Opposing Electrode Test Element for Simultaneous Capillary Wetting

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Solution Overview

Problem

Existing test elements for electrochemically detecting analytes in body fluids are complex and costly to manufacture, with limitations in flexibility and convenience, particularly due to the need for precise alignment of electrodes and separate reagent coating processes, which complicates the production and handling of capillary-based systems.

Innovation Solution

A test element design featuring opposing electrodes arranged on either side of a capillary, allowing simultaneous and equal wetting during filling, with a layer setup that enables independent analyte detection regardless of filling level, and a measurement system capable of detecting both AC and DC signals to monitor filling and analyte presence.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If electrodes are arranged on opposing sides of a capillary with simultaneous wetting design, then manufacturing precision is improved by eliminating alignment requirements, but device complexity increases due to the layer setup structure

Engineering Contradiction:
Improvealignment precisionVSAvoidlayer setup structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies asymmetry by positioning electrodes on opposing sides of the capillary rather than above it, creating an asymmetric wetting path that eliminates the need for precise alignment during manufacturing. The first electrode is positioned to be wetted first during capillary filling, while the second electrode is positioned to be wetted subsequently, creating an asymmetric filling sequence that simplifies manufacturing.

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The patent segments the electrode wetting process into distinct stages by positioning electrodes at different locations along the capillary. The first electrode is positioned in a region that gets wetted during initial filling, while the second electrode is positioned in a region that gets wetted later, allowing independent detection of analyte presence without requiring additional fill detection electrodes.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If additional fill detection electrodes are added to monitor capillary filling, then measurement precision is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improvefilling level detection accuracyVSAvoidnumber of electrodes
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent makes the electrodes serve multiple functions: they simultaneously act as working electrodes for analyte detection and as fill detection indicators. By positioning the electrodes on opposing sides of the capillary with different wetting timings, the electrodes inherently provide information about filling level while performing their primary analyte detection function, eliminating the need for separate fill detection electrodes.

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

Solution Approach 2:

The electrode arrangement allows the system to self-monitor filling status through the sequential wetting pattern. The first electrode detects when filling begins (as it is the first to be wetted), and the second electrode detects when filling progresses (as it is wetted subsequently), allowing the system to use its own components for self-diagnosis of filling status without external sensors.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If electrodes are arranged for simultaneous wetting during capillary filling, then ease of operation is improved by simplifying filling procedure, but manufacturing complexity increases due to precise positioning requirements

Engineering Contradiction:
Improvecapillary filling convenienceVSAvoidelectrode positioning structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

Instead of arranging electrodes to be wetted simultaneously (which would require complex alignment), the patent inverts the approach by intentionally designing asymmetric wetting timing. The electrodes are positioned so that one is wetted before the other during capillary filling, which simplifies the manufacturing positioning requirements while still providing operational benefits through the sequential detection capability.

Inventive Principle:
Principle #13The other way round (Inversion)

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 design simplifies the manufacturing process, enhances flexibility, and improves handling convenience by allowing capillary filling without precise alignment, while enabling accurate analyte detection without the need for additional fill detection electrodes, thus reducing production costs and increasing usability in both home and professional settings.

Implementation Method 1

the test element comprises at least one capillary (3; 3') capable of receiving a sample (10) of the body fluid (5)

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

the first electrode (1; 1') and the second electrode (2; 2') and the capillary (3; 3') in between the first electrode (1; 1') and the second electrode (2; 2') form an electrochemical cell

Methodology Applied
Scientific EffectElectrochemical detection:

Data Source

PatentUS11774395B2Test element for electrochemically detecting at least one analyte
Publication Date: 2023.10.03 ROCHE DIAGNOSTICS OPERATIONS INC
  • US11774395B2 patent drawing
  • US11774395B2 patent drawing
  • US11774395B2 patent drawing

AI summary

A test element for electrochemically detecting at least one analyte in a bodily fluid is disclosed. The test element comprises at least one first electrode and at least one second electrode. The first electrode is designed as a working electrode and the second electrode is designed as a counter electrode. The test element comprises at least one capillary capable of receiving a sample of the body fluid. The first electrode and the second electrode are arranged on opposing sides of the capillary. The first electrode and the second electrode are arranged such that during a capillary filling the first electrode and the second electrode are wetted simultaneously and at an equal rate.