From left: Dr. Bradley Kesser, Professor Shayn Peirce-Cottler experiment on a model of the human ear

One of the most common surgeries performed on pediatric patients could become faster and safer thanks to several U.Va. engineers. Led by Shayn Peirce-Cottler, an assistant professor of biomedical engineering at U.Va.’s Engineering School, and Dr. Bradley Kesser, an ear–nose–throat (ENT) surgeon at U.Va. Health System, a team of undergraduate researchers are in the process of commercializing a novel device to aid in the surgical implantation of ear ventilation tubes.

Each year about 2.2 million young patients need these tubes implanted for the treatment of chronic otitis media with effusion, a common problem associated with earaches. ENT surgeons insert the tubes to relieve pressure and fluid buildup.

“Currently the procedure is tedious,” Peirce-Cottler says. “Small tubes — 2 to 3 millimeters in diameter — are inserted using four different instruments. The new insertion device facilitates safer, easier insertion. It reduces the time of anesthesia and reduces to one the number of instruments inserted into the ear canal, which reduces the risks for the patient.”

Similar in appearance to the current suction tool used to treat chronic ear infections, the new stainless steel device consists of a hollow rod with a collar that holds the tube in place, allowing the surgeon to apply force to insert the tube with one motion.

It has taken several years for the device to go from concept to invention. The project started as an undergraduate Engineering School Capstone biomedical design project in 2004 led by Peirce-Cottler and Kesser. Since its inception the project has been enhanced by three different Capstone teams.

“The momentum of this research has really been driven by students, both in engineering and medicine,” Peirce-Cottler says.

An orthopedic surgeon whose child had required the ear tubes brought the initial idea to the first Capstone team. Soon after, an operating-room visit was scheduled so the engineering students could see firsthand how the tubes were inserted.

“Students saw that the procedure was tedious even for a skilled surgeon,” Peirce-Cottler says. “Getting into the clinical setting with a real-world view made the task and goal immediately apparent.”

There have been some hurdles along the way — in particular, being more responsive to the design needs of surgeons.

“Originally our team wanted to over-engineer the device with too many features,” Peirce-Cottler says. “The surgeons wanted something simpler and streamlined. Having an ENT surgeon on the team helped us to overcome this problem and make the device usable.”

With dedicated groups of student researchers and a $100,000 grant from the Walter H. Coulter Foundation, the device is now approaching commercial viability. The group has completed small-animal studies on chinchillas, rabbit-sized rodents known for having ears very similar to those of humans. The researchers have successfully constructed an anatomically accurate human ear for testing and are now conducting human clinical trials at the U.Va. Hospital. They are still analyzing data and, according to Peirce- Cottler, the results look promising.

The researchers have secured provisional patents and applied for a U.S. Patent in September 2007. They are currently in license negotiations with an ENT product company in Scandinavia.

In the next couple of years, the work of surgeons and the health of millions of children could be vastly improved because this dedicated interdisciplinary team refused to accept the status quo.