SBIR Phase I: Handheld Portable Impulse Oscillometer

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业直接解决了美国哮喘的范围。呼吸系统专家说，他们在试图获得肺部疾病的明确诊断时陷入了困境，因为他们缺乏一种可靠的肺功能测试设备，这种设备可以用于所有患者，而且准确度很高。肺活量测定仪有一长串众所周知的缺点，专家们正在要求一种更好的设备。包括美国国立卫生研究院十多年的研究在内，越来越多的国际研究表明，脉冲振荡测量法是呼吸系统疾病最准确的PFT，它往往会在症状出现前几天使肺部状况恶化。在美国，仅哮喘的总成本估计每年约为560亿美元。这在很大程度上归因于这样一个事实，即如果没有频繁的客观测量，很难维持患者的哮喘控制。失去控制会导致哮喘加重、急诊室就诊、住院、失去工作和上学时间，以及更高的医疗费用。使用方便、临床准确的肺功能检测设备是实现这一目标的关键。这个小型企业创新研究（SBIR）第一阶段项目具有革命性的设计，将先进的脉冲振荡测量技术整合到手持式和具有成本效益的医疗设备中，满足呼吸系统专家在客户发现过程中提出的肺部测量要求。IOS方法的核心是通过患者正常的潮汐呼吸将温和的空气脉冲脉冲送入患者的肺部。低频脉冲穿过中央肺，穿过周围肺（阻力），然后反弹回IOS设备（电抗）。然后测量和分析阻力和电抗压力之间的差异，揭示周围气道阻塞的程度。来自每个设备的测试数据会自动发送到一个安全的云服务器，在那里进行分析，并与其他人口统计学上相似的患者进行比较。然后，分析结果被传输到患者智能手机、护理人员智能手机上的专有应用程序，以及患者的初级保健经理电子病历。该设备的家庭版本将允许远程和频繁地测量客观测量的肺部状态，并自动发送给提供者。这是哮喘社区长期以来所需要的突破。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。

The broader impact/commercial of this Small Business Innovation Research (SBIR)Phase I project directly addresses the scope of Asthma in the United States. Respiratory specialists say they are in a quandary in their attempts to obtain definitive diagnoses of lung diseases because they lack a reliable pulmonary functions test device that can be used on all patients and have a high degree of accuracy. Spirometry has a long list of shortcomings that are well known, and the specialists are asking for a better device. A growing body of international research, that includes ten plus years of NIH studies, is showing that impulse oscillometry is the most accurate PFT for respiratory diseases and that it can often worsening lung status several days before symptoms appear. The overall costs of asthma alone in the U.S. are estimated to be approximately $56 billion a year. Much of this is attributed to the fact that maintaining asthma control in a patient is difficult to do without frequent objective measurement. Losing control leads to increased asthma exacerbations, ER visits, hospitalizations, lost work and school days, and higher medical costs. Having an easy to use and clinically accurate pulmonary functions test device is the key element in this process. This Small Business Innovation Research (SBIR) Phase I project has a revolutionary design that incorporates the advanced technology of impulse oscillometry into a handheld and cost effective medical device that fulfills the lung measurement requirements requested by respiratory specialists during our customer discovery process. The core of IOS methodology is that gentle impulses of air are pulsed into the lungs of a patient via their normal tidal breathing. The low frequency impulses pass through the central lungs, travel throughout the peripheral lungs (resistance) and rebound back to the IOS device (reactance). The differences between the resistance and reactance pressures are then measured and analyzed, revealing the extent of the obstruction in the peripheral airways. Test data from each device is automatically sent to a secure cloud server where it is analyzed and compared to other demographically similar patients. The analyzed results are then transmitted to a proprietary application on the patient's smartphone, the caregiver's smartphone, and to the patient's primary care manager electronic medical record. The home version of the device will allow objectively measured pulmonary status to be remotely and frequently measured, and automatically sent to the provider. This is the breakthrough that the Asthma community has long needed.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.