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

• US 10,195,433 B2
• Filed: 04/05/2016
• Issued: 02/05/2019
• 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:
  US15/091,505
• Publication Number:
  US 20160287873A1
• Time in Patent Office: 1,036 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 affects and associated systems and methods are disclosed. In particular embodiments, a programmer has instructions that, in response to an input, select between at least first and second sets of therapy signal parameters, the first set including a frequency of less than 1.2 kHz and generating a paresthesia-inducing electrical therapy signal, and the second set including a frequency in a range from 1.5 kHz to 50 kHz and generating a non-paresthesia-inducing electrical therapy signal.

Claims

1. A spinal cord stimulation system, comprising:

a signal generator programmable to generate an electrical therapy signal;

an implantable signal delivery device, wherein the signal delivery device is electrically coupleable to the signal generator to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to a patient'"'"'s spinal cord region; and

a programmer wirelessly coupleable to the signal generator,

wherein the programmer includes programming instructions contained in memory, and that, in response to an input, select between at least first and second sets of therapy signal parameters,

wherein the first set of therapy signal parameters generates a paresthesia-inducing electrical therapy signal with a first frequency of less than 1.2 kHz, and wherein the second set of therapy signal parameters generates a non-paresthesia-inducing electrical therapy signal with a second frequency in a frequency range from 1.5 kHz to 50 kHz, and a pulse width in a pulse width range of 10 microseconds to 333 microseconds.

2. The system of claim 1, wherein:

the input is a first input;

in response to the first input, the instructions select the first set of therapy signal parameters;

in response to a second input, the instructions select the second set of therapy signal parameters; and

signals delivered in accordance with the first and second sets of therapy signal parameters do not overlap temporally with each other.

3. The system of claim 1, wherein the first set of therapy signal parameters includes a first target location for the paresthesia-inducing electrical therapy signal, and the second set of therapy signal parameters includes a second target location for the non-paresthesia-inducing electrical therapy signal.

4. The system of claim 3, wherein the first target location and the second target location are the same.

5. The system of claim 1, wherein the signal generator is programmable to deliver the paresthesia-inducing electrical therapy signal or the non-paresthesia-inducing electrical therapy signal to a thoracic vertebral level in the patient via an electrode of the signal delivery device having a position contained in memory corresponding to the thoracic vertebral level.

6. The system of claim 5, wherein the electrode of the signal delivery device has a position contained in memory as corresponding to a thoracic vertebral level between T9 and T12, inclusively.

7. The system of claim 1, wherein the non-paresthesia-inducing electrical therapy signal is at a frequency between 3 kHz and 20 kHz.

8. The system of claim 1, wherein the second frequency is 10 kHz.

9. The system of claim 1, wherein an amplitude of the non-paresthesia-producing electrical therapy signal is between 0.1 mA and 20 mA.

10. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from 0.5 mA to 10 mA.

11. The system of claim 1, wherein the first set of therapy signal parameters includes an amplitude in an amplitude range from 3 mA to 10 mA.

12. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from less than 1 mA to 8 mA.

13. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from less than 1 mA to 6 mA.

14. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from 1 mA to 6 mA.

15. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from 1 mA to 4 mA.

16. The system of claim 1, wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from 0.5 mA to 4 mA.

17. The system of claim 1, wherein the pulse width range is from 25 microseconds to 166 microseconds.

18. The system of claim 1, wherein the pulse width range is from 30 microseconds to 35 microseconds.

19. The system of claim 1, wherein the frequency range is from 5 kHz to 15 kHz, and wherein the second set of therapy signal parameters includes an amplitude in an amplitude range from 0.5 mA to 10 mA.

20. The system of claim 1, wherein the second frequency is 10 kHz, and wherein the pulse width range is from 30 microseconds to 35 microseconds, and wherein the second set of therapy signal parameters includes an amplitude in an amplitude range of up to 6 mA.

21. The system of claim 1, wherein an electrode of the signal delivery device is designed to be positioned laterally from a midline of the patient'"'"'s spinal cord so as to be proximate to a dorsal root, dorsal root entry zone, or dorsal root ganglion.

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

23. The system of claim 22, wherein the programmer is wirelessly coupleable to the implantable signal generator in order to program the implantable signal generator with therapy signal parameters for the electrical therapy signal.