Pacemaker enabled ischemia detection with selective ischemia tests

• US 8,903,487 B1
• Filed: 11/24/2009
• Issued: 12/02/2014
• Est. Priority Date: 11/24/2009
• Status: Expired due to Fees

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., John, Michael Sasha, Hopenfeld, Bruce
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US12/624,521
• Time in Patent Office: 1,834 Days
• Field of Search: 607/9, 607/25
• US Class Current: 607/9
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• 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 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; 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 ventricularly paced beats and supraventricular beats. The processor collects separate reference data for a first one of the beat types indicative of the normal values of a cardiac feature. The processor performs an ischemia test to beats of the first type by first checking whether valid reference data exists for that beat type. If so, the ischemia test is based on this reference data. If no valid reference data exists for the first beat type, the processor applies an ischemia test that is not based on reference data for the first beat type.

Claims

1. An implantable device to detect ischemic events, including:

at least one electrode adapted for implantation in a body;

circuitry coupled to the electrode to sense signals therefrom and to generate corresponding digital signals;

a processor configured to;

identify beats in the digital signals associated with a first beat type and a second beat type;

analyze the digital signals to collect reference data for the first beat type and the second beat type to determine a first beat baseline and a second beat baseline, wherein the reference data pertains to a first heart signal parameter;

measure from the digital signals a plurality of values of the first heart signal parameter for a plurality of beats of the first and second beat types;

determine a number of heart signal parameter values existing for the first beat type;

determine whether the number of heart signal parameter values for the first beat type is greater than a predetermined threshold value, said predetermined threshold value defining valid reference data;

operative when valid reference data exists for the first beat type, apply a first ischemia test that is based at least in part on a comparison of the plurality of values of the first heart signal parameter with said first beat baseline associated with the reference data for the first beat type; and

operative when valid reference data does not exist for the first beat type, apply a second ischemia test to the plurality of beats of the first beat type, said second ischemia test being based upon said second beat baseline.

2. The implantable device of claim 1 wherein the second ischemia test is applied to the plurality of values of the first heart signal parameter.

3. The implantable device of claim 2 wherein the second ischemia test is based at least in part on the time rate of change of the first heart signal parameter.

4. The implantable device of claim 1 wherein the processor is further configured to analyze the digital signals to collect reference data for the second beat type, and wherein the second ischemia test is based at least in part on a comparison of the plurality of values of the first heart signal parameter with said second beat measure associated with the reference data for the second beat type.

5. The device of claim 4 wherein the application of the second ischemia test is based on reference data for a second beat type that has been corrected with a correction factor to compensate for differences between the first and second beat types.

6. The implantable device of claim 1 wherein the first beat baseline of the reference data associated with the first beat type is an average of normal values of the first heart signal parameter over at least one predetermined time.

7. The implantable device of claim 6 wherein each of the plurality of values of the first heart signal parameter is compared separately to the average of normal values of the first heart signal parameter.

8. The device of claim 1 wherein the first beat type corresponds to supraventricular beats, and wherein the processor is configured to determine, at least in part, whether valid reference data exists for supraventricular beats by assessing the length of time that a sinus rhythm has been prevalent.

9. The device of claim 1 wherein the first beat type corresponds to paced beats, and wherein the processor is configured to determine, at least in part, whether valid reference data exists for paced beats by assessing the length of time that a paced rhythm has been prevalent.

10. The device of claim 1 wherein the processor is further configured to determine, at least in part, whether valid reference data exists by computing an amount of time that has elapsed since the reference data was collected.

11. The device of claim 1 wherein the first heart signal parameter pertains to the ST segment.

12. The device of claim 1 wherein the first ischemia test is adjusted as function of heart rate.

13. The device of claim 1 wherein the first and second beat types are associated with supraventricular beats and ventricularly paced beats, respectively, and wherein the first ischemia test is adjusted as function of how long a supraventricular rhythm has occurred since the last period during which a ventricularly paced rhythm lasted for longer than a specified duration.

14. The device of claim 1 wherein the first ischemia test involves the application of ischemia detection threshold values which are based upon the outcome of the comparison indicating a positive change or a negative change, and wherein the values are different for the two types of changes.

15. The device of claim 1 wherein the comparison of the plurality of values of the first heart signal parameter with a measure associated with the reference data is performed by separately comparing each of the plurality of values of the first heart signal parameter with the measure.

16. The device of claim 1 wherein the measure associated with the reference data is an average value of the reference data.