Tamper Evident Adaptor Closure for ENFit Connector Compatibility
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Solution Overview
Problem
Many healthcare facilities maintain inventories of conventional enteral and oral syringes incompatible with the ISO 80369-3 ENFit® connector, which are designed to prevent tubing misconnections, necessitating a cost-effective adapter solution that also provides tamper evident and fluid sealing capabilities.
Innovation Solution
A closure structure for conventional syringes that adapts them for connection to ISO 80369-3 ENFit® connectors, featuring an adapter body with inlet and outlet ports, a removable tip cap for fluid sealing, and tamper evident capabilities through a sleeve and retainer structure, ensuring secure and single-use access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional syringes are used, then inventory costs are reduced, but compatibility with standardized ENFit® connectors is lost
Solution Approach 1:
An adapter closure serves as an intermediary component that bridges the incompatible interface between conventional syringes and standardized ENFit® connectors. The adapter includes a first port that interfaces with the conventional syringe and a second port that interfaces with the ENFit® connector, enabling compatibility without requiring replacement of existing syringe inventories.
2Adaptability or versatility
If adapter closures are added to enable compatibility, then connector adaptability is improved, but device complexity increases
Solution Approach 1:
The adapter closure is segmented into distinct functional components: a body portion with integrated ports, a tamper-evident cap, and sealing elements. This segmentation allows each component to perform its specific function independently while simplifying the overall assembly and sterilization processes.
3Reliability
If tamper evident features are included, then patient safety is improved, but device complexity increases
Solution Approach 1:
The tamper-evident cap incorporates color-changing or visually distinguishable features that indicate whether the adapter has been compromised. When the cap is removed or tampered with, a visible change (such as color shift or breakage of an intact seal) provides clear evidence of potential contamination or misuse.
4Reliability
If fluid sealing capabilities are added, then connection reliability is improved, but device complexity increases
Solution Approach 1:
The adapter closure incorporates flexible sealing elements such as O-rings, gaskets, or deformable port structures that create fluid-tight seals through elastic deformation. These thin-film sealing components conform to the mating surfaces of both the conventional syringe and ENFit® connector, ensuring reliable fluid containment without adding mechanical complexity.
Data Source
AI summary
A closure structured to adapt a syringe for connection to an incompatible standardized medical connector, including either a male or female ISO 80369 series ENFit® connector. An adapter body has an inlet port and an outlet port disposed in fluid communication with one another. The inlet port is dimensioned and configured to accommodate attachment to a discharge port of the syringe and the outlet port is dimensioned and configured to accommodate attachment to the standardized connector. A tip cap is removably connected to the adapter body in flow sealing relation to the outlet port. The closure may include a tamper evident assembly including a sleeve removably disposed in enclosing relation to the adapter body and tip cap and a retainer structure is disposed in removably retaining relation to the sleeve.