This Small Business Innovation Research Phase II project aims to continue work from Phase I around the development of novel trans-cervical devices (TCD) for permanent female sterilization using unique and proprietary shape memory polymer (SMP) technology. The intellectual merit of the proposed activity rests in several areas. First, development of advanced finite element analysis (FEA) methods specifically focused on shape memory polymers will provide a time- and cost-effective means of evaluating medical device designs. Second, large-deformation FEA models have not been thoroughly developed for shape memory polymers; further, user materials routines specifically for shape memory polymers are not available currently and would provide ease-of-use advantages in implementing and optimizing device design. Lastly, although some work has been performed in understanding materials-based aspects of shape memory polymer behavior, much less work has been done in developing useful biomedical devices with this promising technology.
The broader impacts of this work lie in the development of the next generation of medical devices using advanced materials with characteristics that can be customized to the patient. The successful development of useful devices from such technologies should pave the way for a plethora of commercial opportunities including tissue-engineered devices delivered using minimally invasive methods into the target site to eventually grow healthy tissue. Lastly, successful completion of the overall project should have immediate impact on a procedure that is the most common form of permanent birth control in the world.
