Tamper Evident Cap Frangible Connection Syringe
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Solution Overview
Problem
Existing tamper detection systems for syringes are cumbersome, difficult to use, and increase the risk of injury and contamination, while also requiring changes to manufacturing processes, thereby increasing production costs and complexity.
Innovation Solution
A tamper evident cap with a frangible connection that breaks under force, remaining engaged with the syringe to indicate tampering, allowing for use with existing syringe designs without interfering with the seal and requiring no redesign, and secured via an interference fit or film.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing tamper detection systems are implemented, then tampering can be detected, but the system becomes cumbersome and increases the risk of injury and contamination
Solution Approach 1:
The patent extracts the tamper detection function from complex existing systems and implements it through a simple frangible connection mechanism. The frangible connection is a minimal structural element that breaks under tampering force, providing detection capability without the complexity of electronic sensors, mechanical locks, or multiple components. This extraction principle resolves the contradiction by maintaining reliability through the frangible indicator while eliminating cumbersome operational requirements.
2Reliability
If existing tamper detection systems are implemented, then tampering can be detected, but the risk of injury to the user and contamination to the patient increases
Solution Approach 1:
The frangible connection is designed as a disposable, single-use structural element that is discarded after one use. The cap is intended to be removed once to access the syringe, and the frangible connection breaks during this legitimate removal. If tampering occurs, the broken frangible connection provides detection, and the entire cap-syringe assembly can be discarded, eliminating the risk of injury or contamination from repeated use or malfunction.
3Reliability
If tamper detection devices are added, then tampering can be prevented, but changes to manufacturing process are required, increasing production costs and complexity
Solution Approach 1:
The patent merges the tamper detection function with the existing cap structure by incorporating a frangible connection directly into the cap's anatomy. The frangible connection is formed as an integrated feature during cap molding, combining the cap's protective function with tamper detection in a single manufactured component. This merging eliminates the need for separate detection devices, additional assembly steps, or complex manufacturing processes, thereby maintaining ease of manufacture while providing reliable tamper prevention.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The tamper evident cap effectively prevents tampering while maintaining a secure seal and reducing manufacturing complexity, ensuring user safety and cost-effectiveness.
Implementation Method 1
The frangible connection is configured to break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap is configured to remain engaged with the syringe when the frangible connection breaks
Implementation Method 2
secured via an interference fit or film
Implementation Method 3
secured via an interference fit or film
Data Source
AI summary
A syringe assembly includes a syringe and a tamper evident cap disposed over a Luer connection of the syringe, the tamper evident cap having a main body that defines a proximal end defining an opening, a distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage to receive a tip cap and the Luer connection, where the tamper evident cap is spaced from the tip cap. The main body further defines a frangible connection between the proximal and distal ends of the main body. The frangible connection can break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap remains engaged with the syringe when the frangible connection breaks.