A novel scalable electrode array and system for non-invasively assessing gastric function using flexible electronics
Armen A Gharibans, Tommy C L Hayes, Daniel A Carson, Stefan Calder, Chris Varghese, Peng Du, Yaara Yarmut, Stephen Waite, Celia Keane, Jonathan S T Woodhead, Christopher N Andrews, Greg O'Grady, Armen A Gharibans, Tommy C L Hayes, Daniel A Carson, Stefan Calder, Chris Varghese, Peng Du, Yaara Yarmut, Stephen Waite, Celia Keane, Jonathan S T Woodhead, Christopher N Andrews, Greg O'Grady
Abstract
Background: Disorders of gastric function are highly prevalent, but diagnosis often remains symptom-based and inconclusive. Body surface gastric mapping is an emerging diagnostic solution, but current approaches lack scalability and are cumbersome and clinically impractical. We present a novel scalable system for non-invasively mapping gastric electrophysiology in high-resolution (HR) at the body surface.
Methods: The system comprises a custom-designed stretchable high-resolution "peel-and-stick" sensor array (8 × 8 pre-gelled Ag/AgCl electrodes at 2 cm spacing; area 225 cm2 ), wearable data logger with custom electronics incorporating bioamplifier chips, accelerometer and Bluetooth synchronized in real-time to an App with cloud connectivity. Automated algorithms filter and extract HR biomarkers including propagation (phase) mapping. The system was tested in a cohort of 24 healthy subjects to define reliability and characterize features of normal gastric activity (30 m fasting, standardized meal, and 4 h postprandial).
Key results: Gastric mapping was successfully achieved non-invasively in all cases (16 male; 8 female; aged 20-73 years; BMI 24.2 ± 3.5). In all subjects, gastric electrophysiology and meal responses were successfully captured and quantified non-invasively (mean frequency 2.9 ± 0.3 cycles per minute; peak amplitude at mean 60 m postprandially with return to baseline in <4 h). Spatiotemporal mapping showed regular and consistent wave activity of mean direction 182.7° ± 73 (74.7% antegrade, 7.8% retrograde, 17.5% indeterminate).
Conclusions and inferences: BSGM is a new diagnostic tool for assessing gastric function that is scalable and ready for clinical applications, offering several biomarkers that are improved or new to gastroenterology practice.
Keywords: bioelectronics; diagnostics; functional gastrointestinal disorders; gastric motility.
Conflict of interest statement
AG, PD, CNA, and GO hold grants and intellectual property in the field of GI electrophysiology and are members of University of Auckland spin‐out companies: The Insides Company (GO), FlexiMap (PD), and Alimetry (AG, SC, YY, SW, JSTW, PD, CNA and GO). DAC, TCLH, and CV have no relevant conflicts to declare.
© 2022 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.
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