Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods

• US 10,493,275 B2
• Filed: 05/30/2014
• Issued: 12/03/2019
• 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
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): So, Elizabeth K
• Application Number:
  US14/292,671
• Publication Number:
  US 20140296936A1
• Time in Patent Office: 2,013 Days
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods are disclosed. A representative method in accordance with an embodiment of the disclosure includes creating a therapeutic effect and a sensation in a patient by delivering to the patient first pulses having a first set of first signal delivery parameters and second pulses having a second set of second signal delivery parameters, wherein a first value of at least one first parameter of the first set is different than a second value of a corresponding second parameter of the second set, and wherein the first pulses, the second pulses or both the first and second pulses are delivered to the patient'"'"'s spinal cord.

Claims

1. A patient treatment system, comprising:

an implantable pulse generator coupleable to an implantable signal delivery device and having a controller programmed with instructions for;

directing a first, non-paresthesia generating electrical signal to the implantable signal delivery device to create an anesthetic effect in a patient, the first electrical signal having a first set of first signal delivery parameters, including a frequency in a frequency range from 1.5 kHz to 100 kHz, and a pulse width in a pulse width range of 10 microseconds to 333 microseconds; and

directing a second electrical signal to the signal delivery device, the second electrical signal having a second set of second signal delivery parameters, including a frequency in a frequency range from 2 Hz to 1.2 kHz.

2. The system of claim 1, further comprising the implantable signal delivery device, wherein the implantable signal delivery device has a plurality of electrodes configured to be implanted within the patient'"'"'s epidural space, proximate to one or more target neural populations in the patient'"'"'s spinal cord, and wherein the controller is programmed with instructions for:

delivering to the signal delivery device bursts of the first electrical pulses having a frequency in a first frequency range of from 1.5 kHz to 50 kHz, to create an anesthetic, non-paresthetic effect in the patient; and

delivering to the signal delivery device the second electrical pulses to create a paresthetic effect in the patient, wherein the second electrical pulses include a single second pulse during an interval between sequential bursts of the first electrical pulses.

3. The system of claim 2 wherein the controller includes instructions for directing the first pulses to a first electrode of the signal delivery device and directing the second pulses to a second electrode of the signal delivery device, wherein the second electrode is different from the first electrode.

4. The system of claim 2 wherein the controller is programmed with instructions for directing the first and second pulses sequentially to the same electrode of the signal delivery device.

5. The system of claim 2 wherein the first and second pulses have different pulse widths.

6. The system of claim 2 wherein the first pulses have a first pulse width and wherein the second pulses have a second pulse width, and wherein the second pulse width is greater than the first pulse width.

7. The system of claim 1 wherein the first set of first signal delivery parameters includes a frequency of from 3 kHz to 10 kHz, and the second set of second signal delivery parameters includes a frequency of from 20 Hz to 1.2 kHz.

8. The system of claim 1 wherein the first set of first signal delivery parameters includes a pulse amplitude of from 0.5 mA to 4 mA.

9. The system of claim 1 wherein the first set of first signal delivery parameters includes pulse widths between 33 microseconds and 100 microseconds, inclusive.

10. The system of claim 1 wherein the second set of second signal delivery parameters includes a pulse amplitude of from 2 mA to 10 mA.

11. The system of claim 1 wherein the controller is programmed with instructions for directing the first pulses in accordance with a duty cycle.

12. The system of claim 1 wherein the controller further includes instructions for receiving first updates to the first signal delivery parameters and second, independent updates to the second signal delivery parameters.

13. The system of claim 1 wherein the first set of first signal delivery parameters includes a frequency of from 3 kHz to 20 kHz.

14. The system of claim 1 wherein the first set of first signal delivery parameters includes a frequency of from 3 kHz to 15 kHz.

15. The system of claim 1 wherein the first set of first signal delivery parameters includes a frequency of from 5 kHz to 15 kHz.

16. The system of claim 1 wherein the first set of first signal delivery parameters includes a pulse amplitude of from 0.1 mA to 20 mA.

17. The system of claim 1 wherein the first set of first signal delivery parameters includes a pulse width between 25 microseconds and 166 microseconds, inclusive.

18. The system of claim 1 wherein the second set of second signal delivery parameters includes a pulse width from 10 microseconds to 1,000 microseconds, inclusive.

19. The system of claim 1 wherein the controller includes instructions for interleaving one or more second pulses between sequential bursts of the first pulses.

20. The system of claim 1 wherein the controller includes instructions for directing the first pulses to a first electrode of the signal delivery device and directing the second pulses to a second electrode of the signal delivery device different than the first electrode.

21. The system of claim 1 wherein the controller is programmed with instructions for directing the first and second pulses sequentially to a common electrode of the signal delivery device.

22. The system of claim 1 wherein the controller is programmed with instructions for directing the first and second pulses to a common electrode of the signal delivery device, with a single second pulse directed during an interval between sequential bursts of the first pulses, without the first pulses overlapping temporally with the second pulses, and with the first pulses having a first pulse width and the second pulses having a second pulse width greater than the first pulse width.

23. The system of claim 1 wherein the second pulses include a single second pulse delivered during an interval between sequential bursts of the first pulses.

24. The system of claim 1 wherein the controller is programmed with instructions for:

increasing an amplitude of the first pulses;

increasing an amplitude of the second pulses as the amplitude of the first pulses is increased; and

based on patient feedback to the second pulses, changing the first signal delivery parameters.

25. The system of claim 1 wherein the controller is programmed with instructions for changing the amplitudes of the first and second pulses in a parallel manner.

26. The system of claim 25 wherein the amplitudes of the first and second pulses are offset, and wherein changing the amplitudes of the first and second pulses includes changing the amplitudes of the first and second pulses by different amounts.

27. The system of claim 1 wherein the controller is programmed with instructions for identifying a fault with the delivery of the first pulses based at least in part on the presence or absence of patient response to changing an amplitude of the second pulses.

28. The system of claim 27 wherein identifying a fault is based at least in part on an absence of a patient response.

29. A patient treatment system, comprising:

an implantable pulse generator coupleable to an implantable signal delivery device and having a controller programmed with instructions for;

directing a first, non-paresthesia generating electrical signal to the implantable signal delivery device to create an anesthetic effect in a patient, the first electrical signal having a first set of first signal delivery parameters, including a frequency in a frequency range from 1.5 kHz to 100 kHz, a pulse amplitude of from 0.5 mA to 10 mA, and a pulse width of from 10 microseconds to 333 microseconds; and

directing a second electrical signal to the signal delivery device, the second electrical signal having a second set of second signal delivery parameters, including a frequency in a frequency range from 2 Hz to 1.2 kHz.