410 Medical LifeFlow Rapid Infuser

Thanks to the Georgia Tech Alumni Magazine for the great write-up on the 410 Medical LifeFlow Rapid Infuser!  To read the full article, check out Make it Work: A Phaser for Fighting Sepsis

Often in medical emergencies, pushing large amounts of intravenous fluids into a patient can mean the difference between life and death. But it’s not easy to do, and sometimes the right tools to do the procedure can be hard to find.

Case in point: Pediatric intensive care specialist Dr. Mark Piehl found himself in a situation where he needed to pump a lot of fluid very quickly into a patient with sepsis, but couldn’t quickly locate one of his hospital’s precious IV fluid pumps—which cost upward of $30,000 a piece. He eventually found a pump and saved the child from crashing, but he wasted precious time while his patient’s clock was ticking.

That’s when Piehl’s idea for a small, handheld, far less expensive device for pumping fluids crystallized. One that could be stocked and used everywhere: emergency rooms, intensive care units and ambulances. He knew the need for such a tool was dire: Sepsis is a dangerous complication from infection that affects more than 1 million adults and children in the U.S. annually, and it’s the most frequent cause of death in hospitalized patients. One of the key ways to fight sepsis is the early, rapid delivery of IV fluids.

So Piehl created a startup, dubbed 410 Medical, and brought in Galen Robertson, ME 02, MS ME 04, to serve as his COO. The two had worked together previously, and Piehl needed Robertson’s expertise in developing medical devices. “Dr. Piehl started the company in April 2013 and got funded in September 2014, when I quit my day job and started running 410 Medical full time,” Robertson says.

Early on, Robertson worked with Piehl to put together the core requirements for the new device—which they eventually dubbed LifeFlow. “LifeFlow had to be handheld and able to be operated by only one hand,” Robertson says. “The device had to pull fluids quickly from an IV bag and flow easily, delivering an average of one liter every five minutes. It had to be driven by a syringe and tubing system that connected easily to a patient’s catheter. And it had to have a strong spring mechanism for automatically refilling the syringe with fluid.”

That’s a demanding list, but Piehl and Robertson had planned out a simple tool to do the job—a pistol that could be loaded with a syringe and a trigger to control the flow of fluid. They then turned to another Tech alumnus, Ty Hagler, ID 03, president of Trig Innovation, to perfect the design of the device. Not only did LifeFlow have to fulfill these technical requirements, but also it had to be intuitive for nurses, doctors and EMTs to operate.

“It was an easy call to make,” Robertson says. “Ty and I were friends at Georgia Tech, and I knew he had the expertise to come up with a design that would work and medical professionals naturally would want to pick up and use.”

Hagler closely collaborated with Robertson to optimize the design and engineer all the details, such as how to translate the squeezing motion of the hand on the trigger to the depressing of the syringe.

“We figured the basics out quickly to meet the core criteria and built a rapid prototype, but it was pretty rough, looking more like a Star Trek assault rifle than a handheld phaser,” Hagler says. “But the most important thing was that it didn’t break in the investor’s hand. Still, we went back to the drawing board and kept slimming it down. We also beefed up the driving mechanism from plastic to steel, and altered designs so the syringe would drop into the device easily.”

Here’s how Robertson describes how LifeFlow’s final design works: “It consists of a pistol with a handle, matched with a sterile tubing set, all stored in a small box. You open the lid on the device, click the syringe into the handle and the lid captures the syringe and pulls it into place. You put the tubing spike into an IV bag of fluid and prime the device, then you connect to the patient’s catheter and begin delivering fluid.”

410 Medical is working with the FDA for approval on LifeFlow, and hopes to have the device in hospitals treating patients this fall.

Read the medical device development case study here