Systems and methods for implanting an electrical stimulation lead using a sheath

• US 9,283,378 B2
• Filed: 05/22/2013
• Issued: 03/15/2016
• Est. Priority Date: 05/25/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Govea, Michael
• Primary Examiner(s): Manahan, Todd E
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US13/900,247
• Publication Number:
  US 20130317518A1
• Time in Patent Office: 1,028 Days
• Field of Search: 606/129, 607/116, 607/117, 607/48, 607/43, 600/377, 600/373, 600/544, 600/545
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A method for implanting an electrical stimulation lead into a patient includes inserting an elongated sheath into a patient. The sheath includes a sheath body with a proximal end and a distal tip. The sheath defines a lumen extending from the proximal end of the sheath to the distal tip. The distal tip of the sheath is advanced to the patient'"'"'s epidural space. The distal tip of the sheath is positioned at a target implantation location. A lead is advanced along the lumen of the sheath from the proximal end of the sheath body to the distal tip. The lead includes a lead body and a plurality of electrodes disposed along a distal end of the lead body. The sheath is removed from the patient while leaving the distal end of the lead at the target implantation location.

Claims

1. A method for implanting an electrical stimulation lead into a patient, the method comprising:

inserting an elongated sheath into a patient, the sheath comprising a sheath body with a proximal end and a distal tip, the sheath defining a lumen extending from the proximal end to the distal tip;

advancing the distal tip of the sheath to the patient'"'"'s epidural space;

guiding the distal tip of the sheath into and through an intervertebral foramen from a location inside the epidural space;

positioning the distal tip of the sheath at a target implantation location;

advancing a lead along the lumen of the sheath from the proximal end of the sheath body to the distal tip, the lead comprising a lead body and a plurality of electrodes disposed along a distal end of the lead body; and

removing the sheath from the patient while leaving the distal end of the lead at the target implantation location.

2. The method of claim 1, wherein advancing the distal tip of the sheath to the patient'"'"'s epidural space comprises using the distal tip of the sheath to form an incision extending between an exterior location of the patient and the patient'"'"'s epidural space.

3. The method of claim 2, further comprising inserting a plug into the sheath prior to using the distal tip of the sheath to form the incision extending between the exterior location of the patient and the patient'"'"'s epidural space.

4. The method of claim 1, wherein advancing the distal tip of the sheath to the patient'"'"'s epidural space comprises inserting the sheath into a percutaneous needle and using the percutaneous needle to form an incision extending between an exterior location of the patient and the patient'"'"'s epidural space.

5. The method of claim 1, wherein advancing the distal tip of the sheath to the patient'"'"'s epidural space comprises extending the sheath through a previously-formed incision extending between an exterior location of the patient and the patient'"'"'s epidural space.

6. The method of claim 5, further comprising enlarging the previously-formed incision with a dilator prior to extending the sheath through the previously-formed incision.

7. The method of claim 1, wherein positioning the distal tip of the sheath at a target implantation location comprises steering the sheath using one of a stylet or a guidewire.

8. The method of claim 1, further comprising guiding the distal end of the lead from the target implantation location to a target stimulation location.

9. The method of claim 8, wherein guiding the distal end of the lead from the target implantation location to the target stimulation location comprises inserting one of a stylet or a guidewire into the lead body to facilitate guidance of the lead.

10. The method of claim 1, wherein positioning the distal tip of the sheath at a target implantation location comprises guiding the distal tip of the sheath to a target stimulation location.

11. The method of claim 1, further comprising bending, the sheath along at least one flexible region of the sheath body prior to guiding the distal tip of the sheath into and through the intervertebral foramen from inside the epidural space and aligning the bent at least one flexible region with an interface between the epidural space and the intervertebral foramen.

12. The method of claim 1, wherein guiding the distal tip of the sheath into and through an intervertebral foramen from a location inside the epidural space comprises aligning at least one pre-defined bend formed along the sheath with an interface between the epidural space and the intervertebral foramen.

13. The method of claim 1, wherein positioning the distal tip of the sheath at a target implantation location further comprises positioning the distal end of the lead in proximity to a dorsal root ganglion that extends through the intervertebral foramen.

14. The method of claim 1, wherein advancing the lead along the lumen of the sheath comprises inserting one of a stylet or a guidewire into the lead body to facilitate advancement of the lead.

15. The method of claim 1, further comprising disposing a radiopaque material along at least a portion of the sheath body prior to inserting the sheath into a patient.