Biosensor Capillary Reagent Patterning for Hematocrit Correction

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Solution Overview

Problem

Existing biosensors face inaccuracies in measuring blood glucose levels due to variations in hematocrit levels, leading to increased complexity and cost in correction methods, and challenges in reproducibly applying biosensor reagents to multiple sample cavities.

Innovation Solution

A biosensor system with multiple capillaries on a base layer, each containing electrodes and a reagent layer, allows for separate measurement of glucose and hematocrit levels, using sacrificial-spacer layers, surface modifications, and chemical dams to ensure precise reagent application and minimize hematocrit interference.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If correction methods are added to account for hematocrit variations, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improveblood glucose measurement accuracyVSAvoidcorrection method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The test strip is divided into multiple separate sample cavities (first sample cavity for glucose measurement, second sample cavity for hematocrit measurement). Each cavity contains specific reagents and electrodes dedicated to its measurement function, allowing independent measurement of glucose and hematocrit to enable correction without requiring a single complex measurement system.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A single test strip structure performs multiple functions: it measures both glucose concentration and hematocrit level simultaneously using separate but integrated sample cavities. This multi-functional design allows the system to obtain both measurements needed for correction without requiring separate testing procedures or devices.

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

2Adaptability or versatility

If reagents are applied to multiple sample cavities, then versatility is improved, but manufacturing precision deteriorates

Engineering Contradiction:
Improvemultiple analyte measurement capabilityVSAvoidreagent application consistency
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

Different sample cavities are assigned different reagent compositions tailored to their specific measurement purposes. The first sample cavity contains reagents optimized for glucose measurement, while the second sample cavity contains reagents suited for hematocrit measurement. This localized reagent optimization ensures each cavity performs its specific function effectively while maintaining overall manufacturing consistency through standardized application processes.

Inventive Principle:
Principle #3Local quality

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 system provides accurate and efficient measurement of glucose and hematocrit levels, reducing errors and complexity while ensuring uniform reagent distribution across sample cavities, thereby enhancing the precision and reliability of blood glucose monitoring.

Implementation Method 1

electrochemical sensors rely on electron transfer between the electron mediator and the electrode surfaces and function by measuring electrochemical redox reactions

Methodology Applied
Scientific EffectElectrochemical redox reactions: Redox Reactions

Implementation Method 2

electrochemical sensors rely on electron transfer between the electron mediator and the electrode surfaces

Methodology Applied
Scientific EffectElectron transfer: Conduction (electrical)

Implementation Method 3

the electron transfer reactions are transformed into an electrical signal that correlates to the concentration of the analyte being measured

Methodology Applied
Scientific EffectElectrochemical signal transduction: Conduction (electrical)

Implementation Method 4

a first capillary disposed on the base layer configured to electrochemically determine

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS8460524B2System and methods of chemistry patterning for a multiple well biosensor
Publication Date: 2013.06.11 TRIVIDIA HEALTH INC
  • US8460524B2 patent drawing
  • US8460524B2 patent drawing
  • US8460524B2 patent drawing

AI summary

Methods and systems for measuring the concentration of an analyte in a blood sample and, more particularly, to methods of chemistry patterning reagent layers for multiple well biosensors. A first capillary is first configured to receive a dispensed reagent layer such that the reagent layer is distributed in a substantially uniform manner within the first capillary. The first capillary may also configured to isolate the first capillary from other capillaries present in the biosensor. After the reagent layer has been dispensed and dried, the first capillary may then be reconfigured to allow the first capillary to receive a blood sample.