Hydrogen Peroxide Vapor Diffusion for Sterilizing Narrow Lumens
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Solution Overview
Problem
Existing methods for sterilizing medical devices with long, narrow lumens using hydrogen peroxide vapor face challenges due to degradation and blockage, limiting the size and length of lumens that can be sterilized, and often require cumbersome devices or high concentrations that degrade materials.
Innovation Solution
A sterilization system and method that enhances sterilant penetration into lumens by controlling pressure and concentration gradients, using a controlled diffusion process to distribute hydrogen peroxide vapor effectively within lumens without increasing overall concentration, thus maintaining material compatibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hydrogen peroxide vapor is used to sterilize long, narrow lumens, then sterilization effectiveness is improved, but the vapor degrades and blocks before reaching the lumen interior
Solution Approach 1:
The system performs preliminary evacuation of the lumen before introducing hydrogen peroxide vapor. This removes air and water vapor that would otherwise block or degrade the sterilant, allowing the hydrogen peroxide vapor to reach the lumen interior effectively without premature degradation or blockage
Solution Approach 2:
The system controls pressure parameters by creating a pressure differential between the lumen interior and exterior. By maintaining lower pressure inside the lumen, the hydrogen peroxide vapor is driven into the lumen through pressure gradient, enhancing penetration while minimizing degradation
2Reliability
If higher concentration of hydrogen peroxide vapor is used to improve sterilization, then sterilization effectiveness increases, but material degradation increases
Solution Approach 1:
The system creates locally high concentration of hydrogen peroxide vapor inside the lumen through pressure differential, while maintaining lower concentration in the surrounding environment. This localized approach ensures effective sterilization within the lumen without exposing the entire device to high concentrations that would cause material degradation
Solution Approach 2:
The pressure differential acts as an intermediary mechanism that controls the distribution of hydrogen peroxide vapor. It directs the vapor flow to where it is needed (inside the lumen) while preventing excessive concentration elsewhere, thus mediating between sterilization effectiveness and material compatibility
3Reliability
If water is removed from hydrogen peroxide vapor to increase concentration, then sterilization effectiveness improves, but the process becomes more complex
Solution Approach 1:
The system combines the vacuum pump function with the pressure differential creation for lumen evacuation. Instead of using a separate complex water removal system, the same vacuum mechanism serves dual purposes: evacuating the lumen before sterilization and maintaining pressure differential during the process, thereby simplifying the overall system
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
Achieves full sterilization of medical devices with long, narrow lumens efficiently, reducing sterilant use and minimizing material degradation while ensuring thorough sterilization.
Implementation Method 1
A sterilization system and method that enhances sterilant penetration into lumens by controlling pressure and concentration gradients, using a controlled diffusion process to distribute hydrogen peroxide vapor effectively within lumens
Data Source
AI summary
A sterilization cycle for sterilizing material and items containing diffusion restricted spaces and lumens is provided that introduces vaporous sterilant, such as hydrogen peroxide, into the chamber in a controlled manner such that diffusion within the restricted spaces and lumens is enhanced as a precursor to additional sterilization steps thereby enhancing overall sterilization.


