Genderless Aseptic Fluid Couplings for Sterile Leak-Proof Connection
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Solution Overview
Problem
Existing fluid systems, such as bioprocessing and blood handling systems, require aseptic fluid couplings that can connect fluid flow paths without causing biological contamination, while also being easy to use and cost-effective, and capable of maintaining sterility without the need for sterile environments.
Innovation Solution
The development of single-use, genderless, aseptic fluid coupling devices with robust latching systems and non-metallic construction, providing audible, visual, and tactile feedback, and designed to maintain sterility through mechanisms like locks to prevent uncoupling, allowing connections without the need for sterile rooms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional fluid coupling designs are used, then connections can be made, but biological contamination risk increases and sterility cannot be maintained
Solution Approach 1:
The coupling device is divided into two separate coupling halves that connect to each other, with each half maintaining its own sterile barrier. This segmentation allows the sterile interior to be isolated from the external environment while enabling connection between components
Solution Approach 2:
A flexible membrane acts as an intermediary barrier between the sterile fluid path and the external environment. The membrane allows visual inspection and tactile feedback while preventing biological contamination from entering the sterile flow path
2Reliability
If sterile environments (sterile rooms) are used to maintain sterility, then contamination is prevented, but operational complexity and cost increase
Solution Approach 1:
The coupling device maintains its own sterile environment through self-contained barriers (membranes and seals) without requiring external sterile room infrastructure. The device itself provides the sterile barrier function that would otherwise require environmental control systems
Solution Approach 2:
Flexible membranes serve as portable sterile barriers that replace the need for sterile room environments. These thin film barriers can be integrated into the coupling device itself, allowing sterile connections to be made in non-sterile environments
3Ease of operation
If coupling devices are designed to be easily disconnected for reuse, then operational flexibility improves, but sterility cannot be maintained
Solution Approach 1:
The coupling device is designed as a single-use disposable component that is discarded after one connection. This eliminates the risk of contamination from repeated use while maintaining ease of operation during the single use. The low cost of the disposable device makes this economically viable
Solution Approach 2:
The coupling device features dynamic latching mechanisms that provide audible, visual, and tactile feedback during connection, making the single-use connection process intuitive and easy to perform despite the device being discarded after one use
4Reliability
If robust latching systems are added to prevent uncoupling, then connection reliability improves, but device complexity increases
Solution Approach 1:
Complex multi-component latching systems are replaced with simpler integrated mechanical features that provide robust locking through audible and tactile feedback mechanisms. The latching function is achieved through streamlined mechanical interactions rather than multiple separate components
Data Source
AI summary
Some fluid coupling devices described herein are configured for use in fluid systems. For example, some embodiments described in this document are single-use, aseptic fluid coupling devices that can be coupled to create a sterile flow path therethrough. Some such aseptic couplings are genderless couplings such that two identical aseptic couplings can be coupled together and then latched to form a robust connection between the aseptic couplings.