SBIR Phase I: Percutaneous Spinal Cord Stimulation Paddle Lead Using Shape Memory Polymer

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a minimally invasive novel spinal cord stimulation (SCS) lead and procedure for use with spinal cord stimulators to treat chronic pain. Chronic back pain is one of the leading causes of disability worldwide affecting over 50 million adults in the US. Implantable SCS systems have been previously demonstrated to mitigate chronic back pain with an estimated $2.1 billion market. The novel approach combines the benefits of the two currently available types of spinal cord leads: cylindrical percutaneous and surgical paddle. Paddle leads offer greater coverage, better energy efficiency, and lower migration risk over cylindrical percutaneous leads but require more invasive surgical procedures to place. This project will develop a flexible multielectrode interface to improve therapeutic coverage and efficiency that enables minimally invasive placement through a needle. If successful, the project will reduce the invasiveness of current lead placement procedures, improve the rate of successful procedures, reduce opioid usage associated with back pain treatment, and reduce the estimated $300 billion in annual healthcare costs associated with chronic back pain in the US. This Small Business Innovation Research (SBIR) Phase I project will develop a novel minimally invasive procedure deploying an implantable Spinal Cord Stimulation (SCS) lead by utilizing a shape memory polymer (SMP). Current SCS placement procedures require surgical interventions with high rates of chronic morbidity and adverse events. This project develops an 8-channel SMP-based paddle lead that can be molded into a compact configuration for transport and bodily introduction through a tuohy needle, thereby reducing the surgical implications. Once placed, the lead re-expands to provide the benefits of a traditional paddle lead. Finite element computer simulations will determine the best shape to mold the paddle into for transport and successful deployment. Paddle leads will be fabricated using microfabrication processes in accordance with medical device practices, characterized, and tested using benchtop models of the spine. Upon completion the project will demonstrate the feasibility of a novel minimally invasive SCS paddle lead placement procedural system for use with spinal cord stimulators to mitigate chronic back pain. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.