RESUMEN
This paper presents a compact and low-cost on-chip sensor and readout circuit. The sensor achieves high-resolution 5-degrees-of-freedom (DoF) tracking (x, y, z, yaw, and pitch). With the help of an external wire wound sensor, it can also achieve high-resolution 6-degrees-of-freedom (DoF) tracking (x, y, z, yaw, pitch, and roll angles). The sensor uses low-frequency magnetic fields to detect the position and orientation of instruments, providing a viable alternative to using X-rays in image-guided surgery. To measure the local magnetic field, a highly miniaturised on-chip magnetic sensor capable of sensing the magnetic field has been developed incorporating an on-chip magnetic sensor coil, analog-front end, continuous-time ΔΣ analog-to-digital converter (ADC), LVDS transmitter, bandgap reference, and voltage regulator. The microchip is fabricated using 65 nm CMOS technology and occupies an area of 1.06 mm2, the smallest reported among similar designs to the best of our knowledge. The 5-DoF system accurately navigates with a precision of 1.1 mm within the volume-of-intrest (VOI) of 15×15×15 cm3. The 6-DoF system achieves a navigation accuracy of 0.8 mm and an angular error of 1.1 degrees in the same VOI. These results were obtained at a 20 Hz update rate in benchtop characterisation. The prototype sensor demonstrates accurate position tracking in real-life pre-clinical in-vivo settings within the porcine lung of a live swine, achieving a reported worst-case registration accuracy of 5.8 mm.
RESUMEN
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.