Neurostimulation system for selectively estimating volume of activation and providing therapy

• US 8,934,979 B2
• Filed: 12/23/2011
• Issued: 01/13/2015
• Est. Priority Date: 12/27/2010
• 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.
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US13/336,580
• Publication Number:
  US 20120165898A1
• Time in Patent Office: 1,117 Days
• Field of Search: 607/30, 607/45, 607/46, 607/59
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An external control device, neurostimulation system, and method of programming a neurostimulator. A volume of tissue activation for each of a first one or more candidate stimulation parameter sets is simulated without conveying electrical stimulation energy into the tissue. One of the first candidate stimulation parameter set(s) is selected based on each simulated volume of tissue activation. Electrical stimulation energy is conveyed into the tissue in accordance with a second one or more candidate stimulation parameter sets, wherein the initial one of the second candidate stimulation parameter set(s) is the selected one of the first candidate stimulation parameter set(s). One of the second candidate stimulation parameter set(s) is selected based on a therapeutic efficacy of the electrical stimulation energy conveyed into the tissue. The neurostimulator is programmed with the selected one of the second candidate stimulation parameter set(s).

Claims

1. An external control device for use with a neurostimulator coupled to a plurality of electrodes capable of conveying electrical stimulation energy into tissue in which the electrodes are implanted, comprising:

output circuitry configured for communicating with the neurostimulator;

a user interface including a display device and at least a first control element configured to be actuated to selectively place the external control device between a first mode and a second mode, and at least a second control element configured to be actuated to define a plurality of different candidate electrode combinations; and

a processor, when the external control device is in the first mode, configured for simulating a volume of tissue activation based on each of a first one or more candidate electrode combinations, while preventing the output circuitry from transmitting the first one or more of candidate electrode combinations to the neurostimulator in response to the definition of each of the first one or more electrode combinations, and when the external control device is in the second mode, configured for allowing the output circuitry to transmit a second one or more of candidate electrode combinations to the neurostimulator.

2. The external control device of claim 1, wherein the first one or more candidate electrode combinations comprises a plurality of candidate electrode combinations, wherein the user interface is configured for allowing the user to select one of the plurality of candidate electrode combinations, and wherein the processor is configured for automatically using the user selected candidate electrode combination as an initial one of the second one or more candidate electrode combinations during the second mode.

3. The external control device of claim 1, wherein the processor is configured for scoring each simulated volume of tissue activation relative to a target tissue volume.

4. The external control device of claim 1, further comprising memory configured for storing an anatomical representation having a target tissue volume, wherein the processor, when the external control device is in the first mode, is configured for allowing the user interface to display each simulated volume of tissue activation relative to the target tissue volume on the monitor.

5. The external control device of claim 4, wherein the processor, when the external control device is in the second mode, is configured for simulating another volume of tissue activation for each of the second one or more candidate electrode combinations, and for allowing the user interface to display each other simulated volume of tissue activation relative to the target tissue volume.

6. The external control device of claim 5, wherein each volume of tissue activation is represented with a first color, and each other volume of tissue activation is represented with a second color different from the first color.

7. The external control device of claim 4, wherein the user interface is configured for receiving the anatomical representation from a user.

8. The external control device of claim 4, wherein the anatomical representation is a brain model.

9. The external control device of claim 8, wherein the target tissue volume is a subthalamic nucleus.

10. The external control device of claim 1, further comprising a housing containing the output circuitry, user interface, and processor.

11. The external control device of claim 1, wherein the plurality of different candidate electrode combinations comprises a plurality of different candidate fractionalized electrode combinations.

12. A neurostimulation system, comprising:

a plurality of electrodes configured for being implanted within tissue;

a neurostimulator coupled to the electrodes and configured for conveying electrical stimulation energy into the tissue via the electrodes; and

an external control device configured for allowing a user to enter a first one or more candidate electrode combinations and a second one or more candidate electrode combinations, the external control device having a first mode and a second mode, the external control device configured for, when in a first mode, simulating a volume of tissue activation based on each of the first one or more candidate electrode combinations, while preventing the neurostimulator from conveying electrical stimulation energy in response to the user entry of each of the first one or more candidate electrode combinations, and when in an second mode, allowing the neurostimulator to convey electrical stimulation energy in accordance with the second one or more candidate electrode combinations.

13. The neurostimulation system of claim 12, wherein the first one or more candidate electrode combinations comprises a plurality of candidate electrode combinations, wherein the external control device is configured for allowing the user to select one of the plurality of candidate electrode combinations, and for automatically using the user selected candidate electrode combination set as an initial one of the second one or more candidate electrode combinations during the second mode.

14. The neurostimulation system of claim 12, wherein the external control device is configured for scoring each simulated volume of tissue activation relative to a target tissue volume.

15. The neurostimulation system of claim 12, wherein the external control device is configured for storing an anatomical representation having a target tissue volume, and when in the first mode, displaying each volume of tissue activation relative to the target tissue volume.

16. The neurostimulation system of claim 15, wherein the external control device, when in the second mode, is configured for simulating another volume of tissue activation for each of the second one or more candidate electrode combinations, and displaying each other volume of tissue activation relative to the target tissue volume.

17. The neurostimulation system of claim 16, wherein the external control device is configured for displaying an indicator that delineates the displaying of each volume of tissue activation from the displaying of each other volume of tissue activation.

18. The neurostimulation system of claim 17, wherein the indicator is a different color for the volume of tissue activation and the other volume of tissue activation.

19. The neurostimulation system of claim 15, wherein the external control device is configured for receiving the anatomical representation from a user.

20. The neurostimulation system of claim 15, wherein the anatomical representation is a brain model.

21. The neurostimulation system of claim 20, wherein the target tissue volume is a subthalamic nucleus.

22. The neurostimulation system of claim 12, wherein the first one or more candidate electrode combinations and the second one or more candidate electrode combinations are fractionalized electrode combinations.

23. A method of programming a neurostimulator coupled to a plurality of electrodes that are implanted within the tissue of a patient, comprising:

simulating a volume of tissue activation based on each of a first plurality of candidate electrode combinations without conveying electrical stimulation energy into the tissue;

selecting one of the first plurality of candidate electrode combinations based on each simulated volume of tissue activation;

conveying electrical stimulation energy into the tissue in accordance with a second one or more candidate electrode combinations, wherein the initial one of the second one or more candidate electrode combinations is the selected one of the first plurality of candidate electrode combinations;

selecting one of the second one or more candidate electrode combinations based on a therapeutic efficacy of the electrical stimulation energy conveyed into the tissue; and

programming the neurostimulator with the selected one of the second one or more candidate electrode combinations.

24. The method of claim 23, further comprising scoring each simulated volume of tissue activation relative to a target tissue volume.

25. The method of claim 23, wherein each volume of tissue activation is displayed relative to a target tissue volume.

26. The method of claim 25, further comprising simulating another volume of tissue activation for each of the second one or more candidate electrode combinations, and displaying each other volume of tissue activation relative to the target tissue volume.

27. The method of claim 26, further comprising displaying an indicator that delineates the displaying of each volume of tissue activation from the displaying of each other volume of tissue activation.

28. The method of claim 27, wherein the indicator is a different color for the volume of tissue activation and the other volume of tissue activation.

29. The method of claim 25, wherein the target tissue volume is a subthalamic nucleus.

30. The method of claim 23, wherein the first plurality of candidate electrode combinations and the second one or more electrode combinations are fractionalized electrode combinations.