FIU-Developed Device Could Restore Sensation for Amputees

MIAMI, FL — A potentially groundbreaking prosthetic that was developed at Florida International University has won approval to begin human trials, according to the university.

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"Upper extremity amputees are one step closer to successfully picking up a cookie or an egg, thanks to a new advanced prosthetic system that is designed to restore sensation," FIU announced on Tuesday.

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The system was developed at by Ranu Jung and her Adaptive Neural Systems Laboratory team.

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“The system is intended to restore the sense of touch and hand opening which would allow users to precisely differentiate the size and fragility of various objects,” said Jung, who is the interim dean of FIU's College of Engineering and Computing.

“The prostheses that exist today make it difficult for amputees to manipulate delicate and small objects because they can’t feel them," added Jung, who also serves as the Wallace H. Coulter Eminent Scholars Chair in biomedical engineering.

The neural-enabled prosthetic hand system stimulates nerves in the arm to provides sensation as the person uses their prosthetic hand. The prosthetic system has the first fully implantable, wirelessly controlled Class-III device with electrodes that can be surgically implanted within the nerves of the residual arm.

The U.S. Food and Drug Administration has granted an investigational device exemption for the first-in-human trial with this technology, according to FIU.

“The system reflects an almost decade-long collaborative team effort. For the first time, amputees will be able to use a fully implantable, sensory enabled prosthetic hand system at home for daily activities and researchers will be able to assess the long term clinical impact of its use in real-world environments,” Jung added.

Similar to a pacemaker, the system works by delivering small electrical pulses to specific nerves in the arm. Wires as thin as a strand of hair are placed within nerve bundles in the arm and connected to an electrical stimulator.

Embedded sensors in the prosthetic hand wirelessly transmit signals to an implanted stimulator, which then elicits sensation by delivering weak electrical pulses via the implanted electrodes. As a result, the person should be able to sense their hand opening position and then grip items when the prosthetic hand encounters an object.

"Participants in the trial will be able to use the system outside of the laboratory on a daily basis," FIU explained, adding that the system is not yet approved for commercial distribution.

If the trial is successful, Jung and her team will continue testing in larger clinical trials and eventually seek approval for commercial distribution.

The system can potentially be used with several different advanced prosthetic hands that are being developed commercially or under government support.

Florida International University, with Jung as principal investigator, will receive up to $2.2 million in support of this first-in-human trial.

The system and studies have been developed in collaboration with James Abbas, a professor at the School of Biological and Health Systems Engineering at Arizona State University.

Industry partners include Cochlear Ltd of Australia, Motion Control, div. of Fillauer Companies, Inc. of Utah, Nikao Inc. of Florida and clinical teams from the Miami Hand & Upper Extremity Institute in Florida and Ortho Pro of Florida.

Photo and video courtesy Florida International University