Investigation of the dynamic diameter deformation of vascular stents during fatigue testing with radial loading

Abstract

Abstract Endovascular stents are exposed to cyclic loads resulting from daily activity and pulsatile arterial blood pressure. DIN EN ISO 25539-2 and FDA guideline 1545 recommend durability testing, exposing stents to physiological cyclic loads for a 10 year equivalent. For accelerated testing, the simulated deformation has to be comparable to physiological in-vivo deformation. A new test setup is presented to determine diameter deformation of vascular stents during fatigue testing with radial loading. Methods The new setup allows the investigation of stents (n = 1–10) up to a length of 200 mm using a CCD line camera independent from special configurations. For demonstration, the radial deformation of two peripheral stents (stent 1: 8.0×40 mm, stent 2: 4.5×40 mm) and coronary stents (stent 3: 2.5×22 mm, stent 4: 4.0×40 mm) is determined as a function of the longitudinal measuring position. The stents are implanted in polyurethane tubes and exposed to physiologically relevant pressure at test frequencies 100 Hz. Results In addition to the verification of test frequencies for fatigue testing the setup can also be used for the investigation of radial deformation performance. The results show that radial deformation may vary along the stent length. Larger radial deformation was detected at the middle of the stent. For stent 1 a maximum deformation of 0.21 ± 0.07 mm (± 2.65 %) was measured at 50 ± 40 mmHg, 90 Hz. It was also measured that the radial deformation is dependent on stent design, geometric dimension and external loading. Conclusion The new setup allows for test frequency verification for accelerated fatigue testing with radial loading. It is also suitable for more detailed investigation of the radial deformation performance of stents along their longitudinal axis. This is necessary for a better understanding of potential mechanical failure especially in the case of long or overlapping stents.