SELECTIVE HIGH FREQUENCY SPINAL CORD MODULATION FOR INHIBITING PAIN WITH REDUCED SIDE EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS

• US 20100274314A1
• Filed: 04/22/2010
• Published: 10/28/2010
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Chitre, Yougandh, Parker, Jon, Walker, Andre B., Alataris, Konstantinos, Park, Sangsoo Wesley
• Granted Patent: US 8,712,533 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36089 Addiction or withdrawal from substance abuse such as alcohol or drugs
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: G01R 21/133 : by using digital technique

Abstract

Selective high-frequency spinal chord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient'"'"'s spinal chord region to address low back pain without creating unwanted sensory and/or motor side affects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.

Claims

1. A method for treating a patient, comprising:

implanting a signal generator in the patient;

implanting a signal delivery device in a spinal cord region of the patient, with active contacts of the signal delivery device at a vertebral level of from about T9 to about T12; and

activating the signal generator to apply an electrical signal to the patient via the signal delivery device at a frequency of from about 3 kHz to about 15 kHz to inhibit or eliminate chronic, low back pain in the patient, without the electrical signal (a) disrupting other sensory signals along the spinal cord, (b) disrupting motor signals along the spinal cord, and (c) generating a paresthetic sensation in the patient.

2. The method of claim 1 wherein implanting a signal delivery device includes implanting only a single lead, and wherein applying an electrical signal includes applying a down-regulating electrical signal via the single lead at a constant current amplitude, independent of changes in patient position, posture and activity level.

3. The method of claim 1 wherein implanting the signal delivery device includes implanting an electrical contact of the signal delivery device to be in electrical communication with the patient'"'"'s spinal cord at any lateral location within ±

5 mm of the patient'"'"'s spinal cord midline without adjusting the lateral location of the electrical contact to increase treatment efficacy, patient comfort, or both treatment efficacy and patient comfort.

4. The method of claim 1 wherein applying an electrical signal includes applying an electrical signal at a frequency at least sufficient to elicit an asynchronous response in a target neural population at least proximate to the spinal cord.

5. The method of claim 1 wherein implanting the signal delivery device includes implanting an electrical contact of the signal delivery device to be in electrical communication with the patient'"'"'s spinal cord at any axial location from T9 to T12 without adjusting the axial location of the electrical contact to increase treatment efficacy, patient comfort, or both treatment efficacy and patient comfort.

6. The method of claim 1 wherein implanting the signal delivery device includes implanting an electrical contact of the signal delivery device to be in electrical communication with the patient'"'"'s spinal cord at any axial location within a range of at least two vertebral bodies without adjusting the axial location of the electrical contact to increase treatment efficacy, patient comfort, or both treatment efficacy and patient comfort.

7. The method of claim 1 wherein applying an electrical signal to the patient includes applying an electrical signal to the patient to inhibit or eliminate both chronic, low back pain, and leg pain.

8. The method of claim 1 wherein implanting a signal delivery device includes implanting a signal delivery device having neighboring active signal delivery contacts spaced apart from each other by a distance corresponding to a length of from one to two adjacent vertebral bodies.

9. The method of claim 1 wherein implanting a signal delivery device includes implanting a signal delivery device having neighboring active signal delivery contacts spaced apart from each other by a distance corresponding to a length of at least one-half of an adjacent vertebral body.

10. The method of claim 1 wherein the active contacts from about T9 to about T12 are the only active contacts of the signal delivery device in the patient'"'"'s spinal cord region.

11. A method for treating a patient, comprising:

activating an implanted signal generator to apply an electrical signal to the patient at a frequency of from about 3 kHz to about 50 kHz, at a vertebral level of from about T9 to about T12 to at least inhibit chronic, low back pain in the patient, without the electrical signal creating disruptions that are intrinsically detectable by the patient in (a) other sensory signals along the spinal cord and (b) motor signals along the spinal cord.

12. The method of claim 11 wherein applying an electrical signal includes directing the electrical signal to a dorsal region of the spinal cord.

13. The method of claim 11 wherein applying an electrical signal includes directing the electrical signal to a dorsal horn region of the spinal cord.

14. The method of claim 11, further comprising applying the electrical signal at a constant amplitude, independent of patient position.

15. The method of claim 11, further comprising applying the electrical signal at a constant amplitude, independent of patient activity.

16. The method of claim 11, further comprising applying the electrical signal at a constant amplitude, independent of whether the patient is asleep or awake.

17. The method of claim 11, further comprising reducing an amplitude of the signal while the patient is asleep, and simultaneously at least inhibiting chronic low back pain in the patient with the electrical signal.

18. The method of claim 11, further comprising applying the electrical signal to a constant set of electrical contacts, independent of patient position.

19. The method of claim 11, further comprising applying the electrical signal to a constant set of electrical contacts, independent of patient activity.

20. The method of claim 11, further comprising applying the electrical signal to a constant set of electrical contacts, independent of whether the patient is asleep or awake.

21. The method of claim 11, further comprising improving the patient'"'"'s quality of sleep while applying the electrical signal, as compared with the patient'"'"'s quality of sleep without applying the signal.

22. The method of claim 11 wherein applying an electrical signal to the patient includes applying an electrical signal to the patient to at least inhibit both chronic low back pain and leg pain.

23. The method of claim 11 wherein applying an electrical signal includes eliminating the patient'"'"'s low back pain, or inhibiting the patient'"'"'s low back pain, and wherein the method further comprises:

gradually increasing an amplitude of the electrical signal to gradually reduce the inhibition or elimination of the patient'"'"'s pain.

24. The method of claim 11, further comprising adjusting a current amplitude of the electrical signal over a range of from less than 1 mA to about 5 mA without causing patient discomfort.

25. The method of claim 11, further comprising varying a current amplitude from a first value at which the patient'"'"'s pain is eliminated or inhibited to a second value at which the patient'"'"'s pain is eliminated or inhibited, without causing patient pain, wherein the second value is more than 60% greater than the first value.

26. The method of claim 25 wherein the second value is at least 100% greater than the first value.

27. The method of claim 11, further comprising adjusting a current amplitude of the electrical signal over a range of from less than 1 mA to about 5 mA without reducing an efficacy of the electrical signal.

28. The method of claim 11, further comprising halting the electrical signal for a period of at least ten minutes without reducing the pain inhibition experienced by the patient.

29. The method of claim 11, further comprising halting the electrical signal for a period of at least one day without reducing the pain inhibition experienced by the patient.

30. The method of claim 11, further comprising halting the electrical signal for an overnight period without reducing the pain inhibition experienced by the patient.

31. The method of claim 11 wherein applying an electrical signal includes applying an electrical signal from an active contact positioned laterally on one side of the patient'"'"'s spinal cord midline, and achieving pain reduction by affecting a neural population on the other side of the spinal cord midline.

32. The method of claim 11 wherein applying an electrical signal includes applying a suprathreshold, down-regulating electrical signal.

33. A method for treating a patient, comprising:

activating an implanted signal generator to apply an electrical signal to the patient at a frequency of from about 3 kHz to about 50 kHz, at a vertebral level of from about T9 to about T12 to at least inhibit chronic, low back pain in the patient, while maintaining levels of other sensory signals and motor signals along the spinal cord at values at least approximately equal to values prior to activating the signal generator.

34. The method of claim 33 wherein applying an electrical signal includes directing the electrical signal to a dorsal region of the spinal cord.

35. The method of claim 33 wherein applying an electrical signal includes directing the electrical signal to a dorsal horn region of the spinal cord.

36. The method of claim 33, further comprising applying the electrical signal to a constant set of electrical contacts, independent of whether the patient is asleep or awake.

37. The method of claim 33 wherein applying an electrical signal includes applying an electrical signal from an active contact positioned laterally on one side of the patient'"'"'s spinal cord midline, and achieving pain reduction by affecting a neural population on the other side of the spinal cord midline.

38. A method for treating a patient, comprising:

implanting a signal delivery device in a spinal cord region of the patient, at a vertebral level of from about T9 to about T12 and at a lateral location ±

5 mm from the patient'"'"'s spinal cord midline;

coupling a signal generator to the signal delivery device;

conducting post-implant process that includes;

(a) activating the signal generator to apply a suprathreshold electrical signal to the patient at a frequency of from about 3 kHz to about 15 kHz and an amplitude having a first value, and then adjusting the amplitude from the first value to a second value that is more than 60% greater than the first value without causing unwanted patient sensation;

or

(b) releasing the patient without engaging in a signal delivery parameter selection process that includes (i) applying signals to different electrical contacts of the signal delivery device, or (ii) selectively changing the amplitude of the electrical signal, or both (i) and (ii); and

applying a suprathreshold, down-regulating electrical signal to the patient via the signal delivery device at a frequency of from about 3 kHz to about 15 kHz to inhibit or eliminate chronic low back pain in the patient, without the electrical signal creating disruptions that are intrinsically detectable by the patient in (i) other sensory signals along the spinal cord and (ii) motor signals along the spinal cord, and without the electrical signal generating a paresthetic sensation in the patient, wherein the electrical signal is an electrical signal with constant peak amplitude pulses.

39. The method of claim 38 wherein applying a suprathreshold electrical signal includes applying the electrical signal at a frequency of about 10 kHz.

40. The method of claim 38 wherein applying a suprathreshold electrical signal includes applying the electrical signal to neighboring active signal delivery contacts that are spaced apart by at least one half of the length of an adjacent vertebral body.

41. A method for treating a patient, comprising:

activating an implanted signal generator to apply a suprathreshold electrical signal to the patient at a frequency of from about 3 kHz to about 50 kHz, at a vertebral level of from about T9 to about T12 to at least inhibit chronic, low back pain in the patient.

42. The method of claim 41 wherein applying a suprathreshold signal includes applying a biphasic signal, and wherein individual phases of the signal are applied at approximately equal current amplitudes.

43. The method of claim 41 wherein applying a suprathreshold signal includes applying a signal having a current amplitude of at least 1 mA.

44. The method of claim 41 wherein applying a suprathreshold signal includes applying a signal having a current amplitude of from about 1 mA to about 5 mA.

45. The method of claim 41 wherein applying a suprathreshold signal includes applying the signal at a current amplitude that triggers an action potential in a target neural population, independent of any intrinsic neural activity at the target neural population.

46. The method of claim 41 wherein applying a suprathreshold electrical signal includes applying the signal at a frequency of about 10 kHz.

47. The method of claim 41 wherein applying a down-regulating suprathreshold electrical signal includes applying the electrical signal without the electrical signal creating disruptions that are intrinsically detectable by the patient in (a) other sensory signals along the spinal cord and (b) motor signals along the spinal cord.

48. The method of claim 41 wherein applying a suprathreshold electrical signal includes applying the electrical signal without the electrical signal creating a patient sensation of paresthesia.

49. A method for treating a patient, comprising:

at least reducing a patient'"'"'s addiction to a pain relief remedy by activating a signal generator to apply an electrical signal to the patient'"'"'s central nervous system at a frequency of from about 3 kHz to about 50 kHz.

50. The method of claim 49, further comprising identifying the patient as suffering from an addiction.

51. The method of claim 49 wherein at least reducing the patient'"'"'s addiction includes at least reducing the patient'"'"'s opiate addiction.

52. The method of claim 49 wherein applying an electrical signal includes applying an electrical signal to the patient'"'"'s spinal column.

53. The method of claim 49 wherein applying an electrical signal includes applying an electrical signal via a signal delivery device implanted in the patient.

54. The method of claim 49 wherein applying an electrical signal includes applying an electrical signal to the patient'"'"'s spinal column to reduce or eliminate chronic low back pain in addition to at least reducing the patient'"'"'s addiction.

55. The method of claim 49 wherein applying an electrical signal includes, in addition to at least reducing the patient'"'"'s addiction, applying an electrical signal to the patient'"'"'s spinal column at a vertebral level of from about T9 to about T12 and at a frequency of from about 3 kHz to about 10 kHz to inhibit or eliminate chronic, low back pain in the patient, without the electrical signal creating disruptions that are intrinsically detectable by the patient in (a) other sensory signals along the spinal cord and (b) motor signals along the spinal cord, and without the electrical signal generating a paresthetic sensation in the patient, in addition to at least reducing the patient'"'"'s addiction.

56-137. -137. (canceled)