METHOD OF IMPLANTING A SPINAL CORD STIMULATOR LEAD HAVING MULTIPLE OBSTRUCTION-CLEARING FEATURES

摘要

A method of implanting a spinal cord stimulator lead in the epidural space of a human or animal subject. The method includes discharging a first pressurized fluid through a first lumen in the stimulator lead directly onto a tissue obstruction to form a partial/pilot or full/final opening in the tissue obstruction. If a full opening was not formed sufficient for passage of the stimulator lead, the method further includes inserting a distal-end portion of the stimulator lead into the partial opening and then delivering a second pressurized fluid through a second lumen in the spinal cord stimulator lead and into a balloon for expanding a distensible balloon to clear the tissue obstruction sufficient for passage of the stimulator lead. The method further comprising advancing the stimulator lead past the cleared tissue obstruction and into place for use to deliver therapeutic energy to spinal tissue adjacent the contacts.

主权项

1. A method of implanting a spinal cord stimulator lead into an epidural space of a human or animal subject for treatment, the epidural space having a tissue obstruction, the method comprising:
providing the spinal cord stimulator lead with:
a shaft including a longitudinal axis, a distal-end portion having a distal tip that is transverse to the shaft axis, and at least one portion that is flexible;at least one contact positioned on the shaft and adapted to deliver an electrical impulse within the epidural space;a first lumen extending through at least a portion of the shaft and including a first discharge outlet in the distal tip of the shaft, wherein the first lumen carries a first pressurized fluid and the first outlet discharges the first pressurized fluid directly onto the tissue obstruction to pressure-ablate at least a pilot opening therein;a second lumen extending through at least a portion of the shaft and including a second discharge outlet in the distal-end portion of the shaft, wherein the second lumen carries a second pressurized fluid and the second outlet discharges the second pressurized fluid; anda distensible balloon positioned at the distal-end portion of the shaft and in fluid communication with the second lumen and the second outlet, wherein the balloon is inflatable by the second pressurized fluid; guiding the spinal cord stimulator lead forward in the epidural space until the distal tip of the shaft is adjacent and blocked from further advancement by the tissue obstruction; discharging the first pressurized fluid through the first lumen and the first outlet of the shaft directly onto the tissue obstruction thereby imparting a pressure-ablation force on the tissue obstruction to at least partially displace the tissue obstruction and form a pilot opening; guiding the stimulator lead further forward until the balloon is positioned within the pilot opening of the partially-displaced tissue obstruction; discharging the second pressurized fluid through the second lumen and the second outlet of the shaft and into the distensible balloon to inflate the balloon from a deflated position to an inflated position thereby imparting a radial-compression force on the tissue obstruction to further displace the tissue obstruction and form a final opening; guiding the stimulator lead further forward through the final opening past the further-displaced tissue obstruction and into a treatment position within the epidural space with the contact adjacent a treatment area; and operating the stimulator lead to deliver therapeutic electrical impulses from the contact to the a treatment area adjacent the contact within the epidural space,wherein the serial steps of delivering the first pressurized fluid to at least partially displace the tissue obstruction, discharging the second pressurized fluid to further displace the tissue obstruction, and operating the stimulator lead to deliver therapeutic electrical impulses are all performed using the stimulator lead in the epidural space, and are all performed without removing and reinserting the stimulator lead relative to the epidural space.