Irradiated implantable bone material

• US 7,976,861 B2
• Filed: 03/15/2010
• Issued: 07/12/2011
• 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): SCHUBERG, LAURA J
• Application Number:
  US12/724,123
• Publication Number:
  US 20100172954A1
• Time in Patent Office: 484 Days
• Field of Search: None
• 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 producing demineralized bone compositions having uniform osteoinductivity, the method comprising:

(a) obtaining bone portions from a human donor subject;

(b) demineralizing the bone portions to produce demineralized bone portions having no osteoinductivity; and

(c) irradiating the demineralized bone portions at a temperature less than about 0°

C. and at a dose of radiation sufficient to increase osteoinductivity to an Osteoinduction Grading Score of at least 2.

2. A method according to claim 1, wherein the bone portions are obtained from a plurality of donor subjects.

3. A method according to claim 1, wherein the demineralized bone portions comprise bone powder.

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