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System and Method for Use and Implant of a Formed Medical Electrical Lead

IP.com Disclosure Number: IPCOM000018804D
Publication Date: 2003-Aug-11

Publishing Venue

The IP.com Prior Art Database

Abstract

A percutaneous stimulation lead for spinal cord stimulation is provided which has a multiplicity of electrode contacts at the distal end of the lead. The distal portion of the lead has a permanent curvature at implantation which allows the lead to be placed, conforming to the curves of the spinal cord for more effective and efficient stimulation. In addition, the curvature facilitates fixation of the lead to the spinal cord. The curvature of the distal portion of the lead can be pre-formed before implantation or it may be formed in-situ once the lead has been inserted to the target site.

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System and Method for Use and Implant of a Formed Medical Electrical Lead

Background and Summary

        � � � � � � � � � � � The present invention relates to medical lead systems and methods of use and, more particularly, to lead systems used for spinal cord stimulation.

        � � � � � � � � � � � Over the past few decades, significant advances have been made in treating intractable, chronic pain.� One method of treating such pain uses an implanted electrode array to stimulate the target area of the spinal cord to alleviate pain.� Stimulation of this target area results in paresthesia, which can replace the pain sensation with an alternate tingling sensation.� While the mechanism of pain relief resulting from such electrical stimulation is not well understood, one theory, known as the “Melzack-Wall Gate-Control Theory,” posits that stimulating specific spinal cord nerve cells inhibits the conduction through nerve fibers which carry pain signals.� � Stimulation of these ganglion cells causes alternate signals to occupy the same neural pathways leading to the brain which also conduct pain signals and, in effect, block the transmission of those pain signals.

        � � � � � � � � � � � Spinal cord stimulation systems generally have two implantable components:� an implantable pulse generator (IPG) and implantable leads connected to the outputs of the IPG.� The term “lead” will refer to any elongate conductor or conductors, covered with an insulative sheath and having at least one electrode contact connected to the conductor.� The IPG can be a multi-channel stimulating device encased in a biocompatible container such as titanium.� Part of the IPG can also be made from polyurethane, silicone or other body-compatible, insulative, polymer material, which can have ports for accepting the connecting ends of the leads to electrically connect these leads to the stimulation output channels of the IPG.

        � � � � � � � � � � � The spinal cord stimulation system can be comprised of one or more leads, each lead having at least one electrode and, more commonly, a multiplicity of electrodes which can be independently selected to provide multi-polar stimulation between at least two selected electrodes located on a single lead or, alternatively, between two electrodes, wherein the electrodes are located on different leads.

        � � � � � � � � � � � There are several types of leads presently used in spinal cord stimulation.� One type is a paddle lead, which has a multiplicity of electrode contacts spaced apart on a flat, paddle-shaped substrate.� The paddle lead advantageously allows the electrode contacts to be spaced-apart to provide wide coverage over an area for stimulation.� A disadvantage presented with a paddle lead is that it requires a laminotomy, which is a highly invasive surgical implantation procedure.� This surgery can result in significant tissue trauma and subsequent formation of connective scar tissue around the paddle lead, and can subject the patient to a subs...