Frangible Syringe Cap Assembly with Locking Elements
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Solution Overview
Problem
Conventional syringe tip caps are prone to accidental disengagement, leading to medication loss and exposure, and lack evidence of tampering or misuse, with complex manufacturing processes for multi-part assemblies.
Innovation Solution
A cap assembly with a frangible tip and projecting locking elements that require breaking to open, ensuring secure sealing and tamper evidence, featuring a one-piece design with internal and external threads or a bayonet joint for secure attachment and evidence of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If elastomeric tip caps are used with frictional or resilient engagement, then the tip cap can be easily removed, but the tip cap may be accidentally disengaged and provides no tamper evidence
Solution Approach 1:
The tip cap is divided into two functional parts: a resilient cap portion for sealing and a separate frangible ring for secure attachment and tamper evidence. The frangible ring includes locking elements that engage with the syringe barrel, requiring deliberate force to break and remove, preventing accidental disengagement while maintaining ease of intentional removal.
Solution Approach 2:
The frangible ring is pre-formed with breaking points that require deliberate force to activate. This preliminary structuring ensures that once the cap is removed, the breaking points are activated, providing permanent tamper evidence. The locking elements are pre-positioned to engage securely with the syringe barrel, preventing accidental disengagement before use.
2Reliability
If multi-part tip cap assemblies are used, then tamper evidence and secure sealing are achieved, but the manufacturing process becomes complex
Solution Approach 1:
The frangible ring and cap portion are formed as a single integrated unit through one-step molding, eliminating the need for separate assembly operations. The locking elements, sealing surfaces, and breaking points are all incorporated into one component, simplifying manufacturing while maintaining tamper evidence and secure sealing capabilities.
Solution Approach 2:
The frangible ring serves multiple functions simultaneously: it provides secure attachment to the syringe barrel through locking elements, creates tamper evidence through breaking points, and maintains the seal by holding the cap portion in place. This multi-functionality reduces the need for separate components and simplifies the overall manufacturing process.
Data Source
AI summary
The invention relates to a tip cap assembly for closing a distal opening of a receptacle like a syringe body or a tube in a sealed manner, and to a method for producing the tip cap. A cap assembly according to the invention comprises a frangible tip of a receptacle, preferably a pre-filled receptacle. An upper portion of the tip closes the receptacle respectively a lower tip portion comprising a passage as known from the state of the art. Hence, the receptacle is reliably sealed to prevent contamination or loss of the medication. Compared with the state of the art, a receptacle has a more effectively sealed tip. It is necessary to break the upper tip portion away in order to open the receptacle. A cap element protects the tip on one side. On the other side, unscrewing the cap breaks the upper portion away without hurting a person.