Tamper Evident Syringe Assembly with Frangible Tether
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Solution Overview
Problem
Pre-filled syringes are vulnerable to tampering during handling and transportation, as they can be accessed by removing the plunger from the syringe barrel, potentially leading to contamination or substitution of the medication, which poses risks to patient safety and authenticity.
Innovation Solution
A tamper evident assembly is designed to restrict access to the syringe's interior by using an elongated tether and cover that prevent the removal of the plunger, with a connector assembly that maintains a fixed connection, and a frangible link to indicate tampering attempts, ensuring that any unauthorized access is evident through breakage or damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the plunger is made removable from the syringe barrel for authorized use, then ease of operation is improved, but vulnerability to tampering increases
Solution Approach 1:
The patent introduces a tether as an intermediary component that connects the plunger to the syringe barrel. This tether acts as a mediator that allows authorized plunger removal while preventing unauthorized removal, thus resolving the contradiction between ease of operation and vulnerability to tampering.
Solution Approach 2:
The patent changes the state of the tether from intact to broken as a parameter change that indicates tampering. When the plunger is removed authorized, the tether remains intact; when unauthorized removal is attempted, the tether breaks, providing a visible indicator of tampering while still allowing legitimate use.
2Reliability
If the syringe is sealed to prevent tampering, then reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The patent segments the protection mechanism into two parts: the tether that prevents unauthorized access and the syringe contents that remain protected. This segmentation allows the syringe to maintain reliability through the tether while still enabling ease of operation for authorized users who can remove the plunger when the tether allows.
Solution Approach 2:
The tether system provides self-service functionality by automatically indicating tampering through its broken state. The system itself monitors and reports its security status without requiring external verification, maintaining reliability while allowing easy authorized access.
3Object-affected harmful factors
If a tether is added to prevent plunger removal, then protection against tampering is improved, but device complexity increases
Solution Approach 1:
The patent extracts the security function from the main syringe structure and implements it through a separate, simple tether component. This extraction allows the prevention of unauthorized access to be achieved through a minimal addition rather than integrating complexity into the core syringe design.
Solution Approach 2:
The tether is implemented as a flexible, thin component that provides security functionality without adding significant structural complexity. The flexible nature of the tether allows it to perform its security function while maintaining a simple, lightweight design that doesn't substantially increase device complexity.
4Measurement precision
If the tether is made frangible to indicate tampering, then measurement precision of tampering detection is improved, but strength of the connection deteriorates
Solution Approach 1:
The frangible tether is designed with preliminary weakness at specific points to prevent unauthorized access. The predetermined break points are strategically placed to allow authorized use while breaking under unauthorized force, providing precise tampering detection without compromising the strength needed for legitimate operation.
Solution Approach 2:
The tether is designed with partial strength - strong enough to prevent unauthorized access but with deliberate weak points that will break under excessive force. This partial strength approach provides precise tampering detection while maintaining sufficient connection strength for authorized use.
Data Source
AI summary
A tamper evident assembly for retaining a plunger and/or piston within a barrel of a syringe comprises an elongated tether disposed in an operative attachment and position on the syringe. When operatively attached, a connector assembly adjustably and fixedly interconnects the tether to an exterior of the barrel of the syringe concurrently to one end of the tether, and with a retaining member associated with the opposite end of the tether disposed in a removal restrictive relation to the plunger and/or piston, on the interior of the barrel. Movable adjustment of the tether relative to the connector assembly defines a retaining segment which can be disposed into a fixed length and taut orientation, between the ends of the tether, to further define the operative attachment or position.