A NEW PARADIGM FOR NEUROLOGICAL LEAD CYCLIC TESTING

摘要

The feasibility of electrical stimulation of the nervous system to treat chronic pain was proven with implantation of the first device for this purpose by Norm Shealy, MD in 1967. Since then, neurological stimulation has become a standard therapy for pain management. Neurological stimulation devices deliver a signal from the stimulator to the desired site by use of a neurological lead. Lead conductors are constructed of fatigue resistant alloys, and include multiple circuits to provide stimulation along a portion of the lead ranging from less than 1 inch to more than 2 inches in length. Neurological lead development has relied heavily on the cardiovascular lead experience. Common materials and fabrication methods are evident. In both cases, excellent fatigue performance is needed. Many of the testing methods applied to neurological leads have been adapted from cardiovascular lead tests, such as those specified in BS EN 455021. However, evidence suggests there are significant differences in the mechanical environments in which these two types of leads must perform. The purpose of this study was to more clearly delineate the differences in these environments, and to more appropriately align cyclic testing methods applied to neurological leads with the actual use conditions associated with the clinical environment.