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

• US 9,333,358 B2
• Filed: 09/30/2014
• Issued: 05/10/2016
• 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:
  US14/503,304
• Publication Number:
  US 20150039050A1
• Time in Patent Office: 588 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 100 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 spinal cord modulation system for treating a patient, the system comprising:

an implantable signal delivery device configured for delivering a therapy signal to one or more locations in the patient'"'"'s spinal cord region;

a signal generator programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range between 1.5 kHz and 50 kHz at an amplitude that provides pain relief without generating paresthesia; and

wherein the signal generator is in electrical communication with the implantable signal delivery device; and

a power source, wherein the power source is configured to power the signal generator.

2. The system of claim 1, wherein the signal generator is implantable.

3. The system of claim 1, wherein the implantable signal delivery device is a percutaneous lead.

4. The system of claim 1, wherein the implantable signal delivery device is a paddle lead.

5. The system of claim 1, wherein the power source is configured to transmit power to the signal generator using RF signals.

6. The system of claim 1, wherein the power source is configured to transmit power to the signal generator via electromagnetic induction.

7. The system of claim 1, wherein the power source is portable.

8. The system of claim 1, further comprising:

a wireless programmer, wherein the wireless programmer includes programming functionality to select therapy signal parameters in the signal generator.

9. The system of claim 1, wherein the implantable signal delivery device delivers the therapy signal to a vertebral level between T9 and T12, inclusive.

10. The system of claim 1, wherein the implantable signal delivery device includes electrical contacts configured to deliver the therapy signal to a location lateral from the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

11. The system of claim 1, wherein the therapy signal amplitude is in an amplitude range between 0.1 mA and 10 mA.

12. A spinal cord modulation system for treating a patient, the system comprising:

a signal generator having one or more processors programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range between 3 kHz and 20 kHz;

an implantable signal delivery device having two or more electrical contacts configured for delivering the therapy signal to one or more locations in the patient'"'"'s spinal cord region, wherein the implantable signal delivery device is in electrical communication with the signal generator; and

an external power source, wherein the external power source is configured to transmit power to the signal generator via electromagnetic induction.

13. The system of claim 12, wherein the signal generator is implantable.

14. The system of claim 12, wherein the implantable signal delivery device is a percutaneous lead.

15. The system of claim 12, wherein the implantable signal delivery device is a paddle lead.

16. The system of claim 12, wherein the external power source is configured to transmit power to the signal generator using RF signals.

17. The system of claim 12, wherein the external power source is portable.

18. The system of claim 12, further comprising:

a wireless programmer, wherein the wireless programmer includes programming functionality to select therapy signal parameters in the signal generator.

19. The system of claim 12, wherein the signal generator further comprises executable instructions that, when executed, deliver the therapy signal to a vertebral level between T9 and T12, inclusively.

20. The system of claim 12, wherein the electrical contacts of the implantable signal delivery device are configured to deliver the therapy signal to a location lateral from the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

21. The system of claim 12, wherein the therapy signal amplitude is in an amplitude range between 0.1 mA and 10 mA.

22. A spinal cord modulation system for treating a patient, the system comprising:

a pulse generator having a housing and one or more processors programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range between 3 kHz and 15 kHz;

an implantable signal delivery device having one or more electrical contacts configured for delivering the therapy signal to one or more locations in a patient'"'"'s spinal cord region, wherein the implantable signal delivery device is in electrical communication with the pulse generator; and

an external power source, wherein the external power source is configured to transmit power to the pulse generator via RF signals.

23. The system of claim 22, wherein the pulse generator is implantable.

24. The system of claim 22, wherein the implantable signal delivery device is a percutaneous lead.

25. The system of claim 22, wherein the implantable signal delivery device is a paddle lead.

26. The system of claim 22, wherein the external power source is portable.

27. The system of claim 22, wherein the pulse generator is programmed to receive signal parameter updates from a wireless programmer.

28. The system of claim 22, wherein the pulse generator further comprises executable instructions that, when executed, deliver the therapy signal to a vertebral level between T9 and T12, inclusively.

29. The system of claim 22, wherein the electrical contacts of the implantable signal delivery device are configured to deliver the therapy signal to a location proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

30. The system of claim 22, wherein the therapy signal amplitude is in an amplitude range between 0.1 mA and 10 mA.

31. The system of claim 22, wherein the therapy signal amplitude is in an amplitude range between 1 and 5 mA.