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

• US 9,517,344 B1
• Filed: 03/01/2016
• Issued: 12/13/2016
• Est. Priority Date: 03/13/2015
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Bradley, Kerry
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): Tejani, Ankit D
• Application Number:
  US15/057,913
• Time in Patent Office: 287 Days
• Field of Search: None
• US Class Current: 1/1
• 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, 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 signals;

(i) increasing an amplitude of the signal, over multiple steps, from a baseline amplitude at which the patient has a baseline pain score;

(ii) for individual step increases, determining a pain score based on the patient'"'"'s response to the increased amplitude;

(iii) decreasing the amplitude over multiple steps; and

(iv) for individual step decreases, determining a pain score based on the patient'"'"'s response to the decreased amplitude;

(d) comparing the pain scores corresponding to the first therapy signal with the pain scores corresponding to the second therapy signal; and

(e) based on the pain scores and an expected energy consumption for the first and second therapy signals, selecting one of the first and second therapy signals for additional therapy to the patient.

2. The method of claim 1, further comprising halting 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 selecting one of the first and second signals includes selecting the second signal if a pain score corresponding to the second signal at a particular amplitude is the same as or better than a pain score corresponding to the first 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. 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) for both the first and second signals;

(i) increasing an amplitude of the signal, over multiple steps, from a baseline amplitude at which the patient has a baseline response;

(ii) for individual step increases, determining the patient'"'"'s response to the increased amplitude;

(iii) decreasing the amplitude over multiple steps; and

(iv) for individual step decreases, determining the patient'"'"'s response to the decreased amplitude;

(d) comparing the 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) based on the patient responses and an expected energy consumption for the first and second therapy signals, selecting one of the first and second therapy signals for additional therapy to the patient.

10. The method of claim 9 wherein the second frequency is lower than the first frequency.

11. The method of claim 10 wherein, if a patient response to the second signal at a particular amplitude is the same as or better than a patient response to the first signal at the same particular amplitude, selecting one of the first and second therapy signals includes selecting the second therapy signal.

12. The method of claim 9 wherein selecting includes selecting a combination of amplitude and frequency that produces a less than optimum pain score to obtain lower energy consumption.

13. The method of claim 9 wherein selecting includes selecting a combination of amplitude and frequency that produces less than optimum energy consumption to obtain a lower pain score.

14. The method of claim 9 wherein selecting includes selecting a combination of amplitude and frequency that produces the lowest energy consumption and lowest pain score obtained as a result of increasing and decreasing the amplitude at the first and second frequencies.

15. 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

a non-transitory computer readable medium programmed with instructions that, when executed;

for both the first and second signals,

(i) increase an amplitude of the signal, over multiple steps, from a baseline amplitude at which the patient has a baseline response;

(ii) at individual step increases, receive a pain score based on the patient'"'"'s response to the increased amplitude;

(iii) decrease the amplitude over multiple steps; and

(iv) for individual step decreases, receive a pain score based on the patient'"'"'s response to the decreased amplitude;

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

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.

16. The system of claim 15 wherein the signal generator is an implantable signal generator.

17. The system of claim 16 wherein the computer-readable medium is carried by the implantable signal generator.

18. The system of claim 16 wherein a first portion of the computer-readable medium is carried by the implantable signal generator and a second portion of the computer-readable medium is carried off the implantable signal generator.

19. The system of claim 16 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.

20. The system of claim 15 wherein an incremental value for increasing and decreasing the amplitude is 0.1 mA.

21. The system of claim 15 wherein the first frequency is higher than the second frequency.

22. The system of claim 15 wherein the first and second frequencies are both at least 1.5 kHz.

23. The system of claim 15 wherein the first frequency is from 10 kHz to 100 kHz, inclusive and the second frequency is from 1.5 kHz to 10 kHz.