Implantable Analyte Sensor Membrane for Stable Two-Electrode Sensing

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Solution Overview

Problem

Existing analyte sensors, particularly those designed for implantation, face challenges in manufacturability and long-term stability, with manufacturing processes being time-consuming and costly, and they often suffer from biocompatibility issues and reduced sensitivity over time.

Innovation Solution

An analyte sensor design featuring a substrate with a working electrode and a second electrode, covered by a hydrophobic polymer membrane with controlled holes, allowing for efficient analyte detection with improved biocompatibility and long-term stability, utilizing a simplified two-electrode configuration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a three-electrode configuration is used in implanted sensors, then measurement accuracy is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improvemeasurement accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the reference electrode and counter electrode into a single integrated second electrode structure. This merging reduces the total number of electrodes from three to two, simplifying the device architecture while maintaining measurement functionality through the integrated electrode design that performs multiple functions simultaneously

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If multiple membranes are applied to achieve specificity, sensitivity, and biocompatibility, then sensor performance is improved, but manufacturing complexity and time increase

Engineering Contradiction:
Improvesensor performanceVSAvoidmanufacturing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent integrates multiple membrane functions into a single membrane layer that simultaneously provides specificity through selective permeability, sensitivity enhancement through controlled ion transport, and biocompatibility through hydrophilic properties. This consolidation reduces the number of separate membrane application steps while maintaining comprehensive sensor performance

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The single membrane is designed to perform multiple functions: it acts as a selective barrier for specific ions, enhances sensor sensitivity through controlled ion diffusion, and provides biocompatibility through its hydrophilic character. This multi-functional design eliminates the need for separate specialized membranes for each function

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

3Ease of manufacture

If traditional manufacturing processes are used, then sensor fabrication is achieved, but production time and cost increase significantly

Engineering Contradiction:
ImprovemanufacturabilityVSAvoidproduction efficiency
Core Design Contradiction:
Ease of manufactureVSProductivity

Solution Approach 1:

The patent divides the sensor into modular components (substrate with integrated electrodes and a separate membrane layer) that can be manufactured independently and then assembled. This segmentation allows for simplified manufacturing of individual parts using standard processes, reducing overall production complexity and time while maintaining sensor functionality

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

The sensor is cost-effective, easy to manufacture, and exhibits stable sensitivity and biocompatibility, enabling prolonged use without significant deterioration.

Implementation Method 1

a membrane comprising a polymer composition which comprises a hydrophobic polymer, wherein the hydrophobic polymer has a water uptake of less than 1 % by weight, based on the total weight of the hydrophobic polymer, wherein the membrane is located on top of the at least one second electrode

Methodology Applied
Scientific EffectSelective permeability: Semipermeable Membrane

Implementation Method 2

the membrane comprises holes, wherein the total area of holes has a size of at most 0.15 mm2

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

The working electrodes of such a sensor have electrically conductive enzyme layers in which enzyme molecules are bound which release charge carriers by catalytic conversion of the analyte molecules

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 4

enzyme molecules are bound which release charge carriers by catalytic conversion of the analyte molecules

Methodology Applied
Scientific EffectCatalytic conversion: Catalysis

Implementation Method 5

a membrane comprising a polymer composition which comprises a hydrophobic polymer, wherein the hydrophobic polymer has a water uptake of less than 1 % by weight

Methodology Applied
Scientific EffectHydrophobicity: Hydrophobe

Data Source

PatentEP4179104B1Analyte sensor and its manufacturing
Publication Date: 2025.12.03 F HOFFMANN LA ROCHE & CO AG
  • EP4179104B1 patent drawingFigure 1
  • EP4179104B1 patent drawing

AI summary

The present invention relates to an analyte sensor comprising a substrate, at least one working electrode, at least one second electrode and a membrane, wherein the membrane is located on top of the at least one second electrode. The present invention further relates to a process for manufacturing the inventive analyte sensor as well as to an analyte sensor system comprising an analyte sensor according to the present invention and an electronics unit. The analyte sensors according to the present invention may mainly be used for conducting an analyte measurement in a body fluid of a user.