BACKGROUND

A. Technical Field The present invention relates generally non-invasive cardiac medical devices and in particular to a wearable, electrocardiogram (ECG) recording and diagnosis device, system and method thereof.

B. Background of the Invention Cardiovascular diseases are the leading cause of death globally. Deaths, at a given age, from cardiovascular diseases are more common and have been increasing in much of the developing world. It is estimated that 90% of Cardiovascular diseases are preventable. Prevention measures may involve improving risk factors through: healthy eating, exercise, avoidance of tobacco smoke and limiting alcohol intake. Treating risk factors, such as high blood pressure, blood lipids and diabetes is also beneficial.

The death rate due to cardiovascular diseases has risen by 34% in the past 26 years in India and the death toll continues to rise. However, many deaths due to acute cardiac illnesses could have been prevented had the symptom-to-needle time (time lapsed from the onset of cardiac symptoms to initiation of treatment) been lower. The shorter the symptom-to-needle time, the higher the chance of survival and better the outcome of the cardiac event. The delay in diagnosis is caused due to a number of issues including lack of awareness, ignorance, time-constraint and cost- constraint on patient-end and lack of access and lack of ability to report ECG on doctor-end.

An ECG is one of the primary diagnosis tool for cardiovascular diseases detection. An ECG is a representation of the electrical activity of the heart muscle as it changes with time, usually printed on paper for easier analysis. Like other muscles, cardiac muscle contracts in response to electrical depolarization of the muscle cells.

It is the sum of this electrical activity, when amplified and recorded for just a few seconds that is known as an ECG.

Electrodes are the actual conductive pads attached to the body surface. Any pair of electrodes can measure the electrical potential difference between the two corresponding locations of attachment. Such a pair forms a lead. However, "leads" can also be formed between a physical electrode and a virtual electrode, known as the Wilson's central terminal, whose potential is defined as the average potential measured by three limb electrodes that are attached to the right arm, the left arm, and the left foot, respectively.

The 12-lead ECG has become an exceptional prehospital tool in the detection and treatment of life-threatening arrhythmias and cardiac-associated complaints. When performed correctly, the 12-lead ECG provides a more in-depth view than the traditional three-lead ECG. It is a vital diagnostic tool for a potential cardiac event with the capability to reduce symptom-to-needle time by signaling urgency and next course of action pertaining to the prevailing symptoms.

Commonly, 10 electrodes attached to the body are used to form 12 ECG leads, with each lead measuring a specific electrical potential difference.

Fig. 1, shows the various electrode placements in a male user. The placement may be similar for a female user as well. The 10 electrodes in a 12-lead ECG may comprise of:

RA(101) On the right arm, avoiding thick muscle.

LA(102) In the same location where RA was placed, but on the left arm.

RL(103) On the right leg, lower end of medial aspect of calf muscle. (Avoid bony prominences)

LL(104) In the same location where RL was placed, but on the left leg.

Vl(105) In the fourth intercostal space (between ribs 4 and 5) just to the right of the sternum (breastbone).

V2(106) In the fourth intercostal space (between ribs 4 and 5) just to the left of the sternum.

V3(107) Between leads V2 and V4. V4(108) In the fifth intercostal space (between ribs 5 and 6) in the

midclavicular line.

V5(109) Horizontally even with V4, in the left anterior axillary

line. V6(l 10) Horizontally even with V4 and V5 in the midaxillary

line.

There are various problems encountered with ECG collection and analysis. General practitioners are not always well trained in interpreting results of an ECG. Further, incorrect placement and readings can cause misinterpretation of ST changes, electrical axis, location of bundle branch blocks and location of infarct. Proper lead placement is important in avoiding the wrong diagnosis and delay in providing

proper treatment. A wrongly placed leads could cause a provider to initiate treatment from inaccurate ECG data that could be detrimental to the patient.

It is estimated that 4% of all ECGs run are recorded with incorrect lead placements, estimates are even higher for ECGs recorded in areas that necessitate a higher level of care, such as the prehospital environment.

Electrocardiograms are interpreted not only by cardiologists, but also by other specialists, including family physicians. Sometimes, continuous ECG monitoring is needed for prolonged data acquisition and analysis.

However, owing to the traditional process for ECG data collection the process is not catching up as fast as the rise of cardiovascular disease in increased population, such as for example, young adults. There is therefore a need for an ECG recording device, system and method that is easy to use, may be used by minimal assistance and reduces the instances of error. Further, availability of such solution that minimizes the need of trained practitioner to administer an ECG would improve in correct and early detection of CVD in areas having limited practitioners specialized in this field

SUMMARY

In embodiments herein a wearable electrocardiogram device is described, comprising a belt configured to be worn on the trunk of a user, under the arms, having atleast chest electrodes v4,v5 and v6 on an inner surface of the belt for contact with the skin of the user. Further, a fastening mechanism on the belt to secure the belt around the trunk is also provided. A joint is configured to be positioned on the parasternal area, having atleast chest electrodes vl, v2 and v3, thereon, and an electronic interactive unit on the belt, connected to the electrodes configured to detect contact and accurate placement of the 10 electrodes as required to derive the standard 12-lead ECG of the user is provided.

In an embodiment, the wearable electrocardiogram device, further comprises of a supporting strap attached to the joint, configured to be worn around the neck. Further, the belt has an upper segment with chest electrodes v4, v5, v6 and a lower segment configured with LL and RL electrodes. Furthermore, a shoulder belt configured to be worn over the biceps and trunk of a user collectively, having FA and RA electrodes is provided.

In an embodiment, the wearable ECG device, further comprising a lower limb strap connected on one end with the belt and on the other end having LL and RL electrodes on the inner surface and LA and RA electrodes on outer surface, each configured to be held using fingers is provided. Further, the stretchable belt is made up of material to fit multiple sizes. These materials include one or more of Neoprene, Lycra, Silicon, rubber sheet, and elastic material. Other materials to assist the functioning are also provided, such as cotton, polyester and similar fabric materials.

In one embodiment, the electronic interactive unit is configured to check for change in capacitance to a predetermined capacitance level to ascertain proper contact with the user body. In one exemplary embodiment the predetermined capacitance level is lpF to lOpF. Also, in an embodiment the electronic interactive unit is configured to measure ECG from atleast two electrodes every predetermined interval to cross a predetermined signal threshold, to ascertain proper signal reception of ECG signal from the user

In one embodiment, the electronic interactive unit is configured to measure ECG from atleast two electrodes every predetermined interval, perform discrete Fourier analysis and then check frequency of captured ECG signals to be of a predetermined threshold frequency.

A method for electrocardiogram signal capturing and analysis, comprising the steps of: checking for usability of ECG device, capturing signal stream for a predetermined signal stream time from the 10 electrodes of ECG, transmitting a digitized signal stream to a central server, Interpreting ECG data and generation of report; and transmission of ECG data and report to doctors, is provided.

In one embodiment, checking for usability of ECG device comprising the steps of: wearing the ECG device, measuring of discharge of electrons from the 10 electrodes of ECG, checking for change in capacitance of lpF to lOpF from the 10 electrodes; and signaling usability of ECG device if the previous step results in a positive outcome.

In one embodiment, steps for correct location of electrodes and continued capturing of signals, comprising the steps of: measuring ECG signals from 9 electrodes, except ground electrodes intermittently, signaling correct location of electrodes and continued capturing of signals if signals from all 9 electrodes other than ground electrode, has signal streams greater than lOmV spikes

In one embodiment, steps for checking for noise from surrounding electrical wiring, comprising the steps of: measuring ECG signals from 10 electrodes intermittently, performing discrete fourier transform of the ECG signals, signalling acceptable noise from surrounding electrical wiring if frequency of ECG signal is similar to a predetermined pattern of ECG in 20 to 200 BPM frequency.

BRIE F DESCRIPTION OF THE DRAWINGS Reference will be made to embodiments of the invention, examples of which may be illustrated in the accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments. Fig. 1 illustrates various electrode placements in a male and a female user for the 10 electrodes in a 12-lead ECG as per an embodiment herein.

Fig. 2 illustrates a device for ECG recording and analysis as per an embodiment herein.

Figure 3a shows the front view of a device for ECG recording and analysis from the outer view while the belt is unworn as per an embodiment herein.

Figure 3b shows the back view of a device for ECG recording and analysis from the outer view while the belt is unworn as per an embodiment herein.

Fig. 4a illustrates a device for ECG recording and analysis having a shoulder belt as per an embodiment herein.

Fig. 4b illustrates a device for ECG recording and analysis having only upper segment of a belt and lower limb straps as per an embodiment herein.

Figure 4c shows the front view of a device for ECG recording and analysis from the outer view while the belt is unworn as per an embodiment herein.

Figure 4d shows the back view of a device for ECG recording and analysis from the outer view while the belt is unworn as per an embodiment herein.

Fig. 5 illustrates a schematic of a system for ECG recording and analysis as per an embodiment herein.

Fig. 6 illustrates a flowchart of a method the steps taken for checking if the electrodes are in direct contact with a users skin/body as per an embodiment herein. Figure 7 illustrates the steps taken for checking if the electrodes are in the correct location and electrical signals are being captured as per an embodiment herein.

Figure 8 illustrates the steps taken for checking if the signal to noise ratio is of acceptable limits for the analysis as per an embodiment herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A device, system and method for ECG recording and analysis is described. In one embodiment a device is provided in a wearable form for a user. Different configurations of the device allows the same device adjustable for users of various shapes.

Further, a system and method provides for easy administration of ECG recording and analysis by providing interactive features for a user.

In the following description, for purpose of explanation, specific details are set forth in order to provide an understanding of the invention. It will be apparent, however, to one skilled in the art that the invention may be practiced without these details.

One skilled in the art will recognize that embodiments of the present invention, some of which are described below, may be incorporated into a number of different cardiac medical devices. Structures and devices shown below in block diagram are illustrative of exemplary embodiments of the invention and are meant to avoid obscuring the invention. Furthermore, connections between components within the figures are not intended to be limited to direct connections.

Reference in the specification to“one embodiment” or“an embodiment” means that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. The headings and subheadings used in the document are not intended to limit the content therein to respective heading or subheading. Rather, they are used to help reader navigate and prevent obscuring the invention.

A. Overview

23. Fig. 2 illustrates a device for ECG recording and analysis 100 as per an embodiment herein. In one embodiment, the device may comprise of a belt 112 that may in one embodiment be worn just under the breast of a user. The belt may go around from under the arms. An interactive electronic unit 116 may be present on the belt.

24. The belt may comprise of fastening arrangement 122 and 124. This may allow a user to adjust the belt size according to the size suitable for the user. The fastening arrangement may be in form of a Velcro® arrangement, a buckle and a strap or the like. In one embodiment a supporting strap 120 may be worn around the neck. The supporting strap may merge at a joint 115.

25. Figure 3a shows the front view of the device showing the outer surface of the belt while the belt is unworn. Figure 3b shows the back view of the device showing the inner surface thereof while the belt is unworn. Electrodes 114c, 114g, and 114h corresponding to the points (V3, V2, VI) on the user may be present on the joint 115.

26. The belt 112 may be divided into two segments, namely the upper segment 112a and a lower segment 112b. Various electrodes 114d, 114e and 114f corresponding to the points (V6, V5, V4 respectively) on the user may be present on the inner surface of the belt in the upper segment thereof. In one embodiment, the lower segment may cater to electrodes 114a and 114b corresponding to points (LL, RL Respectively) on a user.

he electrodes 114a, 114b, 114c, 114d, 114e, 114f, 114g, 114h, 114i, and 114j may be electrically connected to the electronic interactive unit 116. In an embodiment, the interactive electronic unit may also comprise of electrodes catering to points RA, LA of the user. In one embodiment, the user may touch the sensors with the bare fingers of each hand.

another embodiment, shown in figure 4a, a shoulder belt may be present attached to the joint 115. The shoulder belt 133 may comprise of sensors(134a, 134b) catering to body points (LA and RA Respectively). The shoulder belt may be worn around the chest and the upper biceps.

In yet another embodiment shown in figure 4b only the upper segment of the belt

112 may be present. While Figure 4c and 4d shows the front view and back view respectively, of a device for ECG recording and analysis from the outer view while the belt is unworn as per an embodiment herein. It may comprise of single fastening arrangement 122 for adjusting the size of belt according to user and the interactive electronic unit 116.

one embodiment two lower limb straps 130a and 130b as shown in figure 4b running towards bottom may be provided. In one embodiment the material used may be stretchable. While in another embodiment it might not have the elasticity property.

he lower limb straps 130a and 130b on their one end, may be fixed to the belt. On the loose ends thereof there may be sensors 114a and 114 b catering to body points (LL, RL) facing towards the body and sensors 114i and 114j facing upwards away from the body (or perpendicularly opposite to 114a and 114 b respectively) which may be touched with bare fingers of each hand catering to body points(LA, RA) while simultaneously placing the sensors 114a and 114b at the defined body points.

It may also consist of a supporting strap 120 in one embodiment which may be worn around the neck. The supporting strap may merge at a joint 115.

The material used for the belt may be stretchable. Materials such as for example

Neoprene, Lycra, Silicon, Rubber Sheet, Elastic may be used.

The interactive electronic unit may also provide for a slot 116f for charging cable connector such as for example USB. An indicator 116g may be present to indicate correct placement of the device on the user. A power button 116h may also be provided.

Fig. 5 illustrates a schematic of a system for ECG recording and analysis as per an embodiment herein.

The system may comprise of various ECG electrodes 502 that are in contact with various ECG points of the body under examination. A signal capture module 504 captures the data sent by the ECG electrodes 502. An amplifier 506 may be provided to amplify the signal. An analog to digital converter (ADC) 508 may be provided for conversion of the amplified signal into digital ECG data. The digital

ECG data may be interpreted. In one embodiment the digital ECG data may be interpreted at a central server system 512 that may be in interaction with a database 514 that houses historic as well as current data for data interpretation. In another embodiment an ECG data interpretation module 516 may be present that directly receives the digital ECG data for local interpretation of data. An indicative output module 518 may be present that receives data from ECG data interpretation service module for providing indicative outputs to the user including the normality/abnormality noted in the ECG as well as next steps including further tests/getting admitted/normal. In one embodiment it may be in form of a report available to the user.

The ECG data interpretation module may be in communication with the central server system and the database for receiving past information and updating it with newly collected information. The ECG data interpretation module may also have local storage ( not shown) that may house some of the user data for local analysis. The analysed data may be made available to a medical practitioner module 522. This module may be made available to a medical practitioner. This may be done offline/online or through a cloud service over the internet.

Fig. 6 illustrates a flowcharts of a method for ECG recording and analysis as per an embodiment herein. More particularly figure 6 illustrates the steps taken for checking if the electrodes are in direct contact with a users skin/body

as per an embodiment herein.

The steps include wearing the ECG device and measuring discharge of electrons via the body from all 10 electrodes 604. Further step includes checking for change in capacitance of the 10 electrodes. In one exemplary embodiment this change may range from lpF to lOpF. Depending on the values received a determination of whether or not the electrodes are in direct contact with the users skin/body is carried out. Figure 7 illustrates the steps taken for checking if the electrodes are in the correct location and electrical signals are being captured as per an embodiment herein. This method includes the step of measuring ECG signals from from 9 electrodes (all except ground electrode) at an interval, such as for example, every 2-3 seconds. This interval may be re-configured. Then checking all 9 signal streams if the value of the spike greater than a predetermined value takes place. In one exemplary embodiment the predetermined value of the spike may be lOmV. If the predetermined value of the spike is achieved the device is considered ready to use. Figure 8 illustrates the steps taken for checking if the signal to noise ratio is of acceptable limits for the analysis as per an embodiment herein. The steps include measuring ECG signals every 2-3 seconds 614 and performing 616 a discrete fourier analysis on the data. Further checking if the frequency of signal is similar to that expected in ECG data takes place. In one exemplary embodiment this value may be (20-200 BPM).

In one embodiment the method in flowcharts of figure 6, figure 7 and figure 8 may be performed one after the other, i.e performing method in flowchart 6b after performing method in flowchart in fig. 6 and performing method in flowchart 6c after performing method in flowchart in figure 7. In another embodiment one of the method among the ones described in various figure 6, 7, and 8 may be followed before data capturing.

A method for electrocardiogram signal capturing and analysis, comprising the steps of: checking for usability of ECG device, capturing signal stream for a predetermined signal stream time from the 10 electrodes of ECG, transmitting a digitized signal stream to a central server, Interpreting ECG data and generation of report; and transmission of ECG data and report to doctors, is provided.

In one embodiment, checking for usability of ECG device comprising the steps of: wearing the ECG device 602, measuring of discharge of electrons from the 10 electrodes of ECG 604, checking for change in capacitance of lpF to lOpF from the 10 electrodes 605; and signaling usability of ECG device if the previous step results in a positive outcome 607.

In one embodiment, steps for correct location of electrodes and continued capturing of signals, comprising the steps of: measuring ECG signals from 9 electrodes 609, except ground electrodes intermittently, signaling 612 correct location of electrodes and continued capturing of signals if signals from all 9 electrodes other than ground electrode 610, has signal streams greater than lOmV spikes

In one embodiment, steps for checking for noise from surrounding electrical wiring, comprising the steps of: measuring ECG signals from 10 electrodes intermittently 614, performing discrete fourier transform of the ECG signals 616, signaling 622 acceptable noise from surrounding electrical wiring if 618 frequency of ECG signal is similar to a predetermined pattern of ECG in 20 to 200 BPM frequency.

From the above embodiments it may be derived that the experiment may also solve Problems (but not limited to) such as correct placement of ECG, also may add on easy access to a ECG due to portability and ease of use and therefore, reducing symptom to needle time in emergency cardiac event.

While the subject matter may be susceptible to various modifications and alternative forms, specific embodiments have been shown by the way of figures/ examples in the drawings and have been described herein. Alternate embodiments or modifications may be practiced without departing from the spirit of the subject matter. The drawings shown are schematic drawings and may not be to the scale. While the drawings show some features of the subject, some features may be omitted. In some other cases, some features may be emphasized while other are not. Further, the methods disclosed herein may be performed in manner and/or order in which the methods are explained. Alternately, the methods may be performed in manner or order different than what is explained without departing from the spirit, meets and bounds of the present subject matter. It should be understood that the subject matter is not intended to be limited to the particular forms disclosed. Rather, the subject matter is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as described above and in claims.