Methods and Devices for Accurately Classifying Cardiac Activity

• US 20100094369A1
• Filed: 12/14/2009
• Published: 04/15/2010
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Warren, Jay A., Sanghera, Rick, Allavatam, Venugopal, Palreddy, Surekha
• Granted Patent: US 8,265,749 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• 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

Abstract

Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In illustrative examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. New methods for organizing the use of morphology and rate analysis in an overall architecture for rhythm classification and cardiac signal analysis are also discussed.

Claims

1. A method of cardiac signal analysis in an implantable medical device comprising:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying analysis of the morphology of a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying interval analysis on a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

2. The method of claim 1 wherein step b) further includes:

iii) applying analysis to sequences of consecutive events to identify overdetected events using interval and shape characteristics such that, if a likely overdetection is identified, the likely overdetection is not certified.

3. The method of claim 2 wherein step b) is performed by certifying events that are not identified as overdetections in any of i), ii) and iii).

4. The method of claim 1 further comprising performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal, wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

5. The method of claim 1 wherein step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

6. The method of claim 1 wherein the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

7. The method of claim 1 wherein step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).

8. A method of cardiac signal analysis in an implantable medical device comprising:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying analysis of the morphology of a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying analysis to pairs of consecutive events to identify overdetected events using interval and shape characteristics such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

9. The method of claim 8 further comprising performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal;

wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

10. The method of claim 8 wherein step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

11. The method of claim 8 wherein the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

12. The method of claim 8 wherein step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).

13. A method of cardiac signal analysis in an implantable medical device comprising:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying interval analysis on a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying analysis to identify overdetected events using interval and shape characteristics of pairs of consecutive events such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

14. The method of claim 13 further comprising performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal;

wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

15. The method of claim 13 wherein step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

16. The method of claim 13 wherein the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

17. The method of claim 13 wherein step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).

18. An implantable cardiac stimulus device (ICSD) comprising electrodes for capturing data from a recipient of the ICSD and operational circuitry coupled to the electrodes to analyze signal captured from the patient, wherein the operational circuitry is configured to perform a method comprising the following steps:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying analysis of the morphology of a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying interval analysis on a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

19. The ICSD of claim 18 wherein the operational circuitry is further configured such that step b) further includes:

iii) applying analysis to identify overdetected events using interval and shape characteristics of sequences of consecutive events such that, if a likely overdetection is identified, the likely overdetection is not certified.

20. The ICSD of claim 19 wherein the operational circuitry is further configured such that step b) is performed by certifying events that are not identified as overdetections in any of i), ii) and iii).

21. The ICSD of claim 18 wherein the operational circuitry is further configured such that the method further comprises performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal;

wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

22. The ICSD of claim 18 wherein the operational circuitry is further configured such that step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

23. The ICSD of claim 18 wherein the operational circuitry is further configured such that the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

24. The ICSD of claim 18 wherein the operational circuitry is further configured such that step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).

25. An implantable cardiac stimulus device (ICSD) comprising electrodes for capturing data from a recipient of the ICSD and operational circuitry coupled to the electrodes to analyze signal captured from the patient, wherein the operational circuitry is configured to perform a method comprising the following steps:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying analysis of the morphology of a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying analysis to identify overdetected events using interval and shape characteristics of pairs of consecutive events such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

26. The ICSD of claim 25 wherein the operational circuitry is further configured such that the method further comprises performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal;

wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

27. The ICSD of claim 25 wherein the operational circuitry is further configured such that step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

28. The ICSD of claim 25 wherein the operational circuitry is further configured such that the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

29. The ICSD of claim 25 wherein the operational circuitry is further configured such that step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).

30. An implantable cardiac stimulus device (ICSD) comprising electrodes for capturing data from a recipient of the ICSD and operational circuitry coupled to the electrodes to analyze signal captured from the patient, wherein the operational circuitry is configured to perform a method comprising the following steps:

a) detecting events in a signal;

b) determining which detected events to certify for use in rhythm identification by;

i) applying interval analysis on a set of detected events in order to identify overdetected events such that, if a likely overdetection is identified, the likely overdetection is not certified; and

ii) applying analysis to identify overdetected events using interval and shape characteristics of pairs of consecutive events such that, if a likely overdetection is identified, the likely overdetection is not certified;

c) determining whether a malignant cardiac rhythm is occurring using certified detected events; and

d) delivering therapy in response to the malignant rhythm.

31. The ICSD of claim 31 wherein the operational circuitry is further configured such that the method further comprises performing waveform appraisal on detected events and, for each event, either passing the detected event or marking the detected event as suspect, wherein step b) is performed only on detected events that pass waveform appraisal;

wherein waveform appraisal operates to determine whether a detected event is noisy and, if so, to prevent any noisy detected events from passing further into the analysis.

32. The ICSD of claim 31 wherein the operational circuitry is further configured such that step c) comprises the following:

determining that an X/Y condition has been met, wherein X represents how many malignant events have been identified in a set of Y certified detected events; and

determining that the X/Y condition meets a persistence condition.

33. The ICSD of claim 31 wherein the operational circuitry is further configured such that the signal in which events are detected is created by:

x) capturing a subject signal from electrodes configured to be implanted in a patient subject; and

y) conditioning the signal for use in cardiac signal analysis;

wherein steps x) and y) are performed on a continuous basis, while step a) is performed iteratively using the conditioned signal.

34. The ICSD of claim 31 wherein the operational circuitry is further configured such that step b) is performed by certifying events that are not identified as overdetections in either of i) or ii).