Linked area parameter adjustment for spinal cord stimulation and associated systems and methods

• US 10,220,210 B2
• Filed: 11/17/2017
• Issued: 03/05/2019
• Est. Priority Date: 07/28/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Walker, Andre B., Parker, Jon
• Primary Examiner(s): Johnson, Nicole F
• Assistant Examiner(s): Lavert, Nicole F
• Application Number:
  US15/817,060
• Publication Number:
  US 20180200519A1
• Time in Patent Office: 473 Days
• Field of Search: 607 2, 607 46, 607116
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods for managing pain in a patient using an electrical waveform that link the modulation of a waveform parameter for different areas of a patient. One embodiment in a system for managing pain in a patient comprises an electric device configured to be implanted into the patient and including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient. The system further includes an implantable device configured to be coupled to the electrode device and having a computer-operable medium programmed to change the waveform parameter applied to the first electrode and automatically set the waveform parameter applied to the second electrode based on a relationship between a first therapy range and a second therapy range of the waveform parameter.

Claims

1. A system for providing neurological therapy to a patient using an electrical waveform, comprising:

an electrode device configured to be implanted into a patient to address a target neural population, the electrode device including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter; and

a stimulation device configured to be coupled to the electrode device, the stimulation device including a waveform generator configured to generate a waveform, and a computer-operable medium operatively coupled to the waveform generator, the computer-operable medium being programmed to change the waveform parameter applied to the first electrode and automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range.

2. The system of claim 1 wherein the stimulation device is an implantable stimulation device.

3. The system of claim 1 wherein the stimulation device is an external stimulation device.

4. The system of claim 3 wherein the external stimulation device is a trial stimulator.

5. The system of claim 1, wherein the computer-operable medium is programmed to limit the waveform parameter applied to the first electrode to be within the first therapy range and to limit the waveform parameter applied to the second electrode to be within the second therapy range.

6. The system of claim 1, wherein:

the waveform parameter comprises the amplitude of the waveform, the first therapy range comprises a first amplitude range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the first area, and the second therapy range comprises a second amplitude range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the second area;

the relationship between the first therapy range and the second therapy range comprises a ratio of the first amplitude range to the second amplitude range;

the system further comprises a patient input device having a controller that generates a change command and a transmitter configured to transmit the change command to the stimulation device; and

the computer-operable medium is programmed to (a) change the amplitude of the waveform applied to the first electrode by a first amplitude increment and (b) set the amplitude of the waveform applied to the second electrode by a second amplitude increment in direct proportion to the ratio of the first amplitude range to the second amplitude range, in response to the change command received by the stimulation device.

7. The system of claim 1, wherein:

the waveform parameter comprises the amplitude of the waveform, the first therapy range comprises a first amplitude range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the first area, and the second therapy range comprises a second amplitude range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the second area;

the relationship between the first therapy range and the second therapy range comprises a ratio of the first amplitude range to the second amplitude range;

the system further comprises a patient input device having a controller that generates a change command and a transmitter configured to transmit the change command to the stimulation device; and

the computer-operable medium is programmed to (a) change the amplitude of the waveform applied to the first electrode by a first change increment for each change command received by the stimulation device and (b) set the amplitude of the waveform applied to the second electrode according to a best-fit approximation of the ratio of the first amplitude range to the second amplitude range, in response to a set of change commands received by the stimulation device.

8. The system of claim 7, wherein the computer-operable medium is programmed to set the amplitude of the waveform applied to the second electrode by changing the amplitude applied to the second electrode by the first change increment or holding the amplitude applied to the second electrode constant for each change command received by the stimulation device.

9. The system of claim 1, further comprising a memory containing a history of patient usage patterns of the waveform applied to the first and second electrodes, and wherein the computer-operable medium is further programmed to calculate a ratio of the first parameter range to the second parameter range based on the history of patient usage patterns.

10. The system of claim 1, further comprising a memory containing a history of patient usage patterns of the waveform applied to the first and second electrodes, and wherein the computer-operable medium is further programmed to determine whether the first area of the patient is linked to the second area of the patient.

11. The system of claim 1, wherein the computer-operable medium is programmed to change the first waveform parameter applied to the first electrode and set the second waveform parameter applied to the second electrode independently of each other, in response to the computer-operable medium determining that the first area of the patient is not linked to the second area of the patient.

12. The system of claim 1, wherein the computer-operable medium is further programmed to decouple control of the waveform parameter applied to the first and second electrodes when the waveform parameter exceeds a maximum value for one of the first or second areas.

13. The system of claim 1, wherein the electrode device includes at least one additional electrode associated with an additional area of the patient having an additional therapy range for the waveform parameter, and wherein the computer-operable medium is further programmed to change the waveform parameter applied to the additional electrode based on a ratio of the additional therapy range to the first therapy range and/or the second therapy range.

14. A system for providing neurological therapy to a patient using an electrical waveform, comprising:

an electrode device configured to be implanted into a patient to address a target neural population, the electrode device including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter;

a stimulation device configured to be coupled to the electrode device, the stimulation device including a power supply, a waveform generator configured to generate a waveform, and a computer-operable medium operatively coupled to the waveform generator, the computer-operable medium being programmed to change the waveform parameter applied to the first electrode and automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range; and

a patient input device having a controller that generates a change command and a transmitter configured to transmit the change, command to the stimulation device, and wherein the relationship between the first therapy range and the second therapy range comprises a ratio of the first therapy range to the second therapy range.

15. The system of claim 14, wherein the computer-operable medium is programmed to (a) change the waveform parameter applied to the first electrode by a first increment and (b) set the waveform parameter applied to the second electrode by a second increment in direct proportion to the ratio of the first therapy range to the second therapy range, in response to the change command received by the stimulation device.

16. The system of claim 14, wherein the computer-operable medium is programmed to (a) change the waveform parameter applied to the first electrode by a change increment for each change command received by the stimulation device and (b) set the waveform parameter applied to the second electrode according to a best-fit approximation of the ratio of the first therapy range to the second therapy range, in response to a set of change commands received by the stimulation device.

17. The system of claim 16, wherein the computer-operable medium is programmed to set the waveform parameter applied to the second electrode by changing the parameter applied to the second electrode by the change increment or holding the parameter applied to the second electrode constant for each change command received by the stimulation device.

18. The system of claim 14, wherein:

the waveform parameter comprises the power of the waveform, the first therapy range comprises a first power range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the first area, and the second therapy range comprises a second power range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the second area; and

the computer-operable medium is programmed to (a) change the power of the waveform applied to the first electrode by a first power increment and (b) set the power of the waveform applied to the second electrode by a second power increment in direct proportion to a ratio of the first power range to the second power range, in response to the change command received by the stimulation device.

19. The system of claim 14, wherein:

the waveform parameter comprises the power of the waveform, the first therapy range comprises a first power range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the first area, and the second therapy range comprises a second power range between (a) a sensation threshold and/or a therapeutic threshold and (b) a discomfort threshold for the second area; and

the computer-operable medium is programmed to (a) change the power of the waveform applied to the first electrode by a first change increment for each change command received by the stimulation device and (b) set the power of the waveform applied to the second electrode according to a best-fit approximation of the ratio of the first power range to the second power range, in response to a set of change commands received by the stimulation device.

20. The system of claim 19, wherein the computer-operable medium is programmed to set the power of the waveform applied to the second electrode by changing the power applied to the second electrode by the first change increment or holding the power applied to the second electrode constant for each change command received by the stimulation device.

21. The system of claim 14 wherein the stimulation device is an implantable stimulation device.

22. The system of claim 14 wherein the stimulation device is an external stimulation device.

23. The system of claim 22 wherein the external stimulation device is a trial stimulator.

24. A system for managing pain in a patient using an electrical waveform, comprising:

an electrode device configured to be implanted into a patient and including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter,

an stimulation device configured to be coupled to the electrode device, the stimulation device including a power supply, a waveform generator configured to generate a waveform, and a computer-operable medium operatively coupled to the waveform generator, the computer-operable medium being programmed to change the waveform parameter applied to the first electrode and automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range;

a memory including a first ratio of the first therapy range and the second therapy range associated with a first patient position and a second ratio of the first therapy range and the second therapy range associated with a second patient position; and

a position detector,

wherein the computer-operable medium is programmed to change the waveform parameter applied to the first electrode and set the waveform parameter applied to the second electrode based on (a) the first ratio when the position detector indicates that the patient is in the first patient position or (b) the second ratio when the position detector indicates that the patient is in the second patient position.

25. The system of claim 24, wherein the position detector comprises an accelerometer.

26. The system of claim 24, wherein the position detector comprises an impedance detector.

27. The system of claim 24 wherein the stimulation device is an implantable stimulation device.

28. The system of claim 24 wherein the stimulation device is an external stimulation device.

29. The system of claim 28 wherein the stimulation device is a trial stimulator.

30. A system for providing neurological therapy to a patient using an electrical waveform, comprising:

an implantable electrode device positionable to address a target neural population, the electrode device including a plurality of electrodes having at least a first electrode to be associated with a first area of the patient and a second electrode to be associated with a second area of the patient, wherein—

the first electrode is configured to deliver a first electrical signal including a waveform parameter having a waveform parameter value within a first therapy range, and

the second electrode is configured to deliver a second electrical signal including the waveform parameter having a waveform parameter value within a second therapy range, wherein the first and second therapy ranges differ; and

a stimulation device configured to be coupled to the electrode device, the stimulation device including a waveform generator configured to generate a waveform, and a computer-operable medium operatively coupled to the waveform generator, the computer-operable medium being programmed to (a) change the waveform parameter applied to the first electrode, and (b) automatically set the waveform parameter applied to the second electrode based on a relationship between the first therapy range and the second therapy range.

31. The system of claim 30, wherein the computer-operable medium is programmed to limit the waveform parameter applied to the first electrode to within the first therapy range and to limit the waveform parameter applied to the second electrode to within the second therapy range.

32. The system of claim 30, wherein:

the waveform parameter comprises the amplitude of the waveform, the first therapy range comprises a first amplitude range from (a) a sensation threshold and/or a therapeutic threshold to (b) a discomfort threshold for the first area, and the second therapy range comprises a second amplitude range from (a) a sensation threshold and/or a therapeutic threshold to (b) a discomfort threshold for the second area;

the relationship between the first therapy range and the second therapy range comprises a ratio of the first amplitude range to the second amplitude range;

the system further comprises a patient input device having a controller that generates a change command and a transmitter configured to transmit the change command to the stimulation device; and

the computer-operable medium is further programmed to (c) change the amplitude of the waveform applied to the first electrode by a first change increment for each change command received by the stimulation device and (d) set the amplitude of the waveform applied to the second electrode according to a best-fit approximation of the ratio of the first amplitude range to the second amplitude range, in response to a set of change commands received by the stimulation device.

33. The system of claim 32, wherein the computer-operable medium is further programmed to set the amplitude of the waveform applied to the second electrode by changing the amplitude applied to the second electrode by the first change increment or holding the amplitude applied to the second electrode constant for each change command received by the stimulation device.