Design and Performance Verification of a Novel Eccentric Rotational Cutting Tool for Removal of Vascular Calcification Tissue

Cardiovascular disease is the leading cause of human mortality, and calcified tissue blocking blood vessels is the main cause of major adverse cardiovascular events (MACE). Rotational Atherectomy (RA) is a minimally invasive catheter-based treatment method that involves high-speed cutting of calcified tissue using miniature tools for removal. However, the cutting forces, heat, and debris can induce tissue damage and give rise to serious surgical complications. To enhance the effectiveness and efficiency of RA, a novel eccentric rotational cutting tool, with one side comprising axial and circumferential staggered micro-blades, was designed and fabricated in this study. In addition, a series of experiments were conducted to analyze their performance across five dimensions: tool kinematics, force, temperature, debris, and surface morphology of the specimens. Experimental results show that the force, temperature and debris size of the novel tool were well inhibited at the highest rotational speed. For the tool of standard clinical size (diameter 1.25 mm), the maximum force is 0.75 N, with a maximum temperature rise in the operation area of 1.09 ℃. Debris distribution followed a normal distribution pattern, with 90% of debris measuring smaller than 9.12 μm. All tool metrics met clinical safety requirements, indicating its superior performance. This study provides a new idea for the design of calcified tissue removal tools, and contributes positively to the advancement of RA.