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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是一种新型的可穿戴医疗设备，可提供NALOXONE的按需现场交付，以介入OPIOID过量或类似的医疗紧急情况。 CDC的数据表明，杀菌剂过量是45岁以下的美国人的主要死亡原因，负责在2022年夺取80,000多名美国人的生命。Naloxone的递送代表了当前急性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未能进行旁观者进行干预。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以及能够在阿片类药物过量时输送皮下注射纳洛酮的药物输送系统。这可以使每年阿片类药物过量挽救50,000人生命的潜力。这项小型企业创新研究（SBIR）I期项目是使用传感器衍生的氧气安全和呼吸速率的测量方法来开发和验证新型外部系统的两个组件，以检测和干预。在模拟使用条件下，将开发并验证一种新型的独立可穿戴机械，低功率药物输送机制和一种新型的纳洛酮公式，以实现稳定性。第一个组件是一个基于独立补丁的药物输送平台，将经过设计和验证，可用于可靠的机械输送，从而在可穿戴系统的物理和功率约束中实现多种保守剂量的定制纳洛酮。在指示每日磨损条件的高温下，纳洛酮公式将在加速年龄测试期间进行验证。该组件将与公司的算法集成到心率，呼吸和氧合化，以完成适合未来人类使用的原型系统，将其集成到原型系统中。该奖项反映了NSF的法定任务，并通过使用基金会的智力和更广泛的影响来审查Criteria来诚实地通过评估来诚实地支持。