Method and apparatus for scoring the reliability of shock advisory during cardiopulmonary resuscitation

• US 9,919,160 B2
• Filed: 03/12/2014
• Issued: 03/20/2018
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Koninklijke Philips N.V.
• Original Assignee: Koninklijke Philips N.V.
• Inventors: Firoozabadi, Reza, Babaeizadeh, Saeed
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/775,029
• Publication Number:
  US 20160015991A1
• Time in Patent Office: 1,469 Days
• Field of Search: 607 4, 607 5, 607 7, 607142
• 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 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/39044 in combination with cardiopulmonary resuscitation [CPR] therapy
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A method, system and device to detect and use clean ECG segments, which do not need filtering to remove artifact or CPR-induced noise, is described to provide a reliability score for the decision made by shock advisory algorithms. The method can be implemented in a system and/or device that is provided with a display for indicating to a user the relative quality of the determination of an electrotherapy analysis circuit.

Claims

1. A medical device for determining the reliability of a cardiac rhythm analysis during the performance of cardiopulmonary resuscitation (CPR) comprising:

a front end operable to obtain two or more time-sequential ECG data sets comprised of a first ECG data set and a second ECG data set;

an input sensor operable to acquire two or more time-sequential CPR reference signal data sets which correspond in time to the time-sequential ECG data sets;

a chest compression detector in communication with the input, operable to detect whether or not each of the ECG data sets contains CPR-related noise;

a shock advisory algorithm module in communication with the input and the chest compression detector and operable to analyze and classify each of the ECG data sets that do not contain CPR-related noise as a shock advice or a no-shock advice;

a reliability analyzer in communication with the chest compression detector and the shock advisory algorithm module operable to determine the reliability of the most recent shock or no-shock advice, wherein the reliability analyzer is configured to generate a reliability score at the end of each of the ECG data sets by operations including;

responsive to a number of consecutive ECG data sets that do not contain CPR-related noise being similarly classified as the shock advice, the reliability analyzer is configured to update a value of the reliability score in a direction corresponding to the shock advice until the reliability score reaches a scoring limit corresponding to the shock advice;

responsive to a number of consecutive ECG data sets that do not contain CPR-related noise being similarly classified as the no-shock advice, the reliability analyzer is configured to update the value of the reliability score in a direction corresponding to the no shock advice until the reliability score reaches a scoring limit corresponding to the no shock advice;

responsive to the most recent ECG data set not containing CPR-related noise and being classified as a switched shock or no shock advice, the reliability analyzer is configured to update the value of the reliability score toward a score value indicating an indeterminate condition; and

responsive to the most recent ECG data set containing CPR-related noise, the reliability analyzer is configured to update the value of the reliability score toward the score value indicating the indeterminate condition;

a shock decision generator in communication with the reliability analyzer and the shock advisory algorithm module operable to generate a shock decision based on the reliability score; and

an output generator for issuing a user-perceptible indication of the shock decision and the reliability of the ECG shock advice.

2. The medical device of claim 1, wherein the medical device is a defibrillator.

3. The medical device of claim 1, wherein the shock advisory algorithm module is further operable to analyze and classify each of the ECG data sets as artifact.

4. The medical device of claim 1, wherein the output generator comprises a display disposed in communication with the medical device operable to display an indication of the reliability of the ECG shock advice.

5. The medical device of claim 4, wherein the displayed indication of the reliability of the ECG shock advice comprises a graphical indicator.

6. The medical device of claim 4, wherein the displayed indication of the reliability of the ECG shock advice comprises a textual message.

7. The medical device of claim 1, wherein the reliability analyzer determines the reliability of the most recent ECG device based on a determined reliability of the previous ECG data set.

8. The medical device of claim 1, wherein the shock decision generator is further operable to adjust a shock decision protocol based on a classification by the shock advisory algorithm module of each of the ECG data sets as a shock advice or a no-shock advice and further based on a determination by the reliability analyzer of the reliability of the most recent ECG advice.

9. The medical device of claim 8, wherein the shock decision generator adjusts the shock decision protocol by reducing a duration of a shock decision analysis period for generating the shock decision.

10. The medical device of claim 1, wherein responsive to the number of consecutive ECG data sets being similarly classified as the shock advice and the reliability score reaching the threshold reliability score, the shock decision generator is configured to generate a shock decision.

11. The medical device of claim 10, wherein responsive to the shock decision being generated by the shock decision generator, the output generator is configured to automatically arm a high voltage electrotherapy circuit, the high voltage electrotherapy circuit configured to deliver a defibrillation shock to a patient.

12. The medical device of claim 1, wherein the input sensor comprises one or more of patient electrodes, a force sensor, or an accelerometer.

13. A defibrillator comprising:

a host circuit operable to analyze ECG segments and determine whether each ECG segment is a clean ECG segment that does not contain chest compressions-related noise and to make a shock determination decision for each clean ECG segment;

a reliability analyzing circuit operable to analyze each ECG segment to generate a reliability score at the end of the ECG segment by operations including;

for each clean ECG segment that has a shock determination decision confirming the shock determination decision for the last clean ECG segment, updating the reliability score in a direction corresponding to the confirming shock determination decision until the reliability score reaches a scoring limit corresponding to the confirming shock determination decision;

for each switched clean ECG segment that has a shock determination decision opposite to the shock determination decision for the last clean ECG segment, updating the reliability score toward a score value indicating an indeterminate condition; and

for each ECG segment that is not a clean ECG segment, updating the reliability score toward the score value indicating the indeterminate condition; and

a display disposed on the defibrillator operable to display the generated reliability score.

14. The defibrillator of claim 13, wherein the displayed reliability score is a textual indication of whether or not the shock decision is reliable.

15. The defibrillator of claim 13, wherein the displayed reliability score is a graphical indicator disposed as a pointer graphic which points to one segment of a three-segment bar graphic, wherein one of the segments indicates a reliable no-shock decision, another one of the segments indicates an unreliable decision, and another one of the segments indicates a reliable shock decision.

16. The defibrillator of claim 15, wherein the three-segment bar graphic comprises one color for the unreliable segment and another color for the reliable segments.

17. The defibrillator of claim 13, further comprising a high voltage electrotherapy circuit configured to deliver a defibrillation shock to a patient responsive to the shock determination decision being a shock decision and the reliability score reaching the scoring limit corresponding to the confirming shock determination decision.

18. A defibrillator comprising:

a computer programmed to analyze ECG segments and determine whether each ECG segment is a clean ECG segment that does not contain chest compressions-related noise and to make a shock determination decision for each clean ECG segment, and further programmed to analyze each ECG segment to generate a reliability score at the end of the ECG segment by operations including;

for each clean ECG segment that has a shock determination decision confirming the shock determination decision for the last clean ECG segment, updating the reliability score in a direction corresponding to the confirming shock determination decision until the reliability score reaches a scoring limit corresponding to the confirming shock determination decision;

for each switched clean ECG segment that has a shock determination decision opposite to the shock determination decision for the last clean ECG segment, updating the reliability score toward a score value indicating an indeterminate condition; and

for each ECG segment that is not a clean ECG segment, updating the reliability score toward the score value indicating the indeterminate condition;

a display disposed on the defibrillator operable to display a representation of the most recently generated reliability score; and

a high voltage electrotherapy circuit configured to deliver a defibrillation shock to a patient in accordance with the shock determination decisions.