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

• US 8,838,248 B2
• Filed: 04/22/2010
• Issued: 09/16/2014
• 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:
  US12/765,824
• Publication Number:
  US 20100274318A1
• Time in Patent Office: 1,608 Days
• Field of Search: 607/46, 607/59, 607/117
• US Class Current: 607/46
• 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 patient therapy system, comprising:

a controller operatively coupleable to a patient-implantable pulse generator, the controller including;

a display medium;

a non-transitory machine-readable medium having instructions for presenting at the display medium a non-zero minimum current amplitude level, a graphical indication of signal delivery device locations, a graphical indication of signal amplitude levels available for signals delivered to the signal delivery device, and a graphical indication of multiple patient pain levels as a function of signal delivery device location and amplitude; and

an input device coupled to the machine readable medium to direct an input corresponding to a selection of signal delivery device location, signal amplitude or both signal delivery device location and signal amplitude for a non-paresthesia-producing spinal therapeutic modulation signal.

2. The system of claim 1 wherein:

the machine-readable medium has instructions for simultaneously presenting at the display medium;

the graphical indication of signal delivery device locations;

the graphical indication of signal amplitude levels available for signals delivered to the signal delivery device; and

the graphical indication of multiple patient pain levels as a function of signal delivery device location and amplitude.

3. The system of claim 2 wherein the graphical indication of signal delivery device locations and the graphical indication of signal amplitude levels are presented on orthogonal axes.

4. The system of claim 2 wherein the machine-readable medium has instructions for:

presenting an indication of a maximum amplitude level and a minimum current level; and

presenting a user-manipulatable representation of a present current level at or between the maximum and minimum current level representations.

5. The system of claim 1 wherein the machine-readable medium has instructions for presenting at the display medium a non-zero maximum current amplitude level.

6. The system of claim 1 wherein the machine-readable medium has instructions for directing application of the spinal therapeutic modulation signal at a frequency in a range of from about 3 kHz to about 50 kHz.

7. The system of claim 1 wherein the machine-readable medium has instructions for directing application of the spinal therapeutic modulation signal at a frequency in a range of from about 3 kHz to about 10 kHz.

8. The system of claim 1 wherein the machine-readable medium has instructions for directing application of the spinal therapeutic modulation signal at a frequency in a range of from about 3 kHz to about 20 kHz.

9. The system of claim 1, further comprising the patient-implantable pulse generator.

10. The system of claim 1, further comprising a signal delivery device electrically connected to the pulse generator.

11. The system of claim 1 wherein the machine-readable medium has instructions for directing the spinal therapeutic modulation signal in accordance with two signal delivery programs, 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.

12. The system of claim 11 wherein the machine-readable medium has instructions for directing the spinal therapeutic modulation signal in accordance with the first program when the patient is awake and the second program when the patient is asleep.

13. The system of claim 11 wherein the machine-readable medium has instructions for directing the spinal therapeutic modulation signal in accordance with the first program when the patient engages 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.

14. The system of claim 1 wherein the minimum amplitude is 2 mA.

15. The system of claim 1 wherein the minimum amplitude is 1mA.

16. A patient therapy system, comprising:

a controller operatively coupleable to a patient-implantable pulse generator, the controller including;

a display medium;

a non-transitory machine-readable medium having instructions for simultaneously presenting at the display medium;

a 1 mA minimum current amplitude level and a maximum current amplitude level;

a user-manipulatable representation of a present current level at or between the maximum and minimum current level representations;

a graphical indication of signal delivery device locations;

a graphical indication of signal amplitude levels available for signals delivered to the signal delivery device; and

a graphical indication of multiple patient pain levels as a function of signal delivery device location and amplitude; and

an input device coupled to the machine-readable medium to direct an input corresponding to a selection of signal delivery device location, signal amplitude or both signal delivery device location and signal amplitude for a non-paresthesia producing spinal therapeutic modulation signal.

17. A patient therapy system, comprising:

an patient-implantable signal generator;

a signal delivery device coupled to the implantable pulse generator; and

a controller operatively coupleable to the patient-implantable pulse generator, the controller including;

a display medium;

a non-transitory machine-readable medium having instructions for presenting at the display medium a non-zero minimum current amplitude level, a graphical indication of signal delivery device locations, a graphical indication of signal amplitude levels available for signals delivered to the signal delivery device, and a graphical indication of multiple patient pain levels as a function of signal delivery device location and amplitude; and

an input device coupled to the machine readable medium to direct an input corresponding to a selection of signal delivery device location, signal amplitude or both signal delivery device location and signal amplitude for a non-paresthesia-producing spinal therapeutic modulation signal.