Stimulation systems

• US 8,082,039 B2
• Filed: 09/07/2005
• Issued: 12/20/2011
• Est. Priority Date: 09/08/2004
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated), Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Spinal Modulation, Inc. (Abbott Laboratories Incorporated), Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Kim, Daniel H., Imran, Mir A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): STEWART, JENNIFER LEIGH
• Application Number:
  US11/222,513
• Publication Number:
  US 20060052827A1
• Time in Patent Office: 2,295 Days
• Field of Search: 607/33, 607/61, 607/46, 607/62, 607115-118, 600/372, 600/373, 600/377, 600/378
• US Class Current: 607/46
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Some embodiments of the present invention provide stimulation systems and components for selective stimulation and/or neuromodulation of one or more dorsal root ganglia through implantation of an electrode on, in or around a dorsal root ganglia. Some other embodiments of the present invention provide methods for selective neurostimulation of one or more dorsal root ganglia as well as techniques for applying neurostimulation to the spinal cord. Still other embodiments of the present invention provide stimulation systems and components for selective stimulation and/or neuromodulation of one or more dorsal root ganglia through implantation of an electrode on, in or around a dorsal root ganglia in combination with a pharmacological agent.

Claims

1. A stimulation system, comprising:

a battery;

a pulse generator;

an electrical connection between the battery and the pulse generator; and

a lead connected proximally to the pulse generator and distally to an electrode sized and configured for implantation within a foramen and adjacent a dorsal root ganglion, the electrode driven by a signal from the pulse generator,

wherein the signal is configured to stimulate a volume of tissues including at least a portion of the dorsal root ganglion in the immediate vicinity of the electrode while substantially excluding a ventral root,

wherein the battery, the pulse generator, the electrical connection, the lead and the electrode are configured for implantation in the body in an arrangement wherein the lead passes through at least a portion of an epidural space while the pulse generator is disposed outside of the epidural space.

2. The stimulation system according to claim 1, the pulse generator further comprising a DC-DC converter.

3. The stimulation system according to claim 2 wherein the DC-DC converter is configured to provide a voltage from 0 volts to 30 volts.

4. The stimulation system according to claim 2 wherein the DC-DC converter is configured to provide a voltage from 0 volts to 40 volts.

5. The stimulation system according to claim 1 wherein the pulse generator has an overall volume of less than 200 mm³.

6. The stimulation system according to claim 5 wherein at least one dimension of the pulse generator is 2 mm or less.

7. The stimulation system according to claim 5 wherein at least one dimension of the pulse generator is 10 mm or less.

8. The stimulation system according to claim 1 further comprising:

a second pulse generator separate from the battery;

an electrical connection between the pulse generator and the second pulse generator; and

a second lead connected proximally to the second pulse generator and distally to a second electrode.

9. The stimulation system according to claim 8 wherein the pulse generator and the second pulse generator are independently programmable.

10. The stimulation system according to claim 8 wherein the pulse generator and the second pulse generator are configured to operate in a master-slave configuration.

11. The stimulation system according to claim 8 wherein the activation of the electrode is coordinated with the activation of the second electrode.

12. The stimulation system according to claim 11 wherein the electrode is active when the second electrode is active.

13. The stimulation system according to claim 11 wherein the electrode is inactive when the second electrode is active.

14. A stimulation system according to claim 1 wherein the pulse generator is separate from the battery.

15. A stimulation system for selectively stimulating a dorsal root ganglion, comprising:

a battery;

an implantable pulse generator;

an electrical connection between the battery and the pulse generator; and

an implantable lead connected proximally to the pulse generator and distally to an electrode, wherein the electrode has a size or shape that allows the electrode to selectively stimulate the dorsal root ganglion when the electrode is implanted within a foramen into or on the dorsal root ganglion.

16. A stimulation system according to claim 15 wherein the electrode size or shape excludes stimulation of surrounding neural tissue.

17. A stimulation system according to claim 15 wherein the electrode size or shape is selected from a range of sizes to accommodate specific anatomical characteristics of a patient.

18. A stimulation system according to claim 15 wherein the electrode size or shape is selected based upon an implantation technique used to implant the electrode within the foramen into or on the dorsal root ganglion.

19. A stimulation system according to claim 15 wherein the electrode size or shape is selected based upon anatomical dimensions of an implantation site.

20. A stimulation system, comprising:

a battery;

a pulse generator;

an electrical connection between the battery and the pulse generator; and

a lead connected proximally to the pulse generator and distally to an electrode sized and configured for implantation within a foramen into or on a dorsal root ganglion, the electrode driven by a signal from the pulse generator,

wherein the signal is configured to stimulate a volume of tissues including a portion of the dorsal root ganglion adjacent to the electrode while substantially excluding a ventral root,

wherein the battery, the pulse generator, the electrical connection, the lead and the electrode are configured for implantation in the body in an arrangement wherein the lead passes through at least a portion of an epidural space while the pulse generator is disposed outside of the epidural space.

21. The stimulation system according to claim 20, the pulse generator further comprising a DC-DC converter.

22. The stimulation system according to claim 21 wherein the DC-DC converter is configured to provide a voltage from 0 volts to 30 volts.

23. The stimulation system according to claim 21 wherein the DC-DC converter is configured to provide a voltage from 0 volts to 40 volts.

24. The stimulation system according to claim 20 wherein the pulse generator has an overall volume of less than 200 mm³.

25. The stimulation system according to claim 24 wherein at least one dimension of the pulse generator is 2 mm or less.

26. The stimulation system according to claim 24 wherein at least one dimension of the pulse generator is 10 mm or less.

27. The stimulation system according to claim 20 further comprising:

a second pulse generator separate from the battery;

an electrical connection between the pulse generator and the second pulse generator; and

a second lead connected proximally to the second pulse generator and distally to a second electrode.

28. The stimulation system according to claim 27 wherein the pulse generator and the second pulse generator are independently programmable.

29. The stimulation system according to claim 27 wherein the pulse generator and the second pulse generator are configured to operate in a master-slave configuration.

30. The stimulation system according to claim 27 wherein the activation of the electrode is coordinated with the activation of the second electrode.

31. The stimulation system according to claim 30 wherein the electrode is active when the second electrode is active.

32. The stimulation system according to claim 30 wherein the electrode is inactive when the second electrode is active.

33. A stimulation system according to claim 20 wherein the pulse generator is separate from the battery.

34. A stimulation system for selectively stimulating a dorsal root ganglion, comprising:

a battery;

an implantable pulse generator;

an electrical connection between the battery and the pulse generator; and

an implantable lead connected proximally to the pulse generator and distally to an electrode, wherein the electrode has a size or shape that allows the electrode to selectively stimulate the dorsal root ganglion when the electrode is implanted within a foramen and adjacent to the dorsal root ganglion.

35. A stimulation system according to claim 34 wherein the electrode size or shape excludes stimulation of surrounding neural tissue.

36. A stimulation system according to claim 34 wherein the electrode size or shape is selected from a range of sizes to accommodate specific anatomical characteristics of a patient.

37. A stimulation system according to claim 34 wherein the electrode size or shape is selected based upon an implantation technique used to implant the electrode within the foramen into or on the dorsal root ganglion.

38. A stimulation system according to claim 34 wherein the electrode size or shape is selected based upon anatomical dimensions of an implantation site.