Intervertebral disc annulus fibrosus implant and method for preparing the same

Abstract

This disclosure provides a method for preparing an annulus fibrosus implant for intervertebral discs, comprising: obtaining a sample having a plurality of ring-shaped collagen fiber layers; cutting and shaping the sample into a columnar shape, the columnar shape having opposing top and bottom surfaces, and a peripheral surface connecting the top and bottom surfaces, wherein the area of ​​the top surface is smaller than the area of ​​the bottom surface; removing cells from the sample; sterilizing, drying, and shaping the sample to prepare a columnar annulus fibrosus implant for intervertebral discs. This disclosure also provides an annulus fibrosus implant for intervertebral discs and a method for transplanting such annulus fibrosus implants. This disclosure can repair damage to the annulus fibrosus of the intervertebral disc and prevent leakage or protrusion of gelatinous material from the nucleus pulposus.

Claims

1. A method for preparing an intervertebral disc annulus fibrosus implant, comprising: A sample with annulus fibrosus is obtained, wherein the annulus fibrosus has a plurality of ring-shaped collagen fiber layers; the annulus fibrosus of the sample is cut into a columnar shape, wherein the columnar shape has opposing top and bottom surfaces and a peripheral surface connecting the top and bottom surfaces, and the area of ​​the top surface is smaller than the area of ​​the bottom surface; cells are removed from the sample; the cell-removed sample is sterilized; and the sterilized sample is dried to prepare the intervertebral disc annulus fibrosus implant.

2. The method as described in claim 1, wherein, The top surface and the bottom surface are each independently either circular or polygonal.

3. The method as described in claim 1, wherein, The interlayer density of the multiple cyclic collagen fiber layers increases along the direction from the top surface to the bottom surface.

4. The method as described in claim 1, wherein, The content of type I collagen in the multiple ring-shaped collagen fiber layer increases from the top surface to the bottom surface.

5. The method as described in claim 1, wherein, The intervertebral disc annulus fibrosus implant is derived from the intervertebral disc of a vertebrate or an artificially cultured annulus fibrosus mimic.

6. The method as described in claim 1, wherein, The cell removal step involves immersing the sample in a cell-removing solution containing surfactants, chelating agents, and saline.

7. The method as described in claim 6, wherein, The surfactant is selected from at least one of the group consisting of 3-choleaminopropyl dimethylamino-1-propylsulfonate (CHAPS), NP-40, Tween-20, Triton X-100 and sodium dodecyl sulfate (SDS); and the chelating agent is selected from at least one of the group consisting of ethylenediaminetetraacetic acid (EDTA), ethylene glycol tetraacetic acid (EGTA) and ethylenediamine.

8. The method as described in claim 1, wherein, The disinfection process includes immersing the sample in an antibiotic solution.

9. The method as described in claim 8, wherein, The antibiotic solution contains amphotericin B, gentamicin, and vancomycin.

10. The method as described in claim 9, wherein, The antibiotic solution contains 2.5 μg / mL amphotericin B, 50 μg / mL gentamicin, and 500 μg / mL vancomycin.

11. The method as described in claim 1, wherein, The cell removal and / or disinfection steps are performed on a shaker at a speed of 50 to 200 rpm.

12. The method as described in claim 1, wherein, The drying process is carried out by freeze drying.

13. The method as described in claim 1 further includes, after sterilizing the column sample, washing the sterilized column sample with saline to remove the decellularization solution and antibiotic solution.

14. An intervertebral disc annulus fibrosus implant, which is columnar and has an annulus fibrosus, the annulus fibrosus having a plurality of ring-shaped collagen fiber layers, wherein, The intervertebral disc annulus fibrosus implant has a top surface and a bottom surface opposite each other, and a peripheral surface connecting the top surface and the bottom surface. The area of ​​the top surface is smaller than the area of ​​the bottom surface, and the intervertebral disc annulus fibrosus implant is substantially free of cells, water and microorganisms.

15. The intervertebral disc annulus fibrosus implant as described in claim 14, wherein, The top surface and the bottom surface are each independently either circular or polygonal.

16. The intervertebral disc annulus fibrosus implant as described in claim 14, wherein, The interlayer density of the multiple cyclic collagen fiber layers increases along the direction from the top surface to the bottom surface.

17. The intervertebral disc annulus fibrosus implant as described in claim 14, wherein, The content of type I collagen in the multiple ring-shaped collagen fiber layer increases from the top surface to the bottom surface.

18. The intervertebral disc annulus fibrosus implant described in claim 14 is derived from a vertebrate intervertebral disc or an artificially cultured annulus fibrosus mimic.

19. The intervertebral disc annulus fibrosus implant as described in claim 14, having a column length of 6 to 10 mm and a maximum width of 3 to 5 mm.

20. The annulus fibrosus implant of the intervertebral disc as described in claim 14, which expands upon contact with water to fill the damaged gap.

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