Bone Graft Sterilization Preserving Viscosity
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Solution Overview
Problem
Gamma irradiation for sterilizing bone graft materials alters their physical properties, making them unsuitable for transplantation due to deteriorated viscosity and cohesion, which is a significant issue in maintaining the material's integrity and shape during implantation.
Innovation Solution
A method involving pretreating the bone graft material at a temperature below 0°C, specifically −20°C, followed by gamma irradiation within a 25 to 40 kGy range, to maintain the material's properties intact during sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gamma irradiation is used to sterilize bone graft material, then sterilization effectiveness is improved, but physical properties such as viscosity and cohesion are deteriorated
Solution Approach 1:
The bone graft material is pre-frozen at -20°C or lower before gamma irradiation sterilization. This preliminary freezing action protects the material's physical properties during sterilization by maintaining strong cohesion and viscosity, while still achieving effective sterilization at 25-40 kGy dosage.
2Object-affected harmful factors
If gamma irradiation is applied to sterilize the material, then microorganisms are killed, but the material's shape retention and cohesion are compromised
Solution Approach 1:
The temperature parameter is changed to -20°C or lower before gamma irradiation. This parameter change protects the bone graft material's shape retention and cohesion during sterilization, allowing effective microorganism elimination while maintaining the material's structural integrity for transplantation.
3Device complexity
If the bone graft material is sterilized without pretreatment, then sterilization process is simplified, but the material becomes unsuitable for transplantation due to property deterioration
Solution Approach 1:
A simple pre-freezing step at -20°C or lower is introduced before gamma irradiation. This preliminary action ensures the bone graft material maintains its transplantation suitability with strong cohesion and shape retention, while the overall process remains straightforward and clinically feasible.
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 preserves the physical properties of the bone graft material, ensuring strong cohesion, shape retention, and minimal adhesion during transplantation, allowing for flexible shaping and reduced bone loss.
Implementation Method 1
pretreating the bone graft material prepared in step a) by maintaining it at a temperature below 0° C.
Implementation Method 2
sterilizing the bone graft material pretreated in step b) by gamma irradiation
Data Source
AI summary
The present invention relates to a method for sterilizing a bone graft material, and more specifically, to a method for sterilizing a bone graft material containing sodium carboxymethyl cellulose (CMC) gel without changing its properties.