Design, Testing, and Validation of a Soft Robotic Sensor Array Integrated with Flexible Electronics for Mapping Cardiac Arrhythmias

摘要

Cardiac mapping is a crucial procedure for diagnosing and treating cardiac arrhythmias. Still, current clinical techniques face limitations including insufficient electrode coverage, poor conformability to complex heart chamber geometries, and high costs. This study explores the design, testing, and validation of a 64-electrode soft robotic catheter that addresses these challenges in cardiac mapping. A dual-layer flexible printed circuit board (PCB) was designed and integrated with sensors into a soft robotic sensor array (SRSA) assembly. Design considerations included flex PCB layout, routing, integration, conformity to heart chambers, sensor placement, and catheter durability. Rigorous SRSA in vitro testing evaluated the burst/leakage pressure, block force for electrode contact, mechanical integrity, and environmental resilience. For in vivo validation, a porcine model was used to demonstrate the successful deployment, conformability, and acquisition of electrograms in both the ventricles and atria. This catheter-deployable SRSA represents a meaningful step towards translating the integration of soft robotic actuators and stretchable electronics for clinical use, showcasing the unique mechanical and electrical performance that these designs enable. The high-density electrode array enabled rapid 2 s data acquisition with detailed spatial and temporal resolution, as illustrated by the clear and consistent cardiac signals recorded across all electrodes. The future of this work will lie in enabling high-density, anatomically conformable devices for detailed cardiac mapping to guide ablation therapy and other interventions.