Portable Low-Cost Pulmonary Forced Oscillation Technique Device

Project Summary Abstract Koronis Biomedical Technologies and its collaborators propose to commercialize a low-cost, portable respiratory assessment device using the forced oscillation technique (FOT). The proposed FOT device requires zero skill from the subject and operator, making it ideal for occupational health screening, physician office use, and home monitoring. The current gold standard for accurate and repeatable measurement of lung function is spirometry. Spirometry is a pulmonary function test that measures the volume and rate of airflow a patient can maximally exhale into a tube attached to a precise airflow meter. The role of spirometers has been limited due to their reliance on technique adherence. Unlike many medical diagnostic tests where the patient is essentially a passive participant, spirometry requires active patient participation. The procedure requires the patient to take the deepest breath possible and then exhale as hard as possible for as long as possible. The test is normally repeated to ensure reproducibility. Spirometry results are highly dependent on patient cooperation and effort. Patients often face a significant learning curve. Some patients cannot, or will not, produce interpretable results. FOT measures pulmonary airway resistance and reactance. In contrast to traditional spirometry, the key clinical advantage of FOT is that the technique is passive and does not require the patient to breathe forcefully on command. In this project, all components of the production system will be finalized and evaluated for usability and performance in human evaluations along with market release under FDA market clearance.