Temperature-Insensitive In Vivo Analyte Sensors

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Solution Overview

Problem

In vivo analyte monitoring systems are affected by temperature changes, leading to inaccurate readings due to temperature sensitivity of enzymes and components, with existing systems failing to monitor or correct for assay temperature.

Innovation Solution

Development of temperature-insensitive in vivo analyte monitoring devices and sensors using SMART membranes composed of polymers with heterocyclic nitrogen components and polyetheramine crosslinkers, which regulate analyte permeability across a range of temperatures, maintaining consistent sensor response.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If in vivo analyte monitoring systems use enzymes and components for analyte detection, then analyte detection capability is improved, but temperature sensitivity increases causing inaccurate readings

Engineering Contradiction:

Improveanalyte detection accuracyVSAvoidtemperature sensitivity

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

A membrane is introduced as an intermediary component between the analyte source and the enzyme electrode. This membrane selectively transports analyte while providing thermal buffering, mediating the interaction between temperature changes and the temperature-sensitive enzyme components, thereby reducing the direct impact of temperature fluctuations on detection accuracy

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The membrane's transport properties are designed to change in response to temperature variations in a controlled manner. As temperature increases, the membrane's analyte transport rate increases, which compensates for the decreased enzyme activity at higher temperatures, maintaining overall system output stability across varying temperature conditions

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If in vivo analyte systems operate at different temperatures, then adaptability to physiological conditions is improved, but analyte information accuracy deteriorates

Engineering Contradiction:

Improvetemperature range adaptabilityVSAvoidanalyte information accuracy

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The system exploits the temperature-dependent transport properties of the membrane to adapt to different physiological temperatures. The membrane's increased permeability at higher temperatures compensates for reduced enzyme kinetics, allowing the system to maintain accurate analyte measurements across the full range of in vivo temperature conditions without requiring temperature-specific calibration

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If enzyme activity is increased for better analyte detection, then detection sensitivity is improved, but temperature sensitivity increases causing signal variability

Engineering Contradiction:

Improvedetection sensitivityVSAvoidsignal stability

Core Design Contradiction:

Measurement precisionVSStability of the object's composition

Solution Approach 1:

The membrane serves as a stabilizing intermediary that decouples the enzyme's inherent temperature sensitivity from the overall system output. By controlling analyte delivery to the enzyme through the membrane's temperature-compensated transport, the system achieves both high detection sensitivity (through sufficient enzyme activity) and signal stability (through membrane-mediated temperature compensation)

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The membrane's temperature-dependent transport parameters are designed to offset the enzyme's temperature-dependent activity changes. This parameter coupling ensures that as temperature varies, the combined effect of membrane transport and enzyme catalysis produces a stable output signal, allowing high enzyme activity without proportionally increasing signal variability

Inventive Principle:

Principle #35Parameter changes

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 SMART membranes ensure analyte flux remains constant over a wide temperature range (20° C. to 60° C.), minimizing sensor response variability and maintaining accuracy, with analyte flux changes of 5% or less per degree Celsius, thereby providing stable and accurate analyte monitoring.

Implementation Method 1

the SMART membranes regulate the permeability of analyte (e.g., glucose) through the membrane at different temperatures to maintain a constant permeability over a range of temperatures

Methodology Applied

Scientific EffectPermeation: Permeation

Implementation Method 2

analyte flux through the SMART membranes remains constant or at least changes are small enough to remain clinically insignificant at temperatures from 20° C. to 60° C.

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS9775549B2Temperature insensitive in vivo analyte devices, methods and systems

Publication Date: 2017.10.03 ABBOTT DIABETES CARE INC

AI summary

Disclosed herein are membrane structures for use in analyte sensors, where the membrane structures exhibit low temperature sensitivity.