Method, apparatus and system for validating and quantifying cardiac beat data quality

• US 9,750,448 B2
• Filed: 09/08/2014
• Issued: 09/05/2017
• 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): Alter, Alyssa M
• Application Number:
  US14/480,406
• Publication Number:
  US 20140378851A1
• Time in Patent Office: 1,093 Days
• Field of Search: 607 45
• 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 medical device system, comprising:

a cardiac data collection module capable of collecting cardiac data comprising a fiducial time marker for each of a plurality of candidate heart beats in a first time series;

a heart beat test module capable of performing a plurality of beat validity tests on each of said plurality of candidate heart beats in said first time series;

a beat quality index module capable of determining a beat quality index value for each of said plurality of candidate heart beats, wherein the beat quality index value is based on the result of each beat validity test performed on the candidate heart beat;

at least one responsive action module capable of performing at least one responsive action based upon an output of said beat quality index module, the at least one responsive action module selected from the group consisting of;

a storage unit capable of storing a time series of beat quality index values;

an event detection module capable of detecting at least one of an epileptic seizure event or an increased risk of an epileptic seizure event;

a neurostimulation unit capable of applying a neurostimulation therapy to the patient; and

a warning unit capable of providing a warning to at least one of a caregiver, the patient, or a physician based on an output of said beat quality index module.

2. The medical device system of claim 1, further comprising at least one sensor capable of receiving at least one signal related to a body parameter of a patient;

and wherein said cardiac data collection module is capable of collecting cardiac data from said at least one signal.

3. The medical device system of claim 1, wherein said event detection module is capable of detecting an epileptic seizure event based on a first heart rate parameter determined from candidate heart beats in a first window, and a second heart rate parameter determined from candidate heart beats in a second window.

4. The medical device system of claim 1, wherein said neurostimulation unit is capable of:

initiating a programmed neurostimulation therapy; and

modifying a programmed neurostimulation therapy to obtain a second neurostimulation therapy and applying said second neurostimulation therapy to a target neural structure.

5. The medical device system of claim 1, wherein the at least one responsive action module is capable of modifying an earlier responsive action based upon an output of said beat quality index module.

6. The medical device system of claim 1, further comprising a library of beat validity tests, and wherein said heart beat test module is configured to implement at least one of said plurality of beat validity tests selected from said library of beat validity tests.

7. The medical device system of claim 1, wherein said storage unit is capable of storing beat quality index values for said plurality of candidate heart beats in said first time series as a second time series.

8. The medical device system of claim 1, wherein the beat quality index module is capable of:

setting the value of the beat quality index for a first candidate heart beat to a first integer value;

adjusting said value of the beat quality index for a first candidate heart beat to a second value, wherein adjusting comprises adding 1 to the first integer value, based on the heart beat test module performing at least one of;

a) determining that the interbeat interval falls within a range of physiologically plausible interbeat intervals;

b) determining that the interbeat interval is less than an upper interbeat interval threshold;

c) determining that the interbeat interval is greater than a lower interbeat interval threshold;

or

d) determining that a slope of change between the interbeat interval and one or more preceding interbeat intervals falls within a range of physiologically plausible slopes of change.

9. The medical device system of claim 1, further comprising:

setting the value of the beat quality index for a first candidate heart beat to a first integer value;

adjusting said value of the beat quality index for said first candidate heart beat to a second value, wherein adjusting comprises adding 1 to the first integer value, based on the window analysis module performing at least one of;

a) determining that a dispersion of the candidate heart beats in said window is less than or equal to a predetermined dispersion threshold;

or

b) testing whether said window contains a sufficient number of candidate heart beats determined to be within a range of physiologically plausible heart beats.

10. The medical device system of claim 1, wherein said neurostimulation unit is configured to apply vagus nerve stimulation therapy to said patient.

11. The medical device system of claim 1, wherein said heart beat test module comprises an interbeat interval module capable of determining an interbeat interval for a plurality of candidate heart beats in said first time series, based upon the fiducial time marker for the candidate heart beat and the fiducial time marker for a prior candidate heart beat.

12. The medical device system of claim 1, further comprising a heart beat validity module capable of determining whether a candidate heart beat is a valid heart beat based on the beat quality index value for the candidate heart beat.

13. The medical device system of claim 1, further comprising a window analysis module capable of performing a dispersion test on a plurality of heart beats in a window, wherein said window comprises one of a time window, a number of beats window, or an exponentially forgetting window having a first timescale.

14. The medical device system of claim 13, wherein said window is a backward-looking window comprising a plurality of candidate heart beats, wherein each candidate heart beat in the window has a beat quality index value exceeding a first threshold.

15. The medical device system of claim 13, wherein said event detection module is capable of determining the occurrence of an epileptic seizure event based upon a first heart rate parameter determined from candidate heart beats in a first window, and a second heart rate parameter determined from candidate heart beats in a second window.

16. The medical device system of claim 1, further comprising a window analysis module capable of determining a window beat quality index, said window beat quality index comprising a statistical measure of central tendency of individual beat quality indices for the candidate heart beats in said window.

17. A medical device system, comprising:

a cardiac data collection module capable of collecting cardiac data comprising a fiducial time marker for each of a plurality of candidate heart beats in a first time series;

a heart beat test module capable of performing a plurality of beat validity tests on each of said plurality of candidate heart beats in said first time series;

a beat quality index module capable of determining a beat quality index value for each of said plurality of candidate heart beats, wherein the beat quality index value is based on the result of each beat validity test performed on the candidate heart beat;

an event detection module capable of detecting an epileptic seizure event based on a first heart rate parameter determined from candidate heart beats in a first window, and a second heart rate parameter determined from candidate heart beats in a second window; and

at least one responsive action module capable of performing at least one responsive action based upon an output of said event detection module, the at least one responsive action module selected from the group consisting of;

a storage unit capable of storing a time series of beat quality index values;

a neurostimulation unit capable of applying a neurostimulation therapy to the patient; and

a warning unit capable of providing a warning to at least one of a caregiver, the patient, or a physician based on an output of said beat quality index module.

18. The medical device system of claim 17, wherein said neurostimulation unit is capable of:

initiating a programmed neurostimulation therapy; and

modifying a programmed neurostimulation therapy to obtain a second neurostimulation therapy and applying said second neurostimulation therapy to a target neural structure.

19. A medical device system, comprising:

a cardiac data collection module capable of collecting cardiac data comprising a fiducial time marker for each of a plurality of candidate heart beats in a first time series;

a heart beat test module capable of performing a plurality of beat validity tests on each of said plurality of candidate heart beats in said first time series;

a beat quality index module capable of determining a beat quality index value for each of said plurality of candidate heart beats, wherein the beat quality index value is based on the result of each beat validity test performed on the candidate heart beat;

an event detection module capable of detecting an epileptic seizure event based on a first heart rate parameter determined from candidate heart beats in a first window, and a second heart rate parameter determined from candidate heart beats in a second window; and

a neurostimulation unit capable of applying a neurostimulation therapy to the patient, based upon an output of said event detection module.

20. The medical device system of claim 19, further comprising at least one responsive action module capable of performing at least one responsive action based upon an output of said event detection module, the at least one responsive action module selected from the group consisting of:

a storage unit capable of storing a time series of beat quality index values; and

a warning unit capable of providing a warning to at least one of a caregiver, the patient, or a physician based on an output of said beat quality index module.