Point-and-click programming for deep brain stimulation using real-time monopolar review trendlines

• US 10,016,610 B2
• Filed: 10/10/2017
• Issued: 07/10/2018
• Est. Priority Date: 08/28/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carcieri, Stephen, Chen, Dean, Moffitt, Michael A.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US15/729,383
• Publication Number:
  US 20180028826A1
• Time in Patent Office: 273 Days
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for selecting leadwire stimulation parameters includes a processor iteratively performing, for each of a plurality of values for a particular stimulation parameter, each value corresponding to a respective current field: (a) shifting the current field longitudinally and/or rotationally to a respective plurality of locations about the leadwire; and (b) for each of the respective plurality of locations, obtaining clinical effect information regarding a respective stimulation of the patient tissue produced by the respective current field at the respective location; and displaying a graph plotting the clinical effect information against values for the particular stimulation parameter and locations about the leadwire, and/or based on the obtained clinical effect information, identifying an optimal combination of a selected value for the particular stimulation parameter and selected location about the leadwire at which to perform a stimulation using the selected value.

Claims

1. A method for selecting electrical stimulation parameters for a leadwire implanted in patient tissue and comprising a plurality of electrodes, wherein the plurality of electrodes comprises at least one set of two or more directional electrodes, wherein the directional electrodes of each set are disposed at a same longitudinal level of the leadwire but at different circumferential positions, the method comprising:

for each of a plurality of values for a particular stimulation parameter, each value corresponding to a respective current field produced by a respective combination of one or more of the electrodes of the leadwire, obtaining, by a computer processor, clinical effect information regarding a respective stimulation of the patient tissue produced by the respective current field;

displaying a graph plotting the obtained clinical effect information as respective data points, wherein each data point is characterized by an angle of rotation and a radius from a center of the graph, wherein the radius corresponds to the value for the particular stimulation parameter associated with the data point and the angle of rotation corresponds to a direction characterizing the current field associated with the data point;

receiving a user selection of a point on the graph, wherein the point corresponds to a first value of the particular stimulation parameter and a first combination of one or more of the electrodes of the leadwire;

initiating a signal, by the computer processor, to program an implantable pulse generator with the first value of the particular stimulation parameter and the first combination of the one or more of the electrodes on the leadwire to produce a stimulation; and

stimulating patient tissue using the programmed implantable pulse generator, the first value of the particular stimulation parameter, and the first combination of the one or more of the electrodes on the leadwire.

2. The method of claim 1, wherein, for each of the data points, the direction characterizing the current field associated with the data point arises from the circumferential position of one or more of the electrodes associated with the data point.

3. The method of claim 1, wherein the graph is three dimensional and each data point is characterized by a longitudinal position corresponding to a longitudinal position of the current field along a central axis of the leadwire.

4. The method of claim 1, further comprising positioning, by the computer processor, the respective current field at each of the respective combinations of one or more of the electrodes of the leadwire.

5. The method of claim 4, wherein the positioning is performed by shifting the current field at least one of longitudinally or rotationally.

6. The method of claim 5, wherein the shifting is performed in response to user input of a shift instruction by selection of a control, each selection of which is interpreted by the computer processor as an instruction to shift in a respective direction by a predetermined amount.

7. The method of claim 1, wherein the particular stimulation parameter is amplitude.

8. The method of claim 1, wherein the particular stimulation parameter is one of i) pulse width or ii) frequency.

9. The method of claim 1, wherein the obtained clinical effect information includes therapeutic effect values and adverse side effect values.

10. The method of claim 9, further comprising identifying within the graph, a region whose plotted therapeutic effect values are lower than its adverse side effect values, with a greatest distance between the therapeutic effect values and the adverse side effect values.

11. A system for selecting electrical stimulation parameters, the system comprising:

a leadwire configured for implantation in patient tissue and comprising a plurality of electrodes, wherein the plurality of electrodes comprises at least one set of two or more directional electrodes, wherein the directional electrodes of each set are disposed at a same longitudinal level of the leadwire but at different circumferential positions;

an implantable pulse generator coupled to the leadwire and configured to stimulate the patient tissue using the leadwire;

a screen;

a computer processor coupled to the screen and configured to;

for each of a plurality of values for a particular stimulation parameter, each value corresponding to a respective current field produced by a respective combination of one or more of the electrodes of the leadwire, obtain clinical effect information regarding a respective stimulation of the patient tissue produced by the respective current field;

display, on the screen, a graph plotting the obtained clinical effect information as respective data points, wherein each data point is characterized by an angle of rotation and a radius from a center of the graph, wherein the radius corresponds to the value for the particular stimulation parameter associated with the data point and the angle of rotation corresponds to a direction characterizing the current field associated with the data point;

receive a user selection of a point on the graph, wherein the point corresponds to a first value of the particular stimulation parameter and a first combination of one or more of the electrodes of the leadwire; and

initiate a signal to program the implantable pulse generator with the first value of the particular stimulation parameter and the first combination of the one or more of the electrodes on the leadwire to produce a stimulation;

wherein the implantable pulse generator and leadwire are configured and arranged to stimulate the patient tissue, when programmed, using the first value of the particular stimulation parameter and the first combination of the one or more of the electrodes on the leadwire.

12. The system of claim 11, wherein, for each of the data points, the direction characterizing the current field associated with the data point arises from the circumferential position of the one or more of the electrodes associated with the data point.

13. The system of claim 11, wherein the graph is three dimensional and each data point is characterized by a longitudinal position corresponding to a longitudinal position of the current field along a central axis of the leadwire.

14. The system of claim 11, wherein the computer processor is further configured to position the respective current field at each of the respective combinations of the one or more of the electrodes of the leadwire.

15. The system of claim 14, wherein the positioning is performed by shifting the current field at least one of longitudinally or rotationally.

16. The system of claim 15, wherein the shifting is performed in response to user input of a shift instruction by selection of a control, each selection of which is interpreted by the processor as an instruction to shift in a respective direction by a predetermined amount.

17. The system of claim 11, wherein the particular stimulation parameter is amplitude.

18. The system of claim 11, wherein the particular stimulation parameter is one of i) pulse width or ii) frequency.

19. The system of claim 11, wherein the obtained clinical effect information includes therapeutic effect values and adverse side effect values.

20. The system of claim 19, wherein the computer processor is further configured to identify within the graph, a region whose plotted therapeutic effect values are lower than its adverse side effect values, with a greatest distance between the therapeutic effect values and the adverse side effect values.