Development and Validation in Porcine and Human Models of a Bioimpedance Spectroscopy System for the Objective Assessment of Kidney Graft Viability

This work presents an innovative bioimpedance spectroscopy device, developed as a support tool for decision-making during the evaluation of kidney viability for renal transplantation. Given the increasing demand for organs and the need to optimize donation criteria, the precise and objective assessment of renal graft functionality has become crucial. The device, based on a modular design and adapted to the surgical environment, uses a novel Cole model with a frequency-dependent membrane capacitance, which improves measurement accuracy and repeatability compared to conventional models. Adapting the device for operating room usege involved overcoming significant challenges, such as the need for sterilization and a visual, tactile and acoustic user interface that facilitates device usability. Optimizing the sensing stage has minimized the influence of measurement artifacts, which is crucial for obtaining accurate and representative measurements of renal tissue bioelectrical properties. In addition, a rigorous electrode sterilization protocol was designed, ensuring asepsis during the procedure. The results of tests on porcine renal models demonstrated the device's ability to monitor pathophysiological changes associated with renal ischemia, with a notable improvement against measurement repeatability.