The device looks comically simple, almost like a toy: Royal blue handles curve into a bright white clamp, part pliers, part hole punch.
But FastStitch, a new surgical tool designed by a team of Hopkins students and graduates, has serious ambitions — to quickly and cost-effectively close abdominal incisions after surgeries.
Developed over the course of last year as part of a required project at the Johns Hopkins Center for Bioengineering Innovation & Design, FastStitch has received more than $90,000 in grants and prizes. Now, the eight-member team is shopping the device to venture capitalists, to fund testing and FDA clearance.
"Our device is simple and elegant," said Sohail Zahid, a 2012 graduate who leads the FastStitch team. "It attempts to solve the problems no other device has been able to solve."
When abdominal surgeries, necessary for illnesses such as cancer and appendectomies, aren't properly closed, infections, hernias and other complications can occur. Nine to 15 percent of all surgeries result in hernias, costing the healthcare industry about $2.5 billion annually, according to the 2012 World Market for Gastrointestinal Devices report.
"Surgeons spend a lot of time doing their procedure — they get tired, they have to go to the bathroom, their next procedure's coming up — so the final step of suturing is often hurried," said Jennifer Keller-Jackson, grants manager at the National Collegiate Inventors and Innovators Alliance, which awarded the FastStitch team $14,400. "It's like tripping at the finish line. You've done all this surgery, and the suturing is what sends them back to the hospital."
Zahid heard about this problem when he was brainstorming for his design team's project. While asking Johns Hopkins surgeons about common issues they face during procedures, he met with Dr. Hien Tam Nguyen, director of the Comprehensive Hernia Center.
As a bariatric surgeon, Nguyen works frequently with morbidly obese patients, and saw the need for an inexpensive, precise way to close incisions. Nguyen joined Zahid's team as an adviser, offering medical advice and identifying clinical problems.
"We're focused on three things: simple, stable and safe," Nguyen said. "Nothing overly complex. It's an elegant way of allowing surgeons to do something they have to do anyway."
The eight Hopkins students, all biomedical engineering majors, spent as much as 25 to 30 hours a week developing FastStitch. They used pasta noodles to mimic human intestines, and tested prototypes on the abdomen muscles, or, fascia, of pigs.
"We'd wait for medical students to finish with animal labs and come in afterward and use them to study the device," Nguyen said. "You have to improvise, think on your feet and figure out where to find resources when you have none."
One of the biggest challenges was finding a way to stitch together two layers of muscle and skin while keeping the needle self-contained. This way, there's less risk of puncturing internal organs.
Instead of spending $200-$300 each to build a series of prototypes, the team produced several versions of FastStitch using Hopkins' 3D printer, which builds objects using digital blueprints.
"It works by printing layers of plastic," Peng said. "It goes from bottom up, like spreading icing on a cake, except each layer gets hard pretty quickly."
With the current version of FastStitch, needles are housed in the clamps. To suture, the surgeon clamps down on one layer of muscle and flicks a switch, which releases a spring inside the device. The needle threads the suture through one side of muscle, and the surgeon places the tool on the other side of the wound and repeats the process.
FastStitch allows sutures to be made exactly 1 centimeter apart — evenly distributing muscle tension and helping to eliminate human error.
While working on FastStitch, the designers met with Jerry Brecher, a Johns Hopkins alumnus who had designed a similar suturing device named SuturTek. Surgeons can be reluctant to change the way they operate, he told them.
Yet Zahid and his teammates believe FastStitch is enough of an improvement over Brecher's SuturTek product — the 360° Fascia Closure Device — to entice surgeons. Since FastStitch is plastic and meant for one-time use, it costs significantly less — $30, compared to $3,000 for the reuseable Fascia Closure Device. The Fascia Closure Device also uses cartridges, which are $40 each.
The students have created a start-up company, Archon Medical Technologies, and while they are still testing FastStitch on animals, several universities and other organizations have expressed interest in the device.
"It has the hallmarks of a successful medical device," wrote Thomas Rockwell Mackie, director of medical devices at the University of Wisconsin's Morgridge Institute for Research, in an e-mail. "It seems more effective, inexpensive and easier than hand-stitching. Before I could comment further, I would like to see it in the hands of a surgeon, but it seems very promising."
The team placed first at several contests, including University of Maryland College Park's business plan competition, the NIBIB DEBUT Challenge run by the National Institutes of Health, and the University of California Irvine Business Plan Competition, which awarded the team with lab space on the UC-Irvine campus for six months. And they won the American Society of Mechanical Engineers (ASME) Innovation Showcase, held in Montreal, Canada.
Now, the FastStitch team is meeting with venture capitalists, asking for $2 million to fund testing and FDA approval for the tool. Though the approval process can take up to 10 years, if the FastStitch team can prove their device is similar enough to SuturTek's product, the wait could be reduced to one or two years.
Meanwhile, Zahid is applying to medical school. His first choice is his alma mater — he has no desire to leave his team behind.
"You always want to do something that's more than just what you learn in school; you want to apply what you learn to a greater cause," Zahid said. "When we first started, we only had $1,000 to work with, and it's really hard to believe that we're now talking with venture capitalists in the realm of $2 million. It's quite humbling."Copyright © 2014, The Baltimore Sun