Abstract

Medical grade poly-l-lactide (PLLA) has been widely applied for medical devices and consumables, e.g. biodegradable cardiovascular stents and surgical thread, due to its excellent biocompatibility. High-speed micro-milling technology shows great potential in high-precision and high-quality manufacturing of material PLLA, while it usually produces problems such as material burrs and defects. There is few research and analysis on the material removal mechanism and theory in the micro-milling process of polymers, and thus this paper aims to investigate the burr formation mechanism and processing quality in micro-milling process of medical PLLA. Firstly, a novel thermal-mechanical coupled theoretical model was proposed by considering the minimum cutting thickness and cutting-edge radius size effects, which can reveal the plastic flow law during micro-milling process of polymer material. This model was used to calculate the burr width at up and down milling sides of cutting area. Then material characterization and micro-milling experiments on two types of PLLA with different molecular weights were carried out to validate the established theoretical model, and further the micro-milling parameters were optimized to achieve the control of material burr formation and growth. As a result, a cardiovascular stent was fabricated by micro-milling with the optimized parameters (spindle speed of 25,000 rpm, feed rate of 100 mm/min and axial depth of cut of 5 μm), and the stents obtained significantly high surface quality. These results suggest that the proposed theoretical model has great advantages in the high-quality micro-milling of medical material PLLA. This work provides a potential stent manufacture technique in the development and clinical application of bioresorbable polymeric stents.

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