Accelerated in vitro durability testing of nonvascular Nitinol stents based on the electrical potential sensing method

Abstract

In this paper, we report an evaluation of the performance of a new stent durability tester based on the electrical potential sensing method through accelerated in vitro testing of six different nonvascular Nitinol stents simulating physiological conditions. The stents were subjected to a pulsatile loading of 33 Hz for a total of 62,726,400 cycles, at constant temperature and pressure of 35±0.5 °C and 120±4 mmHg, respectively. The electrical potential of each stent was measured in real-time and monitored for any changes in readings. After conducting test-to-fracture tests, the stents were visually checked, and by scanning electron microscopy. A sudden electrical potential drop in the readings suggests a fracture has occurred, and the only two instances of fracture in our present results were correctly determined by our present device, with the fractures confirmed visually after the test. The excellent performance of our new method shows good potential for a highly reliable and applicable in vitro durability testing for different kinds and sizes of metallic stents.