Mobile three-lead cardiac monitoring device and method for automated diagnostics

• US 10,117,592 B2
• Filed: 06/23/2017
• Issued: 11/06/2018
• Est. Priority Date: 04/09/2015
• Status: Active Grant

• Current Assignee: Heartbeam, Inc.
• Original Assignee: Heartbeam, Inc.
• Inventors: Bojovic, Bosko, Hadzievski, Ljupco, Vukcevic, Vladan, Mitrovic, Uros, Miletic, Marjan
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US15/632,155
• Publication Number:
  US 20170290522A1
• Time in Patent Office: 501 Days
• 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 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• 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, configured to be held by a patient'"'"'s hand against the patient'"'"'s chest;

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

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

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

a resistive network forming a central point in a sagittal plane through the patient'"'"'s chest passing between the third and fourth electrodes when the housing is held against the patient'"'"'s chest, wherein three orthogonal cardiac leads are formed from said electrodes and the central point; and

a processor within the housing configured to process the three orthogonal cardiac leads derived from the first, second, third and fourth electrodes.

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

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

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

5. 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 housing, said plane of symmetry being substantially perpendicular to the back of the housing.

6. 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 first side or front of the housing.

7. The apparatus of claim 1, wherein either the third or fourth electrode is band-shaped and disposed along the first side of the housing.

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

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

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

11. 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.

12. 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.

13. 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.

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

15. The apparatus of claim 2, wherein processor is configured to receive information back from the remote processor.

16. 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, configured to be held by a patient'"'"'s hand against the patient'"'"'s chest;

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

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

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

a resistive network forming a central point in a sagittal plane through the patient'"'"'s chest passing between the third and fourth electrodes when the housing is held against the patient'"'"'s chest, wherein three orthogonal cardiac leads are formed from said electrodes and the central point; and

a processor configured to process the three orthogonal cardiac leads, wherein the processor comprises a register configured to store a first set of values for the three orthogonal cardiac leads taken at a first time, and a comparator configured to determine a difference signal between the first set of values of three orthogonal cardiac leads and a second set of values of the three orthogonal cardiac leads taken at a second time.

17. The apparatus of claim 16, further comprising a communication circuit within the housing configured to transmit the processed three orthogonal cardiac leads to a remote processor.

18. The apparatus of claim 16, further comprising a marker on the housing indicating the orientation of the housing.

19. The apparatus of claim 16, further comprising an LED marker on the housing indicating the orientation of the housing.

20. The apparatus of claim 16, wherein the third and fourth electrodes are disposed on two opposed sides with respect to a longitudinal plane of symmetry of the housing, said plane of symmetry being substantially perpendicular to the back of the housing.

21. The apparatus of claim 16, further comprising a ground electrode on the housing for contacting one of the patient'"'"'s hands disposed on either the first side or front of the housing.

22. The apparatus of claim 16, wherein either the third or fourth electrode is band-shaped and disposed along the first side of the housing.

23. The apparatus of claim 16, wherein the housing comprises a housing of a mobile phone, whereby the third or fourth electrodes are configured as conductive transparent areas on a touch screen of the mobile phone.

24. The apparatus of claim 16, wherein the housing is incorporated in a mobile phone housing.

25. The apparatus of claim 16, wherein the housing is an extension structure of a mobile phone, the housing communicating with the mobile phone using an electrical connector or wireless communication.

26. The apparatus of claim 16, wherein the housing forms one or more of a mobile phone protective case and a back of a mobile phone.

27. The apparatus of claim 16, 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.

28. The apparatus of claim 16, 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.

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

30. The apparatus of claim 17, wherein processor is configured to receive information back from the remote processor.