Prevention of Mechanical Failures in Implanted Spinal Cord Stimulation Systems

Authors


  • The following paper is the result of a Medtronic-sponsored consensus group consisting of five experienced implanters who met to discuss spinal cord stimulation system complications. Medtronic provided its own test data to be used by the consensus group if they so desired. The conclusions reached in this paper are strictly those of the authors.

Address correspondence and reprint requests to: Jaimie M. Henderson, Stereotactic and Functional Neurosurgery, Stanford University School of Medicine, 300 Pasteur Dr., Edwards Bldg./R-227, Stanford, CA 94305, USA. Email: henderj@stanford.edu

Abstract

Introduction.  Spinal cord stimulation (SCS) is an effective procedure for the treatment of neuropathic extremity pain, with success rates approaching 70%. However, mechanical failures, including breakage and migration, can significantly limit the long-term effectiveness of SCS. A systematic analysis of surgical techniques was undertaken by a consensus group, coupled with extensive in vivo and in vitro biomechanical testing of system components.

Methods.  A computer model based on morphometric data was used to predict movement in a standard SCS system between an anchored lead and pulse generator placed in various locations. These displacements were then used to determine a realistic range of forces exerted on components of the SCS system. Laboratory fixtures were constructed to subject leads and anchors to repetitive stresses until failure occurred. An in vivo sheep model also was used to determine system compliances and failure thresholds in a biologically realistic setting. A panel of experienced implanters then interpreted the results and related them to clinical observations.

Results.  Use of a soft silastic anchor pushed through the fascia to provide a larger bend radius for the lead was associated with a time to failure 65 times longer than an anchored but unsupported lead. In addition, failures of surgical paddle leads occurred when used with an anchor, whereas without an anchor, no failures occurred to 1 million cycles. Based on these findings, the panel recommended a paramedian approach, abdominal pulse generator placement, maximizing bend radius by pushing the anchor through the fascia, and anchoring of the extension connector near the lead anchor.

Discussion.  Several factors are important in longevity of SCS systems. We discovered that technical factors can make a large difference in SCS reliability and that strict attention to these “best practices” will provide the best chance for maintaining the integrity of SCS systems over the long term.

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