STTR Phase I: Minimally-invasive reversible thermal nerve block for relief of severe pain

SBIR第一阶段项目将开发和测试一种微创方法和设备，以阻止疼痛。该设备将为患者和医生提供一种控制严重疼痛的新的非成瘾性方法，最终目标是减少或消除社会对阿片类药物和其他麻醉剂的需求。1999年至2016年期间，超过35万美国人死于阿片类药物过量，阿片类药物滥用的社会成本每年超过750亿美元。阿片类药物成瘾的头号危险因素是接受阿片类药物处方。该项目开发的技术使用温和的温暖和凉爽的温度来阻止神经信号的传输，而无需药物或电刺激。独特的是，这种方法似乎可以阻断所有哺乳动物和两栖动物神经的疼痛信号。该项目开发的设备将减少人类的痛苦和成瘾的风险，使患者能够快速调整神经放电的感觉。该设备还将为研究神经机制的研究人员提供对神经传导的精确控制。热神经阻滞代表了一种强大的阻断疼痛的新方法，在手术后和许多疾病中具有广泛的适用性。轻轻地将一小部分神经组织加热到45 ℃，然后将其冷却到15 ℃，可以快速启动完全的神经阻滞，可以通过在这些温度之间循环来维持，同时避免因暴露于更高或更低的温度而造成神经损伤。热神经阻滞将由本项目开发的微创设备提供，该设备包括插入的热探针和外部微流体控制器。这种无药物、无成瘾性的装置将在最初用于手术和术后疼痛管理时提供持续的剧痛阻断。本项目将构建可通过5 mm导引鞘插入的原型热头端，完善器械植入技术并优化体外热性能，然后在麻醉猫的C纤维诱发电位实验中证明系统用于肋间疼痛热阻滞的实用性。热尖端将通过非永久性固定硅胶齿固定到位，而外部可穿戴控制器将具有电池供电的微型压电泵、热电加热器/冷却器和微控制器。这种微创设计为控制剧烈疼痛提供了一种有效的替代方案，不会随着时间的推移而减弱，也不会带来成瘾的风险。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.