Effects of process parameters and geometry on dimensional accuracy and surface quality of thin strut heart valve frames manufactured by laser powder bed fusion

Abstract

Laser powder bed fusion (LPBF) is one of the most popular metal additive manufacturing technologies, which has found its applications in high-value sectors such as aerospace and biomedical devices. Some recent studies on the LPBF of stents have demonstrated its feasibility in the fabrication in thin strut structures including heart valve frames, as used in transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis. The state of the art method of laser cutting TAVI frame limits the scope for novel concepts which are made possible by additive manufacturing. However, the surface quality and dimensional accuracy of LPBF parts are lower than that produced by laser cutting. To start the development of new TAVI concepts, the feasibility of manufacturing thin frames by LPBF has been investigated based on the SAPIEN 3 frame by Edwards Lifesciences. In this study, simplified frames with strut size from 0.3 to 0.5 mm have been successfully manufactured. The effects of strut size, strut angle, laser power and scan speed on the dimensional accuracy and surface quality were systemically studied. In addition, a representative SAPIEN 3 frame was manufactured and assessed with high-resolution X-ray CT scans. Good overall dimensional accuracy and low porosity were obtained for the SAPIEN 3 frame. However, inclined struts were found to have relatively low dimensional accuracy and poor surface quality.