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.

这项小企业创新研究（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，可按需提供纳洛酮，用于在阿片类药物过量或类似医疗紧急情况下进行干预。疾病预防控制中心的数据显示，阿片类药物过量是45岁以下美国人死亡的主要原因，在2022年夺走了8万多名美国人的生命。纳洛酮是目前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。这有可能每年挽救5万美国人因阿片类药物过量而死亡。这个小企业创新研究（SBIR）第一阶段项目是开发和验证一种新型外部系统的两个组成部分，该系统使用传感器衍生的氧饱和度和呼吸速率测量来检测和干预阿片类药物过量的情况。将开发一种新型的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给药平台，将被设计和验证为可靠的机械给药，在可穿戴系统的物理和功率限制下实现多次连续剂量的定制纳洛酮。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。这些组件将与该公司的算法集成到一个原型系统中，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。该奖项反映了美国国家科学基金会的法定使命，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。