T-wave oversensing rejection

• US 9,597,525 B2
• Filed: 05/06/2015
• Issued: 03/21/2017
• Est. Priority Date: 05/06/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhang, Xusheng, Cao, Jian, Stadler, Robert W.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/705,010
• Publication Number:
  US 20160325106A1
• Time in Patent Office: 685 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/355 Detecting T-waves
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A medical device coupled to extracardiac electrodes is configured to analyze a cardiac electrical signal over a signal analysis segment to determine if shockable rhythm classification criteria are met, determine that TWOS detection criteria are met for the signal analysis segment when a predetermined number of TWOS analysis windows are classified as TWOS, and classify the signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met.

Claims

1. A method performed by a medical device, comprising:

receiving a cardiac electrical signal from a patient'"'"'s heart via a plurality of extracardiac electrode electrically coupled to the medical device;

sensing cardiac events from the cardiac electrical signal;

during a first operating state of the medical device, determining an estimated rate of the sensed cardiac events;

transitioning from the first operating state to a second operating state of the medical device when the estimated rate of cardiac events meets a shockable rate detection criterion;

setting a first signal analysis segment of the cardiac electrical signal during the second operating state;

analyzing the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment;

setting a plurality of T-wave oversensing (TWOS) analysis windows;

analyzing cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria;

determining that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS;

classifying the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met; and

remaining in the second operating state without advancing to a third operating state of the medical device when the TWOS detection criteria are met for the first signal analysis segment.

2. The method of claim 1, further comprising determining whether the TWOS detection criteria are met for the first signal analysis segment only after the shockable rhythm classification criteria are met for the first signal analysis segment.

3. The method of claim 1, further comprising classifying a second signal analysis segment preceding the first signal analysis segment as non-shockable when the TWOS detection criteria are met for the first signal analysis segment.

4. The method of claim 3, further comprising:

sensing cardiac events from the cardiac electrical signal;

during a first operating state of the medical device, determining an estimated rate of the sensed cardiac events;

transitioning from the first operating state to a second operating state of the medical device when the estimated rate of the sensed cardiac events meets a shockable rate detection criterion;

setting the first signal analysis segment and the second signal analysis segment during the second operating state; and

remaining in the second operating state for a third signal analysis segment after the first signal analysis segment without advancing to a third operating state of the medical device when the TWOS detection criteria are met for the first signal analysis segment.

5. The method of claim 4, wherein receiving the cardiac electrical signal comprises receiving the cardiac electrical signal from a first sensing channel coupled to the plurality of extracardiac electrodes, the method further comprising:

receiving a second cardiac electrical signal from a second sensing channel coupled to the plurality of extracardiac electrodes;

analyzing the second cardiac electrical signal for classifying each of a plurality of fourth cardiac signal segments as one of shockable and not shockable; and

remaining in the second operating state for the third signal analysis segment when the TWOS detection criteria are met for the first signal analysis segment and the plurality of fourth cardiac signal segments are classified as shockable.

6. The method of claim 4, further comprising:

detecting a shockable rhythm when at least the third signal analysis segment is determined to meet shockable rhythm classification criteria and the TWOS detection criteria are not met for the third signal analysis segment;

advancing to the third operating state from the second operating state when the shockable rhythm is detected; and

charging a capacitor for delivering a shock therapy during the third operating state.

7. The method of claim 1, wherein analyzing cardiac events of the cardiac electrical signal comprises:

selecting at least one group of at least three consecutive cardiac events from the plurality of cardiac events that are within a given one of the plurality of TWOS analysis windows;

determining a maximum event amplitude from the at least one group;

determining an event discrimination threshold using the maximum event amplitude;

identifying as R-waves all cardiac events of the plurality of cardiac events within the given one of the plurality of TWOS analysis windows that are equal to or greater than the event discrimination threshold;

identifying as T-waves all events of the plurality of cardiac events within the given one of the plurality of TWOS analysis windows that is less than the event discrimination threshold; and

identifying a pattern of TWOS when each one of at least a portion of the identified R-waves is consecutively followed by one of the identified T-waves in an R-T pair.

8. The method of claim 7, further comprising:

verifying that the R-T pair is a valid R-T pair by verifying at least one of an R-wave amplitude stability, a T-wave amplitude stability, an R-T interval stability and an R-T frequency difference; and

classifying the given signal analysis segment as TWOS when at least two valid R-T T pairs within the given signal analysis segment are verified.

9. The method of claim 1, wherein determining that the TWOS detection criteria are met for the first signal analysis segment comprises determining that the TWOS detection criteria are met when a first predetermined number of the plurality of TWOS analysis windows are classified as TWOS and a second predetermined number of the plurality of TWOS analysis windows that are classified as TWOS occur within a third predetermined number of the plurality of TWOS analysis windows preceding the shockable rhythm classification criteria being met.

10. An implantable medical device, comprising:

a sensing module configured to receive a cardiac electrical signal via a plurality of extracardiac electrodes coupled to the implantable medical device ; and

a control module coupled to the sensing module and configured to;

set a first signal analysis segment of the cardiac electrical signal;

analyze the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment

set a plurality of T-wave oversensing (TWOS) analysis windows;

analyze cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria;

determine that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS, wherein the control module is further configured to determine whether the TWOS detection criteria are met for the first signal analysis segment only after the shockable rhythm classification criteria are met for the first signal analysis segment; and

classify the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met.

11. An implantable medical device, comprising:

a sensing module configured to receive a cardiac electrical signal via a plurality of extracardiac electrodes coupled to the implantable medical device ; and

a control module coupled to the sensing module and configured to;

set a first signal analysis segment of the cardiac electrical signal;

analyze the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment;

set a plurality of T-wave oversensing (TWOS) analysis windows;

analyze cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria;

determine that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS; and

classify the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met, wherein;

the sensing module is configured to sense cardiac events from the cardiac electrical signal;

the control module is further configured to;

determine an estimated rate of the sensed cardiac events during a first operating state of the medical device;

transition from the first operating state to a second operating state of the medical device when the estimated rate of cardiac events meets a shockable rate detection criterion;

set the first signal analysis segment during the second operating state; and

remain in the second operating state without advancing to a third operating state of the medical device when the TWOS detection criteria are met for the first signal analysis segment.

12. An implantable medical device, comprising:

a sensing module configured to receive a cardiac electrical signal via a plurality of extracardiac electrodes coupled to the implantable medical device; and

a control module coupled to the sensing module and configured to;

set a first signal analysis segment of the cardiac electrical signal;

analyze the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment;

set a plurality of T-wave oversensing (TWOS) analysis windows;

analyze cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria;

determine that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS; and

classify the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met,

wherein the control module is further configured to classify a second signal analysis segment preceding the first signal analysis segment as non-shockable when the TWOS detection criteria are met for the first signal analysis segment.

13. The device of claim 12, wherein:

the sensing module is configured to sense cardiac events from the cardiac electrical signal; and

the control module is further configured to;

determine an estimated rate of the sensed cardiac events during a first operating state of the medical device;

transition from the first operating state to a second operating state of the medical device when the estimated rate of the sensed cardiac events meets a shockable rate detection criterion;

set the first signal analysis segment and the second signal analysis segment during the second operating state; and

remain in the second operating state for a third signal analysis segment after the first signal analysis segment without advancing to a third operating state of the medical device when the TWOS detection criteria are met for the first signal analysis segment.

14. The device of claim 13, wherein:

the sensing module is further configured to;

receive the cardiac electrical signal by receiving the cardiac electrical signal from a first sensing channel coupled to the plurality of extracardiac electrodes; and

receive a second cardiac electrical signal from a second sensing channel coupled to the plurality of extracardiac electrodes; and

the control module is further configured to;

analyze the second cardiac electrical signal for classifying each of a plurality of fourth cardiac signal segments as one of shockable and not shockable; and

remaining in the second operating state for the third signal analysis segment when the TWOS detection criteria are met for the first signal analysis segment and the plurality of fourth cardiac signal segments are classified as shockable.

15. The device of claim 13, wherein the control module is configured to:

detect a shockable rhythm when at least the third signal analysis segment is determined to meet shockable rhythm classification criteria and the TWOS detection criteria are not met for the third signal analysis segment;

advance to the third operating state from the second operating state when the shockable rhythm is detected; and

charge a capacitor for delivering a shock therapy during the third operating state.

16. An implantable medical device, comprising:

a sensing module configured to receive a cardiac electrical signal via a plurality of extracardiac electrodes coupled to the implantable medical device ; and

a control module coupled to the sensing module and configured to;

set a first signal analysis segment of the cardiac electrical signal;

analyze the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment;

set a plurality of T-wave oversensing (TWOS) analysis windows;

analyze cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria, wherein the control module is configured to analyze the cardiac events of the cardiac electrical signal by;

selecting at least one group of at least three consecutive cardiac events from the plurality of cardiac events that are within a given one of the plurality of TWOS analysis windows;

determining a maximum event amplitude from the at least one group;

determining an event discrimination threshold using the maximum event amplitude; and

identifying as R-waves all cardiac events of the plurality of cardiac events within the given one of the plurality of TWOS analysis windows that are equal to or greater than the event discrimination threshold;

identifying as T-waves all events of the plurality of cardiac events within the given one of the plurality of TWOS analysis windows that have a maximum signal amplitude that is less than the event discrimination threshold; and

identifying a pattern of TWOS when each one of at least a portion of the identified R-waves is consecutively followed by one of the identified T-waves in an R-T pair;

determine that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS; and

classify the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met.

17. The device of claim 16, wherein the control module is further configured to:

verify that the R-T pair is a valid R-T pair by verifying at least one of an R-wave amplitude stability, a T-wave amplitude stability, an R-T interval stability and an R-T frequency difference; and

classify the given signal analysis segment as TWOS when at least two valid R-T pairs within the given signal analysis segment are verified.

18. An implantable medical device, comprising:

a sensing module configured to receive a cardiac electrical signal via a plurality of extracardiac electrodes coupled to the implantable medical device ; and

a control module coupled to the sensing module and configured to;

set a first signal analysis segment of the cardiac electrical signal;

analyze the first signal analysis segment to determine if shockable rhythm classification criteria are met for the first signal analysis segment;

set a plurality of T-wave oversensing (TWOS) analysis windows;

analyze cardiac events of the cardiac electrical signal to classify each TWOS analysis window of the plurality of TWOS analysis windows as one of TWOS and no TWOS, each TWOS analysis window being classified as TWOS when cardiac events during the TWOS analysis window satisfy TWOS criteria and classified as no TWOS when the cardiac events during the TWOS analysis window do not satisfy TWOS criteria;

determine that TWOS detection criteria are met for the first signal analysis segment when a predetermined number of the plurality of TWOS analysis windows are classified as TWOS, wherein the control module is configured to determine that the TWOS detection criteria are met for the first signal analysis segment by determining that the TWOS detection criteria are met when a first predetermined number of the plurality of TWOS analysis windows are classified as TWOS and a second predetermined number of the plurality of TWOS analysis windows that are classified as TWOS occur within a third predetermined number of the plurality of TWOS analysis windows preceding the shockable rhythm classification criteria being met; and

classify the first signal analysis segment as non-shockable in response to determining that the TWOS detection criteria are met.