Undergrads design ventilator device; form company to aid newborns during surgery

As American Family Children’s Hospital expanded its neonatal intensive care unit in 2014 to treat Wisconsin’s high-needs surgery patients shortly after birth, anesthesiologist Lana Volz was confronted with a plumbing problem.

The “wye,” a Y-shaped connector to the tube placed inside the infant’s airway, was an awkward combination of rigid, flimsy and heavy. The design hindered the delicate process of performing surgeries in babies to repair life-threatening conditions, like heart and lung defects.

“The commercial systems routinely fall apart … are heavy and place unnecessary torque on the infant airway,” says Volz, a physician and assistant professor of anesthesiology at University of Wisconsin–Madison. “That puts patients at risk for harm and adds to the stress of anesthesiologists during high acuity, complex neonatal surgeries.”

So in 2017, Volz did something unusual: She delivered her problem to the UW–Madison department of biomedical engineering, where undergraduates select real-world design problems to solve during the seven-semester design sequence.

This December, building on work by their predecessors in the BME design sequence, students Sara Jorgensen (age 20) and Margaret Edman (21) filed a provisional patent application for a lighter, tighter and more adjustable wye.

The wye connects to two tubes that supply inhalation gas and remove the exhaled gas during surgery.

The project began by laying out goals to overcome the “heavy, unstable, inflexible” aspects of the marketed wye. When Jorgensen and Edman joined up in September 2017, they saw those shortcomings first-hand while observing surgery: When Volz adjusted the patient position at the surgeon’s request, the tubing disconnected.

As Volz says, that’s simply “unacceptable.”

Doctors at American Family perform hundreds of neonatal surgeries per year, taking care of patients from across Wisconsin, Illinois and Iowa.

Through months of brainstorming, discussing, molding and remolding, the students created a design that promises to solve the basket of problems: The unusual neck holds any angle from straight to a sharp crookneck. The unit is lighter. The connections to the tubes are tighter. And, with advice from an engineer at the School of Medicine and Public Health, the shapes are suited to injection molding.

“We have tested it on a simulated infant, which allowed us to analyze the flow rate and compliance to the mouth, and it’s the same or better than the existing device,” says Jorgensen. “Because we have reduced the interior dead space, the flow is more streamlined, allowing less unwanted mixing of inhaled and exhaled air.”

A student lawyer from the Law and Entrepreneurship Clinic on campus helped file a provisional patent application that allows the women’s startup, called Wye Not Medical LLC, to delay the actual patent filing for one year.

“One of the biggest challenges to getting taken seriously is that we’re two girls in college,” says Jorgensen. The provisional patent application should help, as should the enthusiastic support of Volz. “Working with these biomedical engineering students has been the highlight of my academic career,” says Volz. “They are so smart, hard-working, and enthusiastic about improving patient safety for our pediatric surgical patients! It is a pleasure to work with them.”

“This project is a perfect example of how design throughout the curriculum in BME prepares our students for success outside of the classroom,” says John Puccinelli, course director.

The intense experience in design sets BME apart, says Jorgensen. “A lot of my friends in other engineering majors say they wish they had something like it. I credit the design courses for my going co-op next semester, and for every single interview.” (In the engineering world, a “co-op” is similar to an internship.)

The invention “looks like a simple solution, but there are so many steps you need to get to this point,” says Edman. “A lot of people have ideas, but don’t have a way to develop, fabricate and manufacture them. BME design gave us these resources so we could bring our idea to life.”

Reality is a great teacher, Edman adds. “If the current anesthesia circuit gets tapped, it can fall apart, and the anesthesiologist has less than one minute to reconnect it; otherwise the pause in ventilation can lead to lasting damage. It’s mind boggling, and that’s why the client came to BME, with the hope that students like us could help solve a real-world problem.”

Read about the Biomedical Engineering showcase at UW–Madison.