Claims:1. An apparatus (10) for measuring Electrocardiography of a user comprising:
a plurality of electrodes (20), wherein each of the plurality of electrodes (20) are configured to be placed at a corresponding part of a user’s body, wherein the plurality of electrodes (20) is configured to sense electrical signal from the user’s body,
characterized in that,
one or more processors (30);
a lead management module (40) operable by the one or more processors (30), and configured to receive a lead configuration command from a user via a user interface (50), wherein the lead configuration command is representative of a total number of electrodes to be enabled from the plurality of electrodes (20) to enable the apparatus (10) for measuring Electrocardiography to function as a N-leads ECG apparatus (10), wherein N is any number between 1-12, wherein the user interface (50) is operatively coupled to the apparatus (10) via a communication medium (60);
an analog to digital converter (ADC) (70) operatively coupled to the one or more processors (30), and configured to enable electrical operations between one of more of the plurality of electrodes (20) based on the lead configuration command, upon selection of one or more input channels of the analog to digital converter (ADC) (70);
at least one port (80) operatively coupled to the analog to digital converter (ADC) (70), and configured to transmit or receive signal between each of the plurality of electrodes (20) and the analog to digital converter (ADC) (70);
a data control module (90) operable by the one or more processors (20), and configured to:
set a time frame for recording Electrocardiogram (ECG) signal of the user; and
transmit recorded Electrocardiogram (ECG) signal to a storage medium (100); and
a user data access module (110) operable by the one or more processors (20), and configured to:
access user data associated to the Electrocardiogram (ECG) signal of the user upon entering one or more parameters; and
represent the user data in one or more pre-defined form upon receiving a required access request by one or more entities, wherein the user data is represented on a display interface (120).
2. The apparatus (10) as claimed in claim 1, wherein the one or more parameters comprises at least one of a username, a start time or an end time of the of the time frame for recording the Electrocardiogram (ECG) signal, a unique identification number, or a combination thereof.
3. The apparatus (10) as claimed in claim 1, wherein the one or more input channels of the analog to digital converter (ADC) (70) are enabled or disabled by unblocking or blocking one or more internal registers of the analog to digital converter (ADC) (70) to enable flow of desired Electrocardiogram (ECG) signals from at least one unblocked register from the one or more registers.
4. The apparatus (10) as claimed in claim 1, comprising a user management module (130) operable by the one or more processors (20), and configured to modify one or more details associated to the user data by the one or more entities.
5. The apparatus (10) as claimed in claim 1, comprising a device configuration module (140) operable by the one or more processors (20), and configured to couple or connect at least one external device to the apparatus (10) via the user interface (50), upon entering one or more user details, wherein the one or more user details comprises at least one of user personal details, historic medical details, or a combination thereof.
6. The apparatus as claimed in claim 1, comprising a power management unit operatively coupled to the analog to digital converter (ADC) (70), and configured to manage and supply power to one or more components of the apparatus (10) upon receiving power supply instruction from the one or more processor (20).
Dated this 04th day of October 2021

Signature

Harish Naidu
Patent Agent (IN/PA-2896)
Agent for the Applicant
, Description:FIELD OF INVENTION
[0001] Embodiments of the present disclosure relates to electrocardiography, and more particularly, to an apparatus for measuring Electrocardiography of a user.
BACKGROUND
[0002] Electrocardiography is the process of producing an electrocardiogram (ECG). ECG is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin. These electrodes detect the small electrical changes that are a consequence of cardiac muscle during each cardiac cycle (heartbeat). In a conventional approach, cardiovascular diseases (CVD) are diagnosed through mutually exclusive arrangements comprising of specialized instrument setup such as Chest X-ray and magnetic resonance imaging (MRI) which are very expensive. And also, to operate these instruments and to interpret the information, highly skilled professionals are required. Most of the people cannot afford these. Alternatively, medical expertise uses 12 lead ECG for diagnosing CVDs which is very easy to use method and noninvasive. However, most of the portable devices, for remote health monitoring, available in the market via the conventional approach will not record standard 12 lead ECG data and thus will not be medically useful for diagnosis. In addition, some of the diagnosis can require electrical signals from one or more specific locations which may need devices with lesser leads than 12. In such cases, for every kind of lead configuration, a different setup and usage is required, thereby making the bulky and henceforth difficult to port from one location to another. Because of the large number of components being used, the conventional approach becomes expensive. In addition, due to the large size of the device, power consumption in such devices can be high.
[0003] In comparison to the conventional approach, a newer approach is used in which the bulky ECG devices are reduced in size to obtain a Holter device, which is used as ambulatory electrocardiography device, a portable device for cardiac monitoring of a patient. However, these devices are mostly used with fewer leads than 12 which is the conventional way of measuring the ECG of the user. Each Holter device comes with a pre-defined set of leads and cannot be changed. Henceforth, a separate device needs to be used which makes the newer approach less reliable and less efficient. Since multiple devices need to be used for multiple set of lead configuration, the newer approach becomes expensive.
[0004] Hence, there is a need for an improved apparatus for measuring Electrocardiography of a user to address the aforementioned issues.
BRIEF DESCRIPTION
[0005] In accordance with the present disclosure, an apparatus for measuring Electrocardiography of a user is disclosed. The apparatus includes a plurality of electrodes. Each of the plurality of electrodes are configured to be placed at a corresponding part of a user’s body. The plurality of electrodes is configured to sense electrical signal from the user’s body. The apparatus also includes a lead management module operable by the one or more processors, and configured to receive a lead configuration command from a user via a user interface, wherein the lead configuration command is representative of a total number of electrodes to be enabled from the plurality of electrodes to enable the apparatus for measuring Electrocardiography to function as a N-leads ECG apparatus, wherein N is any number between 1-12, wherein the user interface is operatively coupled to the apparatus via a communication medium. The apparatus also includes an analog to digital converter (ADC) operatively coupled to the one or more processors, and configured to enable electrical operations between one of more of the plurality of electrodes based on the lead configuration command, upon selection of one or more input channels of the analog to digital converter (ADC). The apparatus also includes at least one port operatively coupled to the analog to digital converter (ADC), and configured to transmit or receive signal between each of the plurality of electrodes and the analog to digital converter (ADC). The apparatus also includes a data control module operable by the one or more processors, and configured to set a time frame for recording Electrocardiogram (ECG) signal of the user and transmit recorded Electrocardiogram (ECG) signal to a storage medium. The apparatus also includes a user data access module operable by the one or more processors, and configured to access user data associated to the Electrocardiogram (ECG) signal of the user upon entering one or more parameters and to represent the user data in one or more pre-defined form upon receiving a required access request by one or more entities, wherein the user data is represented on a display interface.
[0006] To further clarify the advantages and features of the present disclosure, a more particular description of the disclosure will follow by reference to specific embodiments thereof, which are illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the disclosure and are therefore not to be considered limiting in scope. The disclosure will be described and explained with additional specificity and detail with the appended figures.
BRIEF DESCRIPTION OF DRAWINGS
The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:
[0007] FIG. 1 is a block diagram representation of an apparatus for measuring Electrocardiography of a user in accordance with an embodiment of the present disclosure;
[0008] FIG. 2 is a block diagram representation of an exemplary embodiment of the apparatus of FIG. 1 in accordance with an embodiment of the present disclosure;
[0009] FIG. 3 is a functional block diagram of an analog to digital converter (ADC) of FIG. 1 in accordance with an embodiment of the present disclosure; and
[0010] FIG. 4 is a block diagram representing WCT measurement of FIG. 1 in accordance with an embodiment of the present disclosure;
[0011] Further, those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the figures with details that will be readily apparent to those skilled in the art having the benefit of the description herein.
DETAILED DESCRIPTION
[0012] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as would normally occur to those skilled in the art are to be construed as being within the scope of the present invention.
[0013] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.
[0014] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more devices or sub-systems or elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other devices, sub-systems, elements, structures, components, additional devices, additional sub-systems, additional elements, additional structures or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.
[0015] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. The system, methods, and examples provided herein are only illustrative and not intended to be limiting.
[0016] Embodiments of the present disclosure relates to apparatus for measuring Electrocardiography of a user. As used herein, the term ‘Electrocardiography’ is defined as a process of producing an electrocardiogram (ECG). Also, the term ‘ECG’ is defined as a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin.
[0017] FIG. 1 is a block diagram representation of an apparatus (10) for measuring Electrocardiography of a user in accordance with an embodiment of the present disclosure. The apparatus (10) includes a plurality of electrodes (20). As used herein, the term ‘electrodes’ is defined as an electrical conductor used to make contact with a nonmetallic part of a circuit. More specifically, electrode is a conductor through which electricity enters or leaves an object, a substance, or a region. Each of the plurality of electrodes (20) are configured to be placed at a corresponding part of a user’s body. The plurality of electrodes (20) is configured to sense electrical signal from the user’s body.
[0018] The apparatus (10) also includes one or more processors (30). The apparatus (10) further includes a lead management module (40) operable by the one or more processors (30). The lead management module (40) is configured to receive a lead configuration command from a user via a user interface (50). The lead configuration command is representative of a total number of electrodes to be enabled from the plurality of electrodes (20) to enable the apparatus (10) for measuring Electrocardiography to function as a N-leads ECG apparatus (10), wherein N is any number between 1-12. Also, the user interface (50) is operatively coupled to the apparatus (10) via a communication medium (60).
[0019] In one exemplary embodiment, the user interface (50) may be a part of a computing device such as a mobile phone, a laptop, a tablet, or the like. In such embodiment, using the interface of the computing device, the user may select the number of leads to be configured.
[0020] Furthermore, the apparatus (10) includes an analog to digital converter (ADC) (70) operatively coupled to the one or more processors (30). As used herein, the term ‘analog to digital converter’ is defined as a system that converts an analog signal, into a digital signal. The analog to digital converter (ADC) is configured to enable electrical operations between one of more of the plurality of electrodes (20) based on the lead configuration command, upon selection of one or more input channels of the analog to digital converter (ADC) (70). In one embodiment, the one or more input channels of the analog to digital converter (ADC) (70) are enabled or disabled by unblocking or blocking one or more internal registers of the analog to digital converter (ADC) (70) to enable flow of desired Electrocardiogram (ECG) signals from at least one unblocked register from the one or more registers. In one specific embodiment, the ADC (70) may be ADS1198.
[0021] The apparatus (10) also includes at least one port (80) operatively coupled to the analog to digital converter (ADC) (70). The at least one port (80) is configured to transmit or receive signal between each of the plurality of electrodes (20) and the analog to digital converter (ADC) (70). In on embodiment, the at least one port (80) may be DB15 port.
[0022] The apparatus (10) further includes a data control module (90) configured to set a time frame for recording Electrocardiogram (ECG) signal of the user. More specifically, the user or any of the authorized entity may set a time frame via the computing device between which the system (10) needs to get activated in order to record ECG signal of the user for the configured time frame. In one exemplary embodiment, the data control module (90) may be configured to record the ECG signal continuously in real time.
[0023] The data control module (90) is also configured to transmit recorded Electrocardiogram (ECG) signal to a storage medium (100). In one exemplary embodiment, the storage medium (100) may be one of a local storage medium, a remote storage medium such as a cloud storage medium, or a combination thereof. In such embodiment, the storage medium may be an SD card operatively coupled to the ADC (70).
[0024] Furthermore, the apparatus (10) includes a user data access module (110) configured to access user data associated to the Electrocardiogram (ECG) signal of the user upon entering one or more parameters. In one embodiment, the one or more parameters may include at least one of a username, a start time or an end time of the of the time frame for recording the Electrocardiogram (ECG) signal, a unique identification number, or a combination thereof.
[0025] The user data access module (110) is also configured to represent the user data in one or more pre-defined form upon receiving a required access request by one or more entities, wherein the user data is represented on a display interface (120). In one exemplary embodiment, the data may be represented in one of a graphical form, a tabular form, a textual form, or a combination thereof.
[0026] In one specific embodiment, the apparatus (10) may further include a user management module (130) configured to modify one or more details associated to the user data by the one or more entities. In such embodiment, the one or more entities may alter, may delete the data associated to the ECG signal of the user.
[0027] In one exemplary embodiment, the apparatus (10) may further include a device configuration module (140) configured to couple or connect at least one external device to the apparatus (10) via the user interface (50), upon entering one or more user details. The one or more user details may include at least one of user personal details, historic medical details, or a combination thereof. In such embodiment, the one or more user details may include at least one of a serial number, a device name, a MAC ID of the corresponding at least one device, or the like.
[0028] In one embodiment, the apparatus (10) may further include a power management unit operatively coupled to the analog to digital converter (ADC) (70). The power management unit is configured to manage and supply power to one or more components of the apparatus (10) upon receiving power supply instruction from the one or more processor (20).
[0029] In one specific embodiment, the apparatus (10) may further include ESP WROOM-32 which is a unit including a microcontroller, a Wi-Fi module and a Bluetooth Module.
[0030] FIG. 2 is a block diagram representation of an exemplary embodiment of the apparatus (150) of FIG. 1 in accordance with an embodiment of the present disclosure. The plurality of electrodes (20) is connected to apparatus (10) via standard DB15 port (80). Signals from this DB 15 port (80) are connected to the ADS1198 (70). ADS1198 (70) is a multi-channel, simultaneous sampling with 16 bit resolution, delta sigma ADC with a built in programmable gain amplifier. The ADC (70) includes Wilson Central Terminal (WCT) generator and thus is specially designed for standard 12 lead medical ECG applications. The ADC (70) has 8 input channels and each of the 8 input channels can be selected or disabled by configuring the internal registers. This feature in the ADC enables a user (160) in configuring the whole device for recording 12 or fewer leads data. The ADC (70) is capable of sampling the data up to 8 KHz. In one exemplary embodiment, the data may be sampled at 1 KHz for proper processing in a cloud server. The ADC (70) is controlled by ESP WROOM-32 micro controller (MCU) (170). ESP WROOM-32 (170) is a powerful, WiFi + Bluetooth micro controller module that targets wide variety of applications. By changing the firmware of the micro controller, the configurability of the apparatus (10) may be enabled. The MCU (170) is configured in a way such that all the controls can be received from an application of a computing device. The device (150) also includes a storage medium (180) which may be an SD card slot. The storage medium may store standard 12 lead ECG data up to 12 days (in one specific embodiment). In addition, with the help of WiFi module, the apparatus (150) may be connected to the cloud server to transmit the recorded data for further processing of the data. Also, a power management unit (190) is operatively coupled to the ADC (70), the MCU (170) and the storage medium (180) to manage and supply power for each of the components.
[0031] FIG. 3 is a functional block diagram (200) of an analog to digital converter (ADC) of FIG. 1 in accordance with an embodiment of the present disclosure. ADS1198 (70) is low-power, multichannel, simultaneously-sampling, 16-bit delta-sigma (ΔΣ) analog-to-digital converter (ADC) with integrated programmable gain amplifiers (PGAs). The ADC integrate various ECG-specific functions that make the ADC (70) well-suited for scalable electrocardiogram (ECG), electroencephalography (EEG), and electromyography (EMG) applications. The ADC (70) can also be used in high-performance, multichannel data acquisition systems by powering down the ECG-specific circuitry.
[0032] The ADS1198 (70) have a highly programmable multiplexer that allows for temperature, supply, input short, and RLD measurements. Additionally, the multiplexer allows any of the input electrodes (210) to be programmed as the patient reference drive. The PGA gain can be chosen from one of seven settings (1, 2, 3, 4, 6, 8, and 12). The ADC in the apparatus (10) offer data rates from 125SPS to 8kSPS. Communication to the device is accomplished using an SPI-compatible interface (280). The device provides four GPIO pins (300) for general use. Multiple devices can be synchronized using the START pin.
[0033] An internal reference (250) can be programmed to either 2.4V or 4V. The internal oscillator (290) generates a 2.048MHz clock. A versatile right leg drive (RLD) block (240) allows the user to choose the average of any combination of electrodes to generate the patient drive signal. Lead-off detection can be accomplished either by using a pull-up or pull-down resistor or a current source or a sink. An internal ac lead-off detection feature is also available. The device supports both hardware pace detection and software pace detection (260). The Wilson center terminal (WCT) block (230) can be used to generate the WCT point (230) of the standard 12-lead ECG.
[0034] ADS1198 (70) devices can be cascaded in high channel count systems in a daisy-chain configuration. Package options may include a tiny 8mm × 8mm, 64-ball BGA and a TQFP-64. Both packages are specified over the temperature range of 0°C to +70°C.
[0035] Furthermore, an RC filter at the input (210) acts as an electromagnetic interference (EMI) filter on all of the channels. The ADS1198 input multiplexers (330) (as shown in FIG. 4) are very flexible and provide many configurable signal switching options. This flexibility allows for significant device and sub-system diagnostics, calibration and configuration. Selection of switch settings for each channel is made by writing the appropriate values to the CHnSET[2:0] register and by writing the RLD_MEAS bit in the CONFIG3 register.
[0036] Consequently, upon setting CHnSET[2:0] = 101 provides internally-generated test signals (220) for use in subsystem verification at power-up. This functionality allows the entire signal chain to be tested out. Control (270) of the test signals is accomplished through register settings. TEST_AMP controls the signal amplitude and TEST_FREQ controls switching at the required frequency.
[0037] The PGA (320) (as shown in FIG. 4) is a differential input or differential output amplifier. It has seven gain settings (1, 2, 3, 4, 6, 8, and 12) that can be set by writing to the CHnSET register. The ADS1198 (70) have CMOS inputs and hence have negligible current noise.
[0038] Further, The ADS1198 is configured by ESP WROOM-32. Configuration details include number of samples the one or more entity may require time to acquire data, sampling frequency or the like for which 1 to 12 lead may be configured. The working of ADS1198 may be tested by generating test signal which we can generate internally. Test signals are the square waves with different frequency and amplitudes. The frequency and amplitude of test signal may be selected as required. The data from passive filter and protection block comes to ADS and each ADC in ADS1198 gives one lead output according to connection which may be made by the one or more entities. The signal may be amplified using different gains (1,2,4,6,12) because ECG amplitude is in the range of millivolts. The chip selects and all proper supply is given to IC by microcontroller. One ADC convert each sample into 16 bit. There is total 156 bits (status bits (24) +8*16 bit) output at the end of all channel of one ADS1198. The ADC also includes an inbuilt digital decimation filter in the IC. After conversion, the data passes through the filter and comes at the output pin of SPI interface. The ADC checks for the data ready acknowledgement signal to read the data. As the signal goes low, microcontroller start to read the data and store the data in the SD card.
[0039] Furthermore, the ESP WROOM-32 uses a 40 MHz crystal oscillator. This ESP module connected to ADS1198 via SPI bus and sets the various registers in ADS1198 with an appropriate value. With the RTC, the apparatus may run in real time and this time will be used for saving the data into SD card. Once the data is saved in the SD card, the Wi-Fi may be turned on in the device and then the upload button may be pressed to send the data stored in SD card to the cloud server. These settings can be done via the application on the computing device. In one specific embodiment, the apparatus (10) may upload and/ or update the data to the cloud automatically at every pre-defined time interval or in a periodic manner.
[0040] FIG. 4 is a block diagram (310) representing WCT measurement of FIG. 1 in accordance with an embodiment of the present disclosure. A WCT voltage is defined as an average of Right Arm (RA), Left Arm (LA), and Left Leg (LL) electrodes. The WCT voltage is used as the reference voltage for the measurement of one or more chest leads. The ADS1198 (10) includes three integrated low-noise amplifiers that generate the WCT voltage.
[0041] The devices provide flexibility to choose any one of the 8 signals (IN1P to IN4N) to be routed to each of the amplifiers to generate an average. Further, the RA, LA, and LL electrodes may be connected to any input of the first four channels depending on the lead configuration. Each of the three amplifiers in the WCT circuitry can be powered down individually with register settings WCT1 (340) and WCT2 (340). By powering up two amplifiers, the average of any two electrodes can be generated at the WCT pin. Powering up one amplifier provides the buffered electrode voltage at the WCT pin (340). WCT amplifiers have limited drive strength and thus should be buffered if used to drive a low-impedance load.
[0042] Typical application would be to connect this WCT signal to the negative inputs of a ADS1198 to be used as a reference signal for the chest leads. The ADS1198 provides the option to generate the augmented leads by routing appropriate averages to channels 5 to 7.
[0043] Various embodiments of the present disclosure enable the apparatus to be capable of recording fewer leads also which facilitates the device to be used as both standard 12-leads acquisition system and holter device. Because of a low form factor, the apparatus is easily portable and re-configurability in recording leads, the apparatus can be easily customizable to use in hospitals, ambulances, home care environments, as a holter device, thereby making the apparatus a 4 in 1 solution. Also, the apparatus is capable of storing standard 12 lead ECG up to 12 days in its memory present on the device. In addition, the apparatus can be reconfigured for measuring Electrocardiography of a user.
[0044] Further, to operate the apparatus and to interpret the information, highly skilled professionals are not required, thereby making the apparatus accessible for common people. Also, for every kind of lead configuration, the same setup can be used, thereby making the apparatus less bulky and henceforth easy to port from one location to another. Because of the less number of components being used, the apparatus becomes less expensive. In addition, due to the small size of the device, power consumption in the apparatus is less. Also, separate device is not required to be used which makes the apparatus more reliable and more efficient. Since multiple devices are not being used for multiple set of lead configuration, the apparatus is cost effective. Due to the said advantages, the apparatus enables reconfigurability based on the requirement, thereby making it a reconfigurable apparatus.
[0045] While specific language has been used to describe the disclosure, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.
[0046] The figures and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, the order of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts need to be necessarily performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples.