High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain

在这份SBIR FastTrack提案中，Micro-Leads将开发HD64-a高分辨率，- 经络脊髓刺激疗法为患者提供更多的疼痛缓解和更大的特异性 慢性神经性疼痛和阿片类药物依赖。在美国，超过2500万人遭受着令人衰弱的疼痛 在躯干和四肢中，有55%的人依赖阿片类药物来减轻痛苦。阿片类药物滥用声称 在过去的十年里，超过20万人的生命，并导致生活质量和能力的毁灭性下降 为了工作，为了活着的人的精神健康。脊髓刺激(SCS)已为60%的患者提供了疼痛缓解 那些有慢性肢体疼痛并完全消除阿片类药物使用的人超过50%。尽管有这些优势， SCS在治疗膝部、足部、腹股沟或下背部的孤立疼痛方面取得了有限的成功。横向定位 脊髓纤维(例如背根进入区和背角)代表一种更具选择性的神经靶向 然而，目前可植入的板式外科引线过于僵硬和笨重，如果没有这些引线就无法接触这些纤维 有很大的瘫痪或神经根压迫的风险。 HD64提供了覆盖整个宽度的超薄保形触点 脊髓。主动引线技术在外科引线中嵌入了一个微小的电子芯片，使数字翻了一番 在不增加导线数量的情况下，与目前的技术相比，治疗触点的数量减少了。总而言之， 这些功能改进了治疗并简化了手术流程。一种新型的可植入主动导联控制器 脉冲发生器(AL-IPG)安全地给芯片供电，与有源引线电子设备同步，配置8 可编程的“治疗小组”，并确保治疗脉冲被传送到组织。HD64疗法是一种高度 治疗慢性疼痛和阿片类药物患者的重要、新的解决方案。 阶段1：先进行身体试验，然后进行无重大风险的术中研究(n=6)。 用于告知高分辨率HD64阵列的几何和电生理设计参数。 这项研究将评估术中测量的脊柱内侧和外侧靶点的激活情况。 肌电的神经监测。在第一阶段结束时，HD64手术导联的临床可行性将 被建立起来。第二阶段：在第二阶段，我们有一个GMP制造商组装的HD64有源引线。我们会 开发外部有源铅脉冲发生器和充电器，将提交给IDE批准。我们会 使用活动HD64和AL-IPG硬件进行早期可行性研究人体试验(n=10名受试者，n=23名 治疗组，n=2个波形)。在第二阶段，我们还将进行机械和电气设计 在大型动物中进行验证测试和慢性安全性研究，以展示功能性能，以告知 最后一个装置。到第二阶段结束时，我们将完成通知最终设备的所有必要任务 设计并实现对慢性疼痛和阿片类药物减少的后续植入纵向研究。

In this SBIR FastTrack proposal, Micro-Leads will develop HD64—a high-resolution, 64- channel spinal cord stimulation therapy to provide more pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependence. Over 25 million in the U.S. suffer from debilitating pain in the trunk and extremities and 55% depend on opioids to ease their suffering. Opioid abuse has claimed the lives of over 200,000 over the past decade and has resulted in devastating reductions in quality of life, in ability to work, and in mental health for the living. Spinal cord stimulation (SCS) has provided pain relief for 60% of those with chronic extremity pain and eliminated opioid use entirely in more than 50%. Despite these advantages, SCS has had a limited success treating isolated pain of the knee, foot, groin, or low-back. The lateral positioned fibers of the spinal cord (ex. the dorsal root entry zone and dorsal horn) represent a more selective neural targeting opportunity yet current, implantable plate-type surgical leads are too rigid and bulky to access these fibers without a significant risk of paralysis or nerve root compression. HD64 provides an ultra-thin and conformal blanket of stimulation contacts across the entire width of the spinal cord. Active-lead technology embeds a tiny electronic chip within the surgical lead and doubles the number of therapy contacts compared with current technology without increasing the number of lead-wires. Collectively, these features improve therapy and simplify surgical workflow. A novel Active-Lead Controller Implantable Pulse Generator (AL-IPG) powers the chip safely, synchronizes with the active-lead electronics, configures the 8 programmable “therapy groups”, and ensures therapy pulses are delivered to the tissue. HD64 therapy is a highly significant, novel solution for the treatment of patients suffering from chronic pain and opioids. PHASE 1: A cadaveric pilot run followed by a non-significant risk intraoperative study (n=6) will be performed to inform the geometric and electrophysiological design parameters of high-resolution HD64 arrays. The study will evaluate activation of medial and lateral spinal targets as measured by intraoperative neuromonitoring of electromyography. At the end of Phase 1, the clinical feasibility of HD64 surgical leads will be established. PHASE 2: In Phase 2, we have HD64 active leads assembled by a GMP manufacturer. We will develop an external Active Lead Pulse Generator and charger which will be submitted for IDE approval. We will perform an Early Feasibility Study Human Trial using active HD64 and AL-IPG hardware (n=10 subjects, n=23 therapy groups, n=2 waveforms). During Phase 2, we will also perform mechanical and electrical design verification testing and chronic safety studies in large animals to demonstrate functional performance to inform the final device. By the end of Phase 2, we will have completed all necessary tasks to inform the final device design and to enable follow-on implanted longitudinal studies of chronic pain and opioid reduction.