Tamper Evident Syringe Assembly with Tether and Cover
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Solution Overview
Problem
Pre-filled syringes are vulnerable to tampering during transportation and handling, as the removal of the plunger from the syringe barrel can indicate unauthorized access, posing risks to the sterility and content integrity of the medication.
Innovation Solution
A tamper evident assembly is designed to restrict access to the syringe by connecting an elongated tether and cover to the syringe barrel, preventing removal of the plunger through the open end, and featuring a ratchet connector and frangible links to indicate tampering attempts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a pre-filled syringe is transported and handled by multiple people, then the medication can be delivered to the patient, but the risk of tampering and contamination increases
Solution Approach 1:
The patent applies preliminary anti-action by pre-assembling the tamper-evident assembly components (tether, cover, connector) onto the syringe before it leaves the filling station. This preliminary protective measure ensures that any subsequent handling or transport attempts at tampering will be detected, thus preventing unauthorized access while maintaining the efficiency of medication delivery across multiple locations.
2Ease of operation
If the plunger is made removable for proper syringe operation, then the syringe can be used to administer medication, but unauthorized removal indicates tampering
Solution Approach 1:
The patent introduces an intermediary mechanism - the tether connected to the plunger and anchored to the syringe barrel - that mediates between the need for plunger removal (ease of operation) and the need to detect unauthorized access. The tether allows legitimate plunger removal for medication administration while simultaneously serving as a detection mechanism that indicates tampering if removed improperly or without authorization.
3Reliability
If a tamper evident assembly is added to prevent plunger removal, then syringe security is improved, but the assembly complexity increases
Solution Approach 1:
The patent applies segmentation by dividing the tamper-evident assembly into distinct functional components: the tether (provides mechanical connection and tamper detection), the cover (protects the distal end and provides additional security), and the connector (joins tether to cover). This segmentation allows each component to perform its specific function independently while collectively providing comprehensive security, making the overall system more manageable despite the increased complexity.
Data Source
AI summary
A tamper evident assembly for retaining a plunger and piston within a barrel of a syringe including an elongated tether and a cover connected to the tether and concurrently disposed in an operative position on the syringe. A connector assembly adjustably and fixedly interconnects the tether to the cover in the operative position, wherein the cover is connected in covering relation to a discharge port of the syringe concurrently to a proximal end of the tether being connected to the syringe barrel in a removal preventative relation to the piston. Movable adjustment of the tether relative to the connector assembly defines a retaining segment disposed into a taut, fixed length orientation between the proximal end of the tether and the cover, to further define the operative position.