Failsafe Controller Seals Tubing to Block Counterfeit Fluid Circuits

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Solution Overview

Problem

Current medical fluid processing systems lack effective failsafe mechanisms to prevent the use of faulty or counterfeit disposable components and ensure sterile conditions during blood component separation, which can lead to contamination and safety risks.

Innovation Solution

A programmable controller-driven failsafe system that recognizes failure events, such as leakage or abnormal hematocrit, and activates a sealer to render unusable any faulty or unauthorized disposable fluid circuit components, ensuring only authorized and functional components are used in the medical fluid processing procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a disposable fluid circuit is used for blood component separation, then contamination and infection risks are reduced, but the system cannot detect or respond to component failures

Engineering Contradiction:
Improvecontamination riskVSAvoidfailure detection capability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

An authentication mark is introduced as an intermediary element between the disposable fluid circuit and the processing system. The mark serves as a mediator that enables the system to verify the authenticity and integrity of the disposable component without compromising the sterile barrier. The programmable controller reads this mark to detect failures or counterfeit components, thus resolving the contradiction between maintaining sterility and enabling failure detection.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If the system allows continuous operation, then productivity is maintained, but faulty or counterfeit components may be used leading to safety risks

Engineering Contradiction:
Improvecontinuous operation capabilityVSAvoidcomponent safety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The system performs preliminary verification by reading the authentication mark on the disposable fluid circuit before allowing operation to commence. This preliminary action ensures that only authenticated, non-counterfeit components are used. If the mark is missing, damaged, or invalid, the system prevents operation before safety risks can materialize, thus maintaining both productivity through legitimate continuous operation and reliability through pre-operation safety checks.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If no authentication mechanism is implemented, then device complexity is reduced, but counterfeit or unauthorized components cannot be identified

Engineering Contradiction:
Improvesystem simplicityVSAvoidcomponent authentication
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The authentication function is extracted from the main processing system and implemented as a separate, dedicated authentication mark on the disposable component. This extraction allows the processing system to maintain relative simplicity while incorporating authentication capability through a separate, specialized element. The programmable controller simply needs to read the mark rather than implement complex authentication logic, thus resolving the contradiction between simplicity and authentication capability.

Inventive Principle:
Principle #2Taking out (Extraction)

4Object-affected harmful factors

If the sealer is activated to seal tubing, then contamination is prevented, but the tubing becomes unusable for further processing

Engineering Contradiction:
Improvecontamination preventionVSAvoidtubing reusability
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The sealing action, which permanently disables the tubing, is converted into a benefit by using it as a failsafe mechanism. When failure or counterfeit is detected, the authentication mark triggers automatic sealing of the tubing, preventing contaminated or unauthorized components from being used. The loss of tubing reusability is transformed into a safety feature that protects patient health, thus converting what appears to be a productivity loss into a beneficial safety outcome.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Data Source

PatentEP3415180B1Failsafe system and method for a medical fluid procedure
Publication Date: 2020.10.14 FENWAL INC
  • EP3415180B1 patent drawingFigure 1
  • EP3415180B1 patent drawingFigure 2A~2B

AI summary

A failsafe system for a medical fluid procedure, comprising a medical fluid processing apparatus comprising a sealer and a programmable controller driven by software, wherein the programmable controller is programmed to recognize a failure event from input from hardware components of the medical fluid processing apparatus. The system also comprises a disposable fluid circuit configured to associate with the medical fluid processing apparatus and comprising a tubing segment configured to fit within the sealer. The programmable controller is configured to seal the tubing segment by activating the sealer surrounding the tubing segment in response to an occurrence of the failure event.