Continuous measurement of vascular and hemodynamic parameters could improve monitoring of disease progression and enable timely clinical decision making and therapy surveillance in patients suffering from cardiovascular diseases. However, no reliable extravascular implantable sensor technology is currently available. Here, we report the design, characterization, and validation of an extravascular, magnetic flux sensing device capable of capturing the waveforms of the arterial wall diameter, arterial circumferential strain, and arterial pressure without restricting the arterial wall. The implantable sensing device, comprising a magnet and a magnetic flux sensing assembly, both encapsulated in biocompatible structures, has shown to be robust, with temperature and cyclic-loading stability. Continuous and accurate monitoring of arterial blood pressure and vascular properties was demonstrated with the proposed sensor in vitro with a silicone artery model and validated in vivo in a porcine model mimicking physiologic and pathologic hemodynamic conditions. The captured waveforms were further used to deduce the respiration frequency, the duration of the cardiac systolic phase, and the pulse wave velocity. The findings of this study not only suggest that the proposed sensing technology is a promising platform for accurate monitoring of arterial blood pressure and vascular properties, but also highlight the necessary changes in the technology and the implantation procedure to allow the translation of the sensing device in the clinical setting.
Keywords: CVD monitoring; arterial distension; arterial strain; blood pressure; hall-effect sensor.
© 2023 The Authors.