Intervertebral disc treatment devices and methods

• US 7,318,840 B2
• Filed: 11/17/2004
• Issued: 01/15/2008
• Est. Priority Date: 12/06/1999
• Status: Expired due to Term

• Current Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): Rodriguez; Cris
• Assistant Examiner(s): STOKES, CANDICE CAPRI
• Application Number:
  US10/990,823
• Publication Number:
  US 20060004456A1
• Time in Patent Office: 1,154 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.13, 623/17.14, 623/17.15, 623/17.16, 606/61
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• 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 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00377 Fibrin
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

Intervertebral disc treatment devices and methods are provided. An intervertebral disc treatment device includes a fibrous body sized for introduction into a disc cavity of a damaged disc wherein the body incorporates an effective amount of a tissue growth factor. Intervertebral disc treatment apparatuses are also described that include such a disc treatment device in combination with a delivery apparatus for retaining and selectively releasing the device into the disc cavity. Methods for treatment include providing a disc treatment device as described above and inserting the device into an opening in an annulus fibrous and into the disc cavity. The methods further include stimulating tissue growth within the disc cavity of the intervertebral disc.

Claims

1. A method of preventing effluence from a disc cavity of a damaged intervertebral disc having an annulus Fibrosus having an opening, said method comprising inserting a fibrous plug into the cavity of said disc defined by the annulus fibrosus so as to position said fibrous plug beyond the annulus fibrosus and completely within the cavity, with said fibrous plug abutting an inner surface of the annulus fibrosus so as to block effluence from said opening.

2. The method of claim 1, wherein said fibrous plug is comprised of fibers coated with a solid carrier matrix comprising the tissue growth factor.

3. The method of claim 1, wherein said plug is cylindrical.

4. The method of claim 1, wherein said fibrous plug comprises synthetic fibers.

5. The method of claim 4, wherein said synthetic fibers comprise a material selected from the group consisting of polyamides, polyesters, polyethylenes, polyacrylonitriles, polyurethanes, polypropylenes and mixtures thereof.

6. The method of claim 1, wherein said fibrous plug comprises natural fibers.

7. The method of claim 6, wherein said natural fibers comprise collagen.

8. The method of claim 6, wherein said natural fibers comprise elastin.

9. The method of claim 1, wherein said plug comprises an effective amount of a tissue growth composition to stimulate disc repair.

10. The method of claim 9, wherein said tissue growth composition is incorporated within said body.

11. The method of claim 9, wherein said tissue growth composition is bound to an exterior surface of said body.

12. The method of claim 11, wherein said tissue growth composition comprises a biocompatible polymeric carrier.

13. The method of claim 12, wherein said polymer is a naturally occurring polymer.

14. The method of claim 13, wherein said polymer is collagen.

15. The method of claim 9, wherein said tissue growth composition comprises tissue growth factor selected from the group consisting of Transforming Growth Factor-beta (TGF-B) and members of the TGF-B superfamily, Fibroblast Growth Factor (FGF) and members of the FGF family, Platelet Derived Growth Factor (PDGF) and members of the PDGF family, members of the hedgehog family of proteins, interleukins (IIs), Insulin-like Growth Factor (IGF) and members of the IGF family, colony-stimulating factor (CSF) and members of the CSF family, Growth Differentiation Factors (GDFs), Cartilage Derived Growth Factors (CDGFs), Cartilage Derived Morphogenic Proteins (CDMPs), Bone Morphogenetic Proteins (BMPs), and mixtures thereof.

16. The method of claim 15, wherein said tissue growth factor is a recombinant human protein.

17. The method of claim 15, wherein said tissue growth factor is a bone morphogenic protein.

18. The method of claim 17, wherein said bone morphogenetic protein is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and mixtures or heterodimers thereof.

19. A method for treating a damaged intervertebral disc, comprising:

(a) providing an opening in an annulus fibrosus of the damaged intervertebral disc;

(b) passing a non-prosthetic delivery body through and beyond said opening and completely into a disc cavity defined by the annulus fibrosus, the delivery body incorporating a tissue growth factor; and

(c) the delivery body releasing the tissue growth factor in the disc cavity and promoting tissue growth in the disc cavity.

20. The method of claim 19, wherein said delivery body comprises a natural polymer.

21. The method of claim 19, wherein said delivery body is cylindrical.

22. The method of claim 19, wherein said delivery body comprises synthetic fibers.

23. The method of claim 22, wherein said synthetic fibers comprise a material selected from the group consisting of polyamides, polyesters, polyethylenes, polyacrylonitriles, polyurethanes, polypropylenes and mixtures thereof.

24. The method of claim 19, wherein said delivery body comprises natural fibers.

25. The method of claim 24, wherein said natural fibers comprise collagen.

26. The method of claim 24, wherein said natural fibers comprise elastin.

27. The method of claim 19, wherein said tissue growth factor is selected from the group consisting of Transforming Growth Factor-beta (TGF-B) and members of the TGF-B superfamily, Fibroblast Growth Factor (FGF) and members of the FGF family, Platelet Derived Growth Factor (PDGF) and members of the PDGF family, members of the hedgehog family of proteins, interleukins (Us), Insulin-like Growth Factor (IGF) and members of the IGF family, colony-stimulating factor (CSF) and members of the CSF family, Growth Differentiation Factors (GDFs), Cartilage Derived Growth Factors (CDGFs), Cartilage Derived Morphogenic Proteins (CDMPs), Bone Morphogenetic Proteins (BMPs), and mixtures thereof.

28. The method of claim 27, wherein said tissue growth factor is a recombinant human protein.

29. The method of claim 27, wherein said tissue growth factor is a bone morphogenic protein.

30. The method of claim 29, wherein said bone morphogenetic protein is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and mixtures or heterodimers thereof.

31. The method of claim 19, wherein said delivery body incorporates a composition comprising the tissue growth factor within a biocompatible carrier.

32. The method of claim 31, wherein said composition is incorporated within said delivery body.

33. The method of claim 31, wherein said composition is bound to an exterior surface of said delivery body.

34. The method of claim 31, wherein said biocompatible carrier comprises a polymer.

35. The method of claim 34, wherein said polymer is a naturally occurring polymer.

36. The method of claim 35, wherein said polymer is collagen.

37. A method for treating a damaged intervertebral disc in a vertebrate, the intervertebral disc having an annulus fibrosus having a rupture opening, the method comprising introducing at least a first amount of a tissue growth factor into a disc cavity of the ruptured intervertebral disc, and sealing the rupture opening of the annulus with a sealant device, wherein said first amount of tissue growth factor is separate from said sealant device during said introducing step, and wherein said introducing step is conducted before or after said sealing step.

38. The method of claim 37, wherein said sealant device comprises synthetic fibers.

39. The method of claim 37, wherein said sealant device comprises a natural polymer.

40. The method of claim 37, wherein said sealant device incorporates a second amount of a tissue growth factor.

41. The method of claim 37, wherein said sealant device has a second amount of a tissue growth factor bound to an exterior surface of said sealant device.

42. The method of claim 37, wherein said sealant device comprises natural fibers.

43. The method of claim 42, wherein said natural fibers comprise collagen.

44. The method of claim 42, wherein said natural fibers comprise elastin.

45. The method of claim 37, wherein said tissue growth factor is incorporated within a biocompatible carrier.

46. The method of claim 45, wherein said biocompatible carrier comprises a naturally occurring polymer.

47. The method of claim 46, wherein said polymer is collagen.

48. The method of claim 37, wherein said tissue growth factor is selected from the group consisting of Transforming Growth Factor-beta (TGF-B) and members of the TGF-B superfamily, Fibroblast Growth Factor (FGF) and members of the FGF family, Platelet Derived Growth Factor (PDGF) and members of the PDGF family, members of the hedgehog family of proteins, interleukins (IIs), Insulin-like Growth Factor (IGF) and members of the IGF family, colony-stimulating factor (CSF) and members of the CSF family, Growth Differentiation Factors (GDFs), Cartilage Derived Growth Factors (CDGFs), Cartilage Derived Morphogenic Proteins (CDMPs), Bone Morphogenetic Proteins (BMPs), and mixtures thereof.

49. The method of claim 48, wherein said tissue growth factor is a bone morphogenic protein.

50. The method of claim 49, wherein said bone morphogenetic protein is selected from the group consisting of BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and mixtures or heterodimers thereof.