For Wilkinson Barker Knauer partner Cheryl Tritt, a five-year campaign to win approval from the Federal Communications Commission came to a happy end Wednesday when the agency approved the use of spectrum for a potentially revolutionary medical treatment that could allow paralyzed people to regain the use of their limbs.
“It was one of the most satisfying days of my career,” said Tritt, who represents the Alfred Mann Foundation, which has developed technology that uses electric pulses from tiny implanted devices to stimulate the muscles of traumatic brain injury, stroke or spinal cord injury victims. The technology could also help people with multiple sclerosis and cerebral palsy.
“The devices that we expect to be deployed under the rules the Commission adopts today hold the promise of safer, less invasive, and more effective treatment options than those available under current medical practice,” said FCC Chairman Julius Genachowski at the meeting. “We’re talking about medical miracles: allowing paraplegics to stand and restoring hand grasp function for quadriplegics.”
The devices use four bands of electromagnetic spectrum to transmit signals within the human body – spectrum already being used by the Department of Defense, emergency mobile radio and commercial land mobile radio.
The foundation sought FCC approval to use the bands on a secondary basis as a so-called Part 15 device – low-power transmitters such as baby monitors or cordless phones that are permitted to operate without an FCC license. Engineers call these "bottom of the RF food chain devices" because they are not allowed to cause interference that could harm licensed spectrum users and must accept interference from the licensees.
The concern was that the high-powered licensed spectrum users would cause interference with the implanted medical devices – and could be held responsible or forced to shoulder new regulatory burdens as a result.
Tritt said keys to winning FCC approval included conducting tests that showed interference would not be a problem and securing the support of the Department of Defense. “We took a very measured strategy with DoD…crossing the t’s and dotting the i’s,” Tritt said. “It took a long time, but it all worked out.”
The technology involves microstimulators so tiny they can be injected into muscles immediately adjacent to or just touching a peripheral nerve. A master control unit designed to be carried on or near the patient's body directs the microstimulators to deliver electric pulses in a coordinated sequence. This causes muscle contractions that replicate the natural movements of a limb.
Tritt said human trials using the technology could begin in 2012 or 2013.
The Alfred Mann Foundation is based in Santa Clarita, Calif. and was established in 1985 by cardiac pacemaker developer Alfred Mann. The foundation is known for initiating research and development on advanced medical devices, including the cochlear implant for profound hearing loss.