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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是一种新型可穿戴医疗设备，可按需现场提供纳洛酮，用于干预阿片类药物过量或类似的医疗紧急情况。疾控中心的数据显示，阿片类药物过量是45岁以下美国人的主要死亡原因，2022年夺走了8万多美国人的生命。纳洛酮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的情况下进行干预。该项目提出了一种可穿戴设备，将外部非侵入性传感器与药物输送系统相结合，能够在阿片类药物过量时输送纳洛酮皮下注射。这有可能挽救每年因阿片类药物过量而导致的5万美国人的生命。这个小企业创新研究(SBIR)第一阶段项目是为一个新的外部系统开发和验证两个组件，以便在阿片类药物过量的情况下使用传感器衍生的氧饱和度和呼吸频率测量来检测和干预。将开发一种新的自含式可穿戴机械低功率药物输送机构和一种新的纳洛酮制剂，并在模拟使用条件下验证其稳定性。第一个组件是一个独立的基于贴片的药物传递平台，将设计并验证可靠的机械传递，在可穿戴系统的物理和功率限制下实现连续多次定制纳洛酮。纳洛酮配方将在指示日常磨损条件的高温加速老化测试中进行稳定性验证。这些组件将被集成到一个原型系统中，该公司的算法集成了心率、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优势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.