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

描述。提出了一种高密度STim-Grid MAP脊髓刺激导联技术 创建预测性地图，详细说明下尿路神经通路如何通过高位激活。 对骶髓和神经根的密度刺激。这些地图将使有原则的开发 神经调节疗法，使用脊髓刺激，以减轻过度活动的膀胱和 大小便失禁。下尿路(LUT)，由膀胱、尿路和相关的肌肉和神经组成， 是神经调节治疗的重要靶器官系统，因为损伤、疾病和衰老可导致 生活质量的损害和随后的降低。虽然现有的神经调节设备已经 植入超过200,000人的设备相关不良事件仍然很常见，尽管功能 尽管情况有所改善，但许多人仍然会出现膀胱过度活动和大小便失禁等不必要的症状。vbl.使用 电场模型，我们的多学科团队已经证明了电极增加了两倍 柱子和密度可以向横向定位的脊髓靶点提供刺激，这是现有的 临床电极。此外，我们已经证明了制造超柔性电极的可行性 可以符合骶髓的神经丛几何形状。这项技术开发工作的目标是 是开发和商业化通道8列8行有源导线，并研制 LUT周围神经通过脊髓刺激的可达性图。我们寻求执行三项任务 研制任务：(目标1)研制一种等高密度等高密度硬膜外脊髓桨阵， (目标2)：开发带有开关矩阵电子组件的STIM-网格地图脊髓桨，(目标3) 通过高分辨率刺激骶髓绘制LUT募集地图。我们的多学科 团队包括设备开发(Micro-Leads)和膀胱电生理学(匹兹堡大学)。在……里面 第1年，我们将创建和演示48通道灵活且高密度的被动引线，并创建地图 描述盆神经、阴部神经和阴部神经分支的选择性通路。在第二年，我们将 仅使用16条线演示具有8列8行(-分辨率通道)的STim-Grid贴图数组。 高分辨率阵列将使我们能够生成LUT周围神经在脊髓的通路地图，但 重要的是，可以立即扩展到映射其他器官模型，而几乎不需要额外的开发工作和时间。 因为STim-Grid MAP技术是基于众所周知的植入性脊髓导联植入 技术，这项技术可以迅速转化为高分辨率的脊髓标测实验 在OT3阶段的术中设置期间的人员。

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.