Development and Evaluation of a Robotic System for Safe Cardiac Sheath Delivery.

Abstract

This study aimed to develop and evaluate a 3-degree-of-freedom (DoF) robotic system for the safe delivery of cardiac sheaths through challenging anatomical structures, including the fossa ovalis and pathways with tight curves. The robot and its kinematic model were built on a previously proposed single-DoF actuation module and bending model. A sheath delivery strategy (SDS) was developed, combining two control methods: tip position control to approach an optimal entry point and point-constrained control to maintain consistent navigation through this point, minimizing tissue contact. Technical performance was evaluated through trajectory-following and point-crossing tests, followed by feasibility experiments in a simulated scenario. Trials were conducted by three cardiologists using a validated phantom model under fluoroscopic guidance, comparing SDS with joint control (JC) and manual control (MC). Average root mean square errors were 2.10 mm for tip position control and 1.86 mm for point-constrained control. SDS outperformed MC with significantly shorter trajectory lengths and lower root mean square jerk. Compared to JC, SDS reduced sheath-induced movements (an indirect measure of force) and increased retraction success rates at the fossa ovalis. The proposed robotic system reduced tissue wall contact compared to JC and provided smoother, more controlled operations than MC, ensuring safer and more effective delivery through confined pathways. This work contributes to advancing robotic-assisted cardiac sheath delivery, providing a reliable and safer method for navigating challenging anatomical structures.