Clinical response data mapping

• US 9,474,903 B2
• Filed: 03/14/2014
• Issued: 10/25/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Chen, Dean, Hoffer, Brian James, Kothandaraman, Sridhar, Lubensky, David Ari, Lui, Mun Pook, Moffitt, Michael A., Vansickle, Dennis Allen
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US14/212,730
• Publication Number:
  US 20140277284A1
• Time in Patent Office: 956 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A system and method include a processor that, based on at least a subset of stored data of clinical effects of one or more stimulations of anatomical tissue performed using electrodes of an implanted leadwire, generates and outputs at least one graphical marking representing the at least the subset of the stored data. Each of the at least one graphical marking represents a respective portion of the at least the subset of the stored data and is output in association with a respective set of values for each of at least two parameters by which one or more the stimulations were performed. The markings are plotted in a graph defined by axes corresponding to values of respective stimulation parameters. Alternative, the markings are arranged in a column of a tabular report. The markings are two-toned to provide respective information for both therapeutic and adverse side effects.

Claims

1. A computer-implemented clinical data output method comprising:

based on at least a subset of stored data of clinical effects, comprising a first clinical effect and a second clinical effect, of one or more stimulations of anatomical tissue performed using electrodes of an implanted leadwire, generating and outputting, by a computer processor, a plurality of graphical markings representing the at least the subset of the stored data by plotting each of the graphical markings at a respective coordinate of a graph, wherein each of the graphical markings represents a respective portion of the at least the subset of the stored data and is output in association with a respective set of values for each of at least two parameters by which one or more the stimulations were performed, wherein each of the graphical markings comprising a center region corresponding to one of a respective clinical effect type of the first clinical effect or a respective score of the first clinical effect and a boundary corresponding to one of a respective clinical effect type of the second clinical effect or a respective score of the second clinical effect; and

responsive to selection of one of the graphical markings and selection of a programming control indicator, transmitting stimulation parameters to an implantable pulse generator corresponding to the selected one of the graphical markings to produce stimulation of patient tissue using the transmitted stimulation parameters.

2. The method of claim 1, wherein the data of clinical effects is stored at a central cloud database accessible by a plurality of terminals via a network.

3. The method of claim 1, wherein the data of clinical effects is stored on a stimulation device that controls the implanted leadwire.

4. The method of claim 1, wherein the data of clinical effects is stored on the implanted leadwire.

5. The method of claim 1, wherein the data of clinical effects is stored in a local database of a computer terminal of which the computer processor is a part.

6. The method of claim 1, wherein:

the graph includes a first axis corresponding to values of a first of the at least two parameters and a second axis corresponding to values of a second of the at least two parameters; and

the association with the respective set of values is via the location at which the respective graphical marking is plotted.

7. The method of claim 6, wherein the first parameter is a leadwire location and the second parameter is a stimulation amplitude.

8. The method of claim 7, wherein the stimulation amplitude is a current amplitude.

9. The method of claim 7, wherein the stimulation amplitude is a voltage amplitude.

10. The method of claim 6, wherein each of the graphical markings is selectable, and the method further comprises:

responsive to a selection of one of the graphical markings, displaying, by the processor, textual details from the stored data of clinical effects on which basis the respective selected graphical marking was generated.

11. The method of claim 10, wherein the selected graphical marking is generated based on data of clinical effects of a plurality of stimulations, and the textual details are based on only one of the plurality of stimulations.

12. The method of claim 11, wherein different ones of the plurality of stimulations occurred at different times, and the method further comprises:

displaying, by the processor, a user-interactive control, user-selection of which is responded to by the processor by replacing the displayed textual details corresponding to a first one of the stimulations with textual details corresponding to a second one of the stimulations that chronologically precedes or follows the first one of the stimulations.

13. The method of claim 6, wherein each of the graphical markings is selectable, and the method further comprises:

displaying, by the processor, a plurality of clinical effect detail indicators, each corresponding to one of a respective clinical effect type or a respective degree of clinical effect; and

responsive to a selection of one of the graphical markings, selectively highlighting, by the processor, those of the clinical effect detail indicators that are associated with the selected graphical marking.

14. The method of claim 13, further comprising:

responsive to user-selection of one of the plurality of clinical effect detail indicators, recording new clinical effects data in association with stimulation parameters to which the selected graphical marking corresponds.

15. The method of claim 14, further comprising:

updating the selected graphical marking in response to the user-selection of the one of the plurality of clinical effect detail indicators.

16. The method of claim 14, wherein, subsequent to the user-selection of the one of the plurality of clinical effect detail indicators and a subsequent navigation away from the selected graphical marking, responsive to a new selection of the graphical marking, the user-selected one of the plurality of clinical effect detail indicators is highlighted based on the prior user-selection of the respective clinical effect detail indicator.

17. The method of claim 13, further comprising:

responsive to user-selection of one of the plurality of clinical effect detail indicators, recording new clinical effects data in association with stimulation parameters of a currently selected stimulation program, and one of updating or generating a graphical marking at one of the coordinates which corresponds to the stimulation parameters of the currently selected stimulation program.

18. The method of claim 6, wherein each of the coordinates of the graph is selectable, and the method further comprises:

responsive to a user-selection of one of the plurality of clinical effect detail indicators and a user-selection of one of the coordinates of the graph;

updating, by the processor, the stored data of clinical effects; and

one of generating or updating, by the processor, a graphical marking for display at the selected one of the coordinates.

19. The method of claim 18, further comprising:

displaying, by the processor, a selectable clinical effect menu control, responsive to selection of which the processor is configured to display a menu of additional selectable clinical effect detail indicators corresponding to clinical effect types other than those to which the plurality of clinical effect detail indicators correspond.

20. The method of claim 19, further comprising:

responsive to a selection of one of the graphical markings for which one of the additional selectable clinical effect indicators had been previously selected, selectively highlighting, by the processor, the clinical effect menu control.

21. The method of claim 6, further comprising:

responsive to user manipulation of a navigation control, shifting focus, by the processor, from a first one of the coordinates of the graph to a second one of the coordinates of the graph, wherein the navigation control includes;

a first navigation component, each selection of which the processor is configured to interpret as an instruction to shift coordinate focus in the graph in a first direction along the first axis;

a second navigation component, each selection of which the processor is configured to interpret as an instruction to shift coordinate focus in the graph in a second direction along the first axis;

a third navigation component, each selection of which the processor is configured to interpret as an instruction to shift coordinate focus in the graph in a first direction along the second axis; and

a fourth navigation component, each selection of which the processor is configured to interpret as an instruction to shift coordinate focus in the graph in a second direction along the second axis.

22. The method of claim 21, further comprising:

responsive to user-manipulation of a step-size control, modifying, by the processor, a step-size setting for each of at least one of the first, second, third, or fourth navigation components, wherein, for a single value of the step-size setting, the coordinate focus shift for each selection of the at least one of the first, second, third, or fourth navigation components is by a same amount, the amount being based on the value of the step-size setting.

23. The method of claim 22, wherein the amount of the coordinate focus shift corresponds to a change in value of the respective parameter to which the respective axis of the respective navigation component corresponds, which change in value is equal to the value of the step-size setting.

24. The method of claim 22, wherein the step-size control is a toggle control for toggling between pre-set toggle-size values.

25. The method of claim 6, further comprising:

displaying, by the processor, a graphical representation of an anatomical structure in which the leadwire is implanted, wherein the graph is displayed within at least a portion of the graphical representation of the anatomical structure.

26. The method of claim 25, further comprising:

determining, by the processor, a relative position of the graph to the graphical representation of the anatomical structure based on a recorded implant location of the leadwire.

27. The method of claim 6, wherein the coordinates of the graph are selectable, the method further comprising:

responsive to selection of one of the coordinates, displaying, by the processor a concentric stimulation magnitude indicator that is centered on the first axis at a value of the first axis corresponding to the selected coordinate and whose outer perimeter one of reaches or crosses the selected coordinate.

28. The method of claim 6, wherein the graph includes a subset of coordinates with which none of the stored data of clinical effects on which basis the graphical markings of the graph are generated is associated, the method further comprising:

interpolating, by the processor, the stored data of clinical effects on which basis the graphical markings of the graph are generated to calculate values for the subset of coordinates; and

displaying, by the processor and in the graph, a graphical screen that gradually varies with respect to a graphical characteristic, the variation in the graphical screen being based on the calculated values obtained by the interpolation.

29. The method of claim 6, further comprising:

displaying, by the processor and one of in the graph, on at least one of the axes, or alongside the at least one of the axes, at least one limit marker, each of the at least one limit marker representing a respective limit to which modification of a value of a respective one of the at least two parameters is permitted.

30. The method of claim 29, further comprising:

obtaining user input of the at least one limit.

31. The method of claim 30, wherein:

the user input of the at least one limit is received in association with a user profile associated with predefined clinician rights; and

in accordance with the obtained user input, an instruction, received in association with a user profile associated with predefined patient rights, to set any of the at least two parameters to a value that is beyond a respective one of the at least one limit that corresponds to the respective parameter, is not followed.

32. The method of claim 6, wherein the coordinates of the graph are selectable, the method further comprising:

programming, by the processor and based on a selection of one of the coordinates of the graph, a stimulation device for operating the implanted leadwire to stimulate anatomical tissue using values of the first and second parameters corresponding to the selected coordinate.

33. The method of claim 32, wherein the coordinates of the graph are selectable by a first type of selection in response to which detailed information corresponding to the selected coordinate are displayed and by a second type of selection in response to which the processor performs the programming of the stimulation device.

34. The method of claim 33, wherein the coordinates of the graph are selectable by a third type of selection in response to which the processor activates a mode by which to enter new clinical effects data.

35. The method of claim 34, wherein the first, second, and third types of selections include a right-click, a left-click, and a touch via touchscreen.

36. The method of claim 6, wherein:

the coordinates of the graph are selectable;

a plurality of leadwires are implanted;

a plurality of stimulation programs are user-definable via a programming module, each of the plurality of stimulation programs defining respective stimulation parameters for each of the plurality of leadwires; and

the method further comprises;

displaying the graph in a user interface screen in which a list of the defined programs is displayed, each of the displayed listings of the defined programs being selectable for toggling between an expanded view in which the plurality of leadwires are listed as child nodes of the selected listing and a collapsed view in which no child nodes of the respective listing are displayed, and each of the displayed listings of the respective leadwires is selectable from within the expanded view of one of the program listings for which the respective leadwire listing is displayed; and

in accordance with a selection of one of the coordinates of the graph, updating settings of the leadwire of a selected one of the leadwire listings for a selected one of the program listings with values of the first and second parameters corresponding to the selected coordinate.

37. The method of claim 1, the method further comprising:

obtaining, by the processor, user input filter criteria, wherein the stored data of clinical effects includes more than the subset set thereof, and, in accordance with the user input filter criteria, the generating of the graphical markings is based selectively on the subset and not the remainder of the stored data of clinical effects.

38. The method of claim 1, wherein the first clinical effect is a therapeutic effect and the second clinical effect is a side effect.

39. The method of claim 1, wherein:

a graphical characteristic of the center region of the graphical markings is set in accordance with a score based on the first clinical effect associated with the set of values with which the respective graphical marking is associated; and

a graphical characteristic of the boundary of the graphical markings is set in accordance with a score calculated based on the second clinical effect associated with the set of values with which the respective graphical marking is associated.

40. The method of claim 1, wherein the center region is displayed in a first color and the boundary is displayed in a second color different than the first color.

41. The method of claim 40, wherein the first and second color vary in transparency based on scores associated with the first and second clinical effects, respectively.

42. The method of claim 41, wherein, for graphical markings where no second clinical effect is present at the corresponding set of values, the boundary is entirely transparent.