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

• US 9,327,127 B2
• Filed: 10/27/2014
• Issued: 05/03/2016
• 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): Wu, Eugene
• Application Number:
  US14/525,178
• Publication Number:
  US 20150142076A1
• Time in Patent Office: 554 Days
• Field of Search: 607/2, 607/46, 607115-117, 607/154
• US Class Current: 1/1
• 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 an electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device; and

wherein the electrical signal has a frequency of from 1.5 kHz to 50 kHz and does not create paresthesia in the patient.

2. The method of claim 1 wherein the electrical signal is delivered to the patient to treat pain in the patient.

3. The method of claim 2 wherein the pain in the patient includes pain associated with chronic regional pain syndrome.

4. The method of claim 3, further comprising placing the at least one signal delivery device at a cervical vertebral level.

5. The method of claim 4 wherein the cervical vertebral level is from about C3 to about C7, inclusive.

6. The method of claim 2 wherein the pain in the patient includes total body pain.

7. The method of claim 6, further comprising placing the at least one signal delivery device at a cervical vertebral level.

8. The method of claim 7 wherein the cervical vertebral level is from about C3 to about C7, inclusive.

9. The method of claim 2 wherein the pain in the patient includes pain associated with shingles.

10. The method of claim 9, further comprising placing the at least one signal delivery device at a thoracic vertebral level.

11. The method of claim 2 wherein the pain in the patient includes at least one of low-back pain and leg pain.

12. The method of claim 2 wherein the pain in the patient includes both low-back pain and leg pain.

13. The method of claim 2 wherein the pain in the patient includes nociceptive pain.

14. The method of claim 2 wherein the pain in the patient includes pain from surgery.

15. The method of claim 1 wherein the at least one signal delivery device is a single electrical lead having a single axial row of electrical contacts.

16. The method of claim 15 wherein the electrical signal is delivered to treat pain in the patient, and wherein the pain in the patient includes bilateral pain.

17. The method of claim 1, further comprising placing the at least one signal delivery device at a position along the patient'"'"'s 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 placing includes placing the at least one signal delivery device at a position having an axial location and a lateral location without using patient feedback to adjust one of (a) the axial location of the at least signal delivery device, or (b) the lateral location of the at least one signal delivery device.

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

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

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

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

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

24. The method of claim 1 wherein the at least one signal delivery device is positioned at a location laterally offset from a midline of the patient'"'"'s spinal cord, and wherein the electrical signal is delivered to treat pain in the patient, and wherein the pain in the patient includes bilateral pain.

25. The method of claim 1, further comprising implanting the at least one signal delivery device at a position along the patient'"'"'s spinal cord.

26. The method of claim 1 wherein the at least one signal delivery device is a paddle.

27. A method for treating a patient, comprising:

activating a signal generator to apply an electrical signal to the patient'"'"'s spinal cord via at least one implantable signal delivery device; and

wherein the electrical signal has a frequency of from 1.5 kHz to 50 kHz and does not create paresthesia in the patient.