COLUMBIA, SC — The creation of a new medical device that allows physicians to more accurately insert needles into deep veins sounds like fiction.
A sketch on a cocktail napkin by a Columbia emergency medicine physician leads to eight years of tweaking designs, finding backers and clearing regulatory hurdles.
Finally, the effort pays off. Not only do major manufacturers jump at the chance to market the device, but Popular Science declares it one of the top new tech innovations.
Im kind of a geek, said Dr. Stephen Ridley, the Columbia emergency physician behind the device. I read those (science) magazines. I thought they were joking. This cant be happening. I guess Ive reached true geekdom.
Ridleys invention of AxoTrack, which combines ultrasound technology and magnets, is a dream come true. Or more accurately, a vision come to life.
Ridley has an engineers sensibility, always looking for mechanical solutions to problems big and small. Before starting at the University of South Carolina School of Medicine in the late 1990s, he worked for an engineering firm and came up with urethane foam technology used by the U.S. Navy. In his spare time, he invented and patented a mountain bike tire that reinflated without using tools.
The tire product took a lot of effort and money and didnt pay off. So when he switched careers and headed to medical school, his wife put him on invention detention.
But that mind simply cant be turned off. Soon after finishing med school in 2001, Ridley started residency in the emergency medicine program at Palmetto Health Richland. While learning the nuances from his mentors, he realized how difficult it was for them to use new ultrasound technology to help guide needles into veins deep below the surface.
Ultrasound is really good at imaging anatomy, but not good at imaging a thin cylindrical item like a needle, Ridley said.
Most ultrasound devices at the time incorporated images of both the anatomy and the needle. Talking with friends about the problem during a break at a medical conference, Ridley sketched what to him seemed like a simple concept on a napkin. It would divide the imaging tasks ultrasound for the anatomy, magnets for the needle.
Ridley adopted magnetic technology used to control flaps on jets. He adapted the ergonomics to make the device easier to hold with a patented needle clamp acting like a third hand. Then there are the algorithms, the step-by-step instructions programmed into the computer software to turn data arriving hundreds of times per second into an image on a screen.
Early in the process, Ridley joined with businessman Dexter Hagy to form Soma Access System, a medical technology company. Because Soma wasnt one of the major medical product companies, Ridley had difficulty finding technology companies willing to work on the complicated computer software and a specially designed transducer on a speculative product.
The design work took about six years. Then came two years of paperwork and testing before approval from the U.S. Food and Drug Administration in March this year. Terason, a leading manufacturer of portable ultrasound systems, was the first to offer AxoTrack devices on its machines commercially. Sonosite, a division of Fujifilm Corp., has reached a deal for its own version of the AxoTrack technology.
The devices cost between $7,000 and $10,000, and they have the potential to save hospitals many times that amount. The earliest applications have been in procedures when central venous catheters have to be inserted into the neck, chest or groin.
Millions of central venous catheter procedures are performed each year in U.S. hospitals, and tens of thousands result in infection complications, according to the Centers for Disease Control and Prevention. Many of those problems are related to the inaccurate insertion of the needle into the vein. Anything that reduces chances of those complications should be a good investment for hospitals.
The AxoTrack technology makes the insertion process not only much more accurate, but quicker. One study of emergency medicine residents using AxoTrack reported in the Supplement to Annals of Emergency Medicine found a nearly 99 percent success rate at first attempt, compared to 37 percent using the conventional methods.
The technology is cheap and safe, said Ridley, who works at Palmetto Health Baptist and Richland. It has provided us for the first time ever to see the needle in these procedures.
Ridley, 50, said the physicians he has taught to use the devices can pick up the procedure in 10 to 15 minutes. Literally, its point and shoot, he said. It really does become a video game.
The images on the computer screen give physicians confirmation the needle isnt hitting anything important on the way to the target, and they give feedback during the entire procedure.
The technology also could be used for biopsies, for anesthetic nerve blocks and epidurals. Eventually, these types of devices could be standard even for finding veins in arms for basic procedures such as donating blood. The potential market is huge. Unlike the easy-to-fix mountain bike tire, this could be an invention that pays off.
The FDA approval and corporate acceptance of AxoTrack come during the same year Ridley was named the S.C. Emergency Physician of the Year and reached age 50. The mention in the December issue of Popular Science is the capper.
Its been a good year, Ridley said.