A Vascular Intervention Assist Device Using Bi-Motional Roller Cartridge Structure and Clinical Evaluation

Conventional vascular intervention procedures present issues including X-ray exposure during operation, and an experience-dependent success rate and clinical outcome. This paper presents a novel robotic system using modularized bi-motional roller cartridge assemblies for robotic vascular interventions, specifically percutaneous coronary interventions (PCIs). The patient-side robot manipulates instruments such as the guiding catheter, guidewire, balloon/stent catheter, and diagnostic sensor catheter via commands from the user interface device, which is controlled by the physician. The proposed roller cartridge assembly can accommodate instruments of various sizes with an active clamping mechanism, and implements simultaneous translation and rotation motions. It also implements force feedback in the physician-side system, to effectively monitor the patient-side system's status. The positioning accuracy and precision in using the robotic system showed satisfactory performance in a phantom-based test. It was also confirmed, through animal experiments and a pilot clinical trial, that the system demonstrates feasibility for clinical use.