BS in Mechanical Engineering
Mechanical Engineering Department
Sarah T. Harding
In today’s world of medical innovation, regulations and requirements set by organizations such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and ASTM International (American Society for Testing and Materials) can inhibit rapid innovation by demanding rigorous testing of new designs. For arterial stents, the standard is that each design must be tested to simulate 10 years of life in an environment congruent to an in vivo environment. Endologix in Irvine, California develops and manufactures minimally invasive treatments for aortic diseases, with a focus on stent grafts for the treatment of abdominal aortic aneurysms (AAA). Stents which are deployed in the renal arteries undergo continuous displacement due to respiratory, cardiac, and skeletal motion. This motion is unique and methods for simulating stents near the heart would be misapplied to renal artery stent fatigue testing. Our team was comprised of Mechanical and Biomedical Engineers from Cal Poly – San Luis Obispo, and the goal for our senior project team was to design a functioning fatigue test method for renal artery stents that would simulate the environment and displacement of the stents in the body. This document is a final project report that defines the design requirements, explains how we determined appropriate modeling of renal artery movement, describes our design process, and outlines the timeline for our entire project. The project concluded with a proof of concept fatigue test of Endologix renal artery stents at the highest frequency our team was able to achieve.