System and method for cardiac monitoring using adaptive sensitivity/specificity levels

• US 10,335,053 B2
• Filed: 11/20/2018
• Issued: 07/02/2019
• Est. Priority Date: 09/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Inventors: Katra, Rodolphe, Chakravarthy, Niranjan
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US16/196,730
• Publication Number:
  US 20190082989A1
• Time in Patent Office: 224 Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2560/0481 in implanted apparatus
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• 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: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Embodiments of the present disclosure describe methods of adaptive arrhythmia detection comprising monitoring ECG signals of a patient via a patient medical device, detecting and capturing ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold; and adjusting the sensitivity level based on previously captured ECG segments. Embodiments of the present disclosure further describe patient medical devices comprising one or more electrodes and sensing circuitry for monitoring ECG signals of a patient; and a processing module configured to receive the monitored ECG signal, wherein the processing module detects and captures ECG segments based on a plurality of heart rate thresholds and one or more sensitivity levels associated with each of the heart rate thresholds, and adjusts at least one of the one or more sensitivity levels associated with each of the heart rate thresholds.

Claims

1. A method of adaptive arrhythmia detection, the method comprising:

monitoring ECG signals of a patient via a patient medical device;

detecting arrhythmic ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold;

incrementing a count of detected arrhythmic ECG segments in response to each arrhythmic ECG segment detected; and

increasing the sensitivity level associated with the heart rate threshold in response to the count of detected arrhythmic ECG segments failing to exceed a threshold within a given time period.

2. The method of claim 1, wherein monitoring ECG signals of a patient via a patient medical device includes sensing ECG signals.

3. The method of claim 1, wherein the patient medical device is one or more of an adherent device, an implantable device, an insertable device, and a wearable device.

4. The method of claim 1, wherein detecting arrhythmic ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold includes determining the number of beats above the heart rate threshold in a case of tachycardia and below the heart rate threshold in a case of bradycardia.

5. The method of claim 1, wherein detecting arrhythmic ECG segments based on a heart rate threshold and an initial sensitivity level associated with the heart rate threshold includes one or more of storing the arrhythmic ECG segment to memory and communicating the arrhythmic ECG segment for one or more of in-monitoring analysis and post-monitoring analysis.

6. The method of claim 1, wherein the adjusting the sensitivity level based on a previously detected arrhythmic ECG segment includes modifying one or more of a X parameter and a Y parameter, the X parameter including the number of detected heart beats above the heart rate threshold in the case of tachycardia and below the heart rate threshold in the case of bradycardia, and the Y parameter including the total number of detected heart beats.

7. The method of claim 1, further comprising resetting the sensitivity level periodically.

8. The method of claim 7, wherein resetting the sensitivity level includes resetting the sensitivity level to the initial sensitivity level.

9. The method of claim 7, wherein resetting the sensitivity level includes resetting the sensitivity level to a sensitivity level determined by a sensitivity profile.

10. The method of claim 1, wherein increasing the sensitivity level further includes increasing the sensitivity level based on one or more of a period of elapsed time, a desired clinical relevance of captured ECG segments, and patient-specific considerations.

11. The method of claim 1, wherein the heart rate threshold includes a plurality of heart rate thresholds corresponding to arrhythmias of various severity, each heart rate threshold characterized by a sensitivity profile, wherein the sensitivity associated with one or more of the plurality of heart rate thresholds is increased in response to the count of detected arrhythmic ECG segments associated with one or more of the heart rate thresholds failing to exceed a threshold within a given time period.

12. The method of claim 1, further including:

decreasing the sensitivity level associated with the heart rate threshold in response to the count of detected arrhythmic ECG segments exceeding a threshold.

13. The method of claim 12, wherein the heart rate threshold includes a plurality of heart rate thresholds corresponding to arrhythmias of various severity, each heart rate threshold characterized by a sensitivity profile, wherein the sensitivity associated with one or more of the plurality of heart rate thresholds is decreased in response to the count of detected arrhythmic ECG segments associated with one or more of the heart rate thresholds exceeding a threshold.

14. A patient medical device, the device comprising:

one or more electrodes and sensing circuitry for monitoring ECG signals of a patient; and

a processing module configured to receive the monitored ECG signal, wherein the processing module detects and captures ECG segments based on a plurality of heart rate thresholds and one or more sensitivity levels associated with each of the heart rate thresholds, increments a count of detected arrhythmic ECG segments corresponding to one of the heart rate thresholds in response to each arrhythmic ECG segment detected based on the heart rate threshold and associated sensitivity level, and increases the sensitivity level associated with the heart rate threshold having a corresponding count of detected arrhythmic ECG segments that fails to exceeds a threshold within a given time period.

15. The patient medical device of claim 14, wherein the patient medical device is one or more of an adherent device, an implantable device, an insertable device, and a wearable device.

16. The patient medical device of claim 14, wherein the processing module is further configured to communicate the captured arrhythmic ECG segment to a patient and/or a remote monitoring center for one or more of in-monitoring review and post-monitoring review.

17. The patient medical device of claim 14, wherein the processing module is further configured to reset at least one of the one or more sensitivity levels periodically.

18. The patient medical device of claim 14, wherein the processing module is further configured to increase the sensitivity level based on one or more of a period of elapsed time, a desired clinical relevance of captured ECG segments, and patient-specific considerations.

19. The patient medical device of claim 18, wherein the processing module is further configured to decrease the sensitivity level associated with the heart rate threshold in response to the count of detected arrhythmic ECG segments exceeding a threshold.