Researchers behind a potential spin-off from Case Western Reserve University should know in about six months how they will develop their neurostimulation technology that helps people swallow.
Thanks to a $25,000 grant from the Innovation Fund of the Lorain County Community College Foundation, the researchers plan to test up to 10 patients with a noninvasive or minimally invasive version of their pacing device. In its implanted version, the device stimulates a nerve in the neck to make vocal cord flaps act like a valve to keep food, water and saliva out of the lungs during swallowing.
Patients who suffer from strokes or neurodegenerative diseases like Parkinson’s can lose their ability to swallow, so they must be fed and hydrated through feeding tubes. Using an electrical device to stimulate normal swallowing could significantly improve the quality of life for these patients. And if the device helps patients avoid repeated bouts of pneumonia, it also could cut healthcare costs.
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“We have one key milestone that we need to reach to see how we’re going to go forward with the device,” said Dustin Tyler, associate professor of biomedical engineering at the Cleveland university that is leading the research project. That milestone is a go or no-go decision on a device that stimulates the nerve indirectly through the trachea rather than directly with an implanted device, as the researchers have done in the past.
“If we’re successful at [the indirect approach], then the next phase will be developing a commercially viable prototype,” said Tyler, who also is associate director of the Cleveland Advanced Platform Technology Center.
Tyler has been working on neurostimulation devices for swallowing for a dozen years. Dr. Michael Broniatowski, an otolaryngologist who practices at St. Vincent Health System in Cleveland, has been working on a device for three decades and received a patent for an implanted system in 2005, Tyler said. The two joined forces a few years ago on a device tentatively named Swallowing Solution.
One of the researchers’ challenges has been coming up with a device that venture capitalists are likely to support with millions of dollars for development and clinical trials. The noninvasive or minimally invasive device would take less time and money to develop, so VCs might find it a more palatable investment. That device also could open the market that eventually pays for development of the implanted device, Tyler said.
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While Tyler and Broniatowski have worked with the vocal flap mechanism to protect the airway during swallowing, other researchers have worked with the alternative mechanism — the elevation motion of the larynx. Both mechanisms “are necessary, but neither is sufficient” for effective swallowing, Tyler said.
“What we’re really working toward is a combined system … an hybrid system” that would use the best of both technologies to fit the needs of each patient, he said.