Impedance waveform monitoring for heart beat confirmation

• US 9,788,742 B2
• Filed: 01/29/2015
• Issued: 10/17/2017
• Est. Priority Date: 02/04/2014
• Status: Expired due to Fees

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Thakur, Pramodsingh Hirasingh, Averina, Viktoria A., Brisben, Amy J., Siejko, Krzysztof Z.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/609,059
• Publication Number:
  US 20150216433A1
• Time in Patent Office: 992 Days
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371

Abstract

Implantable systems and methods directed toward improved accuracy in cardiac signal analysis. An impedance waveform is captured and used to confirm the analysis performed by the system on electrical signals or electrocardiogram. A detected heart beat from the electrocardiogram is either confirmed or identified as a misdetection depending on whether the impedance waveform shows likely correct or incorrect detection. Identified misdetection can then be corrected or otherwise mitigated.

Claims

1. A method of operation in an implantable cardiac stimulus device having operational circuitry for monitoring and analyzing cardiac signals and a plurality of electrodes including at least two electrodes configured for current injection and at least two electrodes configured for electrical monitoring of voltage resultant from the injected current to allow the operational circuitry to generate an impedance waveform for monitoring purposes, the method comprising:

the operational circuitry injecting current using the at least two electrodes configured for current injection and sensing resultant voltage using the at least two electrodes configured for electrical monitoring to generate an impedance waveform;

the operational circuitry capturing an electrocardiogram (ECG) signal using a combination of the plurality of electrodes selected for sensing an ECG signal;

the operational circuitry detecting an event in the ECG;

the operational circuitry analyzing a portion of the impedance waveform relative to the detected event; and

the operational circuitry determining whether the detected event is an overdetection using the analysis of the impedance waveform.

2. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

calculating an integral of the impedance waveform between the detected event and an adjacent-in-time detected event;

comparing the integral to an expected value; and

if the integral does not match the expected value, determining that one of the detected event or the adjacent-in-time detected event is an overdetection;

or

if the integral matches the expected value, determining that a complete cardiac cycle has occurred between the detected event and the adjacent in time detected event.

3. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

defining a window within the impedance waveform to correlate, in time, with a peak in the ECG signal associated with the detected event;

determine whether a positive peak appears in the impedance waveform in the defined window; and

in response to determining there is the positive peak in the impedance waveform in the defined window, determining that the detected event is an overdetection.

4. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

defining a window within the impedance waveform to correlate, in time, with a peak in the ECG signal associated with the detected event;

determining whether a negative peak appears in the impedance waveform in the defined window; and

in response to determining there is no negative peak in the impedance waveform in the defined window, determining that the detected event is an overdetection.

5. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

defining a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event;

determining whether there is an upward slope in the impedance waveform during the defined window; and

in response to determining there is the upward slope, determining that the detected event is not an overdetection.

6. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

defining a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event;

determining whether there is a downward slope in the impedance waveform during the defined window; and

in response to determining there is the downward slope, determining that the detected event is an overdetection.

7. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

calculating a derivative of the impedance waveform;

defining a window within the derivative of the impedance waveform at a time after a peak in the ECG signal associated with the detected event; and

determining whether a peak meeting threshold criteria appears in the defined window of the derivative of the impedance waveform.

8. The method of claim 1 wherein the step of analyzing a portion of the impedance waveform relative to the detected event is performed by the operational circuitry doing the following:

defining a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event; and

comparing the impedance waveform to a stored template of the impedance waveform.

9. The method of claim 1 wherein the operational circuitry is further configured to calculate a cardiac rate using only detected events that are not overdetections.

10. An implantable cardiac stimulus device comprising:

a canister having an external shell composed of material suitable for implantation;

a plurality of electrodes exposed external to the external shell of the canister including electrodes configured to inject current and electrodes configured to monitor a resultant voltage from the injected current;

operational circuitry, disposed within the canister, operatively coupled to the plurality of electrodes, the operational circuitry including;

sensing circuitry configured to sense the resultant voltage and capture an electrocardiogram (ECG) signal; and

a controller configured to;

generate an impedance waveform from the resultant voltage;

detect an event in the ECG;

analyze a portion of the impedance waveform relative to the detected event; and

determine whether the detected event is an overdetection using the analysis of the impedance waveform; and

a power source disposed within the canister and configured to power the operational circuitry.

11. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

calculate an integral of the impedance waveform between the detected event and an adjacent-in-time detected event;

compare the integral to an expected value; and

if the integral does not match the expected value, determine that one of the detected event or the adjacent-in-time detected event is an overdetection;

or

if the integral matches the expected value, determine that a complete cardiac cycle has occurred between the detected event and the adjacent in time detected event.

12. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

define a window within the impedance waveform to correlate, in time, with a peak in the ECG signal associated with the detected event;

determine whether a positive peak appears in the impedance waveform in the defined window; and

in response to determining the positive peak appears in the impedance waveform in the defined window, determine that the detected event is an overdetection.

13. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

define a window within the impedance waveform to correlate, in time, with a peak in the ECG signal associated with the detected event;

determine whether a negative peak appears in the impedance waveform in the defined window; and

in response to determining the negative peak does not appear in the impedance waveform in the defined window, determine that the detected event is an overdetection.

14. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

define a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event;

determine whether there is an upward slope in the impedance waveform during the defined window; and

in response to determining there is the upward slope, determine that the detected event is not an overdetection.

15. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

define a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event;

determine whether there is a downward slope in the impedance waveform during the defined window; and

in response to determining there is the downward slope, determine that the detected event is an overdetection.

16. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

calculate a derivative of the impedance waveform;

define a window within the derivative of the impedance waveform at a time after a peak in the ECG signal associated with the detected event; and

determine whether a peak meeting threshold criteria appears in the defined window of the derivative of the impedance waveform.

17. The device of claim 10 wherein analyzing a portion of the impedance waveform relative to the detected event is performed by the controller being further configured to:

define a window within the impedance waveform at a time after a peak in the ECG signal associated with the detected event; and

compare the impedance waveform to a stored template of the impedance waveform.

18. The device of claim 10 wherein the controller is further configured to calculate a cardiac rate using only detected events that are not overdetections.