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 9,278,215 B2
• Filed: 03/14/2013
• Issued: 03/08/2016
• 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:
  US13/831,241
• Publication Number:
  US 20130261695A1
• Time in Patent Office: 1,090 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 cord 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 neck or brachial plexus pain without creating paresthesia in the patient.

Claims

1. A method of treating a neck or brachial plexus pain indication, exclusive of neck or brachial plexus pain associated with total body pain, comprising:

configuring a signal generator to generate and deliver a neck or brachial plexus pain therapy signal to a target location, wherein the target location is a cervical vertebral location between C2-C6, 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 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 neck or brachial plexus pain indication, exclusive of neck or brachial plexus pain associated with total body pain, without generating paresthesia.

2. The method of claim 1, wherein the cervical vertebral location is between C3C4, inclusive.

3. The method of claim 1, wherein the neck or brachial plexus pain indication is selected from the group consisting of:

cervical facet pain, cervical radiculopathy pain, myofascial pain in the cervical musculature, cervical strain pain, cervicothoracic interspinous bursitis pain, spinal stenosis pain, brachial plexopathy pain, pancoast'"'"'s pain, and thoracic outlet pain.

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

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

6. 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.

7. A method of treating a non-total body pain neck or brachial plexus pain indication, comprising:

applying an electrical therapy signal to a cervical vertebral location of a patient'"'"'s spinal cord, wherein the cervical vertebral location is between C2-C6, 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) 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, and wherein the electrical therapy signal treats the neck or brachial plexus pain indication without generating paresthesia in the patient.

8. The method of claim 7, wherein the cervical vertebral location is between C3-C4, inclusive.

9. The method of claim 7, wherein the neck or brachial plexus pain indication is selected from the group consisting of:

cervical facet pain, cervical radiculopathy pain, myofascial pain in the cervical musculature, cervical strain pain, cervicothoracic interspinous bursitis pain, spinal stenosis pain, brachial plexopathy pain, pancoast'"'"'s pain, and thoracic outlet pain.

10. The method of claim 7, wherein the frequency range is 3 kHz to 20 kHz.

11. The method of claim 7, wherein the frequency range is 5 kHz to 15 kHz.

12. The method of claim 7, further comprising programming the signal generator to generate the electrical therapy signal.

13. The method of claim 7, wherein the electrical therapy signal is applied 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 neck or brachial plexus pain indication by generating the electrical therapy signal and delivering the electrical therapy signal to the cervical vertebral location.

14. The method of claim 13, 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.

15. The method of claim 7, wherein the frequency range is 1.5 kHz to 50 kHz.

16. The method of claim 7, wherein the frequency range is 3 kHz to 10 kHz.

17. The method of claim 7, wherein the frequency is 10 kHz.

18. The method of claim 7, wherein the portion of the electrical therapy signal is a biphasic square wave.

19. The method of claim 7, wherein the pulse width range is 25 microseconds to 166 microseconds.

20. The method of claim 7, wherein the pulse width range is 30 microseconds to 35 microseconds.

21. The method of claim 7, 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.

22. A neck or brachial plexus pain treatment system for treating a nontotal body pain neck or brachial plexus pain indication, comprising:

a spinal cord modulation system having

at least one signal delivery device configured to be implanted proximate to a cervical vertebral location of a patient'"'"'s spinal cord, wherein the cervical vertebral location is between C2C6, inclusive, and

a signal generator programmed with instructions that, when executed, treat the neck or brachial plexus pain indication by generating and delivering a nonparesthesiagenerating electrical therapy signal to the cervical 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 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.

23. The system of claim 22, wherein the cervical vertebral location is between C3-C4, inclusive.

24. The system of claim 22, wherein the neck or brachial plexus pain indication is selected from the group consisting of:

cervical facet pain, cervical radiculopathy pain, myofascial pain in the cervical musculature, cervical strain pain, cervicothoracic interspinous bursitis pain, spinal stenosis pain, brachial plexopathy pain, pancoast'"'"'s pain, and thoracic outlet pain.

25. The system of claim 22, wherein the frequency range is from 3 kHz to 20 kHz.

26. The system of claim 22, wherein the frequency range is from 5 kHz to 15 kHz.

27. The system of claim 22, 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 22, wherein the electrical therapy signal includes one or more pulses with a pulse width between 30 microseconds and 35 microseconds.

29. The system of claim 22, wherein the electrical therapy signal includes one or more pulses with a pulse width between 25 microseconds and 166 microseconds.