Epidural Current-Steering for Selective Modulation of Lower Urinary Tract Function

硬膜外电流引导选择性调节下尿路功能

• 批准号: 9415526
• 负责人: Bryan L McLaughlin
• 金额: $ 106.27万
• 依托单位: MICRO-LEADS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9415526
• 关键词: Action Potentials; Adverse event; Afferent Pathways; Aging; Anatomy; Axon; Biological Assay; Biological Models; Bladder; Bladder Control; Chronic; Clinical; Communication; Critical Pathways; Data Coordinating Center; Development; Device or Instrument Development; Devices; Disease; Dura Mater; Electrodes; Electromyography; Electronics; Electrophysiology (science); Encapsulated; Functional disorder; Future; Geometry; Human; Impairment; Implant; Implanted Electrodes; Incontinence; Injury; Lasers; Lead; Lower urinary tract; Maps; Measures; Methods; Modeling; Molds; Monitor; Motor; Muscle; Nerve; Neurostimulation procedures of spinal cord tissue; Organ; Organ Model; Output; Overactive Bladder; Parasympathetic Nervous System; Pathway interactions; Pelvis; Performance; Peripheral Nerves; Phase; Physiologic pulse; Physiological; Physiology; Positioning Attribute; Process; Quality of life; Recruitment Activity; Research; Resolution; Sacral spinal cord structure; Silicon; Silicones; Sphincter; Spinal Cord; Spinal nerve root structure; Stretching; Structure; Surface; Symptoms; System; Techniques; Technology; Thick; Thinness; Time; Translating; Universities; Urethra; Water; afferent nerve; base; body system; clinically relevant; cost; data sharing; density; electric field; experience; experimental study; flexibility; functional improvement; implantation; improved; in vivo; intravesical; multidisciplinary; nanofiber; neural circuit; neuroregulation; novel; pressure; prevent; relating to nervous system; response; spinal cord mapping; technology development; tool

DESCRIPTION. A high-density Stim-Grid MAP spinal cord stimulation lead technology is proposed to enable the creation of predictive maps that detail how lower urinary tract nerve pathways can be activated through high- density stimulation of the sacral spinal cord and roots. These maps will enable principled development of neuromodulation therapies that use spinal cord stimulation to alleviate the burden of overactive bladder and incontinence. The lower urinary tract (LUT), consisting of the bladder, urethra and associated muscles and nerves, is an important target organ system for neuromodulation therapies as injury, disease and aging can lead to impairment and subsequent reductions in the quality of life. While existing neuromodulation devices have been implanted in over 200,000 people, device related adverse events remain common, and despite functional improvements, many people still deal with unwanted symptoms of overactive bladder and incontinence. Using electric field modelling, our multidisciplinary team has demonstrated that a two-fold increase in electrode columns and density can deliver stimulation to laterally-positioned spinal cord targets not possible with existing clinical electrodes. Furthermore, we have demonstrated feasibility of manufacturing ultra-flexible electrodes that can conform to the plexus geometry of the sacral spinal cord. The objective of this technology development effort is to develop and commercialize a 64-channel active-lead which contains 8-columns and 8 rows, and to develop maps of the accessibility of LUT peripheral nerves through spinal cord stimulation. We seek to perform three development tasks: (AIM 1) Develop a contoured and passive high-density epidural spinal-cord paddle array, (AIM 2): Develop a STIM-GRID MAP spinal cord paddle with a switch-matrix electronics package, (AIM 3) Develop maps of LUT recruitment by high-resolution stimulation of the sacral spinal cord. Our multi-disciplinary team includes device development (Micro-Leads) and bladder electrophysiology (University of Pittsburgh). In Year 1 we will create and demonstrate a 48-channel flexible and high-density passive lead and create maps that describe the selective access to the pelvic nerve, pudendal nerve and pudendal nerve branches. In Year 2 we will demonstrate a Stim-Grid MAP array with 8 columns and 8-rows (64-channels of resolution) using only 16 wires. The high-resolution array will enable us to generate maps of LUT peripheral nerve access at the spinal cord, but importantly, is immediately scalable to map other organ models with little additional development effort and time. Because the Stim-Grid MAP technology is based on well-understood implantable spinal cord lead implantation techniques, this technology could be rapidly translated to high-resolution spinal cord mapping experiments in people during an intraoperative settings in an OT3 phase.

描述。提出了高密度刺激脊髓刺激铅技术以实现 创建预测图，详细介绍如何通过高尿路神经途径激活较低的尿路神经途径 骨脊髓和根的密度刺激。这些地图将使原则开发 使用脊髓刺激来减轻过度活跃的膀胱和 失禁。下尿路（LUT），由膀胱，尿道和相关的肌肉和神经组成， 是神经调节疗法的重要目标器官系统，因为疾病，疾病和衰老可能导致 损害和随后的生活质量降低。虽然现有的神经调节设备已经 与设备相关的不良事件植入了200,000多人，尽管功能功能仍然很常见 改进，许多人仍然应对过度活跃和尿失禁的不良症状。使用 电场建模，我们的多学科团队表明电极增加了两倍 圆柱和密度可以在现有 临床电极。此外，我们已经证明了制造超虚拟电极的可行性 可以符合骨脊髓的丛几何形状。这项技术开发工作的目的 是开发和商业化一个64通道的活动铅，其中包含8列和8行，并开发 通过脊髓刺激的LUT外周神经可及性的地图。我们试图执行三个 开发任务：（目标1）开发一个轮廓和被动的高密度硬膜外脊髓桨板阵列， （AIM 2）：使用开关矩阵电子包装开发刺激栅格地图脊髓桨（AIM 3） 通过高分辨率刺激骨脊髓来形成LUT募集的地图。我们的多学科 团队包括设备开发（微铅）和膀胱电生理学（匹兹堡大学）。在 1年级，我们将创建并演示48通道的灵活和高密度的被动引线，并创建地图 描述选择性接触骨盆神经，底端神经和底端神经分支。在第二年，我们将 仅使用16条电线演示带有8列和8行（64通道的分辨率）的刺激网格地图阵列。 高分辨率阵列将使我们能够在脊髓上生成LUT外周神经通道的地图，但是 重要的是，可以立即扩展以绘制其他器官模型，而几乎没有额外的开发工作和时间。 因为刺激网格地图技术基于良好理解的植入脊髓铅植入 技术，该技术可以迅速转化为高分辨率的脊髓映射实验 在OT3阶段的术中环境中的人们。