Removable Syringe Dust Cap With Tamper-Evident Connector
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Solution Overview
Problem
Medical syringes and fluid delivery systems face challenges in maintaining sterility of the fluid path components during shipping, unpackaging, and setup, with risks of contamination and tampering, especially under emergency conditions.
Innovation Solution
Dust caps with tamper-evident features and configurations that ensure sterility by engaging with syringe connectors, allowing easy removal while preventing contamination, and indicating tampering.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dust cap is securely engaged with connector to maintain sterility, then sterility protection is improved, but ease of removal and operation deteriorates
Solution Approach 1:
The dust cap incorporates a resilient member that can be compressed to overcome engagement forces during removal, then returns to its original state to secure the cap during storage and transport. This dynamic mechanism allows the cap to be both securely engaged during shipping and easily removed when needed by applying force to compress the resilient member.
Solution Approach 2:
The engagement mechanism is divided into separate functional elements: an engagement feature on the dust cap, a corresponding engagement feature on the connector, and an intermediate resilient member. This segmentation allows each component to perform its specific function - maintaining secure engagement during transport while enabling easy removal when force is applied to the resilient member.
2Reliability
If dust cap includes tamper evident features to detect tampering, then sterility assurance is improved, but device complexity increases
Solution Approach 1:
The tamper evident feature incorporates a color-changing indicia that transitions from a first color indicating sterile, untampered status to a second color indicating tampering or compromised sterility. This visual color change provides an intuitive, easy-to-detect method for assessing sterility without requiring complex electronic sensors or sophisticated detection mechanisms.
Solution Approach 2:
The color-changing indicia serves as an intermediary between the dust cap's engagement state and the user's perception of sterility. Rather than requiring direct inspection of engagement features or complex sensing systems, the color change provides a clear, unambiguous visual signal about the sterility status of the connector assembly.
3Ease of operation
If dust cap is designed for quick removal during emergency procedures, then ease of operation is improved, but sterility protection may deteriorate
Solution Approach 1:
The resilient member is pre-loaded in a compressed state during manufacturing and storage, storing elastic potential energy that is released during removal. This preliminary preparation of the resilient member enables quick removal during emergency procedures while maintaining secure engagement during transport, as the pre-compressed state allows the cap to be easily pushed off the connector when force is applied.
Data Source
AI summary
A fluid path connector assembly for a medical fluid delivery system includes a connector element having a body, a lumen extending through the body, and a pair of flexible legs connected to the body, each of the flexible legs having a flange. The connector assembly further includes a dust cap removably connected to the connector element. The dust cap includes a dust cap body positioned between the flexible legs to enclose the lumen, and an engagement element at a distal end of the dust cap body. The engagement element is in contact with the flanges of the flexible legs to prevent disengagement of the dust cap from the connector element while allowing ready removal of the dust cap by medical personnel. A removable/disconnectable tamper resistant and/or tamper-evident and/or tamper resistant feature connecting the dust cap to the connector element is also disclosed.