Syringe Gasket Penetration Paths for Steam Sterilization
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Solution Overview
Problem
Conventional drug-solution administration devices require separate sterilization of syringes and gaskets using high-temperature steam or gases, which may not effectively reach the inner syringe walls and gasket spaces, leading to incomplete sterilization when assembled.
Innovation Solution
A drug-solution administration device design that allows for reliable sterilization using steam or gases while the syringe and gasket are assembled, utilizing a temporary holding portion to ensure steam or gas penetration to all areas, including the gasket and syringe interfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the syringe and gasket are sterilized separately using high-temperature steam or gases, then sterilization can be performed, but the sterilization process becomes more complex and time-consuming
Solution Approach 1:
The patent merges the sterilization of the syringe and gasket into a single integrated process. The gasket is designed with a specific structure that allows steam or gas to penetrate through the needle hub assembly and reach the inner wall of the syringe barrel, enabling both components to be sterilized simultaneously when assembled together rather than requiring separate sterilization steps
Solution Approach 2:
The gasket structure is designed in advance with penetration paths that enable steam or gas flow through the assembled device. The peak portions and gaps are pre-configured to create channels that guide the sterilizing agent to all critical areas, including the inner syringe wall, before sterilization begins
2Device complexity
If the syringe and gasket are assembled before sterilization, then the sterilization process is simplified, but steam or gases cannot reach the inner wall of the syringe and spaces between gasket peak portions, resulting in insufficient sterilization
Solution Approach 1:
The gasket is designed with non-uniform structure featuring peak portions at specific locations. These peak portions create localized gaps between the gasket and needle hub that serve as penetration paths for steam or gas. The local structural variation enables the sterilizing agent to reach previously inaccessible areas like the inner syringe wall while maintaining sealing function in other areas
3Reliability
If the gasket is designed with peak portions to enable steam penetration, then sterilization effectiveness is improved, but the gasket structure becomes more complex
Solution Approach 1:
The gasket structure is segmented into distinct functional regions: peak portions that create penetration paths for steam/gas flow, sealing portions that maintain the barrier function, and transition zones between them. This segmentation allows each region to perform its specific function while keeping the overall design systematic and manufacturable
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
Enables complete and reliable sterilization of both the syringe and gasket when assembled, ensuring a sterile drug administration device without the need for separate sterilization steps.
Implementation Method 1
steam or gases for sterilization hardly reaches an inner wall of the syringe in close contact with the gasket and a space surrounded by two peak portions formed in the gasket and the inner wall of the syringe
Data Source
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AI summary
A drug-solution administration device includes a syringe, a gasket, a plunger member, and a temporary holding portion. The temporary holding portion holds the plunger member in a state where the gasket and an opening formed on the opposite side of a distal end portion of a body portion of the syringe are opposite to each other with a gap between the gasket and the opening.