Editor’s note: This series of articles profiles the inventors of three innovative emergency medical care devices offered by Pulmodyne, an Intersurgical Company.
Nobody likes needles. But when an adult needs an injection, they usually comprehend why. For our smaller patients, that may not be the case.
“Putting an IV in a child is a) difficult and b) quite painful and terrifying to the child,” said Tim Wolfe, M.D., a retired longtime emergency physician and EMS doctor from Utah. “We do it to adults all the time, and it hurts, but they understand what we’re doing. Kids don’t understand why we’re poking them with a needle when they’re sick and already miserable.”
It became clear to Wolfe early in his medical career, back in the late 1980s, that there wasn’t much available in the way of alternatives.
Wolfe had also noted something else: Users of certain hard drugs, like cocaine and heroin, often consumed their substances of choice through the nose. This suggested that – at least for some patients, medications and circumstances – intranasal delivery might be a viable way to administer drugs which could circumvent the needle problem. This, Wolfe came to suspect, might be an easier way to give medications to scared or agitated pediatric patients.
Moving beyond needles had a certain urgency at the time. It was the 1990s, and heroin was popular. But the constant shooting up left users with damaged veins, which made it hard for emergency medical providers.
“We had to start IVs in heroin addicts who had significant damage to their venous structures, and we’d have trouble getting those IVs,” Wolfe recalled. “You’d risk a needlestick because you had to poke them multiple times, and you’d have all these needles floating around. These were patients at very high risk of carrying things like hepatitis and HIV, meaning we’d potentially get our employees infected with an incurable disease.”
By that time Wolfe was using nasal delivery for kids who needed sedatives like midazolam (Versed). And it worked – to a point. “I was dripping drugs into the nose, and it’d have sort of a moderate effect – sometimes it would work great, and sometimes it wouldn’t work at all,” Wolfe said. “I couldn’t figure it out.”
Then, around 3 one morning, a young patient spewed that Versed from the back of his throat back into Wolfe’s face. It was an unpleasant but enlightening moment.
“I realized I’d given him an oral drug through his nose,” Wolfe said. “What I needed to do was convert that drug from a drop form to a mist form, so it would stick to the mucosa and not just run back into his mouth.”
‘THAT WOULD GET THEIR ATTENTION’
Wolfe faced two challenges: The first, and simpler, was to devise a way to give medications in a mist form. The second was to demonstrate to the broader medical community that intranasal delivery could be as effective as intravenous.
Creating an atomizer was fairly straightforward. Wolfe cut the tip off an Afrin bottle and glued a pair of lumens to it, attempting to produce a mist by spraying air and water simultaneously. He quickly realized he didn’t need the air. That led to the concept of a flexible tip that could attach to the end of a syringe, enabling precise doses. “Over a few months of fiddling around,” he said, “I realized I had a really good idea that was simple and could be used by a doctor, nurse, paramedic or layperson.”
Some of Wolfe’s colleagues, however, needed convincing. “When I’d tell other doctors about it, they’d look at me like I had two heads,” he remembered. So whenever one would tell him intranasal delivery wouldn’t work, he’d pantomime snorting a line of cocaine, then smile and say, “You’re right, doc – nasal drugs never work.”
“That,” he chuckled, “would at least get their attention.”
Widespread acceptance, though, was going to take literature. Wolfe worked over several years with investigators around the world to help design studies of intranasal efficacy in various applications. One of the most important of those would turn out to involve naloxone.
The current U.S. opioid crisis began in the mid-1990s, and by the late ’90s growing numbers of users were overdosing and dying. Naloxone, long recognized as a medication used to reverse or reduce the effects of opioids, appeared to have the right molecular characteristics to absorb across mucous membranes into the bloodstream. If that worked, Wolfe realized, it could be safely and easily delivered intranasally to patients in the field, by EMS or even laypersons, and benefit them faster.
Two EMS trials followed, with positive results. And, unsurprisingly, paramedics became some of the first medical providers to embrace the intranasal (IN) capability.
“Paramedics could see how useful it would be for treating opiate overdoses and children with seizures,” Wolfe said. “We got that early literature for opiate overdose and seizure therapy within a couple of years, and then within 10 years we had a pretty extensive body of literature for opiate overdose, seizures and pain control in both children and adults.”
IN BECOMES A VIABLE ALTERNATIVE
Production of Wolfe’s first mucosal atomization devices started small. He and a friend already had a company that offered an esophageal intubation detector (EID) for EMS providers to confirm endotracheal tube placement. The friend was an engineer versed in device production who had worked for some large manufacturers. They created a two-cavity mold and began making the intranasal devices a few thousand at a time.
Interest grew as supporting literature developed, clinical indications expanded and positive clinical experiences mounted.
“We actually saw moderately rapid growth in EMS systems right off the bat,” said Wolfe. “Those providers and their EMS directors recognized the usefulness of the product and didn’t wait around – they tried it, and it worked well, and that was good enough.”
ER docs began to follow once they saw the good EMS results and had substantial literature support, which opened doors throughout the rest of hospitals.
Awareness built, and then in 2009 caregivers widely used the device to deliver vaccines during the global swine flu outbreak. “With that we crossed a tipping point, where enough clinicians were aware of the idea,” said Wolfe. “It just grew after that.”
Wolfe ultimately sold the rights to his device to a major manufacturer, which still makes a version. But in 2018 his original patent expired, meaning others could make it too. With the opioid plague still surging and kids no happier about needles, Pulmodyne, an Intersurgical Company, was among those interested.
But rather than just produce a replica, Pulmodyne went to the source and asked Wolfe to help them launch a version. Their result, DART, debuted soon after.
Available with 1- and 3-milliliter syringes as well as a vial adapter or by itself, the DART can be used by ALS or BLS providers to deliver atomized medications across the mucosa, with a speed of therapeutic onset comparable to IV routes. This is simple and safe for the provider and painless for patients both large and small. It’s especially useful, as Wolfe envisioned, for sedating upset children and quickly treating overdoses, and also for patients in seizure or who need analgesia. Many other drugs can be given intranasally as well, and doses can be easily titrated.
DART is made in the U.S., ensuring quality standards. Pulmodyne also simplified the product to focus just on nasal delivery. A variant of the earlier version came with a malleable atomizing stylet that allowed topical anesthetization down the throat to the vocal cords as well. “The nasal DART doesn’t have that because we didn’t feel like it was necessary in nasal drug delivery,” said Wolfe. “Why add more potential problems to a product when you don’t need them?”
Intranasal medication delivery now stands alongside other routes as a viable, and often preferable, way for providers from EMS to hospital to get essential drugs to the ailing. For a professional dedicated to helping people, that’s especially gratifying.
“I feel good about it,” Wolfe said. “I think it’s sort of my little contribution to help improve patient care and reduce the risks for caregivers and pain for children and patients.
“I think nasal drug delivery is still way underutilized. I think there are a lot more medicines and clinical scenarios where it could be used. Medicine is just very slow to adapt to new ideas sometimes.”
For more information, visit Pulmodyne, an Intersurgical Company.
