Vacuum Packaging Flexible Endoscopes
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Solution Overview
Problem
Flexible endoscopes, being thermolabile and non-sterilizable, face challenges in maintaining asepsis during transportation and storage due to the inability to withstand sterilization processes, and existing methods for safe and aseptic transportation are costly and inefficient.
Innovation Solution
A method involving vacuum packaging with an oxygen concentration of 16% +/- 0.5% by volume in a hermetically sealed bag, which inhibits the growth of both aerobic and anaerobic bacteria, ensuring prolonged aseptic storage and safe transportation of flexible endoscopes, using a triple-sealed bag with a tray and optional additional sterile bag and rigid case for protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sterilization processes are used on flexible endoscopes, then complete destruction of all microorganisms is achieved, but the endoscope is damaged due to thermolabile properties
Solution Approach 1:
The patent applies vacuum packaging with inert or low-oxygen atmosphere to prevent microbial growth without requiring sterilization. By removing oxygen and creating a protective barrier, the endoscope is preserved in its disinfected state during storage and transport, avoiding damage from autoclaving or other sterilization processes while still achieving microorganism control.
2Reliability
If high level disinfection is performed frequently to maintain asepsis, then microbial contamination is reduced, but processing time and cost increase
Solution Approach 1:
The patent performs high-level disinfection once before packaging, then maintains asepsis through vacuum packaging during storage and transport. This preliminary disinfection action, combined with the protective packaging environment, extends the period between reprocessing cycles from what would otherwise require frequent intervention to potentially weeks or months of safe storage without additional processing.
Solution Approach 2:
By creating an oxygen-free or low-oxygen environment through vacuum packaging, the patent prevents aerobic bacterial growth and slows anaerobic bacterial metabolism. This inert environment acts as a continuous protective barrier that maintains asepsis without requiring repeated energy-intensive disinfection cycles, significantly reducing processing time and costs.
3Ease of operation
If conventional storage methods are used, then endoscopes are readily accessible, but microbial colonization occurs in channels over time
Solution Approach 1:
The patent uses flexible vacuum bags that can conform to the endoscope shape while providing hermetic sealing. These flexible containers protect the endoscope from microbial colonization during storage and transport, yet remain manageable and accessible when needed. The flexible nature allows for easy sealing and opening while maintaining the protective environment throughout the storage period.
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
This method effectively reduces microbial populations on endoscopes, maintaining them below permissible levels for extended periods, reducing the need for frequent reprocessing and disinfectant use, and minimizing the requirement for drying cabinets, while ensuring safe and cost-effective transportation.
Implementation Method 1
removing air from the bag by applying a vacuum of less than 1 bar
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A method of packaging a medical device such as an endoscope (10) comprises the steps of placing the medical device in a bag (30), removing air from the bag by applying a vacuum of less than 1 bar; and hermetically sealing the bag while the vacuum is being applied.