Two Electrode Apparatus and Methods for Twelve Lead ECG

• US 20140228665A1
• Filed: 04/16/2014
• Published: 08/14/2014
• Est. Priority Date: 06/08/2010
• Status: Active Grant

• Current Assignee: AliveCor Inc.
• Original Assignee: AliveCor Inc.
• Inventors: Albert, David E.
• Granted Patent: US 9,351,654 B2
• Time in Patent Office: Days
• US Class Current: 600/384
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/327 Generation of artificial ECG signals based on measured signals, e.g. to compensate for missing leads
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

Described herein are methods, apparatuses, and systems for heart monitoring of a patient. The heart monitoring system can be used to take an electrocardiogram (ECG) using only two electrodes. A handheld device can be used to sequentially measure the electrical signal between different positions on a patient'"'"'s body. The electrical signals can be processed and analyzed to prepare an ECG for the patient, including a 12-lead ECG.

Claims

1. An electrocardiograph comprising:

an electrocardiograph device having (a) a first electrode assembly with a first electrode adapted to measure an electrical signal on a patient'"'"'s body;

(b) a second electrode assembly with a second electrode adapted to measure an electrical signal on the patient'"'"'s body;

(c) control circuitry configured to measure electrocardiogram signals between the first and second electrodes; and

(d) a data transmission module configured to transmit the measured electrocardiogram signals to a computing device; and

a computing device having a non-transitory computer-readable storage medium storing software that includes instructions that when executed by a processor causes the processor to (a) calculate an average PQRST beat from the measured electrocardiogram signals as the first and second electrodes are sequentially placed in Limb Lead I, II, and III positions on a patient'"'"'s body for a time required to measure at least one heartbeat in each Limb Lead position, the Limb Lead positions known by the processor;

(b) use the relationship (Lead III=Lead II−

Lead I) to time-align and display Limb Leads I, II, and III; and

(c) calculate and display augmented Leads aVR, aVL, and aVF from the time-aligned Limb Leads.

2. The electrocardiograph of claim 1, wherein software further includes instructions that when executed by the processor causes the processor to (d) calculate and display average Leads V1, V2, and V3 from the measured electrocardiogram signals obtained from sequentially placing one of the first and second electrodes in a V1, V2, and V3 position while contacting the other of the first and second electrodes with a left arm of the patient for a time required to measure at least one heart beat;

and (e) calculate and display average Leads V4, V5, and V6 from the measured electrocardiogram signals obtained from sequentially placing one of the first and second electrodes in a V4, V5, and V6 position while contacting the other of the first and second electrodes with a right arm of the patient for a time required to measure at least one heartbeat.

3. The electrocardiograph of claim 1 or 2, wherein the data transmission module is configured to transmit the measured electrocardiogram signals to the computing device by wire.

4. The electrocardiograph of claim 1 or 2, wherein the data transmission module is configured to transmit the measured electrocardiogram signals to the computing device wirelessly.

5. The electrocardiograph of claim 1 or 2, wherein at least one of the first and second electrode assemblies comprises a spring-hinged cuff.

6. The electrocardiograph of claim 1 or 2, wherein at least one of the first and second electrode assemblies comprises a disposable electrode.

7. The electrocardiograph device of claim 1 or 2, wherein the portable computing device is a smartphone and the electrocardiograph device further comprises a housing for the control circuitry and the data transmission module, the housing adapted to fit onto or within a protective case for the smartphone.

8. The electrocardiograph device of claim 1 or 2, wherein the data transmission module is further configured to transmit the measured ECG signals as ultrasonic, frequency modulated (FM) sound signals.

9. The electrocardiograph device of claim 1 or 2, wherein the data transmission module is further configured to encrypt and transmit encrypted signals.

10. A non-transitory computer-readable storage medium storing software that includes instructions that when executed by a processor causes the processor to:

receive and record electrocardiogram signals between a first electrode and a second electrode, the first and second electrodes sequentially placed in predetermined paired positions on a patient'"'"'s body for a time required to measure at least one heartbeat, the paired positions known by the processor and corresponding to Limb Leads I, II and III, and V1, V2, V3, V4, V5, and V6;

for each Limb Lead paired position, determine electrocardiogram signal sets representing a heartbeat and calculate average time-aligned heartbeat representations for Limb Leads I, II and III; and

calculate augmented leads aVR, aVL, and aVF from the average time-aligned heartbeat representations for Limb Leads I, II, and III and output the electrocardiogram signals in a 12-lead electrocardiogram format.

11. The non-transitory computer-readable storage medium of claim 10, wherein the electrocardiogram signals analyzed comprise at least one of wired electrical signals, wireless electromagnetic signals, and acoustic sound signals.

12. The non-transitory computer-readable storage medium of claim 10, wherein the set of instructions, when executed by the processor, further causes the processor to digitize and demodulate frequency modulated electrocardiogram acoustic signals.

13. The non-transitory computer-readable storage medium of claim 10, wherein the set of instructions, when executed by the processor, further causes the processor to interact with a user to identify first and second electrode paired positions corresponding to a lead.

14. The non-transitory computer-readable storage medium of claim 10, wherein the set of instructions, when executed by the processor, further causes the processor to (a) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left arm and the second electrode to the patient'"'"'s right arm, wherein the electrical signal measured between the left arm and right arm corresponds to Lead I in a 12-lead electrocardiogram, and (b) analyze the electrical signal corresponding to Lead I to calculate an average heartbeat representation for Lead I.

15. The non-transitory computer-readable storage medium of claim 14, wherein the set of instructions, when executed by the processor, further causes the processor to (c) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left leg and the second electrode to the patient'"'"'s right arm, wherein the electrical signal measured between the left leg and right arm corresponds to Lead II in a 12-lead electrocardiogram, and (d) analyze the electrical signal corresponding to Lead II to calculate an average heartbeat representation for Lead II.

16. The non-transitory computer-readable storage medium of claim 15, wherein the set of instructions, when executed by the processor, further causes the processor to (e) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left leg and the second electrode to the patient'"'"'s left arm, wherein the electrical signal measured between the left leg and left arm corresponds to Lead III in a 12-lead electrocardiogram, and (f) analyze the electrical signal corresponding to Lead III to calculate an average heartbeat representation for Lead III.

17. The non-transitory computer-readable storage medium of claim 16, wherein the set of instructions, when executed by the processor, further causes the processor to time-align the average heartbeat representations for Lead I and Lead II and calculate aVR, aVL, and aVF average heartbeat representations from the time-aligned average heartbeat representations for Lead I and Lead II.

18. The non-transitory computer-readable storage medium of claim 17, wherein the set of instructions, when executed by the processor, further causes the processor to (g) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode with each of the V1, V2, V3, V4, V5, and V6 chest locations while contacting the second electrode to one of the patient'"'"'s left arm and the patients right arm, wherein the electrical signals measured between each of the V1, V2, V3, V4, V5, and V6 chest locations and the left arm or the right arm correspond to Leads V1, V2, V3, V4, V5, and V6 in a 12-lead electrocardiogram, and (h) analyze the electrical signals corresponding to Leads V1, V2, V3, V4, V5, and V6 to calculate average heartbeat representations for Leads V1, V2, V3, V4, V5, and V6.

19. The non-transitory computer-readable storage medium of claim 18, wherein the left arm is used for Leads V1, V2, and V3 and the right arm is used for Leads V4, V5, and V6.

20. The non-transitory computer-readable storage medium of claim 18, wherein the right arm is used for each of Leads V1, V2, V3, V4, V5, and V6.

21. The non-transitory computer-readable storage medium of claim 18, wherein the set of instructions, when executed by the processor, further causes the processor to (i) output the average heartbeat representations for Leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6.

22. A method for generating a 12-lead electrocardiogram using an electrocardiograph comprising an electrocardiograph device and a portable computing device, the method comprising:

operating a portable computing device and an ECG device having a first electrode, a second electrode, control circuitry, and a data transmission module, the control circuitry configured to measure ECG signals between the first and second electrodes, the data transmission module configured to transmit the measured ECG signals to the portable computing device;

sequentially measuring ECG signals between the first and second electrodes positioned at predetermined locations on a patient'"'"'s body; and

using the portable computing device to generate a 12-lead ECG from the sequentially measured ECG signals between the first and second electrodes.

23. The method of claim 22, wherein the step of sequentially measuring ECG signals comprises:

contacting one of the first and second electrodes with a left arm of a patient while contacting the other of the first and second electrodes with a right arm of the patient to measure an electrical signal corresponding to a Lead I;

contacting one of the first and second electrodes with a left leg of the patient while contacting the other of the first and second electrodes with the right arm of the patient to measure an electrical signal corresponding to a Lead II;

contacting one of the first and second electrodes with the left leg of the patient while contacting the other of the first and second electrodes with the left arm of the patient to measure an electrical signal corresponding to a Lead III;

sequentially contacting one of the first and second electrodes with a V1, V2, V3, V4, V5, and V6 chest location on the patient while contacting the other of the first and second electrodes with the patient'"'"'s left arm or the patient'"'"'s right arm to measure electrical signals corresponding to a Leads V1, V2, V3, V4, V5, and V6, respectively.

24. The method of claim 22, wherein the step of sequentially measuring ECG signals comprises:

contacting one the first and second electrodes with a left arm of a patient while contacting the other of the first and second electrodes with a right arm of the patient to measure an electrical signal corresponding to a Lead I;

contacting one of the first and second electrodes with a left leg of the patient while contacting the other of the first and second electrodes with the right arm of the patient to measure an electrical signal corresponding to a Lead II;

contacting one of the first and second electrodes with the left leg of the patient while contacting the other of the first and second electrodes with the left arm of the patient to measure an electrical signal corresponding to a Lead III;

sequentially contacting one of the first and second electrodes with a V1, V2, and V3 chest location on the patient while contacting the other of the first and second electrodes with the left arm of the patient to measure electrical signals corresponding to Leads V1, V2, and V3, respectively; and

sequentially contacting one of the first and second electrodes with a V4, V5 and V6 chest location on the patient while contacting the other of the first and second electrodes with the right arm of the patient to measure electrical signals corresponding to Leads V4, V5, and V6, respectively.

25. The method of claim 24, further comprising using the portable computing device to time-align the average heartbeat representations for Lead I and Lead II, and calculate aVR, aVL, and aVF from the time-aligned average heartbeat representations for Lead I and Lead II.

26. The method of claim 25, further comprising using the portable computing device to output the ECG signals in a 12-lead ECG format.

27. A system for generating a 12-lead ECG using two electrodes comprising:

a first electrode assembly having a first electrode adapted to measure an electrical signal on a patient'"'"'s body;

a second electrode assembly configured to removably attach to an upper limb of the patient, the second electrode assembly having a second electrode adapted to measure an electrical signal on the patient'"'"'s body;

control circuitry configured to measure ECG signals between the first and second electrodes;

a data transmission module configured to transmit the measured ECG signals to a portable computing device; and

a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by one or more computing devices, that when executed by the one or more computing devices causes the one or more computing devices to;

(a) analyze ECG signals between a first electrode and a second electrode, the first and second electrodes sequentially placed in predetermined paired positions on a patient'"'"'s body;

(b) average the ECG signals for each paired position to calculate average heartbeat representations for each paired position; and

(c) time-align the average heartbeat representations to output in a 12-lead ECG format.

28. The system of claim 27, wherein the first electrode assembly is configured to be hand held.

29. The system of claim 27, wherein the second electrode assembly comprises a spring-hinged cuff.

30. The system of claim 27, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to interact with a user to identify first and second electrode paired positions corresponding to a lead.

31. The system of claim 27, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to (a) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left arm and the second electrode to the patient'"'"'s right arm, wherein the electrical signal measured between the left arm and right arm corresponds to Lead I in a 12-lead ECG, and (b) analyze the electrical signal corresponding to Lead I to calculate an average heartbeat representation for Lead I.

32. The system of claim 31, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to (c) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left leg and the second electrode to the patient'"'"'s right arm, wherein the electrical signal measured between the left arm and right arm corresponds to Lead II in a 12-lead ECG, and (d) analyze the electrical signal corresponding to Lead II to calculate an average heartbeat representation for Lead II.

33. The system of claim 32, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to (e) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode to the patient'"'"'s left leg and the second electrode to the patient'"'"'s left arm, wherein the electrical signal measured between the left arm and right arm corresponds to Lead III in a 12-lead ECG, and (f) analyze the electrical signal corresponding to Lead III to calculate an average heartbeat representation for Lead III.

34. The system of claim 33, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to time-align the average heartbeat representations for Lead I and Lead II and calculate aVR, aVL, and aVF from the time-aligned average heartbeat representations for Lead I and Lead II.

35. The system of claim 34, wherein the set of instructions, when executed by the one or more computing devices, further causes the one or more computing devices to (g) provide instructions to a user or request placement confirmation from the user regarding contacting the first electrode with each of the V1, V2, V3, V4, V5, and V6 chest locations while contacting the second electrode to one of the patient'"'"'s left arm and the patients right arm, wherein the electrical signals measured between each of the V1, V2, V3, V4, V5, and V6 chest locations and the left arm or the right arm correspond to Leads V1, V2, V3, V4, V5, and V6 in a 12-lead ECG, and (h) analyze the electrical signals corresponding to Leads V1, V2, V3, V4, V5, and V6 to calculate average heartbeat representations for Leads V1, V2, V3, V4, V5, and V6.

36. The system of claim 35, wherein the left arm is used for Leads V1, V2, and V3 and the right arm is used for Leads V4, V5, and V6.