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

Micro-Leads,Inc., Somerville MA

Investigators

Abstract

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.