Design and clinical application of a double helix electrode for functional electrical stimulation.

An electrode, designed to be implanted without a surgical incision, was developed for skeletal muscle stimulation. Stainless steel, Teflon-insulated wire was wound into a helical lead around a polypropylene core and then rewound into a double helix configuration for stress relief during muscle contractions. The electrode tip was augmented with stainless steel barbs to increase anchoring strength. Electrodes were implanted with the help of specially modified hypodermic needles, sheaths, and passing tubes. 775 electrodes were implanted in a five year period in 22 subjects; accumulated implant time was 1,080 electrode years. 453 electrodes (65%) continue to produce strong, stable, muscle contractions. Electrode longevity varied with the location of implant. Electrodes were removed because of (1) inability to locate and properly place the electrode in a suitable site for stimulation during surgery (28.4%), (2) unwanted changes in muscle response to stimulation (91, 12%; one-third occurring during the first six weeks post implant), (3) increase in electrode impedance (74, 10%; assumed breakage, mostly occurring during the first year after implant), (4) intolerable pain during stimulation (8, 1%), and (5) infection (4, 0.5%). 67 (8%) electrodes were removed by accident or when the subjects left the program. This double helix electrode design has proven practical for achieving chronic stimulation of selected muscles in hemiplegic, paraplegic, stroke and brain-injured subjects with minimally invasive surgery.