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

在这个SBIR FastTrack提案中，Micro-Leads将开发HD 64-一种高分辨率，64- 通道脊髓刺激治疗，以提供更多的疼痛缓解与更大的特异性，为那些遭受 慢性神经性疼痛和阿片类药物依赖在美国，超过2500万人患有使人衰弱的疼痛。 在躯干和四肢，55%的人依赖阿片类药物来减轻他们的痛苦。阿片类药物滥用声称， 在过去十年中，超过20万人的生命，并导致生活质量、能力和能力的毁灭性下降。 为了工作，为了生活，为了精神健康。脊髓刺激（SCS）为60%的患者提供了疼痛缓解。 那些患有慢性肢体疼痛并完全消除阿片类药物使用的患者超过50%。尽管有这些优点， SCS在治疗膝关节、足部、腹股沟或下背部的孤立性疼痛方面取得了有限的成功。横向定位 脊髓的纤维（例如，背根进入区和背角）代表更有选择性神经靶向 然而，目前的可植入板型手术引线太硬且体积太大，无法在不使用这些纤维的情况下接近这些纤维。 瘫痪或神经根压迫的重大风险。 HD 64提供了一个超薄和共形毯的刺激接触整个宽度 脊髓有源导线技术在手术导线中嵌入了一个微小的电子芯片， 在不增加引线数量的情况下，总的来说， 这些特征改善了治疗并简化了手术流程。一种新型植入式有源导联控制器 脉冲发生器（AL-IPG）安全地为芯片供电，与有源引线电子器件连接，配置8 可编程的“治疗组”，并确保治疗脉冲输送到组织。HD 64治疗是一种高度 治疗慢性疼痛和阿片类药物患者的重要、新颖的解决方案。 第1阶段：将进行尸体试运行，然后进行非重大风险术中研究（n=6）， 进行了高分辨率HD 64阵列的几何和电生理设计参数的通知。 本研究将评价术中测量的内侧和外侧脊柱靶点的激活情况， 肌电图的神经监测。在第1阶段结束时，HD 64手术电极导线的临床可行性将 建立。第2阶段：在第2阶段，我们有GMP制造商组装的HD 64有源电极导线。我们将 开发外部有源电极导线脉冲发生器和充电器，并提交IDE批准。我们将 使用有源HD 64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 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长期安全性研究，以证明功能性能， 最后的装置。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.