As the coronavirus swept into Maryland in March and health care providers scrambled to contain it, a national shortage of personal protective equipment forced physicians to improvise.
To shield themselves from contracting COVID-19, the disease caused by the virus, some repurposed garbage bags into gowns while others resorted to making their own masks and even procuring scuba, ski and swimming gear to cover their faces. Many took to social media to make public pleas for supplies.
Around that time, Dr. Steven Tropello, a Baltimore-based emergency and critical care physician who rotates among a handful of area hospitals, needed to put a breathing tube down a COVID-19 patient’s throat into their windpipe, a procedure known as intubation. With an airborne virus like this one, it was particularly dangerous to intubate someone, so a colleague suggested he put a plastic grocery bag over the person’s head to keep the virus particles from spreading around the room.
“That was a boiling point,” said Tropello, also an assistant professor at the University of Maryland School of Medicine. “We weren’t prepared to manage a lot of these aerosol-generating procedures.”
Tropello started sketching out a product that he hopes will soon find a place in every hospital. He calls it the “Care Cove,” and it’s designed to keep potentially infected people from transmitting infectious diseases onto their caregivers.
“I want the coves for myself. Is that selfishly clear?” Tropello said. “I’m not just building this for other people, I want to protect me, too.”
The Care Cove, which Tropello called a “bulletproof vest” for medical professionals, is a tented containment device made of clear vinyl that locks in particles and allows physicians to perform vital procedures such as intubations, endoscopies, bronchoscopies, and heart catheterizations without mistakenly suffocating patients.
It creates a negative pressure environment that medical personnel can wrap quickly around infected patients without contaminating any surfaces or workers.
Air enters the Cove through small openings around the perimeter, Tropello said, and the patient is supplied oxygen from devices administered by a health care provider. Because the air pressure is lower inside the Cove, contaminated air remains inside until it is pumped out through a filtered exhaust system.
Tropello founded Drape Medical LLC, where he’s the chief medical officer, to develop and market the Care Cove. He imagines a disposable Cove stored above every ICU bed and even in ambulances, and said they will remain relevant and necessary even after the coronavirus abates.
“The world has really changed, and not everyone’s going to get vaccinated,” Tropello said. “This isn’t going away.”
The coronavirus has caused major deviations from the normal standard of care. Providers are less likely to sit down face-to-face with patients; fewer providers are in hospitals and offices at a time. In May, the American College of Cardiology recommended testing patients for COVID-19 prior to performing heart catheterizations when possible, and carefully weighing the costs and benefits of the procedure against any other available options when rapid tests are not available.
Meanwhile, medical professionals around the world have died from COVID-19. Since July, more than 3,200 Marylanders with confirmed cases reported working in health care settings within 14 days of their positive test diagnosis or onset of symptoms, making it the most common workplace associated with the coronavirus, according to state data.
The Care Cove could restore confidence in medical settings, Tropello said, and return some standards back to their pre-pandemic normal.
“If we can isolate the problem quickly, everyone can take a deep breath and go about doing their job,” he said.
Others have created similar containment devices, and, in May, the U.S. Food and Drug Administration issued Emergency Use Authorization to protective containment devices that added an extra layer of protection during aerosol-generating procedures. But the agency revoked that “umbrella” authorization in August, saying that devices lacking negative pressure environments actually could pose additional risks to patients and providers.
Tropello said his product offers more protection than others with negative pressure because it covers most of a patient’s body.
He submitted a provisional patent March 28 and immediately formed a team to make, license and manufacture the product. He has partnered with Harbor Designs and Manufacturing LLC, a Baltimore-based design, prototyping and contract manufacturing company to help bring Care Cove to the market.
“I can’t see a hospital system not wanting to have this at the ready,” said Josh Barnes, Harbor Design’s co-founder and chief operating officer. “Performing these procedures where you’re putting a tube down a patient’s throat, all those viral particles are just going into the air. Without the right PPE, it’s beyond terrifying.”
Chris Hogan, editor-in-chief of the Journal of Aerosol Science, said products like the Care Cove must account for a lot of variables inside the device, including the patient’s blood oxygen level as well as the air pressure and carbon dioxide.
“These types of devices have a future in medicine, but I think it will take a while,” said Hogan, also a professor of mechanical engineering at the University of Minnesota. “There’s a level of testing you really want to do here.”
Hogan’s research lab also is working on an aerosol containment device, but he said it differs from the Cove because it’s meant for reuse and it might have a larger, battery-operated filter.
Tropello has a background in medical innovation. Four years ago, he founded CoapTech, a medical device company behind the PUMA-G, which enables ultrasound-guided feeding tube placement at a patient’s bedside. That product received clearance by the U.S. Food and Drug Administration last year.
Once the Care Cove’s design is finalized, Tropello’s Drape Medical will apply to the FDA for emergency use authorization.
Marie Yeh, associate professor of marketing at Loyola University Maryland’s Sellinger School of Business, said the company has demonstrated how the product can fulfill a need, but questions remain.
“What’s the price, and how are you going to dispose of it?” Yeh said. “When you say ‘bulletproof vest,' that makes it sound like it’s going to be 100% effective. I hope they can attain some good, hard evidence that supports hospitals using this product. But, I can also understand how something is better than nothing.”
With the help of Harbor Designs, Tropello hopes to bring the costs of making Care Coves down low enough so that clients can buy them in bulk or individually.
In a couple of weeks, Care Coves could be landing in the field for beta testing, he added, with providers at hospital systems throughout the state expressing interest. He declined to say what systems might be testing it.
“Other people have done this do-it-yourself stuff at home and haven’t put a rigorous process to it — but we know what to avoid,” Tropello said. “We are organizing the best talent in Baltimore and putting it to work: engineers, scientists, businessmen, lawyers, public relations, so we can actually build a scalable and manufacturable medical device. That’s what other concepts don’t have and why they will fail.”
So far, the Care Cove does not have any purchase orders, Tropello said, but he hopes the product will attract more attention after it goes through seed funding rounds. He is confident buyers will line up once it becomes available to purchase.
“I’m not making them at this point to make money,” he said. “I’m not unique that it popped in my head, but this is the way to do it.”