Frangible Connector for Sterile Dialysis Fluid Switching

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Solution Overview

Problem

Current fluid management systems for renal replacement therapy, such as dialysis, require frequent connection and disconnection of fluid circuits while maintaining sterility, which is challenging due to the need for rapid switching between fluid sources and preventing reconnection to previously used circuits.

Innovation Solution

A frangible connector that forms a female luer when fractured, allowing immediate connection to a different fluid circuit without undoing previous connections, and featuring a non-reopenable tubing clamp or cap for sealing, preventing reconnection to the previous circuit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a connector is used to allow frequent connection and disconnection of fluid circuits, then the ease of operation is improved, but the risk of reconnection to previously used circuits increases

Engineering Contradiction:
Improveease of connection and disconnectionVSAvoidprevention of reconnection to used circuits
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent employs a disposable connector that is designed to be used once and then discarded. The connector includes a frangible portion that breaks after a single use, ensuring that the connector cannot be reconnected to a previously used circuit. This disposable approach eliminates the risk of reconnection while maintaining ease of operation during the initial connection and disconnection processes.

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

Solution Approach 2:

The connector is divided into multiple segments including a first portion, a frangible portion, and a second portion. The frangible portion is designed to break under finger pressure, separating the connector into distinct segments. This segmentation allows the connector to be easily disconnected after use while preventing reconnection, as the frangible portion cannot be reassembled.

Inventive Principle:
Principle #1Segmentation

2Productivity

If a connector allows rapid switching between fluid sources, then the productivity is improved, but the complexity of the device increases

Engineering Contradiction:
Improvespeed of switching between fluid sourcesVSAvoidconnector structure complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The connector is segmented into a first portion, a frangible portion, and a second portion, where the frangible portion can be easily broken under finger pressure. This segmentation allows for rapid switching between fluid sources by simply breaking the frangible portion and disconnecting the segments, without requiring complex mechanisms or tools, thus achieving fast switching while keeping the device structure relatively simple.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frangible portion is designed to break automatically under finger pressure without requiring additional tools or complex mechanisms. This self-service feature enables rapid switching between fluid sources by allowing the user to simply apply finger pressure to break the frangible portion and disconnect the connector, eliminating the need for complex disconnection mechanisms.

Inventive Principle:
Principle #25Self-service

3Reliability

If a connector is designed to prevent reconnection by breaking, then the reliability is improved, but the ease of operation deteriorates

Engineering Contradiction:
Improveprevention of reconnectionVSAvoidease of fracturing the connector
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The connector is divided into segments with a frangible portion that is specifically designed to break under finger pressure. This segmentation ensures that the connector can be easily fractured by the user without requiring excessive force or complex tools, while the broken frangible portion effectively prevents reconnection to previously used circuits, thus maintaining both ease of operation and reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frangible portion is designed with specific physical parameters (such as material composition, geometry, and strength) that allow it to break under finger pressure. By carefully controlling these parameters, the connector can be easily fractured by the user without requiring excessive force, while still ensuring reliable prevention of reconnection after breaking.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3386561B1Fluid line connector devices methods and systems
Publication Date: 2023.05.03 NXSTAGE MEDICAL INC
  • EP3386561B1 patent drawingFigure 1A~1C
  • EP3386561B1 patent drawingFigure 2~4
  • EP3386561B1 patent drawingFigure 5~6

AI summary

A frangible connector has a first side that forms a female luer when a second side is fractured at a predefined break line. The second side may be connected to a fluid circuit, for example, a source of medical treatment fluid such as dialysate.