Multi-Field Enzyme Electrode for In-Vivo Analyte Measurement

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Solution Overview

Problem

Existing electrode systems for in-vivo analyte concentration measurement are prone to interference and have low accuracy due to their small enzyme layer size, which makes them susceptible to transient local effects and fluid exchange issues, leading to unreliable measurements.

Innovation Solution

The electrode system features a working electrode with an enzyme layer arranged in multiple fields spaced at least 3 mm apart, accompanied by a diffusion barrier and a spacer to slow analyte diffusion and maintain fluid exchange, allowing for more reliable and flexible measurement of analyte concentrations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If the enzyme layer area is increased to improve measurement reliability, then the measurement accuracy improves, but the enzyme layer becomes more susceptible to mechanical damage and leakage

Engineering Contradiction:
Improvemeasurement accuracyVSAvoidenzyme layer integrity
Core Design Contradiction:
Measurement precisionVSStrength

Solution Approach 1:

The enzyme layer is divided into multiple separate fields (first field, second field, third field, fourth field) arranged on the working electrode. Each field is surrounded by its own insulation layer, creating isolated measurement zones. This segmentation allows the total enzyme area to be increased for better measurement reliability while each individual field remains small and mechanically robust.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Insulation layers are introduced as intermediary elements between the enzyme fields and the surrounding tissue, and between adjacent enzyme fields. These insulation layers prevent enzyme leakage into surrounding tissue while maintaining the electrical isolation between different enzyme fields, thus protecting the enzyme layer integrity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If multiple working electrodes are used to improve measurement reliability, then the measurement accuracy improves, but the device complexity and resource utilization increase

Engineering Contradiction:
Improvemeasurement reliabilityVSAvoidnumber of electrodes
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Multiple enzyme fields (first, second, third, and fourth fields) are integrated onto a single working electrode. Each field is electrically isolated by insulation layers but collectively forms part of one electrode system. This merging approach achieves the statistical reliability of multiple electrodes while maintaining a simpler single-electrode structure.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

Instead of adding multiple electrodes in the spatial dimension, the solution extends the enzyme layer functionality across different spatial locations on the same electrode plane, with each field separated by insulation layers. This dimensional arrangement provides multiple measurement zones without increasing the number of discrete electrode components.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Strength

If the enzyme layer is made small to maintain mechanical integrity, then the enzyme layer strength improves, but the measurement reliability decreases due to transient local effects

Engineering Contradiction:
Improveenzyme layer integrityVSAvoidmeasurement reliability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The enzyme layer is segmented into multiple small fields (first, second, third, fourth fields) that are distributed across the working electrode. Each field maintains the small size needed for mechanical integrity, while the collective arrangement of multiple fields provides sufficient total measurement area to overcome transient local effects and improve overall measurement reliability.

Inventive Principle:
Principle #1Segmentation

4Speed

If the enzyme layer is made highly water-permeable to improve analyte diffusion, then the analyte transport improves, but the enzyme molecules can leak into surrounding tissue

Engineering Contradiction:
Improveanalyte diffusion rateVSAvoidenzyme leakage
Core Design Contradiction:
SpeedVSLoss of substance

Solution Approach 1:

Insulation layers are positioned as intermediary barriers between the enzyme fields and the surrounding body tissue. These insulation layers create a physical boundary that prevents enzyme molecules from leaking into the surrounding tissue while still allowing analyte molecules to diffuse from the body fluid through the insulation layer to reach the enzyme fields for measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The insulation layers are implemented as thin film structures that cover the enzyme fields. These thin films provide a selective barrier function - they are sufficiently permeable to allow analyte diffusion to the enzyme while being impermeable to the larger enzyme molecules, thus preventing enzyme leakage into surrounding tissue.

Inventive Principle:
Principle #30Flexible shells and thin films

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 significantly improves measurement reliability and accuracy by reducing the impact of transient local effects and enabling flexible electrode placement, ensuring that analyte concentrations are representative of larger body volumes, even under movement and fluid exchange disturbances.

Implementation Method 1

a diffusion barrier which slows diffusion of the analyte from body fluid surrounding the electrode system to enzyme molecules

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 2

enzyme molecules for catalytic conversion of the analyte. In the process, an electrical current is generated as measuring signal

Methodology Applied
Scientific EffectCatalysis: Catalysis

Data Source

PatentUS10390743B2Electrode system for measuring an analyte concentration under in-vivo conditions
Publication Date: 2019.08.27 ROCHE DIABETES CARE INC
  • US10390743B2 patent drawing
  • US10390743B2 patent drawing
  • US10390743B2 patent drawing

AI summary

Electrode systems are disclosed for measuring the concentration of an analyte under in-vivo conditions, where such systems include a counter electrode having an electrical conductor, a working electrode having an electrical conductor on which an enzyme layer containing immobilized enzyme molecules for catalytic conversion of the analyte is arranged, and a diffusion barrier that slows the diffusion of the analyte from body fluid surrounding the electrode system to enzyme molecules. The enzyme layer is in the form of multiple fields that are arranged on the conductor of the working electrode at a distance from each other.