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

Abstract

Objective: 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.

Methods: 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).

Results: 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.

Conclusion: 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.

Significance: This work contributes to advancing robotic-assisted cardiac sheath delivery, providing a reliable and safer method for navigating challenging anatomical structures.