Sterile Connection System with Peelable Seal Membranes
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Solution Overview
Problem
Existing technologies lack a reliable method for automatically opening a connection between two internal volumes while maintaining sterility, especially when the elements are placed in a non-sterile environment, and require additional piercing of sealing elements.
Innovation Solution
A connection system that allows opening a connection via relative axial movement between two elements, without any action other than axial movement, using seal membranes that remain attached to the elements to maintain sterility and are easily peeled off during connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If seal members are reliably attached to elements to maintain sterility, then sterility is maintained, but the process of removing seal members becomes complex and requires additional devices
Solution Approach 1:
The seal membrane is divided into a first portion and a second portion with different attachment characteristics. The first portion is strongly attached to maintain sterility, while the second portion is weakly attached to allow easy removal. This segmentation resolves the contradiction by allowing different regions of the same component to serve different functions.
Solution Approach 2:
Different regions of the seal membrane have different attachment strengths to the element. The first portion has strong attachment for sterility protection, while the second portion has weak attachment for easy removal. This local differentiation of properties resolves the contradiction between reliable attachment and easy removal.
2Reliability
If additional piercing elements are used to open connections, then connection opening is reliable, but device complexity increases
Solution Approach 1:
The connection opening function is merged with the relative movement between elements. The act of connecting the elements themselves opens the connection by exposing the fluid pathway, eliminating the need for separate piercing elements. This merging resolves the contradiction by combining two functions into a single action.
Solution Approach 2:
The piercing function is extracted from the system by using the relative movement between elements to automatically expose the fluid pathway. The connection action itself performs the opening function, removing the need for additional piercing components and simplifying the device.
3Ease of operation
If elements are placed in non-sterile environment, then ease of handling is improved, but sterility of internal volumes is compromised
Solution Approach 1:
A flexible seal membrane closes the fluid pathway in elements handled in non-sterile environments. The membrane remains intact during handling, maintaining sterility, and is selectively removed only when connection is needed. This allows easy handling in non-sterile environments while preserving internal volume sterility.
Solution Approach 2:
The seal membrane is pre-installed on the element in the non-sterile environment, maintaining sterility of the internal volume during handling and storage. The membrane is removed only at the moment of connection, allowing the element to be handled easily in non-sterile conditions while preserving sterility until use.
Data Source
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AI summary
This connection system (100) for opening a connection between a first internal volume (V4) of a first element (4) and a second internal volume (V6) of a second element (6). The first internal volume is closed by a first seal membrane (134) and the second internal volume is closed by a second seal membrane (154). The connection occurs via a relative translational movement (A1, A2) between the first and second elements (4, 6) along a main axis (A100) of the connection system. This relative translational movement (A1, A2) induces a displacement of at least a first portion (134A) of the first membrane (134) with respect to the first element (4) and a displacement of at least a first portion (154A) of the second membrane (154) with respect to the second element (6).