Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified program selection

• US 9,993,645 B2
• Filed: 01/27/2016
• Issued: 06/12/2018
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Walker, Andre B., Parker, Jon, Alataris, Konstantinos, Thacker, James R.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US15/008,391
• Publication Number:
  US 20160213930A1
• Time in Patent Office: 867 Days
• Field of Search: 607 2, 607 46, 607115-117, 607154
• 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. In particular embodiments, aspects of the foregoing modulation therapies may be implemented by systems and devices that have simplified functionalities.

Claims

1. A method for treating a patient, comprising:

selecting a signal delivery program from between at most two available signal delivery programs stored in a memory device, including a first signal delivery program having first signal delivery parameters and a second signal delivery program having second signal delivery parameters, with at least one of the second signal delivery parameters different than a corresponding one of the first signal delivery parameters; and

applying an electrical signal to the patient via a pulse generator in accordance with the selected signal delivery program at a frequency of from about 3 kHz to about 50 kHz, at a vertebral level of from about T9 to about T12 to at least inhibit chronic low back pain in the patient.

2. The method of claim 1 wherein selecting a signal delivery program includes manually selecting the signal delivery program.

3. The method of claim 1 wherein the first signal delivery program has a first current amplitude and wherein the second signal delivery program has a second current amplitude different than the first current amplitude.

4. The method of claim 3 wherein the first signal delivery program has a first set of active electrical contacts and a first signal delivery frequency, and wherein the second signal delivery program has a second set of active electrical contacts and a second signal delivery frequency, the first and second sets of electrical contacts being the same and the first and second signal delivery frequencies being the same.

5. The method of claim 1 wherein the first signal delivery program has a first current amplitude and wherein the second signal delivery program has a second current amplitude different than the first current amplitude, and wherein the difference between the first and second current amplitudes is the only difference between the first and second signal delivery programs.

6. The method of claim 1 wherein applying an electrical signal to the patient includes applying the electrical signal in accordance with the first signal delivery program when the patient is awake, and in accordance with the second signal delivery program when the patient is asleep.

7. The method of claim 1 wherein applying an electrical signal to the patient includes applying the electrical signal in accordance with the first signal delivery program when the patient engage in a first activity, and in accordance with the second signal delivery program when the patient engages in a second activity different than the first.

8. The method of claim 1 wherein selecting a signal delivery program includes automatically selecting the signal delivery program.

9. A patient therapy system, comprising:

a patient-implantable pulse generator electrically coupleable to a signal delivery device, the pulse generator being programmed with instructions for delivering a modulation signal at a frequency of from about 3 kHz to about 50 kHz; and

a remote control having an input device that is wirelessly coupleable to the pulse generator, the input device being operable to select from at most two selectable signal delivery programs in accordance with which signals are provided to the signal delivery device, including a first signal delivery program having first signal delivery parameters and a second signal delivery program having second signal delivery parameters, with at least one of the second signal delivery parameters different than a corresponding one of the first signal delivery parameter.

10. The system of claim 9 wherein the input device includes a manually activated input device.

11. The system of claim 9 wherein the input device is the only input device of the remote control that is operable to transmit an instruction signal.

12. The system of claim 9 wherein the first signal delivery program has a first current amplitude and wherein the second signal delivery program has a second current amplitude different than the first current amplitude.

13. The system of claim 12 wherein the first signal delivery program has a first set of active electrical contacts and a first signal delivery frequency, and wherein the second signal delivery program has a second set of active electrical contacts and a second signal delivery frequency, the first and second sets of electrical contacts being the same and the first and second signal delivery frequencies being the same.

14. The system of claim 9 wherein the first signal delivery program has a first current amplitude and wherein the second signal delivery program has a second current amplitude different than the first current amplitude, and wherein the difference between the first and second current amplitudes is the only difference between the first and second signal delivery programs.

15. The system of claim 9 wherein the first and second signal delivery programs are selectable by the patient via the input device in a manner that depends on the patient'"'"'s sleep cycle.

16. The system of claim 9 wherein the first and second signal delivery programs are selectable by the patient via the input device in a manner that depends on an activity engaged in by the patient.

17. A method for treating a patient, comprising:

selecting a signal delivery program from between at most three available signal delivery programs stored in a memory device, including a first signal delivery program having first signal delivery parameters, a second signal delivery program having second signal delivery parameters, and a third signal deliver program having third signal delivery parameters, wherein at least one of the first signal delivery parameters is different than a corresponding one of the second signal delivery parameters, and a corresponding one of the third signal delivery parameters is different than the corresponding first and second signal delivery parameters; and

applying an electrical signal to the patient via a pulse generator in accordance with the selected signal delivery program at a frequency of from about 3 kHz to about 50 kHz, at a vertebral level of from about T9 to about T12 to at least inhibit chronic low back pain in the patient.

18. The method of claim 17 wherein the first signal delivery program has a first current amplitude, the second signal delivery program has a second current amplitude different than the first current amplitude, and the third signal delivery program has a third current amplitude different than the first current amplitude and the second current amplitude.

19. The method of claim 18 wherein the first signal delivery program has a first set of active electrical contacts and a first signal delivery frequency, the second signal delivery program has a second set of active electrical contacts and a second signal delivery frequency, and the third signal delivery program has a third set of active electrical contacts and a third signal delivery frequency, the first, second, and third sets of electrical contacts being the same and the first, second, and third signal delivery frequencies being the same.

20. The method of claim 17 wherein the first signal delivery program has a first current amplitude, the second signal delivery program has a second current amplitude different than the first current amplitude, and the third signal delivery program has a third current amplitude different than the first current amplitude and the second current amplitude, and wherein the difference between the first, second, and third current amplitudes is the only difference between the first, second, and third signal delivery programs.

21. The method of claim 17 wherein applying an electrical signal to the patient includes applying the electrical signal in accordance with the first signal delivery program when the patient is awake, in accordance with the second signal delivery program when the patient is asleep, and in accordance with the third signal delivery program when the patient is active.

22. A patient therapy system, comprising:

a patient-implantable pulse generator electrically coupleable to a signal delivery device, the pulse generator being programmed with instructions for delivering a modulation signal at a frequency of from about 3 kHz to about 50 kHz; and

a remote control having an input device that is wirelessly coupleable to the pulse generator, the input device being operable to select from at most three selectable signal delivery programs in accordance with which signals are provided to the signal delivery device, including a first signal delivery program having first signal delivery parameters, a second signal delivery program having second signal delivery parameters, and a third signal deliver program having third signal delivery parameters, wherein at least one of the first signal delivery parameters is different than a corresponding one of the second signal delivery parameters, and a corresponding one of the third signal delivery parameters is different than the corresponding first and second signal delivery parameters.

23. The system of claim 22, further comprising providing signals to the signal delivery device in accordance with the first signal delivery program when the patient is awake, in accordance with the second signal delivery program when the patient is asleep, and in accordance with the third signal delivery program when the patient is active.