ECG DEVICE

• US 20150374256A1
• Filed: 02/21/2014
• Published: 12/31/2015
• Est. Priority Date: 02/22/2013
• Status: Active Grant

• Current Assignee: Falko Skrabal
• Original Assignee: Falko Skrabal
• Inventors: SKRABAL, Falko
• Granted Patent: US 10,517,499 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0285 Measuring or recording phase velocity of blood waves
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/1102 Ballistocardiography
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/252 by suction
• 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 5/35 by template matching
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6829 : Foot or ankle
• CPC Class Codes: A61B 5/6831 : Straps, bands or harnesses
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6834 : using vacuum
• CPC Class Codes: A61B 5/6838 : Clamps or clips
• CPC Class Codes: A61B 5/721 : using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured

Abstract

An ECG device comprising limb leads and chest wall leads is described which is also suitable for deriving the hemodynamic activity of the heart and the function of the vessels and, respectively, also for evaluating the fluid equilibrium. This is achieved in that at least part of the electrodes of the multichannel ECG is developed with additional embodiments for physical emissions and measurements, for example, electric current and voltage, pressure, sound vibrations, light, and that an electrode is provided for the current supply and, respectively, the voltage measurement at the upper thorax aperture. Furthermore, an alternating current field is built up between the electrodes or, respectively, the distance between the electrodes is used as an ion conductor. Thus, during the conventional ECG writing, the acceleration of the blood and hence the cardiac output, the valve closure and the valve opening, as well as the mechanics of individual circulation sections, for example, also the pulse wave transit time, the blood flow in body sections, the body composition etc. can also be registered and output simultaneously with the routine ECG.

Claims

1-27. -27. (canceled)

28. An ECG device with ECG leads comprising at least limb electrodes, wherein at least one of the ECG lead electrodes is designed, in addition to its ECG lead function, for the emission and/or for receiving additional physical signals, in particular current, voltage, pressure, sound, light, temperature, position, wherein the ECG lead electrodes are furthermore designed for being arranged at the human body spaced apart from each other, thereby building up an alternating current field between each other, wherein, in addition to the ECG leads, at least one electrode positionable at the upper thorax aperture, in particular at the head, neck, the back of the neck, at the shoulder or the arms is provided, which is designed for the supply and/or measurement of an alternating current, wherein the ECG device is configured such that also the change in impedance in dependence of the heartbeat is recorded in at least one body segment close to the heart and at least one body segment remote from the heart, wherein at least one of the ECG lead electrodes comprises an electrode body which comprises a sensor for mechanical vibrations being configured as an accelerometer.

29. An ECG device according to claim 28, characterized in that a recess is provided within the electrode body, in which recess the sensor for mechanical vibrations is accommodated asymmetrically opposite to an electrically conductive electrode.

30. An ECG device according to claim 28, characterized in that, for the evaluation of the output signals provided by the sensor for mechanical vibrations, at least one, preferably at least two, frequency filters is/are provided, and at least one, preferably at least two, filtered frequency ranges of the output signals is/are analyzed separately, wherein the filters are preferably designed as band-pass filters with a frequency band of between 50 and 1000 Hz and as band-pass filters with a frequency band of between 0.1 Hz and 70 Hz.

31. An ECG device according to claim 28, characterized in that it calculates and indicates the systolic and/or diastolic function and/or disorders thereof from the change of impedance dz/dt at the thorax and/or the legs determined by the electrodes and/or from physical measurement signals obtained by the at least one sensor for mechanical vibrations.

32. An ECG device according to claim 28, characterized in that it arithmetically estimates the physical performance, e.g., VO2max, the maximum wattage, the performance in percent of the standard, also without a maximum load from the measured parameters, e.g., PEP, LVET, dZ/dtmax, or estimated parameters such as the muscle mass, from the parameters of the accelerometer, e.g., e.g., PEP, LVET, etc., by means of regression equations and, respectively, neural networks.

33. An ECG device according to claim 28, characterized in that the electrodes are designed for inducing an ion conduction in the body.

34. An ECG device according to claim 28, characterized in that it comprises chest wall electrodes according to Wilson.

35. An ECG device according claim 28, characterized in that the ECG devices is configured to switch the current supply to the electrode at the upper body aperture and a distal leg electrode and to measure the impedance and of the change in impedance in dependence of the heartbeat between the electrode at the upper body aperture and a distal leg electrode on the other leg or between the distal leg electrodes on both legs.

36. An ECG device according to claim 28, characterized in that the ECG device is configured to switch the current supply to a distal leg electrode on one leg and to a distal leg electrode on the other leg and to measure the impedance and the change in impedance in dependence of the heartbeat between the electrode at the upper body aperture and alternately one of said distal leg electrodes.

37. An ECG device according to claim 28, characterized in that the electrode at the thorax aperture is designed as a double electrode on a common carrier.

38. An ECG device according to claim 28, characterized in that an alternating current is feedable into the electrodes at several frequencies, preferably at between 1 and 10 kHz, at between 30 and 200 kHz and at between 200 and 1000 kHz.

39. An ECG device according to claim 38, characterized in that the switching apparatus supplies electric current at an electrode of the lower limbs and at the electrode of the upper thorax aperture and that the measurement of the impedance occurs between the electrode of the upper thorax aperture and an electrode positionable at the lower thorax aperture, wherein the electrode of the lower thorax aperture is usable preferably as a chest wall electrode.

40. An ECG device according to claim 28, characterized in that at least several of the electrodes are designed as vacuum electrodes, wherein, optionally, a device is provided which controls and/or optimizes the level of the negative pressure at the suction electrodes with regard to a detected physical signal, for example, a mechanical, acoustic, electric or optical signal.

41. An ECG device according to claim 28, characterized in that several measuring curves detected by the electrodes are laid on top of each other by means of an arithmetic unit in order to form a template measuring curve.

42. An ECG device according to claim 28, characterized in that the ECG device is configured to measure the change in impedance in dependence of the heartbeat at at least two body segments and to calculate therefrom and optionally additionally from a measure for the extracellular volume, e.g., the ratio of extracellular water to total body water or the ratio of extracellular water to intracellular water, the cardiac output and the level of a cardiac insufficiency, and/or a biochemical parameter for the biomechanical stress of myocardium cells and/or a water accumulation and/or one of the atrial natriuretic peptides, e.g., BNP, NT-proBNP or adrenomedullin.

43. An ECG device according to claim 28, comprising an arithmetic unit configured to calculate a relation between a parameter for the body fat percentage or the total body water percentage or the lean body mass, in each case based on the total body weight, and a parameter for the extracellular water, e.g., the ratio ECW/TBW or ECW/ICW, from the segmental impedances at low and high frequencies for segments close to the heart and/or remote from the heart or, respectively, for the total body and to output said ratio in relation to the standard values and/or a regression line.

44. An ECG device according to claim 28, characterized in that it comprises a memory for storing the determined and calculated data and that it comprises an interface for connecting a display and/or a printer for displaying at the display and/or printing at the printer the current values and the previous values of the electrical and physical parameters which have been gathered over time as numbers or graphically with standard panels, wherein the ECG device is preferably designed to graphically depict, during an individual examination, the results of the measurement phases as a trend, in case that several measurement phases are provided, and, in case of a repeated examination at a later point in time, to overlay and illustrate graphically the measurement phases of the different examinations with a time identification.

45. An ECG device according to claim 28, characterized in that an electrode body is provided with an easily detachable connection, for example, a push-button connection, which leads to an electrode which is preferably designed as an adhesive electrode or a clamping electrode or an elastic band electrode, wherein the electrode body can be inserted into a suction cup.

46. An ECG device according to claim 28, characterized in that at least one of the ECG lead electrodes is equipped with an inflatable cuff and with the sensor for mechanical vibrations being configured as the accelerometer, wherein the sensor for mechanical vibrations is developed for being positioned at an underlying artery, the sensor for mechanical vibrations preferably being formed in or at a liquid-filled bubble.

47. An ECG device according to claim 28, characterized in that elastically joined branches of an electrode are provided, one of the branches being developed for the current supply and one branch as a branch for ECG and the impedance measuring electrode, wherein the distance of the two branches is developed as an ion conductor in the state of being applied to the body.