Implantable electrode lead in a growing limb

An implantable electrode leadwire system used to provide limb function for individuals with spinal cord injuries (SCI´s) was evaluated in a series of growing dogs to determine whether it could maintain its performance in the presence of growth. Thirty implantable electrodes (15 epimysial and 15 intramuscular) were implanted in the forelimb muscles of 6 young dogs. The electrodes´ leads were tunneled subcutaneously and anchored proximally in the shoulder with excess lead incorporated into the subcutaneous space to accommodate growth. Six of the leads had some of this excess placed in pouches made from surgical membrane while the other 24 leads had excess placed freely within the subcutaneous space. Motor responses to the electrodes were tested before and after growth with tendon force transducers and were compared to the performance of new electrodes implanted to the same muscles of the mature dog during the explant procedure. Measured were the pulse duration at which a measurable force is first produced (threshold) and the percentage of the maximum force that could be attained from the target muscle before activation of adjacent muscles (usable force range). An analysis of variance indicated that there was no difference in the usable force range (p=0.62) of the original electrodes before and after growth and that of the new electrodes placed at maturity. There was a difference in the threshold (p=0.001) which can be attributed to an increase in the values measured from the original electrodes after growth. However the increase in threshold with growth averaged 6 μs which is not clinically significant and can be accommodated through stimulation programming. Growth of the limb and unwinding of excess lead were quantified by radiograph. Extension of the freely placed excess lead was comparable to growth so that the pouch enclosures were found to be unnecessary for facilitating lead expansion. By radiograph and surgical observations, only two of 30 electrodes (both intramuscular) appeared to have been subjected to lead tension, although they continued to provide adequate motor responses. Insufficient excess lead was judged to be the cause of dislodgment for one of these electrodes. Results of this study suggest that for this implantable leadwire system, excess lead placed in the subcutaneous space can unwind on demand with limb growth such that an electrode will remain in position and provide a stable motor response