Next-Generation High-Density Wireless Peripheral Nerve Stimulator

描述（由申请人提供）： 该提案的目的是开发下一代微型高密度微刺激器，其适合于长期植入患者体内以治疗外周神经系统疾病。可以用这种方法治疗的疾病是行走问题，例如中风后，以及截肢后恢复幻肢的自然感觉。 在这项研究中，我们将使用定制的微制造电极阵列结构，以提供持久的神经接口。还将开发微型植入式假体的定制包装和组装方法。本提案中待完成的任务包括制造新的电极阵列，用于与现有微型神经刺激器设计配合。我们还将通过体外实验和使用有源器械的动物手术试验来评估这些植入物的长期生物相容性和生物稳定性。因此，我们将与我们的供应商一起构建和测试新一代高密度最先进的外周神经刺激器。我们将在概念验证动物植入研究中验证我们的设计，这些将成为向FDA申请进行后续临床工作的基础。 拟议的努力和VA的患者护理使命之间的关系是，这些改进有望通过比以前更具体、更有针对性的神经刺激开辟新的康复可能性。将发明新的辅助行走和恢复截肢者自然感觉的装置。

DESCRIPTION (provided by applicant): The aim of this proposal is to develop the next generation of miniature, high- density micro-stimulators suitable for chronic implantation in a patient's body to treat disorders of the peripheral nervous system. Maladies that could be treated in this way are problems with walking, such as after a stroke, and restoring natural sensations in a phantom limb after amputation. In this study, we will use custom-microfabricated electrode array structures to provide long-lasting neural interfaces. Custom packaging and assembly methods for the miniature implantable prostheses will also be developed. The tasks to be accomplished under this proposal include the fabrication of new electrode arrays for mating with pre- existing micro-neurostimulator designs. We will also evaluate the long-term biocompatibility and bio-stability of these implants through both in vitro experiments and animal surgical trials with active devices. Together with our vendors, we will thus build and test a new generation of high-density state-of-the-art peripheral neural stimulators. We will validate our designs in proof-of-concept animal implantation studies, and these will form the basis of an application to the FDA to do follow-on clinical work. The relationship between the proposed effort and the patient care mission of the VA is that these improvements are expected to open up new rehabilitative possibilities through more specific, targeted neural stimulation than has previously been possible. New devices for assistance with walking and restoring natural sensation in amputated limbs will be invented.