The research program is designed to develop and test an electrode assembly for a device that will restore defecation and micturition in human subjects who have lost control of these functions through neurological disease or damage such as spinal cord injury. It has been demonstrated that it is possible to activate selectively and independently the small parasympathetic and the large somatic nerve fibers in the sacral anterior roots S2, S3, and S4. Small fibers in these roots control lower bowel and bladder contraction. Large somatic nerve fibers Control the external sphincters. With the achievement of selective and independent activation of the small fibers, it now becomes possible to overcome one of the main obstacles to electrical control of the bowel and bladder in paraplegics and quadriplegics. The emphasis of this portion of the research program will be the final development of the necessary electrodes, electrode carrier, leads and connectors for the bowel and bladder assist device, institution of larger scale production techniques, further safety testing in dogs, and an initial clinical trial in one subject. Axon will work towards these goals with its corporate partner, Sigmedics, Inc.
The control of the bowel and bladder would have a major financial impact on the care of paraplegics and quadriplegics, who, at present, require frequent out-patient and in- patient care for treatment of complications in these systems. There are at least 176,000 people in the United States with paralysis due to spinal cord injury and at least 7,800 new injuries occur each year (data from the National Spinal Cord Injury Association). Individuals with multiple sclerosis, currently numbering at least 250,000 in the US (data from the National Multiple Sclerosis Society) are also potential benefactors of this technology. The bowel and bladder assist device could also find applications in similar patients world wide.
