Aseptic Connector Pivot Mechanism for Sterile Dual-Port Transfer
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Solution Overview
Problem
Existing aseptic fluid transfer systems face challenges in maintaining sterility during the transfer of precious medical fluids between containers, particularly in ensuring efficient and sterile filling and evacuation without compromising the container's sterility.
Innovation Solution
A connector assembly with a pivot portion and conduit portion that allows for adjustable movement from a ready to an operative position, enabling aseptic filling and evacuation through the same port, while maintaining sterility and preventing reuse, using materials resistant to sterilization methods like gamma radiation and autoclaving.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate port is used for evacuation, then sterility can be maintained, but device complexity increases
Solution Approach 1:
The fill connector is designed to serve dual purposes: both filling and evacuation operations are performed through the same connector interface. This eliminates the need for separate ports while maintaining sterility through controlled access mechanisms.
Solution Approach 2:
The spike is nested within the fill connector body, allowing it to be stored inside the connector when not in use. During evacuation, the spike extends through the septum to create a sealed pathway, enabling sterile evacuation without requiring an external separate port.
2Productivity
If the connector allows repeated use, then productivity increases, but sterility cannot be guaranteed
Solution Approach 1:
The fill connector is designed as a single-use component that is discarded after one evacuation operation. This disposable nature guarantees sterility by eliminating the risk of contamination from repeated use, while the low cost of the connector allows for replacement without significant productivity loss.
Solution Approach 2:
The connector and spike are pre-sterilized during manufacturing to withstand sterilization methods like gamma radiation and autoclaving. This preliminary sterilization ensures the connector is ready for single-use sterile operations without requiring re-sterilization between uses.
3Device complexity
If the conduit portion is fixed, then device complexity decreases, but adaptability is reduced
Solution Approach 1:
The conduit portion is designed to be movable relative to the fill connector body, allowing it to be positioned at different angles and depths. This dynamic adjustment capability enables the connector to adapt to various container configurations and evacuation requirements while maintaining a relatively simple overall structure.
Data Source
AI summary
An aseptic connector assembly includes a body portion having a receptacle configured to receive a corresponding fill connector. A pivot portion is movably coupled to the body portion, the pivot portion having a channel formed therein. A conduit portion is slidably disposed within the channel formed in the pivot portion. The pivot portion has a ready position and an operative position, the pivot portion being adjustable from the ready position to the operative position via relative movement with respect to the body portion.