Neurostimulation system

• US 8,712,546 B2
• Filed: 03/19/2008
• Issued: 04/29/2014
• 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): Porter, Jr., Allen
• Application Number:
  US12/051,770
• Publication Number:
  US 20080167698A1
• Time in Patent Office: 2,232 Days
• Field of Search: 607/46, 607/117, 607/118
• US Class Current: 607/118
• 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 neurostimulation 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 neurostimulation systems adapted for selective neurostimulation of one or more nerve 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 neurostimulation system for use in selectively stimulating a target dorsal root ganglion having a bulbous shape, comprising:

a lead having a proximal end, a distal end and an electrode,

wherein the distal end of the lead

is advanceable through a percutaneous access catheter,

is flexible so that the lead is advanceable through the percutaneous access catheter in a substantially straightened configuration, and

once advanced beyond a distal end of the percutaneous access catheter the distal end of the lead is wrappable lengthwise at least partially about the target dorsal root ganglion so as to conform to and thereby follow the bulbous shape of the target dorsal root ganglion, so that the electrode is positioned to selectively stimulate the target dorsal root ganglion;

a signal generator coupled to the electrode providing energy to selectively stimulate the target dorsal root ganglion; and

a controller configured to control an output of the signal generator.

2. The neurostimulation system of claim 1 wherein the controller is configured to determine the output of the signal generator using a preset program.

3. The neurostimulation system according to claim 2 wherein one of the preset programs is no stimulation.

4. The neurostimulation system according to claim 1 wherein the controller is configured to determine the output of the signal generator using a dynamic program selected based on an input.

5. The neurostimulation system according to claim 4 wherein the input is provided from a sensor monitoring a parameter in the body.

6. The neurostimulation system according to claim 5 wherein the sensor is an accelerometer coupled to the person being stimulated by the system.

7. The neurostimulation system according to claim 5 wherein the parameter of the body is the position of the body.

8. The neurostimulation system according to claim 4 where in the input is provided by a person being stimulated by the electrode.

9. The neurostimulation system according to claim 8 wherein the person being stimulated by the electrode provides the input by selecting from a plurality of predetermined programs selected by a physician.

10. The neurostimulation system according to claim 4 wherein the input is provided by a physician.

11. The neurostimulation system according to claim 1 wherein the lead or the electrode further comprises a pharmacologically active coating.

12. The neurostimulation system according to claim 11 wherein the pharmacologically active coating comprises an anti-inflammatory agent.

13. The neurostimulation system according to claim 11 wherein a pharmacologically active coating comprises an opiate.

14. The neurostimulation system according to claim 11 wherein the pharmacologically active coating comprises a suitable pharmacological agent to prevent pathological pain changes after surgery.

15. The neurostimulation system according to claim 11 wherein the pharmacologically active coating comprises cyclooxygenase (COX) inhibitor.

16. The neurostimulation system according to claim 11 wherein the pharmacologically active coating comprises a prostaglandin E2 (PGE2) inhibitor.

17. The neurostimulation system according to claim 1 wherein the electrode has an active electrode area of less than 10 mm².

18. The neurostimulation system according to claim 1 wherein the electrode has an active electrode area of less than 5 mm².

19. The neurostimulation system according to claim 1 wherein the signal generator coupled to the electrode provides energy below a threshold for stimulating a ventral root associated with the dorsal root ganglion.

20. The neurostimulation system according to claim 1 wherein the signal generator coupled to the electrode provides energy which only stimulates neural tissue within the dorsal root ganglion.

21. The neurostimulation system according to claim 1 wherein the signal generator coupled to the electrode provides energy which preferentially stimulates myelinated, large diameter fibers over unmyelinated, small diameter fibers.

22. The neurostimulation system according to claim 1, wherein a cross-section at any single location of the distal end of the lead remains substantially circular regardless of whether the distal end of the lead is within the percutaneous access catheter or advanced beyond the distal end of the percutaneous access catheter.

23. The neurostimulation system according to claim 1, wherein the distal end of the lead is advanceable through the percutaneous access catheter unrestrained while in the substantially straightened configuration.

24. A neurostimulation device for use in selectively stimulating a target dorsal root ganglion having a bulbous shape, comprising:

a lead having a proximal end, a distal end and an electrode,

wherein the distal end of the lead

is advanceable through a percutaneous access catheter, and

is flexible so that the lead is advanceable through the percutaneous access catheter in a substantially straightened configuration, and

once advanced beyond a distal end of the percutaneous access catheter the distal end of the lead is wrappable lengthwise at least partially about the target dorsal root ganglion, so as to conform to and thereby follow the bulbous shape of the target dorsal root ganglion, so that the electrode is positioned to selectively stimulate the target dorsal root ganglion.

25. A neurostimulation device as in claim 24, wherein the lead is flexible so that the lead is wrappable so as to form a ring around a portion of the dorsal root ganglion.

26. A neurostimulation device as in claim 24, wherein the lead is flexible so that the lead is wrappable so as to form a coil around a portion of the dorsal root ganglion.

27. The neurostimulation device as in claim 24, wherein a cross-section at any single location of the distal end of the lead remains substantially circular regardless of whether the distal end of the lead is within the percutaneous access catheter or advanced beyond the distal end of the percutaneous access catheter.

28. The neurostimulation device as in claim 24, wherein the distal end of the lead is advanceable through the percutaneous access catheter unrestrained while in the substantially straightened configuration.