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.

这个小型企业创新研究（SBIR）第一阶段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，用于不引人注目地检测慢性呼吸道疾病患者肺部健康的变化。这种被动式非侵入性肺功能监测仪（PULMO）将是唯一一种可以自动测量患者肺部健康信息的设备，无需临床医生的任何主动参与，也不会对患者的日常生活造成任何干扰。PULMO可用于广泛的呼吸系统疾病应用，如肺移植术后护理、哮喘管理和呼吸治疗研究，这些应用需要连续、客观和不显眼地监测肺功能变化。由于PULMO技术与低成本微控制器兼容，因此它有可能通过大批量生产主导肺活量测定市场和呼吸临床试验领域。从2018年到2025年，肺活量测定市场的预期复合年增长率为9.4%，到2025年将达到14亿美元的市场价值，而新的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。这个小企业创新研究（SBIR）第一阶段项目解决了国家的主要缺点，在呼吸系统疾病的连续监测中，这需要患者的日常纪律、努力和适当的技术，导致数据缺失、无效或伪造。在该项目中，制造的PULMO测试设备将采用智能事件检测单元与低功耗微控制器相结合，总平均功耗将低于300微瓦。PULMO的测量误差将在+/-5%范围内，这对于检测肺损伤的变化是必要的。智能事件检测单元将被实现为定制集成电路中的非线性动态系统。针对嵌入式低资源系统进行优化的门控递归神经网络将在低功耗微控制器中实现，并将用于检测呼吸系统疾病症状。将使用硅胶体模胸部进行受控测试，以评估PULMO设备的测量精度。该奖项反映了NSF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。