SBIR Phase I: A Precision, High-Density Stimulation Electrode for Low-Back Pain Relief

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响和商业潜力是使用一种新的刺激主动桨状电极技术更有效地治疗慢性背部和下肢疼痛。超过1亿美国人受到腰痛的影响。虽然脊髓神经调节对大约60%的患者是成功的，但许多人仍然没有得到治疗，并遭受慢性疼痛。下腰痛是最难治疗的，因为传统的电极技术不能选择性地将能量传递到这些纤维上，这是由于传统的制造工艺所带来的笨重的桨状电极体积。此外，为了最大限度地减轻疼痛，神经外科医生必须在手术过程中唤醒受试者，以验证电极放置时患者是否感觉到疼痛减轻。许多受试者由于不准确的电极对准或由于身体活动导致电极随时间移动而进行多次手术。所提出的有源网格电极技术将使治疗表面积增加一倍，包括为传统电极无法到达的低背纤维提供治疗。这项技术将改善腰痛的缓解，并使用无线编程在电极移动的情况下改变治疗方法，避免了再次手术的需要。该项目旨在通过开发一种主动刺激网格电极技术，将脊髓的面积扩大一倍，从而获得治疗效果。通过在桨状电极内放置一个微小的电子电路，我们可以创建一个48或96通道的刺激网格，可以通过编程来提供精确的治疗。为了实现这些目标，我们将执行三个关键任务，包括：(1)使用电场模拟设计桨状电极，以电流引导治疗腰痛纤维；(2)使用微小的陶瓷密封封装和微电路开发主动刺激网格引线的原型；(3)验证脊髓中腰痛纤维的招募。该项目的目标是开发概念验证数据，以证明活性铅技术可以改善对腰痛纤维的治疗。验证将通过记录所有背柱表面的诱发电位来执行，同时有选择地对记录电极尾侧的侧电极施加刺激。肌电控制电极将被放置在邻近的肌肉中，以验证背根没有被激活。

The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to treat chronic back and lower limb pain more effectively using a novel stimulation active paddle electrode technology. Lower back pain affects more than 100M Americans. While spinal cord neuromodulation is successful for about 60% of patients, many people remain untreated and suffer from chronic pain. Low-back pain is the most difficult to treat due as conventional electrode technology cannot selectively deliver energy to these fibers due to the bulky paddle electrode volume associated with the legacy manufacturing processes. Furthermore, to achieve maximal pain relief, neurosurgeons must wake the subjects during an operation to verify if the patient senses pain relief as the electrode is positioned. Many subjects undergo multiple operations due to inaccurate electrode alignment or movement of the electrode over time due to physical activity. The proposed active grid electrode technology will double the therapeutic surface area, including providing therapy to low-back fibers which are not accessible by conventional electrodes. The technology will improve low-back pain relief, as well as use wireless programming to alter the therapy in the event of electrode movement, avoiding the need for re-operation. The proposed project seeks to double the area of the spinal cord which can receive therapeutic benefit, by developing an active stimulation-grid electrode technology. By positioning a tiny electronic circuit within the paddle electrode, we can create a 48 or 96 channel stimulation grid which can be programmed to deliver precision therapy. To accomplish these goals, we will perform three critical tasks including: (1) design of the paddle electrode using electric field simulations to current-steer therapy to low-back pain fibers, (2) develop a prototype of the active stimulation grid lead using a tiny ceramic hermetic package and micro-circuit, and (3) validation of the recruitment of low-back pain fibers in the spinal cord. The goal of the project is to develop proof-of-concept data to show that active-lead technology can improve delivery of therapy to low-back pain fibers. Validation will be performed by recording the evoked potentials across the surface of all dorsal columns while stimulation is selectively applied to lateral electrodes caudal to the recording electrodes. Electromyography control electrodes will be positioned within adjacent muscles to verify that dorsal roots are not activated.