Irradiated Polyoxymethylene Fiber for Low-Temperature Sterilization
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Solution Overview
Problem
Current sterilization methods for medical devices in non-industrial settings, such as hospitals or physician's offices, are not cost-effective or easy to use, particularly for heat-sensitive plastics, as they require expensive equipment and skilled personnel, and existing methods like high temperature steam autoclaves can damage plastics, while gaseous sterilization is inefficient in small facilities.
Innovation Solution
A container insert made of low melt viscosity polyoxymethylene or copolymer fibers with a high surface-to-mass ratio, irradiated to cause chain cleavage without depolymerization, which releases formaldehyde upon low heat application, allowing for efficient sterilization without brittleness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high temperature steam autoclave is used for sterilization, then sterilization effectiveness is improved, but heat-sensitive plastics are damaged
Solution Approach 1:
The invention changes the sterilization parameter from high temperature (autoclave) to low temperature formaldehyde gas generation, enabling sterilization of heat-sensitive plastics without damage while maintaining sterilization effectiveness
Solution Approach 2:
The invention replaces the mechanical/thermal sterilization system (steam autoclave) with a chemical sterilization system (formaldehyde-releasing polymer), eliminating the need for high temperature and high pressure equipment
2Reliability
If gaseous sterilization is used, then sterilization effectiveness is improved, but handling and purge time increase
Solution Approach 1:
The invention extracts the sterilant gas generation process from external gaseous sterilization equipment and incorporates it into a self-contained polymer package that generates formaldehyde gas locally within the sterilization chamber, eliminating complex handling and purge requirements
Solution Approach 2:
The polymer package automatically generates formaldehyde gas when exposed to moisture or heat, eliminating the need for external gas supply systems, complex timing controls, and extensive purge cycles required by traditional gaseous sterilization methods
3Reliability
If irradiation dose is increased to achieve sufficient formaldehyde release, then sterilization effectiveness is improved, but polymer embrittlement increases
Solution Approach 1:
The invention changes the polymer structure by incorporating formaldehyde-generating functional groups into the polymer chain, enabling sufficient formaldehyde release at lower irradiation doses that do not cause severe embrittlement
Solution Approach 2:
The invention uses a composite polymer structure combining a base polymer matrix with formaldehyde-generating moieties, achieving both structural integrity and sterilization function without requiring excessive irradiation that would compromise mechanical properties
4Reliability
If thick poly acetal pieces are used for sterilization, then formaldehyde release is improved, but manufacturing complexity and embrittlement increase
Solution Approach 1:
The invention uses thin film or sheet structures instead of thick pieces, enabling easier manufacturing, better handling, and sufficient formaldehyde release through the thinner material when irradiated at appropriate doses
Solution Approach 2:
The invention optimizes the thickness parameter of the poly acetal material to a thin film configuration, which reduces manufacturing complexity and handling difficulties while maintaining adequate formaldehyde generation capacity through controlled irradiation
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 solution enables effective sterilization of medical devices at low heat, reducing material embrittlement and increasing formaldehyde release efficiency, making it suitable for small medical facilities with cost-effective and easy-to-use methods.
Implementation Method 1
irradiated to cause chain cleavage without depolymerization or brittleness of the insert such that formaldehyde is released upon subsequent application of low heat to the insert
Implementation Method 2
caused the poly acetal to slightly depolymerize which caused a release of trace amounts of formaldehyde gas
Implementation Method 3
upon subsequent heating, caused the poly acetal to slightly depolymerize which caused a release of trace amounts of formaldehyde gas
Data Source
AI summary
The present invention relates to a method for sterilizing an article inside a sealed container by placing a polyoxymethylene melt formable co-polymer fiber that has been irradiated between about 1 and 200 kGy and then heated at from about 20° C. to about 90° C. for a selected period of time.