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

• US 8,423,147 B2
• Filed: 09/26/2011
• Issued: 04/16/2013
• Est. Priority Date: 04/22/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Alataris, Konstantinos, Walker, Andre B., Thacker, James R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US13/245,500
• Publication Number:
  US 20120016439A1
• Time in Patent Office: 568 Days
• Field of Search: 607/46, 607/116, 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

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 pulse generator programmed with instructions for delivering an electrical neural modulation signal;

at least one patient-implantable signal delivery device coupleable to the pulse generator to receive the neural modulation signal, the signal delivery device including an elongated spinal cord lead body having multiple electrical contacts; and

a practitioner remote control operatively coupleable to the pulse generator, the remote control having at least one input device and being programmed to change characteristics of the neural modulation signal directed from the pulse generator to the signal delivery device, the characteristics including;

which of the multiple contacts the modulation signal is to be applied to; and

an amplitude of the modulation signal, wherein the remote control automatically designates electrical contacts as anodic or cathodic without practitioner input, and wherein the remote control is incapable of changing the electrical contacts from anodic to cathodic or from cathodic to anodic based on practitioner input; and

wherein the at least one input device is a first input device, and wherein the remote control further includes;

a display medium;

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

a graphical indication of lead body locations;

a graphical indication of signal amplitude levels available for signals delivered to the lead body; and

a graphical indication of multiple patient pain levels as a function of lead body location and amplitude; and

the at least one input device being operatively coupled to the machine readable medium to direct an input corresponding to a selection of lead body location, signal amplitude or both lead body location and signal amplitude for the neural modulation signal.

2. The system of claim 1 wherein the remote control includes no features for accepting a practitioner input for selecting whether a contact is anodic or cathodic, independent of any other characteristic of the contact.

3. The system of claim 1 wherein the pulse generator is programmed with instructions for delivering a modulation signal at a frequency of from about 1.5 kHz to about 20 kHz.

4. The system of claim 1 wherein the pulse generator is programmed with instructions for delivering a modulation signal at a frequency of from about 5 kHz to about 15 kHz.

5. The system of claim 1 wherein the pulse generator is programmed with instructions for delivering a modulation signal at a frequency of about 10 kHz.

6. The system of claim 1 wherein the pulse generator includes instructions for automatically establishing which contact is anodic and which is cathodic.

7. The system of claim 1 wherein the pulse generator is a patient-implantable pulse generator.

8. The system of claim 1 wherein the pulse generator is an external pulse generator.

9. The system of claim 1 wherein the remote control is a first remote control, and wherein the system further comprises:

a second remote control that is wirelessly coupleable to the pulse generator, the second remote control including;

a wireless communication device; and

a single second input device coupled to the wireless communication device to transmit an instruction signal to the pulse generator, the single second input device being the only input device of the second remote control operatively coupled to the wireless communication device to transmit an instruction signal, the single second input device being operable to produce, at most, two states at the pulse generator;

a first state in which the pulse generator is activated to deliver the neural modulation signal to a patient, and a second state in which the pulse generator is prohibited from delivering the neural modulation signal.

10. The system of claim 9, wherein the pulse generator is programmed with instructions for delivering the modulation signal to a patient in accordance with a first mode and a second mode, and wherein:

under the first mode, the pulse generator is limited to starting and halting delivery of the neural modulation signal in response to an input received at the first wireless communication device, and wherein

under the second mode, the pulse generator is controllable to start, halt and modify delivery of the neural modulation signal, in response to an input received at the first wireless communication device; and

wherein

the pulse generator changes between the first and second modes based upon an authorization signal received via the first remote control.

11. The system of claim 9 wherein (a) the second remote control is prohibited from issuing a directive to change an amplitude of the modulation signal, or (b) the pulse generator is prohibited from responding to a directive received from the second remote control to change an amplitude of the modulation signal, or (c) both (a) and (b).

12. The system of claim 9 wherein (a) the second remote control is prohibited from issuing a directive to change an automated program in accordance with which the modulation signal is delivered, or (b) the pulse generator is prohibited from responding to a directive received from the second remote control to change an automated program in accordance with which the modulation signal is delivered, or (c) both (a) and (b).

13. The system of claim 9 wherein the single second input device includes a push-button.

14. The system of claim 9 wherein the single second input device is operable to change the pulse generator from the first state to the second state, but not the second state to the first state.

15. The system of claim 1 wherein the remote control is a first remote control, and wherein the system further comprises:

a second remote control having a second input device that is wirelessly coupleable to the pulse generator, the second input device being operable to select from at most two selectable signal delivery programs in accordance with which signals are delivered by the pulse generator, 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.

16. The system of claim 15 wherein the second input device includes a manually activated input device.

17. The system of claim 15 wherein the second input device is the only input device of the second remote control that is operable to transmit an instruction signal.

18. The system of claim 15 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.

19. The system of claim 15 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.

20. The system of claim 1, wherein the machine-readable medium has instructions for:

presenting an indication of a maximum current 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.

21. The system of claim 1 wherein the graphical indication of lead body locations and the graphical indication of signal amplitude levels are presented on orthogonal axes.

22. The system of claim 1 wherein the graphical indication of multiple patient pain levels includes a graphical indication of pain levels for a group of patients having a particular symptom.

23. The system of claim 1 wherein the graphical indication of multiple patient pain levels includes a graphical indication of pain levels for a single patient.

24. A patient therapy system, comprising:

at least one implantable electrical lead having a proximal portion and a distal portion, the lead being elongated along a lead axis between the proximal portion and the distal portion, the proximal portion having at least one lead connector, the distal portion having multiple electrical contacts arranged along the distal portion of the lead for delivering a pulsed electrical modulation signal to one or more epidural locations along a patient'"'"'s spinal cord;

an implantable pulse generator having a pulse generator connector positioned to releasably couple to the lead connector of the at least one implantable electrical lead, the implantable pulse generator including a computer-readable medium programmed with instructions that, when executed, direct the modulation signal at a frequency of from about 5 kHz to about 15 kHz, to reduce or inhibit at least one of chronic low-back pain and leg pain in the patient; and

a practitioner remote control operatively coupled to the pulse generator, the remote control having at least one input device and being programmed to change characteristics of the modulation signal directed from the pulse generator to the signal delivery device, the characteristics including;

which of the multiple contacts the modulation signal is to be applied to; and

an amplitude of the modulation signal, wherein the remote control automatically designates the electrical contacts as anodic or cathodic without practitioner input, and wherein the remote control is incapable of changing the electrical contacts from anodic to cathodic or from cathodic to anodic based on practitioner input; and

wherein the at least one input device is a first input device, and wherein the remote control further includes;

a display medium;

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

a graphical indication of lead body locations;

a graphical indication of signal amplitude levels available for signals delivered to the lead body; and

a graphical indication of multiple patient pain levels as a function of lead body location and amplitude; and

the at least one input being operatively coupled to the machine readable medium to direct an input corresponding to a selection of lead body location, signal amplitude or both lead body location and signal amplitude for the neural modulation signal.

25. The system of claim 24 wherein the instructions direct the modulation signal at a frequency of about 10 kHz.

26. The system of claim 24 includes no features for accepting a practitioner input for selecting whether a contact is anodic or cathodic, independent of any other characteristic of the contact.

27. A patient therapy system, comprising:

a pulse generator programmed with instructions for delivering an electrical neural modulation signal;

at least one patient-implantable signal delivery device coupleable to the pulse generator to receive the neural modulation signal, the signal delivery device including an elongated spinal cord lead body having multiple electrical contacts; and

a practitioner remote control operatively coupleable to the pulse generator, the remote control having at least one input device and being programmed to change characteristics of the neural modulation signal directed from the pulse generator to the signal delivery device, the characteristics including;

which of the multiple contacts the modulation signal is to be applied to; and

an amplitude of the modulation signal, wherein the remote control automatically designates electrical contacts as anodic or cathodic without practitioner input, and wherein the remote control includes no features for accepting a practitioner input for selecting whether a contact is anodic to cathodic; and

wherein the at least one input device is a first input device, and wherein the remote control further includes;

a display medium;

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

a graphical indication of lead body locations;

a graphical indication of signal amplitude levels available for signals delivered to the lead body; and

a graphical indication of multiple patient pain levels as a function of lead body location and amplitude; and

the at least one input device being operatively coupled to the machine readable medium to direct an input corresponding to a selection of lead body location, signal amplitude or both lead body location and signal amplitude for the neural modulation signal.

28. The system of claim 27 wherein the remote control includes no features for accepting a practitioner input for selecting whether a contact is anodic or cathodic, independent of any other characteristic of the contact.

29. A patient therapy system, comprising:

a pulse generator programmed with instructions for delivering an electrical neural modulation signal;

at least one patient-implantable signal delivery device coupleable to the pulse generator to receive the neural modulation signal, the signal delivery device including an elongated spinal cord lead body having multiple electrical contacts; and

a practitioner remote control operatively coupleable to the pulse generator, the remote control having at least one input device and being programmed to change characteristics of the neural modulation signal directed from the pulse generator to the signal delivery device, the characteristics including;

which of the multiple contacts the modulation signal is to be applied to; and

an amplitude of the modulation signal, wherein the remote control automatically designates electrical contacts as anodic or cathodic without practitioner input; and

wherein the at least one input device is a first input device, and wherein the remote control further includes;

a display medium;

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

a graphical indication of lead body locations;

a graphical indication of signal amplitude levels available for signals delivered to the lead body; and

a graphical indication of multiple patient pain levels as a function of lead body location and amplitude; and

the at least one input device being operatively coupled to the machine readable medium to direct an input corresponding to a selection of lead body location, signal amplitude or both lead body location and signal amplitude for the neural modulation signal.