SELECTIVE HIGH FREQUENCY SPINAL CORD MODULATION FOR INHIBITING PAIN WITH REDUCED SIDE EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS

• US 20120203304A1
• Filed: 04/13/2012
• Published: 08/09/2012
• 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.
• Granted Patent: US 8,509,905 B2
• Time in Patent Office: Days
• 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 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 an electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz; and

selecting or instructing selection of at least one amplitude of the electrical signal, from within a range of amplitudes, wherein each amplitude within the range is independent of patient position, to cause the electrical signal to be applied delivered at the at least one amplitude to reduce or inhibit pain in the patient.

2. The method of claim 1, further comprising causing variation or instructing causation of variation of a current amplitude of the electrical signal from a first amplitude value at which the patient'"'"'s pain is reduced or inhibited to a second, increased amplitude value at which the patient'"'"'s pain is reduced or inhibited, without causing an increase in patient pain, wherein the second value is more than 60% greater than the first value.

3. 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.

4. The method of claim 3 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.

5. The method of claim 3 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.

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

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

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

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

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

11. The method of claim 1 wherein the electrical signal has a frequency of 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. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical signal to the patient'"'"'s spinal cord via at least one implanted signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz; and

selecting or instructing selection of at least one amplitude of the electrical signal, from within a range of amplitudes, wherein each amplitude within the range is independent of patient activity, to cause the electrical signal to be delivered at the at least one amplitude to reduce or inhibit pain in the patient.

14. The method of claim 13, further comprising causing variation or instructing causation of variation of a current amplitude of the electrical signal from a first amplitude value at which the patient'"'"'s pain is reduced or inhibited to a second, increased amplitude value at which the patient'"'"'s pain is reduced or inhibited, without causing an increase in patient pain, wherein the second value is more than 60% greater than the first value.

15. The method of claim 13, 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.

16. The method of claim 15 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.

17. The method of claim 13 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

18. The method of claim 13 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

19. The method of claim 13 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

20. The method of claim 13 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

21. The method of claim 13 wherein the electrical signal has a frequency of from about 3 kHz to about 10 kHz.

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

23. A method for treating a patient, comprising:

delivering or instructing delivery of an electrical signal to the patient'"'"'s spinal cord via at least one implanted signal delivery device, the signal having a frequency of from about 1.5 kHz to about 50 kHz; and

selecting or instructing selection of at least one amplitude of the electrical signal, from within a range of amplitudes, wherein each amplitude within the range is independent of whether the patient is asleep or awake, to cause the pulsed-electrical signal to be delivered at the at least one amplitude to reduce or inhibit pain in the patient.

24. The method of claim 23, further comprising causing variation or instructing causation of variation of a current amplitude of the electrical signal from a first amplitude value at which the patient'"'"'s pain is reduced or inhibited to a second, increased amplitude value at which the patient'"'"'s pain is reduced or inhibited, without causing an increase in patient pain, wherein the second value is more than 60% greater than the first value.

25. The method of claim 23, 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.

26. The method of claim 23 wherein the electrical signal reduces or inhibits at least one of low-back pain and leg pain.

27. The method of claim 23 wherein the electrical signal has a frequency of from about 5 kHz to about 15 kHz.

28. The method of claim 23 wherein the electrical signal has a frequency of from about 3 kHz to about 15 kHz.

29. The method of claim 23 wherein the electrical signal has a frequency of from about 3 kHz to about 20 kHz.

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