On the battlefield, emergency trauma treatments can be difficult and painful. Field Medics stuff gauze directly into a wound to stop bleeding coming from an artery. The process is agonizing and after three minutes, if the bleeding continues they must remove all the gauze and do the treatment again for it to be effective. It is so painful that they always ensure they disarm the patient before starting so that the patient does not try to defend themselves to stop the pain. (source: PopSci.com)
Even with immediate field treatment, many soldiers still bleed to death. Hemorrhaging is a leading cause of death on the battlefield. Steinbaugh of Oregon Startup RevMedx, who helped invent the new treatment, treated soldiers in over a dozen deployments in Iraq and Afghanistan.
“Gauze bandages just don’t work for anything serious”
With Steinbaugh, a small group of veterans, scientists, and engineers have been working on a better way to stop bleeding.
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XStat, before and after RevMedx
RevMedx recently asked the FDA to approve a pocket-size invention: a modified syringe that injects specially coated sponges into wounds. The xStat device could boost survival and spare injured soldiers from additional pain by plugging wounds faster and more efficiently than gauze.
The team’s early efforts were inspired by Fix-a-Flat foam for repairing tires. “That’s what we pictured as the perfect solution: something you could spray in, it would expand, and bleeding stops,” says Steinbaugh. “But we found that blood pressure is so high, blood would wash the foam right out.”
So the team tried a new idea: sponges. They bought some ordinary sponges from a hardware store and cut them into 1-centimeter circles, a size and shape they chose on a whim but later would discover were ideal for filling wounds. Then, they injected the bits of sponge into an animal injury. “The bleeding stopped,” says Steinbaugh. “Our eyes lit up. We knew we were onto something.” After seeing early prototypes, the U.S. Army gave the team $5 million to develop a finished product.
But kitchen sponges aren’t exactly safe to inject into the body. The final material would need to be sterile, biocompatible, and fast-expanding. The team settled on a sponge made from wood pulp and coated with chitosan, a blood-clotting, antimicrobial substance that comes from shrimp shells. To ensure that no sponges would be left inside the body accidentally, they added X-shaped markers that make each sponge visible on an x-ray image.
“By the time you put a bandage over the wound, the bleeding has already stopped.”
In just 15-20 seconds the small sponges will expand and fill the entire wound cavity and create enough pressure to stop heavy bleeding. Because the sponges cling to moist surfaces they will not be pushed back out of the body by the flow of blood from the injury.
“By the time you even put a bandage over the wound, the bleeding has already stopped,” Steinbaugh says.
In battle, field medics carry all of their equipment with them and wear body armor. RevMedx had to find a lightweight and compact way to deliver sponges deep into an injury. They worked with Portland-based design firm Ziba to create a 3 centimeter in diameter, polycarbonate syringe that stores with the handle inside to save space. To use the applicator, the medic pulls out the handle and then inserts the cylinder into the wound. Pushing down the plunger injects the tiny coated sponges into the wound and as close to arteries as possible.
Cost and Space Savings of xStat
Three single-use XStat applicators replaces five bulky rolls of gauze in a medical kit. RevMedx designed a smaller version of the applicator, with a diameter of 12 millimeters, for narrow injuries as well. XStat will likely cost about $100 per unit at this time, but the price will go down as RevMedx boosts manufacturing of it.
If the FDA approves XStat, it will be the first battlefield dressing created specifically for deep, narrow wounds. Gauze, the standard treatment for gunshot and shrapnel injuries, is only approved by the FDA for external use, but “everyone knows that if you get shot, you have to pack gauze into the wound,” says Steinbaugh.
When RevMedx submitted its application to the FDA, the U.S. Army attached a cover letter requesting expedited approval. According to Steinbaugh, RevMedx and the military are now in final discussions with the FDA.
“I spent the whole war on terror in the Middle East, so I know what a medic needs when someone has been shot, ” Steinbaugh says. “I’ve treated lots of guys who would have benefitted from this product. That’s what drives me.”
