BION Developers Push New Versions and Applications

by James Cavuoto, editor

The BION, one of the most compact and innovative stimulation devices under development, is undergoing continued enhancement in design and applications, even before the first commercial versions have reached the market. In recent weeks, the developers of the device have announced new configurations, accessories, and alliances that they hope will help make the product ubiquitous in the neurostimulation field.

BIONs are microminiature electrical stimulators that can be implanted by injection through a needle. The device was developed by a collaboration among researchers at the Alfred Mann Foundation (AMF), Queen’s University in Canada, and Illinois Institute of Technology, with funding from the NIH Neural Prosthesis Program from 1988 to 1999.

The original glass version of the device is being produced at the Alfred Mann Institute (AMI) of the University of Southern California, where Jerry Loeb, one of the developers, moved in 1999. A later generation under development at AMF incorporates a ceramic case capable of withstanding a 40-lb. crushing force. The Foundation is currently working on perfecting a self-contained power source for the new generation of BIONs. Both groups are working on future versions that incorporate sensors and bidirectional communication that will be required to produce functional movements of paralyzed limbs.

In 1998, Advanced Bionics obtained exclusive marketing rights to the BION. That company is planning to market the device as a treatment for urinary urge incontinence. But in the meantime, both AMI and AMF are exploring other commercial opportunites for the device.

At the recent Neural Prosthesis Workshop in Bethesda, MD, Loeb announced a number of new initiatives, including collaboration with Dick Stein, the developer of the WalkAide, a footdrop stimulation system that previously used surface stimulation electrodes. AMI is also in the planning phase of a cerebral palsy application. Loeb had previously reported promising results from several patients using BIONs to treat post-stroke shoulder subluxation. Other new applications being looked at by AMI include obstructive sleep apnea, cough assist, and constraint-induced therapy for stroke patients.

At the recent Society for Neuroscience meeting in Orlando, FL, AMF displayed a new BION Control Unit and BION fitting software. The Motorola CPU-based control unit communicates with the stimulator at a rate of 19.2 kbaud, and can store up to three programs. The Java-based fitting software controls up to eight BIONs and runs under Microsoft Windows. AMF also showed several new coil designs, including devices configured for use in the knee, shoulder, trunk, arm, and chin regions.

AMF president Joe Schulman has been actively promoting a network configuration of multiple BIONs, which he favors over a lead-based network.