Hopkins students have developed a plier-like device that can expedite and improve suturing, the method of sewing closed a patient’s operating site at the end of surgery. Daniel Peng, a senior Biomedical Engineering major, explained that significant complications can arise from the 4.5 million open abdominal surgeries performed each year.
“These include evisceration, where sutures break and organs come out, and ischameia, where the tissues get squeezed together,” Peng said.
Herniations, another form of surgical complication, can alone cost $2.5 billion a year in follow-up care. Peng explained that patients often do not recognize symptoms immediately, rather waiting until they experience severe pain, at which point they return to the hospital.
After conversing with surgeons at the Hopkins Hospital, Peng and his team of fellow BME’s — all of whom are now in their senior year — sought to develop a device that would help surgeons improve the suturing process. With a bariatric surgeon as their advisor, the group’s BME design team project yielded their suturing prototype, Faststitch.
Typically surgeons perform sutures by hand and needle, aiming to space their needle points by one centimeter. However, surgeons make this measurement by eye, which often leads to inaccuracies. Surgeons also rely on a metal “cutting board” to protect the patient’s internal organs given the short distance between these organs and the skin, and the lack of visible bleeding when many organs are punctured.
“We wanted to replace this metal board, and we have a measuring device to help surgeons measure it evenly,” Peng explained.
When a surgeon squeezes on the handle of Faststitch, the device passes a needle from one arm to the other through a suturing site. With the flick of a switch the device repositions the needle, allowing the surgeon to move to the next spot on the surgical site.
“At the center of the device, we have a one centimeter circle that measure out the stitch distance,” Peng said.
While a new device like Faststitch cannot be field tested in the operating room during its development, Hopkins had an inexpensive option for the students to evaluate the effectiveness of their product.
“We have some animals at Hopkins that we have been piggy-backing on,” Peng said. “Once the medical students were done with a pig we would go in and suture it up.”
Six months into the project, Peng and his team realized that they wanted to enter a business competition and incorporated a company, Archon Medical Technologies. They sought the advice of consultants and mentors to develop business plans to present at competitions, including one at UC Irvine. This landed them membership in an “incubator” at Irvine to help them develop the device.
Peng also entered a competition held by Entrepreneur Magazine for college students. Securing a spot among the finalists after an initial round of judging by the magazine, Peng is in the running for one of several prizes offered to the magazine’s contestants, including an extensive profile in Entrepreneur’s January issue.
“I made it to the top five and the rest of it is up to the voting,” Peng said. The site’s poll closed on Tuesday and Peng is awaiting word from the competition organizers about the input offered by visitors to the magazine’s website.
As for Quickstitch’s future on the road to the surgical stand, Peng explained that the major hurdle is getting clearance from the FDA, which can vary depending on its classification. A device like Quickstitch would fall under class II, but there is a more expedited route through 510(k) clearance.
“If there is a device that is already on the market that is similar to your device, the approval process takes only a year or two,” Peng explained.
Some of the biggest supporters of Quickstitch and Archon Medical are the very surgeons who helped in the development of the device ; they are eager to utilize it in the operating room.
“They are very excited about,” Peng said. “They gave us a lot of feedback on it.”