Single-Piece Medical Fitting with Piercable Membrane for Sterilization
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Solution Overview
Problem
Existing medical fittings face challenges in sterilization, particularly when gas sterilization is compromised during handling and re-closure, and the production process is complicated by the need for multiple molds for separate parts, limiting the sterilization methods available due to material limitations like PVC.
Innovation Solution
A single-piece medical fitting design with a pierceable membrane and an aggregated movable cap that allows for flexible sterilization methods, including ethylene oxide gas, by using a filtering membrane and a pull tab for easy access, ensuring sterility without separate part handling and accommodating various sterilization techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the fitting is made of PVC and sterilized by water vapor or γ/β rays, then sterilization is achieved, but the materials do not react uniformly under temperature increase making sterilization unreliable
Solution Approach 1:
The patent changes the sterilization parameter from thermal (water vapor, γ/β rays) to chemical (ethylene oxide gas), which does not cause non-uniform material reaction in PVC. The gas sterilization method operates at lower temperatures and penetrates materials uniformly, resolving the contradiction between achieving sterilization and preventing material damage.
2Reliability
If the lower room is closed by welding or separate plug to ensure sterility, then hermetic seal is achieved, but gas sterilization is no longer possible
Solution Approach 1:
The patent applies preliminary action by closing the lower room with a plug before gas sterilization. This allows the fitting to be sterilized by ethylene oxide gas while maintaining the hermetic seal. The plug is inserted in advance to create a closed system that can withstand gas sterilization, thus achieving both sterility maintenance and sterilization method flexibility.
3Ease of manufacture
If separate parts are joined by bonding to form the fitting, then assembly is achieved, but operational complication increases due to multiple molds needed
Solution Approach 1:
The patent merges the separate parts (first part and second part) into a single integrated component. This eliminates the need for bonding operations and multiple molds, reducing production process complexity while maintaining the functional separation of components. The unified structure simplifies manufacturing without sacrificing assembly capability.
4Ease of operation
If the lower aperture remains open for needle insertion, then ease of use is improved, but sterility is compromised
Solution Approach 1:
The patent segments the fitting into distinct functional zones: the lower room that remains hermetically sealed for sterility, and the access path through the pierceable membrane for needle insertion. The plug closes the lower aperture while the membrane provides a controlled penetration point. This segmentation allows both ease of operation and sterility maintenance by separating the access function from the sterile storage function.
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
Ensures the fitting remains sterile during use and simplifies production by eliminating the need for separate parts, allowing for reliable closure and sterilization regardless of the method used, ensuring a sterile environment until the cap and needle or perforator are introduced.
Implementation Method 1
in the type in which the cap is provided with a suitable filtering membrane (the order of magnitude of pores in this membrane is generally of diameters ranging from 1.2 μ to 3.0 μ) for carrying out a sterilization by ethylene oxide
Implementation Method 2
The room defined in the second part comprises a membrane that separates the two parts and is pierceable by a cannula perforator or an infusion needle
Data Source
Figure 1~2
Figure 3~4
Figure 5~6
AI summary
The fitting (1) comprises as an enbloc piece a first hollow part (1a), suitable for connecting with a tube of a bag, a second hollow part (1b) suitable for engaging with a cannula, a pierceable membrane (4) that separates the two parts, a cap (2) suitable for closing the lower aperture of the fitting and possibly housing a membrane (22) adapted to filter a sterilization gas (G) introduced into the second part (1b) -