Systems and methods for selecting low-power, effective signal delivery parameters for an implanted pulse generator

• US 9,937,348 B1
• Filed: 11/08/2016
• Issued: 04/10/2018
• Est. Priority Date: 03/13/2015
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Bradley, Kerry
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US15/346,432
• Time in Patent Office: 518 Days
• Field of Search: None
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems and methods for selecting low-power, effective signal delivery parameters for an implanted pulse generator are disclosed. A representative system includes a signal generator and a computer-readable medium that, for first and second signals, increases and decreases an amplitude of the signal over multiple steps from a baseline amplitude at which the patient has a baseline response. At individual step increases and decreases, the system receives a pain score based on the patient'"'"'s response. The instructions compare the pain scores for the two signals and determine one of the signals for additional therapy to the patient, based on the pain scores and an expected energy consumption of the signals.

Claims

1. A method for configuring a spinal cord stimulation system for providing pain relief to a patient, wherein the spinal cord stimulation system includes a signal generator configured to generate an electrical therapy signal, one or more computer-readable media configured to store therapy signal parameters, and a signal delivery device configured to receive the electrical therapy signal from the signal generator and deliver the electrical therapy signal to the patient'"'"'s spinal cord region, the method comprising:

(a) configuring the signal generator to deliver a first therapy signal with a first set of therapy signal parameters, wherein the first set of therapy signal parameters includes a first frequency in a frequency range from 10 kHz to 100 kHz, inclusive;

(b) configuring the signal generator to deliver a second therapy signal with a second set of therapy signal parameters, wherein the second set of therapy signal parameters includes a second frequency in a frequency range from 1.5 kHz to 10 kHz,

(c) for both the first and second therapy signals, configuring the one or more computer-readable media to;

(i) change a therapy signal parameter of the signal, over multiple steps, from a baseline value at which the patient has a baseline pain score, wherein the therapy signal parameter includes at least one of a signal amplitude, a signal pulse width, or a signal duty cycle; and

(ii) configuring the one or more computer-readable media to, for individual step changes, receive a patient pain score corresponding to the changed value;

(d) configuring the one or more computer-readable media to compare the pain scores corresponding to the first therapy signal with the pain scores corresponding to the second therapy signal; and

(e) configuring the one or more computer-readable media to select one of the first and second therapy signals for additional therapy to the patient, based on the pain scores and an expected energy consumption for the first and second therapy signals.

2. The method of claim 1, further comprising configuring the one or more computer-readable media to halt at least one of increasing or decreasing the amplitude if the pain score worsens by at least a threshold value.

3. The method of claim 2 wherein the threshold value is from 10% to 40%, inclusive, of the patient'"'"'s baseline pain score.

4. The method of claim 2 wherein the threshold value is from 15% to 35%, inclusive, of the patient'"'"'s baseline pain score.

5. The method of claim 2 wherein the threshold value is from 10% to 20%, inclusive, of the patient'"'"'s baseline pain score.

6. The method of claim 2 wherein the threshold value is selected by the patient.

7. The method of claim 1 wherein configuring the one or more computer-readable media to select one of the first and second therapy signals includes configuring the one or more computer-readable media to select the second therapy signal if a pain score corresponding to the second therapy signal at a particular amplitude is the same as or better than a pain score corresponding to the first therapy signal at the same particular amplitude.

8. The method of claim 1 wherein the pain score is selected from the group comprising a VAS, NRS, or Likert score.

9. The method of claim 1, further comprising configuring the one or more computer-readable media to determine the expected energy consumption for the first and second therapy signals.

10. The method of claim 1 wherein configuring the one or more computer-readable media to select one of the first and second therapy signals for additional therapy includes configuring the one or more computer-readable media to select based at least in part on a patient preference for at least one of a pain reduction level or a charging interval.

11. A method for programming a spinal cord stimulation system for providing pain relief to a patient, the method comprising:

(a) configuring a signal generator to deliver a first therapy signal at a first frequency;

(b) configuring the signal generator to deliver a second therapy signal at a second frequency different than the first,

(c) configuring one or more computer-readable media to, for both the first and second therapy signals;

(i) change a signal delivery parameter of the therapy signal, over multiple steps, from a baseline value at which the patient has a baseline response; and

(ii) for individual step changes, determine the patient'"'"'s response to the changed value;

(d) configuring the one or more computer-readable media to compare patient responses to the first therapy signal with the patient responses to the second therapy signal;

wherein the patient responses include at least one of a pain score or a value correlated with the patient'"'"'s pain level; and

(e) configuring the one or more computer-readable media to select one of the first and second therapy signals for additional therapy to the patient, based on the patient responses and an expected energy consumption for the first and second therapy signals.

12. The method of claim 11 wherein the second frequency is lower than the first frequency.

13. The method of claim 12, further comprising configuring the one or more computer-readable media to select the second therapy signal if a patient response to the second therapy signal at a particular amplitude is the same as or better than a patient response to the first therapy signal at the same particular amplitude.

14. The method of claim 11 wherein configuring the one or more computer-readable media to select includes configuring the one or more computer-readable media to select a combination of amplitude and frequency that produces a less than optimum pain score to obtain lower energy consumption.

15. The method of claim 11 wherein configuring the one or more computer-readable media to select includes configuring the one or more computer-readable media to select a combination of amplitude and frequency that produces less than optimum energy consumption to obtain a lower pain score.

16. The method of claim 11 wherein configuring the one or more computer-readable media to select includes configuring the one or more computer-readable media to select a combination of amplitude and frequency that produces the lowest energy consumption and lowest pain score obtained as a result of changing the amplitude at the first and second frequencies.

17. The method of claim 11, further comprising configuring the one or more computer-readable media to determine the expected energy consumption for the first and second therapy signals.

18. The method of claim 11 wherein configuring the one or more computer-readable media to select one of the first and second therapy signals for additional therapy includes configuring the one or more computer-readable media to select based at least in part on a patient preference for at least one of a pain reduction level or a charging interval.

19. A spinal cord stimulation system, comprising:

a signal generator coupleable to a signal delivery device to deliver electrical therapy signals to a patient at a first frequency and a second frequency different than the first; and

one or more non-transitory computer readable media programmed with instructions that, when executed;

for both the first and second therapy signals,

change a signal parameter of the signal, over multiple steps, from a baseline value at which the patient has a baseline response, wherein the signal parameter includes at least one of a signal amplitude, a signal pulse width, or a signal duty cycle; and

(ii) for individual step changes, receive a pain score based on the patient'"'"'s response to the changed value;

compare the pain scores corresponding to the first therapy signal to the pain scores corresponding to the second therapy signal;

based on the pain scores and an expected energy consumption for each of the first and second therapy signals, select one of the first and second therapy signals for additional therapy to the patient; and

direct the therapy signal to the patient.

20. The system of claim 19 wherein the signal generator is an implantable signal generator.

21. The system of claim 20 wherein the one or more computer-readable media is carried by the implantable signal generator.

22. The system of claim 20 wherein a first portion of the one or more computer-readable media is carried by the implantable signal generator and a second portion of the one or more computer-readable media is carried off the implantable signal generator.

23. The system of claim 20 wherein a first portion of the instructions are executed by the implantable signal generator and a second portion of the instructions are carried out by a patient remote.

24. The system of claim 19 wherein the signal parameter is a signal amplitude and wherein an incremental value for changing the amplitude is 0.1 mA.

25. The system of claim 19 wherein the first frequency is higher than the second frequency.

26. The system of claim 19 wherein the first and second frequencies are both at least 1.5 kHz.

27. The system of claim 19 wherein the first frequency is from 10 kHz to 100 kHz, inclusive and the second frequency is from 1.5 kHz to 10 kHz.

28. The system of claim 19 wherein the instructions, when executed, determine the expected energy consumption for the first and second therapy signals.

29. The system of claim 19 wherein the instructions, when executed, select one of the first and second therapy signals for additional therapy based at least in part on a patient preference for at least one of a pain reduction level or a charging interval.