Three-Electrode Test Strip for Glucose Measurement

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Solution Overview

Problem

Existing biosensors for glucose monitoring in diabetic patients face errors due to hematocrit and temperature interferences, which prior methods fail to adequately address without increasing complexity or cost.

Innovation Solution

A test strip with three electrodes uses different electrical signal polarities during distinct periods to measure currents, calculating an initial analyte concentration and diffusion factor to correct for interference effects, thereby improving measurement accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If prior methods use multiple electrode sets with DC and AC signals to eliminate hematocrit and temperature effects, then measurement accuracy is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improveglucose measurement accuracyVSAvoidelectrode configuration complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates the harmful hematocrit effect by using a specific amperometric measurement method that compensates for hematocrit interference, removing the need for complex multiple electrode sets while maintaining measurement accuracy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the measurement parameters by using amperometric detection at a fixed potential to specifically measure hydrogen peroxide concentration, which correlates with glucose concentration while being independent of hematocrit variations, thereby simplifying the device architecture

Inventive Principle:
Principle #35Parameter changes

2Reliability

If prior methods use multiple electrode sets and complex signal processing to address temperature and hematocrit interferences, then measurement reliability is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvetesting result reliabilityVSAvoidtesting process simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent removes the complexity of multiple electrode sets and AC signal processing by extracting only the essential amperometric measurement at fixed potential, which inherently compensates for temperature and hematocrit effects, thereby improving ease of operation while maintaining reliability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The measurement method performs self-compensation for temperature and hematocrit variations through the specific electrochemical reaction characteristics, eliminating the need for additional correction mechanisms or complex signal processing steps

Inventive Principle:
Principle #25Self-service

3Measurement precision

If prior methods use silica particles or mesh layers to filter or distribute blood sample, then hematocrit effect is reduced, but manufacturing cost and device complexity increase

Engineering Contradiction:
Improveblood glucose measurement accuracyVSAvoidtest strip manufacturing simplicity
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent eliminates the need for silica particles or mesh layers by using an amperometric measurement approach that is inherently insensitive to hematocrit variations, thereby simplifying the manufacturing process while maintaining measurement precision

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical filtration or distribution systems (silica particles, mesh layers) with an electrochemical measurement method that naturally compensates for hematocrit effects, reducing manufacturing complexity and cost

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 method effectively reduces biases in glucose measurement across varying hematocrit levels and temperatures, enhancing accuracy and simplicity compared to prior solutions.

Implementation Method 1

the plurality of electrons are transferred to a working electrode of the reaction region through a mediator

Methodology Applied
Scientific EffectElectron transfer: Redox Reactions

Implementation Method 2

measuring during a third period a second current through the working electrode, wherein the mediator generates during a second period an intermediate according to the electrical signal

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP2746759B1Method of detecting concentration of an analyte in a sample with a test strip
Publication Date: 2016.09.07 TYSON BIORESEARCH INC
  • EP2746759B1 patent drawingFigure 1
  • EP2746759B1 patent drawingFigure 2
  • EP2746759B1 patent drawingFigure 3

AI summary

A method of a test strip (100, 600, 1100) detecting concentration of an analyte of a sample includes placing the sample in a reaction region (302, 602) of the test strip (100, 600, 1100), wherein the analyte reacts with an enzyme to generate a plurality of electrons, and the plurality of electrons are transferred to a working electrode of the reaction region (302, 602) through a mediator; applying an electrical signal to the working electrode; measuring a first current through the working electrode during a first period; the mediator generating during a second period an intermediate according to the electrical signal; measuring during a third period a second current through the working electrode; calculating initial concentration of the analyte according to the first current; calculating a diffusion factor of the intermediate in the sample according to the second current; and correcting the initial concentration to generate new concentration of the analyte according to the diffusion factor.