Tamper Indicating Closure Assembly with Frangible Seal
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Solution Overview
Problem
There is a need for an efficient, effective, and easily applied closure assembly that can seal a female luer connector during non-use, provide a clear indication of tampering or access, and prevent re-attachment after unauthorized access in IV administration systems.
Innovation Solution
A closure assembly with a housing that includes a flow restrictor and an indicator member, where the flow restrictor is threaded to the female connector and can only be rotated into a sealing position in one direction, and removal requires a sufficient axial force to break frangible members, ensuring tampering is evident and re-attachment is impossible.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a closure assembly is designed to be easily attached and removed from a female connector, then ease of operation is improved, but reliability of preventing unauthorized access deteriorates
Solution Approach 1:
The closure assembly is pre-configured with frangible members (breakable seals) that automatically break when the closure is removed from the female connector. This preliminary action ensures that any removal attempt, whether authorized or unauthorized, immediately triggers a visible indication through the broken seal, thus maintaining reliability while allowing easy operation.
Solution Approach 2:
The indicator member is designed to change its visual state when frangible members break. The indicator may display different colors or visual patterns depending on whether the seal is intact or broken, providing an immediate and obvious visual indication of tampering. This allows the system to maintain both ease of operation and reliability by making unauthorized access visually detectable.
2Reliability
If a closure assembly provides clear visual indication of tampering, then reliability of detecting unauthorized access is improved, but device complexity increases
Solution Approach 1:
The closure assembly is divided into distinct functional segments: a closure body for sealing, frangible members (breakable seals) for tamper indication, and an indicator member for visual display. This segmentation allows each component to perform its specific function simply, while the overall system achieves reliable tamper detection without excessive complexity.
Solution Approach 2:
The frangible members serve as an intermediary element between the closure body and the indicator member. When the closure is removed, the frangible members break and trigger the indicator to change state, providing a clear visual signal. This intermediary mechanism achieves reliable detection with minimal complexity by using a simple breakable connection rather than complex sensors or electronics.
3Reliability
If the flow restrictor can only be rotated into sealing position in one direction, then reliability of preventing re-attachment is improved, but ease of operation deteriorates
Solution Approach 1:
The drive assembly incorporates asymmetric ramp and cliff structures that allow rotation in only one direction. The ramp facilitates easy rotation in the intended direction, while the cliff blocks rotation in the opposite direction. This asymmetric design prevents re-attachment after removal while maintaining ease of operation for the intended attachment direction through the smooth ramp surface.
Solution Approach 2:
The drive assembly uses dynamic mechanical elements (ramp and cliff structures) that change their interaction based on rotation direction. During intended attachment, the ramp guides smooth rotation and engagement. During attempted re-attachment or removal, the cliff creates a mechanical barrier. This dynamic behavior allows the system to be easy to operate in the correct direction while reliably preventing unauthorized operations.
Data Source
AI summary
A closure assembly structured for use with a female connector and being operative to indicate an attempted tampering or access thereto. A flow restrictor is movably and removably disposed within a housing and includes a male connector such as, but not limited to, a male luer connector comprising a plug disposed and structured to be inserted in flow restricting engagement within an interior port of the female connector. An indicator member is removably connected to an interior of the housing in surrounding relation to the flow restrictor and a drive assembly associated with both the flow restrictor and the housing is operable to dispose the male plug into the inserted, flow restricting engagement within the female connector. Attempted removal of the housing from the female connector, such as by an applied axial force, will detach the indicator member from the housing and expose it in a visually observable position on the flow restrictor, thereby indicating attempted access.