Variable amplitude signals for neurological therapy, and associated systems and methods

• US 10,300,277 B1
• Filed: 12/12/2016
• Issued: 05/28/2019
• Est. Priority Date: 12/14/2015
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Dawson, Chris
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US15/376,221
• Time in Patent Office: 897 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Variable amplitude signals for neurological therapy, and associated systems and methods are disclosed. A representative method includes activating automatic delivery of an electrical therapy signal to a patient'"'"'s spinal cord region at a frequency in a frequency range between 1.5 kHz and 100 kHz, via at least one signal delivery contact carried by an implanted signal delivery device. The delivery can include repeatedly and automatically delivering the electrical therapy signal at each of multiple therapy signal amplitudes to the at least one signal delivery contact, without the therapy signal generating paresthesia in the patient. The foregoing process can be used as a screening tool to screen responders from non-responders in the context of a non-paresthesia-generating therapy, and/or can be used during long-term treatment, for example, for chronic pain.

Claims

1. A method for deploying a patient therapy system, comprising:

implanting in a patient'"'"'s spinal cord region at least one signal delivery device having at least one signal delivery contact;

connecting an external signal generator to the at least one signal delivery device;

activating delivery of a first electrical therapy signal to the patient, including a process of repeatedly delivering the first electrical therapy signal to the at least one signal delivery contact at a first set of therapy signal amplitudes; and

if the patient responds favorably to receiving the delivered first electrical therapy signal,

implanting an implantable signal generator in the patient and

after implanting the signal generator, delivering a second electrical therapy signal to the patient at multiple amplitudes of a second set of therapy signal amplitudes.

2. The method of claim 1 wherein delivering the first electrical therapy signal includes stepping from one therapy signal amplitude to another based on a pre-established amplitude increment.

3. The method of claim 1 wherein the first electrical therapy signal does not generate paresthesia in the patient.

4. The method of claim 1 wherein the first electrical therapy signal at least reduces pain in the patient and has no other sensory effects on the patient.

5. The method of claim 1 wherein at least a portion of the first electrical therapy signal is at a frequency in a frequency range between 1.5 kHz and 100 kHz.

6. The method of claim 1 wherein at least a portion of the first electrical therapy signal is at a frequency in a frequency range between 1.5 kHz and 50 kHz.

7. The method of claim 1 wherein at least a portion of the first electrical therapy signal is at a frequency in a frequency range between 3 kHz and 15 kHz.

8. The method of claim 1 wherein at least a portion of the first electrical therapy signal is at a frequency of 10 kHz.

9. The method of claim 1 wherein the first electrical therapy signal includes sequential, bi-phasic square pulses.

10. The method of claim 1 wherein delivering the second electrical therapy signal to the patient at multiple amplitudes of the second set of therapy signal amplitudes is for a duration of at least one day at each of the multiple amplitudes and wherein the method further comprises:

after implanting the signal generator, ceasing to deliver the first electrical therapy signal;

based on results obtained from delivering the second electrical therapy signal to the patient at multiple amplitudes of the second set, selecting an amplitude for additional therapy; and

activating delivery of electrical therapy to the patient at the selected signal amplitude.

11. The method of claim 10 wherein activating delivery of electrical therapy to the patient at the selected signal amplitude includes activating delivery of the electrical therapy at a duty cycle of less than 100%.

12. The method of claim 1 wherein amplitudes of the first set of therapy amplitudes are in an amplitude range between 0.5 mA and 10 mA.

13. The method of claim 1 wherein amplitudes of the first set of therapy amplitudes are in an amplitude range between 0.5 mA and 3.5 mA.

14. The method of claim 1 wherein the first electrical therapy signal is delivered at an individual amplitude over a time period corresponding to one bi-phasic pulse pair.

15. The method of claim 1 wherein the first electrical therapy signal is delivered at an individual amplitude over a time period corresponding to multiple consecutive bi-phasic pulse pairs.

16. The method of claim 1 wherein the first electrical therapy signal is delivered for at least one second at each of the first set of therapy signal amplitudes.

17. The method of claim 1 wherein the first electrical therapy signal is delivered for 20 seconds at each of the first set of therapy signal amplitudes.

18. The method of claim 1 wherein an increment between numerically adjacent therapy signal amplitudes of the first set of therapy signal amplitudes is 0.5 mA.

19. The method of claim 1 wherein an increment between numerically adjacent therapy signal amplitudes of the first set of therapy signal amplitudes is 0.1 mA.

20. The method of claim 1 wherein delivering the first electrical therapy signal at the first set of therapy signal amplitudes includes:

(a) monotonically increasing from a first signal amplitude to a second signal amplitude;

(b) decreasing from the second signal amplitude to the first signal amplitude in one step; and

(c) repeating (a) and (b).

21. The method of claim 1 wherein delivering the first electrical therapy signal at the first set of therapy signal amplitudes includes selecting an amplitude between a first amplitude and a second amplitude in a random or pseudorandom manner.

22. The method of claim 1 wherein at least one of the first set of therapy signal amplitudes produces an effective therapeutic result and at least another one of the first set of therapy signal amplitudes does not.

23. The method of claim 22 wherein adjacent therapeutically effective amplitude pulses are separated by a period of time less than a threshold period of time during which the patient detects the absence of a therapeutically effective amplitude.

24. The method of claim 1 wherein:

the at least one signal delivery device includes a plurality of signal delivery contacts;

delivering the first electrical therapy signal at the first set of therapy signal amplitudes includes simultaneously delivering the first therapy signal to a first number of the signal delivery contacts; and

the method further comprises;

activating delivery of electrical therapy signals to the patient via the implantable signal generator and a second number of signal delivery contacts less than the first number.

25. The method of claim 1 wherein:

the at least one signal delivery device includes a plurality of signal delivery contacts; and

delivering the first electrical therapy signal at each of the first set of therapy signal amplitudes includes simultaneously delivering the therapy signal to at least half of all the signal delivery contacts carried by the signal delivery device.

26. The method of claim 1 wherein delivering the second electrical therapy signal includes a process of repeatedly and automatically delivering the second electrical therapy signal to the at least one signal delivery contact at each of the second set of therapy signal amplitudes.

27. The method of claim 1 wherein at least some of the amplitudes of the first set of therapy signal amplitudes differ from those of the second set of therapy signal amplitudes.

28. The method of claim 1 wherein the second electrical therapy signal delivered to the patient at the second set of therapy signal amplitudes is delivered for a duration of at least one day at each amplitude of the second set of therapy signal amplitudes.

29. The method of claim 1 wherein for each amplitude of the second set of therapy signal amplitudes, the second electrical therapy signal is delivered at a duty cycle less than 100%.

30. A method for deploying a patient therapy system, comprising:

implanting in a patient at least one signal delivery device at an epidural location proximate to the patient'"'"'s spinal cord, the signal delivery device having a plurality of signal delivery contacts;

connecting an external signal generator to the at least one signal delivery device;

activating delivery of a first electrical therapy signal to the patient at a frequency in a frequency range between 1.5 kHz and 100 kHz, including repeatedly stepping through a first set of therapy signal amplitudes in an amplitude range between 0.5 mA and 3.5 mA, with the first electrical therapy signal delivered only once at each amplitude during a period of two minutes, and without the first electrical therapy signal generating paresthesia in the patient; and

if the patient responds favorably to receiving the delivered electrical therapy signal

implanting a signal generator in the patient, and

after implanting the signal generator, delivering a second electrical therapy signal to the patient at multiple amplitudes of a second set of therapy signal amplitudes.

31. The method of claim 30 wherein the first set of therapy signal amplitudes includes at least three different amplitudes.

32. The method of claim 30 wherein the first set of therapy signal amplitudes includes at least five different amplitudes.

33. The method of claim 30 wherein the first set of therapy signal amplitudes includes at least ten different amplitudes.

34. A method for treating a patient, comprising:

activating delivery of a first electrical therapy signal to the patient'"'"'s spinal cord region at a frequency in a frequency range between 1.5 kHz and 100 kHz via at least one signal delivery contact carried by an implanted signal delivery device, including repeatedly delivering the first electrical therapy signal at the first set of therapy signal amplitudes to the at least one signal delivery contact, without the therapy signal generating paresthesia in the patient; and

if the patient responds favorably to receiving the delivered electrical therapy signal,

implanting a signal generator in the patient, and

after implanting the signal generator, delivering a second electrical therapy signal to the patient at multiple amplitudes of a second set of therapy signal amplitudes.

35. The method of claim 34 wherein the first electrical therapy signal is delivered from an external signal generator coupled to the at least one spinal cord signal delivery device.

36. The method of claim 34 wherein the first electrical therapy signal is delivered to all signal delivery contacts carried by the signal delivery device.

37. A patient therapy system, comprising:

a signal generator coupleable to at least one implantable signal delivery device having at least one signal delivery contact, the signal generator being programmed with instructions that, when executed;

direct a non-paresthesia-generating first electrical therapy signal to the patient via the at least one signal delivery contact at a frequency in a frequency range between 1.5 kHz and 100 kHz, including repeatedly and automatically delivering the first electrical therapy signal at a first set of therapy signal amplitudes to the same at least one signal delivery contact; and

if the patient responds favorably to receiving the automatically delivered electrical therapy signal,

implanting an implantable signal generator in the patient, and

after implanting the signal generator, delivering a second electrical therapy signal to the patient at multiple amplitudes of a second set of therapy signal amplitudes.

38. The system of claim 37 wherein the signal generator is an external signal generator.

39. The system of claim 37 wherein the signal generator is another implantable signal generator.

40. The system of claim 37, further comprising the at least one implantable signal delivery device.