Strain relief system for spinal cord stimulation lead

1. Field of the Invention

The present invention relates to medical devices and, more particularly, to a strain relief system for implantable electrical stimulation leads.

2. Description of the Related Art

Spinal cord stimulation (SCS) is frequently used to treat patients with chronic neuropathic pain in who have not found relief using other treatments. In general, neurostimulation works by applying an electrical current to the nerves located near the source of chronic pain. More particularly, a thin wire with an electrical lead at one end is implanted into a patient in the location to be treated, such as a particular portion of the spine. An electrical generator connected to the wire is used to deliver electrical current to the lead, thereby stimulating the nerves at the treatment location.

Although spinal cord stimulation may produce dramatic results for patient pain care, the systems used to supply the electrical stimulation to the spine are subject to failure and may lead to reduced effectiveness or require additional surgery to correct or replace the defective portions of the system. The most common complications associated with spinal cord stimulation fall into two general categories. The first category of problems that affects spinal cord stimulation systems is the migration of the electrodes away from the intended targets. This complication may occur in over ten percent of patients receiving spinal cord stimulation. The second category of problems that affects spinal cord stimulation systems is the breakage of the electrical leads. This complication may occur in nearly ten percent of patients receiving spinal cord stimulation. As a result of these complications, the spinal cord stimulation system may need to be repaired or replaced, if possible, through additional patient surgical procedures. Thus, the risks to the patient of more serious complications and the overall costs associated with obtaining neurostimulation treatment are increased.

Convention methods for affixing stimulation leads in place include suture sleeves having elastomeric gripping portions positioned therein. When the suture sleeve is sutured into position along the spinal column, the gripping sleeve is compressed around the pacing lead, thereby enhancing retention of the lead. While such systems may limit lead migration, they do not limit the stresses that cause fracturing or breaking of the lead wires. Conventional methods for reducing fracturing involve the use of strain relief members that extend from the lead anchors. Unfortunately, these strain relief members simply relocate stress points and thus fail to reduce the occurrence of fractures.

It is therefore a principal object and advantage of the present invention to provide a system and method for anchoring spinal cord stimulation leads that reduces lead migration.

It is a further object and advantage of the present invention to provide a system and method for anchoring spinal cord stimulation leads that reduces lead fractures.

It is an additional object and advantage of the present invention to provide a system for anchoring spinal cord stimulation leads that reduces the risks to patients.

It is another object and advantage of the present invention to provide a system for anchoring spinal cord stimulation leads that reduces the risks to patients.

In accordance with the foregoing objects and advantages, the present invention is an anchor for spinal electrical stimulation leads. The anchor comprises a flexible, tubular housing through which an electrical stimulation electrode may be passed. The housing generally comprises a central portion adapted for attachment to the fascia of the spine, a rear portion extending from the back of the central portions, and a front portion extending forwardly from the central portion. The central portion of the housing may optionally comprise a pair of flanges extending transversely outwardly, each of which includes a pair of holes formed therethrough for accepting the sutures. The central portion of the housing may further include an inner tube disposed therein. When the central portion of the tubular housing is sutured to the fascia of a patient, the inner tube is compressed against the electrical lead, thereby locking it in place and preventing migration of the lead. The front portion of the housing is dimensioned to be inserted at least partially through the ligamentum flavum (interspinal ligament) and, preferably, entirely through the ligamentum flavum into the epidural space of the spine. The anchor is preferably manufactured from a flexible polymer so that the front portion of the housing can bend flex after passing through the spine and into the spinal cavity, thereby providing strain relief for an electrical lead passing therethough and reducing fracturing of the electrical lead. The material used to form the anchor may further be impregnated with barium so that the anchor is visible when imaged using a fluoroscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:

FIG. 1 is perspective view of an electrical stimulation lead anchor according to the present invention.

FIG. 2 is a front end view of another embodiment of an electrical stimulation lead anchor according to the present invention.

FIG. 3 is a rear end view of an electrical stimulation lead anchor according to the present invention.

FIG. 4 is a longitudinal cross-section of an electrical stimulation lead anchor according to the present invention.

FIG. 5 is a partial cross-sectional view of spinal column including an embodiment of an electrical stimulation lead anchor according to the present invention.

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