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Air Force SBIR/STTR Program Manager

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A Life Saving Emergency Medical Device

In the minefields of Afghanistan, a soldier's right leg is blasted off by an explosion. He's dazed, bleeding out, and when it comes to saving his life, every second counts.

As the deafening sound of helicopter blades beat overhead, Air Force pararescue jumpers quickly haul him onto the aircraft. It's still golden hour — the time after a traumatic injury where medical care can still prevent death — but he desperately needs blood.

After unsuccessfully fumbling with a traditional IV, the medics prepare a device called the EZ-IO that drills an infusion needle directly into bone. Within seconds, the needle is implanted into his upper arm, and blood begins to flow.

In crisis situations like these, the EZ-IO Intraosseous Infusion System provides a rapid, near-foolproof way of getting blood, fluids, or medicine into patients. The device, battery-operated and about the size of a glue gun, has helped those experiencing cardiac arrest, major trauma, shock, and severe dehydration.

To date, roughly 3 million patients have been treated with an EZ-IO, saving tens of thousands of lives — including that of the soldier in Afghanistan, a Special Forces medic who survived his injury and was later sent home.

In the U.S., an EZ-IO kit is carried on 95% of all ambulances and in about 85% of emergency departments. Made by San Antonio-based Vidacare Corp., it has an impressive 97% success rate when used, which is much higher than that of a standard IV.

Beginning in 2006, Vidacare was awarded single Phase I and II contracts by the Air Force Small Business Innovative Research (SBIR) program that led to the EZ-IO design still used today. In 2013, the company was acquired by medical device corporation Teleflex Inc. for $262.5 million.

In emergency medicine, the time when patients need an IV the most is also when veins tend to disappear from the range of a traditional IV needle. Severe shock from injury or heart failure often causes peripheral veins to collapse in order to maintain circulation to vital organs such as the heart and brain.

"It's a cruel law of nature: if you don't need an IV, it's easy to find your vein," explains Vidacare founder and former Chief Medical Officer Dr. Larry Miller. "But if you desperately need an IV, then it's very difficult to find a vein."

Miller has over 30 years of experience as an emergency medicine specialist and has treated more than 120,000 patients throughout his career. While acting as Chairman of Emergency Medicine at Baptist Health System in San Antonio, he began dabbling in intraosseous infusion — injecting fluids directly into the bone — in 1989.

Fluid administered into the intraosseous space gains access to the central circulation within seconds. Typically, the ends of long bones such as the humerus are ideal for intraosseous infusion, with their thinner shells of hard compact bone tissue and abundance of spongy bone.

It was around this time when a colleague of Miller's, a paramedic, had a brutal car accident and badly injured his arm. Emergency medical service professionals did their best to try and save him, but they couldn't find a non-collapsed vein to supply the blood he needed to live.

"They stuck him over 20 times trying to get an IV going, but he died before he made it to the hospital," he recalls.

The harrowing incident propelled him to create an intraosseous infusion device for emergency use. If he could come up with an invention that could easily and safely get a needle into the bone, it could prevent unnecessary deaths like this from happening.

"Inside every bone is a huge, non-collapsible vein," said Miller. "You have this spongy network that's the marrow, and it never collapses."

He worked tirelessly out of his own garage, using animal bones from the local slaughterhouse for his makeshift experiments. A nail gun had too much force and ended up shattering the bone. An ordinary drill worked better, but he couldn't find a way to easily insert the needle into the hole afterwards.

Then he remembered that his father, a toolmaker for the auto industry in Detroit, had an oil-cooled, hollow drill bit. Thinking a needle could be coupled with it, Miller delved into his dad's old tool box and tried it out — it worked perfectly.

From there, he built a version of the EZ-IO that received approval by the Food and Drug Administration in 2004, and Vidacare went to market with it a year later. They also donated kits to the military with over 3,000 needles in 2 years, and provided free training to medics.

"We've always had a tight relationship with the military from day one," said engineer Bob Titkemeyer, one of Miller's first employees. "It was really an honor to supply them with a product that would help."

The early prototype got the job done, but the drill portion of it was heavy, bulky, and took 8 AA batteries that had to be replaced after 60 uses. Under the SBIR Fast Track agreement, the Air Force gave Vidacare a much-needed boost in funding to ruggedize and miniaturize the drill, helping it evolve into the version still used today.

"It would have taken a long time to produce without the money from the Air Force, so I really credit the award for giving us a big leap forward," said Miller. "Now it can be used over 500 times [on one battery], you can drive a car over it, and it's half the weight."

With the SBIR funding beginning in 2006, Vidacare switched to a lithium battery and were able to develop new products. The team engineered a sternum needle for amputees, as well as a sturdy stabilizer bandage with plastic parts that held the needle tightly in place. In addition, there are now three different needle sizes available for patients ranging from newborns to larger adults.

Although drilling a needle into bone sounds excruciatingly painful, most healthy volunteers rate the pain as only 2 or 3 out of 10.

"Everyone thinks it's going to hurt terribly, but most of the pain is on the skin," Miller said. "There's no pain fibers inside the bone."

However, infusing fluids under high pressure into the bone can cause pain, so typically a local anesthetic called lidocaine is first administered before any fluids in order to numb the patient's body.

The EZ-IO is currently used in hospitals and emergency medical services in over 50 countries worldwide. It has saved soldiers' lives in Iraq and Afghanistan, and the company still donates drivers and needles to humanitarian efforts and non-profits that can't afford them.

"If they send us a note about where they're going and what they're doing, we will provide them with free IOs," said Titkemeyer, who is now Vidacare's Director of Quality Assurance of Regulatory Affairs.

In 2010, the company donated supplies valued at over $30,000 to help combat Haiti's cholera outbreak. Cholera, a bacterial infection of the small intestine, causes vomiting and diarrhea that can result in severe dehydration. A doctor in Haiti trying his best to fight the epidemic reached out to Miller in a desperate letter, requesting EZ-IO kits since his team had trouble with using standard IVs.

The letter hit him hard. Miller rallied his employees together to pack up a thousand needles and several hundred drivers for a humanitarian mission. When he arrived in Haiti, the situation was dire: over 70,000 people had been infected, 35,000 hospitalized, and more than 2,000 dead.

Miller and his team trained countless doctors, nurses, and volunteers on how to use the EZ-IOs provided to them. Even within a little over a week, countless patients suffering from dehydration were given fluids, and lives were being saved - including that of a 2-year-old child whose mother had already dressed in funeral clothes. Within several minutes, the EZ-IO was able to give her much-needed hydration, and she survived.

Like his colleague's death years earlier, his trip to Haiti is a powerful reminder of why he started the company and made the EZ-IO his life's work.

Vidacare's financial success confirmed the success of the Air Force SBIR investment — sales had reached $70 million by 2010 and started to pique the attention of larger medical device corporations. The company was eventually acquired by Teleflex, a global provider of medical devices used in critical care and surgery, but Miller still works as a consultant for the EZ-IO product line.

"It's like having a daughter and sending her off to marry — it's bittersweet," he said. "I put all my money and effort into [Vidacare], and it's mixed feelings, but overall it's good.