Tamper-Evident Closure Indicator Member with Low-Strength Breakaway
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Solution Overview
Problem
Current tamper evident closures for medical devices with luer-type connections, such as syringes, face challenges in preventing unauthorized access and tampering, especially when the connection is frictional, as they often detach from the device during removal, and there is a need for a solution that provides clear indication of tampering without relying on alternate means and with cost and time savings in manufacture and assembly.
Innovation Solution
A tamper evident closure with a housing and tip cap that includes an indicator member with a low-strength breakaway material, allowing the tip cap to pass through an access opening only when connected to the medical device via a luer-slip or frictional connection, ensuring the closure remains attached and providing a visible rupture indication of tampering.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a tamper evident closure uses a frictional connection (luer-slip) between the tip cap and medical device, then the closure can be easily attached and removed, but the closure may detach from the device during removal operations
Solution Approach 1:
The indicator member is segmented into a first portion (fixed to housing) and a second portion (fixed to tip cap), allowing the tip cap to be removed through the housing while maintaining closure attachment. This segmentation enables the closure to remain on the device during removal operations while still allowing easy attachment and detachment when needed.
2Strength
If the indicator member has high strength resistance, then it provides reliable tamper evidence, but it prevents the tip cap from passing through the access opening during normal operations
Solution Approach 1:
The indicator member exhibits different strength characteristics in different locations: the first portion has higher strength resistance for reliable tamper evidence, while the second portion has lower strength resistance to allow easy passage through the access opening during normal operations. This local differentiation resolves the contradiction between strength and ease of operation.
3Ease of operation
If the indicator member is made of low strength breakaway material, then the tip cap can pass through the access opening easily, but the indicator member may rupture during normal removal operations
Solution Approach 1:
Dividing the indicator member into two portions with different strength characteristics allows the second portion to be weak enough for easy tip cap passage while the first portion remains strong enough for reliable tamper indication. The segmented structure prevents premature rupture during normal operations.
Solution Approach 2:
Different portions of the indicator member have different strength properties: the first portion maintains high strength for reliable tamper evidence, while the second portion has low strength for easy passage. This local quality differentiation resolves the contradiction between ease of operation and tamper indication reliability.
4Reliability
If the closure structure is made more complex to prevent detachment, then attachment reliability improves, but manufacturing and assembly costs increase
Solution Approach 1:
The segmented indicator member provides a relatively simple structural solution to prevent closure detachment during removal operations. By using two portions with different strength characteristics rather than complex locking mechanisms, the design achieves improved reliability while maintaining manufacturing and assembly simplicity.
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 solution effectively prevents unauthorized access and tampering by ensuring the closure remains attached to the medical device, providing a clear visual indication of tampering through the rupture of the indicator member, while reducing manufacturing and assembly costs and time.
Implementation Method 1
At least a portion of the indicator member comprises a material having a predetermined low-strength breakaway resistance, which is easily ruptured upon removal of a tip cap from the interior of the housing
Implementation Method 2
concurrent to its being frictionally connected to a medical device
Data Source
AI summary
A tamper evident closure, intended primarily for a luer-slip or like frictional connection between one or more components associated with the closure and a syringe or other medical device, includes a housing having an open end and a tip cap disposed within the housing. An indicator member is connected to the housing in at least partially covering relation to the open end and includes an access opening disposed in accessible relation with the tip cap. A cover is removably disposed in overlying engagement with at least a portion of said indicator member in covering relation to the access opening. The indicator member has an inner segment disposed in contiguous surrounding relation to the access opening and has a reduced breakaway resistance, capable of being easily ruptured, ripped or torn during passage of said tip cap through the access opening, concurrent to the tip cap being connected to the medical device.