SBIR Phase I: Development of wearable medical device to detect and treat opioid overdose.

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种新型可穿戴医疗器械，可按需现场递送纳洛酮，用于干预阿片类药物过量或类似医疗紧急情况。CDC的数据显示，阿片类药物过量是45岁以下美国人死亡的主要原因，在2022年造成8万多美国人死亡。纳洛酮给药是目前急性稳定阿片类药物过量效应的标准方法，但大约69%的阿片类药物过量死亡发生在没有旁观者在场进行干预的情况下。该项目提出了一种可穿戴设备，该设备集成了外部非侵入式传感器，该传感器与能够在阿片类药物过量时皮下注射纳洛酮的药物输送系统相结合。这有可能每年挽救5万名因阿片类药物过量而死亡的美国人的生命。该小型企业创新研究（SBIR）第一阶段项目旨在开发和验证一种新型外部系统的两个组件，用于在阿片类药物过量的情况下进行检测和干预，使用传感器衍生的血氧饱和度和呼吸率测量。将开发一种新型自含式可穿戴机械、低功率给药机制和一种新型纳洛酮制剂，并验证其在模拟使用条件下的稳定性。第一个组件是一个独立的基于贴片的药物递送平台，将被设计和验证用于可靠的机械递送，从而在可穿戴系统的物理和功率限制内实现多个连续剂量的定制纳洛酮。将在指示日常佩戴条件的高温下进行加速老化试验期间，对纳洛酮制剂的稳定性进行验证。这些组件将被集成到一个原型系统中，并采用该公司的算法集成心率、呼吸和氧合，以完成一个适合未来人类使用的原型系统。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel wearable medical device providing on-demand field delivery of naloxone for intervening in instances of opioid overdose or similar medical emergencies. CDC data indicates opioid overdose was the leading cause of death for Americans under 45, responsible for claiming over 80,000 American lives in 2022. Naloxone delivery represents the current standard method for acutely stabilizing the effects of opioid overdose, but approximately 69% of opioid overdose deaths occur without a bystander present to administer the intervention. This project proposes a wearable device that integrates an external non-invasive sensor coupled with a drug delivery system capable of delivering a subcutaneous injection of naloxone upon opioid overdose. This poses the potential to save 50,000 American lives due to opioid overdose each year. This Small Business Innovation Research (SBIR) Phase I project is to develop and validate two components for a novel external system to detect and intervene during instances of opioid overdose, using sensor-derived measures of oxygen saturation and respiratory rates. A novel self-contained wearable mechanical, low-power drug delivery mechanism and a novel naloxone formulation will be developed and validated for stability under simulated use conditions. The first component, a self-contained patch-based drug delivery platform, will be designed and validated for reliable mechanical delivery, enabling multiple consecutive doses of custom naloxone within the physical and power constraints of the wearable system. The naloxone formulation will be validated for stability during accelerated age testing at elevated temperatures indicative of daily wear conditions. The components will be integrated into a prototype system with the company’s algorithm integrating heart rate, respiration, and oxygenation to complete a prototype system suitable for future human use.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.