Endoscope Sterilization Test Pack with Vacuum Simulation
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Solution Overview
Problem
Conventional sterilization effect checking methods for medical devices, such as autoclave and EOG sterilization, lack reliability in ensuring consistent sterilization conditions, particularly for endoscopes, as they do not accurately replicate the sterilization environment within the device being tested.
Innovation Solution
An endoscope sterilizing test pack with an inner case and connected tubes that mimic the sterilization environment of the endoscope, allowing for the insertion and removal of indicators to check sterilization efficacy, ensuring hermetic seals and vacuum conditions to simulate the sterilization process accurately.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization checking methods (tape-like CI or sheet-like BI) are used, then the checking process is simple, but the reliability of sterilization validation is insufficient for endoscopes
Solution Approach 1:
The test pack is divided into multiple functional segments: an outer case for structural integrity, an inner case for hermetic sealing, tubes for steam/气体 penetration simulation, and indicators for sterilization detection. This segmentation allows each component to perform its specific function optimally, thereby improving sterilization validation reliability while keeping the overall structure manageable.
Solution Approach 2:
The inner case is nested within the outer case, and the tubes are positioned within the inner case. This nested structure allows the test pack to replicate the complex sterilization environment of endoscopes (including external and internal chambers) while maintaining a compact form factor. The nesting enables multi-level sterilization simulation without excessive complexity.
2Measurement precision
If the test pack uses hermetic sealing and vacuum conditions to simulate sterilization environment, then the measurement precision of sterilization effect is improved, but the ease of operation for indicator insertion and removal deteriorates
Solution Approach 1:
The inner case is designed with a removable cap that allows dynamic opening and closing. During sterilization, the cap is closed to maintain hermetic sealing and vacuum conditions for accurate measurement. For indicator insertion and removal, the cap can be opened, temporarily breaking the seal. This dynamic design enables both high measurement precision during sterilization and ease of operation during indicator handling.
Solution Approach 2:
Indicators are pre-inserted into the inner case before sterilization in some embodiments, or the inner case is pre-prepared with connection ports for tubes. This preliminary action ensures that when sterilization begins, the hermetic seal is already in place, maintaining measurement precision without requiring complex operations during the sterilization process itself.
3Reliability
If the test pack replicates the complete sterilization environment within the endoscope, then the reliability of sterilization checking is improved, but the device complexity increases
Solution Approach 1:
The test pack creates a simplified copy of the endoscope's sterilization environment. Instead of replicating the entire endoscope structure, it copies the essential sterilization chambers (external case and internal tube spaces) and uses indicators to represent the sterilization target. This copying approach maintains reliability by capturing the critical sterilization zones while avoiding the complexity of reproducing the full endoscope anatomy.
Solution Approach 2:
The test pack is designed to be versatile and can be used for different sterilization methods (autoclave steam sterilization and EOG sterilization) by simply changing the sterilizing agent. The same basic structure with outer case, inner case, and tubes serves multiple sterilization purposes, reducing the need for multiple specialized test devices and thereby managing overall system complexity.
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 test pack effectively checks the sterilization effect by replicating the sterilization conditions within the endoscope, ensuring reliable and consistent sterilization validation without direct inspection of the device's interior.
Implementation Method 1
a check valve (79) for changing the inner space of the case (74) into substantially vacuum atmosphere
Implementation Method 2
subsequently admitting the sterilizing gas into the case (74)
Data Source
AI summary
An endoscope sterilizing test pack includes an inner case having an open/close mechanism which can insert thereinto and remove therefrom an indicator for checking a sterilization effect of sterilization treatment; at least one tube connected to the inner case so that one end is opened and another end is communicated with an inside of the inner case; and a sheath member housing the tube and the inner case.