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

• US 10,471,258 B2
• Filed: 07/26/2018
• Issued: 11/12/2019
• 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 T
• Application Number:
  US16/046,912
• Publication Number:
  US 20180345017A1
• Time in Patent Office: 474 Days
• 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 spinal cord modulation system for treating a patient, the system comprising:

a pulse generator that, in operation, generates 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 15 kHz;

one or more implantable electrical contacts electrically coupled to the pulse generator and designed to deliver the therapy signal to the patient'"'"'s spinal cord region; and

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

2. The system of claim 1 wherein the frequency is in a frequency range between 3 kHz and 10 kHz.

3. The system of claim 1 wherein the frequency is 10 kHz.

4. The system of claim 1, wherein the therapy signal has an amplitude less than 6 mA.

5. The system of claim 1, wherein the therapy signal has an amplitude in an amplitude range between 0.5 and 4 mA.

6. The system of claim 1, wherein the pulse generator, in operation, also generates a paresthesia-generating electrical signal.

7. The system of claim 1, wherein the pulse generator is implantable.

8. The system of claim 1, wherein the one or more electrical contacts include a cylindrical contact.

9. The system of claim 1, wherein the one or more electrical contacts are adapted to deliver the therapy signal to a location proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

10. A spinal cord modulation system for treating pain in a patient, the system comprising:

an implantable signal generator that, in operation, generates a therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range between 1.5 kHz and 10 kHz and an amplitude that does not generate paresthesia in the patient;

two or more implantable electrical contacts electrically coupled to the signal generator and designed to deliver the therapy signal to one or more locations in the patient'"'"'s spinal cord; and

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

11. The system of claim 10 wherein the frequency is in a frequency range between 3 kHz and 10 kHz.

12. The system of claim 10 wherein the frequency is 10 kHz.

13. The system of claim 10, wherein the amplitude is under 6 mA.

14. The system of claim 10, wherein the signal generator, in operation, also generates a paresthesia-generating electrical signal.

15. The system of claim 10, wherein the external power source is adapted to transmit power to the signal generator using RF signals.

16. The system of claim 10, wherein the two or more electrical contacts include a cylindrical contact.

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

an implantable pulse generator that, in operation, generates 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 10 kHz, and an amplitude in an amplitude range between 0.1 mA and 10 mA;

one or more implantable electrical contacts electrically coupled to the pulse generator and designed to deliver the therapy signal to the patient'"'"'s spinal cord region; and

an external power source, wherein the external power source is wirelessly coupleable to the pulse generator to transmit power to the pulse generator via electromagnetic induction.

18. The system of claim 17, wherein the frequency range is between 3 kHz and 10 kHz.

19. The system of claim 17, wherein the frequency is 10 kHz.

20. The system of claim 17, wherein the amplitude range is between 0.5 mA and 10 mA.

21. The system of claim 17, wherein the amplitude range is between 1 mA and 6 mA.

22. The system of claim 17, wherein the amplitude range is between 0.5 mA and 4 mA.

23. The system of claim 17, wherein the amplitude range is between 0.1 mA and 3 mA.

24. The system of claim 17, wherein the pulse generator, in operation, also generates a paresthesia-generating electrical signal.

25. The system of claim 17, wherein the one or more electrical contacts include a cylindrical contact.

26. The system of claim 17, wherein the external power source is adapted to transmit power to the pulse generator using RF signals.