Designing the mechanical behavior of NiTi self-expandable vascular stents by tuning the heat treatment parameters.

ABSTRACT

The remarkable mechanical properties of nickel-titanium (NiTi) shape memory alloy, particularly its super-elasticity, establish it as the material of choice for fabricating self-expanding vascular stents, including the metallic backbone of peripheral stents and the metallic frame of stent-grafts. The super-elastic nature of NiTi substantially influences the mechanical performance of vascular stents, thereby affecting their clinical effectiveness and safety. This property shows marked sensitivity to the primary parameters of the heat treatment process used in device fabrication, specifically temperature and processing time. In this context, this study integrates experimental and computational analyses to explore the potential of designing the mechanical characteristics of NiTi vascular stents by adjusting heat treatment parameters. To reach this aim, differently heat-treated NiTi wire samples were experimentally characterized using calorimetric and uniaxial tensile testing. Subsequently, the mechanical response of a stent-graft model featuring a metallic frame made of NiTi wire was assessed in terms of radial forces generated at various implantation diameters through finite element analysis. The stent-graft served as an illustrative case of NiTi vascular stent to investigate the impact of the heat treatment parameters on its mechanical response. From the study a strong linear relationship emerged between NiTi super-elastic parameters (i.e., austenite finish temperature, martensite elastic modulus, upper plateau stress, lower plateau stress and transformation strain) and heat treatment parameters (R2 > 0.79, p-value < 0.001) for the adopted ranges of temperature and processing time. Additionally, a strong linear relationship was observed between (i) the radial force generated by the stent-graft during expansion and the heat treatment parameters (R2 > 0.82, p-value < 0.001); (ii) the radial force generated by the stent-graft during expansion and the lower plateau stress of NiTi (R2 > 0.93, p-value < 0.001). In conclusion, the findings of this study suggest that designing and optimizing the mechanical properties of NiTi vascular stents by finely tuning temperature and processing time of the heat treatment process is feasible.