SBIR-STTR Award

This SBIR Phase I project will develop and test a minimally invasive method and device that blocks pain. The device will offer patients and physicians a new non-addictive way of controlling severe pain with the ultimate goal of reducing or eliminating society's need for opioids and other narcotics. More than 350,000 Americans died from opioid overdose during 1999-2016, and the societal cost of opioid misuse exceeds $75 billion per year. The number one risk factor of opiate addiction is receiving a prescription for opiates. The technology developed in this project uses gentle warm and cool temperatures to block the transmission of nerve signals without drugs or electric stimulation. Uniquely, this method appears to block pain signals across all mammalian and amphibian nerves. The device developed in this project will reduce human suffering and risk of addiction by giving patients the ability to rapidly adjust how much of a nerve's firing is felt. The device will also provide researchers studying neurological mechanisms with precise control over nerve conduction. Thermal nerve blocks represent a powerful new way of blocking pain and has broad applicability following surgery and across a number of disorders and diseases. Gently warming a short section of nerve tissue to 45C and then cooling it to 15C can quickly initiate complete nerve block that can be maintained by cycling between these temperatures while avoiding nerve damage from exposure to higher or lower temperatures. Thermal nerve block will be delivered by the minimally invasive device developed in this project, which includes an inserted thermal probe and an external microfluidic controller. The drug-free, non-addictive, device will provide continuous block of severe pain initially for peri- and post-operative pain management. This project will build prototype thermal tips that can be inserted via 5mm introducer sheath, refine the device implantation technique and optimize thermal performance in vitro before demonstrating the utility of the system for thermal block of intercostal pain in C-fiber evoked potential experiments in anesthetized felines. The thermal tips will be held in place with non-permanent anchoring silicone tynes, while the external wearable controller will have battery-powered micro-piezo pump, thermoelectric heater/cooler, and microcontroller. This minimally invasive design offers an effective alternative for controlling severe pain that does not attenuate over time and brings no risk of addiction. 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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of a simple wearable device to manage pain. Despite advances in new therapies, addictive narcotic medications still remain a widely utilized method to control pain for many conditions. The proposed technology represents a new noninvasive approach to blocking nerve conduction without reliance on drugs. The device can be easily adapted to treat any condition wherein pain is transmitted along nerves close to the skin surface. This work will demonstrate feasibility of a novel therapeutic approach to pain management without risk of drug dependence or addiction. This Small Business Innovation Research (SBIR) Phase II project will fully develop a human wearable thermal nerve block device for treating severe head and neck pain by blocking nerves in the occipital region. Occipital pain is driven by a number of physiological and pathological causes, and many patients fail to find adequate pain relief solutions that allow them to continue their daily activities, thus leading to poor quality of life with reduced productivity and socialization. The device developed in this project will thermally modulate the occipital region in such a way as to initiate and then maintain a drug-free nerve block. 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.