Development of Novel, Flexible Printed Lead Body for Use in Minimally Invasive Pain Management Systems

本提案的目的是设计、制造和测试一种新型柔性印刷电极导线体，用于慢性 植入作为周围神经刺激系统的一部分。需要神经刺激的治疗方式 包括瘫痪或截肢后运动控制和感觉恢复，以及慢性疼痛 管理 本研究将着重于利用NanoJetTM技术打印具有新颖设计的电子迹线 这将允许在静态和循环负载条件下的应变消除。柔性印刷电极导线主体将 包括柔性基底、印刷的金属油墨和保护性屏障， 机械可靠性将创建电极导线主体设计，以连接经皮疼痛管理 该系统的配合端将针对应用进行定制。在这方面要完成的任务 建议书包括器件及其连接端的设计、制造和表征。长期 将通过一系列静态和循环力学试验以及体外试验评估结构生物相容性 建立慢性功能的实验。该装置的被动植入还将提供 一般生物相容性信息。通过对测试样本进行评估收集的数据将用于 设计优化过程和来自完整器械测试的数据将有助于将来向FDA申请 进行后续的动物研究和未来的临床工作。 拟议的努力旨在改善康复病人护理和退伍军人的生活质量， 与柔性印刷导线体相关的进步。植入式神经刺激系统， 通道计数为神经选择性提供了最佳选择，如果这些可以以强大的小型化 系统，允许微创手术，然后为发展新的机会， 可以实现经皮疼痛管理。另外，现有的用于神经刺激的可植入系统 可能会受益于高密度柔性导线，这将最大限度地减少与复杂相关的担忧 植入程序和相同数量的通道的更大体积的植入材料。

The aim of this proposal is to design, fabricate, and test a novel, flexible printed lead body for chronic implantation as part of peripheral nerve stimulation systems. Treatment modalities that require nerve stimulation include restoration of motor control and sensation following paralysis or amputation, and chronic pain management. This study will focus on the use of NanoJetTM technology to print electronic traces with a novel design that will allow for strain relief under static and cyclic loading conditions. The flexible, printed lead body will be comprised of a flexible substrate, printed metallic ink, and protective barrier to allow for chronic functional and mechanical reliability. The lead body design will be created to connect with a percutaneous pain management system of which the mating ends will be customized for the application. Tasks to be accomplished under this proposal include the design, fabrication, and characterization of the device and its connecting ends. Long-term structural biocompatibility will be assessed through a series of static and cyclic mechanical tests and in vitro experiments that will establish chronic functionality. Passive implantation of the device will also provide information on general biocompatibility. Data collected through evaluations made with test specimens will feed into the design optimization process and data from full device testing will facilitate future applications to the FDA to perform follow-on animal studies and future clinical work. The proposed effort seeks to improve rehabilitative patient care and the quality of life of Veterans through the advances associated with the flexible, printed lead body. Implantable neurostimulation systems with high channel counts provide the best option for nerve selectivity, and if those can be provided in a robust, miniaturized system that allows for a minimally invasive procedure, then new opportunities for the development of percutaneous pain management can be realized. Additionally, existing implantable systems for neurostimulation may benefit from the high-density flexible lead, which would minimize the concerns related to complex implantation procedures and larger volumes of implanted materials for the same number of channels.