Method and apparatus for detecting arrhythmias in a medical device

• US 7,907,993 B2
• Filed: 04/28/2006
• Issued: 03/15/2011
• Est. Priority Date: 03/29/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Greenhut, Saul E., Kleckner, Karen J., Mahajan, Veerdhaval, Krause, Paul G., Ghanem, Raja N., Stadler, Robert W., Zhang, Xusheng
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/380,794
• Publication Number:
  US 20070270704A1
• Time in Patent Office: 1,782 Days
• Field of Search: 600/509, 600/512, 600/515, 600/516, 600/521, 600/505, 607/5, 607/14
• US Class Current: 600/512
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• 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 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• 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: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: Y10S 128/901 Suppression of noise in electric signal
• CPC Class Codes: Y10S 128/902 Biological signal amplifier

Abstract

A method of detecting a cardiac event in a medical device that includes sensing cardiac signals from a plurality of electrodes forming a first sensing vector and a second sensing vector, and determining first heart rate estimates associated with cardiac signals sensed from the first sensing vector and cardiac signals sensed from the second sensing vector in response to a metric of heart rate associated with the sensed cardiac signals. Second heart rate estimates associated with the first sensing vector and with the second sensing vector are generated in response to the determined first heart rate estimates, and a determination is made as to whether both of the second heart rate estimates are greater than a predetermined heart rate threshold.

Claims

1. A method of detecting a cardiac event of a cardiac signal generated by a heart of a patient with a medical device having a plurality of electrodes forming a first sensing vector and a second sensing vector, comprising the steps of:

sensing data representative of the cardiac signal with the plurality of electrodes;

determining a first heart rate estimate associated with data representative of the cardiac signal sensed from the first sensing vector and a second heart rate estimate associated with data representative of the cardiac signal sensed from the second sensing vector, wherein the data representative of the cardiac signal sensed from the first sensing vector is sensed, at least in part, concurrently with the data representative of the cardiac signal sensed from the second sensing vector, the first heart rate estimate and the second heart rate estimate being based, at least in part, on a metric of heart rate;

determining a reliability for each of the first heart rate estimate and the second heart rate estimate;

delivering a therapy to the patient if;

only one of the first heart rate estimate and the second heart rate estimate is reliable and the reliable one of the first heart rate estimate and the second heart rate estimate is greater than a predetermined heart rate threshold;

or

both of the first heart rate estimate and the second heart rate estimate are reliable and the first heart rate estimate is not equal to the second heart rate estimate and the first heart rate estimate and the second heart rate estimate exceed the predetermined heart rate threshold.

2. The method of claim 1, wherein the metric of heart rate corresponds to one of a mean of a plurality of RR intervals associated with the sensed cardiac signals, a trimmed mean of the plurality of RR intervals, a median of the plurality of RR intervals, and a predetermined RR interval of the plurality of RR intervals.

3. The method of claim 2, wherein the medical device further comprises a buffer configured to store data indicative of RR intervals of the cardiac signal, and further comprising the step of clearing the buffer in response to both of the first heart rate estimate and the second heart rate estimate not being reliable.

4. The method of claim 2, wherein the medical device further comprises a buffer configured to store data indicative of RR intervals of the cardiac signal, and wherein determining reliability of each of the first heart rate estimate and the second heart rate estimate comprise determining whether the buffer includes a cleared entry.

5. The method of claim 2 wherein the determining the reliability of each of the first heart rate estimate and the reliability of the second heart rate estimate step comprises the steps of:

identifying the first heart rate estimate as not reliable based, at least in part, on a plurality of RR intervals sensed by the first sensing vector being sensed at less than a minimum sensing threshold level and the first heart rate estimate being less than a predetermined heart rate threshold; and

identifying the second heart rate estimate as not reliable based, at least in part, on a plurality of RR intervals sensed by the second sensing vector being sensed at less than a minimum sensing threshold level and the second heart rate estimate being less than a predetermined heart rate threshold.

6. The method of claim 5, wherein determining whether the plurality of RR intervals sensed by the first sensing vector are sensed at less than the minimum sensing threshold level comprises determining whether two RR intervals of the plurality of RR intervals are sensed at less than the sensing threshold, wherein determining whether the plurality of RR intervals sensed by the second sensing vector are sensed at less than the minimum sensing threshold level comprises determining whether two RR intervals of the plurality of RR intervals are sensed at less than the sensing threshold, and wherein the plurality of RR intervals is equal to twelve RR intervals and the predetermined heart rate threshold is 180 beats per minute.

7. The method of claim 2, wherein the medical device further comprises a buffer configured to store data indicative of RR intervals of the cardiac signal, and further comprising the steps of:

determining whether a predetermined heart rate condition is present during the plurality of RR intervals sensed from the first sensing vector and during the plurality of RR intervals sensed from the second sensing vector; and

clearing the buffer based, at least in part, on the predetermined heart rate condition being present for at least one of the first sensing vector and the second sensing vector.

8. A method of detecting a cardiac event of a cardiac signal generated by a heart of a patient with a medical device having a plurality of electrodes forming a first sensing vector and a second sensing vector and a buffer configured to store data sensed by the electrodes, comprising the steps of:

sensing data representative of the cardiac signal with the plurality of electrodes;

storing the data representative of the cardiac signal in the buffer;

determining a first heart rate estimate associated with data representative of the cardiac signal sensed from the first sensing vector and a second heart rate estimate associated with data representative of the cardiac signal sensed from the second sensing vector, each of the first heart rate estimate and the second heart rate estimate being based, at least in part, on a metric of heart rate associated with the cardiac signal corresponding to at least one of a mean of a plurality of RR intervals associated with the sensed cardiac signals, a trimmed mean of the plurality of RR intervals, a median of the plurality of RR intervals, and a predetermined RR interval of the plurality of RR intervals, and wherein the data representative of the cardiac signal sensed from the first sensing vector is sensed, at least in part, concurrently with the data representative of the cardiac signal sensed from the second sensing vector;

determining whether asystole is detected for at least one of the cardiac signal sensed from the first sensing vector and the cardiac signal sensed from the second sensing vector;

clearing the buffer in response to asystole being detected for at least one of the cardiac signal sensed from the first sensing vector and the cardiac signal sensed from the second sensing vector;

determining a reliability for each of the first heart rate estimate and the second heart rate estimate based, at least in part, on an RR interval stored in the buffer;

delivering a therapy to the patient if;

only one of the first heart rate estimate and the second heart rate estimate is reliable and the reliable one of the first heart rate estimate and the second heart rate estimate is greater than a predetermined heart rate threshold;

or

both of the first heart rate estimate and the second heart rate estimate are reliable and the first heart rate estimate is not equal to the second heart rate estimate and the first heart rate estimate and the second heart rate estimate exceed the predetermined heart rate threshold.

9. The method of claim 8, further comprising the step of clearing the buffer in response to both of the first heart rate estimate and the second heart rate estimate not being reliable.

10. The method of claim 8, wherein the determining the reliability of each of the first heart rate estimate and the reliability of the second heart rate estimate step is based, at least in part, on whether the buffer including a cleared entry.

11. The method of claim 8, wherein the determining the reliability of each of the first heart rate estimate and the reliability of the second heart rate estimate step comprises the steps of:

identifying the first heart rate estimate as not reliable based, at least in part, on a plurality of RR intervals sensed by the first sensing vector being sensed at less than a minimum sensing threshold level, and the first heart rate estimate being less than a predetermined heart rate threshold; and

identifying the second heart rate estimate as not reliable based, at least in part, on a plurality of RR intervals sensed by the second sensing vector being sensed at less than a minimum sensing threshold level and the second heart rate estimate being less than the predetermined heart rate threshold.

12. The method of claim 11, wherein determining whether the plurality of RR intervals sensed by the first sensing vector are sensed at less than the minimum sensing threshold level comprises determining whether two RR intervals of the plurality of RR intervals are sensed at less than the sensing threshold, wherein determining whether the plurality of RR intervals sensed by the second sensing vector are sensed at less than the minimum sensing threshold level comprises determining whether two RR intervals of the plurality of RR intervals are sensed at less than the sensing threshold, and wherein the plurality of RR intervals is equal to twelve RR intervals and the predetermined heart rate threshold is 180 beats per minute.

13. A non-transitory computer readable medium having computer executable instructions for performing a method of detecting a cardiac event of a cardiac signal generated by a heart of a patient with a medical device having a plurality of electrodes, comprising the steps of:

sensing data representative of the cardiac signal with the a plurality of electrodes;

determining a first heart rate estimate associated with data representative of the cardiac signal sensed from the first sensing vector and a second heart rate estimate associated with data representative of the cardiac signal sensed from the second sensing vector, wherein the data representative of the cardiac signal sensed from the first sensing vector is sensed, at least in part, concurrently with the data representative of the cardiac signal sensed from the second sensing vector, the first heart rate estimate and the second heart rate estimate being based, at least in part, on a metric of heart rate;

determining a reliability for each of the first heart rate estimate and the second heart rate estimate;

delivering a therapy to the patient if;

only one of the first heart rate estimate and the second heart rate estimate is reliable and the reliable one of the first heart rate estimate and the second heart rate estimate is greater than a predetermined heart rate threshold;

or

both of the first heart rate estimate and the second heart rate estimate are reliable and the first heart rate estimate is not equal to the second heart rate estimate and the first heart rate estimate and the second heart rate estimate exceed the predetermined heart rate threshold.

14. The computer readable medium of claim 13, wherein the metric of heart rate corresponds to one of a mean of a plurality of RR intervals associated with the sensed cardiac signals, a trimmed mean of the plurality of RR intervals, a median of the plurality of RR intervals, and a predetermined RR interval of the plurality of RR intervals, and wherein determining the reliability of each of the first heart rate estimate and the reliability of the second heart rate estimate step comprises the steps of

determining the first heart rate estimate are not reliable based, at least in part, on a plurality of RR intervals sensed by the first sensing vector being sensed at less than a minimum sensing threshold level, and the first heart rate estimate being less than a predetermined heart rate threshold;

and identifying the second heart rate estimate as not reliable based, at least in part, on a plurality of RR intervals sensed by the second sensing vector being sensed at less than a minimum sensing threshold level and the second heart rate estimate being less than a predetermined heart rate threshold.

15. The computer readable medium of claim 13, wherein the metric of heart rate corresponds to one of a mean of a plurality of RR intervals associated with the sensed cardiac signals, a trimmed mean of the plurality of RR intervals, a median of the plurality of RR intervals, and a predetermined RR interval of the plurality of RR intervals, the method further comprising:

determining whether a predetermined heart rate condition is present during the plurality of RR intervals sensed from the first sensing vector and during the plurality of RR intervals sensed from the second sensing vector; and

clearing the buffer based, at least in part, on the predetermined heart rate condition being present for at least one of the first sensing vector and the second sensing vector.