Heuristic safety net for transitioning configurations in a neural stimulation system

• US 9,517,346 B2
• Filed: 11/17/2014
• Issued: 12/13/2016
• Est. Priority Date: 03/23/2012
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed Incorporated
• Original Assignee: Boston Scientific Scimed Incorporated
• Inventors: Lee, Dongchul, Zhu, Changfang, Moffitt, Michael A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/543,696
• Publication Number:
  US 20150073502A1
• Time in Patent Office: 757 Days
• Field of Search: 607/59
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A system and method using a plurality of electrodes. An immediate electrode configuration is defined, electrical energy is conveyed to the electrodes in accordance with the immediate electrode configuration, a final electrode configuration is defined, a series of intermediate electrode configurations is defined using a heuristic set of rules based on the immediate electrode configuration and the final electrode configuration, electrical energy is conveyed to the electrodes in accordance with the series of intermediate electrode configurations, and electrical energy is conveyed to the electrodes in accordance with the subsequent electrode configuration.

Claims

1. A system for an electrical neurostimulator coupled to a plurality of electrodes, comprising:

telemetry circuitry configured for communicating with the electrical neurostimulator; and

a controller/processor configured for implementing a semiautomatic programming mode to electrically steer the electric current in real-time, including defining an immediate electrode configuration, conveying electrical energy to the plurality of electrodes in accordance with the immediate electrode configuration, defining a final electrode configuration in response to a user input, automatically defining a series of intermediate electrode configurations using a heuristic set of rules based on the immediate electrode configuration and the final electrode configuration, instructing the electrical neurostimulator to convey electrical energy to the plurality of electrodes in accordance with the series of intermediate electrode configurations, and instructing the electrical neurostimulator to convey electrical energy to the plurality of electrodes in accordance with the subsequent electrode configuration, wherein the heuristic set of rules limit shifting of current between the series of intermediate electrode configurations.

2. The system of claim 1, wherein the controller/processor is configured for defining the series of intermediate electrode configurations by repeatedly defining a next intermediate electrode configuration based on an immediate previously defined electrode configuration and the final electrode configuration until the next intermediate electrode configuration matches the final electrode configuration.

3. The system of claim 2, wherein the controller/processor is configured for repeatedly defining the next intermediate electrode configuration by shifting anodic and/or cathodic current from the immediate previously defined electrode configuration to the next intermediate electrode configuration until the intermediate electrode configuration matches the final electrode configuration.

4. The system of claim 3, wherein the heuristic set of rules comprises limiting shifting of the anodic and/or cathodic current from the immediate previously defined electrode configuration to the next intermediate electrode configuration based on one or more of the following:

a maximum change in a cathodic current on an individual one of the electrodes, a maximum change in an anodic current on an individual one of the electrodes, a total maximum change in cathodic current on the electrodes, and a total maximum change in anodic current on the electrodes.

5. The system of claim 3, wherein each of the electrodes has an electrical current transition between the immediate previously defined electrode configuration and the final electrode configuration that is one of the following:

no current change transition, a cathodic current increase transition, a cathodic current decrease transition, a cathodic current decrease/anodic current increase transition, an anodic current increase transition, an anodic current decrease transition, and an anodic current decrease/cathodic current increase transition, and wherein the controller/processor is configured for applying the heuristic set of rules to the electrical current transitions to define the next intermediate electrode configuration.

6. The system of claim 5, wherein one of the electrodes has the cathodic decrease transition, another one of the electrodes has the cathodic increase transition, and the heuristic set of rules shifts the cathodic current from the one electrode to the other one electrode.

7. The system of claim 5, wherein one of the electrodes has the cathodic current decrease/anodic current increase transition, and the heuristic set of rules comprises shifting cathodic current from the one electrode to another one of the electrodes.

8. The system of claim 7, wherein the other one electrode has the cathodic current increase transition.

9. The system of claim 7, wherein the other one electrode has either the no current change transition or the cathodic current decrease transition.

10. The system of claim 7, wherein the other one electrode has the cathodic current decrease/anodic current increase transition, and the other one electrode has the greatest cathodic current for the final electrode configuration.

11. The system of claim 5, wherein one of the electrodes has the anodic decrease transition, another one of the electrodes has the anodic increase transition, and the heuristic set of rules shifts the anodic current from the one electrode to the other one electrode.

12. The system of claim 5, wherein one of the electrodes has the anodic current decrease/cathodic current increase transition, and the heuristic set of rules shifts the anodic current from the one electrode to another one of the electrodes.

13. The system of claim 12, wherein the other one electrode has the anodic current increase transition.

14. The system of claim 12, wherein the other one electrode has either the no current change transition or the anodic current decrease transition.

15. The system of claim 12, wherein at least one more of the electrodes has the anodic current decrease/cathodic current increase transition, and the one electrode has a greater cathodic current than does the at least one more electrode for the final electrode configuration.

16. The system of claim 5, wherein the heuristic set of rules further comprises:

determining whether there exists a first electrode having the anodic current decrease/cathodic current increase transition and whether exists a second electrode having either the no current change transition or the anodic current decrease transition; and

if the first and second electrodes exist, shifting anodic current from the first electrode to the second electrode.

17. The system of claim 16, wherein the heuristic set of rules further comprises, if either the first electrode or the second electrode does not exist, shifting cathodic current from an electrode having the cathodic current decrease/anodic current increase transition to an electrode having either the no current change transition or the cathodic current decrease transition.

18. The system of claim 5, wherein the heuristic set of rules further comprises determining whether all of the electrodes either have the cathodic current decrease/anodic current increase transition or the anodic current decrease/cathodic current increase transition.

19. The system of claim 1, further comprising a housing containing the telemetry circuitry and the controller/processor.

20. A method of providing therapy to a patient using a plurality of electrodes, comprising implementing a semiautomatic programming mode to electrically steer the electric current in real-time, wherein implementing the semiautomatic programming mode includes:

defining an immediate electrode configuration;

conveying electrical energy to the plurality of electrodes in accordance with the immediate electrode configuration;

defining a final electrode configuration in response to a user input; and

automatically defining a series of intermediate electrode configurations using a heuristic set of rules based on the immediate electrode configuration and the final electrode configuration, conveying electrical energy to the plurality of electrodes in accordance with the series of intermediate electrode configurations, and conveying electrical energy to the plurality of electrodes in accordance with the subsequent electrode configuration,

wherein the heuristic set of rules limit shifting of current between the series of intermediate electrode configurations.

21. The method of claim 20, wherein defining the series of intermediate electrode configurations comprises repeatedly defining a next intermediate electrode configuration based on an immediate previously defined electrode configuration and the final electrode configuration until the next intermediate electrode configuration matches the final electrode configuration.

22. The method of claim 21, wherein repeatedly defining the next intermediate electrode configuration comprises shifting anodic and/or cathodic current from the immediate previously defined electrode configuration to the next intermediate electrode configuration until the intermediate electrode configuration matches the final electrode configuration.

23. The method of claim 22, wherein the heuristic set of rules comprises limiting shifting of the anodic and/or cathodic current from the immediate previously defined electrode configuration to the next intermediate electrode configuration based on one or more of the following:

a maximum change in a cathodic current on an individual one of the electrodes, a maximum change in an anodic current on an individual one of the electrodes, a total maximum change in cathodic current on the electrodes, a total maximum change in anodic current on the electrodes, and a maximum change in the total current on the electrodes.

24. The method of claim 22, wherein each of the electrodes has an electrical current transition between the immediate previously defined electrode configuration and the final electrode configuration that is one of the following:

no current change transition, a cathodic current increase transition, a cathodic current decrease transition, a cathodic current decrease/anodic current increase transition, an anodic current increase transition, an anodic current decrease transition, and an anodic current decrease/cathodic current increase transition, and wherein the heuristic set of rules are applied to the electrical current transitions to define the next intermediate electrode configuration.

25. The method of claim 24, wherein one of the electrodes has the cathodic decrease transition, another one of the electrodes has the cathodic increase transition, and the heuristic set of rules shifts the cathodic current from the one electrode to the other one electrode.

26. The method of claim 24, wherein one of the electrodes has the cathodic current decrease/anodic current increase transition, and wherein the heuristic set of rules comprises shifting cathodic current from the one electrode to another one of the electrodes.

27. The method of claim 26, wherein the other one electrode has the cathodic current increase transition.

28. The method of claim 26, wherein the other one electrode has either the no current change transition or the cathodic current decrease transition.

29. The method of claim 26, wherein the other one electrode has the cathodic current decrease/anodic current increase transition, and the other one electrode has the greatest cathodic current for the final electrode configuration.

30. The method of claim 24, wherein one of the electrodes has the anodic decrease transition, another one of the electrodes has the anodic increase transition, and the heuristic set of rules shifts the anodic current from the one electrode to the other one electrode.

31. The method of claim 24, wherein one of the electrodes has the anodic current decrease/cathodic current increase transition, and wherein the heuristic set of rules shifts the anodic current from the one electrode to another one of the electrodes.

32. The method of claim 31, wherein the other one electrode has the anodic current increase transition.

33. The method of claim 31, wherein the other one electrode has either the no current change transition or the anodic current decrease transition.

34. The method of claim 31, wherein at least one more of the electrodes has the anodic current decrease/cathodic current increase transition, and the one electrode has a greater cathodic current than does the at least one more electrode for the final electrode configuration.

37. The method of claim 22, wherein the heuristic set of rules further comprises determining whether all of the electrodes either have the cathodic current decrease/anodic current increase transition or the anodic current decrease/cathodic current increase transition.

35. A method of providing therapy to a patient using a plurality of electrodes, comprising:

defining an immediate electrode configuration;

conveying electrical energy to the plurality of electrodes in accordance with the immediate electrode configuration;

defining a final electrode configuration;

defining a series of intermediate electrode configurations using a heuristic set of rules based on the immediate electrode configuration and the final electrode configuration;

conveying electrical energy to the plurality of electrodes in accordance with the series of intermediate electrode configurations; and

conveying electrical energy to the plurality of electrodes in accordance with the subsequent electrode configuration,

wherein the heuristic set of rules limit shifting of current between the series of intermediate electrode configurations,

wherein defining the series of intermediate electrode configurations comprises repeatedly defining a next intermediate electrode configuration based on an immediate previously defined electrode configuration and the final electrode configuration until the next intermediate electrode configuration matches the final electrode configuration,

wherein repeatedly defining the next intermediate electrode configuration comprises shifting anodic and/or cathodic current from the immediate previously defined electrode configuration to the next intermediate electrode configuration until the intermediate electrode configuration matches the final electrode configuration,

wherein each of the electrodes has an electrical current transition between the immediate previously defined electrode configuration and the final electrode configuration that is one of the following;

no current change transition, a cathodic current increase transition, a cathodic current decrease transition, a cathodic current decrease/anodic current increase transition, an anodic current increase transition, an anodic current decrease transition, and an anodic current decrease/cathodic current increase transition, and wherein the heuristic set of rules are applied to the electrical current transitions to define the next intermediate electrode configuration, and

wherein the heuristic set of rules further comprises;

determining whether there exists a first electrode having the anodic current decrease/cathodic current increase transition and whether exists a second electrode having either the no current change transition or the anodic current decrease transition; and

if the first and second electrodes exist, shifting anodic current from the first electrode to the second electrode.

36. The method of claim 35, wherein the heuristic set of rules further comprises, if either the first electrode or the second electrode does not exist, shifting cathodic current from an electrode having the cathodic current decrease/anodic current increase transition to an electrode having either the no current change transition or the cathodic current decrease transition.