Means and method for the detection of cardiac events

• US 7,844,323 B2
• Filed: 06/22/2007
• Issued: 11/30/2010
• 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., Fischell, Robert E., Johnson, Steven R., Harwood, Jonathan, Fischell, Tim A.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/812,827
• Publication Number:
  US 20070249947A1
• Time in Patent Office: 1,257 Days
• Field of Search: 607 4- 28, 600508-519
• US Class Current: 600/517
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• 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
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician'"'"'s programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient'"'"'s electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Claims

1. A system for identifying an ischemic event in a human patient including:

at least two electrodes implanted in the patient for obtaining an electrical signal from the patient'"'"'s heart;

an implanted device including;

(a) analog-to-digital converter circuitry for digitizing the electrical signal to produce a multiplicity of segments, each having a duration of least 1 second, each of the periods between successive segments being at least as long as the segment duration;

(b) memory means designed to store a first segment at a first predetermined time;

(c) memory means designed to store a recently collected segment at a second time that is later than the first predetermined time;

(d) processor means coupled to said memory means for comparing the ST segment voltage of at least one beat of the recently collected segment at the second time with the average ST segment voltage of at least two beats of the first segment stored in the memory means at the first predetermined time; and

,

(e) means for identifying that the ischemic event has occurred by applying a test that is based on whether the difference between the ST segment voltage of the at least one beat of the recently collected segment and the average ST segment voltage of the at least two beats of the first segment exceeds a detection threshold, wherein the detection threshold is a preset percentage of the average signal amplitude of the at least two beats of the first segment.

2. The system of claim 1 where the average signal amplitude of the at least two beats of the first segment is the R wave peak voltage minus the average PQ segment voltage averaged over the at least two beats of the first segment.

3. The system of claim 1 where the average signal amplitude of the at least two beats of the first segment is the average peak-to-peak, R-to-S, signal amplitude of the at least two beats of the first segment.

4. The system of claim 1 where the average signal amplitude of the at least two beats of the first segment is the difference between the average PQ segment voltage and the peak S wave voltage averaged over the at least two beats of the first segment.

5. The system of claim 1 where the average signal amplitude of the at least two beats of the first segment is the larger of the R wave to PQ segment voltage difference or the PQ segment to S wave voltage difference.

6. The system of claim 1 wherein the first segment is a baseline segment.

7. The system of claim 1 wherein the test is based on whether the difference between the ST segment voltage of at least one beat of within a plurality of recently collected segments and the average ST segment voltage of the at least two beats of the first segment exceeds the detection threshold.

8. The system of claim 1 wherein the processor is configured to compute the difference between the ST segment voltage of a plurality of beats within the current electrogram segment and the average ST segment voltage of the at least two beats of the first segment, thereby generating a plurality of ST shifts, and wherein the test is based on the number of the plurality of ST shifts that exceed the detection threshold.

9. The system of claim 1 wherein the ST segment voltage is computed relative to PQ segment voltage.

10. A system for identifying an ischemic event in a human patient including:

at least two electrodes implanted in the patient for obtaining an electrical signal from the patient'"'"'s heart;

an implanted device including;

(a) analog-to-digital converter circuitry for digitizing the electrical signal;

(b) a memory;

(c) a processor configured to;

(i) compute ST segment deviation of a first plurality of beats within the electrical signal;

(ii) compute a measure of QRS amplitude for the first plurality of beats;

(iii) compute ST segment deviation of a second plurality of beats within the electrical signal, wherein the second plurality of beats occur after the first plurality of beats;

(iv) compute a measure of the difference between the ST segment deviations of the first plurality of beats and the ST segment deviations of the second plurality of beats;

(v) apply an ischemia detection test that is based on a comparison of the measure of the difference and a threshold, wherein the test is further based on the measure of QRS amplitude of the first plurality of beats.

11. The system of claim 10 wherein the threshold is a preset percentage effectively multiplied by the measure of QRS amplitude.

12. The system of claim 11 wherein the processor computes the threshold by multiplying the preset percentage by the measure of QRS amplitude.

13. The system of claim 10 wherein the difference between the ST segment deviations of the first plurality of beats and the ST segment deviations of the second plurality of beats is computed separately for each of the second plurality of beats, thereby generating a plurality of ST shifts, and wherein the ischemia test is based on the number of said plurality of ST shifts that exceed the threshold.

14. The system of claim 10 wherein the processor is further configured to separate the electrical signal into a plurality of segments, each of the plurality of segments having a time duration of least 1 second, each of the periods between successive segments being at least as long as the segment duration, and wherein the second plurality of beats is distributed across a plurality of segments.

15. The system of claim 14 wherein each of the plurality of segments is categorized as ischemic or non-ischemic, and wherein the test is positive for ischemia when a plurality of consecutive segments are categorized as ischemic.

16. The system of claim 15 wherein the difference between the ST segment deviations of the first plurality of beats and the ST segment deviations of the second plurality of beats is computed separately for each of the second plurality of beats, thereby generating a plurality of ST shifts, and wherein a segment is classified as ischemic or non-ischemic according to the number of ST shifts within the segment that exceed the threshold.