Development of a Tetherless Bioimpedance Device That Uses Morphologic Changes to Predict Blood Flow Restrictions Mimicking Peripheral Artery Disease Progression

Abstract

A tetherless multi-targeted bioimpedance device was designed, modeled, built, and tested for measuring arterial pulse and, using morphological analysis, its potential for monitoring blood flow restrictions that mimic Peripheral Artery Disease (PAD) was assessed across multiple peripheral arteries. Specifically, we first developed a small form factor, tetherless, bioimpedance device, based on high-frequency structure simulator (HFSS) simulations. After designing and building the device we then tested it in vivo on human subjects on multiple arteries and found that we did not need to modify the gain on the device compared to the bench top system. Further, it was found that changes in the morphology of the bioimpedance signal over time, depicted through the ratio of the first and second harmonic in the signal frequency, could be used to predict blood flow restrictions that mimic peripheral artery disease (PAD). The HFSS simulations helped guide the modulation frequency selection and the placement of the bioimpedance electrodes. We built the device and compared it to two commercially available bioimpedance devices and it was shown to demonstrate a distinct advantage in its multi-target capability, enabling more accurate pulse measurements from different arteries without the need for tuning the circuit for each artery. Comparing the ratio of the 1st and 2nd harmonics as a function of the blood flow restriction, the two commercial devices showed a maximum error across arteries of between 22% and 27% depending on the measurement location, whereas our system consistently displayed a stable value of just below 4%. With this system, there is the potential for comprehensive and personalized medical examinations for PAD at the point of care (POC).