Development of a Portable Automated System for Intravascular Delivery of Oxygen

Acute Respiratory Distress Syndrome (ARDS) is a form of acute lung injury with resultant hypoxemia that is associated with significant morbidity and mortality. ARDS can be caused by a variety of lung injuries common both in civilian and military settings such infection (i.e. influenza and Covid-19), sepsis, blunt thoracic trauma, blast lung injury (BLI), or aspiration. Despite the morbidity and mortality related to ARDS, few proven treatment options exist beyond conventional mechanical ventilation. In severe cases not responsive to mechanical ventilation, patients may require veno-venous extracorporeal membrane oxygenation (ECMO). Both mechanical ventilation and ECMO require highly trained personnel, are resource intense, and are associated with considerable risk and morbidity. There is an urgent need for a safer, simpler, less-invasive therapy that sustains healthy oxygenation in patients with ARDS that can function independent of the injured lungs. To address this urgent need, our team has developed a minimally-invasive intravascular membrane oxygenator catheter and control system that is able to deliver supplemental oxygen directly to the bloodstream. Our catheter is intended to support patients with acute hypoxic respiratory failure (i.e., ARDS) in conjunction with, or in place of mechanical ventilation, in situations where mechanical ventilation cannot adequately or safely provide sufficient oxygenation. During this project period we will develop an improved portable breadboard control system that is capable of automatically operating two catheters in a patient using closed-loop controls. The controls will be such that continuous manual intervention will not be required to maintain desired blood oxygenation targets following catheter insertion and initial input of system settings. Additionally, we will optimize the oxygen delivery of our catheter so that it is both smaller (no larger than 25 Fr) and more effective (delivers =50 mL/min) through a variety of engineering approaches. Our control system and catheters will be tested extensively during development in a custom in vitro benchtop system capable of mimicking mixed venous conditions. The project will culminate with a series of clinically-relevant pilot in vivo tests using a large animal ARDS model to demonstrate and validate the functionality of our catheters and automated breadboard control system. Successful completion of this project by integrating these highly-efficient catheters with our automated control system will allow for simplified and improved care of the warfighter with injured lungs by reducing the reliance on mechanical ventilation and eliminating the need for VV-ECMO altogether. Our technology will revolutionize the way patients with ARDS can be treated allowing clinicians to support patients in a lung-protective manner and will allow the military to support wounded warfighters safely throughout prolonged field care in austere environments.