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

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的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。 下背痛影响超过1亿美国人。 虽然脊髓神经调节对大约60%的患者来说是成功的，但许多人仍然未经治疗并患有慢性疼痛。 下背痛是最难治疗的，因为传统电极技术无法选择性地将能量输送到这些纤维，这是由于与传统制造工艺相关的桨状电极体积庞大。 此外，为了实现最大程度的疼痛缓解，神经外科医生必须在手术过程中唤醒受试者，以验证患者在电极定位时是否感觉到疼痛缓解。 许多受试者由于身体活动导致电极对准不准确或电极随时间移动而经历多次手术。 所提出的有源网格电极技术寻求使治疗表面积的大小加倍，包括对常规电极无法接近的下背部纤维提供治疗。 该技术有望改善腰痛缓解，并在电极移动时使用无线编程来改变治疗，避免再次手术。 拟议的项目旨在通过开发一种主动刺激网格电极网格技术，将可以获得治疗益处的脊髓面积增加一倍。 通过在桨状电极内放置一个非常小的电子电路，该团队预计将创建一个64接触治疗阵列，以提供精确的治疗。 为了实现这些目标，该项目包括三项关键任务，包括：（1）开发植入式电子器件、包装和电极导线阵列的医用级设计，（2）进行机械老化和拉伸测试，以及（3）为后续ISO 14708确认测试准备原型。 该项目的目标是加速医疗级硬件的开发工作，使未来的治疗方法能够治疗腰痛。 该项目完成后的最终验证将在人体中进行，方法是选择性地施加刺激并记录患者是否在腰部区域感觉到治疗。

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.