SBIR Phase II: Novel SMP-based TCD Devices

这个小企业创新研究第二阶段项目旨在继续第一阶段的工作，围绕使用独特和专有的形状记忆聚合物（SMP）技术开发用于永久性女性绝育的新型经宫颈装置（TCD）。拟议活动的智力价值体现在几个方面。首先，先进的有限元分析（FEA）方法的发展，特别是专注于形状记忆聚合物，将为评估医疗器械设计提供一种时间和成本效益的手段。其次，形状记忆聚合物的大变形有限元模型尚未完全建立；此外，目前还没有专门用于形状记忆聚合物的用户材料程序，并且将在实现和优化设备设计方面提供易于使用的优势。最后，尽管在理解基于材料的形状记忆聚合物行为方面已经做了一些工作，但在利用这种有前途的技术开发有用的生物医学设备方面做的工作要少得多。这项工作的更广泛影响在于使用先进材料开发下一代医疗设备，这些材料具有可为患者定制的特性。从这些技术中成功开发出有用的设备应该为大量的商业机会铺平道路，包括使用微创方法将组织工程设备输送到目标部位，最终培养健康组织。最后，整个项目的成功完成应对作为世界上最常见的永久节育形式的程序产生直接影响。

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.