BION/sup TM/. Bionic neurons for functional and therapeutic electrical stimulation

The goal of this project is to develop complete clinical systems for the application of functional electrical stimulation to alleviate disabilities and morbidity associated with musculoskeletal paralysis and atrophy. Over the past 8 years, the authors have designed, built and successfully tested in animals the first device in a new class of implantable electronic interfaces with nerve and muscle. BIONs are hermetically encapsulated, leadless electrical devices that are small enough to be injected percutaneously into muscles (2 mm diameter by 15 mm long). They receive their power and digital addressing and command signals from an external transmitter coil that can be worn by or placed under the patient. The authors have designed and built a family of accessory items required for clinical trials, including sterile testing and insertion tools and a bedside control unit so that clinicians can program various patterns of therapeutic stimulation to build strength and bulk in hypotrophic muscles, e.g. following stroke, spinal cord injury, major trauma and orthopedic reconstructions. Other potential applications include urinary incontinence, prevention of deep vein thrombosis and alleviation of chronic pain. Functional recovery of limb movement requires feedback signals about ongoing movement, for which the authors are developing second-generation BIONs that provide outgoing telemetry of such data.