SBIR Phase II: Handheld and Low-cost Pulmonary Function Testing Device using Smart Coherent Multi-signal Oscillometry Technique

该小型企业创新研究（SBIR）第二阶段项目的更广泛影响/商业影响是开发用于检测和诊断肺部疾病的肺功能检测设备。如今，全球有超过6.5亿人（占世界人口的近10%）患有哮喘和慢性阻塞性肺病（COPD）等肺部疾病。目前，肺功能测试的最完善的方法是肺活量测定法，其需要患者进行不自然的呼吸动作。此外，肺活量测定法不能检测某些肺部疾病。所提出的技术将在没有特殊呼吸动作的情况下使用，并且将能够比肺活量计区分更多的肺部状况。由于所提出的设备可以在患者正常呼吸时使用，因此它还将满足目前服务不足的患者群体，例如幼儿和老年人，用于肺部状况的检测和诊断。通过瞄准便携式外形，所提出的技术将使目前不可行的护理点肺部测试成为可能。拟议的项目将开发第一个手持实施的强迫振荡技术（FOT）的充分研究的原则，其中声压波通过嘴发送到患者的肺部和反射用于测量肺功能。因此，不需要患者进行特殊的呼吸操作。Cognita Labs将采用模块化方法进行产品设计，并开发产品级的先进集成设备，包括硬件、平板电脑应用程序和EHR集成。该设计将包括在第一阶段开发的所有创新，以减少设备尺寸和成本，同时提高其测量精度。拟议的设备将进一步开发和集成一个新的基于超声的非侵入式传感器到设备中，以显着降低消耗品（一次性接口）的成本，并最终降低测试成本。该团队还将开发一种新的多分辨率预筛选测试，目的是减少门诊诊所的工作时间。

The broader impact/commercial impact of this Small Business Innovation Research (SBIR) Phase II project is the development of a pulmonary function testing device for detection and diagnosis of pulmonary conditions. Today more than 650 million globally, nearly 10% of the world's population, suffer from lung conditions like Asthma and Chronic Obstructive Pulmonary Disease (COPD). Currently, the most well-established method for lung function testing is spirometry, which requires the patient to conduct an unnatural breathing maneuver. In addition, spirometry cannot detect certain lung conditions. The proposed technology will be used without special breathing maneuver, and will be able to differentiate more lung conditions than spirometer. Since the proposed device can be used while the patient is breathing normally, it will also cater to currently under-served patient segments, e.g. young children and senior citizens, for detection and diagnosis of pulmonary conditions. By targeting a portable form-factor, the proposed technology will empower point-of-care pulmonary testing where it is currently infeasible. The proposed project will develop the first handheld implementation of the well-studied principle of forced oscillation technique (FOT), where an acoustic pressure wave is sent via the mouth to a patient's lungs and reflections are used to measure lung function. Thus, no special breathing maneuver is required from the patient. Cognita Labs will adopt a modular approach for product design, and develop product-caliber advanced and integrated devices, that will include hardware, tablet app and EHR integration. The design will include all the innovations developed during Phase I to reduce the device size and cost while increasing its measurement accuracy. The proposed device will further develop and integrate a new ultra-sound based non-invasive sensor into the device to significantly reduce the cost of the consumable (disposable mouthpiece) and ultimately the cost of test. The team will also develop a new multi-resolution pre-screening test, with the objective to reduce bench time in outpatient clinics.