Ischemia monitoring system for patients having periods of left bundle branch block

• US 8,676,304 B2
• Filed: 06/01/2010
• Issued: 03/18/2014
• Est. Priority Date: 11/24/2009
• Status: Active Grant

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., Hopenfeld, Bruce, John, Michael Sasha, Keenan, David
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US12/791,327
• Publication Number:
  US 20110125041A1
• Time in Patent Office: 1,386 Days
• Field of Search: 600/373, 600/374, 600/481, 600/508, 600/509, 600/512, 600515-519, 600/521, 607/18, 607/25, 607/119, 607/4, 607/5, 607/9, 607/14
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1112 Global tracking of patients, e.g. by using GPS
• 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 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

A device for detecting cardiac ischemia is disclosed. The device includes a processor that is configured to distinguish between two different heart beats types such as left bundle branch block beats and normal sinus beats. The processor applies different ischemia tests to the two different beat types, and generates alert when it detects ischemia.

Claims

1. A cardiac monitoring device configured to analyze electrical signals from the heart to detect ischemic events, including:

at least one sensor designed to collect the electrical signal from the heart;

electrical circuitry coupled to the sensor and configured to amplify and digitize the electrical signal to produce sensed data;

memory storage coupled to the electrical circuitry to store the sensed data;

a processor configured to;

analyze the sensed data in the memory storage;

based on the sensed data, distinguish between sinus beats, left bundle branch block beats and other types of beats, and measure at least one feature of beats associated with sinus beats and left bundle branch block beats during a predetermined time interval, respectively; and

detect the presence or absence of an ischemic event by applying a first ischemia detection criterion to the sinus beat measured feature and a second ischemia detection criterion to the left bundle branch block measured feature dependent upon a number of sinus beats and left bundle branch block beats during said predetermined time interval;

wherein (1) when said number of left bundle branch block beats are less than a first threshold value, then apply said first ischemia detection criterion to said sinus beat measured feature, (2) when said number of left bundle branch block beats are greater than a second threshold value, then apply said second ischemia detection criterion to said left bundle branch block measured feature, and (3) when said number of left bundle branch block beats and said sinus beats are greater than a third threshold value, respectively then apply said first and second ischemic detection criteria to both said left bundle branch block measured feature and said sinus beat measured feature.

2. The device of claim 1, wherein the processor is configured to distinguish other types of beats from both sinus and left bundle branch block beats by computing the value of a heart signal parameter associated with an early portion of a QRS complex and comparing the value of the heart signal parameter to an expected value that applies to both sinus and left bundle branch beats.

3. The device of claim 2 wherein the heart signal parameter is a function of one of:

Q wave amplitude, Q wave slope, R wave amplitude, R wave slope, or duration between the Q and R waves.

4. The device of claim 1, wherein the processor is configured to distinguish between sinus and left bundle branch block beats by computing the value of a heart signal parameter associated with a late portion of a QRS complex and comparing the value of the heart signal parameter to an expected value that applies to sinus beats exclusively or left bundle branch beats exclusively.

5. The device of claim 4 wherein the heart signal parameter is a function of one of:

S wave slope, ratio of S wave slope to R wave slope, duration between the R and S waves, or duration of the S wave.

6. The device of claim 5 wherein the duration of the S wave is a function of the time between the minimum slope of the S wave and the time the QRS slope reaches a threshold.

7. The device of claim 6 wherein the threshold is a specified percentage of the minimum S wave slope.

8. The device of claim 6 wherein the threshold is a specified percentage of a measure of signal amplitude.

9. The device of claim 1, wherein an ischemic event is detected when the number of detected ischemic beats which occur within a time interval exceeds a pre-set threshold.

10. The device of claim 1, wherein a calculation performed upon detected ischemic beats which occurred within an interval of sensed data is used to score the interval in relation to detection of medically relevant ischemic event.

11. The device of claim 1, wherein the processor is configured to detect an ischemic event only when a sufficient number beats of sinus or left bundle branch block beats exist within a specified interval.

12. The device of claim 1, wherein the measured feature associated with sinus beats is the same as the measured feature associated with left bundle branch beats.

13. The device of claim 12 wherein the measured feature pertains to ST-segment amplitude.

14. The device of claim 1, wherein at least one of the ischemia detection criteria is modified as a function of heart rate.

15. The device of claim 1, wherein the processor is configured to apply the first ischemia detection criteria for sinus beats by evaluating the difference between the sinus beat measured feature and a reference value calculated for sinus beats.

16. The device of claim 1, wherein the processor is configured to apply the first ischemia detection criteria for left bundle branch beats by evaluating the difference between the left bundle branch beat measured feature and a reference value calculated for left bundle branch beats.

17. The device of claim 1, further containing alerting means for alerting when ischemic events are detected.

18. The device of claim 1 further comprising a wireless communication subsystem coupled to the processor, wherein the processor is configured to activate the wireless communication system upon detecting an ischemic event.

19. The device of claim 1 wherein the processor is further configured to collect data from the digital signals for sinus beats and left bundle branch block beats and to derive corresponding reference baselines of the measured feature for sinus beats and the measured feature for left bundle branch block beats, and wherein the ischemia criteria for sinus beats and left bundle branch block beats are based at least in part on the reference baselines for the sinus beats and left bundle branch block beats, respectively.

20. The device of claim 1 wherein the processor is further configured to collect data from the digital signals for sinus beats and left bundle branch block beats and to derive corresponding reference data of the measured feature for sinus beats and the measured feature for left bundle branch block beats, and wherein the ischemia criteria for sinus beats and left bundle branch block beats are based at least in part on the reference data for the sinus beats and left bundle branch block beats, respectively.