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

• US 8,694,108 B2
• Filed: 04/22/2010
• Issued: 04/08/2014
• 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): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US12/765,790
• Publication Number:
  US 20100274316A1
• Time in Patent Office: 1,447 Days
• Field of Search: 607/46, 607/60, 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

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 patient-implantable signal delivery device;

a patient-implantable pulse generator electrically connected to the 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 only a single input device that is wirelessly coupleable to the pulse generator, the input device being operable to produce no more than two states at the pulse generator;

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

wherein the single input device is operable to change the pulse generator back and forth between the first and second states.

2. The system of claim 1 wherein (a) the 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 remote control to change an amplitude of the modulation signal, or (c) both (a) and (b).

3. The system of claim 1 wherein (a) the 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 remote control to change an automated program in accordance with which the modulation signal is delivered, or (c) both (a) and (b).

4. The system of claim 1 wherein the signal delivery device includes multiple electrical contacts, and wherein (a) the remote control is prohibited from issuing a directive to change which contacts receive the modulation signal, or (b) the pulse generator is prohibited from responding to a directive received from the remote control to change which contacts receive the modulation signal, or (c) both (a) and (b).

5. The system of claim 1 wherein the input device includes a push-button.

6. The system of claim 1 wherein the remote control includes an indicator identifying which state the pulse generator is in.

7. The system of claim 1 wherein the remote control includes an indicator identifying whether or not a wireless link is established with the pulse generator.

8. The system of claim 1 in which the remote control is a first remote control, and wherein the system further comprises a second remote control, the second remote control having at least one input device that is wirelessly coupleable to the pulse generator, the input device of the second remote control being actuatable to produce multiple active states at the pulse generator, with the pulse generator directing the modulation signal in accordance with different signal delivery parameters for corresponding different active states.

9. The system of claim 1 wherein the signal delivery device includes an elongated spinal lead body.

10. A patient therapy system, comprising:

a first remote control that is wirelessly coupleable to an implantable pulse generator, the first control including;

a wireless communication device;

a single input device coupled to the wireless communication device to transmit an instruction signal, the single input device being the only input device of the first remote control operatively coupled to the wireless communication device to transmit an instruction signal, the single 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 a modulation signal to a patient, and a second state in which the pulse generator is prohibited from delivering the modulation signal; and

a second remote control including;

at least one input device that is wirelessly coupleable with the pulse generator, the input device of the second remote control being actuatable to produce greater than two states at the pulse generator, and wherein the states include multiple active states, with individual active states directing the modulation signal in accordance with corresponding different signal delivery parameters;

wherein the first and second remote controls have different access security features.

11. The system of claim 10 wherein the single 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.

12. The system of claim 10 wherein the single input device is operable to change the pulse generator back and forth between the first and second states.

13. The system of claim 10, further comprising the implantable pulse generator, and wherein the implanted pulse generator is programmed with instructions for delivering a modulation signal at a frequency of from about 3 kHz to about 50 kHz.

14. The therapy system of claim 10, further comprising a signal delivery device coupled to the implantable pulse generator, and wherein the signal delivery device includes an elongated spinal lead body.

15. A patient therapy system, comprising:

an implantable pulse generator that is wirelessly coupleable to a first remote control device, the pulse generator including;

a wireless receiver;

a machine-readable medium operatively coupled to the wireless receiver and having instructions for delivering an electrical modulation signal to a patient in accordance with a first mode and a second mode, wherein;

under the first mode, the pulse generator is limited to starting and halting delivery of the electrical modulation signal in response to inputs received at the first wireless receiver, and wherein

under the second mode, the pulse generator is controllable to start, halt and modify delivery of the electrical modulation signal, in response to inputs received at the wireless receiver; and

wherein

the pulse generator changes between the first and second modes based upon an authorization signal received via the wireless receiver;

wherein the first remote control has instructions for transmitting a first authorization signal to the wireless receiver to allow operation of the pulse generator in the first mode; and

a second remote control having instructions for transmitting a second authorization signal to the wireless receiver to allow operation of the pulse generator in the second mode;

wherein the first and second remote controls have different access security features.

16. The system of claim 15 wherein the machine-readable medium is programmed with instructions for delivering the electrical modulation signal at a frequency of from about 3 kHz to about 50 kHz.

17. The system of claim 15 wherein the machine-readable medium is programmed with instructions for delivering the electrical modulation signal at a frequency of from about 5 kHz to about 15 kHz.

18. The system of claim 15, further comprising an implantable signal delivery device coupleable to the pulse generator, and wherein the signal delivery device includes an elongated spinal lead.

19. A method for making a patient system, comprising:

programming a patient-implantable pulse generator with an instruction set for delivering an electrical therapy signal to a patient, the pulse generator having a wireless receiver to receive signals from a first remote control; and

(a) providing first remote control with a pulse generator control function limited to activating and halting the electrical therapy signal;

or

(b) providing the pulse generator with a response function to the first remote control that is limited to activating and halting the electrical therapy signal;

or

(c) both (a) and (b); and

providing a second remote control with a control function that includes producing multiple active states at the pulse generator, with the pulse generator directing the modulation signal in accordance with different signal delivery parameters for corresponding different active states;

wherein the first and second remote controls have different access security features.

20. The method of claim 19 wherein programming the pulse generator includes programming the pulse generator with an instruction set for delivering the electrical therapy signal at a frequency of from about 3 kHz to about 50 kHz.

21. The method of claim 19 wherein programming the pulse generator includes programming the pulse generator with an instruction set for delivering the electrical therapy sign frequency of from about 5 kHz to about 15 kHz.

22. A method for operating a patient therapy system, comprising:

controlling a signal delivery device implanted in a patient, via a wireless remote control positioned external to the patient, wherein controlling the signal delivery device via the remote control is limited to controlling only whether the signal delivery device delivers signals to the patient at a frequency of from about 3 kHz to about 50 kHz, or does not deliver signals to the patient;

wherein controlling a signal delivery device includes controlling a signal delivery device without changing an amplitude of the modulation signal.

23. The method of claim 22 wherein controlling a signal delivery device includes controlling a signal delivery device implanted proximate to the patient'"'"'s spine, within a foramen of at least one of the patient'"'"'s vertebra.

25. The method of claim 23 wherein controlling a signal delivery device includes controlling a signal delivery device without changing an automated program in accordance with which the modulation signal is delivered.

26. The system of claim 22 wherein the signal delivery device includes multiple electrical contacts, and wherein controlling a signal delivery device includes controlling a signal delivery device without changing which contacts the modulation signal is delivered to.

24. A method for operating a patient therapy system, comprising:

controlling a signal delivery device implanted in a patient, via a wireless remote control positioned external to the patient, wherein controlling the signal delivery device via the remote control is limited to controlling only whether the signal delivery device delivers signals to the patient at a frequency of from about 3 kHz to about 50 kHz, or does not deliver signals to the patient;

wherein controlling a signal delivery device includes controlling a signal delivery device without changing an automated program in accordance with which the modulation signal is delivered.

28. The method of claim 24 wherein controlling a signal delivery device includes controlling a signal delivery device without changing an amplitude of the modulation signal.

27. A patient therapy system, comprising:

a patient-implantable signal delivery device;

a patient-implantable pulse generator electrically connected to the 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 only a single input device that is wirelessly coupleable to the pulse generator, the input device being operable to produce no more than two states at the pulse generator;

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

wherein the single 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.

29. A method for operating a patient therapy system, comprising:

controlling a signal delivery device implanted in a patient, via a wireless remote control positioned external to the patient, wherein controlling the signal delivery device via the remote control is limited to controlling only whether the signal delivery device delivers signals to the patient at a frequency of from about 3 kHz to about 50 kHz, or does not deliver signals to the patient;

wherein the signal delivery device includes multiple electrical contacts, and wherein controlling a signal delivery device includes controlling a signal delivery device without changing which contacts the modulation signal is delivered to.