Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods

• US 8,792,988 B2
• Filed: 09/25/2013
• Issued: 07/29/2014
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Alataris, Konstantinos, Walker, Andre B., Parker, Jon, Chitre, Yougandh, Park, Sangsoo Wesley, Thacker, James R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US14/037,193
• Publication Number:
  US 20140031896A1
• Time in Patent Office: 307 Days
• Field of Search: 607/2, 607/46, 607115-117
• 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 cord modulation for inhibiting pain with reduced side effects 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 cord region to address low back pain without creating unwanted sensory and/or motor side effects. 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 programming a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the implantable signal delivery device is positioned to deliver the therapy signal to the patient'"'"'s spinal cord at a vertebral level between T9 and T12, inclusively, the method comprising:

configuring the signal generator to generate a therapy signal, wherein the therapy signal is a plurality of bi-phasic pulses having a pulse width between 25 microseconds and 166 microseconds; and

programming the signal generator to deliver the therapy signal at a frequency and amplitude that at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.

2. The method of claim 1, wherein the frequency is in a frequency range of from 1.5 kHz to 50 kHz.

3. The method of claim 2, wherein the frequency is 10 kHz.

4. The method of claim 1, further comprising:

programming the signal generator to deliver the therapy signal, via the implantable signal deliver device, to a vertebral level between T9 and T10, inclusively.

5. The method of claim 1, wherein the therapy signal amplitude is between 0.1 mA and 20 mA.

6. The method of claim 1, wherein the therapy signal amplitude is between 0.5 mA and 10 mA.

7. The method of claim 1, wherein the therapy signal amplitude is between 1 mA and 4 mA.

8. A method for programming a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord via at least one implantable signal delivery device, wherein the implantable signal delivery device is positioned to deliver the therapy signal to the patient'"'"'s spinal cord at a vertebral level between T9 and T12, inclusively, the method comprising:

configuring the signal generator to generate a therapy signal, wherein the therapy signal is a bi-phasic square-wave having a plurality of electrical pulses having a pulse width between 25 microseconds and 166 microseconds; and

programming the signal generator to deliver the therapy signal at a frequency and amplitude that at least partially reduces the patient'"'"'s sensation of pain without generating paresthesia.

9. The method of claim 8, wherein the therapy signal amplitude is between 0.1 mA and 20 mA.

10. The method of claim 8, further comprising:

programming the signal generator to deliver the therapy signal, via the implantable signal deliver device, to a vertebral level between T9 and T10, inclusively.

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

12. The method of claim 8, further comprising:

programming the signal generator to deliver the therapy signal at a duty cycle.

13. The method of claim 8, wherein the therapy signal includes a plurality of pulses having a pulse width between 30 microseconds and 35 microseconds.

14. A method for programming a signal generator to deliver a therapy signal to a patient'"'"'s spinal cord, to at least partially alleviate the patient'"'"'s sensation of pain without using paresthesia or tingling to mask the patient'"'"'s sensation of pain, wherein the signal generator is configured to deliver the therapy signal to the patient'"'"'s spinal cord, via at least one implantable signal delivery device, and wherein the signal generator is configured to deliver the therapy signal at a frequency above 1.5 kHz, the method comprising:

programming the signal generator to generate and deliver the therapy signal at a frequency and amplitude that alleviates the patient'"'"'s pain without generating the sensation of paresthesia in the patient.

15. The method of claim 14, wherein programming the signal generator includes:

programming the signal generator to generate and deliver the therapy signal at a frequency between 1.5 kHz and 50 kHz.

16. The method of claim 14, wherein programming the signal generator includes:

programming the signal generator to generate and deliver the therapy signal at a frequency between 5 kHz and 15 kHz.

17. The method of claim 14, wherein programming the signal generator includes:

programming the signal generator to generate and deliver the therapy signal at an amplitude between 0.1 mA and 20 mA.

18. The method of claim 14, wherein programming the signal generator includes:

programming the signal generator to generate and deliver the therapy signal at an amplitude between 0.5 mA and 10 mA.

19. The method of claim 14, wherein the implantable signal delivery device is implanted proximate to a vertebral level between about T9 and about T12.

20. The method of claim 14, further comprising:

programming the signal generator to deliver the therapy signal at a duty cycle.

21. The method of claim 14, wherein the frequency is about 10 kHz and the pulse width of the therapy signal is between 30 microseconds and 35 microseconds.

22. The method of claim 14, further comprising:

programming the signal generator to apply the therapy signal at a duty cycle.

23. A method for programming a signal generator to generate a therapy signal that when delivered to a patient'"'"'s spinal cord at least partially alleviates the patient'"'"'s sensation of pain without using paresthesia or tingling to mask the patient'"'"'s sensation of pain, wherein the signal generator is configured to deliver the therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, the method comprising:

programming the signal generator to generate and deliver the therapy signal at a frequency between 1.5 kHz and 100 kHz, and

at an amplitude that at least partially reduces the patient'"'"'s sensation of pain without inducing paresthesia in the patient.

24. The method of claim 23, wherein the frequency is between 3 kHz and 20 kHz.

25. The method of claim 24, wherein at least a portion of the therapy signal is a bi-phasic square-wave.

26. The method of claim 25, further comprising:

programming the signal generator to deliver the therapy signal at a duty cycle.

27. The method of claim 25, wherein at least a portion of the therapy signal has a pulse width between 25 microseconds and 166 microseconds.

28. The method of claim 25, wherein at least a portion of the therapy signal has a pulse width between 30 microseconds and 35 microseconds.

29. The method of claim 23, wherein the amplitude is between 0.1 mA and 20 mA.

30. The method of claim 23, wherein the amplitude is between 0.5 mA and 10 mA.