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

• US 8,509,905 B2
• Filed: 04/13/2012
• Issued: 08/13/2013
• 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:
  US13/447,026
• Publication Number:
  US 20120203304A1
• Time in Patent Office: 487 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 treating a patient, comprising:

delivering or instructing delivery of an electrical therapy signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device to reduce or inhibit pain in the patient without the patient perceiving paresthesia, the signal having a frequency in a range of from about 1.5 kHz to about 50 kHz; and

continuing to deliver or instruct delivery of the electrical therapy signal without;

(a) changing or instructing the patient to change an amplitude of the signal in response to a change in patient position;

or

(b) causing the system to change an amplitude of the signal in response to a change in patient position.

2. The method of claim 1, wherein the method further comprises:

at a subsequent point in time, varying a current amplitude of the electrical therapy signal from a first amplitude value to a second, increased amplitude value that is more than 60% greater than the first value.

3. The method of claim 2 wherein reducing or inhibiting pain in the patient without the patient perceiving paresthesia is maintained as the current amplitude is varied from the first amplitude value to the second amplitude value.

4. The method of claim 1, further comprising:

placing or instructing placement of the at least one signal delivery device at a position lateral of a midline of the spinal cord as at least part of a placement process, without using patient feedback during the placement process to at least assist in selecting the position.

5. The method of claim 4 wherein the position has an axial location and a lateral location, and wherein placing or instructing placement includes identifying or instructing identification of the position of the at least one signal delivery device without using or instructing use of patient feedback to adjust one of (a) the axial location of the at least one signal delivery device, or (b) the lateral location of the at least one signal delivery device.

6. The method of claim 4 wherein the position has an axial location and a lateral location, and wherein placing or instructing placement includes identifying or instructing identification of the position of the at least one signal delivery device without using or instructing use of patient feedback to adjust both (a) the axial location of the at least one signal delivery device, and (b) the lateral location of the at least one signal delivery device.

7. The method of claim 1 wherein the electrical therapy signal reduces or inhibits at least one of low-back pain and leg pain.

8. The method of claim 1 the electrical therapy signal reduces or inhibits both low-back pain and leg pain.

9. The method of claim 1 wherein the electrical therapy signal has a frequency of from about 5 kHz to about 15 kHz.

10. The method of claim 1 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 15 kHz.

11. The method of claim 1 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 20 kHz.

12. The method of claim 1 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 10 kHz.

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

14. A method for treating a patient, comprising:

delivering an electrical therapy signal to the patient'"'"'s spinal cord via at least one implanted signal delivery device to reduce or inhibit pain in the patient without the patient perceiving paresthesia, the signal having a frequency in a range of from about 1.5 kHz to about 50 kHz; and

continuing deliver the electrical therapy signal without;

(a) changing or instructing the patient to change an amplitude of the signal in response to a change in patient activity;

or

(b) causing the system to change an amplitude of the signal in response to a change in patient activity.

15. The method of claim 14, wherein the method further comprises:

at a subsequent point in time, varying a current amplitude of the electrical therapy signal from a first amplitude value to a second, increased amplitude value that is more than 60% greater than the first value.

16. The method of claim 15 wherein reducing or inhibiting pain in the patient without the patient perceiving paresthesia is maintained as the current amplitude is varied from the first amplitude value to the second amplitude value.

17. The method of claim 14, further comprising:

placing or instructing placement of the at least one signal delivery device at a position lateral of a midline of the spinal cord as at least part of a placement process, without using patient feedback during the placement process to at least assist in selecting the position.

18. The method of claim 17 wherein the position has an axial location and a lateral location, and wherein placing or instructing placement includes identifying or instructing identification of the position of the at least one signal delivery device without using or instructing use of patient feedback to adjust one of (a) the axial location of the at least one signal delivery device, or (b) the lateral location of the at least one signal delivery device.

19. The method of claim 14 wherein the electrical therapy signal reduces or inhibits at least one of low-back pain and leg pain.

20. The method of claim 14 wherein the electrical therapy signal has a frequency of from about 5 kHz to about 15 kHz.

21. The method of claim 14 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 15 kHz.

22. The method of claim 14 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 20 kHz.

23. The method of claim 14 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 10 kHz.

24. The method of claim 14 wherein the electrical therapy signal has a frequency of about 10 kHz.

25. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical therapy signal to the patient'"'"'s spinal cord via at least one implanted signal delivery device to reduce or inhibit pain to the patient without the patient perceiving paresthesia, the signal having a frequency in a range of from about 1.5 kHz to about 50 kHz; and

continuing to deliver or instruct delivery of the electrical therapy signal without;

(a) changing or instructing the patient to change an amplitude of the signal in response to a change in patient sleep state;

or

(b) causing the system to change an amplitude of the signal in response to a change in patient sleep state.

26. The method of claim 25, wherein the method further comprises:

at a subsequent point in time, varying a current amplitude of the electrical signal from a first amplitude value to a second, increased amplitude value that is more than 60% greater than the first value.

27. The method of claim 26 wherein reducing or inhibiting pain in the patient without the patient perceiving paresthesia is maintained as the current amplitude is varied from the first amplitude value to the second amplitude value.

28. The method of claim 25, further comprising:

placing or instructing placement of the at least one signal delivery device at a position lateral of a midline of the spinal cord as at least part of a placement process, without using patient feedback during the placement process to at least assist in selecting the position.

29. The method of claim 25 wherein the electrical therapy signal reduces or inhibits at least one of low-back pain and leg pain.

30. The method of claim 25 wherein the electrical therapy signal has a frequency of from about 5 kHz to about 15 kHz.

31. The method of claim 25 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 15 kHz.

32. The method of claim 25 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 20 kHz.

33. The method of claim 25 wherein the electrical therapy signal has a frequency of from about 3 kHz to about 10 kHz.