Intervertebral disc treatment devices and methods

• US 20060004456A1
• Filed: 11/17/2004
• Published: 01/05/2006
• Est. Priority Date: 12/06/1999
• Status: Active Grant

• Current Assignee: William F. Mckay
• Original Assignee: William F. Mckay
• Inventors: McKay, William F.
• Granted Patent: US 7,318,840 B2
• Time in Patent Office: Days
• US Class Current: 623/17.160
• 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. An intervertebral disc treatment device for treating an intervertebral disc of a vertebrate while retaining an intact annulus fibrosis, comprising:

a compressible fibrous body configurable to a compressed state for passage through an opening in the annulus fibrosis and into a disc cavity defined by the annulus fibrosis;

said body configurable to an expanded state to reside within the disc cavity and have a dimension greater than said opening so as to resist expulsion from said opening; and

said body incorporating an effective amount of a tissue growth factor.

2. The device of claim 1, wherein said fibrous body comprises synthetic fibers.

3. The device of claim 2, wherein said synthetic fibers comprise a material selected from the group consisting of polyamides, polyesters, polyethylenes, polyacrylonitriles, polyurethanes, polypropylenes and mixtures thereof.

4. The device of claim 2, wherein said synthetic fibers comprise polyester.

5. The device of claim 1, wherein said fibrous body is comprised of fibers coated with a solid carrier matrix comprising the tissue growth factor.

6. The device of claim 1, wherein said fibrous body is comprised of natural fibers.

7. The device of claim 6, wherein said natural fibers are collagen.

8. The device of claim 6, wherein said natural fibers are elastin.

9. The device of claim 1, wherein said body incorporates a tissue growth composition comprising a tissue growth factor within a biocompatible carrier.

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

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

12. The device of claim 11, wherein said biocompatible carrier comprises a polymer.

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

14. The device of claim 12, wherein said polymer is collagen.

15. The device of claim 9, 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 (Ils), 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 device of claim 9, wherein said tissue growth factor is a Bone Morphogenetic Protein.

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

18. The device of claim 16, 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. The device of claim 1, wherein said fibrous body is a multi-layered body.

20. The device of claim 1, wherein said body is cylindrical.

21. An intervertebral disc repair device, comprising a mesh sized for introduction into a disc cavity, said mesh incorporating an effective amount of a tissue growth factor to promote tissue growth within the disc cavity.

22. The device of claim 21, wherein said mesh is comprised of synthetic fibers.

23. The device of claim 22, wherein said synthetic fibers comprise a material selected from the group consisting of polyamides, polyesters, polyacrylonitrile, polyurethanes, polypropylene and mixtures thereof.

24. The device of claim 22, wherein said synthetic fibers comprise polyester.

25. The device of claim 21, wherein said mesh is comprised of natural fibers.

26. The device of claim 25, wherein said natural fibers are selected from the group consisting of elastin and collagen.

27. The device of claim 21, which incorporates a tissue growth composition including the tissue growth factor and a biocompatible carrier.

28. The device of claim 27, 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 (Ils), 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.

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

30. The device of claim 27, wherein said biocompatible carrier includes a natural or synthetic polymer.

31. An intervertebral disc repair device, comprising a bioresorbable body sized for introduction into a disc cavity, said body incorporating an effective amount of a tissue growth factor.

32. The device of claim 31, wherein said bioresorbable body is comprised of natural fibers.

33. The device of claim 32, wherein said natural fibers are selected from the group consisting of elastin and collagen.

34. The device of claim 31, which incorporates a tissue growth composition including a tissue growth factor and a biocompatible carrier.

35. The device of claim 34, 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 (Ils), 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.

36. The device of claim 34, wherein said tissue growth factor is a bone morphogenetic protein.

37. The device of claim 34, wherein said biocompatible carrier includes a natural or synthetic polymer.

38. An apparatus for treating an intervertebral disc, comprising:

(a) a disc treatment device comprising a fibrous body sized for introduction into a disc cavity of a damaged disc, said body incorporating an effective amount of a tissue growth factor; and

(b) a delivery apparatus adapted to retain and selectively release the disc treatment device into the disc cavity.

39. The apparatus of claim 38, wherein said delivery apparatus comprises:

a member having a proximal end, a distal end and a lumen extending longitudinally therethrough, said disc treatment device disposed in said lumen; and

means at the proximal end of said member for forcing said disc treatment device distally through said lumen and into said disc cavity of said damaged disc.

40. A method for treating an intervertebral disc, comprising:

(a) providing a fibrous body sized for introduction into a disc cavity of a damaged disc;

(b) introducing said fibrous body into the disc cavity of said intervertebral disc through an opening in said disc; and

(c) providing a tissue growth factor within the disc cavity of said intervertebral disc.

41. The method of claim 40, wherein said body is in a compressed configuration prior to said introducing, and expands within the disc cavity after said introducing.

42. The method of claim 40, including sealing said opening after said introducing.

43. The method of claim 40, comprising removing a portion of the nucleus pulposus of said disc prior to said introducing.

44. The method of claim 40, wherein said tissue growth factor is combined with a biocompatible carrier.

45. The method of claim 44, wherein said tissue growth factor stimulates the formation of nucleus pulposus, annulus, ligament, tendon and/or fibroblast cells.

46. The method of claim 40, wherein said tissue growth factor is non-osteogenic.

47. The method of claim 40, wherein said fibrous body is bioresorbable.

48. A method of treating an intervertebral disc, comprising introducing a fibrous body into a disc cavity of a damaged disc between adjacent vertebrae, said body incorporating an effective amount of a tissue growth composition to stimulate soft tissue formation within the disc cavity sufficient to accommodate at least a portion of compressive loads occurring between the adjacent vertebrae.

49. The method of claim 48, wherein said fibrous body is comprised of synthetic fibers.

50. A method of treating an intervertebral disc, comprising:

(a) providing a fibrous body sized for introduction into an opening of an annulus fibrosus of said disc;

(b) inserting said fibrous body through said opening, said body thereby blocking effluence from said opening; and

(c) providing a tissue growth composition within the disc space of said intervertebral disc.

51. The method of claim 50, wherein said fibrous body is comprised of synthetic fibers.

52. 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 so as to block effluence from said opening.

53. The method of claim 52, wherein said plug comprises an effective amount of a tissue growth composition to stimulate disc repair.

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

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

(b) passing a non-prosthetic delivery body through said opening and into a disc cavity defined by the annulus fibrosis, 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.

55. A method for treating a damaged intervertebral disc in a vertebrate, the intervertebral disc having an annulus fibrosis having a rupture opening, the method comprising introducing 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.

56. A method of treating an intervertebral disc, comprising:

introducing a load-bearing, polyester implant into an opening of an annulus fibrosus of said disc.