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

SBIR 第一阶段：开发可穿戴医疗设备来检测和治疗阿片类药物过量。

• 批准号: 2335577
• 负责人: Bradford Holden
• 金额: $ 27.5万
• 依托单位: RESILIENT LIFESCIENCE, INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2335577&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; wearable; medical

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.

该小企业创新研究 (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，可按需现场输送纳洛酮，以干预阿片类药物过量或类似的医疗紧急情况。疾病预防控制中心的数据表明阿片类药物过量。导致 45 岁以下美国人死亡的主要原因，到 2022 年将导致 80,000 多名美国人丧生。纳洛酮给药代表了目前快速稳定阿片类药物过量影响的标准方法，但大约69% 的阿片类药物过量死亡是在没有旁观者在场的情况下进行干预的。该项目提出了一种可穿戴设备，该设备集成了外部非侵入性传感器和药物输送系统，能够在阿片类药物过量时皮下注射纳洛酮。每年挽救 50,000 名因阿片类药物过量服用的美国人的生命。该小型企业创新研究 (SBIR) 第一阶段项目旨在开发和验证新型外部系统的两个组件，以在阿片类药物过量情况下进行检测和干预。将开发一种新型自给式可穿戴机械、低功率药物输送机制，并验证其在模拟使用条件下的稳定性。基于贴片的药物输送平台将被设计和验证以实现可靠的机械输送，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，并将在加速老化测试期间验证纳洛酮配方的稳定性。这些组件将被集成到一个原型系统中，该系统集成了心率、呼吸和氧合的算法，以完成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，并被视为值得通过使用基金会的智力优点和更广泛的影响审查标准进行评估来支持。