Devices and methods using an implantable pulse generator for brain stimulation

• US 7,783,359 B2
• Filed: 09/19/2005
• Issued: 08/24/2010
• Est. Priority Date: 01/05/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Meadows, Paul Milton
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/230,052
• Publication Number:
  US 20060149336A1
• Time in Patent Office: 1,800 Days
• Field of Search: 607/48, 607/45, 607/46, 607/115, 607/116, 607/117
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A device for brain stimulation includes a lead having a longitudinal surface; at least one stimulation electrode disposed along the longitudinal surface of the lead; at least one recording electrode, separate from the at least one stimulation electrode, disposed on the lead; and an implantable pulse generator coupled to the at least one stimulation electrode. In some instances, the implantable pulse generator can be implanted into a burr hole in the skull made for insertion of the lead into the brain.

Claims

1. A method for brain stimulation, the method comprising:

inserting a lead into a cranium of a patient, the lead comprising at least one stimulation electrode disposed along a longitudinal surface of the lead; and

at least one recording electrode, separate from the at least one stimulation electrode, disposed on the lead;

inserting a stylet into the lead to assist in inserting the lead into the cranium of the patient;

identifying target neurons using the at least one recording electrode;

rotating the stylet to rotate the lead and assist in identifying the target neurons;

implanting a pulse generator in the patient; and

stimulating the target neurons using the at least one stimulation electrode and the implanted pulse generator.

2. The method of claim 1, wherein implanting a pulse generator comprises implanting the pulse generator in a burr hole in a skull of the patient.

3. The method of claim 1, further comprising receiving signals at the implanted pulse generator from an external source.

4. The method of claim 3, further comprising transmitting signals from the implanted pulse generator to an external receiver.

5. The method of claim 1, further comprising operating the at least one recording electrode using the implanted pulse generator.

6. The method of claim 5, wherein operating the at least one recording electrode comprises operating the at least one recording electrode after stimulating the target neurons with the at least one stimulation electrode.

7. The method of claim 6, further comprising analyzing signals from the at least one recording electrode after stimulating the target neurons with the at least one stimulation electrode.

8. The method of claim 1, wherein the lumen is a stylet lumen and the lumen comprises a non-circular lateral cross-section comprising a plurality of arms extending from a central cavity.

9. The method of claim 1, wherein the lead comprises a plurality of stimulation electrodes disposed along the longitudinal surface of the lead;

and wherein at least one of the at least one recording electrodes is disposed between two of the plurality of stimulation electrodes.

10. The method of claim 1, wherein the at least one recording electrode comprises one or more sets of recording electrodes disposed at intervals around the circumference of the lead at a same longitudinal position along the lead.

11. The method of claim 10, wherein at least one of the sets of recording electrodes comprises four recording electrodes disposed around the circumference of the lead at 90°

intervals.

12. The method of claim 8, wherein the stylet has a lateral cross-section corresponding to the lateral cross-section of the stylet lumen.

13. A method for brain stimulation, the method comprising:

inserting a stylet into a lead to assist in inserting the lead into a cranium of a patient, the lead comprising a plurality of stimulation electrodes disposed along a longitudinal surface of the lead; and

at least one recording electrode, separate from the plurality of stimulation electrodes, disposed along the longitudinal surface of the lead, wherein at least one of the at least one recording electrodes is disposed between two of the plurality of stimulation electrodes, wherein the lead defines a lumen having a non-circular lateral cross-section extending longitudinally through at least a portion of the lead and the stylet has a corresponding lateral cross-section;

inserting the lead and stylet into the cranium of the patient;

identifying target neurons using the at least one recording electrode;

stimulating the target neurons using at least one of the plurality of stimulation electrodes; and

rotating the lead using the stylet, after identifying the target neurons, to align at least one of the plurality of stimulation electrodes with the target neurons.

14. The method of claim 13, wherein the lumen has a lateral cross-section comprising a plurality of arms extending from a central cavity.

15. The method of claim 14, wherein the lumen has a cruciform or star-shaped lateral cross-section.

16. The method of claim 13, wherein a one of the plurality of stimulation electrodes circumferentially surrounds a one of the at least one recording electrode, wherein the recording electrode and stimulation electrode are separated by a non-conductive region.

17. The method of claim 13, wherein each recording electrode consists essentially of an exposed tip of a wire.

18. The method of claim 13, wherein the at least one recording electrode comprises one or more sets of recording electrodes disposed at intervals around the circumference of the lead at a same longitudinal position along the lead.

19. The method of claim 18, wherein the at least one of the sets of recording electrodes comprises four recording electrodes disposed around the circumference of the lead at 90°

intervals.

20. A method for brain stimulation, the method comprising:

inserting a lead into a cranium of a patient, the lead comprising at least one stimulation electrode disposed along a longitudinal surface of the lead; and

at least one recording electrode, separate from the at least one stimulation electrode, disposed on the lead;

inserting a stylet into the lead to assist in inserting the lead into the cranium of the patient;

identifying target neurons using the at least one recording electrode;

rotating the stylet to rotate the lead and assist in identifying the target neurons;

implanting a pulse generator in the patient; and

stimulating the target neurons using the at least one stimulation electrode and the implanted pulse generator, wherein each recording electrode consists essentially of an exposed tip of a wire.

21. The method of claim 20, wherein a one of the stimulation electrodes circumferentially surrounds a one of the at least one recording electrode, wherein the recording electrode and stimulation electrode are separated by a non-conductive region.