Tamper Evident Cap Deflectable Arm Visual Indication
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Solution Overview
Problem
Existing tamper evident caps for enteral feeding bags lack clear visual indication of unauthorized access, posing risks to sterility and safety due to difficulty in determining if the cap has been unscrewed.
Innovation Solution
A tamper evident cap with a deflectable arm that permanently deflects outward when unscrewed, providing a clear visual indication, and includes a rotational stop feature to prevent overtightening, integrated with an ENFit connector for secure enteral fluid delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a breakaway ring is used as a tamper evident feature, then the cap can indicate tampering, but it is difficult to visualise the breakage
Solution Approach 1:
The patent applies color changes by incorporating a colored band or indicator on the deflectable arm that changes position or appearance when the arm deflects. This allows users to visually detect tampering through color or positional changes, resolving the contradiction between reliable tamper indication and visual detectability
Solution Approach 2:
The patent moves the tamper indication from a hidden internal breakage (3D internal feature) to an external visible deflection (2D surface feature). The deflectable arm's outward movement creates a visible dimensional change that can be easily observed, transforming the indication mechanism into a visually detectable state
2Ease of operation
If the cap is made small for convenience, then it is easier to handle, but it may pose a choking hazard
Solution Approach 1:
The patent segments the cap into two functional parts: a smaller inner cap that provides good grip and handling, and a larger outer shell that provides safety by preventing choking. This segmentation allows each part to optimize its size for its specific function while working together as a complete unit
Solution Approach 2:
The patent uses nesting by placing the smaller inner cap inside the larger outer shell. The inner cap can be removed and handled separately for ease of operation, while the outer shell remains as a safety barrier. This nested structure allows the system to兼具 both small handling dimensions and large safety dimensions
3Ease of operation
If the deflectable arm is made flexible for deflection, then it can indicate tampering, but it may be damaged during production and sorting
Solution Approach 1:
The patent applies preliminary action by providing a protective ring that covers the deflectable arm during production, sorting, and assembly. This protective covering prevents premature deflection or damage to the flexible arm before it reaches the user, allowing the arm to remain flexible for tamper indication while protecting it from manufacturing-related damage
Solution Approach 2:
The protective ring acts as a cushioning element that shields the vulnerable deflectable arm from mechanical stress during handling and assembly. This beforehand protection allows the arm to be made flexible for its intended function without compromising its strength during the manufacturing process
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 cap provides a clear and unambiguous visual indication of unauthorized access, preventing accidental or malicious tampering and ensuring secure enteral fluid delivery by clearly showing if the cap has been unscrewed, while the ENFit integration prevents misconnection errors.
Implementation Method 1
The deflectable element is momentarily deflectable in a longitudinal direction... configured to be deflected by the deflecting element only whilst the deflecting element is in contact with and applying force in a longitudinal direction to the deflectable element... When the deflecting element is no longer applying force in a longitudinal direction then the deflectable element returns to its non-deflected position.
Data Source
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AI summary
The invention relates to a tamper evident cap for removable screwing onto a fluid outlet provided on an enteral fluid source, the cap includes a tamper evident feature comprising a deflectable element configured to be momentarily deflectable in a longitudinal direction by a deflecting element provided on the fluid outlet as the cap is screwed onto the fluid outlet, and wherein the deflectable element is configured to be permanently deflected outwardly in relation to the longitudinal axis by the deflecting element as the cap is unscrewed from the fluid outlet to provide a visual indication that the cap has been unscrewed.