SBIR Phase I: Handheld Portable Impulse Oscillometer

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.