SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I research project aims to develop a novel trans-cervical device using biocompatible shape memory polymers to achieve permanent female sterilization as an alternative to fallopian tube ligation. Such a methodology could potentially benefit all women undergoing permanent sterilization procedures and would be a significant improvement over existing methods which although relatively new, have been adopted by the medical community despite certain issues. Indeed, current procedures for the ligation of the fallopian tubes are hysteroscopic (visually guided) and although significantly better than the surgically invasive techniques of past, still have several draw backs. One of the most important of these shortcomings is the length of time that is required to get fibrotic-proliferative-based closure of the tube after the insertion of the device. Currently a woman has to wait between 3 and 6 months to ensure full closure of the tubes. The proposed system on the other hand, obviates the wait time and can fully close the fallopian tube upon insertion. As such, this technology is likely to be a very favorable addition to the presently available trans-cervical devices

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