A fracture-mechanics-based approach to fracture control in biomedical devices manufactured from superelastic Nitinol tube.

Several key fracture-mechanics parameters associated with the onset of subcritical and critical cracking, specifically the fracture toughness, crack-resistance curve, and fatigue threshold, have recently been reported for the superelastic alloy Nitinol, in the product form of the thin-walled tube that is used to manufacture several biomedical devices, most notably endovascular stents. In this study, we use these critical parameters to construct simple decision criteria for assessing the quantitative effect of crack-like defects in such Nitinol devices with respect to their resistance to failure by deformation or fracture. The criteria are based on the (equivalent) crack-initiation fracture toughness and fatigue threshold stress-intensity range, together with the general yield strength and fatigue endurance strength, and are used to construct a basis for design against single-event (overload) failures as well as for time-/cycle-delayed failures associated with fatigue.