Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods

• US 9,283,388 B2
• Filed: 03/14/2013
• Issued: 03/15/2016
• Est. Priority Date: 09/08/2011
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Alataris, Konstantinos, Gliner, Bradford Evan
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/831,381
• Publication Number:
  US 20130261696A1
• Time in Patent Office: 1,097 Days
• Field of Search: 607/46
• US Class Current: 1/1
• 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 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• 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 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

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 100 KHz may be applied to the patient'"'"'s spinal cord region to address pelvic pain without creating paresthesia in the patient.

Claims

1. A method of treating a pelvic pain indication, exclusive of pelvic pain associated with total body pain, comprising:

configuring a signal generator to generate and deliver a pelvic pain therapy signal to a target location, wherein the target location is between T12-L5, inclusive, via one or more implanted signal delivery devices coupled to the signal generator,

wherein at least a portion of the therapy signal is at a frequency in a frequency range of from 1.5 kHz to 100 kHz, includes pulses with a pulse width in a pulse width range of 10 microseconds to 333 microseconds, and has an amplitude in an amplitude range of 0.1 mA to 20 mA, which at least partially alleviates the pelvic pain indication, exclusive of pelvic pain associated with total body pain, without generating paresthesia.

2. The method of claim 1, wherein the pelvic pain is selected from the group consisting of:

osteitis pubis pain, cancer pain, gluteus maximus pain, visceral pain, piriformis pain, ischiogluteal pain, levator ani pain, and coccydynia pain.

3. The method of claim 1, wherein the frequency range is from 3 kHz to 20 kHz.

4. The method of claim 1, wherein the frequency range is from 5 kHz to 15 kHz.

5. The method of claim 1, wherein the one or more signal delivery devices include a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

6. The method of claim 1, wherein the pulse width is between 30 microseconds and 35 microseconds.

7. The method of claim 1, wherein the pulse width is between 25 microseconds and 166 microseconds.

8. The method of claim 1 wherein the frequency is 10 kHz.

9. A method of treating a non-total body pain pelvic pain indication, comprising:

applying an electrical therapy signal to a target vertebral location at a patient'"'"'s spinal cord, wherein the target vertebral location is between T12-L5, inclusive, wherein at least a portion of the electrical therapy signal (a) is at a frequency in a frequency range of from 1.5 kHz to 100 kHz, (b) has pulses in a pulse width range of 10 microseconds to 333 microseconds, and (c) is at an amplitude in an amplitude range of 0.1 mA to 20 mA, and wherein the electrical therapy signal treats the pelvic pain indication without generating paresthesia in the patient.

10. The method of claim 9, wherein the pelvic pain indication is selected from the group consisting of:

osteitis pubis pain, cancer pain, gluteus maximus pain, visceral pain, piriformis pain, ischiogluteal pain, levator ani pain, and coccydynia pain.

11. The method of claim 9, wherein the frequency range is from 3 kHz to 20 kHz.

12. The method of claim 9, wherein the frequency range is from 5 kHz to 15 kHz.

13. The method of claim 9, further comprising programming the signal generator to generate the electrical therapy signal.

14. The method of claim 9,

wherein the electrical therapy signal is delivered via one or more implanted signal delivery devices coupled to an implanted signal generator, wherein the signal generator is programmed with instructions that, when executed, treat the pelvic pain indication by generating and delivering the electrical therapy signal to the target vertebral location.

15. The method of claim 14, wherein the one or more signal delivery devices include a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

16. The method of claim 9, wherein the pulse width is between about 30 microseconds and 35 microseconds.

17. The method of claim 9, wherein the pulse width is between 25 microseconds and 166 microseconds.

18. The method of claim 9 wherein the frequency range is 1.5 kHz to 50 kHz.

19. The method of claim 9 wherein the frequency range is 3 kHz to 10 kHz.

20. The method of claim 9 wherein the frequency is 10 kHz.

21. The method of claim 9 wherein the portion of the electrical therapy signal is a biphasic square wave.

22. The method of claim 9 wherein the frequency range is 5 kHz to 15 kHz, the pulse width range is 30 microseconds to 35 microseconds, and the amplitude range is 0.5 mA to 10 mA.

23. A pelvic pain treatment system for treating a non-total body pain pelvic pain indication, comprising:

a spinal cord modulation system having

at least one signal delivery device configured to be implanted proximate to a target vertebral location at a patient'"'"'s spinal cord, wherein the target vertebral location is between T12-L5, inclusive, and

a signal generator programmed with instructions that, when executed, treat the pelvic pain indication by generating and delivering a non-paresthesia-generating electrical therapy signal to the target vertebral location, via the at least one signal delivery device,

wherein at least a portion of the electrical therapy signal (a) is at a frequency in a frequency range of from 1.5 kHz to 100 kHz, (b) includes pulses having a pulse width in a pulse width range of 10 microseconds to 333 microseconds, and (c) is at an amplitude in an amplitude range of 0.1 mA to 20 mA.

24. The system of claim 23, wherein the pelvic pain indication is selected from the group consisting of:

osteitis pubis pain, cancer pain, gluteus maximus pain, visceral pain, piriformis pain, ischiogluteal pain, levator ani pain, and coccydynia pain.

25. The system of claim 23, wherein the frequency range is from 3 kHz to 20 kHz.

26. The system of claim 23, wherein the frequency range is from 5 kHz to 15 kHz.

27. The system of claim 23, wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

28. The system of claim 23, wherein the pulse width is between 30 microseconds and 35 microseconds.

29. The system of claim 23, wherein the pulse width is between 25 microseconds and 166 microseconds.

30. The method of claim 23 wherein the frequency is 10 kHz.