Sterile Fluid Connector Assembly With Folding Valve Interface
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Solution Overview
Problem
Existing connector assemblies for pharmaceutical and medical applications often introduce seals within the fluid path, leading to potential contamination and exposure to ambient environments, which compromises the sterility of the connection.
Innovation Solution
A connector assembly featuring a stem with a fluid passage that interlocks with a housing, utilizing a valve system to maintain sterility by aligning and folding with a complementary valve, preventing exposure to contaminants and ensuring a secure, frictional fit without introducing seals within the fluid path.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If seals are introduced within the fluid path to ensure connection integrity, then connection reliability is improved, but the risk of contamination and exposure to ambient environment increases
Solution Approach 1:
The patent removes seals from the fluid path entirely, extracting the harmful element that caused contamination risks. Instead of using seals within the fluid path, the invention uses seals only at the interface between mating connectors, eliminating the source of potential contamination while maintaining connection integrity.
Solution Approach 2:
The connector is divided into separate functional zones: sealed zones at the interface and unsealed zones in the fluid path. This segmentation allows seals to provide connection integrity at the interface while keeping the fluid path free of seals, thus preventing contamination.
2Ease of operation
If removable seals are used to allow connection disassembly, then ease of operation is improved, but exposure to ambient environment and contamination risk increases
Solution Approach 1:
The connectors are pre-configured with interlocking features and aligned seal positions that automatically engage when brought together. The seals are pre-positioned to seal the interface before any fluid path exposure occurs, allowing easy assembly while preventing ambient exposure.
3Ease of operation
If puncturable seals are used to eliminate removal steps, then ease of operation is improved, but the seal design complexity and potential for fluid path contamination increases
Solution Approach 1:
The patent extracts puncturable seals from the design entirely, replacing them with simple, non-puncturable seals positioned at the interface. This eliminates the complexity of puncture mechanisms and the risk of puncture-related contamination while maintaining ease of operation through simple mating connectors.
4Reliability
If seals are placed in the fluid path to ensure leak-proof connection, then connection reliability is improved, but the integrity and sterility of the fluid path is compromised
Solution Approach 1:
The connector design segments the sealing function from the fluid path, placing seals only at the interface between mating connectors. This segmentation maintains leak-proof connection reliability while preserving fluid path sterility by eliminating seals from the fluid path entirely.
Solution Approach 2:
Seals are extracted from the fluid path and relocated to the interface zone only. This extraction ensures leak-proof connections at the interface while maintaining the sterility and integrity of the fluid path by removing potential contamination sources.
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 maintains a sterile environment by preventing contaminants from entering the fluid path and ensuring a secure, leak-proof connection, enhancing the integrity and safety of fluid transfer in medical and pharmaceutical applications.
Implementation Method 1
the valve folds with the complimentary valve in the direction of movement of the stem when the stem moves through the valve and the complimentary valve
Implementation Method 2
engaging the housing and the complimentary housing comprises interlocking the housing in a predetermined relationship with the complimentary housing by an interlocking mechanism
Implementation Method 3
ensuring a secure, frictional fit without introducing seals within the fluid path
Data Source
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AI summary
A method of coupling a connector and a complimentary connector is provided. The connector comprises a stem defining a fluid passage therethrough. The stem is configured to matingly engage a complimentary structure located on the complimentary connector. The connector comprises a housing surrounding the stem and defining an aperture. The housing is configured to engage a complimentary housing of the complimentary connector. The connector comprises a valve disposed over the aperture. The valve is configured to align with a complimentary valve when the housing engages the complimentary housing. The method comprises engaging the housing and the complimentary housing, and moving the stem in relation to the housing to push open the valve and complimentary valve and to move through the valve and the complimentary valve to matingly engage the complimentary structure after the housing engages the complimentary housing, wherein the valve folds with the complimentary valve in the direction of movement of the stem when the stem moves through the valve and the complimentary valve.