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

• US 9,656,085 B2
• Filed: 09/22/2015
• Issued: 05/23/2017
• 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: Parramon, Jordi, Zhu, Changfang, Kothandaraman, Sridhar, Moffitt, Michael A., Hershey, Bradley Lawrence
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/861,178
• Publication Number:
  US 20160082265A1
• Time in Patent Office: 609 Days
• Field of Search: 607 46, 607 59, 607 62, 607116
• 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 method for delivering sub-perception modulation to targeted neural tissue using electrodes in one or more electrode arrays, the method comprising:

receiving a user-provided selection of a desired active electrode list that identifies active electrodes for use to deliver the sub-perception modulation to the 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 of the electrodes within the one or more electrode arrays; and

delivering 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 electrodes within the one or more electrode arrays.

2. The method of claim 1, wherein:

the delivering the sub-perception modulation includes using an implantable medical device to deliver the sub-perception modulation to the targeted tissue; and

the receiving the user-provided selection includes receiving a user-provided selection using a graphical user interface of an external device and using the external device to program the implantable device to activate the electrodes identified in the desired electrode list.

3. The method of claim 1, wherein the desired active electrode list includes a first desired active electrode list, the method further comprising receiving a user-provided selection of a second desired active electrode list.

4. The method of claim 1, wherein the receiving the user-provided selection of the desired active electrode list includes:

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

5. The method of claim 4, wherein the implementing the refinement algorithm includes implementing a binary search algorithm, and the implementing the binary search algorithm includes providing 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.

6. The method of claim 5, wherein the implementing the binary search algorithm further includes providing 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.

7. The method of claim 4, wherein the implementing the refinement algorithm includes implementing an edge search algorithm, and the implementing the edge search algorithm includes:

selecting 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;

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

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

returning 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

repeating 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.

8. The method of claim 4, wherein the receiving feedback regarding the therapeutic effectiveness to relieve pain for at least one of the candidate active electrode list includes receiving user-provided feedback regarding the therapeutic effectiveness to relieve pain.

9. The method of claim 4, wherein the receiving feedback regarding the therapeutic effectiveness to relieve pain for at least one of the candidate active electrode list includes detecting a biomarker signal regarding the therapeutic effectiveness to relieve pain.

10. The method of claim 4, wherein the implementing the refinement algorithm includes implementing the refinement algorithm in an external device that is configured to program an implantable medical device.

11. The method of claim 4, wherein the implementing the refinement algorithm includes implementing the refinement algorithm in an implantable medical device that is configured to receive feedback from an external device.

12. 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 of the 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 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 electrodes within the arrangement of electrodes.

13. The system of claim 12, wherein:

the system includes an implantable medical device and an external device configured to communicate with the implantable medical device;

the implantable medical device includes the neural modulation generator, the communication module and the controller; and

the external device includes a graphical user interface configured to receive the user-provided selection of the desired active electrode list, the external device configured to program the internal device with the active electrodes.

14. The system of claim 12, wherein the desired active electrode list includes a first desired active electrode list, the controller configured to use the communication module to receive a second user-provided selection of another desired active electrode list.

15. The system of claim 12, further comprising a feedback module to receive feedback regarding the therapeutic effectiveness to relieve pain for at least one of the candidate active electrode lists, the feedback module to:

receive user-provided feedback regarding the therapeutic effectiveness to relieve pain;

or detect a biomarker signal regarding the therapeutic effectiveness to relieve pain.

16. The system of claim 12, wherein the system is configured to implement a binary search routine to provide candidate active electrode lists for testing therapeutic effectiveness to relieve pain and select one of the candidate active electrode lists as the desired active electrode list using feedback regarding therapeutic effectiveness to relieve pain, the binary search routine implemented by the controller includes providing at least a first candidate active electrode list toward a first end of the electrode array and a second candidate active electrode list at a second end of the electrode array for the electrode array, the first and second candidate active electrodes lists being subsets of the arrangement of electrodes.

17. The system of claim 12, wherein the system is configured to implement an edge search routine to provide candidate active electrode lists for testing therapeutic effectiveness to relieve pain and select one of the candidate active electrode lists as the desired active electrode list using feedback regarding therapeutic effectiveness to relieve pain, the edge search routine implemented by the controller includes:

selecting 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;

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

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

returning 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

repeating 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.

18. A method for delivering sub-perception modulation to targeted neural tissue using electrodes in one or more electrode arrays, the method comprising:

implementing a refinement algorithm to provide candidate active electrode lists for testing therapeutic effectiveness of the sub-perception modulation the stimulation, testing therapeutic effectiveness to relieve pain including receiving feedback regarding the therapeutic effectiveness to relieve pain of the sub-perception modulation the stimulation for at least one of the candidate active electrode lists, and selecting 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 of the electrodes within the one or more electrode arrays;

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

delivering 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 electrodes within the one or more electrode arrays.

19. The method of claim 18, wherein the implementing the refinement algorithm includes implementing a binary search algorithm, and the implementing the binary search algorithm includes providing 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.

20. The method of claim 18, wherein the implementing the refinement algorithm includes implementing an edge search algorithm, and the implementing the edge search algorithm includes:

selecting 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;

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

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

returning 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

repeating 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.