The present invention pertains to a device and system for conducting a remote physical examination and further diagnosis, more particularly the present invention provides a handheld ECG device configured for collecting home-generated measurements of the electrical activity of a patient's heart and communicating them remotely.

BACKGROUND OF INVENTION

The prior art also includes numerous systems wherein ECG data or the like is monitored and/or transmitted from a patient to a particular doctor's office or health service center. Many of these rely on transmission of an audible or sub-audible audio signal which is converted to an electrical signal which is then transmitted to a remote recording station for example US Pat. No. 5,735,285 discloses use of a handheld device that converts a patient ^' s ECG signal into a frequency modulated audio signal that may then be analyzed by audio inputting via a telephone system to a selected hand-held computer device or to a designated doctor ^' s office.

US Pat. App. No. 2010/01 13950 discloses an electronic device having a heart sensor including several leads for detecting a user's cardiac signals. The leads are coupled to interior surfaces of the electronic device housing to hide the sensor from view. Using the detected signals, the electronic device can then identify or authenticate the user US Pat. No. 8,301,232 discloses an ECG device which includes an electrode assembly configured to sense heart-related signals upon contact with a user's skin, and to convert the sensed heart-related signals to ECG electrical signals. A converter assembly, integrated with, and electrically connected to the electrode assembly, is configured to receive the ECG electrical signals generated by the sensor and output ECG sound signals through an audio transmitter to a microphone in a computing device within range of the audio transmitter. The converter assembly is further configured to output the ECG signals as an ultrasonic FM sound signal.

US Pat. App. No. 2004/0220487 discloses a system with ECG electrodes which sense ECG electrical signals which are combined and amplitude modulated. The composite signal is transmitted via wire or wirelessly to the sound port in a computing device. A digital band pass filter having a pass band from 19 kHz to 21 kHz is considered; however, there is no consideration of demodulation means at this frequency range using commercially available computing devices. Additionally, the use of sound waves to effect transmission is not contemplated.

These and other prior art solutions fail to provide a reliable, inexpensive personal monitoring device that is readily compatible with existing computing devices without transmission of audio signals. It would be advantageous if these issues were addressed in a personal monitoring device transmitting real time physiological data.

Therefore, there is a long unmet need for a smal l and lightweight monitoring and diagnostic device for obtaining ambulatory ECG signals. There is a need for a device that is durable and accurate that can be used in an in-home environment therefore, easy to use without the need for special electrodes and/or complicated wiring and which provides sufficient data for therapeutic or diagnostic use by health care personnel. Furthermore, there is a need for a device that provides simple set-up and data optimization features while still being unobtrusive.

SUMMARY OF THE INVENTION

It is hence one object of the invention to provide a handheld ECG device for collecting home-generated measurements of the electrical activity of a patient's heart and communicating them remotely comprising:

a. at least two finger pressable electrode pads for capturing data indicative of at least one electrical signal of the patient's heart; and b. a housing portion comprising at least one ECG analog front end (ECG -AFE) for recording the signal; at least two filter circuit means for filtering out background noise and frequency interference; digital signal processing unit (DSP) for transmitting the at least o ne signal; and a wireless communication means;

wherein the finger pressable pads are operably coupled to the ECG-AFE by at least one lead, the pressable electrode pads are configured to activate the ECG-AFE by a single finger press on the pads; the DSP is configured to transmit samples of finger- based signal via the wireless communication means to at least one remote

communication unit. It is within the scope of the invention to provide the device as mentioned above, wherein the housing portion is fist sized and shaped for grasping by one user hand.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the housing further comprising a USB connection.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the housing further comprising a power circuit unit.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the home -generated measurements of a patient are collectable, storable and deliverable by demand of a physician.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the filter means is selected from the group consisting of FIR filter, multiband filter and a combination thereof.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the pads are attached to the external portion of the barrel.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the housing shape is selected from the group consisting of : spherical, round ,fist shaped, tubular, cylinder, roll, annular, arced , arched, arci-form , bent , bowed bulbous ,circular , coiled , curled , curved , curvilinear , cylindrical , discoid , disk-shaped domical , egg-shaped , elliptical , globoid , globose , globular , looped , orbed , orbicular, orbiculate , oval , ringed , rotund , rounded , spherical , spheroid , spiral , circular , convex , globular , orbicular , oval , rotund , ball-shaped and a combination thereof.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the home -generated measurements constitutes a physical examination by the patient or administered by non-medically trained person in physical proximity to the patient selected from the group consisting of a relative, a friend, a neighbour, or another non medically trained subject.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the DSP additionally comprises instructions for implementing a ranking mechanism for ranking patient's and data of the home -generated

measurements according to at least one parameter selected from the group consisting of patient's age, gender, race, emotional condition, physical condition, health condition, known patient and a combination thereof. It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the home generated measurements are classified and transmitted by the DSP according to a predefined emergency classification of ECG electric signal intervals characteristic; the electric signal intervals is selected from the group consisting of normal sinus rhythm, AV block, premature beats, atrial and

supraventricular arrhythmias, ventricular, AV nodal reentrant tachycardia and a combination thereof.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the wireless means comprises a wireless network connection selected from the group consisting of: Bluetooth, antenna, Wifi, wireless sensor networks, satellite communications, mobile data service, ibeacon, zigbee, GPS and a combination thereof.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein additionally comprising at least one central processing unit (CPU) for processing data of the signals and to provide instructions according to a

predetermined protocol.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the communication unit is selected from the group consisting of a tablet, a kiosk, a CPU, a smart phone, a telephone, a laptop and any combination thereof.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the at least one communication unit is configured for transferring, receiving, monitoring and/or processing the signals to a user-end listening and displaying the device.

It is within the scope of the invention to provide the device as mentioned in any of the above, wherein the barrel is detachable and replaceable.

It is hence another object of the invention to provide a method for home generating an

ECG measurement comprising steps of:

a. providing a handheld ECG device configured for collecting home- generated measurements of the electrical activity of a patient's heart and communicating them remotely comprising:at least two pressable electrode pads for capturing data indicative of at least one electrical signal of a heart of patient heart; and a housing portion comprising at least one ECG analog front end for recording the signal; at least two filter circuit means for filtering out background noise and frequency interference; digital signal processing unit (DSP) for transmitting the at least one signal; and a wireless communication means; b. physically contacting the pressable electrode pads with at least two fingers of the patient;

c. pressing the electrode pads operably coupled to the ECG analog front end by at least one lead when pressed by a single finger press for activating the ECG analog front end; and

d. receiving and wirelessly transmitting samples of the signal by the DSP via the wireless communication means to at least one remote communication unit .

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the step of providing the housing portion shaped as a fist sized for grasping by one user hand.

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the method additionally comprising step of providing the communication unit for transferring, receiving, monitoring and/or processing the signals to a user-end listening and displaying the device.

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein method additionally comprising step of transferring data of the home -generated measurements by demand of a physician.

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the method additionally comprising step of ranking the emergency level of the home -generated measurements of the patient according to at least one parameter selected from the group consisting of patient's age, gender, race, emotional condition, physical condition, health condition, known patient and a combination thereof.

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the method additionally comprising step of providing at least one central processing unit (CPU) for processing data of the signals.

It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the method additionally comprising step of selecting filter means FIR filter, multiband filter and any combination thereof. It is within the scope of the invention to provide the method as mentioned in any of the above, wherein the method additionally comprising step of providing the wireless means comprising a wireless network connection selected from the group consisting of: Bluetooth, antenna, Wifi, wireless sensor networks, satellite communications, mobile data service, ibeacon, zigbee,GPS and a combination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a few preferred embodiments will now be described, by way of non-limiting example only, with reference to be accompanying drawings, in which:

Fig. 1 illustrates the handheld ECG device of the present invention;

Fig. 2 illustrates a cross section of the handheld ECG device of the present invention;

Fig. 3 presents a schema the remote communication system comprising handheld ECG device of the present invention;

Fig. 4 presents a flow chart of the the remote communication system comprising handheld ECG device of the present invention; and

Fig. 5 presents a graph of frequency vs. the magnitude response to MBF filter;

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide product and method of the invention described herein.

The present invention provides a portable handheld ECG device comprising an electronic circuitry for selectively measuring, collecting, recording and further monitoring a patient's Electrocardiography, ECG or EKG signals at home and/or during normal daily activities and for compiling a personal cardiac database. In accordance with the present invention, the handheld ECG device is configured for biometric identification and authentication based on 1-lead ECG signals collected at patient's fingers.

The present invention provides a handheld ECG device having improved signal processing device for heart-rate, heart rhythm and ECG determination with both reliable accuracy and low power consumption. The handheld ECG device provides a transthoracic interpretation of the electrical activity of the heart over a period of time, as detected by at least two finger pressable electrodes attached to the surface of the patient's skin and recorded or displayed .

The One-lead handheld ECG device is configured to record and transmit heart signals by single and continuous attachment of fingers upon the pads of the device.

The handheld ECG device records signals from at least one electrode and generates an ECG recording from the signals. The handheld ECG may also provide placement information regarding locations on a user's body that are to be brought into contact with the at least one electrode whilst recording the signals. The handheld device wirelessly communicates with a smartphone or a PDA.

In accordance with the present invention, the handheld ECG device comprising a Digital signal processing (DSP) unit may further store an exemplary normal ECG recording, and compares a newly generated ECG recording with the stored ECG recording and generates an indication that indicates whether the newly generated ECG recording is consistent with the stored ECG recording.

In accordance with the present invention, the handheld device provides a typical ECG tracing of the cardiac cycle (heartbeat) consists of a P wave, a QRS complex, a T wave, and a U wave, which is normally invisible in 50 to 75% of ECGs because it is hidden by the T wave and upcoming new P wave. The baseline of the

electrocardiogram (the flat horizontal segments) is measured as the portion of the tracing following the T wave and preceding the next P wave and the segment between the P wave and the following QRS complex (PR segment). In a normal healthy heart, the baseline is equivalent to the isoelectric line (0 mV) and represents the periods in the cardiac cycle when there are no currents towards either the positive or negative ends of the ECG leads. However, in a diseased heart, the baseline may be depressed (e.g., cardiac ischaemia) or elevated (e.g., myocardial infarction) relative to the isoelectric line due to injury currents during the TP and PR intervals when the ventricles are at rest. The ST segment typically remains close to the isoelectric line as this is the period when the ventricles are fully depolarised and thus no currents can be in the ECG leads. Since most ECG recordings do not indicate where the 0 mV line is, baseline depression often gives the appearance of an elevation of the ST segment and conversely baseline elevation gives the appearance of depression of the ST segment. In accordance with the present invention, the handheld ECG device configured for collecting self-generated measurements of the electrical activity of patient's heart and communicating them remotely comprising: at least two finger pressable electrodes pads for activating the ECG-AFE by a single finger press on the electrodes pads. In accordance with the present invention, the finger pressable electrode pads are operatively connected to the housing portion by at least one lead, the pressable pads are configured to activate the ECG analog front end by a single push or press. The finger pressable electrode pads are operably coupled to a ECG analog front end by at least one lead. The pressable electrode pads are configured to activate the ECG-AFE by a single finger press on the pads. The handheld ECG device is a finger-based ECG that uses signals collected at the fingers, through a minimally intrusive 1-lead ECG setup recurring to Ag/AgCl electrodes without gel or conductive paste as interface with the skin. The collected signal comprises less noises than the common ECG acquired at the chest.

In accordance with the present invention, the pressable electrode pads may operatively be activated when urged against the chest or other skin surface (fingers) of a patient.

In accordance with the present invention, the handheld ECG device further comprises digital signal processing unit (DSP) for transmitting samples of signals via the wireless communication means to at least one remote communication unit. Furthermore, the housing portion is fist sized and shaped for grasping by at least one patient or user hand. The housing portion is further adapted as a griping portion.

In accordance with the present invention, the handheld ECG or EKG device provides electrical impulses generated by the polarization and depolarization of cardiac tissue and translates into a waveform. The waveform is then used to measure the rate and regularity (rhythm) of heartbeats.

In another embodiment of the present invention, the handheld ECG device may comprise filter means or algorithms for signal processing. The most common settings are monitor mode and diagnostic mode. In monitor mode, the low-frequency filter (also called the high-pass filter because signals above the threshold are allowed to pass) is set at either 0.5 Hz or 1 Hz and the high-frequency filter (also called the low- pass filter because signals below the threshold are allowed to pass) is set at 40 Hz. This limits artifacts for routine cardiac rhythm monitoring. The high-pass filter helps reduce wandering baseline and the low-pass filter helps reduce 50- or 60-Hz power line noise (the power line network frequency differs between 50 and 60 Hz in different countries). In diagnostic mode, the high-pass filter is set at 0.05 Hz, which allows accurate ST segments to be recorded. The low-pass filter is set to 40, 100, or 150 Hz. As a consequence, the monitor mode ECG display is more filtered than diagnostic mode, because its passband is narrower.

In accordance with the present invention, the ECG device of the present invention is further comprising a DC signal filter which filters background noises according to the following formula:

H(z) = = ^-

The filter means is a filter selected from the group consisting of a FIR filter, multiband filter and a combination thereof. The Multiband filter uses an aperture having a size of 50Hz for receiving a signal at 30dB. The filter means comprises DC filter signal for blocking or/and removing the amplification of DC currents at 22db for receiving signals at 16 bite.

In another embodiment of the present invention, the shape of the housing is selected from the group consisting of : spherical, fist shaped, round , ball, tubular, cylinder, roll, annular, arced , arched, arci-form , bent , bowed bulbous ,circular , coiled , curled , curved , curvilinear , cylindrical , discoid , disk-shaped domical , egg-shaped , elliptical , globoid , globose , globular , looped , orbed , orbicular, orbiculate , oval , ringed , rotund , rounded , spherical , spheroid , spiral , circular , convex , globular , orbicu81ar , oval , rotund , ball-shaped and a combination thereof.

The device has a multi- architectural structure and may be designed in different shapes and sizes to be adjacent and affixed to user's hand and fingers respectively.

The term 'self generated measurements' or 'home generated measurements' herein refers to physical measurements or medical check -up conducted or administered by a patient itself or by a non-medically trained person such as a relative, friend, neighbour, carer or by another subject which is not a physician. The term 'medical examination' herein refers to a physical examination, medical analysis or clinical examination (more popularly known as a check-up or medical) according to a predetermined protocol comprising a plurality of medical

characteristics and/or conditions such that a patient may select a relevant

characteristic and/or condition from a list according to patient's current physical condition. Therefore, the process by which a medical professional investigates the body of a patient for signs of disease. It generally follows the taking of the medical history- an account of the symptoms as experienced by the patient. Together with the medical history, the physical examination aids in determining the correct diagnosis and devising the treatment plan. This data then becomes part of the medical record. Terms such as "attached, " "affixed, " "connected, " "coupled," "interconnected ^' ," and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. Moreover, the features and benefits of the invention are illustrated by reference to the exemplified embodiments. Accordingly, the invention expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features t at may ex st alone or in other comb nations of features; the scope of the invention being defined by the claims appended hereto.

The handheld ECG device of the present invention is configured to receive, record and transmits the signals of electrical activity of a patient's heart as long as the pressable electrode pads are pressed by fingers or other body organ. The device is activated by attachment of at least two fingers.

Reference is now made to Figure 1 which illustrates a handheld ECG device for medical examination by a user and further for collecting home-generated

measurements of the electrical activity of a patient's heart and communicating them remotely. The handheld ECG device comprises at least two finger pressable electrode pads for capturing data indicative of at least one electrical signal of the patient's heart; and a housing portion comprising at least one ECG analog front end (ECG -AFE) for recording the signal; at least two filter circuit means for filtering out background noise and frequency interference; digital signal processing unit (DSP) for transmitting at least one signal; and a wireless communication means.

The handheld ECG device records the received signals which may further be presented simultaneously on a screen of smartphone, notebook, tablet, laptop or/and computer .Reference is now made to Figure 2 which illustrates a handheld ECG device for collecting home-generated measurements of the electrical activity of a patient's heart and communicating them remotely comprising: at least two finger pres sable electrode pads for capturing data indicative of at least one electrical signal of the patient's heart and a housing portion comprising at least one ECG analog front end (ECG -AFE) for recording the signal; at least two filter circuit means for filtering out background noise and frequency interference; digital signal processing unit (DSP) for transmitting the at least one signal; and a wireless communication means. The DSP is further configured for transmitting a modified and improved signal. Furthermore, the finger pressable pads are operably coupled to the ECG-AFE by at least one lead, the pressable electrode pads are configured to activate ECG-AFE by a single finger press on the pads; the DSP is configured to transmit samples of the signal via the wireless communication means to at least one remote communication unit. Furthermore, the ECG-AFE is configured to achieve monitor- and diagnostic- quality performance.

The electrode pads may be detachable, replaceable and/or a movable portion in variety of positions. The electrode pads are semiflexible and may be positioned vertically, horizontally or in any desired angel to the housing respectively.

In another embodiment of the present invention, the handheld ECG device may further comprise a display screen for displaying the measurements and/or results. In another embodiment of the present invention, Electrocardiogram (ECG) system analog front-end (AFE) devices are typically designed from various semiconductor vendors or custom-designed as application-specific integrated circuits (ASICs).

The ECG-AFE of the present invention includes instrumentation amplifiers, operational amplifiers that implement active filters, and analog-to-digital converters (ADCs). Furthermore, the filter means for reducing signal to noise ratio from the group consisting of ambient noises, voices, metallic sounds and any combination thereof. The handheld ECG device collects and records the electrical activity signals of a patient's heart which are autonomously measured by the patient, or by guidance of a medical professional (e.g physician, nurse, paramedic, medic, physician assistant, nurse practitioner, emergency technician, etc. ).

Reference is now made to Figure 3 presenting a schema of the remote communication system comprising handheld ECG device 20 a remote communication unit 22, a CPU, processor or/and server 24a, 24b for data receiving, processing and/or storing the electronic signals. The signal are further transferred to a remote communication unit 22, 23 such as tablet, smartphone or/and laptop via the wireless means 21.

In another embodiment of the present invention, the communication unit is capable of receiving a wireless signal from one or more wireless means.

The wireless communication means is selected from the group consisting of a Bluetooth connection, antenna, Wifi, wireless sensor networks, satellite communications, mobile data service, ibeacon, zigbee, GPS and a combination thereof.

Reference is now made to Figure 4 presenting a flow chart of the the remote communication system comprising handheld ECG device of the present invention. As illustrated in Fig. 4, additional probes may be combined such as thermometer, statoscope and/or HD CMOS. The medical information and measurements received and collected by the handheld ECG device are wirelessly transmitted to smart phone via wireless communication means , after the measurements are analyzed, processed and valid they are transferred to an external database or a medical center for further observation, storing and medical examination. The measurements may further transferred to an additional smartphone of a physician for further analysis and conducting a video call with the patient.

In another embodiment of the present invention, the home-generated measurements may be conducted and/or transferred in real time and further in an offline transmitting manner.

In another embodiment of the present invention, the user may further download the recorded data to a variety of data repositories including personal computer via a communications port for the purpose of storing it for personal use or to make it available to their physicians retrospectively. The handheld ECG device further enables both monitoring and self-monitoring as well as recording and is suitable for drug evaluation purposes; cardiac screening and ambulatory home based ECG monitoring.

Reference is now made to Figure 5 which presents a graph of the frequency VS magnitude of an ECG generated measurements. The devise may further provides an electrocardiogram output of an ECG recorder presenting a graph pattern reflecting the electrical activity of the patient heart. In accordance with the present invention, the ECG may further rank the urgency of patient home-generated measurements according to a predefined range of variety of ECG 'intervals' such as PR interval (measured from the beginning of the P wave to the first deflection of the QRS complex). Normal range 120-200 ms (3- 5 small squares on ECG paper).

QRS duration (measured from first deflection of QRS complex to end of QRS complex at isoelectric line). Normal range up to 120 ms (3 small squares on ECG paper).

QT interval (measured from first deflection of QRS complex to end of T wave at isoelectric line). Normal range up to 440 ms (though varies with heart rate and may be slightly longer in females).

In another embodiment of the present invention, the home generated measurements are classified and transmitted by the DSP according to a predefined emergency classification of ECG electric signal intervals characteristic; the electric signal intervals is selected from the group consisting of normal sinus rhythm, AV block, premature beats, atrial and supraventricular arrhythmias, ventricular, AV nodal reentrant tachycardia and a combination thereof.

In another embodiment of the present invention, the handheld ECG device may further detects and diagnose conduction abnormalities such as atrioventricular block (or AV block) which involves the impairment of the conduction between the atria and ventricles of the heart. Under normal conditions, SA node in the atria sets the pace for the heart, and these impulses travel down to the ventricles. In an AV block, this message does not reach the ventricles or is impaired along the way. The ventricles of the heart have their own pacing mechanisms, which can maintain a lowered heart rate in the absence of SA stimulation. The causes of pathological AV block are varied and include ischaemia, infarction, fibrosis or drugs, and the blocks may be complete or may only impair the signaling between the SA and AV nodes. Certain AV blocks can also be found as normal variants, such as in athletes or children, and are benign.

Strong vagal stimulation may also produce AV block. The cholinergic receptor types affected are the muscarinic receptors. There are three types: First degree AV block - PR interval greater than 0.20sec. Second degree AV block - Type 1 (aka Mobitz 1, Wenckebach): Progressive prolongation of PR interval with dropped beats (the PR interval gets longer and longer; finally one beat drops) . Type 2 (aka Mobitz 2, Hay): PR interval remains unchanged prior to the P wave which suddenly fails to conduct to the ventricles. Third degree AV block - No association between P waves and QRS complexes.

The handheld ECG device may further detects rhythm abnormalities selected from the group consisting of atrial arrhythmias, supraventricular tachycardia, atrial fibrillation, atrial flutter, nodal rhythm, APB's, VPB's, complex arrhythmias and a combination thereof.

The present invention further provides a method for home generating an ECG measurement comprising steps of providing a handheld ECG device configured for collecting home-generated measurements of the electrical activity of a patient's heart and communicating them remotely comprising: at least two pressable electrode pads for capturing data indicative of at least one electrical signal of a heart of patient heart; and a housing portion comprising at least one ECG analog front end for recording the signal, at least two filter circuit means for filtering out background noise and frequency interference, digital signal processing unit (DSP) for transmitting the at least one signal; and a wireless communication means.

The method additionaly comprising steps of physically contacting the pressable electrode pads with at least two fingers of the patient, pressing the electrode pads operably coupled to the ECG analog front end by at least one lead when pressed by a single finger press for activating the ECG analog front end and receiving and wirelessly transmitting samples of the signal by the DSP via the wireless

communication means to at least one remote communication unit .