Bone allograft material and method

• US 5,112,354 A
• Filed: 11/16/1989
• Issued: 05/12/1992
• Est. Priority Date: 11/16/1989
• Status: Expired due to Fees

• Current Assignee: Northwestern University
• Original Assignee: Northwestern University
• Inventors: Sires, Bryan S.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US07/437,189
• Time in Patent Office: 908 Days
• Field of Search: 623/16, 623/66, 424/549
• US Class Current: 600/36
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2825 Femur
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30232 Half-cylinders
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3081 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment

Abstract

A textured, demineralized, and unitary mammalian bone section for providing a rigid, foraminous, collagen scaffold for allogenic skeletal reconstruction. The allograft is prepared by treating a section of cadaver bone to remove all soft tissue, then texturing the bone surface to produce a pattern of holes of selected size, density, and depth, and finally demineralizing the bone section to leave a rigid, insoluble collagen scaffold suitable for osteoinduction upon implantation. All such steps are performed with minimal denaturing of the extracellular matrix proteins which remain bound to the collagen scaffold and which are necessary to complete the process of new bone formation.

Claims

1. A method for preparing a bone allograft comprising the steps of treating a section of cadaver bone to remove all soft tissue therefrom;

then texturing said section b forming a multiplicity of holes extending inwardly from a surface thereof;

said holes being of a diameter within the range of 200 to 2000 um and being spaced apart distances within the range of 100 to 1200 um; and

then demineralizing said section by immersing the same in a demineralizing bath containing a protease inhibitor for retaining the bioactivity of the extracellular matrix proteins bound thereto and providing a rigid collagen scaffold for reconstructive allogenic implantation in a living subject.

2. The method of claim 1 in which said section is demineralized by immersing the same in a dilute acid bath.

3. The method of claims 1 or 2 in which said holes are of a diameter within the preferred range of 500 to 800 um.

4. The method of claims 1 or 2 in which said holes are spaced apart distances within the preferred range of 300 to 700 um.

5. The method of claims 1 or 2 in which some of said holes extend completely through said section and others of said holes extend only partially through said section.

6. The method of claim 5 in which said others of said holes extend 5 to 90% of the thickness of said section.

7. The method of claim 6 in which said others of said holes extend 30 to 50% of the thickness of said section.

8. The method of claims 1 or 2 in which said holes are formed in said section by a laser beam.

9. The method of claims 1 or 2 in which said holes have their longitudinal axes perpendicular to said surface.

10. The method of claim 9 in which said surface is curved and said axes are generally converging in directions extending inwardly from said surface.

11. The method of claim 10 in which some of said holes extend completely through said section and others of said holes extend only partially through said section.

12. The method of claims 1 or 2 in which there is the further step of defatting and sterilizing said section in a liquid medium that dissolves fat without denaturing extracellular matrix proteins.