Sterile Connector Packaging for In-Pouch Fluid Line Assembly
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Solution Overview
Problem
Connecting multiple fluid connector pieces in medical treatments introduces the risk of contamination, and certain devices like force activated separation devices (FASD) require pre-connection before use, necessitating unconnected storage to prevent performance degradation.
Innovation Solution
Packaging that includes an outer pouch with a lid and a component holder within, allowing for sterile connection of device parts by maintaining their orientation and enabling connection within the sealed pouch through a buckling or sliding mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple fluid connector pieces are connected to form a complete infusion system, then the device functionality is improved, but the risk of contamination increases
Solution Approach 1:
The packaging system segments the connector components into separate sterile compartments within a single pouch, allowing each component to remain individually sterile while enabling controlled connection within the same sterile environment
Solution Approach 2:
The packaging pouch acts as an intermediary sterile environment that allows components to be connected without direct exposure to external contamination, serving as a controlled medium between the components and the external environment
2Reliability
If device parts are stored unconnected to prevent performance degradation, then the device reliability is improved, but the complexity of assembly increases
Solution Approach 1:
The packaging system performs preliminary positioning and orientation of components within the pouch, pre-aligning them for connection while maintaining their unconnected state for reliability, thus reducing assembly complexity when the pouch is opened
3Adaptability or versatility
If components are connected before use, then the device functionality is improved, but the sterility maintenance becomes more difficult
Solution Approach 1:
The system merges the advantages of pre-connection (functional readiness) with sterile storage by allowing components to be connected within the sealed sterile pouch environment, thus maintaining sterility while achieving functional readiness
Data Source
AI summary
Packaging may be designed to allow for the forced connection of separate parts without breaching the sterile barrier of the packaging. A component holder housed within sterile packaging may hold device parts such that the device parts can shipped and stored separated and can be pushed together to create a sterile connection between the parts while the parts are housed within the packaging.


