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Title:
INTERMEDIATE-LENGTH ECG EVENT IDENTIFICATION
Document Type and Number:
WIPO Patent Application WO/2023/186638
Kind Code:
A1
Abstract:
A controller includes a memory that stores instructions; and a processor that executes the instructions. When executed by the processor, the instructions cause the controller to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event.

Inventors:
GREGG RICHARD (NL)
BABAEIZADEH SAEED (NL)
Application Number:
PCT/EP2023/057264
Publication Date:
October 05, 2023
Filing Date:
March 22, 2023
Export Citation:
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Assignee:
KONINKLIJKE PHILIPS NV (NL)
International Classes:
A61B5/361; A61B5/00; A61B5/024
Domestic Patent References:
WO1999008592A11999-02-25
Foreign References:
US20150272464A12015-10-01
EP2030565A12009-03-04
Other References:
CHATTERJEE SHUBHOJEET ET AL: "Review of noise removal techniques in ECG signals", IET SIGNAL PROCESSING, THE INSTITUTION OF ENGINEERING AND TECHNOLOGY, MICHAEL FARADAY HOUSE, SIX HILLS WAY, STEVENAGE, HERTS. SG1 2AY, UK, vol. 14, no. 9, 1 December 2020 (2020-12-01), pages 569 - 590, XP006094054, ISSN: 1751-9675, DOI: 10.1049/IET-SPR.2020.0104
Attorney, Agent or Firm:
PHILIPS INTELLECTUAL PROPERTY & STANDARDS (NL)
Download PDF:
Claims:
CLAIMS:

1. A controller, comprising: a memory that stores instructions; and a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the controller to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event.

2. The controller of claim 1 , wherein, when executed by the processor, the instructions cause the controller further to: identify noise in the electrocardiograph signal, and eliminate a period where the noise occurs.

3. The controller of either of claims 1 or 2, wherein, when executed by the processor, the instructions cause the controller further to: quantify differences between the electrocardiograph signal and a baseline; determine when the differences exceed a predetermined threshold, and identify the reportable event based on determining that the differences exceed the predetermined threshold.

4. The controller of claim 3, wherein the differences comprise differences between characteristics of the electrocardiograph signal and characteristics of the baseline.

5. The controller of claim 3, wherein, when executed by the processor, the instructions cause the controller further to: quantify differences between a characteristic derived from the electrocardiograph signal and a baseline; determine when the differences exceed a predetermined threshold, and identify the reportable event based on determining that the differences exceed the predetermined threshold.

6. The controller of any one of claims 1, 2, 3, 4 or 5, wherein the report is generated while the electrocardiograph signal is obtained in real-time.

7. A method for clinically analyzing diagnostic electrocardiograph events, the method comprising: obtaining, by an electrocardiograph apparatus, an electrocardiograph signal; identifying a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiating generation of a report of the reportable event.

8. The method of claim 7, further comprising: recording the electrocardiograph signal in real-time to obtain the electrocardiograph signal, wherein the report is generated while the electrocardiograph signal is obtained in realtime.

9. The method of either of claims 7 or 8, further comprising: applying a real-time electrocardiograph algorithm to the electrocardiograph signal to identify the reportable event.

10. The method of any one of claims 7, 8 or 9, further comprising: identifying noise in the electrocardiograph signal, and eliminating a period where the noise occurs.

11. The method of claim 7, 8, 9 or 10, further comprising: quantifying differences between the electrocardiograph signal and a baseline; determining when the differences exceed a predetermined threshold, and identifying the reportable event based on determining that the differences exceed the predetermined threshold, wherein the differences comprise differences between characteristics of the electrocardiograph signal and characteristics of the baseline.

12. A tangible non-transitory computer readable storage medium that stores a computer program, wherein the computer program, when executed by a processor, causes a computer apparatus to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event.

13. The tangible non-transitory computer readable storage medium of claim 12, wherein the computer program, when executed by a processor, causes the computer apparatus further to: record the electrocardiograph signal in real-time to obtain the electrocardiograph signal, wherein the report is generated while the electrocardiograph signal is obtained in real-time.

14. The tangible non-transitory computer readable storage medium of either of claims 12 or 13, wherein the computer program, when executed by a processor, causes the computer apparatus further to: apply a real-time electrocardiograph algorithm to the electrocardiograph signal to identify the reportable event.

15. The tangible non-transitory computer readable storage medium of any one of claims 12, 13 or 14, wherein the computer program, when executed by a processor, causes the computer apparatus further to: identify noise in the electrocardiograph signal, and eliminate a period where the noise occurs.

16. The tangible non-transitory computer readable storage medium of any one of claims 12, 13, 14 or 15, wherein the computer program, when executed by a processor, causes the computer apparatus further to: quantify differences between the electrocardiograph signal and a baseline; determine when the differences exceed a predetermined threshold, and identify the reportable event based on determining that the differences exceed the predetermined threshold, wherein the differences comprise differences between characteristics of the electrocardiograph signal and characteristics of the baseline.

17. A system, comprising: an electrocardiograph apparatus including a memory that stores instructions and a processor that executes the instructions; and a display, wherein, when executed by the processor, the instructions cause the electrocardiograph apparatus to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event for display on the display.

Description:
INTERMEDIATE-LENGTH ECG EVENT IDENTIFICATION

BACKGROUND

[0001] Electrocardiography is used to produce records derived from voltages produced by the heart on the surface of the human body. The terms electrocardiograph and electrocardiogram may be synonymous, and for the sake of consistency the term “electrocardiograph” will be used consistently herein. An electrocardiograph (ECG or EKG) uses electrodes to detect abnormalities in the electrical impulses from a heart. The records produced are graphical in character and require expert interpretation and analysis to relate the resulting information to the heart condition of the patient. Electrocardiographs generally have the ability to record or print a continuous electrocardiograph stream to paper. The paper recordings are used to find an intermittent arrhythmia that can be provoked in some way. Electrocardiograph snapshots of a 10 second duration are the most common diagnostic electrocardiograph when looking for ischemic heart disease (where the heart does not receive enough blood) or persistent arrhythmia (irregular heartbeat). It may take a recording that is longer than 10 seconds to diagnose a difficult arrhythmia. If a patient is suspected to have an intermittent arrhythmia that is not immediately obvious with a 10 second electrocardiograph, a Holter monitor may be prescribed, the patient must be fitted with the Holter monitor, the Holter monitor must record for the required number of days, and then the recorder from the Holter monitor is returned for analysis of the long term recording.

[0002] Several types of intermediate length electrocardiograph analysis of intermediate lengths of time such as 5 minutes have been proposed and implemented. The most common electrocardiograph test which lasts several minutes is an electrocardiograph stress test and involves provoking an ischemic response due to exercise to find underlying coronary heart disease. A signal averaged electrocardiograph test looks for low level fragmented signals at the end of the QRS complex (Q-wave, R-wave and S-wave complex). The high resolution QRS can only be found after several minutes of averaging to remove noise. Additionally, a stress test is a separate test that requires specialized equipment. Short term heart rate variability (HRV) for electrocardiograph segments of 5 minutes has also been investigated as an alternative to 24 hour heart rate variability. As another alternative electrocardiograph analysis which has been used, micro T-wave alternans and macro T-wave alternans (TWA) have been used in conjunction with an electrocardiograph stress test to indicate heart disease. T-wave is the deflection in an electrocardiograph that represents the electrical activity produced by ventricular repolarization. Each one of these electrocardiograph tests has its own specialized system.

[0003] Currently, there are only two solutions for intermittent cardiac symptoms, 10 second resting test or 24 hour ambulatory, but nothing in between. Patients are not diagnosed for intermittent cardiac symptoms when they present for a 10 second electrocardiograph test, and instead, a separate test that requires a wait of days for a result is the only current option for intermediate cardiac symptom diagnosis.

SUMMARY

[0004] According to an aspect of the present disclosure, a controller includes a memory that stores instructions; and a processor that executes the instructions. When executed by the processor, the instructions cause the controller to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event.

[0005] According to another aspect of the present disclosure, a method for clinically analyzing diagnostic electrocardiograph events includes: obtaining, by an electrocardiograph apparatus, an electrocardiograph signal; identifying a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiating generation of a report of the reportable event.

[0006] According to another aspect of the present disclosure, a tangible non-transitory computer readable storage medium stores a computer program. The computer program, when executed by a processor, causes a computer apparatus to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event.

[0007] According to another aspect of the present disclosure, a system includes an electrocardiograph apparatus and a display. The electrocardiograph apparatus includes a memory that stores instructions and a processor that executes the instructions. When executed by the processor, the instructions cause the electrocardiograph apparatus to: obtain an electrocardiograph signal; identify a reportable event from the electrocardiograph signal based on a waveform in the electrocardiograph signal; and initiate generation of a report of the reportable event for display on the display.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The example embodiments are best understood from the following detailed description when read with the accompanying drawing FIG.s. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.

[0009] FIG. 1 A illustrates a system for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0010] FIG. IB illustrates a device for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0011] FIG. 1C illustrates a controller for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0012] FIG. 2A illustrates a method for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0013] FIG. 2B illustrates a method for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0014] FIG. 3 illustrates a flowchart for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0015] FIG. 4 illustrates a visualization of an arrhythmia event in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0016] FIG. 5 illustrates a visualization of a morphology event in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0017] FIG. 6 illustrates a visualization of a morphology comparison in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0018] FIG. 7 illustrates a visualization of a morphology trend in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0019] FIG. 8 illustrates a computer system, on which a method for intermediate-length ECG event identification is implemented, in accordance with another representative embodiment.

DETAILED DESCRIPTION

[0020] In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.

[0021] It will be understood that, although the terms first, second, third etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept.

[0022] The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms ‘a’, ‘an’ and ‘the’ are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms "comprises", and/or "comprising," and/or similar terms when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

[0023] Unless otherwise noted, when an element or component is said to be “connected to”, “coupled to”, or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.

[0024] The present disclosure, through one or more of its various aspects, embodiments and/or specific features or sub-components, is thus intended to bring out one or more of the advantages as specifically noted below. For purposes of explanation and not limitation, example embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. However, other embodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted so as to not obscure the description of the example embodiments. Such methods and apparatuses are within the scope of the present disclosure.

[0025] As described herein, an electrocardiograph system, apparatus, device and/or controller is configured to identify reportable events from electrocardiograph signals based on waveforms in the electrocardiograph signal, so as to initiate generation of a report of the reportable event. The identification of reportable events may occur in real-time or near real-time, and may be performed by the same electrocardiograph system, apparatus, device and/or controller as is used to perform the electrocardiography.

[0026] FIG. 1A illustrates a system 100 for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0027] The system 100 in FIG. 1 A is a system for intermediate-length ECG event identification and includes components that may be provided together or that may be distributed. The system 100 includes an ECG apparatus 110 with wires 112, and a display 180. A computer system that can be used to implement some of the logical circuitry of the ECG apparatus 110 is depicted in FIG. 8, though the ECG apparatus 110 may include more or fewer elements than depicted in FIG. 8. The ECG apparatus 110 may be a 12-lead electrocardiograph apparatus, adapted to implement the intermediate-length ECG event identification described herein. The ECG apparatus 110 may be a device 101 as shown in FIG. IB and may include a controller 150 as shown in and described with respect to FIG. 1C. The wires 112 may include ten wires in a 12- lead electrocardiograph configuration, with each wire terminating with an electrode, so as to include nine signal electrodes and one active ground electrode.

[0028] A 12-lead electrocardiograph apparatus uses nine signal electrodes and one active ground electrode. Three signal electrodes are placed on limbs including the right arm, left arm, and left leg. Six signal electrodes are placed on the chest. The active ground or reference electrode is placed on the right leg, although it may be placed anywhere. Each of the nine signal electrodes acts in combination with one or more other of the nine signal electrodes to detect voltages produced by depolarization and repolarization of the sum of individual heart muscle cells. The detected voltages are combined and processed to produce twelve tracings of time varying voltages as the 12 electrocardiograph leads. The 12 electrocardiograph leads consist of three limb leads (I, II, and III), three augmented limb leads (aVR, aVL, and aVF), and six precordial leads (VI to V6). The three limb leads and the three augmented limb leads record the electrical potentials in the frontal plane. The six precordial leads VI -V6 are located on the torso of the patient. The twelve tracings of time varying voltages for an ECG apparatus 110 which has 12 leads are as listed in Table 1 below:

TABLE 1

Lead Voltage

I VL - VR

II VF - VR

III VF - VL aVR VR - (VL + VF)/2 aVL VL - (VR + VF)/2 aVF VF - (VL + VR)/2

VI VI - (VR + VL+ VF)/3 Lead Voltage

V2 V2 - (VR + VL + VF)/3

V3 V3 - (VR + VL + VF)/3

V4 V4 - (VR + VL + VF)/3

V5 V5 - (VR + VL + VF)/3

V6 V6 - (VR + VL + VF)/3

[0029] In a standard electrocardiograph system for generating short term electrocardiographic recordings of supine subjects, the potentials indicated above, and their associated electrode positions, are: VL potential of an electrode on the left arm; VR potential of an electrode on the right arm; VF potential of an electrode on the left leg; VI potential of an electrode on the front chest, right of sternum in the 4th rib interspace; V2 potential of an electrode on the front chest, left of sternum in the 4th rib interspace; V4 potential of an electrode at the left mid-clavicular line in the 5th rib interspace; V3 potential of an electrode midway between the V2 and V4 electrodes; V6 potential of an electrode at the left mid-axillary line in the 5th rib interspace; V5 potential of an electrode midway between the V4 and V6 electrodes; G (not indicated above) is an active ground or reference potential with respect to which potentials VL, VR, VF, and VI through V6 are measured. As noted, the active ground or reference voltage is typically, though not necessarily, positioned on the right leg.

[0030] The display 180 may be local to the ECG apparatus 110 or may be remotely connected to the ECG apparatus 110. The display 180 may be connected to the ECG apparatus 110 via a local wired interface such as an HDMI cable or via a local wireless interface such as a Wi-Fi connection. The display 180 may be interfaced with other user input devices by which users can input instructions, including microphones for spoken instructions, mouses, keyboards, thumbwheels, gyro-accelerometer based gesture devices and so on.

[0031] The display 180 may be a monitor such as a computer monitor, a display on a mobile device, an augmented reality display, a television, an electronic whiteboard, or another screen configured to display electronic imagery. The display 180 may also include one or more input interface(s) such as those noted above that may connect other elements or components to the controller 150, as well as an interactive touch screen configured to display prompts to users and collect touch input from users.

[0032] FIG. IB illustrates device 101 for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0033] The device 101 includes a controller 150, the display 180, and the wires 112. In the embodiment of FIG. IB, the device 101 comprises the entirety or substantially the entirety of the elements of the system 100 in FIG. 1A. The controller 150 is further depicted in FIG. 1C, and includes at least a memory 151 that stores instructions and a processor 152 that executes the instructions. A computer that can be used to implement the device 101 is depicted in FIG. 8, though a device 101 may include more or fewer elements than depicted in FIG. 1C or in FIG. 8. [0034] Insofar as the ECG apparatus 110 and the device 101 are each configured to be used as patient-connected hardware, the ECG apparatus 110 and the device 101 may be electrically isolated in accordance with safety standards. The electrical isolation may help prevent patients from being connected to power if a fault occurs.

[0035] FIG. 1C illustrates a controller 150 for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0036] The controller 150 includes a memory 151, a processor 152, a first interface 156, a second interface 157, a third interface 158, and a fourth interface 159. The memory 151 stores instructions which are executed by the processor 152. The processor 152 executes the instructions. The controller 150 may be implemented in the ECG apparatus 110 of FIG. 1 A or the device 101 of FIG. IB. The first interface 156, the second interface 157 and the third interface 158 are representative of interfaces to elements such as individual wires among the wires 112, ports, disk drives, wireless antennas, or other types of circuitry. The fourth interface 159 is representative of a user interface, such as a keyboard or one or more individual buttons in on or the ECG apparatus 110 or the device 101.

[0037] The controller 150 may perform some of the operations described herein directly and may implement other operations described herein indirectly. For example, the controller 150 may directly perform logical operations attributed to the ECG apparatus 110, the device 101 or the system 100, and indirectly control other operations such as by generating and transmitting content to be displayed on the display 180. Accordingly, the processes implemented by the controller 150 when the processor 152 executes instructions from the memory 151 may include steps not directly performed by the controller 150.

[0038] The system 100, the device 101 and the controller 150 may each be configured to generate a high-resolution intermediate-length electrocardiograph recording. The memory 151 is configured to store the intermediate-length electrocardiograph recording. The system 100, the device 101 and the controller 150 may execute algorithms, including: an algorithm to detect arrythmia events, an algorithm to detect noise levels, an algorithm to calculated heart rate variability, an algorithm to evaluate events as standard 10 second, 12-lead electrocardiographs, and an algorithm for morphology comparisons. The algorithm for morphology comparisons may generate results showing intensifying chest pain events, results showing QT interval prolonging drugs, and repolarization changes such as ST-segment, T-wave amplitude and T-wave morphology.

[0039] The system 100, the device 101 and the controller 150 may execute the algorithms to detect arrythmia events, detect and filter out noise, perform high resolution signal averaging, macro T-wave alternans averaging, determine signal-averaged electrocardiography (SAECG ) status, generate heart rate trends and statistics, generate a heart rate variability (HRV) report, identify ST-segment, T-wave and widening QRS trends, generate a report of arrhythmia events, identify changes in morphology in events in the summary report, and more.

[0040] FIG. 2A illustrates a method for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0041] The method of FIG. 2A starts by obtaining an electrocardiograph signal. The electrocardiograph signal may be obtained on an intermediate basis, such as for a period of 5 minutes or 10 minutes, and may be obtained by the ECG apparatus 110 or the device 101. [0042] At S220, the method of FIG. 2A includes identifying noise and eliminating or ignoring a period where noise occurs. The period where noise occurs may be identified by analyzing data of the electrocardiograph signal, and identifying anomalies in the data so that a period in which the anomalies occurs may be eliminated from consideration in the event identification described herein.

[0043] At S230, the method of FIG. 2A includes identifying a reportable event. The reportable event may be a cardiac event that occurs periodically or intermittently, and that is detectable in the same session in which the electrocardiograph signals are obtained at S210. The identification may be performed by analyzing electrocardiograph data of the 12 time-sensitive tracings obtained by the ECG apparatus 110 or the device 101 over an intermediate length of time such as 5 minutes, 10 minutes or 20 minutes. The intermediate length of time may be uninterrupted, and the identification at S230 may be performed in the same uninterrupted intermediate-length session as when the electrocardiograph signal is obtained at S210. Additionally, the identification at S230 may be performed even while the electrocardiograph signal is still being obtained at S210.

[0044] At S240, the method of FIG. 2A includes initiating generation of a report. For example, the controller 150 may generate and output data reporting the reportable event identified at S230, and may send the data reporting the reportable event to a predetermined recipient over an electronic communication network. For example, the report may be an alert such as a visual and/or audible signal if the reportable event warrants immediate attention. The report may include an analysis including one or more graphs of the electrocardiograph signal, a description of the reportable event and when it occurred and where it appears on one or more graph(s), a characterization of the seriousness of the reportable event, and other information. Generation of the report may be initiated during the same session in which the electrocardiograph signals are obtained at S210. Therefore, the report may be generated while the electrocardiograph signal is still being obtained in real-time, or otherwise in near real-time. The method of FIG. 2A may include recording the electrocardiograph signal in real-time, so that the report is generated while the electrocardiograph signal is obtained in real-time.

[0045] FIG. 2B illustrates a method for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0046] The method of FIG. 2B may be performed after the noise is eliminated from consideration at S220 in FIG. 2A, and may be performed as part of the identification at S230 in FIG. 2A. The method of FIG. 2B starts at S223 by quantifying differences. The differences which are quantified may be differences between characteristics of the electrocardiograph signal and characteristics of a baseline. The baseline may be a predetermined baseline or may be dynamically adjusted on an ongoing basis, such as a running average of measurements of the electrocardiograph signal. Many types of differences from electrocardiograph signals may be quantified at S223. For example, an individual waveform may have an amplitude, and adjacent waveforms may have frequencies and periods. Differences may be identified between minimums, maximums and/or medians, such as minimum amplitudes, maximum amplitudes and/or median amplitudes.

[0047] In some embodiments, a quantification at S223 may be between periods such as heart rates at different times. For example, if a heart rate in a 10 second segment starting at 40 seconds into an ECG session is 70 beats per minute, and the heart rate increases to 90 beats per minute in a 10 second segment starting at 4 minutes, 20 seconds into the ECG session, the increase in heart rate may be quantified as a difference. Analysis at S223 may, for example, include searching for the largest increase or decrease between heart rates during the ECG session, or the largest increase or decrease adjusted for the difference in times when the measurements of the compared heart rates are taken.

[0048] In some embodiments, a quantification at S223 may be between a difference between an extreme measurement and an average of measurements. For example, the ECG apparatus 110 may periodically or constantly record an average of measurements such as heart rates, and then compare the average to each new measurement to identify extreme measurements. In some embodiments, the average may be maintained on a trailing basis, such as the trailing 30 or 60 seconds. Differences that are larger than a predetermined threshold may result in identification of a reportable event at S230 and initiation of generation of a report at S240.

[0049] In some embodiments, comparisons may be between real-time measurements and baselines such as values that are considered “normal” for a demographic group which includes the patient. In some embodiments, comparisons may be between real-time measurements and averages, such as averages for a demographic group which includes the patient or averages specific to measurements of the patient.

[0050] In some embodiments, comparisons may be made to identify sudden differences from a baseline QRS axis and QRS duration. Sudden differences from a baseline QRS axis and QRS duration may indicate an intermittent conduction defect. For example, sudden differences from a baseline QRS axis and QRS duration may indicate a change from normal conduction to right bundle branch block. [0051] At S226, the method of FIG. 2B includes determining when the differences exceed a predetermined threshold. Predetermined thresholds may be set for multiple different characteristics of electrocardiograph signals. Additionally, predetermined thresholds may be customized based on demographic characteristics of patients. Thresholds may also be adjusted, such as for trailing averages of the characteristics, so that a measurement that is more (or less) than a trailing average by 20%, for example, indicates a reportable event.

[0052] At S230, the method of FIG. 2B includes identifying the reportable event. The reportable event may be identified based on the differences exceeding a predetermined threshold as determined at S226. The reportable event may be reported as a summary report and/or a full report, and may provide a summary and/or details of the reportable event and the context in which the reportable event occurred.

[0053] In some embodiments, a trained artificial intelligence model may be applied to identify reportable events at S230. For example, a trained artificial intelligence model may be trained to identify characteristics of electrocardiograph waveforms that indicate an illness, and the training may be used to identify patients with an illness even though the patients are not complaining about related symptoms. Large datasets of electrocardiograph waveforms with varying corresponding diagnoses may be used to train such artificial intelligence models, and inputs to such trained artificial intelligence models may include demographic information of patients as well as characteristics of the electrocardiograph waveforms or the electrocardiograph waveforms themselves.

[0054] FIG. 3 illustrates a flowchart for intermediate-length ECG event identification, in accordance with a representative embodiment.

[0055] FIG. 3 shows a high level block diagram of the main embodiment. A real-time electrocardiograph signal is analyzed by the event detector 301 on the left. The event detector 301 may comprise a real-time electrocardiograph algorithm. Detected events are passed to a 12- lead electrocardiograph analysis 303 on the bottom via the event handler 302 as a 10 second ECG for further evaluation. The 12-lead event becomes a standard 12-lead electrocardiograph report, and may be provided as one standard 12-lead electrocardiograph report per detected event. An analysis summary 304 provides a summary for the 12-lead electrocardiograph report, and the 12-lead electrocardiograph analysis 303 provides a description of the events for the 12- lead electrocardiograph report. When a report is triggered, the report is generated from a predetermined list for different 12-lead electrocardiograph events, and may include a summary of heart rate, arrhythmia and morphology changes during the recording period, as well as details of the events or a subset of events as a 12-lead electrocardiograph interpretation.

[0056] A user may be enabled to specify a maximum number of each type of event that appears in the final report. Some types of event may be set to a maximum of zero (0) so that these types of events are effectively ignored in the report.

[0057] FIG. 4 illustrates a visualization of an arrhythmia event in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0058] FIG. 4 shows a sample arrhythmia event as a 12-lead electrocardiograph report including the ECG signal at the bottom, ECG measurements on the upper left and ECG interpretation top center.

[0059] The visualization in FIG. 4 is for a 10 second segment and shows an arrythmia event which serves as the start of a ventricular run or ventricular tachycardia. The visualization in FIG. 4 is provided via a user interface 481, such as via the display 180. The visualization in FIG. 4 includes an indicator labeled “START” at the top to indicate the start of a ventricular run. A report for the event may identify that the 10 second segment has been identified as the start of the ventricular run on a specified date at a specified time. The report may also specify the age and gender of the patient, and various measurements and observable characteristics. For example, the report may include an average heart rate of 138, and a variety of cardiac characteristics such as a probable precordial electrode reversal, an atrial flutter, ventricular tachycardia, nonspecific intraventricular conduction delay, a probably anterior infarct, and suggestions for review by the clinician.

[0060] FIG. 5 illustrates a visualization of a morphology event in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0061] FIG. 5 shows a morphology event as a 12-lead electrocardiograph report. The visualization in FIG. 5 is for a 10 second segment with readings for 4 leads of the 12-lead electrocardiograph report. The visualization in FIG. 5 is provided via a user interface 581, such as via the display 180. A report for the event may identify that the 10 second segment has been identified as a standard event on a specified date at a specified time. The report may also specify the age and gender of the patient, and various measurements and observable characteristics. For example, the report may include an average heart rate of 74, and a variety of cardiac characteristics such as sinus rhythm, in acute inferior posterior infarction, and suggestions for review by the clinician.

[0062] FIG. 6 illustrates a visualization of a morphology comparison in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0063] The visualization in FIG. 6 is provided via a user interface 681, such as via the display 180. FIG. 6 shows the morphology event as a morphology comparison where the average beat of the event is shown on top of the average beat from the earlier reference ECG. In this example, the ST-segment elevation in leads II, III and aVF along with ST-segment depression in leads VI - V4 make up the morphology change.

[0064] FIG. 7 illustrates a visualization of a morphology trend in intermediate-length ECG event identification, in accordance with a representative embodiment.

[0065] The visualization in FIG. 7 is provided via a user interface 781, such as via the display 180. FIG. 7 shows an example morphology trend, in this case ST-segment deviation due to blockage of a coronary artery.

[0066] Using the teachings herein, events such as arrhythmia may be detected by a real-time electrocardiograph algorithm with a short latency. For example, the method of FIG. 2A may include applying a real-time electrocardiograph algorithm to the electrocardiograph signal to identify the reportable event. Arrhythmia events include: the start of episodes such as atrial fibrillation or ventricular tachycardia; and the end of episodes such as atrial fibrillation to sinus rhythm change. Low-noise events may be detected by local minima in a derived noise parameter. [0067] Using the teachings herein, events may be evaluated using a diagnostic 12-lead electrocardiograph algorithm. Arrhythmia events may be passed to a host of the ECG apparatus 110 in real-time for immediate viewing on the display 180. Arrhythmia events may be confirmed by the 12-lead electrocardiograph algorithm, and expert rules used to confirm the arrhythmia events may be forwarded along with the reports for the events. Unconfirmed reports may be withheld from forwarding to the host of the ECG apparatus 110. Events may be reviewed manually, either in real-time or after the report is generated, either ignored in the report or deleted later from the report. Additionally, periodic low noise events may be evaluated for morphology changes

[0068] Reports may be provided as summaries and/or as full reports. A summary report may include a list of confirmed event times and event label, a heart rate trend, heart rate summary statistics, morphology parameter trends with statistics, and a morphology comparison. Heart rate summary statistics may include a minimum heart rate, a maximum heart rate and a mean heart rate. Morphology parameter trends with statistics may include global parameters such as heart rate corrected QT interval, QRS axis, QRS duration, in addition to per lead measurements such as T-wave amplitude and ST-segment amplitude per ECG lead. A morphology comparison may include an average beat of the event shown on top of the average beat of the reference.

[0069] In some embodiments, a signal-averaged electrocardiography (SAECG) analysis may be provided as part of a report. The SAECG analysis may add a high resolution beat averager which uses cross correlation for alignment. A report using an SAECG analysis may also add a noise threshold for a high resolution beat average, a beat count.

[0070] The ECG apparatus 110 may also be provided with a real-time SAECG status monitor showing progress toward a low noise average beat, so that an operator or patient is made aware when an ECG exam has been performed for enough time to identify and filter out noise.

[0071] In some embodiments, a report may include heart rate variability (HRV) analysis.

[0072] In some embodiments, a report may include a T-wave alternans analysis. For example, an even/odd beat averager may be included in a report. Evan and odd beat averages may be compared to detect macro T-wave alternans. A report may also include a macro T-wave alternans report.

[0073] FIG. 8 illustrates a computer system, on which a method for intermediate-length ECG event identification is implemented, in accordance with another representative embodiment.

[0074] Referring to FIG.8, the computer system 800 includes a set of software instructions that can be executed to cause the computer system 800 to perform any of the methods or computer- based functions disclosed herein. The computer system 800 may operate as a standalone device or may be connected, for example, using a network 801, to other computer systems or peripheral devices. In embodiments, a computer system 800 performs logical processing based on digital signals received via an analog-to-digital converter.

[0075] In a networked deployment, the computer system 800 operates in the capacity of a server or as a client user computer in a server-client user network environment, or as a peer computer system in a peer-to-peer (or distributed) network environment. The computer system 800 can also be implemented as or incorporated into various devices, such as a workstation that includes a controller, a stationary computer, a mobile computer, a personal computer (PC), a laptop computer, a tablet computer, or any other machine capable of executing a set of software instructions (sequential or otherwise) that specify actions to be taken by that machine. The computer system 800 can be incorporated as or in a device that in turn is in an integrated system that includes additional devices. In an embodiment, the computer system 800 can be implemented using electronic devices that provide voice, video or data communication. Further, while the computer system 800 is illustrated in the singular, the term “system” shall also be taken to include any collection of systems or sub-systems that individually or jointly execute a set, or multiple sets, of software instructions to perform one or more computer functions.

[0076] As illustrated in FIG. 8, the computer system 800 includes a processor 810. The processor 810 may be considered a representative example of a processor of a controller and executes instructions to implement some or all aspects of methods and processes described herein. The processor 810 is tangible and non-transitory. As used herein, the term “non- transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period. The term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time. The processor 810 is an article of manufacture and/or a machine component. The processor 810 is configured to execute software instructions to perform functions as described in the various embodiments herein. The processor 810 may be a general- purpose processor or may be part of an application specific integrated circuit (ASIC). The processor 810 may also be a microprocessor, a microcomputer, a processor chip, a controller, a microcontroller, a digital signal processor (DSP), a state machine, or a programmable logic device. The processor 810 may also be a logical circuit, including a programmable gate array (PGA), such as a field programmable gate array (FPGA), or another type of circuit that includes discrete gate and/or transistor logic. The processor 810 may be a central processing unit (CPU), a graphics processing unit (GPU), or both. Additionally, any processor described herein may include multiple processors, parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices.

[0077] The term “processor” as used herein encompasses an electronic component able to execute a program or machine executable instruction. References to a computing device comprising “a processor” should be interpreted to include more than one processor or processing core, as in a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed among multiple computer systems. The term computing device should also be interpreted to include a collection or network of computing devices each including a processor or processors. Programs have software instructions performed by one or multiple processors that may be within the same computing device or which may be distributed across multiple computing devices.

[0078] The computer system 800 further includes a main memory 820 and a static memory 830, where memories in the computer system 800 communicate with each other and the processor 810 via a bus 808. Either or both of the main memory 820 and the static memory 830 may be considered representative examples of a memory of a controller, and store instructions used to implement some or all aspects of methods and processes described herein. Memories described herein are tangible storage mediums for storing data and executable software instructions and are non-transitory during the time software instructions are stored therein. As used herein, the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period. The term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time. The main memory 820 and the static memory 830 are articles of manufacture and/or machine components. The main memory 820 and the static memory 830 are computer-readable mediums from which data and executable software instructions can be read by a computer (e.g., the processor 810). Each of the main memory 820 and the static memory 830 may be implemented as one or more of random access memory (RAM), read only memory (ROM), flash memory, electrically programmable read only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), registers, a hard disk, a removable disk, tape, compact disk read only memory (CD-ROM), digital versatile disk (DVD), floppy disk, blu-ray disk, or any other form of storage medium known in the art. The memories may be volatile or non-volatile, secure and/or encrypted, unsecure and/or unencrypted. [0079] “Memory” is an example of a computer-readable storage medium. Computer memory is any memory which is directly accessible to a processor. Examples of computer memory include, but are not limited to RAM memory, registers, and register files. References to “computer memory” or “memory” should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices. [0080] As shown, the computer system 800 further includes a video display unit 850, such as a liquid crystal display (LCD), an organic light emitting diode (OLED), a flat panel display, a solid-state display, or a cathode ray tube (CRT), for example. Additionally, the computer system 800 includes an input device 860, such as a keyboard/virtual keyboard or touch-sensitive input screen or speech input with speech recognition, and a cursor control device 870, such as a mouse or touch-sensitive input screen or pad. The computer system 800 also optionally includes a disk drive unit 880, a signal generation device 890, such as a speaker or remote control, and/or a network interface device 840.

[0081] In an embodiment, as depicted in FIG. 8, the disk drive unit 880 includes a computer- readable medium 882 in which one or more sets of software instructions 884 (software) are embedded. The sets of software instructions 884 are read from the computer-readable medium 882 to be executed by the processor 810. Further, the software instructions 884, when executed by the processor 810, perform one or more steps of the methods and processes as described herein. In an embodiment, the software instructions 884 reside all or in part within the main memory 820, the static memory 830 and/or the processor 810 during execution by the computer system 800. Further, the computer-readable medium 882 may include software instructions 884 or receive and execute software instructions 884 responsive to a propagated signal, so that a device connected to a network 801 communicates voice, video or data over the network 801. The software instructions 884 may be transmitted or received over the network 801 via the network interface device 840.

[0082] In an embodiment, dedicated hardware implementations, such as application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), programmable logic arrays and other hardware components, are constructed to implement one or more of the methods described herein. One or more embodiments described herein may implement functions using two or more specific interconnected hardware modules or devices with related control and data signals that can be communicated between and through the modules. Accordingly, the present disclosure encompasses software, firmware, and hardware implementations. Nothing in the present application should be interpreted as being implemented or implementable solely with software and not hardware such as a tangible non-transitory processor and/or memory.

[0083] In accordance with various embodiments of the present disclosure, the methods described herein may be implemented using a hardware computer system that executes software programs. Further, in an exemplary, non-limited embodiment, implementations can include distributed processing, component/object distributed processing, and parallel processing. Virtual computer system processing may implement one or more of the methods or functionalities as described herein, and a processor described herein may be used to support a virtual processing environment.

[0084] Accordingly, intermediate-length ECG event identification enables analysis of ECGs of intermediate length, such as 5, 10 or 20 minutes and from a variety of diagnostic ECG devices. The teachings herein may also be applied in prehospital defibrillator monitors to detect ST- segment changes in chest pain patients. Intermediate-length ECG event identification provided recordings at a duration longer than 10 seconds, allowing a detailed review at high resolution by scrolling. The longer duration recordings are stored, and may be automatically marked with detected events. The results of the longer recording in intermediate-length ECG event identification occurs in real-time, and results in detection of illnesses that are not detected in standard 10-second ECG segments. Additionally, intermediate-length ECG event identification can be used with provoked arrythmia or provoked morphology changes, and the provoked arrythmia or provoked morphology changes may be captured for several minutes or longer if the arrhythmia does not occur immediately. Examples of provoked morphology changes include ST- segment changes and T-wave changes in response to drugs used to simulate exercise. The events may be recorded, automatically marked, and added to a report. Moreover, intermediate-length ECG event identification may be used to perform several types of specialized testing without requiring different recordings or tests.

[0085] Although intermediate-length ECG event identification has been described with reference to several exemplary embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of intermediate-length ECG event identification in its aspects. Although intermediate-length ECG event identification has been described with reference to particular means, materials and embodiments, intermediate- length ECG event identification is not intended to be limited to the particulars disclosed; rather intermediate-length ECG event identification extends to all functionally equivalent structures, methods, and uses such as are within the scope of the appended claims.

[0086] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the FIGs are to be regarded as illustrative rather than restrictive.

[0087] One or more embodiments of the disclosure may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept. Moreover, although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.

[0088] The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.

[0089] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.