Biosensor Reagent Coating Composition for Consistent Analyte Detection

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Solution Overview

Problem

Current analytical sensors for bioanalytes face challenges in producing consistent and accurate test results, requiring improvements in reagent composition and coating methods to ensure reproducibility and economic manufacturing.

Innovation Solution

A reagent composition comprising a release polymer, an effective amount of an enzyme, an enzyme cofactor, and a redox compound, which can act as a redox mediator or couple in biosensors, is used to create a uniform coating on electrodes, utilizing polymers like polyvinyl alcohol-polyethylene glycol graft copolymer or polyvinyl acetate, with specific molecular weights and rheological properties for efficient analyte detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional reagent compositions are used, then manufacturing is simpler, but test result consistency and accuracy deteriorate

Engineering Contradiction:
Improvetest result consistencyVSAvoidreagent composition complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent uses a composite reagent composition containing multiple polymers (first polymer with high glass transition temperature, second polymer with low glass transition temperature), enzymes, cofactors, and redox mediators. This composite approach enables consistent analyte detection while maintaining manufacturability through controlled material interactions and phase behavior.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent controls the glass transition temperatures of polymer components and their weight ratios to achieve desired reagent film properties. By adjusting these parameters, the composition maintains stability during manufacturing and storage while providing reproducible test results.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If soluble reagents are used for easy coating, then ease of manufacture improves, but wash-through during processing deteriorates

Engineering Contradiction:
Improvecoating easeVSAvoidreagent retention
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent creates a flexible reagent film that adheres to the test strip substrate. The polymer matrix forms a cohesive film structure that retains soluble reagents (enzymes, cofactors, redox mediators) while allowing the film itself to be flexible and conformable to the substrate geometry.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent uses polymers with different glass transition temperatures to create zones of different flexibility and adhesion within the reagent film. The first polymer provides structural integrity and adhesion to the substrate, while the second polymer provides flexibility and prevents cracking, together ensuring reagent retention during processing.

Inventive Principle:
Principle #3Local quality

3Reliability

If reagent films are made durable for processing, then reliability improves, but flexibility during application deteriorates

Engineering Contradiction:
Improveprocessing durabilityVSAvoidfilm flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent combines polymers with complementary properties: high glass transition temperature polymers provide thermal stability and adhesion for processing durability, while low glass transition temperature polymers provide flexibility and crack resistance. This composite approach achieves both durability and flexibility simultaneously.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent creates a reagent film with dynamic mechanical properties that adapt to different conditions. The polymer blend exhibits temperature-dependent behavior, being more flexible at application temperatures and more rigid at processing temperatures, thus achieving both flexibility and durability as needed.

Inventive Principle:
Principle #15Dynamics

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 enables the production of biosensors with consistent and accurate analyte detection, preventing wash-through of soluble reagents and ensuring durable, flexible films that maintain performance throughout processing and shelf life.

Implementation Method 1

The coating composition includes a release polymer that has dispersed within it an effective amount of an enzyme, an enzyme cofactor, and a redox compound. The release polymer controls the release rate of these soluble reagents.

Methodology Applied
Scientific EffectRelease polymer mechanism:

Implementation Method 2

a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode; (ii) a redox couple associated with a reference electrode; or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode

Methodology Applied
Scientific EffectRedox reaction: Redox Reactions

Data Source

PatentUS8409425B2Biosensor coating composition and methods thereof
Publication Date: 2013.04.02 ABBOTT DIABETES CARE INC
  • US8409425B2 patent drawing
  • US8409425B2 patent drawing
  • US8409425B2 patent drawing

AI summary

The disclosure provides for reagent compositions for biosensors comprising release polymers, methods of making such biosensors and films of reagent compositions comprising release polymers. The reagent compositions comprise a release polymer and an effective analyte detecting amount of an enzyme an enzyme cofactor and a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode (ii) a redox couple associated with a reference electrode or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.