SBIR Phase II: New Elastomeric Microelectrodes for Improved Neuroprostheses

这个小企业创新研究二期项目是开发导电聚合物-硅树脂复合材料，以提高植入式神经假体的性能。前期I阶段的研究已经证明了合成具有硅弹性体力学性能的导电聚合物纳米复合材料的可行性。基于聚合物的原型电器件对模拟生理条件和循环电流脉冲具有稳定性。二期项目将把这些系统的优势扩展到制造更复杂的设备，如用于慢性周围神经刺激和记录的多极袖带电极。扩展的测试计划将包括开发先进的设备制造方法，并广泛测试神经假体原型的电反应、组织相容性和慢性植入应用的耐久性。优化后的弹性电极具有生物相容性、稳定性和电学性能。方法学将开发制造假体电极广泛的体外脉冲研究和急性动物试验。最后，将建立新电极产品的测试方案，以努力获得FDA的批准。该项目的商业应用将在生物医学设备和系统领域，为中风或脊髓损伤后的残疾人提供服务。

This Small Business Innovation Research Phase II project is to develop electrically conductive polymer-silicone composite materials for improving the performance of implantable neural prostheses. Prior Phase I study has demonstrated the feasibility of synthesizing electrically conductive polymer nanocomposites with mechanical properties of silicone elastomers. Polymer-based prototype electrical devices were found to be stable toward simulated physiological conditions and cyclic current pulsing. The Phase II program will extend the benefits of these systems to the fabrication of more complex devices such as multi-poled cuff electrodes for chronic peripheral nerve stimulation and recording. An expanded test plan would include development of advanced device fabrication methods and extensive testing of the prototype neural prostheses for electrical response, tissue compatibility, and durability in chronic implantation applications. The optimized elastomeric electrodes will be characterized for biocompatibility, stability and electrical properties. Methodology will be developed for fabricating prosthetic electrodes for extensive in vitro pulsing studies and acute animal testing. Finally, test protocols for the new electrode products will be established in an effort to obtain FDA approval. The commercial applications of this project will be in the area of biomedical devices and systems that serve the needs of disabled individuals following stroke or spinal cord injury.