier and the wefts are twisted up to 50-100 denier.

As used herein, the term "woven" is woven in such a way that warps and wefts are interwoven or perpendicular to each other, and the weaving points formed thereby are continuous or non-continuous. It may be arranged continuously, and the positions of the weaving points may be selected periodically or irregularly.

In one embodiment, the tissue scaffold fabric of the present disclosure has a pore size of 0.1-1 mm, the pores of the fabric providing sufficient growth space for the cells, gas exchange during cell growth, nutrients. And provides a transport space for metabolism.

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

In the texture scaffold of the present disclosure, the material of the woven fabric may be a polymer material or a polymer composite material. Polymer composites include, in addition to polymer materials, other fillers such as carbon fibers. Polymeric materials are selected in consideration of their mechanical properties, stability, wear resistance and biocompatibility, but are not limited thereto.

In an exemplary embodiment, the polymer material is of polyethylene terephthalate, polyethylene, polytetrafluoroethylene, polyurethane, polycaprolactone, polylactic acid, polyglycolic acid, polyether ether ketone, polyether ketone, or mixtures or copolymers thereof. The polyethylene may include ultra-high molecular weight polyethylene.

In another particular embodiment, the material for the woven fabric is polyethylene terephthalate.

As used herein, the term "alternatively shaped cross-sectional structure" refers to a fiber structure with a non-circular cross section that has a relatively high fiber surface area and has the effect of enhancing cell adhesion. In one embodiment, the cross-sectional structure of the alternative shape of the warp fibers of the present disclosure may include 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 texture scaffold of the present disclosure, the fiber thickness of the fabric corresponds to the total surface area and affects the surface and mechanical properties of the fabric. In another embodiment, the diameter of the major axis of the fiber having the cross-sectional structure of the alternative shape contained in the warp is 15 to 50 μm (micrometer), and the diameter of the fiber of the warp and weft constituting the woven fabric is 20 to 50 μm. be. In another embodiment, the fineness of the fibers having an alternative shape cross-sectional structure contained in the warp is 1.5 to 50 denier, and the fineness of the fibers of the warp and weft constituting the woven fabric is 40 to 100 denier. be. As shown in FIG. 2, FIG. 2 shows an actual implementation of the organizational scaffold of the present disclosure. The "body portion" 11 refers to a portion of the fabric exposed to the outside of the bone, and the "fixing portions" 121 and 122 are used, for example, in the bone connected to the original tendon and / or ligament tissue. Refers to the part of the embedded fabric.

In order to further induce the repair of tendon and / or ligament tissue, there is a bioactive component on the fiber surface of the main body, and the bioactive component can be further impregnated into the pores of the main body to enhance the cell proliferation ability. .. Here, the biologically active ingredient is collagen.

In one embodiment, modification of the tissue scaffold containing the bioactive ingredients of the present disclosure is performed by the following steps:
A step of providing a reaction solution containing a biologically active ingredient, and a step of bringing the main body into contact with the reaction solution.

The term "reaction solution" includes a solvent and a pH regulator in addition to the biologically active ingredient.

The above-mentioned biologically active ingredients include collagen, gelatin, silk protein and the like.

In another embodiment, the bioactive ingredient comprises collagen, which accounts for 0.5-5% by weight of the total weight of the body.

In some embodiments, the weight ratio of collagen to the total weight of the body is about 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2.0, 2. It may be 5, 3.0, 3.5, 4.0 or 4.5% by weight, but is not limited thereto.

In an exemplary embodiment, the biologically active ingredient in the above reaction solution is collagen. The solvent is an acetic acid aqueous solution having a pH of ≦ 3.0. The pH regulators are phosphate buffered saline and sodium hydroxide. The specific preparation method is to dissolve 0.1 g of collagen powder in 60 ml of acetic acid aqueous solution, add 1 g of the main body of the fabric, then add 40 ml of phosphate buffered saline, and adjust the pH with sodium hydroxide. Includes adjusting to 7.5. Collagen is formed on the fiber surface of the main body.

In another embodiment, the solid content of collagen dissolved in acetic acid is 0.01 to 0.1% by weight, the reaction temperature between the main body and the reaction solution is 20 to 40 ° C., and the reaction time is 24 to 48. It's time.

In addition, the main body of the present disclosure can be modified to contain other cell proliferation stimulating components such as gelatin, silk protein and keratin.

A bioceramic material is added to the warp and weft of the above-mentioned fixed portion in order to effectively enhance the healing power of the bone interface. In one embodiment, the bioceramic material is, for example, calcium phosphate, calcium sulfate, bioglass, or a combination thereof. In one embodiment, the calcium phosphate may be hydroxyapatite or tricalcium phosphate.

In another embodiment, the bioceramic material is hydroxyapatite, the average particle size thereof being about 10-200 nm (nanometers).

In one embodiment, the bioceramic material is present in the warp and weft of the fixed portion, and the bioceramic material accounts for 1 to 4% of the total weight of the warp and weft of the fixed portion. In another embodiment, the bioceramic material is greater than 1% by weight and less than or equal to 4% by weight of the total weight of the warp and weft in the fixation portion. If the weight ratio of the bioceramic material is too low, bone growth cannot be promoted. If the weight ratio of the bioceramic material is too high, it will be fragile when spinning the fibers.

In other embodiments, the weight ratio of the bioceramic material to the total weight of the warp and weft of the fixation may be about 1.5, 2.0, 2.5, 3.0, or 3.5% by weight. However, it is not limited to these.

On the other hand, the weft containing the bioceramic material and the weft not containing the bioceramic material can be selected for the fixing portion of the present disclosure, or each weft may contain the bioceramic material. In an exemplary embodiment, the ratio of warp and weft containing the bioceramic material to the warp and weft not containing the bioceramic material is from about 1: 9 to 10: 0. In another embodiment, the warp and weft containing the bioceramic material can be used alone in the fixed portion of the present disclosure.

The weft fibers containing the bioceramic material in the fixation part of the texture scaffold of the present disclosure are prepared by the following steps:
The process of providing a masterbatch mixed with a bioceramic material and the process of spinning in a masterbatch.

In certain embodiments, the masterbatch comprises the textile material and the bioceramic material, the content of the bioceramic material occupying 1 to 4% by weight of the masterbatch.

In addition to the above textile and bioceramic materials, the masterbatch system also includes dispersants. The dispersant may be a polyester polymer material and the dispersant content accounts for 0.1-2% by weight of the masterbatch.

In one embodiment, a particular method of making a masterbatch comprises the steps of forming a masterbatch by mixing and granulating polyethylene terephthalate, hydroxyapatite and a polyester dispersant.

The present disclosure will be described in more detail below with reference to specific embodiments, but the scope of the present disclosure is not limited by the description of the embodiments.

[Example]
Example 1: Preparation of Tissue Scaffold Preparation of Warp: Fused Deposition Modeling of polyethylene terephthalate is performed to obtain a semi-drawn yarn from a cross-section spinning nozzle modified at a temperature of 270 ° C. or higher, and then drawn at a temperature of 100 to 200 ° C. A fully stretched yarn with a Y-shaped cross section was obtained.

Warp and Weft Fabrication: The warp and weft fabrication method was the same as the warp and weft fabrication method described above, except that the modified cross-section spinning nozzle was adjusted to a circular spinning nozzle.

When preparing wefts containing bioceramic, a masterbatch incorporating bioceramic is used, where the method for preparing a masterbatch incorporating bioceramic is carried out in the following steps: polyethylene terephthalate, average. A step of mixing a hydroxyapatite having a particle size of 60 nm and a polyester dispersion to granulate the mixture to form a masterbatch containing 2% by weight of a bioceramic material.

Fabrication: Based on the woven fabric body and fixation shown in FIG. 1, warps and wefts were selected for interweaving and the body was contacted with a reaction solution containing a bioactive ingredient.

For the above reaction solution, collagen was used as a biologically active ingredient. In addition to the bioactive ingredients, the reaction solution also contains a solvent and a pH adjuster, the solvent is an aqueous acetic acid solution with pH ≧ 3.0 and the pH adjusters are phosphate buffered saline and sodium hydroxide. Met. The particular modification method comprises the following steps for preparation: dissolving 0.1 g of collagen powder in 60 ml of acetic acid aqueous solution, adding 1 g of the body of the fabric, then 40 ml of phosphate buffered saline. A step of adding water, adjusting the pH to 7.5 with sodium hydroxide, reacting at a reaction temperature of 20 to 40 ° C. for 48 hours, and then forming collagen on the fiber surface of the main body.

Finally, the tissue scaffold fabric prepared above was cut to the appropriate size and the following cell tests and analyzes were performed.

(1) Measurement of cell proliferation number and cell adhesion rate: The woven fabric (1 cm ² ) of the main body of this example was taken, placed in a 48-well plate, and a small amount of cell suspension (20 μl) was dropped on the surface to 37. Placed in the incubator at ° C for 2 hours. 0.8 ml of bone marrow mesenchymal stem cell culture medium was added, and non-attached cells were removed from the fiber surface of the fabric by the culture medium. After overnight culturing, the cell-attached fabric was transferred to a new 48-well plate and 0.3 ml PrestoBlue was applied in a 37 ° C. incubator. PrestoBlue was reduced to pink by nicotinamide adenine dinucleotide (NADH) dehydrogenase in mitochondria, and the number of cells that reacted could be detected by fluorescence (Ex / Em: 560 nm / 590 nm). After the reaction for 1 hour, 100 ul of the reactants were removed, transferred to a 96-well plate for analysis and the fluorescence reading (Ex / Em: 560 nm / 590 nm) was detected. The number of cells attached to the fiber surface is quantified by interpolation according to a standard curve, and the results of the number of cell proliferation and the cell adhesion rate are recorded in FIGS. 3 and 4, respectively. From the results of FIGS. 3 and 4, the tissue scaffold of this example has the effect of significantly improving cell proliferation and cell adhesion by surface modification of the main body of the woven fabric and the warp fibers having a cross-sectional structure of an alternative shape. You can see that.

(2) Measurement of ALP activity of bone-forming enzyme: The activity of bone-forming enzyme ALP was measured using mesenchymal stem cells (MSC). The cell seeding density was 5 × 10 ⁴ / cm ² , and the bone differentiation medium was 10% fetal bovine serum (FBS), ascorbic acid (50 μg / ml), dexamethasone (0.1 μM), and β-sugar phosphorus. The α-MEM containing the acid (10 mM) was included and the control medium contained the α-MEM containing 10% FBS. Samples were collected on days 7 and 14 for analysis. The activity of the bone-forming enzyme ALP is measured using a pNPP alkaline phosphatase detection kit (SensoLyte®) and a microplate reader (Biotek, Synergy® H1), and the results are recorded in FIG. The results of ALP activity on the cell culture plate (dish) were used as controls. Since the tissue scaffold of this example enhances the effect of the activity of the bone-forming enzyme ALP by containing the bioceramic material, it is clear that the tissue scaffold of the present disclosure can effectively promote bone regeneration. Is.

(3) Measurement of bone differentiation ability: Mesenchymal stem cells (MSC) were used for calcium deposition analysis. The cell seeding density was 5 × 10 ⁴ / cm ² , and the bone differentiation medium was 10% fetal bovine serum (FBS), ascorbic acid (50 μg / ml), dexamethasone (0.1 μM), and β-sugar phosphate. Α-MEM containing (10 mM) was included. Control medium contained α-MEM containing 10% FBS. Samples were collected on days 7, 14, and 21 for analysis. Cell samples are treated with medium and then stained with alizarin red to evaluate calcium deposition on days 7, 14, and 21 and record in FIG. The results of FIG. 6 show that the tissue scaffold containing the bioceramic material of this example significantly increases calcification. This indicates that the tissue scaffolds of the present disclosure have the ability to promote bone differentiation of mesenchymal stem cells.

The tissue scaffold prepared above was then used in subsequent animal experiments.

Animal Experiments for Ligament Reconstruction Surgery: A New Zealand white rabbit was used as an animal model for medial collateral ligament (MCL) reconstructive surgery. For preoperative anesthesia, an anesthetic (zoletil50: Lampun20 = 1: 1, 0.5 ml / kg) was used. The knee joint of the hind limb was opened with a scalpel, and bone tunnels were opened in the femur and tibia, respectively. The tissue scaffold was then pierced from the tibial end into the bone tunnel and then through the femoral end of the bone tunnel. The ends of the tibia were secured with metal buttons and the ends of the femur were secured with metal bone nails. Finally, the surgery was completed by suturing the separated layers of tissue and skin.

Finally, the following analysis was performed on the transplanted tissue scaffolds of the above animal experiments after 1 month or 3 months.

(1) Scanning electron microscope: Using a scanning electron microscope (QUANTA400F / Thermo Scientific (registered trademark)), the cross-sectional and surface tissue growth of the transplanted tissue scaffold was observed in an animal experiment after 3 months. .. From FIG. 7A, it can be seen that fibroblasts were observed on the fiber surface of the tissue scaffold of this example. In FIGS. 7B and 7C, it can be seen that the collagen fibrous soft tissue is distributed inside and on the surface of the tissue scaffold, forms a rope-like structure of the tissue network, and firmly covers the tissue scaffold of this example. The tissue scaffold of this example has excellent biocompatibility and bioactivity, indicating that it can induce the regeneration of tendon and ligament tissues (fibroblasts and collagen fibers).

(2) Tissue section: The tissue section was embedded in paraffin and stained with hematoxylin / eosin and Masson's trichrome stain. Tissue growth of the transplanted tissue scaffold in animal experiments after 3 months was observed. The perimeter and internal space of the tissue scaffold of this example can be filled with new cells and collagen fibrous tissue via both hematoxylin and eosin staining (FIG. 8A) and Masson's trichrome staining (FIG. 8B). I understand. It is clear that the tissue scaffold of this example has the effect of promoting the regeneration of tendon and ligament tissue (cells and collagen fibers), which means that the tissue scaffold is ligamentized.

(3) Microcomputer tomography analysis (micro-CT): Using microcomputer tomography (Bruker micro-CT, Kontich, Belgium), it was immobilized in a bone tunnel of a transplant in an animal experiment after 3 months. Tissue scaffold was analyzed. From FIGS. 9A and 9B, it can be seen that the tissue scaffold fixed to the bone tunnel of this example forms a new bone. It is clear that the tissue scaffold of this example has the ability to heal the interface between the implant and the bone (meaning it has the ability to osseointegrate).

(4) Biomechanical test: A tensile tester (INSTRON 3400) was used to measure the mechanical strength of the tissue scaffold fixed in the bone tunnel. First, the metal button holding the sample to the tibia was cut off, and then the sample was transferred to the test bench and fixed. Tissue scaffolds were tested for force to pull out of the tibia, or ultimately to rupture the tibia, one and three months after being implanted in animal studies. As shown in FIG. 10, the unique woven structure design and excellent osseointegration capability of the tissue scaffold of this example can withstand higher tensile tensions, thus improving the mechanical properties of the tissue scaffold. do.

Examples 2 to 5: Different cross-sectional structures of warp fibers Regarding the method for producing a tissue scaffold, the examples except that the cross-sectional structure of the warp fibers is changed to H-shaped, S-shaped, W-shaped and cross-shaped, respectively. It was the same as 1. The tissue scaffolds made are then used to measure the number of cell proliferations, analyze cell adhesion rates and record in FIGS. 3 and 4.

Example 6: Different Concentrations of Bioceramic Material The method for producing the tissue scaffold was the same as that of Example 1 except that the content of the bioceramic material was 4%. Next, the activity of the bone-forming enzyme in the prepared tissue scaffold is analyzed and recorded in FIG.

Comparative Example 1
The method for producing the tissue scaffold was the same as in Example 1 except that the cross-sectional structure of the warp fiber was a circular cross section. The tissue scaffolds made are then used to measure the number of cell proliferations, analyze cell adhesion rates and record in FIGS. 3 and 4.

Comparative Example 2
The method for producing the tissue scaffold was the same as in Example 1 except that the surface of the main body of the woven fabric was not changed. Next, using the prepared tissue scaffold, the number of cell proliferation is measured, the cell adhesion rate is analyzed, and it is recorded in FIGS. 3 and 4.

Comparative Examples 3 to 7
The method for producing the tissue scaffold was the same as in Comparative Example 2 except that the cross-sectional structures of the warp fibers were changed to 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, respectively. .. The tissue scaffolds made are then used to measure the number of cell proliferations, analyze cell adhesion rates and record in FIGS. 3 and 4.

Comparative Example 8
The method for producing the tissue scaffold was the same as in Example 1 except that the bioceramic material was not added. Next, the activity and bone differentiation ability of the bone-forming enzyme of the prepared tissue scaffold are analyzed and recorded in FIGS. 5 and 6.

Comparative Example 9
The method for producing the tissue scaffold was the same as in Example 1 except that the content of the bioceramic material was adjusted to 1%. Next, the activity of the bone-forming enzyme in the prepared tissue scaffold is analyzed and recorded in FIG.

Comparative Example 10
A commercially available tissue scaffold (Orthomed, LCA60NEF) was used in the animal test of ligament reconstruction surgery of Example 1. Next, the tissue scaffold was analyzed by surface observation, tissue section, micro CT, biomechanical test and the like. The results are recorded in FIGS. 7D-7E, 8C-8D, 9C-9D and 10.

Taken together, the present disclosure induces tendon or ligament regeneration by combining corresponding bioactive materials according to different sections of tissue scaffold, while at the same time improving osseointegration capacity. This gradually forms tendon and ligament tissues similar to those of the autologous, solving problems such as fatigue, wear, rupture and loss of stability of existing artificial implants after long-term use.

The embodiments described above are merely exemplary and are not intended to limit the scope of the invention. Those skilled in the art can modify or modify the above embodiments without departing from the spirit of the present invention. Accordingly, the scope of the claims of the present disclosure is limited by the claims of the invention, and the technical content of the present disclosure, as long as it does not affect the effectiveness and feasible purposes of the present disclosure. Should be included in.

1: Tissue scaffold 11: Main body 101: Warp 110, 120: Weft 121, 122: Fixed part

Claims (10)

Includes a woven fabric formed by interweaving warp (101) and warp (110, 120).
The warp (101) has a plurality of fibers, each having a cross-sectional structure of an alternative shape, and has a plurality of fibers.
The woven fabric has a main body portion (11) and a fixing portion (121, 122).
The main body portion (11) contains a bioactive component on the surface of the fiber and contains the bioactive component.
The fixing portions (121, 122) are formed on both sides of the main body portion (11).
The warp and weft (120) comprises a bioceramic material.
Tissue scaffold for use on tendons and / or ligaments (1). The warp (101) comprises a fiber having an alternative shaped cross-sectional structure.
The diameter of the major axis of the fiber is 15 to 50 μm.
The tissue scaffold (1) according to claim 1, wherein the diameter of each fiber of the warp and weft (110, 120) constituting the woven fabric is 20 to 50 μm, respectively. The tissue scaffold (1) according to claim 1, wherein the cross-sectional structure of the alternative shape includes 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. The warp fineness, including fibers with alternative shaped cross-sectional structures, is 1.5-50 denier.
The tissue scaffold (1) according to claim 1, wherein the fibers of the warp and weft (110, 120) constituting the woven fabric have a fineness of 40 to 100 denier. The tissue scaffold (1) according to claim 1, wherein the pore size of the woven fabric is 0.1 to 1 mm. The tissue scaffold (1) according to claim 1, wherein the material of the woven fabric includes polyethylene terephthalate, polyethylene, polytetrafluoroethylene, polyurethane, or a combination thereof. The bioactive ingredient contains collagen and
The tissue scaffold (1) according to claim 1, wherein the collagen content accounts for 0.5 to 5% by weight of the total weight of the main body (11). The tissue scaffold (1) according to claim 1, wherein the bioceramic material comprises calcium phosphate, calcium sulfate, bioglass, or a combination thereof. The weft (120) of the fixing portion (121, 122) includes the bioceramic material, and the content of the bioceramic material is the total weight of the weft (120) of the fixing portion (121, 122). Occupies 1 to 4% by weight,
The tissue scaffold (1) according to claim 1, wherein the warp (101) of the fixing portion (121, 122) does not contain the bioceramic material. The tissue scaffold (1) according to claim 1, wherein the bioceramic material is hydroxyapatite and has an average particle size of 10 to 200 nm.

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