SBIR Phase I: Novel Device for detecting changes in the esophageal lumen using single point ultrasonic transducers

Reflodx, Inc., Kaysville UT

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will benefit nearly 6 million children per year who are suspected of having abnormal Gastroesophageal Reflux (GER) which can lead to a more serious condition with numerous complications referred to as Gastroesophageal Reflux Disease (GERD). Current detection paradigms include costly and invasive procedures that often require overnight hospitalization, prescribing pharmacological Proton Pump Inhibitors (PPIs) without objective evidence and or exposure to radiological imaging. The outcomes of this project will lead to a low cost, non-invasive method for detecting GER, without requiring hospitalization. This will facilitate earlier detection of GER and reduce overall healthcare costs and burdens associated with GERD and its accompanying complications. The proposed project will demonstrate the feasibility of using single point ultrasonic transducers to non-invasively detect and characterize reflux. Current reflux detection relies on impedance and pH probes which are placed in the patient?s esophagus through a nasogastric probe. This often requires anesthesia and overnight hospital observation which is costly, invasive, and prone to artifacts that change the reflux episodes normally experienced by the patient. Ultrasonic imaging can observe reflux occurring in the esophagus but requires hundreds of ultrasonic transducers in a single probe and a trained clinician to manually observe and identify the reflux events. These two factors make ultrasonic imaging costly to use and prevents it from being used for extended periods of time, which is necessary to determine if abnormal amounts of reflux are occurring. The proposed project will use ultrasonic imaging as a control method to demonstrate the ability of single point ultrasonic transducers to generate an acoustic signature capable of detecting whether the esophagus is expanded or collapsed to identify episodes of reflux. Detection and characterization of reflux through single point transducers would ultimately enable the development of a portable, safe, and accurate home monitoring device.