Sensor Strip with Segmented Reactive Areas for Hematocrit Correction

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Solution Overview

Problem

Existing electrochemical biosensor strips face challenges in accurately measuring analyte concentrations due to interference from hematocrit levels, which can lead to contamination and increased manufacturing complexity and cost, particularly when using enzymatic electrodes and non-enzymatic electrodes with complex signal interference and sensitivity to sample volume.

Innovation Solution

A sensor strip with two independent reactive areas, where one area measures analyte concentration and the other measures hematocrit, using separate electrode sets and signals to prevent cross-contamination and simplify operations, reducing the need for temperature corrections and complex frequency measurements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single reactive area is used for both analyte measurement and hematocrit measurement, then device complexity is reduced, but measurement precision deteriorates due to signal interference and cross-contamination

Engineering Contradiction:
Improvestructure complexityVSAvoidanalyte concentration measurement accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent divides the reactive area into two separate zones: a first reactive area for analyte measurement and a second reactive area for hematocrit measurement. This segmentation prevents signal interference and cross-contamination between the two measurement processes, thereby improving measurement precision while maintaining reasonable device complexity through functional separation.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If enzymatic electrodes are used for biosensing, then measurement precision for analyte concentration is improved, but manufacturing complexity and cost increase due to restrictive moisture preservation and complicated manufacturing processes

Engineering Contradiction:
Improveanalyte concentration measurement accuracyVSAvoidmanufacturing process complexity
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent separates the enzymatic electrode (first electrode set) from the hematocrit measurement electrode (second electrode set). The second electrode set uses non-enzymatic measurement that does not require moisture preservation, simplifying the overall manufacturing process. Only the first electrode set requires specialized enzymatic electrode manufacturing, while the second can be manufactured using standard techniques.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sensor strip performs multiple functions: it measures both analyte concentration (using enzymatic electrode) and hematocrit level (using non-enzymatic electrode). This multi-functionality allows the system to obtain corrected analyte measurements without requiring separate devices, balancing manufacturing complexity with measurement precision.

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

3Productivity

If screen printing is used to spread reaction layer formulation covering two electrode systems, then manufacturing productivity is improved, but measurement precision deteriorates due to large amounts of polymers and salt buffer interfering with analyte concentration measurement

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidanalyte concentration measurement accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent divides the reaction layer formulation into separate compositions for the first electrode set and second electrode set. The first reaction layer is optimized for enzymatic analyte measurement with minimal polymers and salt buffer, while the second reaction layer is designed for hematocrit measurement. This segmentation eliminates cross-interference between the two measurement systems, improving measurement precision while maintaining manufacturing efficiency through screen printing.

Inventive Principle:
Principle #1Segmentation

4Measurement precision

If hematocrit correction is incorporated using separate electrode sets and reactive areas, then measurement precision for analyte concentration is improved, but device complexity increases

Engineering Contradiction:
Improvecorrected analyte concentration accuracyVSAvoidelectrode set configuration
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent implements functional segmentation by creating distinct first and second electrode sets with dedicated reactive areas. The first electrode set measures analyte concentration while the second measures hematocrit level. This segmentation enables accurate hematocrit correction of analyte measurements by providing separate, interference-free measurement zones, improving measurement precision while keeping device complexity manageable through clear functional separation.

Inventive Principle:
Principle #1Segmentation

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 enhances accuracy by isolating signals and reducing interference, allowing for simultaneous measurement of analyte and hematocrit levels with a simpler, cost-effective system that minimizes contamination and operational complexity.

Implementation Method 1

The first electrode layer (712) includes a reference electrode (712A), a working electrode (712B) and a sensor electrode (712C)... configured to measure an analyte concentration

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 2

The second electrode layer (721) includes a reference electrode (721A), a working electrode (721B) and a sensor electrode (721C)... configured for measuring hematocrit

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 3

a vent hole (750) penetrates the second insulation layer (722), the second electrode layer (721) and the first insulation layer (713) to connect the first reactive area (715) and the second reactive area (724)

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP2687841B1Sensor strip and manufacture method thereof and system thereof
Publication Date: 2019.11.27 APEX BIOTECH CORP
  • EP2687841B1 patent drawingFigure 8
  • EP2687841B1 patent drawingFigure 9
  • EP2687841B1 patent drawingFigure 12

AI summary

The present disclosure relates to an electrode strip, a sensor strip (70), a system thereof and a manufacturing method thereof. The sensor strip (70) includes a first reactive film (710), a second reactive film (720) and a vent hole (750). The first reactive film includes a substrate (711), a first electrode layer (712) and a first insulation layer (713). The first end of the first insulation layer is concaved to a first depth to form a first reactive area (715). The second reactive film includes a second electrode layer (721) and a second insulation layer (722). The first end of the second insulation layer is concaved to a second depth to form a second reactive area (724). The vent hole (750) penetrates the second insulation layer, the second electrode layer and the first insulation layer so as to connect the first reactive area (715) and the second reactive area (724).