MOBILE THREE-LEAD CARDIAC MONITORING DEVICE AND METHOD FOR AUTOMATED DIAGNOSTICS

• US 20160296132A1
• Filed: 04/11/2016
• Published: 10/13/2016
• Est. Priority Date: 04/09/2015
• Status: Active Grant

• Current Assignee: Heartbeam, Inc.
• Original Assignee: Bosko Bojovic, Ljupco Hadzievski, Uros Mitrovic
• Inventors: VUKCEVIC, Vladan, MITROVIC, Uros, MILETIC, Marjan, BOJOVIC, Bosko, HADZIEVSKI, Ljupco
• Granted Patent: US 10,433,744 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/747 in case of emergency, i.e. alerting emergency services
• CPC Class Codes: G16H 40/63 for local operation
• 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: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods and apparatuses, including devices and systems, for remote and detection and/or diagnosis of acute myocardial infarction (AMI). In particular, described herein are handheld devices having an electrode configuration capable of recording three orthogonal ECG lead signals in an orientation-specific manner, and transmitting these signals to a processor. The processor may be remote or local, and it may automatically or semi-automatically detect AMI, atrial fibrillation or other heart disorders based on the analyses of the deviation of the recorded 3 cardiac signals with respect to previously stored baseline recordings.

Claims

1. A mobile, hand-held apparatus for automated cardiac electrical signal analysis, the apparatus comprising:

a housing having a back, a first side, and a front;

a first electrode and a second electrode integrated on the back of the housing configured to measure bioelectric signals from a patient'"'"'s chest, wherein the first and second electrode are positioned a distance of at least 5 cm apart;

a third electrode configured to measure bioelectric signals from the patient'"'"'s right hand;

a fourth electrode configured to measure bioelectric signals from the patient'"'"'s left hand;

wherein one or both of the third electrode and the fourth electrode are integrated on the front of the housing; and

a processor within the housing configured to record at least three orthogonal cardiac leads from the first, second, third and fourth electrodes, wherein less than three pairs of said electrodes comprise the third electrode.

2. The apparatus of claim 1, further comprising a resistive network connecting at least two of the first, second, third and fourth electrodes, wherein the resistive network forms a central point.

3. The apparatus of claim 2, wherein at least one lead is formed between one of the said electrodes and the central point formed by mutually connecting at least two electrodes by the resistive network.

4. The apparatus of claim 1, further comprising a communication circuit within the housing configured to transmit the three orthogonal cardiac leads to a remote processor.

5. The apparatus of claim 1, further comprising a marker on the housing indicating the orientation of the housing.

6. The apparatus of claim 1, further comprising an LED marker on the housing indicating the orientation of the housing.

7. The apparatus of claim 1, wherein the third and fourth electrodes are disposed on two opposed sides with respect to a longitudinal plane of symmetry of the device housing, said plane of symmetry being substantially perpendicular to the back surface of the device housing.

8. The apparatus of claim 1, further comprising a ground electrode on the housing for contacting one of the patient'"'"'s hands disposed on either the side or front of the housing.

9. The apparatus of claim 1, wherein either the third or fourth electrodes is band-shaped and disposed along the side of the device housing.

10. The apparatus of claim 1, wherein the housing comprises a mobile phone housing, whereby the third or fourth electrodes are configured as conductive transparent areas on the touch screen of the mobile phone.

11. The apparatus of claim 1, wherein the housing is incorporated in a mobile phone housing.

12. The apparatus of claim 1, wherein the housing is the extension structure of a mobile phone housing communicating with the said phone using an electrical connector or wireless communication.

13. The apparatus of claim 1, wherein the housing forms one or more of a mobile phone protective case and a back of a mobile phone.

14. The apparatus of claim 1, further comprising an adhesive patch configured to secure the housing to the user'"'"'s chest so that the first and second electrodes contact the user'"'"'s chest.

15. The apparatus of claim 1, wherein the housing forms a mobile phone protective case with a phone display protective cover and the third and fourth electrodes incorporated in the phone display protective cover.

16. The apparatus of claim 1, further comprising an output in communication with the processor configured to present an output based solely on the processed three orthogonal cardiac leads.

17. The apparatus of claim 1, further wherein the processor is configured to store a first set of three orthogonal cardiac leads taken at a first time, and to determine a differential signal between the three orthogonal cardiac leads taken at the first time and a second set of three orthogonal cardiac leads taken at a different time.

18. A mobile, hand-held apparatus for automated cardiac electrical signal analysis, the apparatus comprising:

a housing having a back, a first side, and a front;

a first electrode and a second electrode integrated on the back of the housing configured to measure bioelectric signals from a patient'"'"'s chest, wherein the first and second electrode are positioned a distance of at least 5 cm apart;

a third electrode configured to measure bioelectric signals from the patient'"'"'s right hand;

a fourth electrode configured to measure bioelectric signals from the patient'"'"'s left hand; and

a processor configured to record at least 3 orthogonal cardiac leads from the first, second, third and fourth electrodes, wherein the processor comprises a register configured to store a first set of three orthogonal cardiac leads taken at a first time, and a comparator configured to determine a difference signal between the first set of three orthogonal cardiac leads and a second set of three orthogonal cardiac leads taken at a second time.

19. A method for automated cardiac diagnostics, the method comprising:

acquiring a first set of at least three orthogonal leads from a patient'"'"'s chest and hands at a first time;

acquiring a second set of at least three orthogonal leads from the patient'"'"'s chest and hands a second time;

performing a beat alignment in a processor on the first and second sets of at least three orthogonal leads to synchronize representative beats from the first and second sets of at least three orthogonal leads;

calculating a difference signal representing the change between the first and second at least three orthogonal leads;

detecting cardiac changes suggestive of a cardiac condition by comparing parameters of the first and second at least three orthogonal leads or by comparing parameters of the difference signal to a predefined threshold; and

communicating cardiac changes from the device to the patient.

20. A method for automated cardiac diagnostics, the method comprising:

positioning a device configured to detect at least three orthogonal leads from a patient'"'"'s chest and hands against the subject'"'"'s chest in a first recording position;

acquiring a first set of at least three orthogonal leads from the device at a first time;

communicating the first set of at least three orthogonal leads to a processor;

positioning the device against the subject'"'"'s chest in a second recording position;

acquiring a second set of at least three orthogonal leads from the patient using the device at a second time;

communicating the second set of at least three orthogonal leads to the processor;

performing a beat alignment in the processor to synchronize representative beats from the first and second sets of at least three orthogonal leads;

calculating a difference signal representing the change between the first and second sets of at least three orthogonal leads;

detecting cardiac changes suggestive of a cardiac condition by comparing one or more parameters of the difference signal to a predefined threshold;

communicating cardiac changes from the device to the patient.

21. The method of claim 20, wherein positioning the device comprises placing a housing of the device having four integrated electrodes against the patient'"'"'s chest.

22. The method of claim 20, wherein communicating the first and second sets of at least three orthogonal leads to the processor comprises communicating the first and second sets of at least three orthogonal leads to a local processor within the housing.

23. The method of claim 20, wherein detecting cardiac changes comprises detecting one or more of:

acute ischemia, atrial fibrillation, atrial flutter, PVCs, and PACs.

24. The method of claim 20, wherein the first and second recording positions are the same position.

25. The method of claim 20, wherein the first and second recording positions are different.

26. The method of claim 20, wherein communicating the first and second sets of at least three orthogonal leads to the processor comprises wirelessly transmitting the first and second sets of at least three orthogonal leads to a remote processor.

27. The method of claim 20, further comprising pre-processing the first and second sets of at least three orthogonal leads in the processor to achieve one or more of:

eliminate power line interference, baseline wandering and/or muscle noise;

obtain a representative beat using fiducial points and median beat procedure; and

check for switching of the left and right finger.

28. The method of claim 20, further comprising compensating for chest electrode miss-positioning between the first and second recording positions in the processor by compensating a heart electrical axis deviation in a three lead vector space.

29. The method of claim 20, wherein detecting cardiac changes suggestive of the cardiac condition comprises determining the Clew of a P wave and processing said Clew in order to detect atrial fibrillation.

30. The method of claim 20, further comprising transmitting any ECG changes suggestive of a cardiac condition from the processor to the device.

31. The method of claim 20, wherein communicating any ECG changes suggestive of a cardiac condition from the device to the patient comprises presenting a visual and/or audible alert to the patient.

32. A method for automated ECG diagnostics, the method comprising:

placing a device comprising a housing having four integrated electrodes arranged to measure three orthogonal leads from a patient'"'"'s chest and hands against the subject'"'"'s chest in a first recording position;

acquiring a first 3 lead ECG recording from the device at a first time;

communicating the first 3 lead ECG recording to a processor;

storing the first 3 lead ECG recording as baseline recording;

placing the device against the subject'"'"'s chest in a second recording position;

acquiring a second 3 lead ECG recording from the device at a second time;

communicating the second 3 lead ECG recording to the processor;

pre-processing the first and second 3 lead ECG recordings in the processor to eliminate power line interference, baseline wandering and muscle noise, obtain a representative beat using fiducial points and median beat procedure, and to check for switching of the left and right finger;

performing beat alignment in the processor to bring representative beats from the first and second 3 lead ECG recordings in a same time frame so that corresponding points are synchronized;

compensating for chest electrode miss-positioning between the first and second recording positions in the processor by compensating a heart electrical axis deviation in a 3 ECG leads vector space;

calculating a difference signal representing the change between the first and second 3 ECG leads recordings;

detecting ECG changes suggesting ischemia by comparing parameters of the first and second 3 lead ECG recording or by comparing parameters of the difference signal to a predefined threshold;

communicating any ECG changes suggesting ischemia from the device to the patient.