Next-Generation High-Density Wireless Peripheral Nerve Stimulator

下一代高密度无线周围神经刺激器

• 批准号: 9017824
• 负责人: Douglas B. Shire
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9017824
• 关键词: Address; Affect; Amputation; Amputees; Animal Experiments; Animal Model; Animals; Ankle; Award; Boston; Chronic; Clinical; Clinical Trials; Custom; Data; Devices; Electrodes; Environment; Equilibrium; Esthesia; Evaluation; Exhibits; Failure; Family Felidae; Foot-drop; Foundations; Functional disorder; Funding; Gait; Generations; Grant Review; Hip region structure; Human; Hybrids; Implant; In Vitro; Incidence; Individual; Injury; Intervention; Intramuscular; Investments; Knee; Life; Limb structure; Mechanics; Methods; Mission; Motor; Multiple Sclerosis; Muscle; Nerve; Neurological rehabilitation; Operative Surgical Procedures; Output; Paraplegia; Partner in relationship; Patient Care; Patients; Peripheral; Peripheral Nerves; Peripheral Nervous System Diseases; Phantom Limb; Physical activity; Physiologic pulse; Population; Positioning Attribute; Production; Prosthesis; Rehabilitation therapy; Research Personnel; Residual state; Retinal; Saline; Speed; Spinal cord injury; Stimulus; Stroke; Structure; System; Techniques; Technology; Testing; Upper Extremity; Vendor; Veterans; Visual; Walking; Wireless Technology; Work; advanced system; afferent nerve; base; biomaterial compatibility; clinical application; combat; density; design; experience; falls; implantation; improved; in vitro testing; in vivo; innovation; neural stimulation; neuroprosthesis; next generation; post stroke; pre-clinical; public health relevance; relating to nervous system; research clinical testing; research study; sensory feedback; success

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.

描述（由申请人提供）： 该提案的目的是开发适合患者体内慢性植入的下一代微型，高密度微刺激剂，以治疗周围神经系统的疾病。可以以这种方式治疗的疾病是步行问题（例如中风后）的问题，并在截肢后恢复了幻影肢体中的自然感觉。 在这项研究中，我们将使用定制的微生物电极阵列结构来提供持久的神经界面。还将开发用于微型植入植物假体的定制包装和装配方法。在此提案中要完成的任务包括与预先现有的微型神经刺激器设计的新电极阵列的制造。我们还将通过体外实验和具有活性设备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建造和测试新一代高密度的最新外围神经刺激剂。我们将验证概念验证动物植入研究的设计，这将构成FDA应用于进行后续临床工作的基础。 拟议的努力与VA的患者护理任务之间的关系是，预计这些改进将通过更具体的，有针对性的神经刺激开放新的康复可能性。将发明新的设备，以帮助步行和恢复截肢的四肢自然感觉。