Glucose Sensor Reagent Stability and Fill Rate

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Solution Overview

Problem

Existing glucose test sensors face issues with low stability due to environmental factors, leading to increased background current and reduced precision, and have slow fill rates, which limit their shelf-life and accuracy.

Innovation Solution

A reagent comprising a flavoprotein enzyme, a phenothiazine or phenoxazine mediator, a surfactant, and a cellulose-based polymer, with a buffer and inorganic salt ratio less than 3:1, is used to enhance the stability and fill rate of glucose test sensors, reducing background current and improving kinetic performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional electron transfer mediators (potassium ferricyanide, PMS, DCIP) are used with FAD-GDH, then the sensor can detect glucose through enzyme-catalyzed oxidation, but the reagent stability decreases due to susceptibility to temperature and moisture, resulting in increased background current and reduced shelf-life

Engineering Contradiction:
Improvereagent stabilityVSAvoidmeasurement precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent changes the chemical parameters of the electron transfer mediator by selecting compounds with specific structural characteristics (phenothiazine, phenoxazine, or indole rings with particular substituent patterns) that inherently provide greater stability to temperature and moisture while maintaining their redox functionality for glucose detection

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite reagent system combining the stable electron transfer mediator with FAD-GDH enzyme and coenzyme, where the mediator's structural stability compensates for the enzyme's sensitivity to environmental conditions, achieving overall improved reagent stability without sacrificing measurement precision

Inventive Principle:
Principle #40Composite materials

2Productivity

If the sensor fill rate is increased to achieve faster reagent re-hydration, then the test precision and stability improve, but the sensor design becomes more complex and the manufacturing difficulty increases

Engineering Contradiction:
Improvefill rateVSAvoidmanufacturing ease
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

The patent employs a porous hydrogel matrix as the reagent carrier, which provides capillary channels that naturally facilitate rapid fluid wicking and fill rates. The porous structure enables fast reagent re-hydration through capillary action without requiring complex external pumping mechanisms, thus maintaining manufacturing simplicity while achieving high productivity

Inventive Principle:
Principle #31Porous materials

3Measurement precision

If the amount of mediator or enzyme is increased to enhance the electrical signal, then the signal magnitude increases, but the background current increases over time due to reduced mediator production, decreasing precision and accuracy

Engineering Contradiction:
Improvesignal magnitudeVSAvoidbackground current stability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent extracts or removes the problematic component responsible for background current generation by eliminating the need for reduced mediator production through the stable mediator design. The new mediator structure prevents the formation of reduced mediator that would otherwise accumulate and increase background current, allowing the use of higher mediator concentrations for enhanced signal without the penalty of increasing background noise

Inventive Principle:
Principle #2Taking out (Extraction)

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

The solution results in more precise and stable glucose readings with faster fill rates and extended shelf-life, maintaining accuracy across varying glucose concentrations and temperatures.

Implementation Method 1

The fluid may be drawn into a capillary channel that extends in the sensor from the testing end to the reagent material by capillary action so that a sufficient amount of fluid to be tested is drawn into the sensor

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

Electrochemical test sensors are based on enzyme-catalyzed chemical reactions involving the analyte of interest. In the case of glucose monitoring, the relevant chemical reaction is the oxidation of glucose to gluconolactone or its corresponding acid. This oxidation is catalyzed by a variety of enzymes

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

the relevant chemical reaction is the oxidation of glucose to gluconolactone or its corresponding acid

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 4

The transfer of redox equivalents from the site of chemical reaction in the enzyme to the surface of the electrode is accomplished using electron transfer mediators

Methodology Applied
Scientific EffectElectron transfer: Conduction (electrical)

Data Source

PatentUS11180790B2Reagents and methods for detecting analytes
Publication Date: 2021.11.23 ASCENSIA DIABETES CARE HLDG AG
  • US11180790B2 patent drawing
  • US11180790B2 patent drawing
  • US11180790B2 patent drawing

AI summary

A reagent for detecting an analyte comprises a flavoprotein enzyme, a mediator such as a phenothiazine mediator, at least one surfactant, a polymer and a buffer. The reagent may be used with an electrochemical test sensor that includes a plurality of electrodes.