Sterile Access Port Frangible Segment Torsional Separation
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Solution Overview
Problem
Existing medical fluid containers with pierceable membranes face challenges in maintaining sterility and efficient access, as the cover or closure can contaminate the membrane before use and is difficult to remove without compromising sterility.
Innovation Solution
A sterile connector with an integral cover that breaks at a frangible segment, allowing torsional force to separate the cover from the pierceable membrane, ensuring sterility and easy access, featuring gripable surfaces with reinforcing elements and a tubular extension to reduce friction during spike penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cover or closure is provided to seal the access port and protect the membrane, then sterility is maintained, but the cover can contaminate the membrane before use and is difficult to remove without compromising sterility
Solution Approach 1:
The connector is divided into two separable portions (first portion with cover and second portion with membrane) joined by a frangible segment. This segmentation allows the cover to be easily separated from the membrane component, enabling sterile access while maintaining protection during storage and transport.
Solution Approach 2:
The frangible segment acts as an intermediary weak link between the cover portion and the membrane portion. It is designed to break under controlled conditions (such as application of force through gripable surfaces) to separate the cover from the membrane, facilitating easy removal while maintaining sterility.
2Ease of manufacture
If the cover is made integral with the connector for easy manufacture and sterilization, then manufacturing efficiency is improved, but the cover becomes difficult to remove without compromising sterility
Solution Approach 1:
The integral connector is segmented into separable portions joined by a frangible segment. This allows the cover to remain integral to the connector for manufacturing and sterilization efficiency, while still being easily removable when needed through controlled breaking of the frangible segment.
Solution Approach 2:
The frangible segment is designed as a disposable, single-use separation mechanism. Once the connector is opened, the frangible segment is discarded along with the cover portion, ensuring sterility while enabling easy removal. This disposable approach simplifies the separation process without requiring complex mechanisms.
3Ease of operation
If the frangible segment has reduced wall thickness to facilitate breaking, then ease of separation is improved, but the structural strength of the connector is reduced
Solution Approach 1:
The connector exhibits local quality variations in wall thickness, with the frangible segment having reduced thickness to facilitate breaking and the main body portions having sufficient thickness to maintain structural strength. This localized differentiation allows easy separation at the frangible segment while preserving overall connector integrity.
Solution Approach 2:
The connector is segmented into a frangible segment with reduced wall thickness and main body portions with normal wall thickness. This segmentation allows the reduced thickness to be localized only where separation is needed, while the main body maintains sufficient structural strength for its function.
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
Facilitates efficient manufacture, sterilization, and use by maintaining sterility until access is needed, reducing the risk of contamination and simplifying the access process while ensuring the spike penetrates without direct contact with non-sterile surfaces.
Implementation Method 1
The first portion and second portion are joined to each other by a frangible segment, with each of the first portion and the second portion having a gripable surface associated therewith that is configured to facilitate the application of torsional force to the tubular member at the frangible segment. Upon the application of a sufficient amount of torsional force, the frangible segment will break, permitting the first and second portions to be separated from each other.
Implementation Method 2
the gripable surfaces on the first and second portions have a generally planar configuration and comprise one or more reinforcing elements that serve to rigidify the gripable surfaces
Implementation Method 3
The tubular extension comprises an inside surface configured to engage the spike during penetration of the piercreable membrane, with the inside surface of the tubular extension having a surface finish roughness for reducing friction
Data Source
AI summary
A connector for providing sterile access to a flexible container is provided that comprises a tubular member having a first portion and a second portion, each of the first portion and the second portion having an open end. The first portion and second portion are joined to each other by a frangible segment, with each of the first portion and the second portion having a gripable surface associated therewith that is configured to facilitate the application of torsional force to the tubular member at the frangible segment. Upon the application of a sufficient amount of torsional force, the frangible segment will break, permitting the first and second portions to be separated from each other.