Inventor: Mark Piehl, MD, pediatric intensivist, WakeMed Children’s Hospital, Raleigh, N.C.

Company and website: 410 Medical, https://410medical.com

After years of searching for a better way to provide fluids to critically ill children, pediatric intensivist Mark Piehl, MD, said an idea for a new product came to him while he was on a ski lift in Park City, Utah with his cofounder. The resulting device, the LifeFlow Rapid Infuser, may just change the way hypovolemic patients are resuscitated.

The LifeFlow Rapid Infuser is a fluid administration tool shaped like a large water gun containing a custom syringe, valve and high-flow tubing set. After connecting the tubing to a bag of IV fluids, a provider can deliver one liter of fluid to a patient in shock in less than 5 minutes. That’s a huge improvement in fluid replacement over the standard rapid infusion setup most EMS systems use—a pressure bag device or squeezing the IV fluids bag, which can only deliver one liter in about 15 minutes or more.

Piehl is cofounder and chief medical officer of 410 Medical, the company he formed after inventing the device. He and his colleagues have been using LifeFlow at WakeMed Children’s Hospital for about the last six months.

Piehl says prospective users often ask the same question: “’Can I use it with a 24 GA IV catheter in a kid? Doesn’t it blow the vein?’ The answer is no,” he reports. “We have been successful in administering fluids using sizes from 14- to 24-gauge catheters.”

Patients in various types of shock, including sepsis, hypovolemia and anaphylaxis, benefit from a rapid infusion of fluids. Studies show that patients who receive more prehospital fluid early in cases of septic shock have better outcomes.¹ Piehl and his team are currently planning two studies in the prehospital environment with two large EMS agencies in Florida and Texas.

EMS protocols in North Carolina recommend that patients with septic shock and hypotension receive an initial 500 ml bolus of fluids and then should be reassessed. Because the LifeFlow Rapid Infuser allows a provider to administer that 500 ml in minutes, patients can be reassessed more often.

“I think we are providing an opportunity for prehospital providers to treat critically ill patients in a more efficient and intuitive way than they have currently,” Piehl says.

In addition, Piehl is currently conducting simulated patient care scenarios in which the LifeFlow Rapid Infuser reduces total care time. So far in these scenarios, providers are able to administer fluids in one-third the time they would with another method. This gives the provider greater efficiency and more time to assess the patient, deliver other medications, document accurately and communicate with other caregivers.
Each LifeFlow device costs $242, and Piehl advocates that the device remain with the patient to continue using its rapid infusion method as an advantage. Piehl also argues that by treating the patient early and effectively, overall patient care costs can be recouped because earlier treatment may lead to fewer ICU days.

The LifeFlow Rapid Infuser has already been used in over 20 EMS and hospital systems, with positive feedback so far. 410 Medical is looking forward to making small modifications such as longer IV tubing, and eventually hopes to gain FDA approval for the administration of blood products, which Piehl anticipates will happen in the next few years.

“In patients with shock, our goal is to rapidly improve perfusion and prevent tissue damage in the brain, the kidneys and the heart. LifeFlow can treat hypotension and reverse shock in minutes,” Piehl says. “LifeFlow speeds the care of the sickest of the sick who may be headed for cardiovascular collapse.”