Neurostimulation methods and systems

• US 9,205,261 B2
• Filed: 12/05/2012
• Issued: 12/08/2015
• 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., Kramer, Jeffery M.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US13/706,100
• Publication Number:
  US 20130165991A1
• Time in Patent Office: 1,098 Days
• Field of Search: 607/46, 607115-118, 607/2, 607/3, 607/61, 607/62, 600/372, 600/373, 600/377, 600/378
• US Class Current: 1/1
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 1/36071 Pain
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628

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 method of stimulating a target dorsal root ganglion of a patient, comprising:

implanting at least one electrode in proximity to the target dorsal root ganglion; and

activating the at least one electrode to deliver neurostimulation energy to at least a portion of the target dorsal root ganglion, without passing the neurostimulation energy through an intervening physiological structure, to selectively stimulate at least a portion of the target dorsal root ganglion to create paresthesia in an area of the patient'"'"'s body.

2. A method as in claim 1, wherein activating the at least one electrode to selectively stimulate comprises providing stimulation energy below a threshold for stimulating a ventral root associated with the target dorsal root ganglion.

3. A method as in claim 1, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy that stimulates sensory nerves without stimulating motor nerves.

4. A method as in claim 1, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy which preferentially stimulates myelinated fibers over unmyelinated fibers.

5. A method as in claim 1, wherein intensity and/or distribution of the paresthesia lacks clinically significant changes during movement of the patient.

6. A method as in claim 5, wherein movement of the patient comprises movement of the patient from an upright position to a recumbent position or vice versa.

7. A method as in claim 5, wherein movement of the patient comprises flexion, extension or rotation of a portion of a spine of the patient.

8. A method as in claim 5, wherein the lack of clinically significant changes during movement of the patient is due to anchoring of the electrode in position by an anchor.

9. A method as in claim 5, wherein the lack of clinically significant changes during movement of the patient is achieved without the use of an anchor.

22. A method as in claim 1, wherein intensity and/or distribution of the paresthesia lacks clinically significant changes during movement of the patient.

23. A method as in claim 22, wherein movement of the patient comprises movement of the patient from an upright position to a recumbent position or vice versa.

24. A method as in claim 22, wherein movement of the patient comprises flexion, extension or rotation of a portion of a spine of the patient.

25. A method as in claim 22, wherein the lack of clinically significant changes during movement of the patient is due to anchoring of the electrode in position by an anchor.

26. A method as in claim 22, wherein the lack of clinically significant changes during movement of the patient is achieved without the use of an anchor.

10. A method of stimulating a target dorsal root ganglion of a patient, comprising:

implanting at least one electrode in proximity to the target dorsal root ganglion so that the at least one electrode maintains its position in proximity to the target dorsal root ganglion throughout a body position change of the patient; and

activating the at least one electrode to deliver neurostimulation energy to at least a portion of the target dorsal root ganglion, without passing the neurostimulation energy through an intervening physiological structure, to selectively stimulate at least a portion of the target dorsal root ganglion.

11. A method as in claim 10, wherein activating the at least one electrode to selectively stimulate comprises providing stimulation energy below a threshold for stimulating a ventral root associated with the target dorsal root ganglion.

12. A method as in claim 10, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy that stimulates sensory nerves without stimulating motor nerves.

13. A method as in claim 10, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy which preferentially stimulates myelinated fibers over unmyelinated fibers.

14. A method as in claim 10, wherein the body position change of the patient comprises moving to a recumbent position from an upright position or vice versa.

15. A method as in claim 10, wherein the body position change of the patient comprises flexion, extension or rotation of a portion of a spine of the patient.

16. A method as in claim 10, wherein maintaining position of the at least one electrode maintains intensity of paresthesia.

17. A method as in claim 10, wherein maintaining position of the at least one electrode maintains distribution of paresthesia.

18. A method as in claim 10, wherein maintaining position of the at least one electrode maintains intensity and distribution of paresthesia.

19. A method as in claim 10, wherein the at least one electrode maintains its position due to anchoring by an anchor.

20. A method as in claim 10, wherein the at least one electrode maintains its position without the use of an anchor.

21. A method of stimulating a target dorsal root ganglion of a patient, comprising:

implanting at least one electrode in proximity to the target dorsal root ganglion; and

activating the at least one electrode to selectively stimulate at least a portion of the target dorsal root ganglion to create paresthesia in an area of the patient'"'"'s body, wherein activating the at least one electrode to selectively stimulate comprises providing stimulation energy below a threshold for stimulating a ventral root associated with the target dorsal root ganglion.

27. A method of stimulating a target dorsal root ganglion of a patient, comprising:

implanting at least one electrode in proximity to the target dorsal root ganglion; and

activating the at least one electrode to selectively stimulate at least a portion of the target dorsal root ganglion to create paresthesia in an area of the patient'"'"'s body, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy which preferentially stimulates myelinated fibers over unmyelinated fibers.

28. A method as in claim 27, wherein intensity and/or distribution of the paresthesia lacks clinically significant changes during movement of the patient.

29. A method as in claim 28, wherein movement of the patient comprises movement of the patient from an upright position to a recumbent position or vice versa.

30. A method as in claim 28, wherein movement of the patient comprises flexion, extension or rotation of a portion of a spine of the patient.

31. A method as in claim 28, wherein the lack of clinically significant changes during movement of the patient is due to anchoring of the electrode in position by an anchor.

32. A method as in claim 28, wherein the lack of clinically significant changes during movement of the patient is achieved without the use of an anchor.

33. A method of stimulating a target dorsal root ganglion of a patient, comprising:

implanting at least one electrode in proximity to the target dorsal root ganglion; and

activating the at least one electrode to selectively stimulate at least a portion of the target dorsal root ganglion to create paresthesia in an area of the patient'"'"'s body, wherein activating the at least one electrode to selectively stimulate comprises providing a stimulation energy that stimulates sensory nerves without stimulating motor nerves.