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

该方案的目的是设计、制造和测试一种用于慢性疾病的新颖、灵活的印刷铅体 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 包括瘫痪或截肢后恢复运动控制和感觉，以及慢性疼痛 管理层。 这项研究的重点是利用NanoJetTM技术以一种新颖的设计打印电子痕迹 这将允许在静态和循环加载条件下缓解应变。灵活的印刷铅体将是 由柔性基板、印刷金属油墨和防护屏障组成，以实现慢性功能性和 机械可靠性。引导体的设计将与经皮疼痛管理相连接 将为应用程序定制其配合端的系统。在此框架下要完成的任务 建议书包括该装置及其连接端的设计、制造和表征。长期的 将通过一系列静态和循环力学测试以及体外实验来评估结构的生物兼容性 将建立慢性功能的实验。被动植入装置也将提供 关于一般生物兼容性的信息。通过对测试样本进行评估而收集的数据将提供 设计优化过程和来自全设备测试的数据将促进FDA未来的应用 进行后续的动物研究和未来的临床工作。 拟议的努力旨在通过以下方式改善康复患者护理和退伍军人的生活质量 与柔性印刷铅体相关的技术进步。植入式高强度神经刺激系统 通道计数提供了神经选择性的最佳选择，如果这些能够以强大的、微型化的 允许微创手术的系统，然后为发展新的机会 可以实现经皮疼痛管理。此外，现有的植入式神经刺激系统 可能受益于高密度柔性引线，这将最大限度地减少与复杂的 植入程序和更大体积的植入材料用于相同数量的通道。

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.