Non-Invasive Analyte Sensor Detector Array RF Safety
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Solution Overview
Problem
Current non-invasive analyte detection methods, particularly for glucose, face challenges such as lack of specificity, accuracy issues, interference from temperature fluctuations, skin compounds, and pigments, and non-compliance with RF radiation exposure limits, making them ineffective for continuous and reliable glucose monitoring.
Innovation Solution
A non-invasive analyte sensor using a detector array with multiple antenna elements operating in the radio or microwave frequency range, capable of transmitting and receiving signals to detect glucose and other analytes non-invasively, while ensuring safety by meeting RF radiation exposure limits and performance standards for continuous glucose monitoring systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If non-invasive detection methods are used, then patient comfort and safety are improved, but measurement accuracy and specificity deteriorate due to interference from temperature fluctuations, skin compounds, and pigments
Solution Approach 1:
The detection system is divided into multiple detector elements arranged in arrays, each detecting signals at different locations. By segmenting the detection process across multiple elements and combining their outputs, the system achieves both non-invasive operation and improved measurement accuracy through spatial diversity that helps distinguish analyte signals from interfering substances.
Solution Approach 2:
The patent transitions from single-point detection to two-dimensional detector arrays, adding spatial dimensionality to the detection process. This dimensional expansion enables the system to capture signal variations across different tissue depths and locations, improving specificity by distinguishing between signals from different tissue layers and reducing interference from surface compounds.
2Length of stationary object
If non-optical frequencies (radio/microwave) are used for detection, then penetration depth and tissue interaction are improved, but RF radiation exposure limits and safety compliance become more challenging
Solution Approach 1:
The system operates in the radio frequency to microwave range (approximately 100 MHz to 10 GHz), utilizing specific frequency parameters that balance penetration depth with safety. By carefully selecting and tuning the operating frequency, the system achieves sufficient tissue penetration for non-invasive detection while maintaining RF exposure within regulatory limits through controlled power levels and duty cycles.
Solution Approach 2:
The detector elements transmit electromagnetic signals in periodic pulsed sequences rather than continuous waves. This periodic operation allows the tissue to recover between pulses, reducing cumulative RF energy absorption and heat buildup, thereby enabling deeper penetration during active transmission while maintaining safety during idle periods.
3Measurement precision
If detector arrays with multiple elements are used, then signal detection capability and accuracy are improved, but device complexity and placement difficulty increase
Solution Approach 1:
Multiple detector elements are merged into integrated detector array modules that function as unified sensing units. By combining multiple elements into consolidated modules with integrated electronics and signal processing, the system maintains the signal detection advantages of arrays while reducing the number of separate components that need to be individually placed and configured on the patient.
Solution Approach 2:
The detector array modules are designed with multi-functionality to perform various detection tasks using the same hardware platform. The arrays can detect different analytes, operate at multiple frequencies, and adapt to different measurement modes, reducing the need for multiple specialized devices and simplifying placement procedures through universal applicability.
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 achieves high accuracy in glucose detection, meeting performance parameters for integrated continuous glucose monitoring systems and ensuring safe RF radiation emission, allowing for reliable non-invasive glucose monitoring that surpasses conventional methods in accuracy and safety.
Implementation Method 1
a detector array having a plurality of detector elements (also referred to as antenna elements or antennas) at least one of which can transmit an electromagnetic signal in the radio or microwave frequency range into a target and at least one of which can receive an electromagnetic signal in the radio or microwave frequency range resulting from transmission of the electromagnetic signal
Data Source
AI summary
A highly accurate and safe analyte sensor that detects an analyte by transmitting and receiving sensing signals in a radio or microwave frequency range of the electromagnetic spectrum is provided. The analyte sensor has at least two antennas at least one of which operates as a transmit antenna to transmit one or more of the sensing signals and at least one of which operates as a receive antenna, and the analyte sensor meets or exceeds performance parameters for integrated continuous glucose monitoring systems as set forth in 21 C.F.R. 862.1355 (Feb. 18, 2022) and is configured to emit radiofrequency radiation less than radiofrequency radiation exposure limits as set forth in 47 C.F.R. 1.1310 (Apr. 1, 2020).