“When I’ve had situations [treating infants] where there have been difficulties, you absolutely stop and think there must be a better way—or at least I should be looking for a better way,” says Rodefeld, an associate professor of surgery at the IU School of Medicine. “That’s part of my job as a surgeon: to try to improve the way we take care of these kids.”
A normal heart has two ventricles: a right and left that act as the heart’s pumping chambers. However, children with single ventricle heart disease are born with only one functioning ventricle. Among all structural birth defects, single ventricle births are the leading cause of death for children in the first year of life.
A baby born with single ventricle heart disease faces a difficult road to recovery. A minimum of three open heart surgeries, called the Fontan procedures, are required to treat the condition, and only 50 to 70 percent of infants survive the surgeries. Additionally, the cost of intensive care for the infant is more than $1 million.
“During my fellowship at Stanford, when I was caring for some of the babies that had bad outcomes, it forced me to step back and critically think about why things are done the way they’re being done,” says Rodefeld. “I started to look into alternatives that might make it possible to do it better.”
About five years ago, Rodefeld realized a device to help these infants did not exist, so he began collaborating with other industry experts to create an entirely new heart pump: the viscous impeller (VIP) pump. A breakthrough came in August 2008 with the help of Purdue University engineer Steven Frankel, a professor in the School of Mechanical Engineering who helped create a novel design that solved critical functional issues.
“The pump has to basically augment blood flow in four different directions,” says Rodefeld. “Previously, we were looking at one-way pumps that would do this, but that would require two pumps to do the job. Now, we’ve come up with a single pump solution that will basically augment blood flow in four different directions. That was one of the major pieces that really moved us forward.”
Powered by magnetic coupling, the pump uses a spinning disc to pull blood from the veins and push it into the arteries. The pump is catheter-based, meaning a surgeon could insert it through a needle and advance it to the vessels near the heart. The pump also has the potential to reduce the three required open heart surgeries to a single operation.
Collaboration didn’t stop at the bench; a number of partnerships are also vital to move the pump toward commercialization. The Indiana University Research and Technology Corporation (IURTC), a not-for-profit agency that helps bring new technology to the marketplace, announced a partnership with Rose-Hulman Ventures to develop a prototype for the heart pump.
Despite the collaboration among three Indiana universities, the path to commercialization for the infant heart pump will be a difficult one—as is the case with many pediatric devices—and funding will likely be among the biggest challenges.
“The number of pumps that’d be sold or applied in the U.S. each year is a pretty small number; there’s not really commercial incentive to develop it,” says Rodefeld. “It’s difficult for physicians and surgeons like me to have devices that are ideally designed for kids, basically due to the small number of kids involved.”
While it’s a source of frustration for him, Rodefeld plans to rely on the business expertise of colleagues at the IURTC to navigate the sometimes murky waters of bringing a product to market.”
A lot of times, there are important inventions that may be difficult to commercialize, but still need to get out there for the public good,” says IURTC Business Development Manager Brad Fravel. “If we can help these children and reduce the burden on their families, hospitals and the health care system, that has a tremendous amount of value.”
Rodefeld is hopeful he could be using his device in the operating room in about five years—helping infants who face a devastating medical condition that threatens their life before it’s even had a chance to begin.
Source: Inside Indina Business