Systems and methods for receiving user-provided selection of electrode lists

• US 10,328,265 B2
• Filed: 05/22/2017
• Issued: 06/25/2019
• Est. Priority Date: 09/23/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Moffitt, Michael A., Hershey, Bradley Lawrence, Zhu, Changfang, Parramon, Jordi, Kothandaraman, Sridhar
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): Moss, James
• Application Number:
  US15/601,006
• Publication Number:
  US 20170319856A1
• Time in Patent Office: 764 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An example of a system may include an arrangement of electrodes configured to be operationally positioned for use in modulating targeted neural tissue, a neural modulator, a communication module, and a controller. The neural modulator may be configured to use at least some electrodes within the arrangement of electrodes to generate a modulation field. The communication module may be configured to receive user-provided selections. The controller may be configured to use the communication module to receive a user-provided selection of a desired electrode list where the electrode list identifies electrodes within the arrangement of electrodes that are available for use in modulating the targeted neural tissue, control the neural stimulation modulator to generate the modulation field, and use the electrodes identified in the electrode list to modulate the targeted neural tissue.

Claims

1. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

receive a user-provided selection of a desired active electrode list that identifies active electrodes for use to deliver the sub-perception modulation to targeted neural tissue, the targeted neural tissue including dorsal horn tissue or dorsal root tissue, wherein the desired active electrode list is less than all available electrodes; and

deliver the sub-perception modulation to the targeted neural tissue using the electrodes identified in the desired active electrode list and using a modulation parameter set to promote uniformity of a sub-perception modulation field within the targeted neural tissue, wherein the delivered sub-perception modulation using the desired active electrode list is therapeutically effective to relieve pain and uses less power than would be used to deliver sub-perception modulation using all of the available electrodes.

2. The non-transitory machine-readable medium of claim 1, further comprising instructions, which when executed by the machine, cause the machine to:

implement a refinement algorithm to provide candidate active electrode lists for testing therapeutic effectiveness to relieve pain of the sub-perception modulation, test therapeutic effectiveness to relieve pain including receive feedback regarding the therapeutic effectiveness to relieve pain of the sub-perception modulation for at least one of the candidate active electrode lists, and select one of the candidate active electrode lists as the desired active electrode list using the feedback.

3. The non-transitory machine-readable medium of claim 2, wherein the instructions, which when executed by the machine, cause the machine to implement the refinement algorithm include instructions, which when executed by the machine, cause the machine to implement a binary search algorithm including provide at least a first candidate active electrode list identifying electrodes toward a first end of an electrode array and a second candidate active electrode list identifying electrodes at a second end of the electrode array, the first and second candidate active electrode lists identifying electrode subsets of the electrode array.

4. The non-transitory machine-readable medium of claim 3, wherein the instructions, which when executed by the machine, cause the machine to implement the binary search algorithm further include instructions, which when executed by the machine, cause the machine to provide a third candidate list that overlaps a portion of the first candidate active electrode list and overlaps a portion of the second candidate active electrode list.

5. The non-transitory machine-readable medium of claim 2, wherein the instructions, which when executed by the machine, cause the machine to implement the refinement algorithm include instructions, which when executed by the machine, cause the machine to implement an edge search algorithm including:

select a first edge or a second edge of a candidate active electrode list to be a selected edge for movement inward to provide a smaller candidate active electrode list;

move the selected edge inward to provide the smaller candidate active electrode list;

test the smaller candidate active electrode list for therapeutic effectiveness to relieve pain;

return the selected edge if the tested smaller candidate active electrode list is not effective to relieve pain and setting the selected edge as a set edge to prevent further selection for movement; and

repeat selecting moving, testing and returning until both the first edge and the second edge are set as a set edge to prevent further selection for movement.

6. The non-transitory machine-readable medium of claim 2, wherein the instructions, which when executed by the machine, cause the machine to receive feedback regarding the therapeutic effectiveness to relieve pain for at least one of the candidate active electrode list include instructions, which when executed by the machine, cause the machine to receive user-provided feedback regarding the therapeutic effectiveness to relieve pain.

7. The non-transitory machine-readable medium of claim 2, wherein the instructions, which when executed by the machine, cause the machine to receive feedback regarding the therapeutic effectiveness to relieve pain for at least one of the candidate active electrode list include instructions, which when executed by the machine, cause the machine to detect a biomarker signal regarding the therapeutic effectiveness to relieve pain.

8. The non-transitory machine-readable medium of claim 1, further comprising instructions, which when executed by the machine, cause the machine to deliver the sub-perception modulation to the targeted neural tissue in pulse trains of at least two pulses, wherein a time between successive pulse trains is more than a duration of each of the successive pulse trains.

9. The non-transitory machine-readable medium of claim 8, wherein each pulse train has less than 10 pulses.

10. A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to:

implement a refinement algorithm to provide candidate active electrode lists for testing therapeutic effectiveness of sub-perception modulation, test therapeutic effectiveness to relieve pain including receive feedback regarding the therapeutic effectiveness to relieve pain of the sub-perception modulation for at least one of the candidate active electrode lists, and select one of the candidate active electrode lists as a desired active electrode list using the feedback, wherein the desired active electrode list is less than all available electrodes within one or more electrode arrays;

program the implantable device to activate the electrodes identified in the desired active electrode list; and

deliver the sub-perception modulation to the targeted tissue using the activated electrodes and using a modulation parameter set to promote uniformity of the sub-perception modulation field within the targeted neural tissue, the targeted neural tissue including dorsal horn tissue or dorsal root tissue,

wherein the delivered sub-perception modulation using the desired active electrode list is therapeutically effective to relieve pain and uses less power than would be used to deliver sub-perception modulation using all of the available electrodes within the one or more electrode arrays.

11. The non-transitory machine-readable medium of claim 10, wherein the instructions, which when executed by the machine, cause the machine to implement the refinement algorithm include instructions, which when executed by the machine, cause the machine to implement a binary search algorithm including provide at least a first candidate active electrode list identifying electrodes toward a first end of an electrode array and a second candidate active electrode list identifying electrodes at a second end of the electrode array, the first and second candidate active electrode lists identifying electrode subsets of the electrode array.

12. The non-transitory machine-readable medium of claim 10, wherein the instructions, which when executed by the machine, cause the machine to implement the refinement algorithm include instructions, which when executed by the machine, cause the machine to implement an edge search algorithm including:

select a first edge or a second edge of a candidate active electrode list to be a selected edge for movement inward to provide a smaller candidate active electrode list;

move the selected edge inward to provide the smaller candidate active electrode list;

test the smaller candidate active electrode list for therapeutic effectiveness to relieve pain;

return the selected edge if the tested smaller candidate active electrode list is not effective and setting the selected edge as a set edge to prevent further selection for movement; and

repeat the select, the move, the test and the return until both the first edge and the second edge are set as a set edge to prevent further selection for movement.

13. The non-transitory machine-readable medium of claim 10, further comprising instructions, which when executed by the machine, cause the machine to deliver the sub-perception modulation to the targeted neural tissue in pulse trains of at least two pulses, wherein a time between successive pulse trains is more than a duration of each of the successive pulse trains, wherein each pulse train has less than 10 pulses.

14. A system for delivering sub-perception modulation to targeted neural tissue that includes dorsal horn tissue or dorsal root tissue, the system comprising:

a neural modulation generator configured to use active electrodes within an arrangement of electrodes to generate a sub-perception modulation field, wherein the active electrodes are less than all available electrodes within the arrangement of electrodes;

a communication module configured to receive user-provided selections; and

a controller configured to;

use the communication module to receive a user-provided selection of a desired active electrode list that identifies the active electrodes within the arrangement of electrodes for use in delivering sub-perception modulation to the targeted neural tissue; and

control the neural stimulation modulator to deliver the sub-perception modulation field in pulse trains of at least two pulses using a modulation parameter set to promote uniformity of the sub-perception modulation field within the targeted tissue using the active electrodes identified in the desired active electrode list, wherein the delivered sub-perception modulation using the desired active electrode list is therapeutically effective to relieve pain and uses less power than would be used to deliver sub-perception modulation using all of the available electrodes within the arrangement of electrodes.

15. The system of claim 14, wherein each pulse train has pulse train has an interpulse duration within a range of 2 ms to 5 ms, and a time between successive pulse trains is more than the interpulse duration of each pulse train.

16. The system of claim 14, wherein a time between successive pulse trains is more than the duration of each pulse train.

17. The system of claim 14, wherein each pulse train has less than 10 pulses.

18. The system of claim 14, wherein generating the modulation field includes generating an approximately constant electric field in the dorsal horn tissue using the modulation parameter set to promote uniformity of the electric field in one or more orientations within the neural tissue.

19. The system of claim 14, wherein the neural modulation generator is configured to use the modulation parameter set to fractionalize current among at least some electrodes to promote uniformity of the modulation field in the neural tissue.

20. The system of claim 14, wherein the neural tissue has an activating function, and the modulation parameter set has values selected to control energy delivery using the at least some electrodes to achieve an objective function specific to the activation function of the volume of neural tissue.