Aseptic Fluid Connector Closure Mechanism

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Solution Overview

Problem

Existing filling devices and connectors fail to prevent contamination of aseptic or sterile fluids during transfer and filling, leading to risks of nosocomial infections and product contamination, as they expose fluids to the ambient atmosphere, allowing ingress of contaminants and potential harm to operators.

Innovation Solution

A device with a movable closure that forms a fluid-tight seal between the flow outlet and ambient atmosphere, using a spring bias to maintain the closure in a closed position, and a method involving a cannula with a septum and valve system that allows aseptic fluid transfer while preventing contact between the outlet and septum, ensuring sterility throughout the process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If open ports are used in filling cannulas, then ease of operation is improved, but contamination risk increases

Engineering Contradiction:
Improveease of operationVSAvoidcontamination risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The closure is positioned at the port before filling begins, preliminarily preventing contamination. The closure is then opened only when needed for fluid passage, maintaining protection during critical periods.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The closure acts as an intermediary element between the port and the ambient atmosphere, blocking contaminants while allowing controlled fluid passage when opened.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If connectors are disconnected for reuse, then adaptability is improved, but contamination risk increases

Engineering Contradiction:
ImprovereusabilityVSAvoidcontamination risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The closure is closed before disconnection occurs, preliminarily sealing the port to prevent contamination during the disconnection and reconnection process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The closure automatically protects the port whenever the connector is disconnected, providing self-service contamination protection without requiring additional protective measures.

Inventive Principle:
Principle #25Self-service

3Object-affected harmful factors

If alcohol wipes are used to clean connectors, then contamination prevention is improved, but time consumption increases

Engineering Contradiction:
Improvecontamination preventionVSAvoidtime consumption
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The closure provides a permanent, reusable barrier instead of requiring repeated use of disposable alcohol wipes, eliminating the need for continuous cleaning operations.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The closure automatically prevents contamination without requiring operator intervention for cleaning, making the system self-protecting rather than relying on periodic manual maintenance.

Inventive Principle:
Principle #25Self-service

4Ease of operation

If open fluid ports are used, then ease of operation is improved, but product safety worsens

Engineering Contradiction:
Improveease of operationVSAvoidproduct safety
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The closure is in place before filling begins, preliminarily ensuring product safety by preventing contamination during the entire operation until the closure is intentionally opened.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The closure serves as an intermediary barrier that protects the product from contamination while allowing controlled fluid transfer when needed, maintaining both safety and functionality.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 provides a closed system for sterile transfer, preventing contamination and maintaining the sterility of fluids during filling and transfer, even in non-aseptic environments, thereby reducing the risk of infections and product contamination.

Implementation Method 1

using a spring bias to maintain closure in a sealed position

Methodology Applied
Scientific EffectSpring bias: Spring

Data Source

PatentUS10351271B2Device for connecting or filling and method
Publication Date: 2019.07.16 GETINGE ASEPTIC SOLUTIONS LLC
  • US10351271B2 patent drawing
  • US10351271B2 patent drawing
  • US10351271B2 patent drawing

AI summary

A valve comprises a shell, a flexible valve member sealingly mounted within the shell, and a valve body mounted atop the flexible valve member within the shell. The flexible member is moveable between closed and open positions to allow the flow of fluid therethrough. The valve is engageable with a filling device having flow ports and a surrounding closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). Alternatively, the valve may comprise a portion of a female connector and the filling device may comprise a portion of a male connector to form an aseptic fluid connector for the aseptic transfer of fluid therethrough.