Methods for delivering cortical electrode leads into patient's head

• US 7,937,160 B2
• Filed: 12/10/2004
• Issued: 05/03/2011
• Est. Priority Date: 12/10/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Garabedian, Robert J., Wallace, Michael P., Heit, Gary
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US11/010,232
• Publication Number:
  US 20060129203A1
• Time in Patent Office: 2,335 Days
• Field of Search: 607/116, 607/45, 606129-130, 600/378
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Methods and kits for delivering an electrode lead into the head of a patient are provided. A burr hole is formed within the cranium of the patient, and an electrode lead is threaded through the burr hole. The electrode lead is then placed in a pre-shaped two-dimensional geometry between the cranium and cortical brain tissue of the patient. An access anchor may be mounted into the burr hole to facilitate introduction and removal of the electrode lead and other devices. In some circumstances, it may be desirable to separate the dura mater overlying the cortical brain tissue from the cortical brain tissue to create a pocket in which the electrode lead may be manipulated. In this case, a tissue layer dissection device can be introduced through the burr hole, operated to separate the dura mater from the cranium, and then removed from the burr hole. In one embodiment, the dissection device comprises a balloon that can be inflated to separate the dura mater and cranium, and then deflated prior to removing the dissection device from the burr hole.

Claims

1. A method of delivering an electrode lead into the head of a patient, comprising:

forming a burr hole within the cranium of the patient;

linearly introducing the electrode lead through the burr hole;

advancing the electrode lead between the cranium and cortical brain tissue of the patient; and

winding the electrode lead into a two-dimensional coiled shape as the electrode lead is linearly advanced between the cranium and cortical brain tissue.

2. The method of claim 1, wherein the electrode lead is an electrical stimulation lead.

3. The method of claim 2, further comprising electrically coupling the stimulation lead to an electrical stimulation source.

4. The method of claim 2, wherein the patient suffers from a disorder, the method further comprising conveying stimulation energy from the stimulation lead to the cortical brain tissue to treat the disorder.

5. The method of claim 1, wherein the burr hole has a diameter that is equal to or less than 3 millimeters.

6. The method of claim 1, wherein the electrode lead comprises a flexible tubular body and a resilient center support extending through the flexible tubular body, thereby providing the flexible tubular body with axial rigidity and urging the electrode lead into the two-dimensional coiled shape.

7. The method of claim 1, wherein the electrode lead has a lumen and a stylet disposed within the lumen, and the stylet urges the electrode lead into the two-dimensional coiled shape from within a portion of the lumen in which the stylet is present, the method further comprising removing the stylet from the lumen after the electrode lead has been placed into the two-dimensional coiled shape between the cranium and the cortical brain tissue.

8. The method of claim 1, further comprising mounting an access anchor into the burr hole, wherein the electrode lead is introduced through the access anchor.

9. The method of claim 8, further comprising electrically coupling an extension lead to the electrode lead via the access anchor.

10. The method of claim 1, wherein the electrode lead is placed between the cranium and the dura mater of the patient.

11. The method of claim 10, further comprising:

introducing a tissue layer dissection device through the burr hole prior to introduction of the electrode lead;

operating the dissection device to separate the dura mater overlying the cortical brain tissue from the cranium; and

removing the dissection device from the burr hole.

12. The method of claim 11, wherein the tissue layer dissection device comprises a balloon, and operation of the dissection device comprises inflating a balloon to separate the dura mater from the cranium, the method further comprising deflating the balloon prior to removing the dissection device from the burr hole.

13. The method of claim 1, wherein the electrode lead has a monitoring lumen, the method further comprising aspirating any fluid between the cranium and the cortical brain tissue through the lumen.

14. The method of claim 1, wherein the electrode lead has a monitoring lumen, the method further comprising introducing a scope through the lumen into the patient'"'"'s head.

15. The method of claim 1, wherein the electrode lead carries a plurality of electrodes, and wherein the electrodes are arranged in the two-dimensional coiled shape.

16. The method of claim 1, wherein the electrode lead is placed in the two-dimensional coil shape along a plane conforming to a surface of the cortical brain tissue.

17. The method of claim 15, wherein the electrodes are ring electrodes.

18. The method of claim 1, wherein the electrode lead is pre-shaped with the two-dimensional coil shape.

19. The method of claim 1, wherein the electrode lead winds outwardly into the two-dimensional coil shape.

21. The method of claim 1, wherein the electrode lead is introduced through the burr hole along an axis, and the two-dimensional coiled shape is formed on a plane substantially perpendicular to the axis.

20. A method of delivering an electrode lead into the head of a patient, comprising:

forming a burr hole within the cranium of the patient;

linearly introducing the electrode lead through the burr hole with a sheath;

advancing the electrode lead between the cranium and cortical brain tissue of the patient; and

outwardly winding the electrode lead into a two-dimensional coiled shape between the cranium and cortical brain tissue as the electrode lead is axially advanced from the sheath.