COLLECTION OF CLINICAL DATA FOR GRAPHICAL REPRESENTATION AND ANALYSIS

• US 20120303087A1
• Filed: 05/25/2012
• Published: 11/29/2012
• Est. Priority Date: 05/27/2011
• 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., Reinhold, John J.
• Granted Patent: US 9,643,015 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• 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 method of treating a patient and an external programmer for use with a neurostimulator. Electrical stimulation energy is conveyed into tissue of the patient via a specified combination of a plurality of electrodes, thereby creating one or more clinical effects. An influence of the specified electrode combination on the clinical effect(s) is determined. An anatomical region of interest is displayed in registration with a graphical representation of the plurality of electrodes. The displayed anatomical region of interest is modified based on the determined influence of the specified electrode combination on the clinical effect(s).

Claims

1-41. -41. (canceled)

42. A method of treating a patient, comprising:

conveying electrical stimulation energy into tissue of the patient via a specified combination of a plurality of electrodes, thereby creating one or more clinical effects;

determining an influence of the specified electrode combination on the one or more clinical effects;

displaying an anatomical region of interest in registration with a graphical representation of the plurality of electrodes; and

modifying the displayed anatomical region of interest based on the determined influence of the specified electrode combination on the one or more clinical effects.

43. The method of claim 42, wherein the anatomical region of interest is an anatomical structure functionally delineated from surrounding tissue.

44. The method of claim 42, wherein the anatomical region of interest is an arbitrarily defined anatomical region of interest.

45. The method of claim 42, wherein the displayed anatomical region of interest is modified by spatially translating the displayed anatomical region of interest relative to the graphical electrode representation.

46. The method of claim 42, wherein the displayed anatomical region of interest is modified by changing the shape of the displayed anatomical region of interest.

47. The method of claim 42, wherein the anatomical region of interest is a therapy tissue region.

48. The method of claim 42, wherein the anatomical region of interest is a side-effect tissue region.

49. The method of claim 42, further comprising determining a displayed proximity between the displayed anatomical region of interest and the specified electrode combination in the graphical electrode representation, implying an actual proximity between the anatomical region of interest and the specified electrode combination based on the determined influence of the specified electrode combination on the one or more clinical effects, wherein the displayed anatomical region of interest is modified by spatially translating the displayed anatomical region of interest relative to the specified electrode combination in the graphical electrode representation to better match the displayed proximity to the actual proximity.

50. The method of claim 49, wherein the displayed proximity is greater than the actual proximity, and the displayed anatomical region of interest is spatially translated closer to the specified electrode combination in the graphical electrode representation.

51. The method of claim 49, wherein the displayed proximity is less than the actual proximity, and the displayed anatomical region of interest is spatially translated further from the specified electrode combination in the graphical electrode representation.

52. The method of claim 42, further comprising displaying another anatomical region of interest in registration with a graphical representation of the plurality of electrodes, wherein the one or more clinical effects comprises a therapeutic effect and a side-effect, the anatomical region of interest is a therapy tissue region, the other anatomical region of interest is a side-effect tissue region, determining the influence of the specified electrode combination on the one or more clinical effects comprises determining a relative influence of the specified electrode combination on the therapeutic effect and the side-effect, and the displayed therapy tissue region and displayed side-effect tissue region are modified by spatially translating the displayed therapy tissue region and the side-effect tissue region relative to the specified electrode combination in the graphical electrode representation based on the determined relative influence of the specified electrode combination on the therapeutic effect and the side-effect.

53. The method of claim 52,

wherein the specified electrode combination in the graphical electrode representation is closer to the displayed therapy tissue region than the displayed side-effect tissue region;

and

wherein the displayed therapy tissue region is spatially translated further from the specified electrode combination in the graphical electrode representation and the displayed side-effect tissue region is spatially translated closer to the specified electrode combination in the graphical electrode representation if the specified electrode combination is determined to influence the side-effect more than the therapeutic effect.

54. The method of claim 52,

wherein the specified electrode combination in the graphical electrode representation is closer to the displayed side-effect tissue region than the displayed therapy tissue region;

and

wherein the displayed therapy tissue region is spatially translated closer to the specified electrode combination in the graphical electrode representation and the displayed side-effect tissue region is spatially translated further from the specified electrode combination in the graphical electrode representation if the specified electrode combination is determined to influence the therapeutic effect more than the side-effect.

55. The method of claim 42, further comprising:

conveying electrical stimulation energy into the tissue of the patient via first and second combinations of the electrodes, thereby creating the one or more clinical effects, wherein the first electrode combination in the graphical electrode representation is further away from the displayed anatomical region of interest than the second electrode combination in the graphical electrode representation; and

determining an influence of each of the first and second electrode combinations on the one or more clinical effects, wherein the first electrode combination is determined to have a higher influence on the one or more clinical effects than the second electrode combination; and

wherein the displayed anatomical region of interest is modified by spatially translating the displayed anatomical region of interest away from the second electrode combination in the graphical electrode representation towards the first electrode combination in the graphical electrode representation.

56. The method of claim 42, further comprising:

conveying electrical stimulation energy into tissue of the patient via different combinations of electrodes implanted within the patient, thereby creating one or more clinical effects for each of the different electrode combinations, wherein the one or more clinical effects comprises one or more therapeutic effects and one or more side-effects, and the displayed anatomical region is a therapy tissue region;

incrementally increasing an intensity level of the conveyed electrical stimulation energy for each of the different electrode combinations, wherein the influence of the each different electrode combination on the one or more clinical effects is determined by determining the highest intensity level at which a metric of the one or more therapeutic effects occurs prior to an initial occurrence of a metric of the one or more side-effects; and

wherein the displayed therapy tissue region is modified by changing the shape of the therapy tissue region based on the determined highest intensity levels for the specified electrode combinations.

57. The method of claim 42, wherein the electrical stimulation energy is conveyed from a neurostimulator, the method further comprising programming the neurostimulator based on the modified anatomical region of interest.

58. The method of claim 42, further comprising recording the modified anatomical region of interest in computer memory.

59. The method of claim 42, wherein the tissue is brain tissue.

60. An external programmer for use with a neurostimulator, comprising:

output circuitry configured for communicating with the neurostimulator;

control circuitry configured for instructing the neurostimulator via the output circuitry to convey electrical stimulation energy into the tissue of the patient via a specified combination of a plurality of electrodes, thereby creating one or more clinical effects, and for instructing a display device to display an anatomical region of interest in registration with a graphical representation of a plurality of electrodes; and

processing circuitry configured for determining an influence of the specified electrode combination on the one or more clinical effects, and modifying the anatomical region of interest based on the determined influence of the specified electrode combination on the one or more clinical effects.

61. The external programmer of claim 60, wherein the anatomical region of interest is an anatomical structure functionally delineated from surrounding tissue.

62. The external programmer of claim 60, wherein the anatomical region of interest is an arbitrarily defined anatomical region of interest.

63. The external programmer of claim 60, wherein the processing circuitry is configured for modifying the displayed anatomical region of interest by spatially translating the displayed anatomical region relative to the graphical electrode representation.

64. The external programmer of claim 60, wherein the processing circuitry is configured for modifying the displayed anatomical region of interest by changing the shape of the displayed anatomical region.

65. The external programmer of claim 60, wherein the anatomical region of interest is a therapy tissue region.

66. The external programmer of claim 60, wherein the anatomical region of interest is a side-effect tissue region.

67. The external programmer of claim 60, wherein the processing circuitry is further configured for determining a displayed proximity between the displayed anatomical region of interest and the specified electrode combination in the graphical electrode representation, implying an actual proximity between the anatomical region of interest and the specified electrode combination based on the determined influence of the specified electrode combination on the one or more clinical effects, and modifying the displayed anatomical region of interest by spatially translating the displayed anatomical region of interest relative to the specified electrode combination in the graphical electrode representation to better match the displayed proximity to the actual proximity.

68. The external programmer of claim 67, wherein the displayed proximity is greater than the actual proximity, and the processing circuitry is configured for spatially translating the displayed anatomical region of interest closer to the specified electrode combination in the graphical electrode representation.

69. The external programmer of claim 67, wherein the displayed proximity is less than the actual proximity, and the processing circuitry is configured for spatially translating the displayed anatomical region of interest further from the specified electrode combination in the graphical electrode representation.

70. The external programmer of claim 60, wherein the control circuitry is further configured for instructing the display device to display another anatomical region of interest in registration with a graphical representation of a plurality of electrodes, the one or more clinical effects comprises a therapeutic effect and a side-effect, the anatomical region of interest is a therapy tissue region, the other anatomical region of interest is a side-effect tissue region, and the processing circuitry is configured for determining the influence electrode combination on the one or more clinical effects by determining a relative influence of the specified electrode combination on the therapeutic effect and the side-effect, and modifying the displayed therapy tissue region and displayed side-effect tissue region by spatially translating the displayed therapy tissue region and the side-effect tissue region relative to the specified electrode combination in the graphical electrode representation based on the determined relative influence of the specified electrode combination on the therapeutic effect and the side-effect.

71. The external programmer of claim 70, wherein the specified electrode combination in the graphical electrode representation is closer to the displayed therapy tissue region than the displayed side-effect tissue region, and the processing circuitry is configured for spatially translating the displayed therapy tissue region further from the specified electrode combination in the graphical electrode representation and the displayed side-effect tissue region closer to the specified electrode combination in the graphical electrode representation if the specified electrode combination is determined to influence the side-effect more than the therapeutic effect.

72. The external programmer of claim 70, wherein the specified electrode combination in the graphical electrode representation is closer to the displayed side-effect tissue region than the displayed therapy tissue region, and the processing circuitry is configured for spatially translating the displayed therapy tissue region closer to the specified electrode combination in the graphical electrode representation and the displayed side-effect tissue region further from the specified electrode combination in the graphical electrode representation if the specified electrode combination is determined to influence the therapeutic effect more than the side-effect.

73. The external programmer of claim 60,

wherein the control circuitry is configured for conveying electrical stimulation energy into the tissue of the patient via first and second combinations of the electrodes, thereby creating the one or more clinical effects, and wherein the first electrode combination in the graphical electrode representation is further away from the displayed anatomical region of interest than the second electrode combination in the graphical electrode representation;

and

wherein the processing circuitry is configured for determining an influence of each of the first and second electrode combinations on the one or more clinical effects, wherein the first electrode combinations is determined to have a higher influence on the one or more clinical effects than the second electrode combination, and further configured for modifying the displayed anatomical region of interest by spatially translating the displayed anatomical region of interest away from the second electrode combination in the graphical electrode representation towards the first electrode combination in the graphical electrode representation.

74. The external programmer of claim 60,

wherein the control circuitry is configured for conveying electrical stimulation energy into tissue of the patient via different combinations of electrodes implanted within the patient, thereby creating one or more clinical effects for each of the different electrode combinations, wherein the one or more clinical effects comprises one or more therapeutic effects and one or more side-effects, and the displayed anatomical region is a therapy tissue region, and further configured for incrementally increasing an intensity level of the conveyed electrical stimulation energy for each of the different electrode combinations;

and

wherein the processing circuitry is configured for determining the influence of the each different electrode combination on the one or more clinical effects by determining the highest intensity level at which a metric of the one or more therapeutic effects occurs prior to an initial occurrence of a metric of the one or more side-effects, and modifying the displayed therapy tissue region by changing the shape of the therapy tissue region based on the determined highest intensity levels for the specified electrode combinations.

75. The external programmer of claim 60, wherein the control circuitry is further configured for programming the neurostimulator via the output circuitry based on the modified anatomical region of interest.

76. The external programmer of claim 60, further comprising memory configured for storing the modified anatomical region of interest.

77-102. -102. (canceled)