Nerve stimulation as a treatment for pain

• US 6,721,603 B2
• Filed: 01/25/2002
• Issued: 04/13/2004
• Est. Priority Date: 01/25/2002
• Status: Active Grant

• Current Assignee: Jacob Zabara
• Original Assignee: Cyberonics, Inc
• Inventors: Parnis, Steven M., Zabara, Jacob, Barrett, Burke T.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US10/055,021
• Publication Number:
  US 20030144709A1
• Time in Patent Office: 809 Days
• Field of Search: 607/46
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A method and apparatus are disclosed for treating patients suffering from severe, unrelenting pain. A therapeutic stimulation signal is selectively applied from a stimulus generator, when activated, to at least some of plural electrodes implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and the stimulus generator is activated to generate the therapeutic stimulation signal to alleviate the pain under treatment. Alternatively, the therapeutic stimulation signal is selectively applied to at least one electrode implanted in stimulating relation to at least one of the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and if the selected nerve is the vagus nerve, the signal is applied to a supra-diaphragmatic or sub-diaphragmatic site, either unilaterally or bilaterally to one or both branches, respectively, of the vagus nerve.

Claims

1. A method of treating patients suffering from chronic or persistent pain of neuropathic, psychogenic or nociceptive origin or causation, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to at least some of plural electrodes implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment.

2. The method of claim 1, wherein:

the therapeutic stimulation signal is an electrical pulse signal.

3. The method of claim 2, including:

programming parameters of the stimulation signal, including at least some of current, pulse width, pulse frequency, and duration, period and rate of stimulation, according to the nature of the pain under treatment and the condition of the patient receiving the treatment.

4. The method of claim 1, including:

selectively applying the therapeutic stimulation signal to the patient'"'"'s trigeminal and vagus nerves only.

5. The method of claim 4, including:

selecting the stimulation site for the vagus nerve to be at least one of the cervical, supra-diaphragmatic and sub-diaphragmatic regions, and for unilateral or bilateral stimulation.

6. The method of claim 4, including:

selecting the stimulation site for the trigeminal nerve to be at least one of the three nerve roots or the Gasserian ganglion.

7. The method of claim 1, including:

adapting the stimulus generator for manual activation by the patient.

8. The method of claim 1, including:

adapting the stimulus generator for automatic activation in response to sensing a detectable manifestation of pain.

9. The method of claim 1, including:

adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

10. The method of claim 1, including:

selecting the stimulation site for the vagus nerve to be at least one of the cervical, supra-diaphragmatic and sub-diaphragmatic regions, and for unilateral or bilateral stimulation.

11. The method of claim 1, including:

selecting the stimulation site for the trigeminal nerve to be at least one of the three nerve roots or the Gasserian ganglion.

12. The method of claim 1, including:

selecting the stimulation site for the glossopharyngeal nerve to be the proximal jugular foremen just before the nerve enters the brain, or the carotid sinus branch running along the carotid sinus that connects to the bifurcation of the carotid artery.

13. The method of claim 1, including:

adapting the stimulus generator to generate the therapeutic stimulation signal continuously.

14. The method of claim 1, including:

adapting the stimulus generator to generate the therapeutic stimulation signal periodically.

15. The method of claim 1, including:

adapting the stimulus generator to generate the therapeutic stimulation signal intermittently.

16. A method of treating patients suffering from chronic or persistent pain of neuropathic, psychogenic or nociceptive origin or causation, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to one or more electrodes implanted in stimulating relation to the patient'"'"'s trigeminal nerve, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment.

17. The method of claim 16, including:

selecting the stimulation site for electrode placement to be at least one of the three nerve roots or the Gasserian ganglion of the trigeminal nerve.

18. The method of claim 16, wherein:

the therapeutic stimulation signal is a pulse signal.

19. The method of claim 18, including:

programming parameters of the stimulation signal, including at least some of current, pulse width, pulse frequency, and duration, period and rate of stimulation, according to the nature of the pain under treatment and the condition of the patient receiving the treatment.

20. The method of claim 16, including:

adapting the stimulus generator for manual activation by the patient.

21. The method of claim 16, including:

adapting the stimulus generator for automatic activation in response to sensing a detectable manifestation of pain.

22. The method of claim 16, including:

adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

23. A method of treating patients suffering from chronic or persistent pain of neuropathic, psychogenic or nociceptive origin or causation, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to one or more electrodes implanted in stimulating relation to the patient'"'"'s glossopharyngeal nerve, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment.

24. The method of claim 23, including:

selecting the stimulation site for electrode placement to be the proximal jugular foramen just before the nerve enters the brain, or the carotid sinus branch running along the carotid sinus that connects to the bifurcation of the carotid artery.

25. The method of claim 23, wherein:

the therapeutic stimulation signal is a pulse signal.

26. The method of claim 25, including:

programming parameters of the stimulation signal, including at least some of current, pulse width, pulse frequency, and duration, period and rate of stimulation, according to the nature of the pain under treatment and the condition of the patient receiving the treatment.

27. The method of claim 23, including:

adapting the stimulus generator for manual activation by the patient.

28. The method of claim 23, including:

adapting the stimulus generator for automatic activation in response to sensing a detectable manifestation of pain.

29. The method of claim 23, including:

adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

30. A method of treating patients suffering from chronic or persistent pain of neuropathic, psychogenic or nociceptive origin or causation, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to at least one electrode implanted in stimulating relation to the patient'"'"'s vagus nerve at one of a supra-diaphragmatic or a sub-diaphragmatic site, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment.

31. The method of claim 30, including:

selectively applying said therapeutic stimulation signal unilaterally at the supra-diaphragmatic or a sub-diaphragmatic site.

32. The method of claim 30, including:

selectively applying said therapeutic stimulation signal bilaterally at the supra-diaphragmatic or a sub-diaphragmatic site.

33. Apparatus for treating patients suffering from chronic or persistent pain of neuropathic, psychogenic or nociceptive origin or causation, comprising:

an implantable stimulus generator for selectively applying, when activated, a therapeutic stimulation signal to at least some electrodes of plural leads electrically coupled to said stimulus generator, including plural receptacles of said generator for receiving said plural leads, said plural electrodes adapted to be implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

means for activating the stimulus generator to generate said therapeutic stimulation signal for application to implanted ones of the plural electrodes to alleviate the pain under treatment.

34. The apparatus of claim 33, wherein:

said activating means comprises a sensor associated with the stimulus generator for detecting a predetermined action initiated by the patient.

35. The apparatus of claim 34, wherein:

said sensor is responsive to a magnet wielded by the patient into proximity to the site at which flue stimulus generator is implanted.

36. The apparatus of claim 34, wherein;

said sensor is responsive to tapping by the patient in proximity to the site at which the stimulus generator is implanted.

37. The apparatus of claim 33, wherein:

said activating means comprises a sensor associated with the stimulus generator for detecting a detectable manifestation of pain experienced by the patient.

38. The apparatus of claim 33, wherein:

said activating means comprises a clock for activation according to circadian cycle.

39. A method of treating patients suffering from chronic or persistent pain, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to plural electrodes implanted in stimulating relation to the patient'"'"'s trigeminal and vagus nerves only, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment.

40. The method of claim 39, including:

selecting the stimulation site for the vagus nerve to be at least one of the cervical, supra-diaphragmatic and sub-diaphragmatic regions, and for unilateral or bilateral stimulation.

41. The method of claim 39, including:

selecting the stimulation site for the trigerminal nerve to be at least one of the three nerve roots or the Gasserian ganglion.

42. A method of treating patients suffering from chronic or persistent pain, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to at least some of plural electrodes implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment, and

further including adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

43. A method of treating patients suffering from chronic or persistent pain, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to at least some of plural electrodes implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment, and

further including selecting the stimulation site for the vagus nerve to be at least one of the cervical, supra-diaphragmatic and sub-diaphragmatic regions, and for unilateral or bilateral stimulation.

44. A method of treating patients suffering from chronic or persistent pain, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to at least some of plural electrodes implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment, and

further including adapting the stimulus generator to generate the therapeutic stimulation signal continuously.

45. A method of treating patients suffering from chronic or persistent pain, comprising the steps of;

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to one or more electrodes implanted in stimulating relation to the patient'"'"'s trigeminal nerve, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment, and

further including adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

46. A meted of treating patients suffering from chronic or persistent pain, comprising the steps of:

selectively applying a therapeutic stimulation signal from a stimulus generator, when activated, to one or more electrodes implanted in stimulating relation to the patient'"'"'s glossopharyngeal nerve, and

activating the stimulus generator to generate said therapeutic stimulation signal to alleviate the pain under treatment, and

further including adapting the stimulus generator for prophylactic activation according to the patient'"'"'s circadian rhythm.

47. Apparatus for treating patients suffering from chronic Or persistent pain, comprising:

an implantable stimulus generator for selectively applying, when activated, a therapeutic stimulation signal to at least some electrodes of plural leads electrically coupled to said stimulus generator, including plural receptacles of said generator for receiving said plural leads, said plural electrodes adapted to be implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

means for activating the stimulus generator to generate said therapeutic stimulation signal for application to implanted ones of the plural electrodes to alleviate the pain under treatment,

wherein said activating means comprises a sensor associated with the stimulus generator for detecting a predetermined action initiated by the patient.

48. Apparatus for treating patients suffering from chronic or persistent pain, comprising:

an implantable stimulus generator for selectively applying, when activated, a therapeutic stimulation signal to at least some electrodes of plural leads electrically coupled to said stimulus generator, including plural receptacles of said generator for receiving said plural leads, said plural electrodes adapted to be implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

means for activating the stimulus generator to generate said therapeutic stimulation signal for application to implanted ones of the plural electrodes to alleviate the pain under treatment,

wherein said sensor is responsive to a magnet wielded by the patient into proximity to the site at which the stimulus generator is implanted.

49. Apparatus for treating patients suffering from chronic or persistent pain, comprising:

an implantable stimulus generator for selectively applying, when activated, a therapeutic stimulation signal to at least some electrodes of plural leads electrically coupled to said stimulus generator, including plural receptacles of said generator for receiving said plural leads, said plural electrodes adapted to be implanted in stimulating relation to at least two nerves among the patient'"'"'s trigeminal, vagus, glossopharyngeal and sympathetic nerves, and

means for activating the stimulus generator to generate said therapeutic stimulation signal for application to implanted ones of the plural electrodes to alleviate the pain under treatment,

wherein said sensor is responsive to tapping by the patient in proximity to the site at which the stimulus generator is implanted.