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

开发用于微创疼痛管理系统的新型柔性印刷铅体

• 批准号: 10554097
• 负责人: Janet L Gbur
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10554097
• 关键词: Acute Pain; Adhesions; Aerosols; Affect; Amputation; Animals; Architecture; Biological; Biotechnology; Chronic; Clinical; Complex; Computer-Aided Design; Core Facility; Coupled; Data; Development; Devices; Diameter; Electric Stimulation; Electrodes; Electronics; Ensure; Environment; Esthesia; Evaluation; Family Felidae; Fatigue; Foundations; Funding; Future; Implant; Implantation procedure; In Vitro; Ink; Journals; Lead; Limb structure; Mechanics; Medical Device; Modality; Monitor; Nerve; Pain management; Paralysed; Partner in relationship; Patient Care; Patients; Performance; Periodicity; Peripheral Nerve Stimulation; Phantom Limb Pain; Power Sources; Preclinical Testing; Printing; Procedures; Prosthesis; Publishing; Quality of life; Rehabilitation therapy; Research; Research Personnel; Resistance; Resources; Sampling; Science; Series; Specimen; Spectrum Analysis; System; Technology; Testing; Tissues; Translating; Trauma; Tube; Universities; Veterans; Work; biomaterial compatibility; chronic pain; chronic pain management; density; design; electric impedance; experimental study; fabrication; flexibility; functional independence; implant material; implantable device; implantation; improved; in vivo; limb loss; manufacture; manufacturing technology; metallicity; military veteran; miniaturize; minimally invasive; motor control; nanoscale; neural; neurological rehabilitation; neuroprosthesis; neurorestoration; neurotechnology; non-opioid analgesic; novel; preclinical trial; process optimization; prototype; rehabilitation research; response; restoration; technology platform

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.

该建议的目的是设计，制造和测试一个慢性的新颖，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 包括瘫痪或截肢后的运动控制和感觉的恢复，以及慢性疼痛 管理。 这项研究将重点介绍使用纳米夹技术用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减轻应变。灵活的印刷铅体将是 由柔性基材，印刷金属墨水和保护性障碍物组成，可允许慢性功能和 机械可靠性。将创建铅体设计以与经皮疼痛管理联系 配合末端的系统将为应用程序定制。在此下完成的任务 建议包括设备及其连接端的设计，制造和表征。长期 结构生物相容性将通过一系列静态和环状机械测试以及体外评估 建立慢性功能的实验。该设备的被动植入也将提供 有关一般生物相容性的信息。通过用测试标本进行的评估收集的数据将进食 进入设计优化过程和完整设备测试的数据将有助于FDA的未来应用 进行跟进动物研究和未来的临床工作。 拟议的努力旨在通过通过 与灵活的印刷铅体相关的进步。植入性神经刺激系统高 频道计数为神经选择性提供了最佳选择，如果可以以稳健的方式提供这些选择 系统允许最低侵入性的程序，然后开发新的机会 可以实现经皮疼痛管理。另外，现有的神经刺激系统 可能会受益于高密度柔性铅，这将使与复杂有关的问题最小 相同数量的通道的植入程序和大量的植入材料。