Luer-Lock Syringe Cap Assembly With Visible Tamper Break
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Solution Overview
Problem
Existing tamper-proof syringe caps with Luer-lock connectors fail to guarantee the total absence of tampering, allowing unauthorized access to the syringe contents, and are structurally complex, requiring machine tools for assembly.
Innovation Solution
A syringe with a tamper-proof cap featuring a tamper-proof insert immovably coupled to the closure cap and Luer-lock connector, ensuring separation only through breaking a frangible connection, using unmovable coupling elements and frangible connections to prevent unauthorized removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a snap-fitting coupling is used between the ring and the sleeve to hold the protective cap, then the cap can be easily assembled and disassembled, but the system can be elastically deformed to release the cap without breaking the frangible connection, compromising tamper-proof integrity
Solution Approach 1:
The invention extracts the snap-fitting coupling function from the tamper-proof system by introducing a separate retention member that engages with the frangible connection. This allows the snap-fitting ring to be removed or made non-functional while preserving the integrity-critical frangible connection between the protective cap and syringe body, thus maintaining tamper-proof reliability while improving ease of operation.
Solution Approach 2:
The invention segments the cap retention system into multiple independent functional components: a snap-fitting ring for easy assembly/disassembly operations, and a separate frangible connection with retention member for tamper-proof integrity. This segmentation allows each component to perform its specific function optimally without compromising the other.
2Strength
If micro-welds are used to attach the cap to the syringe components, then the cap is securely fixed, but the micro-welds can be removed with special tools allowing unauthorized access without visible damage
Solution Approach 1:
The invention changes the physical parameter of the connection from permanent micro-welds to a frangible mechanical connection that breaks at a specific stress point. This frangible connection is designed to break cleanly and visibly when excessive force is applied, providing obvious visual evidence of tampering while maintaining secure attachment during normal use.
Solution Approach 2:
The frangible connection is designed to provide visible visual indication when broken, creating a clear color or structural change that signals tampering. This allows healthcare professionals to immediately detect if the cap has been compromised, addressing the detection reliability issue.
3Reliability
If a complex multi-component tamper-proof system is implemented, then tamper resistance is improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The invention merges multiple functions into integrated components: the retention member combines the functions of securing the protective cap and providing visual tamper indication, while the frangible connection integrates both mechanical attachment and breakable security features. This reduces the number of separate components needed while maintaining high tamper resistance.
Solution Approach 2:
The frangible connection serves multiple functions simultaneously: it provides secure mechanical attachment during storage and transport, enables easy legitimate removal by breaking, and provides visible tamper indication. This multi-functionality reduces overall system complexity while enhancing reliability.
Data Source
AI summary
A syringe including a hollow cylindrical body containing a product to be injected and from which there extend a hollow tip equipped with a Luer-lock connector and a plunger, sliding inside the hollow cylindrical body; and a tamper-proof cap including a closure cap and a tamper-proof insert, where the closure cap includes a portion for coupling with the Luer-lock connector and a handle portion. An external seat for housing the tamper-proof insert is formed in the handle portion of the main body of the closure cap. The tamper-proof insert includes at least one longitudinal section, a transverse section and a terminal element, which is connected to a free end of the longitudinal section by a frangible connection, the terminal element configured to be immovably housed in a corresponding groove formed on an external surface of the Luer-lock connector. The tamper-proof insert is immovably coupled to the closure cap.