阅读说明：本技术 一种多层复合的仿生人工韧带及其制备方法 (Multilayer composite bionic artificial ligament and preparation method thereof ) 是由 胡艳飞 王云兵 于 2020-07-06 设计创作，主要内容包括：本发明属于人工韧带的制备技术领域,尤其涉及一种多层复合的仿生人工韧带及其制备方法。所述人工韧带由多束改性纤维编制而成；所述改性纤维包括内层和外层,所述外层的材料为生物可降解弹性材料,所述内层的材料为PET纤维。本发明制备的人工韧带有利于细胞吸附、增殖、集落化和细胞分化以及胞外基质的生成。(The invention belongs to the technical field of artificial ligament preparation, and particularly relates to a multilayer composite bionic artificial ligament and a preparation method thereof. The artificial ligament is woven by a plurality of bundles of modified fibers; the modified fiber comprises an inner layer and an outer layer, wherein the outer layer is made of biodegradable elastic material, and the inner layer is made of PET fiber. The artificial ligament prepared by the invention is beneficial to cell adsorption, proliferation, colony formation, cell differentiation and extracellular matrix generation.)

1. A multi-layer composite bionic artificial ligament is characterized in that: the artificial ligament is woven by a plurality of bundles of modified fibers; the modified fiber comprises an inner layer and an outer layer, wherein the outer layer is made of biodegradable elastic material, and the inner layer is made of PET fiber.

2. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the artificial ligament is woven by 40-160 bundles of modified fibers, and each bundle of modified fibers comprises 20-100 modified fibers.

3. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the length of the artificial ligament is 25-50 cm.

4. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the inner layer and the outer layer of the modified fiber are of concentric structures.

5. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the monofilament fiber diameter of the PET fiber is 0.01-0.04 mm.

6. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the biodegradable elastomeric material is selected from one or more of PTMC, PHA, P4HB, PCL, PGS, PDDO, or a copolymer of any two of the monomers.

7. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the thickness of the outer layer of the modified fiber is 0.005-0.02 mm.

8. The multilayer composite biomimetic artificial ligament of claim 1, wherein: the weight average molecular weight of the biodegradable elastic material is 1-30 ten thousand, and the weight average molecular weight of the PET fiber is 150-200 ten thousand.

9. A method of producing a multilayered composite biomimetic artificial ligament according to any of claims 1-8, comprising the steps of:

step 1: surface pretreatment of PET fibers: soaking medical PET fiber in a sodium carbonate solution for pretreatment, washing the medical PET fiber to be neutral by distilled water, and drying the medical PET fiber;

step 2: preparing the composite fiber: the melted biodegradable elastic material is sprayed on the surface of the PET monofilament fiber in a rotating way; then cooling to room temperature;

and step 3: weaving and sterilizing the artificial ligament: weaving the fibers in the step 2 into an artificial ligament by a twisting weaving method; sterilizing the artificial ligament, and packaging.

10. The method of claim 9, wherein: in the step 1, the pretreatment step specifically comprises: soaking medical PET fiber in 5% sodium carbonate solution at 60-120 deg.c and stirring speed of 100-; in the step 2, the melting temperature of the biodegradable elastic material is 40-80 ℃.

Technical Field

The invention belongs to the technical field of artificial ligament preparation, and particularly relates to a multilayer composite bionic artificial ligament and a preparation method thereof.

Background

With the improvement of living standard of people, severe exercise is generally adopted to maintain healthy body, so that cases of ligament contusion, rupture or defect are more and more emphasized. If the treatment is not appropriate, articular cartilage damage may occur, and serious cases may lead to complications such as osteoarthritis.

The substitutes selected by the conventional ligament repair surgery comprise variant tendons, autologous tendons and artificial ligaments, and because of rejection reaction of the variant tendons and the source problem of the autologous tendons, the artificial ligaments are mostly adopted in the ligament repair surgery at present.

The artificial ligament has been made of various materials, such as polytetrafluoroethylene (ptfe) and other fluoropolymers, carbon fiber, Polyethylene (PE), polystyrene, and nylon, but the artificial ligament made of these materials has not been effective for a long time. The main problems are: a. the artificial ligament is broken due to abrasion, fatigue or severe load, b, chronic synovitis is caused due to poor biocompatibility of the artificial ligament material, and c, ligament creep or fixing elements are easy to loosen.

The most widely used artificial ligament in clinical practice is currently the LARS artificial ligament developed by Laboureau corporation of france (patent publication No. CN 1777450a), the main material being semi-crystalline polyethylene terephthalate (PET) and having a glass transition temperature of 81 ℃. However, the PET material has poor biocompatibility, is not favorable for surface cell adsorption and proliferation, and is not favorable for forming functional tissues around the artificial ligament. Therefore, the LARS ligament is grafted with methacrylic acid or styrene sulfonate on the surface through solution polymerization bionic functionalization to improve the surface, and then collagen is poured to improve the fibroblast capacity. However, this method requires the use of a large amount of organic solvents, and also requires the use of collagen of animal origin, which is also highly desirable for immunogenicity.

Therefore, there is a need to prepare an artificial ligament which has good biocompatibility and is beneficial to the adsorption and proliferation of surface cells.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a multilayer composite bionic artificial ligament and a method thereof.

The invention provides a multilayer composite bionic artificial ligament which is woven by a plurality of bundles of modified fibers; the modified fiber comprises an inner layer and an outer layer, wherein the outer layer is made of biodegradable elastic material, and the inner layer is made of PET fiber.

Preferably, the artificial ligament is woven by a twisting weaving method, and in a preferred weaving direction, the weaving direction of the artificial ligament corresponding to the right limb is clockwise, and the weaving direction of the artificial ligament corresponding to the left limb is counterclockwise.

Preferably, the artificial ligament is woven by 40-160 bundles of modified fibers, and more preferably, the artificial ligament is woven by 90-120 bundles of modified fibers.

Preferably, the human ligament has a length of 25-50cm, preferably 30-35 cm.

Preferably, the yield strength of the artificial ligament is 100-300MPa, and the tensile modulus is 400-1300 MPa.

Preferably, the inner layer and the outer layer of the modified fiber are of a concentric structure.

Preferably, the PET fibers have a monofilament fiber diameter of 0.01 to 0.04mm, most preferably 0.02 mm.

Preferably, the biodegradable elastomeric material comprises one or more of PTMC, PHA, P4HB, PCL, PGS, PDDO, or a copolymer of any two monomers thereof.

Preferably, the outer layer of the modified fibre has a thickness of 0.005 to 0.02mm, most preferably 0.01 mm.

Preferably, the biodegradable elastomeric material has a weight average molecular weight of 1 to 30 ten thousand, most preferably 4 to 20 ten thousand.

The invention also aims to provide a preparation method of the multilayer composite bionic artificial ligament, which comprises the following steps:

step 1: surface pretreatment of PET fibers: soaking medical PET fiber in a sodium carbonate solution for pretreatment, washing the medical PET fiber to be neutral by distilled water, and drying the medical PET fiber;

step 2: preparing the composite fiber: the melted biodegradable elastic material is sprayed on the surface of the PET monofilament fiber in a rotating way; then cooling to room temperature;

and step 3: weaving and sterilizing the artificial ligament: weaving the fibers in the step 2 into an artificial ligament by a twisting weaving method; sterilizing the artificial ligament, and packaging.

Preferably, in the step 1, the step of preprocessing specifically includes: soaking medical PET fiber in 5% sodium carbonate solution at 60-120 deg.c and stirring speed of 100-300rpm for 30-60 min.

Preferably, in the step 1, the drying is vacuum drying at 50 ℃.

Preferably, in the step 2, the melting temperature of the biodegradable elastic material is 40-80 ℃; most preferably 70 ℃.

Preferably, in the step 3, the twisting and weaving method specifically includes that 20 to 100 monofilament fibers are regarded as 1 bundle, 40 to 160 bundles are twisted into a string, two ends of the string are fixed in a sewing manner, and the artificial ligament is obtained by washing and drying with deionized water.

Preferably, in the step 3, the sterilization mode adopts ethylene oxide, gamma ray or electron beam irradiation for sterilization.

Preferably, before the step 2, a pretreatment of the biodegradable elastic material is further included, and the pretreatment method comprises plasma treatment or coating of dopamine.

By the scheme, the invention at least has the following advantages:

the artificial ligament prepared by the invention is beneficial to cell adsorption, proliferation, colony formation, cell differentiation and extracellular matrix generation. Further, an inner layer material mainly made of semi-crystalline PET is coated on the surface of PET after a biodegradable elastic material such as PTMC (or PDDO or PHA or PCL or P4HB, or a copolymer thereof such as PCL-co-PTMC, PHA-co-P4HB and the like) is melted as an outer layer material. PET is a mechanical supporting material, PTMC (or PDDO or PHA or P4HB or PCL-PTMC) provides an artificial ligament surface beneficial to cell adsorption and proliferation, and finally, the fiber is woven into an artificial ligament with good biocompatibility.

Detailed Description

Embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention.