An Infrastructure for the Development and Validation of Ingestible Sensors

Abstract

Ingestible sensors provide non-invasive access to relatively inaccessible regions of the gastrointestinal tract. Data from the sensors is wirelessly transmitted to an external receiver for real-time processing, storage, and transfer to a computer, where it can be visualised, post-processed, and compiled into a clinician-accessible report. We developed a wearable receiver (WR) for real-time data acquisition from miniaturised ingestible sensors - Gastrointestinal Smart Modules (GISMOs). The receiver operates at 868 MHz, measures 90×65×28 mm, and supports 144 h of continuous use on two AA batteries. It is part of a broader infrastructure developed to support GISMO production, testing, and clinical validation. We describe the architecture of the infrastructure and how it enabled production and verification testing of 471 GISMOs. User feedback from a usability study showed positive ratings for the WR comfort and visual feedback. RF link performance was evaluated in a phantom simulating tissue attenuation, with a 95−100% reception rates up to 20 cm. Finally, we report the results of in-vivo validation in pigs and humans, where reception rates of 83.98 % and 90.8 % were achieved, respectively.