METHODS, SYSTEMS AND DEVICES FOR REDUCING MIGRATION

• US 20160279408A1
• Filed: 06/09/2016
• Published: 09/29/2016
• Est. Priority Date: 05/10/2010
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: St. Jude Medical Luxembourg Holdings Ii S.A.R.L.
• Inventors: Grigsby, Eric J., Brounstein, Daniel M., Linker, Fred I.
• Granted Patent: US 10,456,576 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

Devices, systems and methods for reducing migration of leads, catheters and similar devices are provided. In particular, devices, systems and methods are provided for creating a slack anchor which assists in maintaining the lead or catheter in a desired position. In some embodiments, the slack anchor is created within the epidural space. When targeting nerve anatomy within the spinal column or in the vicinity of the epidural space, anchoring within the epidural space allows the associated lead or catheter to be anchored as close to the target therapy site as desired or possible. By anchoring close to the target therapy site, the risk of movement or migration is significantly reduced or eliminated.

Claims

1. A method of positioning a lead to electrically stimulate a dorsal root ganglion of a patient, comprising:

accessing an epidural space of a patient with an introducer sheath at an entry point;

advancing a distal end of the lead with a stylet through the introducer sheath to enter the epidural space, wherein the lead comprises a lead body, of a soft pliant polymer material, without a mechanical bias to assume a predetermined shape;

advancing the lead from the epidural space through a foramen in a position wherein electrodes of the lead are positioned proximate to the dorsal root ganglion;

after the lead is positioned with electrodes proximate to the dorsal root ganglion, introducing an additional portion of a shaft of the lead into the epidural space with the stylet withdrawn from the additional portion of the shaft, wherein the additional portion of the shaft is more flexible than the distal end of the lead to cause the additional portion of the shaft to form an undulating or loop shape in the epidural space without displacing the electrodes from a location proximate to the dorsal root ganglion; and

connecting the lead to an implantable pulse generator to provide electrical stimulation to the dorsal root ganglion through electrodes of the lead, wherein the undulating or loop shape of the additional portion of the lead forms a slack anchor between electrodes of the lead and the entry point.

2. The method of claim 1 wherein the introducer sheath comprises a tip that is adapted to direct the additional portion of the shaft to form an undulating or loop shape in the epidural space.

3. The method of claim 1 wherein the shaft of the lead comprises a kink point to assist formation of an undulating or loop shape in the epidural space.

4. The method of claim 1 further comprising:

partially withdrawing the introducer tool before introducing the additional portion of the shaft of the lead into the epidural space.

5. The method of claim 1 wherein the undulating or loop shape of the additional portion of the lead forms multiple switchbacks between the dorsal root ganglion and the entry point.