Percutaneous implantation of an electrical stimulation lead for stimulating dorsal root ganglion

• US 9,199,074 B2
• Filed: 09/15/2014
• Issued: 12/01/2015
• 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: Pianca, Anne Margaret
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/486,793
• Publication Number:
  US 20150005782A1
• Time in Patent Office: 442 Days
• 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: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A method of implanting an electrical stimulation lead to stimulate a dorsal root ganglion includes providing an electrical stimulation lead having a distal end, a proximal end, a longitudinal length, electrodes disposed along the distal end of the lead, terminals disposed on the proximal end of the body, a plurality of conductors electrically coupling the electrodes to the terminals. The method further includes sequentially inserting a series of hollow introducers into the back of a patient to open a passage to the dorsal root ganglion. Each introducer in the series has an inner diameter larger than an inner diameter of a preceding introducer in the series. The method also includes implanting the electrical stimulation lead through the passage formed using the series of hollow introducers. Upon implantation of the electrical stimulation lead, at least one of the plurality of electrodes is adjacent the dorsal root ganglion.

Claims

1. A method of implanting an electrical stimulation lead to stimulate a dorsal root ganglion, the method comprising:

providing an electrical stimulation lead having a distal end, a proximal end, a longitudinal length, a plurality of electrodes disposed along the distal end of the lead, a plurality of terminals disposed on the proximal end of the lead, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals;

sequentially inserting a series of hollow introducers into a back of a patient to open a passage to the dorsal root ganglion, each introducer in the series sliding over a preceding introducer in the series; and

implanting the electrical stimulation lead through the passage formed using the series of hollow introducers, wherein, upon implantation of the electrical stimulation lead, at least one of the plurality of electrodes is adjacent the dorsal root ganglion.

2. The method of claim 1, further comprising, prior to implanting the electrical stimulation lead, removing a plurality of the introducers in the series leaving at least a last-inserted introducer in the patient.

3. The method of claim 2, wherein removing a plurality of the introducers comprises removing all of the introducers except the last-inserted introducer.

4. The method of claim 1, wherein the electrical stimulation lead is an isodiamctric lead.

5. The method of claim 1, wherein the electrical stimulation lead further comprises a paddle body disposed at the distal end of the electrical stimulation lead.

6. The method of claim 1, wherein implanting the electrical stimulation lead comprises implanting the lead around at least a portion of the dorsal root ganglion with the distal end of the lead formed into a hook shape situated around the portion of the dorsal root ganglion.

7. The method of claim 1, wherein implanting the electrical stimulation lead comprises implanting the lead around at least a portion of the dorsal root ganglion with the distal end of the lead formed into a coil shape situated around the portion of the dorsal root ganglion.

8. The method of claim 1, wherein implanting the electrical stimulation lead comprises implanting the electrical stimulation lead so that the lead forms an angle of at least 45°

with respect to a dorsal root extending from the dorsal root ganglion.

9. The method of claim 1, wherein implanting the electrical stimulation lead comprises implanting the electrical stimulation lead so that the lead forms an angle of no more than 25°

with respect to a dorsal root extending from the dorsal root ganglion.

10. An electrical stimulation lead implantation kit, comprising:

an electrical stimulation lead having a distal end, a proximal end, a longitudinal length, a plurality of electrodes disposed along the distal end of the lead, a plurality of terminals disposed on the proximal end of the lead, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals, wherein the distal end of the electrical stimulation lead is formed in a hook or coil shape; and

a series of hollow introducers configured and arranged for insertion into a back of a patient to open a passage to a dorsal root ganglion, each introducer in the series configured and arranged to slide over a preceding introducer in the series.

11. The electrical stimulation lead implantation kit of claim 10, wherein the electrical stimulation lead is an isodiametric lead.

12. The electrical stimulation lead implantation kit of claim 10, further comprising a control module coupleable to the terminals of the electrical stimulation lead.

13. The electrical stimulation lead implantation kit of claim 10, further comprising a lead extension coupleable to the electrical stimulation lead.

14. A method of implanting an electrical stimulation lead, the method comprising:

providing an electrical stimulation lead having a distal end, a proximal end, a longitudinal length, a plurality of electrodes disposed along the distal end of the lead, a plurality of terminals disposed on the proximal end of the lead, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals, wherein the distal end of the electrical stimulation lead is formed in a hook or coil shape;

sequentially inserting a series of hollow introducers into a patient to open a passage to an implantation site, each introducer in the series having an inner diameter larger than an inner diameter of a preceding introducer in the series; and

implanting the electrical stimulation lead through the passage formed using the series of hollow introducers, wherein, upon implantation of the electrical stimulation lead, at least one of the plurality of electrodes is adjacent to the implantation site.

15. The method of claim 14, further comprising, prior to implanting the electrical stimulation lead, removing a plurality of the introducers in the series leaving at least a last-inserted introducer in the patient.

16. The method of claim 14, wherein sequentially inserting a series of hollow introducers into the patient comprises inserting at least one of the introducers of the series deeper into patient tissue than an immediately preceding one of the introducers was inserted.

17. The method of claim 16, wherein sequentially inserting a series of hollow introducers into the patient comprises inserting each of the introducers of the series deeper into patient tissue than an immediately preceding one of the introducers was inserted.

18. The method of claim 14, wherein sequentially inserting a series of hollow introducers into the patient comprises inserting each of the introducers of the series a substantially identical depth into the patient.

19. The method of claim 14, further comprising inserting a guidewire into the patient prior to sequentially inserting the series of hollow introducers into the patient.

20. The method of claim 19, wherein sequentially inserting a series of hollow introducers into the patient comprises inserting a first introducer of the series of hollow introducers over the guidewire.