Fabrication of polymer-based stents: Impact of test specimen manufacturing protocol

Various manufacturing techniques are available for polymer stent fabrication. Polymer semi-finished products can be prepared using solvent based methods, e.g. dip coating, as well as thermal processes, e.g. extrusion. These different methods may lead to an altered polymer crystal structure, resulting in a different deformation mechanism during mechanical stress. For the material property characterization needed for implant development, the test specimens usually are prepared using laser-cut or die-cut methods. Due to these different preparation protocols, a change in polymer microstructure, causing a material property variation, may also result. For this purpose, comparison of laser-cut versus die-cut of PLLA films has been performed. PLLA films have been prepared by dip-coating and were evaluated with respect to structural, thermal, and mechanical properties. In this study, a combination of uniaxial tensile tests, SEM and DSC studies was used. The results of the mechanical tests showed drastic differences in the elongations at break of die-cut specimens compared to laser-cut ones. The results point out formation of complex crystal structures during the manufacturing process. By the use of SEM imaging and DSC measurements, we were able to attribute these changes to the different plastic deformation mechanisms.