Vertebral disc repair

• US 7,879,103 B2
• Filed: 04/17/2006
• Issued: 02/01/2011
• Est. Priority Date: 04/15/2005
• Status: Expired due to Fees

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Merboth, Barbara L., Schuler, Michael, Steiner, Anton J., Semler, Eric J., Yannariello-Brown, Judith I., Gertzman, Arthur A.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): Cotroneo; Steven J
• Application Number:
  US11/404,806
• Publication Number:
  US 20060235534A1
• Time in Patent Office: 1,751 Days
• Field of Search: 623 1711- 1716, 623/23.51, 623/23.61, 623/919, 8 9/411
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/842 Flexible wires, bands or straps A61B17/72, A61B17/82, A61B17/86 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30172 T-shaped
• CPC Class Codes: A61F 2002/30177 W-shaped, M-shaped or sigma shaped
• CPC Class Codes: A61F 2002/30181 Y-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30932 : for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0061 : swellable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0052 : T-shaped
• CPC Class Codes: A61F 2230/0056 : W-shaped, e.g. M-shaped, sigma-shaped
• CPC Class Codes: A61F 2230/006 : Y-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2400/16 : Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/38 : containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: Y10S 623/919 : Bone

Abstract

A sterile implant for treatment of a spinal disc defect comprising an allograft cortical bone demineralized to a Type I collagen having a specific shape which is treated to eliminate osteoinductivity. The implant is lyophilized and compressed into smaller first shape which 20 to 80% from its original shape in at least one dimension and hardened. The implant expanding when hydrated into a second shape having the shape memory of the first shape and expanded in dimensional size from the first compressed shape.

Claims

1. An implant for non-fusion repair of a defective vertebral disc which occupies a space between a superior vertebra and an inferior vertebra and which includes an annulus fibrosus having outer and inner walls and a nuclear cavity having a boundary bordered by the inner wall of the annulus fibrosus and by the superior and inferior vertebrae, said implant comprising:

an exterior surface and a porous load-bearing body defining said exterior surface and having an original shape selected to at least partially fill the nuclear cavity of the defective vertebral disc, said body being formed from substantially demineralized, non-osteoinductive bone such that said body is deformable from its said original shape into a compressed shape that facilitates the insertion of said body into the nuclear cavity of the defective vertebral disc, said body having shape memory such that it assumes its said original shape in response to its exposure to fluid, said body being sized and shaped such that said exterior surface is engageable with a substantial portion of the boundary of the nuclear cavity of the defective vertebral disc when said body assumes its said original shape after insertion into the nuclear cavity of the defective vertebral disc, and wherein said body includes a first section made of cortical bone and a second section made of cancellous bone.

2. The implant of claim 1, wherein said bone has a calcium content that does not exceed about 0.2% wt/wt.

3. The implant of claim 1, wherein said original shape has at least one dimension that is reduced within a range of from 20% to 50% when said body is deformed into its said compressed shape.

4. The implant of claim 1, wherein said original shape has at least one dimension that is reduced by more than 50% when said body is deformed into its said compressed shape.

5. The implant of claim 1, wherein said body has a ring shape, said body including an annular exterior member and a hollow space within said exterior member, said exterior member collapsing when said body is in its said compressed shape to thereby collapse said hollow space.

6. The implant of claim 1, wherein said first section has a ring shape and wherein said second section is positioned within said first section.

7. The implant of claim 1, wherein said body has a cylindrical shape.

8. The implant of claim 1, wherein said body has a spheroid shape.

9. The implant of claim 1, wherein said body has a spiral shape.

10. The implant of claim 1, wherein said body has an accordion shape.

11. The implant of claim 1, wherein said body has a W shape.

12. The implant of claim 1, wherein said body has a rectangular shape.

13. The implant of claim 1, wherein said body includes at least one bioactive agent.

14. The implant of claim 13, wherein said at least one bioactive agent includes one or more substances taken from a group consisting of growth factors, hormones, viral particles, platelet rich plasma, and naked DNA.

15. The implant of claim 14, wherein said growth factors include TGFβ

, FGF, VEGF, PDGF, EGF, HGF, IGF and IL superfamilies.

16. The implant of claim 13, wherein said at least one bioactive agent is adsorbed to said body.

17. The implant of claim 13, wherein said body includes a collagen backbone, said at least one bioactive agent being covalently bonded to said collagen backbone.

18. The implant of claim 13, wherein said body is impregnated with said at least one bioactive agent.

19. The implant of claim 1, wherein said body includes at least one tissue fragment.

20. The implant of claim 1, wherein said body includes bone marrow aspirate.

21. The implant of claim 1, wherein said body includes live cells.

22. The implant of claim 21, wherein said live cells include disc cells.

23. The implant of claim 21, wherein said live cells include marrow cells.

24. The implant of claim 21, wherein said live cells include stroma cells.

25. The implant of claim 21, wherein said live cells include mesenchymal cells.

26. The implant of claim 21, wherein said live cells include chondrocytes.

27. The implant of claim 21, wherein said live cells include autogenic stem cells.

28. The implant of claim 21, wherein said live cells are adhered to a surface of said body.

29. The implant of claim 21, wherein said body includes a collagen network, said collagen network being impregnated with said live cells.

30. The implant of claim 1, wherein said body includes a radiopaque marker.

31. The implant of claim 1, wherein said body includes a top face and a bottom face opposite said top face.

32. The implant of claim 31, wherein said top face of said body has a lordotic curvature that conforms to the curvature of a vertebral end plate of the superior vertebra.

33. The implant of claim 31, wherein said bottom face of said body has a lordotic curvature that conforms to the curvature of a vertebral end plate of the inferior vertebra.

34. The implant of claim 31, wherein said body includes a plurality of holes, each of said holes having a diameter less than 1 mm and extending in an axial direction that is substantially perpendicular to said top face and said bottom face of said body.

35. The implant of claim 31, wherein said body includes a plurality of holes, each of said holes having a diameter less than 1 mm and extending in a radial direction that is substantially parallel to said top face and said bottom face of said body.

36. The implant of claim 1, wherein said body has a pH in range of from 6.6 to 7.4.

37. The implant of claim 1, wherein said body assumes its said original shape in response to its exposure to a physiological fluid.

38. The implant of claim 1, wherein the annulus fibrosus has a major axis and a minor axis, said body being sized and shaped such that said exterior surface is engageable with a substantial portion of the inner wall of the annulus fibrosus along its major and minor axes when said body assumes its said original shape after insertion into the nuclear cavity of the defective vertebral disc, whereby said implant exerts a tensile force on the inner wall of the annulus fibrosus along its major and minor axes to thereby resist hoop stresses generated by the annulus fibrosus.

39. The implant of claim 1, wherein said exterior surface includes a top face and a bottom face, said body being sized and shaped such that said top face of said implant is engageable with a substantial portion of an end plate of the superior vertebra when said body is in its said original shape, and such that said bottom face of said implant is engageable with a substantial portion of an end plate of the inferior vertebra when said body is in its said original shape, whereby said implant inhibits further vertebral disc height collapse when said body is in its said original shape.

40. The implant of claim 1, wherein the annulus fibrosus of the defective vertebral disc includes an opening that extends from its outer wall to its inner wall, said original shape of said body being selected so as to inhibit the expulsion of said implant through the opening in the annulus fibrosus when said body is in its said original shape, whereby said implant is retained within the nuclear cavity of the defective vertebral disc when said body is in its said original shape.

41. The implant of claim 40, wherein said body includes a plug section extending therefrom and having a size and shape selected such that said plug section fits within the opening in the annulus fibrosus upon insertion of said body into the nuclear cavity of the defective vertebral disc.

42. The implant of claim 41, wherein said body has a T shape.

43. The implant of claim 41, wherein said body has a Y shape.

44. The implant of claim 41, wherein said body has a ring shape, said body including an annular exterior member and a hollow space within said exterior member, and said plug section extending radially outwardly from said annular exterior member.

45. The implant of claim 1, wherein said exterior surface of said body has a shape that substantially conforms to the shape of the inner wall of the annulus fibrosus.