Right now there are more than 100,000 people in need of an organ. The long list isn’t just an issue of supply and demand, but of delivery too. When a heart becomes available, a four-hour clock starts ticking — it has to be put on ice, shipped to where it’s needed, and patient, surgeon and support staff have to be summoned. If that takes longer than four hours, the chance of a body accepting the organ diminishes rapidly. By six hours, it’s pretty much too late.
But if that heart could be kept alive for longer, the chance of getting hearts to patients that need them would skyrocket. Now, thanks to the work of researchers at Vascular Perfusion Solutions, there’s a device that can do just that. In fact, it won its inventors the SAE’s Create the Future Design Contest award in 2019.
At that time, it was called the ULiSSES (for Universal Limb/Organ Stasis System for Extended Storage). Instead of using ice for preservation, the device pumped oxygen into the aorta of a heart, or a major artery of other organs or limbs. That prototype (developed by one of the company’s founders, Leonid Bunegin) was 3D printed, assembled by hand, and used no electricity — all its power needs came from the expansion of the compressed oxygen.
Since then, it’s come a long way. “The first device was maybe like a fast car, like a Mustang. What we have now is like a Ferrari, but affordable — it’s amazing,” said Rafael Veraza, the Director of Translational Science at the company. “We’re using the same principles, but now we’ve hired engineers with medical device experience to perfect it and make it more efficient.”
The new version is still primarily powered by compressed oxygen but has been reengineered to consume less. It includes a backup pump in case one fails, and sensors and a display for monitoring system performance. And now it’s called the VP.S ENCORE. But the biggest change is the amount of experience the device has seen. It’s already been used with over 66 pig hearts and even several human hearts (that were previously deemed not acceptable for a transplant).
The company has also completed an experiment where they took a heart from one sheep and transplanted it in another, once with the traditional on-ice method and once with the ENCORE. The animal that received the heart with the new device spent less time on the heart and lung machine, required less medication to keep the heart pumping, had less inflammation, and required less pace-making to help it beat.
VPS has been focusing on hearts because they’re in high demand and are the hardest organ to keep viable. But the company plans to create devices for other organs as well. They’re also working on other methods of keeping organs alive for prolonged periods of time. For instance, they are running a study testing compounds that would induce hibernation to extend organ viability. “Persevering organs on demand could really change how transplants are done,” said Veraza. “It sounds like sci-fi, but you could have scheduled transplants, and preserve organs on demand — you’d basically have organ banking.”
As a result of the device’s successes — and potential — the FDA has given the ENCORE “Breakthrough Device” designation. Now the company can work more efficiently with the agency to move quickly toward approval. A human clinical trial is likely to start within a year and a half.
“We see the potential for this machine to save many lives,” said Veraza. “In an ideal world we want this device to be in every transplant center in the world.”
2019 GRAND PRIZE WINNER
INNOVATORS: Rafael J. Veraza (left), Leonid Bunegin, and Tom DeBrooke
INNOVATION: A medical device extends organ and limb viability by providing organ and limb resuscitation, preservation, and transport capabilities.
IMPACT: By keeping organs alive for prolonged periods of time, the device has the potential to save many lives.
Learn more about the 20th Anniversary Contest at https://contest.techbriefs.com/
Michael Abrams is a science and engineering writer based in New Jersey.