Electron beam irradiated osteoinductive bone implant

Patent metadata

Field	Value
Publication number	US-11918705-B2
Application number	US-202117403314-A
Country	US
Kind code	B2
Filing date	Aug 16, 2021
Priority date	Jan 28, 2016
Publication date	Mar 5, 2024
Grant date	Mar 5, 2024

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.

First claim

What is claimed is:

1. A method of treating a bone cavity, the method comprising:
providing an osteoinductive implant,
the osteoinductive implant being irradiated with electron beam radiation at a dose of from about 10 kilograys to 100 kilograys for a period of time to reduce microorganisms in the osteoinductive implant, the osteoinductive implant containing demineralized bone matrix (DBM) fibers having a length from about 1 to about 70 micrometers and being free of a carrier, wherein the electron beam irradiated osteoinductive implant retains at least about 80% osteoinductive properties; and
implanting the irradiated osteoinductive implant into the bone cavity.

2. A method of claim 1 , wherein the method further comprises hydrating the irradiated osteoinductive implant with a liquid before implanting.

3. A method of claim 2 , wherein after hydrating, the hydrated osteoinductive implant is formed into a putty or paste.

4. A method of claim 2 , wherein the method further comprises molding the hydrated osteoinductive implant into a shape before implanting the osteoinductive implant.

5. A method of claim 2 , wherein the osteoinductive implant is molded to conform to the bone cavity after it is hydrated.

6. A method of claim 1 , wherein the osteoinductive properties of the irradiated osteoinductive implant are measured up to 6, 12, 18, 24, 32 or 36 months after storage at room temperature in a moisture barrier packaging.

7. A method of claim 1 , wherein the electron beam irradiation reduces the microorganisms to a sterility assurance level (SAL) of about 10 −6.

8. A method of claim 1 , wherein the electron beam irradiation reduces microorganisms by 1-log reduction to 10-log reduction.

9. A method of claim 1 , wherein the electron beam irradiated osteoinductive implant is hydrated by from about 1% to about 60% after it is irradiated.

10. A method of claim 9 , wherein before the osteoinductive implant is hydrated, the irradiated osteoinductive implant comprises a low moisture content comprising less than 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% moisture.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Schlachter Kelly W
• Vasquez Erick
• Shimko Daniel A

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L27/3691 Primary

  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 title

• A61L2/087

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• A61L27/3608

  Bone, e.g. demineralised bone matrix [DBM], bone powder · CPC title

• A61L27/365

  Bones · CPC title