Multiple Electrode Arrangement for Sample Fill Monitoring

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Solution Overview

Problem

Existing test elements for biological fluids often provide inaccurate indications of sample sufficiency and fill direction due to variable user dosing, leading to biased analyte concentration measurements.

Innovation Solution

A method utilizing a test element with a multiple electrode arrangement, including a primary and secondary electrode pair, where the secondary electrodes function as alternative or supplemental counter or working electrodes, allowing for dynamic assignment and enabling monitoring of sample sufficiency, fill time, and fill direction through signal application and response detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a capillary channel is open on two or more sides to enable multi-directional dosing, then ease of operation is improved, but measurement precision deteriorates due to variable fill location and direction

Engineering Contradiction:
Improvemulti-directional dosing capabilityVSAvoidanalyte concentration measurement accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The test element is divided into multiple electrode pairs positioned at different locations within the capillary channel. Each electrode pair independently detects fill status, allowing the system to segment the monitoring function across multiple sensing points to compensate for variable fill directions.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system dynamically determines fill direction based on which electrode pairs detect the sample first, and adapts the measurement process accordingly. The electrode pairs are selectively activated based on detected fill progression, making the measurement system responsive to actual sample introduction patterns.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If fill monitoring is simplified to reduce device complexity, then device complexity is reduced, but measurement precision deteriorates due to inaccurate sample sufficiency indication

Engineering Contradiction:
Improveelectrode arrangement complexityVSAvoidsample sufficiency detection accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The electrode pairs serve multiple functions: they detect sample presence, determine fill direction, monitor fill progression, and verify adequate coverage of the reaction zone. This multi-functionality allows comprehensive fill monitoring without adding separate dedicated sensors for each function.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system continuously monitors signals from the electrode pairs to detect sample progression and provides feedback on fill status. This feedback mechanism allows real-time assessment of sample sufficiency and enables the system to determine when adequate sample has been introduced based on signal changes across the electrode pairs.

Inventive Principle:
Principle #23Feedback

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

This approach provides improved monitoring of sample sufficiency, fill time, and electrode coverage, resulting in more accurate analyte concentration measurements and reduced errors, ensuring reliable results.

Implementation Method 1

a capillary channel formed between a cover and the electrode-support substrate... the fluid sample flows into the capillary channel

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

electrochemical testing methods are known that generally rely upon a correlation between a current (amperometry), a potential (potentiometry), or an accumulated charge (coulometry) and an analyte concentration

Methodology Applied
Scientific EffectElectrochemical reaction: Electrochemiluminescence

Data Source

PatentEP3216076B1Method of using electrochemical test elements having multiple electrode arrangements
Publication Date: 2024.03.06 ROCHE DIABETES CARE GMBH
  • EP3216076B1 patent drawingFigure 1
  • EP3216076B1 patent drawingFigure 2
  • EP3216076B1 patent drawingFigure 3

AI summary

Electrode arrangements for test elements, test elements and methods of determining sample sufficiency, monitoring fill time, establishing fill directions and/or confirming electrode coverage by a sample for test elements are disclosed. The test elements have an electrode-support substrate including a spacer having an edge defining a boundary of a capillary channel. The electrode-support substrate also includes a first electrode pair and a second electrode pair, wherein the first electrode pair is positioned between the second electrode pair. The method includes dosing the test sensor with the fluid sample; applying a signal to the first electrode pair and the second electrode pair, detecting a first response to the signal from the first electrode pair, and detecting a second response to the signal from the second electrode pair; determining a time period between the first response and the second response