Method for treatment of defects in the intervertebral disc

• US 20050069571A1
• Filed: 09/30/2003
• Published: 03/31/2005
• Est. Priority Date: 09/30/2003
• Status: Active Grant

• Current Assignee: Depuy Acromed Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Acromed Incorporated (Johnson & Johnson)
• Inventors: Slivka, Michael, Serhan, Hassan
• Granted Patent: US 7,879,102 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4445 Means for culturing intervertebral disc tissue
• CPC Class Codes: A61F 2002/445 Intervertebral disc tissue harvest sites
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

A minimally invasive spinal disc defect repair method is disclosed. The method relates to insertion of disc defect repair materials that are substantially two-dimensionally shaped and which allow for insertion and preferably self retention within the disc defect with plugging of the annulus fibrosis.

Claims

1. ) A method of treating spinal disc defects comprising the steps of:

a) preparing a disc treatment site;

b) providing a substantially two-dimensionally shaped disc defect repair material; and

c) inserting the repair material into the disc to be repaired.

2. ) The method of claim 1, wherein the substantially two-dimensionally shaped material is a strip.

3. ) The method of claim 1, wherein the substantially two-dimensionally shaped material is a circle.

4. ) The method of claim 1, wherein the disc repair material comprises a porous, biocompatible material.

5. ) The method of claim 4, wherein the bioabsorbable or non bioabsorbable material.

6. ) The method of claim 5, wherein the material is a bioabsorbable material selected form the group consisting of small intestine submucosa (SIS), collagen, hyaluronic acid, elastin, albumin, reticulin, synthetic polyamino acids, prolamines, polysaccharides, alginate, heparin, biodegradable polymers of sugar units, synthetic polymers including polylactide, polyglycolide, polydioxanone, polyhydroxybutyrate, polyhydroxyvalerate, poly(propylene fumarate), polyoxaesters, synthetic polyamino acids, biodegradable polyurethanes and their copolymers, and combinations thereof.

7. ) The method of claim 6, wherein the bioabsorbable material is SIS.

8. ) The method of claim 6, wherein the bioabsorbable material is collagen.

9. ) The method of claim 5, wherein the material is a non-bioabsorbable material.

10. ) The method of claim 9, wherein, the non-bioabsorbable material is selected from the group consisting of polyacrylates, ethylene-vinyl acetates (and other acyl-substituted cellulose acetates), polyester (Dacron®

), poly(ethylene terephthalate), polypropylene, polyethylene, polyurethanes, polystyrenes, polyvinyl oxides, polyvinyl fluorides, poly(vinyl imidazoles), chlorosulphonated polyolefins, polyethylene oxides, polyvinyl alcohols (PVA), polytetrafluoroethylenes, nylons, and combinations thereof.

11. ) The method of claim 10, wherein the non-bioabsorbable material is polyester (Dacron®

)

12. ) The method of claim 1, wherein the step of inserting further comprises twisting the material being inserting into the disc.

13. ) The method of claim 1, wherein the material is a strip and is bioabsorbable.

14. ) The method of claim 13, wherein the material is selected form the group consisting of SIS, collagen, hyaluronic acid, elastin, albumin, reticulin, synthetic polyamino acids, prolamines, polysaccharides, alginate, heparin, biodegradable polymers of sugar units, synthetic polymers including polylactide, polyglycolide, polydioxanone, polyhydroxybutyrate, polyhydroxyvalerate, poly(propylene fumarate), polyoxaesters, synthetic polyamino acids, biodegradable polyurethanes and their copolymers, and combinations thereof.

15. ) The method of claim 14, wherein the material is collagen.

16. ) The method of claim 14, wherein the material is SIS.

17. ) The method of claims 1-16, wherein the material is cell seeded.

18. ) The method of claim 17, wherein the cells are selected from stem cells, bone marrow cells, fibrocytes, adipocytes, chondrocytes, cells harvested from spinal discs in the body such as nucleus pulposus cells and annulus fibrosis, and combinations thereof.

19. ) The method of claim 18, wherein the cells are stem cells.

20. ) The method of claims 1-16, wherein the material is combined with an autologous medium prior to implantation.

21. ) The method of claim 20, wherein the autologous medium is selected from platelet-rich plasma, platelet-poor plasma, bone marrow, whole blood and serum.

22. ) The method of claim 20, wherein the autologous medium is bone marrow.

23. ) The method of claim 1-16 wherein the material further comprises a bioactive factor.

24. ) The method of claim 23 wherein, the bioactive agent is selected from the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

25. ) The method of claim 24, wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

26. ) The method of claim 17 wherein the material further comprises a bioactive factor.

27. ) The method of claim 26 wherein the bioactive factor is selective form the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

28. ) The method of claim 27 wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

29. ) The method of claim 18 wherein the material further comprises a bioactive factor.

30. ) The method of claim 29 wherein the bioactive factor is selective form the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

31. ) The method of claim 30 wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

32. ) The method of claim 20 wherein the material further comprises a bioactive factor.

33. ) The method of claim 32 wherein the bioactive factor is selective form the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

34. ) The method of claim 33 wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

35. ) The method of claim 21 wherein the material further comprises a bioactive factor.

36. ) The method of claim 35 wherein the bioactive factor is selective form the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

37. ) The method of claim 36 wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

38. ) The method of claim 22 wherein the material further comprises a bioactive factor.

39. ) The method of claim 38 wherein the bioactive factor is selective form the group consisting of transforming growth factor-beta and agents in the same family of growth factors, platelet-derived growth factors, fibroblast growth factors, insulin-like growth factors, protein polymers such as RGD-peptides and Indian Hedgehog proteins, anti-inflammatory agents, angiogenic factors, hormones, hyaluronic acid and combinations thereof.

40. ) The method of claim 39 wherein the bioactive factor is a transforming growth factor-beta selected from the group consisting of TGF-β

I, TGF-β

2, and TGF-β

3, GDF-5, MP52, and BMPs.

41. ) A method of treating spinal disc defects comprising the steps of:

a) preparing a disc treatment site;

b) manipulating a substantially two-dimensionally shaped disc defect repair material into a mushroom shape; and

c) inserting the repair material into the disc to be repaired.