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

• US 8,428,748 B2
• Filed: 04/13/2012
• Issued: 04/23/2013
• 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:
  US13/447,050
• Publication Number:
  US 20120209349A1
• Time in Patent Office: 375 Days
• Field of Search: 607/2, 607/16, 607/46, 607/59, 607115-117
• US Class Current: 607/117
• 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:

delivering or instructing delivery of at least one non-paresthesia-producing electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency in a frequency range of from about 1.5 kHz to about 50 kHz; and

on a repeated basis, interrupting or instructing interruption of the electrical signal for a period of at least 10 minutes.

2. The method of claim 1 wherein the repeated basis is a cyclic basis.

3. The method of claim 1 wherein the interruption is performed automatically.

4. The method of claim 1 wherein interruption of the electrical signal includes interruption of the electrical signal for a period of up to 20 minutes.

5. The method of claim 1 wherein the period is up to one hour.

6. The method of claim 1 wherein the period is up to one day.

7. The method of claim 1 the period is more than one day.

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

9. The method of claim 1 wherein the frequency range is from about 3 kHz to about 15 kHz.

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

11. The method of claim 1 wherein the frequency range is from about 3 kHz to about 10 kHz.

12. The method of claim 1 wherein the electrical signal has a frequency of about 10 kHz.

13. The method of claim 1 wherein when applied, the electrical signal causes reduction or inhibition of patient pain.

14. A patient treatment device, comprising:

an implantable signal generator having a connector and being programmed to;

direct generate at least one non-paresthesia-producing electrical signal having a frequency in a frequency range of from about 1.5 kHz to about 50 kHz, and

on a repeated basis, automatically interrupt the electrical signal for a period of time, and

after completion of the period, automatically resume generating a non-paresthesia-producing electrical signal; and

at least one implantable signal delivery device having a proximal portion and a distal portion, the proximal portion coupleable to the connector of the implantable signal generator, the distal portion having multiple electrical contacts for delivering the electrical signal to one or more locations along a patient'"'"'s spinal cord.

15. The patient treatment device of claim 14 wherein the period is up to 20 minutes.

16. The patient treatment device of claim 14 wherein the period is up to one hour.

17. The patient treatment device of claim 14 wherein the period is up to one day.

18. The patient treatment device of claim 14 wherein the period is up to ten minutes.

19. The patient treatment device of claim 14 wherein the patient treatment device is configured to deliver the electrical signal to reduce or inhibit pain in the patient.

20. The patient treatment device of claim 14, further comprising an extension, and wherein the connector is directly connectable to the extension toward a first end of the extension, and the at least one implantable signal delivery device is directly connectable to the extension toward a second end of the extension.

21. A method for treating a patient, comprising:

programming a signal generator to deliver at least one non-paresthesia-producing electrical signal to the patient'"'"'s spinal cord, via at least one implantable signal delivery device, the signal having a frequency in a frequency range of from about 3 kHz to about 20 kHz; and

programming the signal generator to repeatedly interrupt the signal delivery for periods of time.

22. The method of claim 21 wherein the signal generator is programmed to repeatedly interrupt the signal delivery on a cyclic basis.

23. The method of claim 21 wherein the signal generator is programmed to repeatedly interrupt the signal delivery automatically.

24. The method of claim 21 wherein the periods of time are up to 20 minutes.

25. The method of claim 21 wherein the periods of time are up to one hour.

26. The method of claim 21 wherein the periods of time are up to one day.

27. The method of claim 21 wherein the periods of time are more than one day.

28. The method of claim 21 wherein the frequency range is from about 5 kHz to about 15 kHz.

29. The method of claim 21 wherein the frequency range is from about 3 kHz to about 15 kHz.

30. The method of claim 21 wherein the frequency range is from about 3 kHz to about 10 kHz.

31. The method of claim 21 wherein at least a portion of the electrical signal has a frequency of about 10 kHz.

32. The method of claim 21 wherein when applied, the electrical signal causes reduction or inhibition of patient pain.

33. A spinal cord stimulation system, comprising:

a signal generator programmed to;

generate at least one non-paresthesia-producing electrical signal having a frequency in a frequency range of from about 1.5 kHz to about 50 kHz,

automatically interrupt the electrical signal for a period of time, and

after completion of the period, automatically resume generating at least one non-paresthesia-producing electrical signal having a frequency in a frequency range of from about 1.5 kHz to about 50 kHz; and

at least one implantable signal delivery device electrically coupled to the signal generator and configured to deliver the electrical signal to one or more locations along a patient'"'"'s spinal cord.

34. The system of claim 33, wherein the period is up to 20 minutes.

35. The system of claim 33, wherein the period is up to one hour.

36. The system of claim 33, wherein the period is up to one day.

37. The system of claim 33, wherein the period is more than one day.

38. The system of claim 33, wherein the frequency range is from about 3 kHz to about 15 kHz.

39. The system of claim 33, wherein the frequency range is from about 3 kHz to about 20 kHz.

40. The system of claim 33, wherein the frequency range is from about 3 kHz to about 10 kHz.