Enhancing Neuroprosthesis Performance with Nerve Cuff Electrodes - Administrative Supplement for Exercise Equipment

描述(申请人提供)：EB001889项目的延续将扩展植入神经假体接受者的功能能力，通过应用新的神经袖带电极来恢复脊髓损伤(SCI)后的下肢功能，这种电极可以选择性地激活人股神经和坐骨神经中的神经束，以隔离膝关节伸展来站立，并通过髋关节屈曲和脚踝足底/背屈来有效地行走。我们将开发和部署的新使能技术包括合规FINE(C-FINE)和用于网络神经假体系统(NNPS)的8通道神经袖带模块。与早期的神经袖带设计相比，C-FINE提供了明显的优势，包括与天然神经形态匹配的形状、沿神经长度具有灵活性的轮廓刚性轮廓、适合微制造更高密度接触阵列的简单分层结构。这 新的神经接口将显著简化植入手术并提高下肢神经假体的性能，而NNPS的新刺激模块将使采用多种C-FINE的复杂系统得以实现，以实现先进的下肢功能。我们将在现有16通道植入式刺激器(IST-16)的基础上，在三个新的站立系统接受者中，将C-FINE植入缝匠肌神经分支近端的股神经和股四头肌个别头部。我们预计C-FINE的卓越选择性将允许独立激活支配膝关节伸肌和髋屈肌的不同功能组的轴突。这应该会通过增加可用的刺激伸膝力量来保持或改善其他电极的站立性能，同时提供控制相互步进所需髋关节屈曲的神经通道。主动的足底/背屈和平衡的内翻/外翻还可以通过注入向前推进的能量和增强摆动肢体的足底间隙来极大地提高步行的质量和速度。我们将在另外三个受试者的胫骨和腓骨神经上植入C-FINE，并利用它们的选择性，通过新的NNPS系统产生强健的脚踝足底/背屈和平衡的内翻/外翻。坐骨神经近端的复杂结构阻碍了现有的低密度神经电极应用于腿肌肌，这对安全、站立和行走非常重要。我们预计，位于坐骨神经近端的单个神经袖带电极具有大量的接触，将能够隔离和充分激活单独的腿筋，以提供强大的髋关节伸展和膝关节屈曲。我们将在急性术中测试中建立与坐骨神经的高密度接口的可行性，这将改善未来的下肢神经假体的性能并简化手术植入。

DESCRIPTION (provided by applicant): This continuation of project EB001889 will extend the functional capabilities of recipients of implanted neuroprostheses for restoring lower extremity function after spinal cord injury (SCI) by applying new nerve cuff electrodes that selectively activate fascicles within the human femoral and sciatic nerves to isolate knee extension for standing, and both hip flexion and ankle plantar/dorsiflexion for efficient stepping. The new enabling technologies we will develop and deploy include the Compliant FINE (C-FINE), and an 8-channel nerve cuff module for the Networked Neuroprosthesis System (NNPS). The C-FINE offers distinct advantages over earlier nerve cuff designs, including a shape that matches the native nerve morphology, a contoured stiffness profile for flexibility along the nerve's length, an simple layered construction suitable for micro- fabrication of higher density contact arrays. This new neural interface will significantly simplify implant surgery and improve the performance of lower extremity neuroprostheses, while the new stimulation module for the NNPS will enable the realization of sophisticated systems employing multiple C-FINEs for advanced lower extremity functions. We will implant C-FINEs on the femoral nerves proximal to branching of the innervation to the sartorius and individual heads of the quadriceps in three new recipients of standing systems based on our existing 16- channel implanted stimulators (IST-16). We expect the superior selectivity of the C-FINE to allow independent activation of functionally distinct groups of axons innervating knee extensors and hip flexors. This should maintain or improve the standing performance achieved with other electrodes by increasing the available stimulated knee extension strength, while simultaneously providing access to the nerves that control the hip flexion required for reciprocal stepping. Active plantar/dorsiflexion with balanced inversion/eversion should also greatly improve the quality and speed of walking by injecting propulsive energy for forward progression, and enhancing foot-floor clearance of the swinging limb. We will implant C-FINEs on the tibial and fibular nerves above the knee in three additional subjects, and exploit their selectivity to produce strong ankle plantar/dorsiflexion with balanced inversion/eversion with the new NNPS system. The complex structure of the proximal sciatic nerve has prevented application of existing low-density nerve- based electrodes to the hamstring muscles, which are important for safe and standing and stepping. We expect that a single nerve cuff electrode with high number of contacts located on the proximal sciatic nerve will be able to isolate and fully activate the individual hamstrings to provide strong hip extensio and knee flexion. We will establish the feasibility of high density interfaces to the sciatic nerv in acute intraoperative tests, which will improve the performance and simplify the surgical implantation of future lower extremity neuroprostheses.