The U.S. is currently facing a shortage of ventilators. Here’s how they work and why they are so important in fighting COVID-19. USA TODAY
When Vermont’s economy shut down to battle the coronavirus, Jim Richards felt fortunate his aviation company in South Burlington, Aerodyme Corp., was allowed to stay open.
Business fell off significantly for the small company offering engineering support to owners of Rockwell Commander airplanes. Soon Aerodyme was down to Richards, 66, his wife and a key engineer, and even the three of them had time on their hands.
“We’re a pretty sharp bunch of engineers, the three of us,” Richards said. “We just got talking one day about this need for breathing assistance machines — ventilators, in a word.”
Richards, a graduate of the Massachusetts Institute of Technology in electrical engineering, spent his career innovating and inventing in the consumer electronics field before opening Aerodyme in 2002. He felt sure he could design a ventilator that would be effective, cheap and easy to build.
After getting started in early March, Richards and his team are on the verge of human trials for the AeroBreath Ventilator, a simple, low-cost device that promises to bring new life-saving capabilities to the developing world. With the coronavirus crisis in mind, Roberts also hopes to free up expensive, sophisticated ventilators for those who need them most in American hospitals by allowing recovering patients to transition to the AeroBreath ventilator.
Drawing on his connections at MIT, Roberts teamed up with a doctor at a Boston hospital, who is forming a clinical trial in May for 20 patients using the AeroBreath ventilator. The trial will generate data that will be used to apply for approval for the device from the U.S. Food and Drug Administration.
“The physician who has guided this project from Day 1 is a pulmonary specialist and ICU doctor doing this on off days when he’s not in the ICU,” Richards said.
Richards said the specialist asked to remain anonymous because he would be besieged with phone calls if word got out he was involved in the project, and he is already stretched thin by the pandemic.
“They’re still in a world of hurt down there,” Richards said.
The pulmonary specialist is speaking with some potentially large donors for the project, according to Richards.
“It’s not that he’s hidden away,” Richards said. “We simply have to shield him so he can get the job done.”
Richards said he is also planning to do a test session on an artificial lung at the University of Vermont’s IMFLabs, which offers custom design and fabrication services. These tests will confirm results Richards generated using the AeroBreath ventilator on himself and are an important step in preparing for the human trials in Boston.
An aggressive attack on the lungs
On the AeroBreath website, the Boston doctor explains the purpose the patent-pending ventilator would fulfill: “The primary application of simple vents in this country will be in the recovery phase of COVID-19, where it is taking us 1 to 3 weeks to wean our patients off the complex ventilators that were used to save their lives, and to free up those complex machines for the next person.”
The pulmonary specialist told Richards COVID-19 launches the most aggressive attack on the respiratory system he has ever seen. His input has been invaluable in designing the AeroBreath, Richards said.
“He’s right there on the battlefront, and knows exactly what’s going on and what the needs are,” Richards said.
Another advantage the pulmonary specialist brings to the project is that his hospital is part of a multinational health organization that works in countries all over the world.
“He saw both how this device could help here and equally how it could help in resource-poor countries that don’t have big, expensive machines, and probably never will have them,” Richards said.
Richards and his team are working on three versions of the AeroBreath, the S, E, and SE. The simplest version, the S model, is hand-cranked and is intended for the most difficult situations in terms of infrastructure. Richards said these units could be produced for as little as $10 and would be provided free of charge.
Low cost and speed of production has been at the forefront of Richards’ thoughts from the beginning on the AeroBreath project, which is why he has steered clear of 3D printing as a method of producing the ventilators.
“3D printing is fantastic for prototyping, but not high volume and low cost,” Richards said. “That’s where you got to be if you want to be able to deliver thousands, tens of thousands or hundreds of thousands of breathing assistance machines all over the world, to help this time and be ready for next time.”
Richards turned instead to injection molding, a fast and inexpensive way to manufacture products he was well versed in, given his 30 years of designing consumer electronics. An injection-molding company in Wisconsin called Fathom is a benefactor of the AeroBreath project, contributing a “fair amount” of free service, Richards said, and building the injection molding tools required at a reduced cost.
Fathom has begun the process of creating the tools, but to finish all of them will require about $150,000, which Richards is trying to fundraise.
The National Institute for Aviation Research at Wichita State University in Kansas is another benefactor of the AeroBreath project. The Institute is providing 3D printing services to prototype three sets of six different parts, Richards said, using the best 3D printers available.
If he had to pay full price for the parts, Richards said, it would cost $15,000 to $20,000. Richards paid for materials only, which amounted to about $200.
Add a motor
The E version of the AeroBreath ventilator adds a motor and some simple electronic circuits that automate the machine, but don’t overly complicate it.
“The caregiver can walk away from it, and doesn’t have to be bedside,” Richards said. “There are alarms to alert you if the patient stops breathing.”
Even the automated version of the AeroBreath could cost as little as $50 if Richards achieves the volume he needs of delivering tens of thousands of the units.
The SE model is being designed in response to a request from the Boston doctor to develop a version of the ventilator that could be taken into the ICU. Patients on sophisticated mechanical ventilators are kept sedated to allow them to tolerate having a tube down their throats.
There comes a point, Richards said, when a patient is sufficiently recovered to remove her from the ventilator, but is not yet ready to breathe on her own. Currently, doctors have no choice but to leave the patient on the sophisticated ventilator for up to three weeks while she completes her recovery, potentially depriving other more seriously ill patients from using the ventilator instead.
“They’d like to extubate you at the same time you’re ready to leave the ICU,” Richards said. “That isn’t happening.”
The SE version of the AeroBreath would be a “recovery ventilator,” Richards said, capable of transitioning a patient from being on the sophisticated, expensive ventilator to breathing on her own.
This will require a more sophisticated machine, which Richards still hopes to keep inexpensive. One of the most important tasks the AeroBreath SE will have to perform is to keep the walls of the patient’s lungs from touching as she exhales. Normally, the walls do touch, but in a COVID-19 patient, the interior of the lungs becomes so sticky that if they touch they’ll adhere, and when the patient breathes in the lungs will tear.
Richards tested the capability in the AeroBreath SE, known as PEEP, or positive expiatory ending pressure, on himself, after being assured it would not put him at any risk.
“It’s a pretty weird feeling,” Richards said. “You feel like you didn’t finish breathing out.”
Richards has been paying for work on the AeroBreath project himself, together with friends and family, and “forward-thinking groups and businesses.” He is making his initial submissions to the FDA this week, and is hoping to produce the first 10,000 units of the two simplest models by early June.
That will be possible, Richards said, only if he is able to raise the $150,000 he needs to pay for the remaining injection molding tools required.
Contact Dan D’Ambrosio at 660-1841 or email@example.com. Follow him on Twitter @DanDambrosioVT. This coverage is only possible with support from our readers. Sign up today for a digital subscription.
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