Apparatus and method for cordless recording and telecommunication transmission of three special ECG leads and their processing

• US 7,647,093 B2
• Filed: 08/19/2004
• Issued: 01/12/2010
• Est. Priority Date: 08/20/2003
• Status: Active Grant

• Current Assignee: Heartorum, LLC
• Original Assignee: New Cardio Incorporated
• Inventors: Hadzievski, Ljupco, Bojovic, Bosco, Belicev, Petar
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/568,868
• Publication Number:
  US 20060217620A1
• Time in Patent Office: 1,972 Days
• Field of Search: 600/508, 600/509, 600/512, 600/520, 600/522, 600/523, 600/525
• US Class Current: 600/509
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/308 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor

Abstract

The invention is related to a device and method for cordless recording, telecommunication transmission, and processing of three special ECG leads by the means of the mobile device (1) and diagnostic-calibration center (2) where the reconstruction of standard ECG leads is performed. Reconstruction parameters are determined previously by calibration for each patient. In urgent situation, a patient (3) performs recording of three special ECG leads with the mobile device (1), and sends the memorized data to the diagnostic-calibration device (2) via a cellular telephone (4). The patient can trace the process of recording and sending the data with the help of sound and light indicators. Diagnostic-calibration center (2) is equipped with a PC computer (6) connected to a receiving cellular telephone (7) and calibration ECG device (8) with 14 electrodes. Ten electrodes are grouped into a standard 12-channel ECG cable, while the remaining four are used for recording of three special ECG leads and are grouped into a separate box (9) with integrated electrodes arranged identically as the integrated electrodes on the mobile device (1).

Claims

1. A handheld device adapted for placement against the body of a patient in a measurement position to thereby extract special ECG signals for combining with a predetermined calibration matrix in order to construct an ECG, the handheld device comprising:

at least three integrated active electrodes, including first and second integrated active electrodes adapted to electrically contact the chest of the patient in the measurement position, and a third integrated active electrode adapted to electrically contact the left hand of the patient in the measurement position; and

a integrated fourth electrode adapted to electrically contact the right hand of the patient in the measurement positions

wherein said integrated active electrodes and integrated fourth electrode are disposed in the device such that, when in the measurement position, said contact with the chest of the patient by the first and second integrated active electrodes, with the left hand of the patient by the third integrated active electrode, and with the right hand of the patient by the integrated fourth electrode, is operative to achieve maximum recording point vector orthogonality, to thereby optimize ECG reconstruction.

2. The device of claim 1, wherein the first and second integrated active electrodes are arranged such that in the measurement position they are disposed on the patient between the right and left mamilar lines (linea mamillaris) and lie in a line transverse to the medial line (linea mediana anterior) at an angle ranging from about 30°

to about 90°

.

3. The device of claim 1, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the third integrated active electrode is disposed on a side of the handheld device different from the first side.

4. The device of claim 1, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the integrated fourth electrode is disposed on a side of the handheld device different from the first side.

5. The device of claim 1, further comprising a integrated fifth electrode arranged such that in the measurement position, the integrated fifth electrode is in electrical contact with the chest of the patient.

6. The device of claim 5, wherein the first and second integrated active electrodes and the integrated fifth electrode are all disposed on a first side of the handheld device.

7. The device of claim 5, further comprising an amplifier module including first, second and third amplifiers each having associated therewith a first input node adapted for connection to the first, second and third integrated active electrodes, respectively, a reference node adapted for connection to the integrated fourth electrode, and a ground node adapted for connection to the integrated fifth electrode.

8. The device of claim 7, further comprising a control module adapted to receive the outputs of first, second and third amplifiers of the amplifier module and to indicate whether said outputs are within or outside a predetermined range.

9. The device of claim 8, wherein the control module provides an indication of ECG recording status.

10. The device of claim 1, wherein the ECG is a standard 12-lead ECG.

11. A diagnostic system for constructing an ECG of a patient, the system comprising:

a field unit including a handheld device adapted for placement against the body of the patient in a measurement position to thereby extract special ECG signals for combining with a predetermined calibration matrix, the handheld device comprising;

at least three integrated active electrodes, including first and second integrated active electrodes adapted to electrically contact the chest of the patient in the measurement position, and a third integrated active electrode adapted to electrically contact the left hand of the patient in the measurement position; and

an integrated fourth electrode adapted to electrically contact the right hand of the patient in the measurement position wherein said integrated active electrodes and integrated fourth electrode are disposed in the device such that, when in the measurement position, said contact with the chest of the patient by the first and second integrated active electrodes, with the left hand of the patient by the third integrated active electrode, and with the right hand of the patient by the integrated fourth electrode, is operative to achieve maximum recording point vector orthogonality, to thereby optimize ECG reconstruction; and

a diagnostic center in communication with the field unit, the diagnostic center configured to receive signals derived from the three integrated active electrodes and construct therefrom, and from said predetermined calibration matrix, an ECG of the patient.

12. The system of claim 11, wherein the first and second integrated active electrodes are arranged such that in the measurement position they are disposed on the patient between the right and left mamilar lines (linea mamillaris) and lie in a line transverse to the medial line (linea mediana anterior) at an angle ranging from about 30°

to about 90°

.

13. The system of claim 11, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the third integrated active electrode is disposed on a side of the handheld device different from the first side.

14. The system of claim 11, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the integrated fourth electrode is disposed on a side of the handheld device different from the first side.

15. The system of claim 11, further comprising integrated fifth electrode arranged such that in the measurement position, the integrated fifth electrode is in electrical contact with the chest of the patient.

16. The system of claim 15, wherein the first and second integrated active electrodes and the integrated fifth electrode are all disposed on a first side of the handheld device.

17. The system of claim 15, further comprising an amplifier module including first, second and third amplifiers each having associated therewith a first input node adapted for connection to the first, second and third integrated active electrodes, respectively, a reference node adapted for connection to the integrated fourth electrode, and a ground node adapted for connection to the integrated fifth electrode.

18. The system of claim 17, further comprising a control module adapted to receive the outputs of first, second and third amplifiers of the amplifier module and to indicate whether said outputs are within or outside a predetermined range.

19. The system of claim 18, wherein the control module provides an indication of ECG recording status.

20. The system of claim 11, wherein the field unit includes a communication module adapted to communicate with the diagnostic center.

21. The system of claim 20, wherein the communication module is a cellular device.

22. The system of claim 20, wherein the communication module is a modem.

23. The system of claim 11, wherein the ECG is a standard 12-lead ECG.

24. A method for constructing a patient ECG, the method comprising:

placing against the body of the patient in a measurement position a handheld device having first, second and third integrated active electrodes and an integrated fourth electrode, wherein said integrated active electrodes and fourth integrated electrodes are disposed in the device such that, when in the measurement position, contact is with the chest of the patient by the first and second integrated active electrodes, with the left hand of the patient by the third integrated active electrode, and with the right hand of the patient by the integrated fourth electrode, and is operative to achieve maximum recording point vector orthogonality, to thereby optimize ECG reconstruction;

extracting from the first and second integrated active electrodes, respectively, first and second electrical signals derived from the chest of the patient;

extracting from the third integrated active electrode a third electrical signal derived from the left hand of the patient;

extracting from the integrated fourth electrode a reference signal derived from the right hand of the patient;

communicating signals corresponding to the extracted signals to a diagnostic center; and

combining, at the diagnostic center, the communicated signals with a predetermined calibration matrix to construct, an ECG of the patient.

25. The method of claim 24, wherein, in the measurement position, the first and second integrated active electrodes are disposed on the chest between the right and left mamilar lines

(linea mamillaris) and lie in a line transverse to the medial line (linea mediana anterior) at an angle ranging from about 30°

to about 90°

.

26. The method of claim 24, wherein, in the measurement position, both arms of the patient are folded such that at least portions of the right and left hands of the patient establish electrical contact with the handheld device placed against the chest of the patient.

27. The method of claim 24, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the third integrated active electrode is disposed on a side of the handheld device different from the first side.

28. The method of claim 24, wherein the first and second integrated active electrodes are disposed on a first side of the handheld device and the integrated fourth electrode is disposed on a side of the handheld device different from the first side.

29. The method of claim 24, further comprising providing an indication of whether the first, second and third electrical signals are within or outside a predetermined range.

30. The method of claim 24, further comprising providing an indication of ECU recording status.

31. The method of claim 24, wherein the ECG is a standard 12-lead ECG.

32. The method of claim 24, wherein the predetermined calibration matrix is acquired using a calibration device having an electrode arrangement and amplifiers nodes arrangement which is substantially identical to that of the handheld device.

33. The method of claim 24, wherein the predetermined calibration matrix is acquired using a calibration device in the same position on the patient'"'"'s body and in a substantially identical manner as the handheld device.