Baseline processing for the detection of cardiac events

• US 8,170,653 B2
• Filed: 02/06/2009
• Issued: 05/01/2012
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., Harwood, Jonathan, Johnson, Steven R., Keenan, David
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US12/367,155
• Publication Number:
  US 20090171228A1
• Time in Patent Office: 1,180 Days
• Field of Search: 607 4- 28, 607/59, 600508-519
• US Class Current: 600/517
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002

Abstract

A system for the detection of cardiac events occurring in a human patient is provided. At least two electrodes are included in the system for obtaining an electrical signal from a patient'"'"'s heart. An electrical signal processor is electrically coupled to the electrodes for processing the electrical signal and a patient alarm means is further provided and electrically coupled to the electrical signal processor. The electrical signal is acquired in the form of electrogram segments, which are categorized according to heart rate, ST segment shift and type heart rhythm (normal or abnormal). Baseline electrogram segments are tracked over time.

Claims

1. A cardiac event detection system for detecting a cardiac event in a patient comprising:

(a) at least two electrodes for sensing an electrical signal from the patient'"'"'s heart;

(b) an implantable device coupled to said electrodes, said implantable device having an analog-to-digital circuit system contained therein for digitizing said electrical signal to produce a multiplicity of sequential temporally spaced electrical signal segments, each electrical signal segment encompassing a first time period corresponding to a plurality of PQRST waveform signals and being temporally spaced by a second time period from a sequentially adjacent electrical signal segment;

(c) a processor contained in said implantable device and electrically coupled to said electrodes, said processor configured to;

(i) determine whether an electrical signal segment qualifies as a baseline segment for one of a plurality of discrete temporally spaced time slots based on at least one heart signal parameter criterion;

(ii) compute from said plurality of PQRST waveform signals of each electrical signal segment qualifying as a baseline segment, a value of a heart signal parameter therefore and update stored baseline heart signal parameter values for corresponding time slots, (iii) compute said value of said heart signal parameter for said plurality of PQRST waveform signals of an additional electrical signal segment;

(iv) generate a statistical measure of said heart signal parameter value based on said baseline heart signal parameter values of a number of said discrete time slots;

(v) detect said cardiac event based on a comparison of said statistical measure with said value of said heart signal parameter of said additional electrical signal segment.

2. The system of claim 1, where said statistical measure is an average of said baseline heart signal parameter values.

3. The system of claim 1, where said heart signal parameter is calculated by said processor from an ST segment voltage.

4. The system of claim 3, where said heart signal parameter is calculated by said processor by computing a difference between the ST segment voltage and a PQ segment voltage.

5. The system of claim 3, where said heart signal parameter is calculated by said processor by computing an R wave amplitude, and normalizing said heart signal parameter by an R wave amplitude.

6. The system of claim 3, where said cardiac event is ischemia, and said processor is configured to detect ischemia when a difference between said ST segment voltage of said additional electrical signal segment and said statistical measure exceeds a detection threshold.

7. The system of claim 1, where said processor further includes means for assigning a predetermined heart signal parameter value to a respective time slot when corresponding electrical signal segments fail to be determined to qualify as a baseline segment and an existing baseline segment for said time slot has not been updated within a specified time period.

8. The system of claim 1, where said statistical measure is a weighted average of said baseline heart signal parameter values.

9. The system of claim 8, where said weighted average weights baseline heart signal parameter values having time slots temporally closer to a time of day of said additional electrical signal segment less heavily than baseline heart signal parameter values having time slots temporally more distant from said time of day of said additional electrical signal segment.

10. The system of claim 1, where said statistical measure is an average of said baseline heart signal parameter values that fall within a standard deviation of a distribution of said baseline heart signal parameter values.

11. A cardiac event detection system for detecting a cardiac event in a patient comprising:

(a) at least two electrodes for sensing an electrical signal from the patient'"'"'s heart;

(b) an implantable device coupled to said electrodes, said implantable device having an analog-to-digital circuit system contained therein for digitizing said electrical signal to produce a multiplicity of sequential temporally spaced segments, each segment encompassing a first time period corresponding to a plurality of PQRST waveform signals and being temporally spaced by a second time period from a sequentially adjacent segment;

(c) a processor contained in said implantable device and electrically coupled to said electrodes, said processor configured to;

(i) compute values of a heart signal parameter for said plurality of PQRST waveform signals within each of a plurality of said segments, (ii) generate a plurality of representative values of said heart signal parameter, each of said plurality of representative values being based on said plurality of values of said heart signal parameter in a respective one of said plurality of segments meeting predetermined criteria;

(iii) generate a statistical measure that is based on at least a portion of said plurality of representative values; and

(iv) applying a test to detect a cardiac event, said test being based on said statistical measure.

12. The system of claim 11, where each of the plurality of representative values is an average of a plurality of heart signal parameter values computed from said plurality of PQRST waveform signals within a corresponding segment.

13. The system of claim 11, where said statistical measure is an average of said at least a portion of said plurality of representative values.

14. The system of claim 11, where said processor is configured to acquire an additional segment and to calculate said value of said heart signal parameter of at least one PQRST waveform signal in said additional segment, and said test thereby including a comparison of said value of said heart signal parameter of said at least one PQRST waveform signal in said additional segment with said statistical measure.

15. The system of claim 11, where said cardiac event is ischemia.

16. The system of claim 15, where said heart signal parameter pertains to ST segment shift.

17. The system of claim 11, where said statistical measure is a weighted average of said plurality of representative values.

18. The system of claim 17, where said weighted average weights representative values having time slots temporally closer to a time of day of said one of said multiplicity of segments less heavily than representative values having time slots temporally more distant from said time of day of said one of said multiplicity of segments.

19. The system of claim 11, where said statistical measure is an average of said plurality of representative values that fall within a standard deviation of a distribution of said plurality of representative values.

20. A cardiac event detection system for detecting a cardiac event in a patient comprising:

(a) at least two electrodes for sensing an electrical signal from the patient'"'"'s heart;

(b) an implantable device coupled to said electrodes, said implantable device having an analog-to-digital circuit system contained therein for digitizing said electrical signal to produce a multiplicity of sequential temporally spaced electrical signal segments, each electrical signal segment encompassing a first time period corresponding to a plurality of PQRST waveform signals and being temporally spaced by a second time period from a sequentially adjacent electrical signal segment;

(c) a programmable memory having a default baseline heart signal parameter value stored therein;

(d) a processor contained in said implantable device and electrically coupled to said electrodes and said programmable memory, said processor configured to;

(i) respectively compute values of a heart signal parameter for said multiplicity of electrical signal segments from said plurality of PQRST waveform signals of each corresponding electrical signal segment;

(ii) selectively establish a number of baseline heart signal parameter values from said computed heart signal parameter values of a portion of said multiplicity of electrical signal segments;

(iii) periodically update said established baseline heart signal parameter values;

(iv) select a portion of said baseline heart signal parameter values from said established baseline heart signal parameter values, and if any of said selected baseline heart signal parameter values have not been updated within a specified time period or are unavailable, selecting said stored default baseline heart signal parameter value therefore to define a set of baseline heart signal parameter values;

(v) generate a statistical measure of said heart signal parameter value from said set of baseline heart signal parameter values to compare with said value of said heart signal parameter for another electrical signal segment;

(vi) detect said cardiac event responsive to the results of said comparison being outside at least one established criterion.