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

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.