Method and apparatus for detecting arrhythmias in a subcutaneous medical device

• US 9,872,630 B2
• Filed: 05/07/2015
• Issued: 01/23/2018
• Est. Priority Date: 03/29/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stadler, Robert W, Ghanem, Raja N, Zhang, Xusheng
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/706,414
• Publication Number:
  US 20150230723A1
• Time in Patent Office: 992 Days
• 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 subcutaneously implantable cardiac medical device and a method of sensing a cardiac signal therein that includes a plurality of electrodes to sense a cardiac signal along a plurality of sensing vectors to detect a first interval and a second interval associated with a first detected event, and a processor configured to determine whether the first interval and the second interval are shorter than a predetermined threshold, determine whether the first interval and the second interval are similar, and determine, in response to the first interval and the second interval being similar, whether the sensed cardiac signal is either a noisy signal or a QRS signal.

Claims

1. A subcutaneously implantable cardiac medical device, comprising:

a plurality of electrodes to sense a cardiac signal along at least one sensing vector to detect a first interval and a second interval associated with a first detected event; and

a processor configured to;

determine that the first interval and the second interval are shorter than a predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise,

in response to determining that the first interval and the second interval are shorter than the predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise, determine whether a comparison of the first interval to the second interval satisfies a predetermined stability threshold, the stability threshold comprising an indication of a threshold level of similarity between the first interval and the second interval,

based on the determination of whether the comparison satisfies the predetermined stability threshold, select a criterion to apply to the cardiac signal to determine whether the detected event is shockable, and

control delivery of an anti-tachyarrhythmia shock based on the application of the selected criterion to the cardiac signal indicating that the detected event is shockable.

2. The subcutaneously implantable cardiac medical device of claim 1, wherein determining whether the comparison of the first interval to the second interval satisfies the predetermined stability threshold comprises determining whether the cardiac signal comprises regular intervals.

3. The subcutaneously implantable cardiac medical device of claim 1, wherein the processor is configured to determine that the cardiac signal sensed along the sensing vector is not corrupted by noise by performing an amplitude analysis on a segment of the cardiac signal and determining whether a mean rectified amplitude value associated with the cardiac signal segment is within an amplitude range.

4. The subcutaneously implantable cardiac medical device of claim 3, wherein the processor is further configured to determine the mean rectified amplitude value associated with the cardiac signal segment by determining an amplitude value associated with each of a plurality of signal samples derived from the segment of the cardiac signal, and calculating the mean rectified amplitude value for the segment based on the amplitude values associated with the plurality of signal samples.

5. The subcutaneously implantable cardiac medical device of claim 4, wherein the mean rectified amplitude comprises a ratio of the sum of the amplitude values associated with the plurality of signal samples to the total number of signal samples derived from the segment of the cardiac signal.

6. The subcutaneously implantable cardiac medical device of claim 3, wherein the amplitude range comprises a range of mean rectified amplitude values that are not associated with cardiac signals sensed along a sensing vector that is corrupted by noise.

7. The subcutaneously implantable cardiac medical device of claim 1, wherein the processor is configured to select either a VF detection criterion or a VT detection criterion to apply to the cardiac signal to determine whether the detected event is shockable based on the determination of whether the comparison satisfies the predetermined stability threshold.

8. A method, comprising:

sensing the cardiac signal along at least one sensing vector to detect a first interval and a second interval associated with a first detected event;

determining that the first interval and the second interval are shorter than a predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise;

in response to determining that the first interval and the second interval are shorter than a predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise, determining whether a comparison of the first interval to the second interval satisfies a predetermined stability threshold, the stability threshold comprising an indication of a threshold level of similarity between the first interval and the second interval;

based on the determination of whether the comparison satisfies the predetermined stability threshold, selecting a criterion to apply to the cardiac signal to determine whether the detected event is shockable, and

controlling delivery of an anti-tachyarrhythmia shock based on the application of the selected criterion to the cardiac signal indicating that the detected event is shockable.

9. The method of claim 8, wherein determining whether the comparison of the first interval to the second interval satisfies the predetermined stability threshold comprises determining whether the cardiac signal comprises regular intervals.

10. The method of claim 8, further comprising:

determining that the cardiac signal sensed along the sensing vector is not corrupted by noise by performing an amplitude analysis on a segment of the cardiac signal and determining whether a mean rectified amplitude value associated with the cardiac signal segment is within an amplitude range.

11. The method of claim 10, wherein determining the mean rectified amplitude value associated with the cardiac signal segment by determining an amplitude value associated with each of a plurality of signal samples derived from the segment of the cardiac signal, and calculating the mean rectified amplitude value for the segment based on the amplitude values associated with the plurality of signal samples.

12. The method of claim 11, wherein the mean rectified amplitude comprises a ratio of the sum of the amplitude values associated with the plurality of signal samples to the total number of signal samples derived from the segment of the cardiac signal.

13. The method of claim 10, wherein the amplitude range comprises a range of mean rectified amplitude values that are not associated with cardiac signals sensed along a sensing vector that is corrupted by noise.

14. The method of claim 8, wherein selecting the criterion to apply to the cardiac signal to determine whether the detected event is shockable comprises selecting either a VF detection criterion or a VT detection criterion based on the determination of whether the comparison satisfies the predetermined stability threshold.

15. A non-transitory computer-readable medium storing a set of instructions which cause a processor of an implantable medical device to perform a method of sensing a cardiac signal in a subcutaneously implantable cardiac medical device, comprising:

sensing the cardiac signal along at least one sensing vector to detect a first interval and a second interval associated with a first detected event;

determining that the first interval and the second interval are shorter than a predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise;

in response to determining that the first interval and the second interval are shorter than a predetermined threshold and that the cardiac signal sensed along the sensing vector is not corrupted by noise, determining whether a comparison of the first interval to the second interval satisfies a predetermined stability threshold, the stability threshold comprising an indication of a threshold level of similarity between the first interval and the second interval;

based on the determination of whether the comparison satisfies the predetermined stability threshold, selecting a criterion to apply to the cardiac signal to determine whether the detected event is shockable, and

controlling delivery of an anti-tachyarrhythmia shock based on the application of the selected criterion to the cardiac signal indicating that the detected event is shockable.

16. The non-transitory computer-readable medium of claim 15, wherein determining whether the comparison of the first interval to the second interval satisfies the predetermined stability threshold comprises determining whether the cardiac signal comprises regular intervals.

17. The non-transitory computer-readable medium of claim 15, the method further comprising:

determining that the cardiac signal sensed along the sensing vector is not corrupted by noise by performing an amplitude analysis on a segment of the cardiac signal and determining whether a mean rectified amplitude value associated with the cardiac signal segment is within an amplitude range.

18. The non-transitory computer-readable medium of claim 17, wherein determining the mean rectified amplitude value associated with the cardiac signal segment by determining an amplitude value associated with each of a plurality of signal samples derived from the segment of the cardiac signal, and calculating the mean rectified amplitude value for the segment based on the amplitude values associated with the plurality of signal samples.

19. The non-transitory computer-readable medium of claim 18, wherein the mean rectified amplitude comprises a ratio of the sum of the amplitude values associated with the plurality of signal samples to the total number of signal samples derived from the segment of the cardiac signal.

20. The non-transitory computer-readable medium of claim 17, wherein the amplitude range comprises a range of mean rectified amplitude values that are not associated with cardiac signals sensed along a sensing vector that is corrupted by noise.

21. The non-transitory computer-readable medium of claim 15, wherein selecting the criterion to apply to the cardiac signal to determine whether the detected event is shockable comprises selecting either a VF detection criterion or a VT detection criterion based on the determination of whether the comparison satisfies the predetermined stability threshold.