Analyte Sensor IRM and HDA Layers for Interferent Rejection

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Solution Overview

Problem

Analyte sensors face challenges with interferent rejection and longevity due to reactions with electroactive species other than the intended analyte, and they require time for signal stabilization, leading to early wear issues.

Innovation Solution

The implementation of two chemical layers within analyte sensors: an interferent rejection membrane (IRM) layer and a high density adhesion (HDA) layer. The IRM layer is negatively charged to reject interferents, while the HDA layer, being positively charged, cooperates with the IRM layer to enhance interferent rejection and sensor longevity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional single-layer sensor design is used, then the device complexity is low, but the interferent rejection capability is poor and sensor longevity is reduced

Engineering Contradiction:
Improvesensor longevityVSAvoidchemical layer structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sensor membrane is divided into two distinct functional layers: an interferent rejection membrane (IRM) layer for blocking electroactive interferents, and a high density adhesion (HDA) layer for enzyme attachment and signal generation. This segmentation allows each layer to specialize in one function, improving overall sensor performance and longevity while maintaining manageable complexity through clear functional separation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sensor employs a composite membrane structure combining the IRM layer and HDA layer, where the IRM layer (e.g., polyvinyl alcohol-sulfosuccinic acid crosslinked polymer) provides interferent rejection and the HDA layer (e.g., poly-L-lysine) provides enzyme adhesion. This composite approach creates synergistic effects that improve both interferent rejection and sensor longevity compared to single-layer designs.

Inventive Principle:
Principle #40Composite materials

2Reliability

If the IRM layer is made thicker to improve interferent rejection, then the interferent rejection capability increases, but the sensor response time increases due to slower signal stabilization

Engineering Contradiction:
Improveinterferent rejection capabilityVSAvoidsignal stabilization speed
Core Design Contradiction:
ReliabilityVSSpeed

Solution Approach 1:

The sensor membrane exhibits local quality differentiation with the IRM layer optimized for interferent rejection (thicker, more dense) and the HDA layer optimized for rapid signal response (thinner, more porous). This local optimization allows the IRM layer to provide strong interferent rejection while the HDA layer maintains fast signal stabilization, resolving the trade-off between rejection capability and response speed.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The problem is solved by adding a dimensional aspect - creating a two-layer vertical structure instead of a single-layer design. This dimensional change allows simultaneous optimization of interferent rejection (in the IRM layer) and signal response speed (in the HDA layer), as each layer operates in its own functional dimension without compromising the other.

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

3Loss of time

If the sensor is designed to quickly stabilize signals, then the early wear issues are reduced, but the interferent rejection capability may be compromised

Engineering Contradiction:
Improvesignal stabilization timeVSAvoidinterferent rejection capability
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

By segmenting the membrane into IRM and HDA layers, the HDA layer can be optimized for rapid signal stabilization (thinner, more porous structure) while the IRM layer provides the interferent rejection function. This segmentation allows the sensor to achieve both fast signal stabilization and maintained interferent rejection capability, reducing early wear issues without compromising reliability.

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

This configuration improves interferent rejection capabilities and extends the longevity of analyte sensors by stabilizing sensor signals more quickly, reducing early wear issues, and maintaining sensitivity over time.

Implementation Method 1

The IRM layer is negatively charged to reject interferents

Methodology Applied
Scientific EffectElectrostatic repulsion: Electrostatics

Implementation Method 2

The HDA layer, being positively charged, cooperates with the IRM layer to enhance interferent rejection and sensor longevity

Methodology Applied
Scientific EffectElectrostatic attraction: Electrostatics

Implementation Method 3

the enzyme layer includes an enzyme selected to generate a detectable electrical signal upon exposure to the glucose

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 4

The glucose oxidase is used to catalyze the reaction between glucose and oxygen to yield gluconic acid and hydrogen peroxide

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 5

the current can be measured by a potentiostat

Methodology Applied
Scientific EffectElectrochemical detection:

Data Source

PatentUS20250116625A1Analyte sensors and methods for improving interferent rejection and longevity
Publication Date: 2025.04.10 MEDTRONIC MINIMED INC
  • US20250116625A1 patent drawing
  • US20250116625A1 patent drawing
  • US20250116625A1 patent drawing

AI summary

An analyte sensor includes a microcontroller, a base layer, a conductive layer disposed on the base layer where the conductive layer includes a working electrode configured to provide a current signal in presence of glucose, an interference rejection membrane (“IRM”) layer disposed on the working electrode where the IRM layer is negatively charged, and an enzyme layer disposed on the IRM layer where the enzyme layer includes an enzyme selected to generate a detectable electrical signal upon exposure to the glucose. The microcontroller is configured to process an electrochemical impedance spectroscopy (EIS) parameter to determine a state of the IRM layer.