Ischemia detection systems for paced-patients having three different detection modes

• US 8,452,404 B1
• Filed: 11/24/2009
• Issued: 05/28/2013
• 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, Keenan, David
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Flory, Christopher A
• Application Number:
  US12/624,506
• Time in Patent Office: 1,281 Days
• Field of Search: 600/509, 600/510, 607/9, 607/28
• US Class Current: 607/28
• 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 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

A device for detecting cardiac ischemia is disclosed. The device includes a processor that is configured to operate in three different modes according to relative frequency of different beat types. If beats of a first beat type, such as ventricularly paced beats, are predominant, the processor ignores other beat types and performs ischemia detection only on ventricularly paced beats. Conversely, if beats of a second beat type, such as sinus or atrially paced beats, are predominant, the processor ignores ventricularly paced beats and performs ischemia detection only on sinus or atrially paced beats. If there is a mixture of beat types such that neither predominates, the processor performs ischemia detection on both beat types.

Claims

1. An implantable medical device including:

at least one electrode adapted to be located within the heart to sense an electrical signal from the heart;

electrical circuitry configured to amplify and digitize the electrical signal;

memory storage coupled to the electrical circuitry for storing the digitized electrical signal;

a processor configured to;

distinguish between supraventricular beats and ventricularly paced beats;

identify which of at least three pacing modes of operation is active at any time, wherein a first pacing mode is identified when the number of ventricularly paced beats is sufficiently small to meet a first criterion and ischemic event is identified based on supraventricular beats, wherein a second pacing mode is identified when the number of supraventricular beats is sufficiently small to meet a second criterion and ischemic event is identified based on ventricularly paced beats, and a third pacing mode is identified when the number of ventricularly paced beats and the number of supraventricular beats are large that neither the first nor the second criteria are met and ischemic event is identified as a function of supraventricular beats and ventricularly paced beats;

identify ischemic events by implementing an ischemia detection protocol specific to that mode, and applying the ischemia detection protocol to the digitized electrical signal.

2. The device of claim 1 wherein the ischemia detection protocol for the first mode of pacing processes only supraventricular beats and ignores ventricularly paced beats.

3. The device of claim 2 wherein the processor is further configured to:

calculate a baseline value from supraventricular beats processed over an earlier time period;

detect ischemia by comparing the ST segment of the supraventricular beats to a baseline value.

4. The device of claim 1 wherein the ischemia detection protocol for the second mode of pacing processes only ventricularly paced beats and ignores supraventricular beats.

5. The device of claim 4 wherein the processor is further configured to:

calculate a baseline value from ventricular paced beats processed over an earlier time period;

detect ischemia by comparing the ST segment of the ventricularly paced beats to a baseline value.

6. The device of claim 4 wherein the processor is further configured to detect ischemia by comparing the ST segment of the ventricularly paced beats to a paced beat reference value.

7. The device of claim 4 wherein the processor is further configured to detect ischemia by comparing the ST segment of the ventricularly paced beats to a non-paced beat reference value that is adjusted by a correction factor to compensate for an estimated difference in the reference values of paced and non-ventricularly paced beats.

8. The device of claim 1 wherein the ischemia detection protocol for the third mode of pacing includes a comparison of current data during periods of pacing and non-pacing when no ischemia was detected to reference data collected during periods of pacing and non-pacing when no ischemia was detected.

9. The device of claim 1 wherein for the third mode of pacing an ischemic event is identified in the ischemia detection protocol when the number of ischemic ventricularly paced beats within a pre-set period of time exceeds a threshold for ischemic ventricularly paced beats.

10. The device of claim 1 wherein for the third mode of pacing an ischemic event is identified in the ischemia detection protocol when the number of ischemic non-paced beats within a pre-set period of time exceeds a threshold for ischemic non-paced beats.

11. The device of claim 1 wherein for the third mode of pacing an ischemic event is identified in the ischemia detection protocol when the number of ischemic ventricularly paced beats plus the number of ischemic non-paced beats within a pre-set period of time exceeds at least one threshold defined to detect ischemic beats.

12. The device of claim 1 wherein the processor is further configured to identify pacing mode transitions which are determined when the pacing mode which is currently active is different than the pacing mode which was active within a prior defined period.

13. The device of claim 1 wherein the processor is configured to identify pacing mode transitions based on a change in the proportion of ventricularly paced beats and supraventricular beats.

14. The device of claim 1 wherein the processor is configured to determine whether the second pacing mode is active, and operative upon a determination that the second pacing mode is active, to determine whether there are a sufficient number of ventricularly paced beats, and operative upon a determination that the there are an insufficient number of ventricularly paced beats, then causing the device to provide pacing in order to obtain a sufficient number of ventricularly paced beats to allow ischemia detection to occur.

15. The device of claim 1 wherein the processor is configured to determine whether there are a sufficient number of sinus and ventricularly paced beats, respectively, when operating in the first and second modes, respectively, and to delay ischemia detection until a sufficient number of sinus or ventricularly paced beats, respectively, are detected.

16. The device of claim 2 wherein ischemia is identified by comparing the ST segment of the supraventricular beats to a non-paced reference value.

17. The device of claim 1 wherein at least one ischemia detection criterion for each of the three modes is specific to the corresponding mode.