Electron Beam Sterilization of Osteoinductive Bone Implants
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Solution Overview
Problem
There is a need for a method to sterilize bone graft materials while preserving their osteoinductive potential, as existing methods can damage biologic components and reduce the effectiveness of demineralized bone products.
Innovation Solution
Exposing demineralized bone matrix fibers to electron beam radiation at a dose of 10 to 100 kilograys to reduce microorganisms and maintain osteoinductive properties, allowing for the production of electron beam-irradiated osteoinductive implants that are free from carriers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sterilization methods (gamma irradiation, chemical sterilants, autoclaving) are used on demineralized bone matrix, then microorganisms are eliminated, but osteoinductive potential is destroyed or reduced
Solution Approach 1:
The patent changes the sterilization parameter from traditional gamma irradiation or chemical methods to electron beam irradiation at specific energy levels (0.5-5 MeV) and dose ranges (2-20 kGy). This parameter change allows selective microbial destruction while preserving the osteoinductive proteins and growth factors in the demineralized bone matrix, achieving sterilization without destroying the biologic activity.
2Reliability
If electron beam irradiation is applied to sterilize bone graft materials, then microorganisms are reduced, but damage to biologic components may occur
Solution Approach 1:
The patent applies partial action by using controlled electron beam irradiation doses (2-20 kGy) that are sufficient to achieve sterilization (reducing microorganisms by 1-10 logs) but not excessive enough to damage the biologic components. This precise dose control allows selective destruction of microbial DNA while preserving osteoinductive proteins and growth factors.
Solution Approach 2:
The patent optimizes the electron beam parameters (energy level of 0.5-5 MeV and dose of 2-20 kGy) to achieve the desired balance between sterilization and preservation of biologic activity. These specific parameter settings enable effective microbial killing while minimizing damage to the osteoinductive components of the bone matrix.
3Reliability
If aseptic processing with extensive prescreening and strict environmental controls is used, then microorganisms are reduced, but processing complexity and cost increase
Solution Approach 1:
The patent replaces complex mechanical and chemical sterilization systems (autoclaves, chemical sterilants, gamma irradiation facilities) with electron beam irradiation technology. This substitution simplifies the processing system while maintaining effective sterilization, reducing both complexity and cost compared to traditional aseptic processing methods with extensive prescreening and strict environmental controls.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method effectively sterilizes the implants, reducing microorganisms by 1 to 10 logs while retaining up to 99% of their osteoinductive potential, making them suitable for bone repair procedures without the need for additional carriers.
Implementation Method 1
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 to reduce microorganisms
Implementation Method 2
All radiation stems from ionizing radiation that can originate either from a radioactive source or from highly accelerated electrons
Data Source
AI summary
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.