ABSTRACT
OBJECTIVE: The goal of this study was to demonstrate the technical feasibility of automated balloon pressure management during resuscitative endovascular balloon occlusion of the aorta (REBOA) in the pre-clinical setting. METHODS: This paper presents an intelligent balloon management device which automates the balloon inflation process, preventing the possibility of balloon over or under inflation, optimizes inflation pressure, and if indicated, deflates automating partial REBOA to allow the distal organ perfusion. Edwards TruWave pressure transducers are used to monitor the blood pressure proximal and distal to the balloon, as well as the internal balloon pressure. A faux PID controller, implemented on an Arduino platform, is used in a feedback control loop to allow a user-defined mean arterial pressure setpoint to be reached, via a syringe driver which allows intelligent inflation and deflation of the catheter balloon. RESULTS: Ex vivo testing on a vascular perfusion simulator provided the characteristic behavior of a fully occluded aorta, namely the decrease of distal pressure to zero. In vivo testing on live porcine models indicated that automated partial REBOA is achievable and by enabling partial occlusion may offer improved medical outcomes compared to the manual control. CONCLUSION: Automated balloon pressure management of endovascular occlusion is feasible and can be successfully implemented without changes on current clinical workflows. SIGNIFICANCE: With further development, automated balloon management may significantly improve clinical outcomes in REBOA.
