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

这项小企业创新研究（SBIR）二期项目的更广泛影响和商业潜力是使用高分辨率刺激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。提出的有源网格电极技术旨在将治疗表面积的大小扩大一倍，包括为传统电极无法到达的低背纤维提供治疗。这项技术有望改善腰痛的缓解，同时在电极移动的情况下使用无线编程来改变治疗，避免再次手术的需要。该项目旨在通过开发一种主动刺激-网格电极网格技术，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非常小的电子电路，该团队有望创建一个64个接触的治疗阵列，以提供精确的治疗。为了实现这些目标，该项目包括三个关键任务，包括：(1)开发医疗级的植入式电子元件、封装和引脚阵列设计，(2)进行机械老化和拉伸测试，以及(3)为后续的ISO 14708验证测试准备原型。该项目的目标是加速医疗级硬件的开发工作，使未来的疗法能够治疗腰痛。该项目完成后，将在人体中进行最终验证，通过选择性地施加刺激并记录患者是否在腰背区域感受到治疗。

The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to treat chronic back and lower limb pain more effectively using a high-resolution stimulation technology. Lower back pain affects more than 100M Americans. While spinal cord neuro-modulation 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 seeks to double the size of therapeutic surface area, including providing therapy to low-back fibers which are not accessible by conventional electrodes. The technology is expected to 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 grid technology. By positioning a very small electronic circuit within the paddle electrode, the team is expected to create a 64 contact therapy array to deliver precision therapy. To accomplish these goals, the project includes three critical tasks including: (1) develop a medical-grade design of the implantable electronics, package, and lead array, (2) perform mechanical aging and stretch testing, and (3) prepare prototypes for subsequent ISO 14708 validation testing. The goal of the project is to accelerate the medical-grade hardware development effort to enable future therapies to treat low-back pain. Eventual validation after this project is completed will be performed in humans by selectively applying stimulation and recording if the patient feels therapy in the low-back area.