iWRAP: A Theranostic Wearable Device With Real-Time Vital Monitoring and Auto-Adjustable Compression Level for Venous Thromboembolism

Objective: Venous Thromboembolism (VTE) is a commonly underdiagnosed disease with severe consequences and an exceedingly high mortality rate. Conventional compression wraps are devised for therapeutic purpose but lack diagnostic capacity. Recent advances in flexible electronics and wearable technologies offer many possibilities for chronic disease management. In particular, vital signs have been studied to show a strong correlation with the risk of VTE patients. In this study, we aim to develop an intelligent theranostic compression device, referred to as iWRAP, with the built-in capacity of real-time vital sign monitoring together with auto-adjustable compression level. Methods: An instantaneous pneumatic feedback control with a high-resolution pressure sensor is integrated to provide a highly stabilized compression level at the prescribed interface pressure for an improved therapeutic outcome. Meanwhile, arterial pulse waveforms extracted from the pressure readings from the smart compression device can be utilized to derive the body vital signs, including heart rate (HR), respiratory rate (RR) and blood pressure (BP). Results: A reliable delivery of the targeted compression level within ±5% accuracy in the range of 20-60 mmHg has been achieved through the feedback of the interface pressure. Both HR and RR have been measured within clinical-grade accuracies. Moreover, BP estimated using an ALA model has been achieved at low compression levels, which is also within a clinical-acceptable accuracy. The acquired vital information has been instantaneously fit into the clinically acceptable criteria for life-threatening PE risk with timely assessments. Conclusion: The iWRAP has shown the potential to become the first theranostic wearable device with both continuous delivery of accurate and effective compression therapy and real-time monitoring of life-threatening conditions for VTE patients.