Sterile Connector Joining via Tape-Actuated Mating
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Solution Overview
Problem
Current methods for joining sterile fluidic systems are either permanent, difficult to automate, and expensive, or they introduce chemical contaminants and are not suitable for high-throughput manufacturing and clinical settings.
Innovation Solution
A semi-sterile connector system using holders with channels for tubing, male and female hollow connectors, and tape to advance the connectors for secure, leak-free connections, allowing for repeated connections and disconnections while maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tube welding is used to create fluidic connections, then the connection is permanent and secure, but the process is difficult to automate and expensive
Solution Approach 1:
The connector system is divided into separate components: a first connector with a first lumen and a second connector with a second lumen. These segmented connectors can be independently manufactured, sterilized, and assembled, enabling automation while maintaining secure connections through the mating of lumens via the tape mechanism.
Solution Approach 2:
A sterile tape is introduced as an intermediary element between the first and second connectors. The tape is applied to the exterior of the connectors and pulled taut to force the connectors together, creating a secure connection without requiring complex welding equipment or procedures, thus enabling automation.
2Reliability
If chemical agents are used for sterilization, then sterile breaking and re-establishing connections are permitted, but the agents introduce contaminants into the fluid network
Solution Approach 1:
The sterile barrier function is extracted from chemical agents and transferred to a physical tape layer. The tape is applied to the exterior of the connectors and maintains sterility through physical separation and sealing, eliminating the need for chemical sterilization agents that could contaminate the fluid network.
Solution Approach 2:
The connector system uses a disposable sterile tape that is applied once and then removed after use. This single-use tape maintains sterility during the connection process and is discarded afterward, eliminating the need for persistent chemical sterilization agents and reducing contamination risks.
3Reliability
If multiple redundant paths are kept together with sealing means, then contamination is avoided during breaking connections, but the complexity and cost increase
Solution Approach 1:
The system segments the fluidic pathway into distinct, separable connectors that can be independently connected and disconnected. The first connector with its first lumen and the second connector with its second lumen can be assembled and disassembled without requiring complex sealing mechanisms, reducing system complexity while maintaining contamination prevention.
Solution Approach 2:
The sterile tape serves as an intermediary sealing element that simplifies the connection process. By applying the tape to the exterior of the connectors and pulling it taut, the system creates an effective seal without requiring complex internal sealing mechanisms or multiple redundant paths, thus reducing overall system complexity.
4Ease of manufacture
If autoclaving is used for waste treatment, then hazardous waste is treated, but the process is expensive and does not consider environmental impact
Solution Approach 1:
The connector system employs disposable connectors and tape that are designed for single use. After use, these components are discarded as low-hazard waste rather than requiring expensive autoclaving. The disposable nature of the components simplifies waste treatment requirements and reduces energy consumption compared to sterilizing reusable components.
Data Source
AI summary
Disclosed is a convenient joining of tubing in a secure, leak-free connection, suitable for aseptic fluid transfer, wherein two holders each have a channel designed to house tubing and each holder has a mating surface at one end of the channel. The ends of the respective tubing closest to the mating surfaces are fitted with male and female hollow connectors. Tape is attached to the region of the connectors near the tubing and/or to the tubing itself. After the holders are joined, the ends of the tape are pulled to advance the male and female connectors to mate and form a secure connection.