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.

该提案的目的是设计、制造和测试一种新颖的、柔性的印刷铅体，用于治疗慢性疾病 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的恢复以及慢性疼痛 管理。 本研究将重点关注使用 NanoJetTM 技术以新颖的设计打印电子迹线 这将允许在静态和循环负载条件下消除应力。柔性印刷引线体将是 由柔性基材、印刷金属油墨和保护屏障组成，以实现长期功能和 机械可靠性。将创建主导体设计以与经皮疼痛管理相连接 系统的配合端将根据应用进行定制。本办法所要完成的任务 提案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循环机械测试以及体外评估 将建立长期功能的实验。该设备的被动植入还将提供 有关一般生物相容性的信息。通过对测试样本进行评估收集的数据将提供给 设计优化过程和完整设备测试的数据将有助于未来向 FDA 的申请 进行后续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患者康复护理和退伍军人的生活质量 与柔性印刷引线体相关的进步。植入式神经刺激系统具有高 通道数为神经选择性提供了最佳选择，如果这些可以以稳健、小型化的方式提供 允许微创手术的系统，然后是开发的新机会 可以实现经皮疼痛管理。此外，现有的神经刺激植入系统 可能受益于高密度柔性引线，这将最大限度地减少与复杂相关的担忧 相同数量的通道的植入程序和更大体积的植入材料。