SBIR Phase I: Medical Device for Monitoring Respiratory Disease

SBIR 第一阶段：监测呼吸系统疾病的医疗设备

• 批准号: 1843658
• 负责人: Justice Amoh
• 金额: $ 22.5万
• 依托单位: Clairways LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1843658&HistoricalAwards=false
• 关键词: SBIR; Phase; Medical; Device; Monitoring

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be a novel wearable device for unobtrusively detecting changes in the lung health of patients with chronic respiratory disease. This Passive Unobtrusive Lung function Monitor (PULMO) will be the only device that can automatically measure a patient's lung health information without requiring any active engagement from the clinician, and without imposing any obtrusive changes to the patient's daily routine. The PULMO is useful in a broad range of respiratory disease applications, such as lung transplant post-operative care, asthma management and respiratory therapy research, that require continuous, objective and unobtrusive monitoring of lung function change. Since PULMO technology is compatible with low-cost microcontrollers, it has the potential to dominate the spirometry market and respiratory clinical trials space with high-volume production. The spirometry market has an expected CAGR of 9.4 % from 2018 to 2025, reaching a $1.4 billion market value by 2025, while clinical trials expenditures on new respiratory therapy drugs is forecast to reach $1.7 billion in 2025.This Small Business Innovation Research (SBIR) Phase I project addresses the major drawback of the state-of-the-art in continuous monitoring of respiratory disease, which is that it demands daily discipline, effort and proper technique of the patient, resulting in missing, invalid or fabricated data. In this project, a manufactured PULMO test device will be implemented with an intelligent event detection unit combined with a low power microcontroller, and the total average power consumption will be less than 300 microWatts. The measurement error of the PULMO will be within +/- 5 %, which is necessary for detecting changes in lung impairment. The intelligent event detection unit will be implemented as a nonlinear dynamical system in a custom integrated circuit. A gated recurrent neural network that is optimized for embedded low resource systems will be implemented in the low power microcontroller and will be used to detect respiratory disease symptoms. Controlled tests will be performed with a silicone phantom chest to evaluate the measurement accuracy of the PULMO device.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/商业潜力将是一种新型的可穿戴设备，可无效地检测患有慢性呼吸系统疾病患者肺部健康的变化。这种被动的不引人注目的肺功能监测仪（PULMO）将是唯一可以自动测量患者的肺部健康信息的设备，而无需临床医生进行任何积极参与，并且不会对患者的日常工作进行任何令人讨厌的变化。 PULMO在广泛的呼吸道疾病应用中很有用，例如肺移植后护理，哮喘管理和呼吸疗法研究，需要持续，客观且不受欢迎的肺功能变化监测。由于PULMO技术与低成本的微控制器兼容，因此它有可能以大量生产来支配肺活量计和呼吸道临床试验空间。从2018年到2025年，肺活量测量市场预期的CAGR预期为9.4％，到2025年达到14亿美元的市场价值，而新呼吸治疗药物的临床试验支出预计将在2025年达到17亿美元，在2025年达到17亿美元。患者的纪律，精力和适当的技术，导致缺失，无效或捏造的数据。在该项目中，将使用智能事件检测单元和低功率微控制器结合使用制造的PULMO测试设备，总平均电力消耗将少于300 microwatts。 PULMO的测量误差将在+/- 5％之内，这对于检测肺部损伤变化所必需。智能事件检测单元将在自定义集成电路中作为非线性动力系统实现。在低功率微控制器中将实施针对嵌入式低资源系统进行优化的封闭式复发性神经网络，并将用于检测呼吸道疾病症状。对照测试将使用硅胶板箱进行评估PULMO设备的测量准确性。该奖项反映了NSF的法定任务，并认为使用基金会的智力优点和更广泛的影响评估标准，认为值得通过评估来获得支持。