Detecting and validating a detection of a state change from a template of heart rate derivative shape or heart beat wave complex

• US 8,948,855 B2
• Filed: 05/21/2013
• Issued: 02/03/2015
• Est. Priority Date: 09/16/2010
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US13/899,267
• Publication Number:
  US 20130296730A1
• Time in Patent Office: 623 Days
• Field of Search: 600508-509
• US Class Current: 600/509
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy

Abstract

Methods, systems, and apparatus for detecting and/or validating a detection of a state change by matching the shape of one or more of an cardiac data series, a heart rate variability data series, or at least a portion of a heart beat complex, derived from cardiac data, to an appropriate template.

Claims

1. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for indicating an occurrence of a brain state change, comprising:

obtaining shape data relating to a shape of at least a portion of a heart beat complex from a patient;

comparing said shape data with a corresponding first reference shape template for said at least a portion of a heart beat complex; and

,

indicating an occurrence of a brain state change based upon a determination that said shape data fails to match said first reference shape template.

2. The non-transitory computer readable program storage unit of claim 1, wherein said shape data comprises at least one parameter selected from a morphology of a P wave, a morphology of a Q wave, a morphology of an R wave, a morphology of an S wave, and a morphology of a T wave.

3. The non-transitory computer readable program storage unit of claim 1, wherein said first reference shape template comprises at least a first matched filter.

4. The non-transitory computer readable program storage unit of claim 3, wherein said shape data fails to match said first reference shape template if a first matched filter output for said first reference shape template is less than a first matched filter threshold, or differs from said first matched filter threshold by at least a predetermined magnitude.

5. The non-transitory computer readable program storage unit of claim 1, wherein said comparing further comprises comparing said shape data with a corresponding second reference shape template for said at least a portion of a heart beat complex of said patient, and wherein said indicating is based upon a determination that said shape data fails to match at least one of said first reference shape template and said second reference shape template.

6. The non-transitory computer readable program storage unit of claim 5, wherein said second reference shape template comprises a brain state change template, and wherein said indicating said occurrence of said brain state change is based upon both said determination that said shape data fails to match said first reference shape template and a determination that said shape data matches said second reference shape template.

7. The non-transitory computer readable program storage unit of claim 6, wherein said first reference shape template is a non-ictal template and said second reference shape template is an ictal template.

8. The non-transitory computer readable program storage unit of claim 1, wherein said method further comprises:

obtaining second shape data relating to a shape of a plurality of heart beat complexes from said patient, said obtaining occurring after said indicating an occurrence of a brain state change;

comparing said second shape data with said first reference shape template; and

,

indicating a termination of said brain state change based upon a determination that said second shape data matches said first reference shape template.

9. The non-transitory computer readable program storage unit of claim 1, wherein said method further comprises taking an action in response to said indicating, wherein said action is selected from providing a warning of said brain state change, logging a time of said brain state change, computing one or more brain state change indices, logging one or more computed brain state change indices, and providing at least one treatment of said brain state change.

10. The non-transitory computer readable program storage unit of claim 1, wherein said comparing further comprises comparing said shape data with a corresponding third reference shape template for said at least a portion of a heart beat complex of said patient, and wherein said indicating is based upon a determination that said shape data fails to match said first reference shape template and a determination that said shape data fails to match said third reference shape template.

11. The non-transitory computer readable program storage unit of claim 1, wherein obtaining shape data comprises obtaining shape data relating to a shape of at least a portion of a plurality of heart beat complexes;

wherein said comparing comprises comparing said shape of at least a portion of a plurality of heart beat complexes with said first reference shape template; and

wherein said indicating is based upon a determination that said shape of at least a portion of said plurality of heart beat complexes fails to match said first reference shape template.

12. The non-transitory computer readable program storage unit of claim 1, wherein obtaining shape data comprises obtaining data relating to a shape of a plurality of portions of a heart beat complex, and wherein comparing said shape data comprises comparing said shape of a plurality of portions of a heart beat complex with each of a corresponding plurality of portions of said first reference shape template.

13. The non-transitory computer readable program storage unit of claim 1, wherein obtaining shape data comprises obtaining data relating to the shape of a PQRST complex from a patient, and wherein comparing said shape data comprises comparing said shape a PQRST complex with a PQRST reference shape template.

14. The non-transitory computer readable program storage unit of claim 1, wherein said comparing comprises comparing said shape data with a plurality of reference shape templates, and wherein said indicating is based upon a determination that said shape data fails to match said plurality of reference shape templates.

15. The non-transitory computer readable program storage unit of claim 1, wherein said first reference shape template is selected from a non-ictal template, an ictal template, and a post-ictal template.

16. The non-transitory computer readable program storage unit of claim 1, wherein said shape data comprises at least one parameter selected from an area under the curve of a P wave, an area under the curve of a Q wave, an area under the curve of an R wave, an area under the curve of an S wave, and an area under the curve of a T wave.

17. The non-transitory computer readable program storage unit of claim 1, wherein said shape data comprises at least one parameter selected from a polarity of a P wave, a polarity of a Q wave, a polarity of an R wave, a polarity of an S wave, and a polarity of a T wave.

18. The non-transitory computer readable program storage unit of claim 1, wherein said shape data comprises at least two parameters selected from a magnitude of a change in the distance from a P wave to a Q wave, a magnitude of a change in the distance from a P wave to an R wave, a magnitude of a change in the distance from a Q wave to an R wave, a magnitude of a change in the distance from an R wave to an S wave, a magnitude of a change in the distance from an R wave to a T wave, a magnitude of a change in the distance from an S wave to a T wave, a magnitude of an S-T segment elevation, a magnitude of S-T segment depression, a magnitude of a Q-T segment elevation, a magnitude of a Q-T segment depression, a P-R interval, an R-S interval, an S-T interval, an R-T interval, and a Q-T interval.

19. A method for indicating an occurrence of an epileptic seizure, comprising:

obtaining a time series of heart beat complex data from a patient;

determining at least one heart beat complex shape parameter for each of a plurality of heart beat complexes in said time series of heart beat complex data;

comparing said at least one heart beat complex shape parameter for each of said plurality of heart beat complexes to a first reference heart beat complex shape template;

indicating an occurrence of an epileptic seizure based upon a determination that said at least one heart beat complex shape parameter for at least a portion of said plurality of heart beat complexes fails to match said first reference heart beat complex shape template.

20. The method of claim 19, further comprising:

in response to said indicating, performing at least one further action selected from providing a warning;

logging at least one of said indicating, the time of said indicating, and a seizure severity metric; and

initiating at least one therapy to treat said epileptic seizure.

21. The method of claim 20, wherein said at least one therapy is selected from:

applying an electrical signal to a neural structure of the patient, wherein said neural structure is selected from a portion of a brain structure of the patient, a portion of a cranial nerve of a patient, a portion of a spinal cord of a patient, a portion of a sympathetic nerve structure of the patient, a portion of a parasympathetic nerve structure of the patient, and a portion of a peripheral nerve of the patient;

delivering a drug to a patient; and

cooling a neural structure of a patient.

22. The method of claim 19, wherein determining at least one heart beat complex shape parameter comprises determining a plurality of heart beat complex shape parameters defining a shape of each of a plurality of heart beat complexes in said time series;

and wherein said comparing comprises comparing said plurality of heart beat complex shape parameters for each of said plurality of complexes to a corresponding plurality of reference heart beat complex shape parameters defining said first reference heart beat complex shape template.

23. The method of claim 19, wherein said first reference heart beat complex shape template is selected from one of a non-ictal heart beat complex template, an ictal heart beat complex template, and a post-ictal heart beat complex template.

24. The method of claim 19, wherein determining at least one heart beat complex shape parameter comprises using ECG data to determine a heart beat complex shape for each of a plurality of heart beat complexes in said time series, and wherein said first reference heart beat complex shape template comprises a reference non-ictal PQRST complex template.

25. The method of claim 24, wherein said first reference non-ictal PQRST complex template is a composite PQRST complex template constructed from a plurality of non-ictal PQRST complexes of said patient.

26. A method for indicating an occurrence of an epileptic seizure, comprising:

obtaining a time series of heart beat complex data from a patient;

determining at least one heart beat complex shape parameter for each of a plurality of heart beat complexes in a moving window comprising a portion of said time series;

comparing said at least one heart beat complex shape parameter for each of said plurality of heart beat complexes in said moving window to a first reference heart beat complex shape template;

indicating an occurrence of an epileptic seizure based upon a determination that a threshold fraction of said at least one heart beat complex shape parameters of said plurality of heart beat complexes in said moving window fail to match said first reference heart beat complex shape template.