Validity test adaptive constraint modification for cardiac data used for detection of state changes

• US 9,468,761 B2
• Filed: 02/10/2014
• Issued: 10/18/2016
• Est. Priority Date: 04/29/2010
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Frei, Mark G, Osorio, Ivan
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/177,066
• Publication Number:
  US 20140155772A1
• Time in Patent Office: 981 Days
• US Class Current: 1/1
• 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 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Methods, systems, and apparatus for quantifying the quality of a fiducial time marker for a candidate heart beat, quantifying the quality of a candidate heart beat, or determining a time of beat sequence of the patient'"'"'s heart. A fiducial time marker is obtained for a candidate heart beat. A quality index of said candidate heart beat is set to a first value. The candidate heart beat is tested with at least one beat validity test. At least a second value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least one beat validity test. The candidate heart beat is tested with at least a second heart beat validity test. At least a third value is added to said quality index of said candidate heart beat if said candidate heart beat passes said at least second heart beat validity test. In one class of beat validity test, a constraint defining a pass is modified at one or more times after the most recent prior valid heart beat that is greater than a constraint modification time threshold.

Claims

1. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for determining a time of beat sequence of the patient'"'"'s heart, comprising:

obtaining a time series of fiducial time markers for candidate heart beats;

identifying valid heart beats from said candidate heart beats by subjecting a plurality of said candidate heart beats to at least one beat validity test, said at least one beat validity test comprising at least one interbeat interval test applied to a candidate heart beat interval derived from a candidate heart beat and at least one prior heart beat;

accepting as accepted valid heart beats the candidate heart beats that pass said at least one beat validity test, wherein a constraint used in defining said pass is modified after a time period since the most recent prior valid heart beat reaches or exceeds a constraint modification time threshold;

detecting an epileptic seizure using a seizure detection algorithm based on said accepted valid heart beats; and

performing at least one responsive action selected from the group consisting of

issuing a detection for an epileptic seizure event;

delivering a neurostimulation therapy to the patient to treat an epileptic seizure event;

warning at least one of a caregiver, the patient, or a physician; and

logging said modified constraint to a memory.

2. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified by relaxing said constraint by from 1% to 50%.

3. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified by relaxing said constraint by greater than 50%.

4. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified by tightening said constraint by greater than 1%.

5. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified once after the constraint modification time threshold is passed.

6. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified a plurality of times after the constraint modification time threshold is passed.

7. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified according to a step function at one or more times after the constraint modification time threshold is passed.

8. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified according to a linear function over a range of times after the constraint modification time threshold is passed.

9. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified according to a non-linear function over a range of times after the constraint modification time threshold is passed.

10. The non-transitory computer readable program storage unit of claim 1, wherein the constraint is modified to no more than a finite maximum value or no less than a finite minimum value.

11. The non-transitory computer readable program storage unit of claim 1, wherein said fiducial time markers are selected from one or more of:

a time-stamped R-wave peak;

a time-stamped R-wave threshold crossing;

a time-stamped P-wave peak;

a time-stamped P-wave threshold crossing;

a time-stamped T-wave peak;

or

a time-stamped T-wave threshold crossing.

12. A method, comprising:

applying a beat validity test to a prior candidate heart beat comprising at least a first fiducial marker;

identifying, in response to said prior candidate heart beat failing said beat validity test, a plurality of candidate heart beats in a first time window, wherein said plurality of candidate heart beats comprises a second fiducial marker for a most recent candidate heart beat and at least said first fiducial marker for said prior candidate heart beat;

applying a first beat validity test to each said candidate heart beat, said a least one first beat validity test comprising at least one interbeat interval test applied to a candidate heart beat interval derived from a third fiducial marker for the candidate heart beat and a fourth fiducial marker for an immediately preceding candidate heart beat;

accepting said most recent candidate heart beat as a valid heart beat if said most recent candidate heart beat passes said at least one beat validity test;

detecting an epileptic seizure using a seizure detection algorithm based on said accepted valid heart beat; and

performing at least one responsive action selected from the group consisting of

issuing a detection for an epileptic seizure event;

delivering a neurostimulation therapy to the patient to treat an epileptic seizure event;

warning at least one of a caregiver, the patient, or a physician; and

logging said modified constraint to a memory.

13. The method of claim 12, wherein said fiducial marker is a fiducial time marker.

14. The method claim 13, wherein said fiducial marker is at least one of:

a time stamped R-wave peak;

a time stamped R-wave threshold crossing;

a time stamped P-wave peak;

a time stamped P-wave threshold crossing;

a time stamped T-wave peak;

or

a time stamped T-wave threshold crossing.

15. The method of claim 12, wherein the method further comprises modifying a constraint used in defining said pass after a time period since a most recent prior valid heart beat reaches or exceeds said constraint modification time threshold.

16. The method of claim 15, wherein the constraint is modified a plurality of times after the constraint modification time threshold is reached or exceeded.

17. A non-transitory computer readable program storage unit encoded with instructions that, when executed by a computer, perform a method for determining a time of beat sequence of the patient'"'"'s heart, comprising:

obtaining a time series of fiducial markers for candidate heart beats, wherein said time series comprises a first fiducial marker for a most recent candidate heart beat and at least a second fiducial marker for a prior candidate heart beat;

subjecting at least said most recent candidate heart beat to at least one beat validity test, said at least one beat validity test comprising at least one interbeat interval test applied to a most recent candidate heart beat interval derived from the most recent candidate heart beat and at least one prior candidate heart beat;

performing at least one of

accepting said most recent candidate heart beat as a valid heart beat if said most recent candidate heart beat passes said at least one beat validity test, and

rejecting said most recent candidate heart beat to provide a rejected most recent candidate heart beat if said most recent candidate heart beat does not pass said at least one beat validity test;

using said valid heart beat accepted when said most recent candidate heart beat passed said at least one beat validity test in a seizure detection algorithm; and

in response to a seizure detection by said seizure detection algorithm, performing at least one responsive action selected from the group consisting of

issuing a detection for an epileptic seizure event;

delivering a neurostimulation therapy to the patient to treat an epileptic seizure event;

warning at least one of a caregiver, the patient, or a physician; and

logging said modified constraint to a memory.

18. The non-transitory computer readable program storage unit of claim 17, wherein the fiducial marker is at least one of a time marker, an R-wave threshold crossing, an R-wave peak, a T-wave threshold crossing, a T-wave peak, a P-wave threshold crossing, or a P-wave peak.

19. The non-transitory computer readable program storage unit of claim 17, wherein the method further comprises modifying said constraint after a time period since a most recent prior valid heart beat reaches or exceeds said constraint threshold time.

20. The non-transitory computer readable program storage unit of claim 19, wherein the constraint is modified a plurality of times after the constraint modification time threshold is reached or exceeded.