Neurostimulation system for selectively estimating volume of activation and providing therapy

• US 9,289,609 B2
• Filed: 11/28/2014
• Issued: 03/22/2016
• 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:
  US14/556,037
• Publication Number:
  US 20150088228A1
• Time in Patent Office: 480 Days
• US Class Current: 1/1
• 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 transmitting sets of stimulation parameters to the neurostimulator;

a user interface including a display device, wherein the user interface is configured and arranged to display a programming screen on the display device, wherein the programming screen comprises a first control element configured to be actuated by a user to selectively place the external control device in either a pre-programming mode in which changes to stimulation parameters are not transmitted to the neurostimulator or a live stimulation mode in which changes to stimulation parameters are transmitted to the neurostimulator using the output circuitry and the neurostimulator stimulates the tissue using a current set of the stimulation parameters, wherein the programming screen further comprises a second control element configured to be actuated by the user to change a stimulation amplitude and a third control element configured to be actuated by the user to select at least one stimulation electrode; and

a processor, when the external control device is in the pre-programming mode, configured for simulating a volume of tissue activation using a computational modeling technique for each of one or more candidate stimulation parameter sets, while preventing the output circuitry from transmitting the one or more of candidate stimulation parameter sets to the neurostimulator.

2. The external control device of claim 1, wherein the processor is configured for automatically directing the output circuitry to transmit a current set of stimulation parameters to the neurostimulator when the user selecting the live stimulation mode using the first control element.

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 pre-programming mode, is configured for allowing the user interface to display on the display device and in the programming screen each simulated volume of tissue activation relative to the target tissue volume on the display device.

5. The external control device of claim 4, wherein the processor, when the external control device is in the live stimulation mode, is configured for simulating another volume of tissue activation for each of one or more candidate stimulation parameter sets, and for allowing the user interface to display on the display device and in the programming screen 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 4, further comprising a housing containing the memory, output circuitry, user interface, and processor.

11. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to move a stimulation field associated with a current set of stimulation parameters axially along a lead of the neurostimulator and generate, using the processor, a new set of current stimulation parameters.

12. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to move a stimulation field associated with a current set of stimulation parameters circumferentially around a lead of the neurostimulator and generate, using the processor, a new set of current stimulation parameters.

13. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to change a stimulation pulse width.

14. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to change a stimulation pulse rate.

15. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to change a stimulation pulse width.

16. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to expand or contract a stimulation field associated with a current set of stimulation parameters axially along a lead of the neurostimulator and generate, using the processor, a new set of current stimulation parameters.

17. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to expand or contract a stimulation field associated with a current set of stimulation parameters circumferentially around a lead of the neurostimulator and generate, using the processor, a new set of current stimulation parameters.

18. The external control device of claim 1, wherein the programming screen further comprises a fourth control element configured to be actuated by the user to select either monopolar or multipolar stimulation.

19. 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

the external control device of claim 1.

20. The neurostimulation system of claim 19, wherein the external control device is configured for allowing a user to enter one or more candidate stimulation parameter sets.

21. The neurostimulation system of claim 19, wherein the external control device is configured for allowing the user to select a candidate stimulation parameter sets, and for automatically using the user selected candidate stimulation parameter set when the user selects the live stimulation mode.

22. The neurostimulation system of claim 19, wherein the external control device is configured for scoring each simulated volume of tissue activation relative to a target tissue volume.

23. The neurostimulation system of claim 19, wherein the external control device is configured for storing an anatomical representation having a target tissue volume, and when in the pre-programming mode, displaying on the display device and in the programming screen each volume of tissue activation relative to the target tissue volume.

24. The neurostimulation system of claim 23, wherein the external control device, when in the live stimulation mode, is configured for simulating another volume of tissue activation for each of one or more candidate stimulation parameter sets, and displaying on the display device and in the programming screen each other volume of tissue activation relative to the target tissue volume.

25. The neurostimulation system of claim 24, 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.

26. The neurostimulation system of claim 25, wherein the indicator is a different color for the volume of tissue activation and the other volume of tissue activation.

27. The neurostimulation system of claim 23, wherein the external control device is configured for receiving the anatomical representation from a user.

28. The neurostimulation system of claim 23, wherein the anatomical representation is a brain model.

29. The neurostimulation system of claim 28, wherein the target tissue volume is a subthalamic nucleus.