The Bion^® Microstimulator and its Clinical Applications

The Bion (R) microstimulator is a miniature leadless implantable neurostimulator designed to be implanted through a minimally invasive procedure. The small profile of the microstimulator allows it to be implanted through a small incision or by injection. Additionally, the stimulating electrodes are mounted directly on the microstimulator, which eliminates possible complications associated with the use of a lead (e.g., migration). An RF-powered version of the Bion (R) microstimulator was developed over a decade ago and that device has been used in feasibility clinical studies for several functional electrical stimulation (FES) applications, Including shoulder subluxation and post-stroke hand rehabilitation. It has also been explored in clinical applications for knee osteoarthritis rehabilitation, obstructive sleep apnea, and pressure ulcer prevention. A version of the Bion (R) microstimulator with a rechargeable battery has also been developed, and the first-generation battery-powered microstimulator was used in a feasibility clinical trial for headaches. It is also being used in a clinical trial for overactive bladder. Preclinical experiments on the use of the microstimulator for gastroesophageal reflux disease have also been promising. Battery-Powered Microstimulator-sensors with bidirectional propagated wave telemetry, capable of coordinating hundreds of injectable devices for stroke and quadriplegic patients, are presently in the last stages of development.