Methods and kits for delivering cortical electrode leads into patient's head

• US 20060129203A1
• Filed: 12/10/2004
• Published: 06/15/2006
• Est. Priority Date: 12/10/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Garabedian, Robert J., Wallace, Michael P., Heit, Gary
• Granted Patent: US 7,937,160 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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; and

placing the electrode lead in a pre-shaped two-dimensional geometry between the cranium and cortical brain tissue of the patient.

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, further comprising advancing the electrode lead between the cranium and the cortical brain tissue, wherein the electrode lead is placed into the two-dimensional geometry during the advancement of the electrode lead.

7. The method of claim 1, wherein the electrode lead is introduced through the burr hole with a sheath, the method further comprising removing the sheath from the electrode lead to place the electrode lead into the two-dimensional geometry.

8. The method of claim 1, wherein the two-dimensional geometry is a coil-shape.

9. The method of claim 1, wherein the electrode lead comprises a center support that urges the electrode lead into the two-dimensional geometry.

10. 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 geometry, the method further comprising removing the stylet from the lumen after the electrode lead has been placed into the two-dimensional geometry between the cranium and the cortical brain tissue.

11. 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.

12. The method of claim 11, further comprising electrically coupling an extension lead to the electrode lead via the access anchor.

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

14. The method of claim 13, 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.

15. The method of claim 14, 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.

16. 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.

17. 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.

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

introducing a balloon through the burr hole prior;

inflating the balloon to create a pocket between the dura mater and cranium of the patient;

deflating the balloon;

removing the balloon from burr hole;

introducing the electrode lead through the burr hole; and

placing the electrode lead within the pocket.

19. The method of claim 18, wherein the electrode lead is linearly introduced through the burr hole, and the electrode lead is placed in a pre-shaped two-dimensional geometry within the pocket.

20. The method of claim 18, wherein the electrode lead is an electrical stimulation lead.

21. The method of claim 20, further comprising electrically coupling the stimulation lead to an electrical stimulation source.

22. The method of claim 20, 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.

23. The method of claim 18, wherein the burr hole has a diameter that is less than 15 millimeters.

24. The method of claim 18, wherein the burr hole has a diameter that is equal to or less than 3 millimeters.

25. The method of claim 18, further comprising mounting an access anchor into the burr hole, wherein the electrode lead is introduced through the access anchor.

26. The method of claim 25, further comprising electrically coupling an extension lead to the electrode lead via the access anchor.

27. The method of claim 18, 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.

28. The method of claim 18, wherein the electrode lead has a monitoring lumen, the method further comprising introducing a scope through the lumen into the patient'"'"'s head.

29-51. -51. (canceled)