Flexible Implantable Device Shape History

Background and Objectives For devices that will be implanted in a patient for years, the long-term durability of the device requires careful attention. It is especially challenging to measure the time-varying shape of implanted medical devices that can bend, twist, or stretch in vivo as the patient moves. Predicting long-term performance of these implanted devices is a critical part of ensuring patient safety. Case Studies: Four case studies are presented here: Conclusions: While there are many studies of motion affecting implanted devices, understanding the impact of those motions on the shape history of the device is challenging. Patient volunteers and preclinical or cadaver studies may be used in combination with image analysis techniques to quantify device shape history and translate measurements into numerical analysis and bench tests. Defining the use conditions that cause medical device deformation is critical to ensuring that patients can rely on these lifesaving technologies to provide safe and effective therapy.