Methods and systems for detecting epileptic events using NNXX, optionally with nonlinear analysis parameters

• US 8,827,912 B2
• Filed: 04/27/2010
• Issued: 09/09/2014
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Bukhman, Vladislav
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): CATINA, MICHAEL ANTHONY
• Application Number:
  US12/768,472
• Publication Number:
  US 20110270095A1
• Time in Patent Office: 1,596 Days
• Field of Search: 600/483, 600/509, 607/2, 607/3, 607/45
• US Class Current: 600/483
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36064 Epilepsy

Abstract

Disclosed herein are methods, systems, and apparatus for detecting an epilepsy event in a patient using a medical device. The medical device is capable of determining an occurring epilepsy event, for example a seizure or an increased risk of a seizure. The determination is performed by determining at least one NNXX value from the beat sequence of the patient'"'"'s heart. The medical device may then take a responsive action, such as warning, logging the time of the seizure, computing and storing one or more seizure severity indices, and treating the epilepsy event.

Claims

1. A non-transitory computer readable storage device storing instructions that, when executed by a processor, cause the processor to perform operations comprising:

receiving data related to a beat sequence of a patient'"'"'s heart;

dynamically recalculating an XX value used to determine at least one NNXX value, wherein the at least one NNXX value corresponds to a number of adjacent normal R-R intervals in a sample that differ by more than XX milliseconds;

determining the at least one NNXX value based on the beat sequence of the patient'"'"'s heart;

performing a first comparison of the at least one NNXX value to an NNXX threshold; and

providing an output indicative of an unstable brain state, a brain state indicative of an elevated probability of a seizure event, a brain state indicative of an impending seizure, an aura, a seizure, or a combination thereof, wherein the output is determined based on the first comparison.

2. The non-transitory computer readable storage device of claim 1, wherein the operations further comprise performing a responsive action, the responsive action including providing a warning, logging a time of the output, determining one or more seizure severity indices based on the seizure event, treating the seizure event based upon the first comparison of the at least one NNXX value to the NNXX threshold, or any combination thereof.

3. The non-transitory computer readable storage device of claim 1, wherein the XX value is dynamically recalculated based on an equation:

XX=(a+b*x),

wherein x is a standard deviation (SD) value or a root mean squared successive distances (RMSSD) value, wherein the SD and the RMSSD are based on each interval between beats of the beat sequence of the patient'"'"'s heart;

wherein a is a first constant; and

wherein b is a second constant.

4. The non-transitory computer readable storage device of claim 1, wherein the at least one NNXX value is determined during a time period that is less than 60 contiguous beats of the beat sequence of the patient'"'"'s heart.

5. The non-transitory computer readable storage device of claim 1, wherein the operations further comprise:

determining at least one regularity nonlinear analysis parameter based on the beat sequence of the patient'"'"'s heart;

determining at least one predictability nonlinear analysis parameter based on the beat sequence of the patient'"'"'s heart; and

performing a second comparison of the at least one regularity nonlinear analysis parameter to a regularity nonlinear analysis threshold, performing a third comparison of the at least one predictability nonlinear analysis parameter to a predictability nonlinear analysis threshold, or performing both the second comparison and the third comparison; and

wherein the output is further determined based on the second comparison, the third comparison, or both.

6. The non-transitory computer readable storage device of claim 5, wherein the at least one regularity nonlinear analysis parameter is a sample entropy (SampEN) value and the at least one predictability nonlinear analysis parameter is a similarity of distribution (SOD) value.

7. The non-transitory computer readable storage device of claim 1, wherein receiving the data related to the beat sequence of the patient'"'"'s heart includes sensing a time of the beat sequence of the patient'"'"'s heart and generating a time series data stream from the time of the beat sequence.

8. The non-transitory computer readable storage device of claim 7, wherein generating the time series data stream includes sensing a plurality of R peaks from the R-R intervals and determining a time stamp based on the plurality of R peaks to generate the time series data stream.

9. The non-transitory computer readable storage device of claim 2, wherein the responsive action further includes applying an electrical signal to a neural structure of the patient, delivering a drug to the patient, or both.

10. The non-transitory computer readable storage device of claim 9, wherein the electrical signal is provided to the neural structure of the patient via an electrode.

11. A non-transitory computer readable storage device storing instructions that, when executed by a processor, cause the processor to perform operations comprising:

receiving data related to a beat sequence of a patient'"'"'s heart;

determining, based on the beat sequence, a first cardiac parameter and a second cardiac parameter;

adjusting the first cardiac parameter based on the second cardiac parameter to generate an adjusted first cardiac parameter;

performing a comparison of the adjusted first cardiac parameter to a first cardiac parameter threshold;

providing an output indicative of an occurrence of a seizure event of the patient based on the comparison,

wherein the first cardiac parameter is adjusted based on a nonlinear mathematical function,

wherein the first cardiac parameter corresponds to an XX parameter for determining an NNXX value according to a number of adjacent normal R-R intervals in a sample that differ by more than XX milliseconds,

wherein the XX parameter is dynamically adjusted based on an equation;

XX=(a+b*x),

wherein x is a standard deviation (SD) value or a root mean squared successive distances (RMSSD) value,

wherein the SD value and the RMSSD value are based on each interval between beats of the beat sequence of the patient'"'"'s heart,

wherein a is a first constant, and

wherein b is a second constant.

12. The non-transitory computer readable storage device of claim 11, wherein the seizure event includes an unstable brain state, a brain state indicative of an elevated probability of a seizure event, a brain state indicative of an impending seizure, an aura, a seizure, or a combination thereof.

13. A non-transitory computer readable storage device storing instructions that, when executed by a processor, cause the processor to perform operations comprising:

receiving data related to a beat sequence of a patient'"'"'s heart;

dynamically recalculating an XX value used to determine at least one NNXX value corresponding to a number of adjacent normal R-R intervals in a sample that differ by more than XX milliseconds, wherein the XX value is dynamically recalculated based on an equation;

XX=(a+b*x), wherein x is a standard deviation (SD) value or a root mean squared successive distances (RMSSD) value, wherein the SD value and the RMSSD value are based on each interval between beats of the beat sequence of the patient'"'"'s heart, wherein a is a first constant, and wherein b is a second constant;

determining the at least one NNXX value based on the beat sequence of the patient'"'"'s heart and the XX value;

performing a first comparison of the at least one NNXX value to an NNXX threshold; and

providing an output indicative of an unstable brain state, a brain state indicative of an elevated probability of a seizure event, a brain state indicative of an impending seizure, an aura, a seizure, or a combination thereof, wherein the output is determined based on the first comparison.

14. The non-transitory computer readable storage device of claim 13, wherein the at least one NNXX value is determined during a time period that is less than 60 contiguous beats of the beat sequence of the patient'"'"'s heart.

15. The non-transitory computer readable storage device of claim 13, wherein the operations further comprise:

determining at least one regularity nonlinear analysis parameter based on the beat sequence of the patient'"'"'s heart;

determining at least one predictability nonlinear analysis parameter based on the beat sequence of the patient'"'"'s heart; and

performing a second comparison of the at least one regularity nonlinear analysis parameter to a regularity nonlinear analysis threshold, performing a third comparison of the at least one predictability nonlinear analysis parameter to a predictability nonlinear analysis threshold, or performing both the second comparison and the third comparison;

wherein the output is further determined based on the second comparison, the third comparison, or both.

16. The non-transitory computer readable storage device of claim 15, wherein the at least one regularity nonlinear analysis parameter is a sample entropy (SampEN) value and the at least one predictability nonlinear analysis parameter is a similarity of distribution (SOD) value.

17. The non-transitory computer readable storage device of claim 13, wherein receiving the data related to the beat sequence of the patient'"'"'s heart includes sensing a time of the beat sequence of the patient'"'"'s heart and generating a time series data stream from the time of the beat sequence.

18. The non-transitory computer readable storage device of claim 17, wherein receiving the data related to the beat sequence of the patient'"'"'s heart includes receiving a series of R-R intervals, and wherein generating the time series data stream includes sensing a plurality of R peaks from the R-R intervals and determining a time stamp based on the plurality of R peaks to generate the time series data stream.

19. The non-transitory computer readable storage device of claim 13, wherein the operations further comprise performing a responsive action, the responsive action including providing a warning, logging a time of the output, determining one or more seizure severity indices based on the seizure event, treating the seizure event based upon the first comparison of the at least one NNXX value to the NNXX threshold, or any combination thereof.

20. The non-transitory computer readable storage device of claim 19, wherein the responsive action further includes applying an electrical signal to a neural structure of the patient, delivering a drug to the patient, or both.

21. The non-transitory computer readable storage device of claim 20, wherein the electrical signal is provided to the neural structure of the patient via an electrode.