Irradiated implantable bone material

• US 7,678,385 B2
• Filed: 04/28/2004
• Issued: 03/16/2010
• Est. Priority Date: 04/28/2004
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Reddi, A. Hari
• Primary Examiner(s): Weber; Jon p
• Assistant Examiner(s): Schuberg; Laura
• Application Number:
  US10/834,562
• Publication Number:
  US 20050244457A1
• Time in Patent Office: 2,148 Days
• Field of Search: 623/17.14, 424/425
• US Class Current: 424/423
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2002/2817 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 2310/00359 Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 Gelatin
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• 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 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

A method for making an implantable bone material. The method includes providing a bone composition consisting essentially of demineralized human bone, and irradiating the composition at a temperature less than about 0° C.

Claims

1. A method for making an implantable bone material, comprising:

irradiating a bone composition consisting essentially of demineralized human bone, the bone composition having no osteoinductivity prior to the irradiating, at a temperature less than about 0°

C., and at a dose of radiation sufficient to increase the osteoinductivity of the bone composition to an Osteoinduction Grading Scale score of at least 2.

2. A method according to claim 1, wherein irradiating further comprises cooling the composition using dry ice.

3. A method according to claim 1, wherein irradiating comprises administering a dose of radiation of at least about 1.0 Mrad to the composition.

4. A method according to claim 3, wherein the dose of radiation is from about 2.0 Mrad to about 10 Mrad.

5. A method according to claim 1, wherein irradiating comprises administering a sterilizing dose of radiation to the composition.

6. A method according to claim 1, wherein the composition additionally comprises a carrier.

7. A method according to claim 1, wherein the composition consists of demineralized human bone powder.

8. A method according to claim 1, further comprising:

adding a biocompatible carrier after irradiating; and

forming the mixture into an article.

9. A method according to claim 8, wherein the article is selected from the group consisting of a sheet, an elongated member, a plate, a plug, a ball, and a porous member.

10. A method for improving the osteoinductivity of demineralized bone comprising:

(a) providing a bone composition consisting essentially of demineralized human bone, the bone composition having no osteoinductivity; and

(b) irradiating the bone composition at a temperature less than about 0°

C., at a radiation dose sufficient to produce an increase in the osteoinductivity of the bone composition to an Osteoinduction Grading Scale score of at least 2.

11. A method according to claim 10, wherein the human demineralized bone comprises human demineralized bone powder.

12. A method according to claim 10, wherein irradiating comprises administering a sterilizing dose of radiation to the composition.

13. A method according to claim 10, wherein the composition additionally comprises a biocompatible carrier.