Cardiac monitoring system for paced patients having paced and non-paced ischemia detection thresholds

• US 8,275,457 B1
• Filed: 11/24/2009
• Issued: 09/25/2012
• 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., John, Michael Sasha, Hopenfeld, Bruce, Keenan, David
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/624,496
• Time in Patent Office: 1,036 Days
• Field of Search: 607/9, 607/25
• US Class Current: 607/9
• 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 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/63 for local operation

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 ventricularly paced beats and supraventricular 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 for analyzing 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;

distinguish between beat types including a first beat type and a second beat type and measure at least one feature of beats associated with the first and second beat types, respectively; and

determine a first ischemic measure based upon a first number of beats of the first beat type, if said first ischemic measure is less than a first predetermined value then determining a second ischemic measure based upon a second number of beats of the second beat type, and if said second ischemic measure is less than a second predetermined value, then determining a third ischemic measure based upon the sum of the first and second ischemic measures, and if said first, second or third ischemic measures are greater than respective first, second or third predetermined values sending an alarm signal.

2. The device of claim 1, wherein the first beat type has a supraventricular origin and the second beat type is a beat paced in at least one ventricle.

3. The device of claim 2, further comprising a communication subsystem that is configured for communication with a second device having heart pacing capability, and wherein said processor is configured to distinguish between ventricularly paced and supraventricular beats by examining paced beat timing data received through the communication subsystem to determine when ventricularly paced beats occurred.

4. The device of claim 2, wherein a beat is identified as a ventricularly paced beat only if its associated R-R interval is within a predetermined range.

5. The device of claim 1, wherein the processor is configured to distinguish between first and second beat types is done by analyzing the sensed data.

6. The device of claim 1 further including heart pacing circuitry.

7. The device of claim 6, wherein the processor is configured to determine when a pacing pulse has been captured and to maintain a pacing capture record for captured pacing pulses, and wherein the processor is configured to distinguish between supraventricular beats and ventricularly paced beats by examining the pacing capture record.

8. The device of claim 1, wherein an ischemic event is detected when the number of detected ischemic first, second and third ischemic measures occurring within a time interval exceeds a pre-set threshold.

9. The device of claim 1, wherein a calculation performed upon said first and second beat types occurring within an interval of sensed data is used to score the interval in relation to detection of a medically relevant ischemic event.

10. The device of claim 1, wherein the processor is configured to detect an ischemic event only when a sufficient number beats of the first or second beat types exist within a specified interval.

11. The device of claim 10, wherein the first feature involves the determination of a first time interval that is different for first and second beat types, respectively.

12. The device of claim 11, wherein the first feature is a measurement of ST-segment amplitude, and wherein the first time interval is an offset from a QRS fiducial point.

13. The device of claim 12, wherein the ST-segment is measured at a plurality of samples defined by a second time interval, and wherein the second time interval is different for said first and second beat types, respectively.

14. The device of claim 1, wherein a first feature measured for first type beats is measured differently than a corresponding feature measured for second type beats.

15. The device of claim 1, wherein the measured feature associated with said first beat types is the same as the measured feature associated with said second beat types.

16. The device of claim 15 wherein the measured feature associated with said first and second beat types pertains to ST-segment amplitude.

17. The device of claim 1, wherein at least one of the ischemia detection criteria defined by said first, second and third ischemic measures is modified as a function of heart rate.

18. The device of claim 1, wherein the processor is configured to apply a first ischemia detection criteria defined by said first ischemic measure for said first beat type by evaluating the difference between the first beat type measured feature and a reference value calculated for the first beat types.

19. The device of claim 1, wherein the processor is configured to apply a first ischemia detection criteria defined by said first ischemic measure for said second beat types by evaluating the difference between the second beat type measured feature and a reference value calculated for second beat types.

20. The device of claim 1, wherein the processor is further configured to apply data acceptance criteria to sensed data and to reject sensed data that does not meet the data acceptance criteria.

21. The device of claim 1, further containing alerting means for alerting when said first, second or third ischemic measures are greater than respective first, second or third predetermined values.

22. 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 defined by said first, second and third ischemic measures.

23. The device of claim 1 wherein the first ischemia measure is determined by applying a first ischemia detection criterion separately to each of a plurality of beats, thereby determining a number of beats of the first beat type that are classified as ischemic, and wherein the first ischemia measure is equal to the number of beats of the first beat type that are classified as ischemic.

24. The device of claim 1 wherein the third ischemia measure is equal to the sum of the first and second ischemia measures, and wherein the ischemia test is performed by comparing the third ischemia measure with a threshold.