Multi-Range Analyte Sensor for Accurate Glucose Monitoring

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Solution Overview

Problem

Conventional continuous analyte sensors face challenges in achieving accurate measurements across a physiologically relevant range, often sacrificing accuracy in low-analyte environments to maintain accuracy in high-analyte environments, and vice versa.

Innovation Solution

A sensor system comprising multiple sensor elements, each designed to measure analyte concentrations in different ranges with distinct characteristics, such as sensitivity and current density, and configured to operate effectively across a wide range of glucose concentrations, including both hypoglycemic and hyperglycemic ranges, using membranes with varying properties to manage hydrogen peroxide flux and oxygen availability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sensor sensitivity is increased to detect low analyte concentrations, then detection capability in low-analyte environments is improved, but measurement linearity in high-analyte environments deteriorates

Engineering Contradiction:
Improvedetection capability in low-analyte environmentsVSAvoidmeasurement linearity in high-analyte environments
Core Design Contradiction:
Measurement precisionVSStability of the object's composition

Solution Approach 1:

The measurement function is segmented across two sensor elements with different sensitivity characteristics. The first sensor element operates at high sensitivity for low-concentration detection, while the second sensor element operates at lower sensitivity to maintain linearity at high concentrations, eliminating the need to compromise either detection capability or linearity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system changes the sensitivity parameter between sensor elements to match different measurement requirements. By having the first sensor element with higher sensitivity and the second with lower sensitivity, the system adapts the sensitivity parameter to the appropriate range for each measurement condition

Inventive Principle:
Principle #35Parameter changes

2Device complexity

If a single sensor element is used across all concentration ranges, then device complexity is reduced, but measurement accuracy across the full physiologically relevant range deteriorates

Engineering Contradiction:
Improvesensor element quantityVSAvoidmeasurement accuracy across full range
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

Rather than using a single sensor element across all ranges, the system segments the measurement function into two specialized sensor elements, each handling specific concentration ranges. This segmentation improves overall accuracy across the full physiologically relevant range from 30-400 mg/dL

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sensor system achieves multi-functionality by having two sensor elements that together cover the entire physiologically relevant glucose concentration range. The first element handles low-range measurements while the second element handles high-range measurements, creating a universal sensing capability across all clinically relevant conditions

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

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 achieves high accuracy in measuring glucose concentrations across a physiologically relevant range, with measurements within 20% of true values 80% of the time for over 7 days, and maintains linearity up to 400 mg/dL even in low oxygen conditions.

Implementation Method 1

Electrochemical sensors are useful in chemistry and medicine to determine the presence or concentration of a biological analyte

Methodology Applied
Scientific EffectElectrochemical reaction:

Implementation Method 2

using membranes with varying properties to manage hydrogen peroxide flux and oxygen availability

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentUS11559229B2Analyte sensor
Publication Date: 2023.01.24 DEXCOM INC
  • US11559229B2 patent drawing
  • US11559229B2 patent drawing
  • US11559229B2 patent drawing

AI summary

Devices and methods are provided for continuous measurement of an analyte concentration. The device can include a sensor having a plurality of sensor elements, each having at least one characteristic that is different from other sensor(s) of the device. In some embodiments, the plurality of sensor elements are each tuned to measure a different range of analyte concentration, thereby providing the device with the capability of achieving a substantially consistent level of measurement accuracy across a physiologically relevant range. In other embodiments, the device includes a plurality of sensor elements each tuned to measure during different time periods after insertion or implantation, thereby providing the sensor with the capability to continuously and accurately measure analyte concentrations across a wide range of time periods. For example, a sensor system 180 is provided having a first working electrode 150 comprising a first sensor element 102 and a second working electrode 160 comprising a second sensor element 104, and a reference electrode 108 for providing a reference value for measuring the working electrode potential of the sensor elements 102, 104.