Electron beam irradiated osteoinductive bone implant
AssigneeWarsaw Orthopedic, Inc.
InventorsKelly W. Schlachter, Erick Vasquez, Daniel A. Shimko
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Abstract
A method of making an electron beam irradiated osteoinductive implant is provided. The method comprises exposing an osteoinductive implant containing demineralized bone matrix (DBM) fibers to electron beam radiation at a dose of from about 10 kilograys to 100 kilograys for a period of time. The electron beam irradiation reduces microorganisms in the osteoinductive implant, and the electron beam irradiated osteoinductive implant retains osteoinductive properties. Methods of implantation and an irradiated osteoinductive implant are also disclosed.
Claims16
An osteoinductive implant, the osteoinductive implant comprising:
- demineralized bone fibers that are free from a carrier, the osteoinductive implant being an irradiated osteoinductive implant formed from electron beam radiation at a dose of from about 10 kilograys to 100 kilograys for a period of time, the irradiated osteoinductive implant having reduced microorganisms to a sterility assurance level (SAL) of about 10−6 and reduced osteoinductive properties by 0% to 20% compared to an non-irradiated osteoinductive implant.
An osteoinductive implant, the osteoinductive implant comprising:
- demineralized bone fibers that are free from a carrier, the osteoinductive implant being an irradiated osteoinductive implant formed from electron beam radiation at a dose of from about 10 kilograys to 100 kilograys for a period of time, the irradiated osteoinductive implant having reduced microorganisms to a sterility assurance level (SAL) of about 10−6 and reduced osteoinductive properties by 0% to 20% compared to an non-irradiated osteoinductive implant, wherein the demineralized bone fibers are entangled in a coherent mass.
Dependencies are inferred from the claim text.