STTR Phase I: Tracheal Phrenic Nerve Stimulation Device To Support Lung And DiaphrAgm Protective Ventilation

Xn Health Inc., Newark NJ

Investigators

Abstract

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase I project is to advance the in-hospital care and health of patients who are critically ill due to respiratory issues requiring mechanical ventilation. This project aims to reduce one of the major issues driving the economic cost of hospitalizations – length of stay in the intensive care unit (ICU). An estimated 1.2 million Americans per year require mechanical ventilation while hospitalized. Although critical to a patient’s survival, ventilator use rapidly weakens a person’s respiratory muscles (the diaphragm) and can quickly lead to lung injuries. It is estimated ~40% of ventilator time, is time spent recovering and attempting to wean patients off the ventilator. Prolonged time on mechanical ventilation increases the risk of ventilator dependence, failed extubation, and other long-term complications. These risks impact a patient’s well-being with significant implications for healthcare resources as prolonged mechanical ventilation results in 3-4 fold costs versus short-term ventilator use. This Small Business Innovation Research (SBIR) Phase I project seeks to develop a novel transtracheal phrenic nerve stimulation device that reduces injury rates caused by mechanical ventilation. The system stimulates the phrenic nerves to induce diaphragmatic contractions thereby increasing the size of the chest cavity and allowing the lungs to inflate such as during normal breathing. In this project the stimulation parameters inducing natural diaphragm contractions will be optimized, an automated algorithm developed for prolonged use as intended, and the external system validated for chronic use using a large animal model study. It is expected this Phase project will result in a robust safe and automatic phrenic nerve stimulation prototype system. The successful completion of this project will be followed by integrating additional safety features, refine pacing parameters, and investigate the effect of varying treatment protocols on clinical outcomes in patients in the next subsequent phase. 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.