Reinforced bone graft substitutes

• US 6,039,762 A
• Filed: 06/11/1997
• Issued: 03/21/2000
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/872,689
• Time in Patent Office: 1,014 Days
• Field of Search: 623/16, 623/17, 606/60, 606/61
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00095 Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00125 Hafnium or Hf-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00137 : Tungsten or W-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/025 : Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 27/10 : Ceramics or glasses
• CPC Class Codes: A61L 27/12 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/22 : Polypeptides or derivatives thereof , e.g. degradation products
• CPC Class Codes: A61L 27/24 : Collagen
• CPC Class Codes: A61L 27/306 : Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3654 : Cartilage, e.g. meniscus
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/42 : having an inorganic matrix
• CPC Class Codes: A61L 27/44 : having a macromolecular matrix
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 89/00 : Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00
• CPC Class Codes: C08L 89/06 : derived from leather or skin , e.g. gelatin
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/909 : Bone

Abstract

One embodiment of a spinal spacer 10 includes a body 11 sized and configured for engagement between adjacent vertebrae V. The body 11 includes two opposite faces 12, 14 and an outer surface 13 between the two faces 12, 14. In one embodiment, the body 11 includes deactivated bone material in synergistic combination with a bone growth factor. A sleeve 15 is disposed around the outer surface 13 of the body 11. The sleeve 15 is composed of a second material which is relatively stronger under compressive loads than the biocompatible material of the body 11. Also provided is a plurality of apertures 16 through the sleeve 15 in communication with the outer surface 13 of the body 11 for bone ingrowth. Means for attaching the sleeve to the endplates of adjoining vertebral bodies are also provided.

Claims

1. An interbody fusion spacer, comprising:

a body having an outer surface and a height approximating the height of a human disc space, said body composed of a porous, biocompatible ceramic material for permitting tissue ingrowth therethrough; and

a reinforcing sleeve disposed around said outer surface of said body, said sleeve including a material relatively stronger under compression than said porous, biocompatible ceramic material; and

said reinforcing sleeve having an inner surface defining a chamber, said chamber having an inner dimension that is slightly smaller than said body so as to engage said sleeve to said body.

2. The spacer of claim 1 wherein said sleeve defines a plurality of apertures therethrough in communication with said outer surface of said body for bone ingrowth.

3. The spacer of claim 2 wherein said apertures are generally circular.

4. The spacer of claim 2 wherein said apertures are generally oval.

5. The spacer of claim 2 wherein said apertures are generally diamond-shaped.

6. The spacer of claim 2 wherein said apertures are generally rectangular.

7. The spacer of claim 1 wherein:

said sleeve includes an inner surface for contacting said outer surface of said body, said inner surface of said sleeve defining a chamber;

said sleeve being formed of a temperature responsive material such that said chamber has a first inner dimension that is slightly larger than an outer dimension of said body when said sleeve is in a heated state to slidably receive said body therein; and

said chamber has a second inner dimension that is slightly smaller than said body when said sleeve is in a cooled state to thereby clamp said body therein.

8. The spacer of claim 1 wherein said sleeve has a height less than a height of said outer surface to permit contact of said opposite faces with endplates of the corresponding vertebrae when the spacer is implanted between the vertebrae.

9. The spacer of claim 1, further comprising:

attaching means for attaching said sleeve to the endplates of the adjacent vertebral bodies.

10. The spacer of claim 9 wherein:

said sleeve includes an inferior end and a superior end; and

said attaching means includes teeth disposed at said superior end and said inferior end of said sleeve.

11. The spacer of claim 9 wherein:

said sleeve includes an inferior end and a superior end; and

said attaching means includes roughened surfaces defined on said superior end and said inferior end of said sleeve.

12. The spacer of claim 1 wherein said body is cylindrical and said sleeve is a hollow cylinder.

13. The spacer of claim 1 wherein said opposite faces of said body each have a size and shape corresponding to the shape of a vertebral endplate.

14. The spacer of claim 1 wherein said sleeve has an outer shape approximating the shape of a vertebral endplate.

15. The spacer of claim 1 wherein said sleeve is composed of a metal material.

16. The spacer of claim 15 wherein said metal material includes a metal selected from the group consisting of tantalum, niobium, hafnium, tungsten and alloys thereof.

17. The spacer of claim 15 wherein said metal material is a tantalum foam.

18. The spacer of claim 15 wherein said sleeve is composed of a metal material including a metal selected from the group consisting of titanium, titanium-vanadium-aluminum alloy, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy, cobalt-nickel-chromium-molybdenum alloy and biocompatible stainless steel.

19. The spacer of claim 18 wherein said biocompatible stainless steel is 316 LVM stainless steel.

20. The spacer of claim 15 wherein said metal material includes titanium.

21. The spacer of claim 1 wherein said spacer has an ASTM C-773 compressive strength of at least 7.1 MPa.

22. The spacer of claim 20 wherein said spacer has a compressive strength of at least 20 MPa.

23. The spacer of claim 21 wherein said spacer has a compressive strength of at least 40 MPa.

24. The spacer of claim 1 wherein said body has a kidney-shaped cross-section to conform to the shape of vertebral endplates.

25. The spacer of claim 1 wherein said body is configured to approximate a size and shape of a nucleus pulposus of a natural intervertebral disc.

26. The spacer of claim 1 wherein said ceramic material is a calcium phosphate ceramic.

27. The spacer of claim 1 wherein said ceramic material is a biphasic calcium phosphate ceramic.

28. An interbody fusion device, comprising:

a body having an outer surface and a height approximating the height of a human disc space, said body including a porous, biocompatible, biodegradable material for permitting tissue ingrowth therethrough; and

a sleeve engaged to said outer surface of said body, said sleeve including a material relatively stronger under compressive loads than said biocompatible material and including an inner surface for contacting said outer surface of said body, said inner surface of said sleeve defining a chamber, said sleeve being formed of a temperature responsive material such that said chamber has a first inner dimension that is slightly larger than an outer dimension of said body when said sleeve is in a heated state to slidably receive said body therein, and said chamber having a second inner dimension that is slightly smaller than said body when said sleeve is in a cooled state to thereby clamp said body therein.

29. An interbody fusion spacer, comprising:

a body having an outer surface and a height approximating the height of a human disc space, said body composed of a porous, biocompatible material for permitting tissue ingrowth therethrough; and

a reinforcing sleeve clamped around said outer surface of said body, said sleeve including a material relatively stronger under compression than said porous, biocompatible material.

30. The spacer of claim 29, further comprising a therapeutically effective amount to stimulate bone growth of a bone growth factor dispersed within said body.

31. The spacer of claim 29 wherein said sleeve defines a plurality of apertures therethrough in communication with said outer surface of said body for bone ingrowth.

33. The spacer of claim 29, wherein said body is composed of bone.

34. The spacer of claim 29, wherein said porous, biocompatible material comprises biocompatible ceramic.

35. The spacer of claim 33, wherein said bone has been processed to remove associated non-collagenous bone proteins, said bone containing native collagen materials and naturally associated bone minerals and substantially free from non-collagenous protein.

32. A spinal implant for engagement between vertebrae, comprising:

a monolithic body having two opposite faces and an outer surface disposed between said two faces, said body including a porous, biocompatible material for permitting tissue ingrowth therethrough, said body being sized and configured for engagement between two vertebrae;

a sleeve disposed around said outer surface of said body, said sleeve including a second material relatively stronger under compressive loads than said porous, biocompatible material;

said sleeve including an inner surface for contacting said outer surface of said body, said inner surface of said sleeve defining a chamber; and

said chamber having an inner dimension that is slightly smaller than said body so as to engage said sleeve to said body.

36. An interbody fusion spacer, comprising:

a body having an outer surface and a height approximating the height of a human disc space, said body composed of a porous, biocompatible ceramic material for permitting tissue ingrowth therethrough; and

a reinforcing sleeve engaged to said outer surface of said body, said sleeve including a material relatively stronger under compression than said porous, biocompatible ceramic material;

said sleeve including an inner surface for contacting said outer surface of said body, said inner surface of said sleeve defining a chamber;

said sleeve being formed of a temperature responsive material such that said chamber has a first inner dimension that is slightly larger than an outer dimension of said body when said sleeve is in a heated state to slidably receive said body therein; and

said chamber having a second inner dimension that is slightly smaller than said body when said sleeve is in a cooled state to thereby clamp said body therein.