Extracorporeal Membrane Oxygenation, better known as ECMO, was developed in the late 1960s as an emergency rescue for preterm babies, and also gained use for long-term heart and lung support for durations beyond the capabilities of conventional bypass machines.
“The fundamental technology has remained largely unchanged since it was originally developed,” said Dr. Jeff Borenstein, laboratory fellow and director of Draper’s Biomedical Engineering Center in Cambridge, Massachusetts. “What’s used in clinical practice does not change quickly.”
Borenstein leads programs in organ and disease models for drug discovery and safety testing, organ assist devices and drug delivery systems.
Since its inception, the safety and availability of ECMO has been limited by the complexity of the blood circuitry and complications in the oxygenator and circuit components during blood circulation, such as clotting, bleeding and inflammatory responses.
Also, only the largest medical centers have access to the life-saving technology, and it requires a large team of highly specialized personnel to administer the treatment and deal with the frequent complications.
ECMO first gained wider public attention during the swine flu epidemic and then again during the COVID-19 pandemic, as a last-ditch intervention for the sickest patients, whose lungs were so damaged that conventional mechanical ventilation could not be used.
“Injured lungs need time to heal,” said Borenstein. “Mechanical ventilation applies too much pressure and increases the risk for infection and damage from exposure to pure oxygen, when the lungs are already compromised.”
Borenstein’s team addressed these challenges by developing an alternative approach to gas exchange based on a 3-D branching network of blood channels, effectively mimicking the human body’s natural microcirculation. This was previously unheard of at the human-ready testing footprint they have achieved
“What Jeff and his team have accomplished here is beyond anyone’s dreams,” said Petrie.
They used microfluidic technology, a specialty at Draper, to control for flow behavior, fluidic resistance, shear stresses and uniform distribution across a large-scale oxygenator.
“Here we report on development and demonstration of the first microfluidic respiratory assist device at a clinical scale, demonstrating efficient oxygen transfer at blood flow rates of 750 milliliters per minute, the highest ever reported for a microfluidic device,” said the author of the results article, published in the Journal of Advanced Science.
Mimicking the human lung’s natural branch-like structure mitigates the risk of complications such as clotting, which is frequently experienced with traditional ECMO.
Borenstein’s team began work on lung technology in 2010 with internal Draper funding, which was later advanced by the National Institutes of Health, Department of Defense, and commercial device manufacturers. In 2021, Draper’s advancements received recognition from the American Society for Artificial Internal Organs.
The research is currently a collaboration between Draper and The Geneva Foundation’s Autonomous Reanimation and Evacuation (AREVA) Research Program. AREVA is a pioneer in groundbreaking treatments for trauma care and lung injuries.
“Especially combat-relevant trauma and novel critical care interventions,” says Teryn R. Roberts, Ph.D., a co-principal investigator along with Dr. Andriy I. Batchinsky for Geneva at AREVA and a co-author of the research study.
“While ECMO has been around for a while, it is not widely adopted in combat scenarios or in the clinical environment,” Roberts said. “Draper’s innovations in solutions for the warfighter, including ECMO, was a natural fit for our work at The Geneva Foundation and AREVA.”
This work was funded by the U.S. Army Medical Research Acquisition Activity and supported by the U.S. Army through the Peer Reviewed Medical Research Program under award number W81XWH1910518.
In a National Institute of Health study of 876 burned military casualties called “Acute respiratory distress syndrome in wartime military burns: application of the Berlin criteria”, 291 required mechanical ventilation.
“Of those, nearly one third developed ARDS, and nearly one third of patients with ARDS did not survive. Moderate and severe ARDS increased the odds of death by more than fourfold and ninefold, respectively,” the study concluded.
“Early application of ECMO could mean a better prognosis for the patients who need it,” said Timothy Petrie, head of business for medical devices, responsible for the commercialization of the new ECMO technology and generating interest from investors.
Once further preclinical testing is completed, the team plans to conduct first-in-human testing in the next few years, as they translate the technology as a safer and simpler critical care treatment for much wider use than current ECMO.
Petrie attributes the rapid progress Borenstein’s team has made to Draper’s in-house, multidisciplinary team that in an expedited process of innovation, develops ideas, produces models, prototypes, tests, analyzes results, and then reiterates, ensuring diverse, critical perspective along an efficient timeline.
“We also have a thankfully hard-headed leader who has brought this to where it’s at,” said Petrie of Borenstein. “He has driven this since the beginning.”
“It’s all about having lifesaving impact,” said Borenstein. “We are all here to innovate and because we love what we do, but it’s the call to answer an urgent need that has kept us going.”