When Gloria Gogola, an orthopedic hand surgeon specializing in pediatrics, visited a senior design class at Rice University (Houston) and challenged students in the class to create a device that accurately measures intrinsic hand muscles, the students saw it as an opportunity to make a real difference in a clinic setting.
Graduates Caterina Kaffes, Matthew Miller, Neel Shah and Steve Xu invented the Peg Restrained Intrinsic Muscle Evaluator (PRIME), for their senior project. They are working with the Rice Alliance, which aids early stage technology ventures, and the Jones Graduate School of Business to refine their business plan while validation of the device is under way at two Texas Medical Center (Houston) institutions, the Methodist Hospital and Shriners Hospital for Children, both in Houston.
"We really wanted to create a device that was applicable and ready to go and wasn't sort of pie in the sky," Xu told Medical Device Daily. "We're excited about creating a device that doesn't just get shelved."
According to Rice University, the students who invented PRIME have won two prestigious honors for their creation. The students say the device could revolutionize the diagnosis and treatment of hand injuries and neurological disorders. The team won first place and $10,000 at Ishow, an innovation competition for graduate and undergraduate students sponsored by the American Society of Mechanical Engineers (New York) in Palm Desert, California last month.
They were then named one of five winners in a student design competition sponsored by the National Science Foundation (Arlington, Virginia) at the Rehabilitation Engineering and Assistive Technology Society of North America (also Arlington) conference in New Orleans in late June. The top five, unranked, were selected from more than 60 entries.
The intrinsic hand muscles which the device was designed to measure are the same muscles that allow humans to play a piano or perform any task that requires dexterity and precision such as buttoning a shirt, Xu said.
"Twenty percent of all ER admissions are hand-related," Xu said. "Neuromuscular disorders like spinal cord injuries, Lou Gehrig's, diabetes, multiple sclerosis – all these diseases affect the intrinsic hand muscles."
For starters, the team is honing in on carpal tunnel syndrome. "U.S. surgeons will perform over 500,000 procedures for carpal tunnel this year. We spend $2 billion per year treating this disease but up to 20% of all surgeries need to be redone. Our invention can be used across the spectrum of care from diagnosis to outcome measurements," Xu said.
When doctors perform checkups to test hand strength, the assessment is by feel, nothing quantifiable, Xu said. He said previous devices lack the repeatability to be useful and do not adjust for small hands or unusual morphologies. PRIME is intended to fill that gap.
Miller told MDD the device has three elements: a pegboard restraint, a force transducer enclosure and a PDA custom-programmed to capture measurements.
In a five-minute test, a doctor uses pegs to isolate a patient's individual fingers. "You wouldn't think it works as well as it does, but once you are pegged in, you can't move anything but the finger we want you to," Miller said.
A loop is fitted around the finger, and when the patient moves it, the amount of force generated is measured. "PRIME gets the peak force," Xu said. "Then the doctor can create a patient-specific file with all your information, time-stamped, and record every single measurement." PRIME integrates with existing systems in a manner compliant with HIPAA, he said.
Xu hopes it will help hospitals and rehabilitation clinics compare the effectiveness of surgical interventions and diagnose neuromuscular degenerative diseases. "There's so much applicability, it's hard to pinpoint our market size," he said.
Gogola said PRIME has found a home in her clinic. "We've been using it on patients, and it's working very nicely," she said. "This particular student group worked extremely hard on the project, and they went above and beyond the course requirements. They took this from a concept to an actual working, clinically useful device."
For now, PRIME is being used for research purposes in the clinic, Xu said. However, the students do envision seeking FDA 510(k) clearance for the device down the road.