Cardiovascular monitoring devices and related methods and systems

Abstract

A cardiac sensor system includes a cardiac device capable of sampling electrical signals generated by a patient's heartbeat and transmitting signals representative of the heartbeat to a receiving device that can analyze the signals to identify features of interest and / or display a graph of the heartbeat based on the signals.

Description

[Technical Field]

[0001] The present invention relates to patient monitoring devices, particularly cardiac monitoring devices and monitoring methods. [Background technology]

[0002] Continuous, mobile monitoring of biopotential signals requires that skin-worn electronics be conformable to improve physiological signal quality and comfort for the wearer. 1,2 Typically, cardiovascular monitoring requires bulky biopotential acquisition systems with complex wire connections and high-frequency operation to detect sufficient information. This ultimately consumes significant power and requires extensive signal processing methods for visual inspection. Such systems make continuous, real-time monitoring extremely difficult. 1,3 To address these issues, assessment of a patient's cardiovascular activity has traditionally been subjective and recorded only at clinical visits.

[0003] Unassisted real-time monitoring of the electrocardiogram (ECG) is particularly important for detecting, diagnosing, and monitoring various potential cardiovascular diseases. The surface ECG is a time-domain representation of the electrical signal of the ventricular depolarization vector of a beating heart within the chest. 7 In standard cardiovascular monitoring systems, this electrical signal is acquired by a conventional 12-lead ECG. These systems generate 12 ECG signals based on one reference electrode placed on the right leg (RL), three limb electrodes (left arm (LA), right arm (RA), and left leg (LL)), and six precordial or chest leads (V1-V6) placed on the torso near the heart. 8 The limb leads represent electrical signals from the front of the heart, while the chest leads represent electrical signals from the horizontal plane of the heart. 9

[0004] The ECG signal detected by a continuous ambulatory monitoring system must also be capable of transmitting this information wirelessly to a receiver, where it can be visually inspected by the user or cardiologist. As such, these ECG monitoring devices have extremely limited energy consumption. To transmit the signal, digitization of the analog ECG signal is necessary, necessitating sampling the signal at a high frequency; however, such systems typically consume power (e.g., battery) from the device and prevent uninterrupted monitoring. A balance must be struck between a high sampling rate, which allows for digitization and spectral analysis of heart rate variability (HRV) parameters, and a low rate for optimal power consumption. Summary of the Invention [Problem to be solved by the invention]

[0005] There is a need to overcome or at least alleviate one or more of the difficulties or deficiencies associated with the prior art. [Means for solving the problem]

[0006] In one aspect, the present invention provides a device for monitoring cardiovascular activity in a patient, the device comprising: a. at least one power management unit for powering the device; b. an analog front-end unit for recording cardiac data; c. a data transmission unit for transmitting the recorded data; The device provides a means for recording and transmitting a patient's cardiac data.

[0007] The term "patient" as used herein may include, but is not limited to, individuals with cardiovascular health problems, elderly individuals, immunocompromised individuals, individuals in compromised health, individuals with suspected or undiagnosed medical conditions, athletes, and individuals in need of measuring the individual's cardiovascular status. For example, a "patient" may be an individual working in a high-risk environment, and measuring the individual's cardiovascular status is necessary to ensure the individual's safety. As a further example, a "patient" may be an individual of any age in which a suspected or undiagnosed medical condition is suspected or undiagnosed, and the individual's cardiovascular status needs to be measured.

[0008] In a preferred embodiment, the power management unit a. A power supply; b. A low dropout regulator.

[0009] In a further preferred embodiment, the device is powered by a power supply, which may be a remote power source. In a further preferred embodiment, the device is powered by a power supply, which may be a battery power source. In a further preferred embodiment, the power source may be a combination of a remote power source and a battery power source.

[0010] In a preferred embodiment, the device is remotely powered. In a further preferred embodiment, the device is powered by connecting to a Wi-Fi, Bluetooth, cellular, or low-power wide-area network power source. In a further preferred embodiment, the device comprises an electromagnetic radiation receiver for receiving electromagnetic radiation and circuitry for deriving power for the device from the received electromagnetic radiation. In a further preferred embodiment, the electromagnetic radiation is received from Wi-Fi, Bluetooth, cellular, or a low-power wide-area network. In a further preferred embodiment, the cellular network is a 4G or 5G cellular network. In an even further preferred embodiment, the cellular network is a 6G cellular network. In an alternative preferred embodiment, the low-power wide-area network is a Long Range Wide Area Network (LoRaWAN). In a further preferred embodiment, the device is powered by any suitable low-power communication mechanism designed for Internet of Things (IoT) networks. For example, the remote power source may include ISim, or an on-board or native connection to a network or other device, or a connection via cellular telephone.

[0011] In a preferred embodiment, the device is powered by a battery power source. In a particularly preferred embodiment, the battery power source is a rechargeable battery. In an alternatively preferred embodiment, the battery power source is a replaceable battery.

[0012] The battery power source referred to herein may include a gel pack battery, a lithium ion battery, a coin cell battery, or any other battery type capable of powering a device for monitoring a patient's cardiovascular activity. For example, the battery type may include a battery powered by a tape-based power supply integrated into the device's form factor, a battery power source from a skin connection, or a power relay from an associated device such as a smartwatch or smartphone. The battery power source may include a lightweight biofuel cell power source. For example, the battery power source may include a paper biofuel cell, a bioenzyme fuel cell, or other lightweight, flexible, reusable, and recyclable battery power source.

[0013] In a preferred embodiment, the power source is capable of powering the device for at least 8 days. Preferably, the power source is capable of powering the device for a longer period of time, for example, 1 or 2 months.

[0014] For example, a battery type may include a single 145mAh battery weighing 2g that can power the device for approximately 7 days. However, by incorporating a single switching system, the device can function for extended periods of time, such as approximately one month or more.

[0015] Furthermore, the firmware running the Bluetooth Low Energy chip can be implemented to encrypt transmitted data to avoid cyberattacks while the data is passing through the cloud for remote monitoring. Optimizing minimum power consumption, operating range, and data encryption is important in building a platform that can comprise a wireless, battery-free, cyber-secure remote cardiovascular monitoring system.

[0016] In a preferred embodiment, the analog front end unit comprises a. at least three electrodes; b. an integrated instrumentation amplifier, and / or c. Includes a second-order low-pass filter.

[0017] In a further preferred embodiment, the device includes a positive terminal electrode, a negative terminal electrode, and a reference electrode. In a further preferred embodiment, each electrode includes an adhesive. The adhesive may include any suitable adhesive for attaching the device and / or electrodes to a patient's skin surface. For example, the adhesive may include a soft adhesive that allows for movement and / or re-attachment of the device or electrodes.

[0018] The electrodes of the devices described herein may, for example, include electrodes housed within one or more film / foam elements, thereby providing simplified adhesion / attachment of the device to the patient.

[0019] In a further preferred embodiment, the device further comprises at least two resistors at the electrodes, preferably in the range of about 100 kΩ to 470 kΩ, more preferably 180 kΩ.

[0020] As used herein, the term "transmission unit" refers to any suitable element capable of transferring recorded data to a database for storage. For example, the transmitter may include a removable SIM card, eSIM, iSIM, or any suitable silicon wafer capable of transferring recorded physiological inputs to a database for storage. In one preferred embodiment, the data transmission unit is a. Analog-to-digital converters, and b. Including an antenna for wirelessly transmitting digitized data.

[0021] In a preferred embodiment, the sampling of electrical activity is continuous or selective. In a further preferred embodiment, the sampling of electrical activity is selective.

[0022] In a preferred embodiment, the device is remotely controlled. In a further preferred embodiment, the device is remotely activated and / or deactivated. In a preferred embodiment, the electrodes are remotely activated and / or deactivated. In a further preferred embodiment, the device includes a receiver that receives signals to control circuitry that activates and / or deactivates the sensors. For example, the device can be paused, secured, or deactivated as directed by the patient, a medical professional, or for security purposes.

[0023] In a preferred embodiment, the device includes a receiver that receives signals to control circuitry that activates and / or deactivates the electrodes.

[0024] In a preferred embodiment, the thickness of the device substrate is between about 80 and 120 μm, providing sufficient flexibility to allow the device to conform to the curves of human skin. In a further preferred embodiment, the thickness of the device substrate is between about 90 and 110 μm. In a further preferred embodiment, the thickness of the device substrate is about 101 μm.

[0025] In a preferred embodiment, the device includes one or more sensors or other such sensing elements capable of receiving and responding to physiological inputs. In one embodiment, the physiological inputs may include signals or stimuli emanating from the patient. For example, the signals or stimuli may include motion sensors for monitoring patient movement, electrical signals, electromagnetic radiation, physical properties, temperature, gases, liquids, proteins, hormones, or other such biological factors.

[0026] In a preferred embodiment, the physiological input includes heart rate, blood pressure, pulse, SpO2, V02 max, movement time, rest time, lay time, body temperature, cardiac electrical activity (ECG), wound recovery factor measurements, skin surface stress factor measurements, blood glucose measurements, audio output, and / or patient geographic location information. In a further preferred embodiment, the physiological input may include changes in the patient's red blood cell levels. In a further preferred embodiment, the physiological input may include changes in the patient's chest region, including patient mobility, movement, muscle contraction, and / or tension. For example, monitoring the patient's chest region to obtain the physiological input may be used to monitor audio detection or to monitor patients suffering from reduced cardiac function or chronic obstructive pulmonary disease (COPD).

[0027] In a further preferred embodiment, the physiological input may include a rate of movement indicated by the patient and / or an accelerometer input.

[0028] In a further preferred embodiment, the physiological input may include perfusion within the monitored region of the patient.

[0029] As used herein, "SpO2" means peripheral oxygen saturation, an estimate of the oxygen saturation level of hemoglobin observed in the patient.

[0030] As used herein, "V02 max" means a patient's maximum rate of oxygen consumption as measured under increasing physical stress or exercise.

[0031] As used herein, the term "travel time" means the amount of time a patient spends traveling in the same mobility activity.

[0032] As used herein, the term "rest time" means the amount of time a patient spends resting at the same resting position between performing an activity.

[0033] As used herein, the term "recumbent time" means the length of time a patient spends lying down in the same recumbent session. "Recumbent time" may include, but is not limited to, any length of time during which the patient is sleeping, resting, experiencing a fall, or any other event in which the patient is in a non-upright position.

[0034] As used herein, "audio output" means an audible noise emitted by or generated by a patient. For example, the audio output may include monitoring the number of words spoken by the patient. In a further example, the audio output may include monitoring the patient's respiratory rate and / or intensity.

[0035] As used herein, "perfusion" means the rate of passage of fluid through a patient's circulatory or lymphatic system to an organ or tissue.

[0036] In one embodiment, measuring wound healing factors includes recording levels of biological factors and / or recording physiological responses involved in wound healing. For example, wound healing factors in patients recovering from surgery (outpatients) or infections may be monitored to assess cardiac effects, such as increased heart rate.

[0037] Biological factors may include, but are not limited to, proteins, hormones, enzymes, and / or platelets expressed as a result of wound healing. Physiological responses may include, but are not limited to, thrombus formation, vasoconstriction, and / or physical contraction. In a preferred embodiment, measuring skin surface stress factors includes recording the level of biological factors and / or recording physiological responses involved in skin surface stress recovery. For example, one such biological factor that can be monitored is changes in hormone expression or hormone levels in the patient's body, and one example of such a hormone is the steroid hormone cortisol.

[0038] In a preferred embodiment, measuring blood glucose levels includes recording blood glucose levels, blood ketone levels, or other such indicators that indicate changes in the patient's blood glucose levels.

[0039] In a preferred embodiment, the devices described herein may be partially or fully recyclable and / or refurbished. In a preferred embodiment, elements within the device may be replaceable. For example, elements or components such as electrodes, battery power (if necessary), coatings, adhesive layers, films, etc., may be replaced or refurbished after the patient no longer requires use of the device. Such functionality is advantageous for the sustainability and / or use of the device in emerging economies where enhanced, low-cost cardiac devices are needed.

[0040] In a second aspect, a method for monitoring cardiovascular activity in a patient is provided, comprising: a. applying to a patient a device for monitoring cardiovascular activity, the device comprising: i. at least one power management unit for powering the device; ii. an analog front-end unit for recording cardiac data; iii. a data transmission unit for transmitting the recorded data; b. displaying the recorded data on the secondary device; The device includes an adhesive layer that provides a means for maintaining contact between the device and a patient's skin surface; The device performs high-frequency sampling of cardiovascular events to achieve all the required P, Q, R, S, and T peaks of the ECG signal, The device enables wireless communication with a secondary device.

[0041] In one embodiment, the device for monitoring cardiovascular activity may be attached to the patient's chest or back.

[0042] In a further embodiment, the adhesive layer comprises a chemical composition that can be adhered to the skin surface of a patient.

[0043] In a preferred embodiment, the adhesive layer is resistant to damage from sweat and / or water. Alternatively, in a preferred embodiment, the adhesive layer is resistant to causing irritation or damage to the patient.

[0044] In one preferred embodiment, the adhesive layer comprises an adhesive selected to minimize irritation or damage to the patient's skin while maintaining functional contact with the skin for an extended period of time.

[0045] In a preferred embodiment, the method includes the use of a secondary device to receive and / or display the recorded data.

[0046] In a preferred embodiment, the secondary device is a remote device. In a further preferred embodiment, the secondary device is selected from a computer, a smartphone, a smartwatch, a tablet, a touchscreen device, or any other suitable "smart device." In a further preferred embodiment, the secondary device comprises a data module configured to receive, monitor, and / or analyze cardiac data recorded by the device.

[0047] In a preferred embodiment, the secondary device is a remote device that provides a means for remotely powering the primary device.

[0048] In a preferred embodiment, a device for monitoring cardiovascular activity provides real-time, continuous ECG data to a body-worn electronic device, such as a smartphone or smartwatch, for the user, and to a cloud-connected interface for remote monitoring (i.e., by a cardiologist or other healthcare professional). For example, a low-cost, lightweight (approximately 5 g) device such as those described herein provides a means for collecting data in real time on-site and to a remotely connected interface, and also allows for records to be kept for future use.

[0049] The device as described herein enables the use of a Bluetooth low energy system-on-chip, which requires only a 50 Hz sampling frequency to detect all critical patient events, and further enables wireless data transmission to occur at extremely low power (-19 dB), allowing the device to operate continuously for approximately 8 days using a simple CR1632 battery.

[0050] In a further aspect, a system for monitoring the cardiovascular activity of a patient is provided, comprising: a. A device for monitoring the cardiovascular activity of a patient, the device comprising: i. at least one power management unit for powering the device; ii. an analog front-end unit for recording cardiac data; iii. a data transmission unit for transmitting the recorded data; b. A secondary device for receiving the recorded data.

[0051] In a preferred embodiment, the secondary device is a remote device. In a further preferred embodiment, the secondary device is selected from a computer, a smartphone, a tablet, a touchscreen device, or any other suitable "smart device." In a further preferred embodiment, the secondary device comprises a data module configured to receive, monitor, and / or analyze cardiac data recorded by the device.

[0052] As used herein, a "secondary device" is any such device capable of transmitting and / or receiving information for monitoring the cardiovascular activity of a wearer. Secondary devices may include, but are not limited to, computers, smartphones, smartwatches, tablets, touchscreen devices, or any other suitable "smart devices."

[0053] In a preferred embodiment, the electrodes are activated and / or deactivated remotely. In a further preferred embodiment, the device includes a receiver that receives signals to control circuitry that activates and / or deactivates the electrodes.

[0054] In a fourth aspect, a wireless cardiac sensor device is provided, comprising: a. at least three electrodes mounted on a substrate for contact with the skin over the patient's heart to receive electrical signals generated by the beating of the heart; b. a digital-to-analog converter for converting the signal into digital form; c. a wireless transmitter of a digital form of the signal.

[0055] In a preferred embodiment, the signals from the electrodes are fed to a filter before being converted to digital form.

[0056] In a preferred embodiment, the substrate is flexible to conform to the contours of the skin.

[0057] In a preferred embodiment, the electrodes are mounted on the substrate in a triangular shape that is smaller in size than the triangle formed between each of the shoulders and the midpoint between the base of each side of the rib cage. In a preferred embodiment, the electrode triangle is an equilateral triangle with side lengths between about 2 and 15 cm, preferably between about 3 and 12 cm, and most preferably between about 4 and 10 cm.

[0058] In a preferred embodiment, one of the electrodes is a positive terminal electrode, one of the electrodes is a negative terminal electrode, and another of the electrodes is a reference electrode. Preferably, in use, the positive terminal electrode is oriented closest to the patient's right arm, the negative terminal electrode is oriented closest to the patient's left arm, and the reference electrode is oriented closest to the patient's left leg.

[0059] In a fifth aspect, a wireless cardiac sensor monitoring system is provided, comprising: A monitoring device comprising: a. at least three electrodes mounted on a substrate for contact with the skin over the patient's heart to receive electrical signals generated by the beating of the heart; b. a digital-to-analog converter for converting the signal into digital form; c. a monitoring device including a wireless transmitter of a digital form of the signal; and a receiver of the transmitted signals configured to analyze the signals to identify features of interest and / or display a graph of the heart rate based on those signals.

[0060] In a sixth aspect, there is provided a process for monitoring a patient, said process comprising: providing a wireless cardiac sensor device as described herein; a. contacting at least three electrodes mounted on a substrate for contacting the skin over the patient's heart to receive electrical signals generated by the beating of the heart; b. converting the signal into a digital form; c. wirelessly transmitting the digital form of the signal.

[0061] In a seventh aspect, there is provided a process for monitoring a patient, said process comprising: providing a wireless cardiac sensor device as described herein; a. contacting at least three electrodes mounted on a substrate with the skin over the patient's heart to receive electrical signals generated by the beating of the heart; b. converting the signal into a digital form; c. wirelessly transmitting a digital form of the signal; d. receiving a transmission signal; e. Analyzing the signal to identify features of interest and / or displaying a graph of a heartbeat tracing based on the signal.

[0062] In a preferred embodiment, the electrical signal is received (sampling period) approximately every 18 to 30 ms, preferably approximately every 19 to 25 ms, and most preferably approximately every 20 to 22 ms.

[0063] In a preferred embodiment, the identified features of interest include the P, Q, R, S and / or T peaks. Preferably, the identified features of interest include the RRI, PRI, QTI and / or QRSI.

[0064] In a preferred embodiment, the wireless transmission has sufficient power to be received at a distance of at least about 0.5 to 10 m, preferably at least about 0.75 to 5 m, and most preferably at least about 1 to 3 m.

[0065] In a further embodiment, a device as described herein may include additional Bluetooth modules to improve the sensor design to accommodate additional sensors and capabilities.

[0066] In a further embodiment, a device as described herein may include an additional Bluetooth module for connecting to a fall gateway.

[0067] In a further embodiment, a device as described herein may include one or more enhanced BTLE chips for connecting to a BTLE, Wi-Fi hub, and / or a tip / motion IoT gateway.

[0068] In a further embodiment, a device as described herein may include future processing on-board functions for efficiency.

[0069] In a further embodiment, a device as described herein may include one or more flat, stickable EcoCells and a rechargeable battery.

[0070] In a further embodiment, a device as described herein may include one or more antennas for power harvesting to extend the life of the device or provide backup power access, if needed.

[0071] In a further embodiment, a device as described herein may be equipped with one or more antennas for harvesting the device's power for backup power, which may be done via a BTLE hub or a tip / motion IoT gateway.

[0072] In a further embodiment, a device as described herein may comprise a single (three-point) electrode, which may be triangular in configuration, or alternatively, for sampling, may be a standard three-clip electrode.

[0073] In a further embodiment, a device as described herein may include artificial intelligence (AI) capabilities on the device or on the system supporting the device, for example, the AI ​​capabilities may provide means for generating local alerts and processing data recorded by the device.

[0074] For example, a device as described herein may be adapted to turn sensors on or off as needed, with human or AI intervention. For a further example, the device may provide simultaneous or parallel processing from sensors via algorithms, including multimodal modes or advanced alerts to identify worsening patient conditions. In a further preferred embodiment, a device as described herein may include one or more elements that provide a means for incorporating additional sensing technologies on the device to monitor alternative risks related to cardiac effects. For example, the device may include one or more of an accelerometer, or elements for measuring chronic obstructive pulmonary disease (COPD), blood pressure analysis, and / or GAIT decline via a fall / risk monitoring gateway.

[0075] In a further preferred embodiment, a device as described herein may include elements that provide means for connecting to other Bluetooth gateways, potentially LiFi (i.e., data transmission via lighting, particularly LED or infrared lighting with WiFi-enabled capabilities), and / or other connection paths. For example, a device as described herein may enable connection or communication with any sensors or radars of secondary devices, including secondary devices that may be mounted on walls, rooms, furniture, or near the patient for further data capture.

[0076] In an eighth aspect, there is provided a device for monitoring cardiovascular activity in a patient, the device comprising: a. at least one power management unit for powering the device; b. an analog front-end unit for recording cardiac data; c. a data transmission unit for transmitting the recorded data; The device provides a means for recording and transmitting the patient's cardiac data; The device is i. A power supply selected from additional or remote power sources and / or battery power sources; ii. A single (three-point) electrode for sampling; iii. Antennas for power harvesting to extend the life of the device and / or provide backup power access; iv. means for wireless communication with a secondary device; v. Comprises one or more of the following elements: BTLE, Wi-Fi hub, and / or means for connecting to a tip / motion IoT gateway.

[0077] In a further preferred embodiment, the device may be equipped with a battery power source including a flat, stickable EcoCell and / or a rechargeable battery power source.

[0078] In a further preferred embodiment, the device may include an antenna for power harvesting, which may be done via a BTLE hub or a tip / motion IoT gateway.

[0079] In a further preferred embodiment, the device may include means for monitoring the patient for fall detection.

[0080] In a further preferred embodiment, the device may include a single (three-point) electrode in the shape of a triangle.

[0081] In a further preferred embodiment, the device may include means for wireless communication with secondary devices allowing continuous real-time communication with said device.

[0082] In this specification, the term "comprises" and variations thereof are not intended to exclude the presence of other integers, components or steps.

[0083] Any reference herein to prior art is not, and should not be construed as, an acknowledgment or any form of suggestion that this prior art forms part of the common general knowledge in Australia or any other jurisdiction, or that this prior art could reasonably be expected to have been adapted by a person skilled in the art.

[0084] The present invention will now be described in more detail with reference to the accompanying examples and drawings, however it should be understood that the following description is merely illustrative and should not be construed in any way as limiting the generality of the invention described above. [Brief explanation of the drawings]

[0085] [Figure 1] FIG. 1 illustrates the data flow from a biosignal to an IoT cloud and a smartphone as a user interface. [Figure 2a] FIG. 1 shows the fabrication of a 3-lead ECG wearable sensor patch. Schematic diagram for circuit operation showing power management, analog front end for cardiac monitoring and wireless data transmission and demonstration. [Figure 2b] FIG. 1 shows the fabrication of a 3-lead ECG wearable sensor patch. Schematic of the circuit design. [Figure 2c] FIG. 10 shows the fabrication of a 3-lead ECG wearable sensor patch. Schematic of the designed circuit in Altium. [Figure 2d] FIG. 1 shows the fabrication of a three-lead wearable sensor patch and is a photograph of the fabricated device. [Figure 2e] FIG. 1 shows the fabrication of a three-lead wearable sensor patch, showing the wireless sensor patch WSP attached to the skin. [Figure 3a] FIG. 10 illustrates power management, showing the effect of transmit power on operational range. [Figure 3b] FIG. 1 illustrates power management, showing the effect of transmit power on battery life. [Figure 3c] FIG. 10 illustrates power management and the effect of sampling rate on battery life. [Figure 4a] FIG. 10 shows the effect of sampling rate on the acquired desired peak, showing the recorded signal for analog-to-digital conversion at a sampling rate of 40 ms. [Figure 4b] FIG. 10 shows the effect of sampling rate on the acquired desired peak, showing the recorded signal for analog-to-digital conversion at a sampling rate of 30 ms. [Figure 4c] FIG. 10 shows the effect of sampling rate on the acquired desired peak, showing the recorded signal for analog-to-digital conversion at a sampling rate of 20 ms. [Figure 4d] FIG. 10 shows the effect of sampling rate on the acquired desired peak, showing the recorded signal for analog-to-digital conversion at a sampling rate of 15 ms. [Figure 5] Figure 2 illustrates validation of the systolic Einthoven triangle. (a) Triangle placement using extended wires for T1 and T2, but placement of T3 is based on wireless connection as shown in Figure 2e. (b) Recorded signals for T1, (c) T2, and (d) T3. Legend: RRI is the R peak-to-R peak interval, PRI is the P peak-to-R peak interval, QTI is the Q peak-to-T peak interval, and QRSI is the interval between Q, R, and S peak appearances. Comparative studies of the 3-lead ECG system compared to a 12-lead commercial device show similar characteristics of the anterior cardiac surface (represented by leads I, II, and III of the 12 leads) in terms of heart rate variability (HRV), PR interval, QRS complex, QT, and mean RR. [Figure 6a]FIG. 1 illustrates real-time monitoring and data analysis. FIG. 1 is a screenshot of a mobile device screen showing a summary of a patient's ECG monitoring. [Figure 6b] FIG. 1 shows real-time monitoring and data analysis, illustrating the overlap of R-wave fiducial points. [Figure 6c] FIG. 1 illustrates real-time monitoring and data analysis of a commercially available 12-lead ECG system. [Figure 7] FIG. 10 shows the device indwelled in a patient. [Figure 8] FIG. 1 illustrates atrial depolarization, ventricular depolarization, and ventricular repolarization, including clinically relevant P, Q, R, S, and T peaks. [Figure 9] 9-A and 9-B illustrate alternative forms of a wearable device, including adhesive gel, a top protective layer, and a flexible printed circuit board (PCBA) featuring: 9-A. A standard small cell battery that can also be replaced with a single stickable square or triangular EcoCell-type battery. These features provide sufficient power to drive a multi-sensing ECG, accelerometer BTLE module, iSim module, and other new and additional sensors, such as a blood pressure monitor or oximeter (Spo2) via additional photonics. 9-B. A wearable device including a single (3-point) electrode for sampling or alternatively a standard 3-clip electrode, where the electrodes may be triangular in shape and may be rechargeable. [Figure 10] 1A-1C illustrate alternative arrangements of features of the ECG and wearable sensor device, including the BLE chip, ECG chip, battery holder, copper circuitry, and polyimide base. [Figure 11] FIG. 1 illustrates a sensor device as described herein in use with a patient. [Figure 12]FIG. 10 illustrates the data flow from bio-signals to the IoT Cloud and Fall Gateway as an access interface, including connecting to a Fall Risk Gateway or complementary sensing hub modification of the previous data and operational pathways, and further including connection via a Bluetooth connector module / antenna on the patch connection and receiving, auto-connect functionality, and ID detection and secure data transfer features on the Fall Gateway. [Figure 13] FIG. 1 illustrates an integrated screening and detection process including a sensor device (new patch / new ECG patch) incorporating fall detection via a fall detection gateway. [Figure 14] FIG. 10 illustrates an alternative arrangement of an ECG and sensor device including a primary housing / soft foam cover, a liquid silicone rubber (LSR) or similar silicone layer, a polyimide PCB surface, and a bottom adhesive layer. [Figure 15] This figure shows a step-by-step explanation of the procedure for attaching a wearable sensor device to a patient, including removing the back-release protective material. The figure shows the procedure including step 1, in which the protective material is partially peeled off without being completely removed; step 2, in which the adhesive part is attached to a flat area on the upper body and the protective material is slowly peeled off without stretching it; and step 3, in which the borders of the adhesive part are lightly tapped to flatten them. [Figure 16] FIG. 10 shows an alternative arrangement of the sensor device with a charging module, aiming for a more efficient, thinner and environmentally friendly battery design in a rechargeable form suitable for nanotechnology forms. DETAILED DESCRIPTION OF THE INVENTION

[0086] Generally, a wireless cardiac sensor system comprises a wireless cardiac device capable of sampling electrical signals generated by a patient's heartbeat and transmitting signals representative of the heartbeat to a receiving device that can analyze the signals to identify features of interest and / or display a graph of the heartbeat based on the signals.

[0087] The wireless cardiac device includes three electrodes mounted on a substrate for contacting the skin over the patient's heart to receive electrical signals. Preferably, the signals are filtered and then sent to a digital-to-analog converter in the device, which converts the signals to digital form. A wireless transmitter in the device transmits the digital form of the signals to a receiving device.

[0088] In one preferred embodiment, the substrate is thin and flexible to conform to the contours of the skin. In a preferred embodiment, the electrodes are mounted on the substrate in the shape of an equilateral triangle with sides between 5 and 12 cm, preferably between 6 and 10 cm in length. Preferably, the positive terminal electrode is oriented closest to the patient's right arm, the negative terminal electrode is oriented closest to the patient's left arm, and the reference electrode is oriented closest to the patient's left leg.

[0089] In one preferred form, the wireless cardiac device is powered by a coin cell battery, and power consumption is kept low enough so that the battery has a life of at least 1 hour by balancing a sample rate of at least 25 ms, preferably 20 ms, between samples with a transmit strength sufficient to transmit samples over at least 0.5 m, preferably with a signal power of at least -20 dB.

[0090] In one preferred form, the receiving device is a portable computing device configured to identify features of interest including one or more of the P, Q, R, S and / or T peaks, RRI, PRI, QTI and / or QRSI, and the receiving device is configured to display these features of interest and a trace of the heartbeat based on the received signals. [Example]

[0091] Wireless Sensor Patch (WSP) The operating principle of one embodiment of the wireless sensor patch is shown diagrammatically in Figure 2a. A fully integrated three-electrode (RA, LA, and RL) ECG with an analog front-end signal conditioner (such as an AD8232 with 4 mm × 4 mm dimensions) is used to extract weak biopotential signals under noisy conditions, such as motion artifacts. The signal is amplified, such as by using an integrated instrumentation amplifier that amplifies the extracted signal by 1100 times. A second-order low-pass filter is used to remove additional noise before the signal is fed to an analog-to-digital converter, such as a Bluetooth Low Energy (BLE) module, such as the DA14531. The DA14531 is a compact, low-power Bluetooth 5.1 system-on-chip integrated with an antenna. It is used for digitizing the sensor's analog data using high-frequency sampling to achieve all the necessary P, Q, R, S, and T peaks of the ECG signal, and for wireless communication with a receiver, such as a smartphone. A low-dropout regulator (LDO) ensures that the supply voltage never exceeds 2.8 V. Figure 2b illustrates the overall circuit diagram of the WSP. Two 180 kΩ resistors at input electrodes 1 and 2 are used to protect the user from defects in the patch. To acquire the ECG signal with minimal distortion, a bandpass filter is set using a 0.5 Hz, two-pole high-pass filter followed by a two-pole, 40 Hz low-pass filter. For continuous real-time monitoring, the shutdown control pin (SDN) and fast restore control pin (FR) are always connected to the power supply. Figure 2c shows the circuit diagram for device fabrication using Altium PCB design tools. Both the top and bottom copper (Cu) circuit layers are 18 μm thick, while the flexible polyimide layer is 75 μm thick. The overall board thickness of 101 μm provides sufficient flexibility for attaching the device to the curved surface of human skin. The surface-mount active components and 0201 form factor passive components are then reflow soldered as shown in Figure 2d.Figure 2e shows the placement of the WSP on the torso near the heart according to the Einthoven triangle rule based on bipolar leads. The so-called 12-lead ECG based on the Wilson-coupled electrodes invented by F.N. Wilson was further modified by E. Goldberger as an augmented lead, and the precordial leads (V1 to V6) have been modified in this invention to allow access to real-time ambulatory monitoring of cardiovascular events. The negative and positive electrodes of the WSP are placed on the right and left sides of the heart around the fourth rib, while the reference electrode is placed parallel to the main ventricular depolarization of the heart, pointing to the left bundle branch. The fabrication of the device and the connection of the ECG electrodes are described in detail in the experimental section. [Example]

[0092] Power management and firmware for high frequency sampling Efficient data transfer and battery life are two critical requirements for real-time untethered cardiovascular monitoring. Keil embedded development tools were used to modify and develop Dialog Semiconductor's software development kit, SDK6.0.16.1144, for the DA14531. Details of the programming and modifications are described in the experimental section. The minimum achievable transmit power from the DA14531 is -19 dB, making it currently the lowest-power BLE chip known in the industry. Firmware was programmed using the recommended Keil IDE, and different DA14531s were flashed using the Smartbond Flash Programmer provided by Dialog Semiconductor for different transmit powers within the range of +2.5 dB to -19 dB. This allows for recording the transmission data and understanding the physical distance range versus battery life. A 140 mAh CR1632 coin-cell battery (manufactured by Panasonic) was used in this characterization. Figure 3a illustrates the relationship between distance and transmit power, clearly showing the linear increase in distance range with transmit power. On the other hand, as shown in Figure 3b, battery life decreases with increasing transmit power. Therefore, there is a trade-off between range and battery life. A distance of 1 m is sufficient for mobile monitoring, but a longer operating distance can be selected upon request. Selecting -19 dB results in a battery life of 8 days for the device to advertise that connection is available. Note that in this case, we only observed the advertised battery life, not the continuous recording life on the smartphone. At the same time, sampling rate is another important factor affecting battery life. Sampling periods of 20 ms, 30 ms, and 40 ms for -19 dB transmit power on three different devices were tested, and the decay in battery power for continuous recording of the signal on the smartphone screen was observed.From Figure 3c, we can see that the battery life decreases linearly with decreasing sampling period or increasing sampling frequency. Therefore, we need not only to select an appropriate sampling period for battery life, but also to detect all the important peaks of the ECG, such as P, Q, R, S, and T, as will be explained in the next paragraph.

[0093] The data coming from the analog front-end must be digitized before wireless transmission. This can be achieved by using the BLE system-on-chip (SoC)'s built-in 4-channel 10-bit analog-to-digital converter (ADC). Small wearable devices that monitor ECG signals are strongly energy-constrained. Therefore, to achieve an ECG signal that still allows accurate HRV analysis, the ADC's sampling rate must be carefully selected. A key step in analyzing HRV is measuring the time interval between R-peaks of the ECG signal. A low sampling rate can reduce the accuracy of the R-wave fiducial points. To achieve an accurate sampling period, the BLE SoC was flashed with sampling periods of 40 ms, 30 ms, 20 ms, and 15 ms. We attached the device to the volunteer's chest as shown in Figure 2e, monitored the signal on a smartphone screen, and recorded the data in a cloud-based spreadsheet. As can be seen in Figures 4a and 4b, the time intervals between R-peaks are not the same. Furthermore, R-peaks are missing for the 40 ms and 30 ms sampling periods. Meanwhile, the accurate HRV is shown in Figure 4c for a 20 ms sampling period. It is noteworthy that, as shown in Figure 4d, we rarely observe a significant R-peak for a 15 ms sampling period. This is likely due to our use of a direct notification method to overcome the need to utilize the SOC's internal memory. At sampling rates faster than 20 ms, clustering of sampled data may occur due to the increased packet size at the longer time period of each notification. Therefore, we conclude that at a 20 ms sampling period or a 50 Hz sampling frequency, the system transmits the entire ECG signal to the smartphone for visual inspection by the user or cardiologist. [Example]

[0094] Validation of the reduction of the triangle to be placed close to the fuselage It is crucial to validate the presence of prominent peaks (P, Q, R, S, and T) in the ECG signal when the Einthoven triangle-based WSP is placed on the chest, as shown in Figure 4d. The size of the triangle can be varied to define the region (Figure 5a). Thus, while the device was placed with extended wire connections to implement triangles T1 and T2 as shown in Figure 5a, triangle T3 was formed by simply attaching the WSP, as shown in Figure 2e. The T1 triangle is formed according to the three limb leads of a 12-lead ECG system, with electrodes placed on the right hand, left hand, and left calf. Because the triangle must be reduced to realize a wearable device, we reduced the size of the triangles from T1 to T2 and T3 to understand the effect of size reduction. T2 runs from axilla to axilla or shoulder to shoulder, descending to the midpoint of the base of each half of the rib cage. T3 is a smaller equilateral triangle with sides approximately 50 mm long. Figures 5b-5d show the corresponding ECG graphs obtained from different triangles. Comparing intervals such as RRI (R-peak to R-peak interval), PRI (P-peak to R-peak interval), QTI (Q-peak to T-peak interval), and QRSI (QRS interval) for the different triangles is key to confirming the results. From these results, it is clear that the PRI (120 ms), QTI (260 ms), and QRSI (80 ms) are identical for all triangles. However, the RRI, a key indicator of heart rate (HR), differs slightly. The RRIs for T1, T2, and T3 are 760 ms (79 bpm), 840 ms (71 bpm), and 740 ms (81 bpm), respectively. Although there is some variation in heart rate, these are still within the range of a normal person at rest. Therefore, considering all intervals, we can confirm that the smaller triangle T3 produces identical results to the limb electrodes and infers ECG results from the anterior aspect of the heart. These results validate the performance of functional miniature triangles, which are essential for realizing wireless sensor patches.

[0095] Comparative studies of a 3-lead ECG system compared with a 12-lead commercially available device have shown similar characteristics of the anterior surface of the heart (represented by leads I, II, and III of the 12 leads) with respect to heart rate variability (HRV), PR interval, QRS complex, QT, and mean RR. [Example]

[0096] Real-time monitoring and data analysis Figure 6a shows real-time monitoring of ECG signals on a smartphone screen and a cloud-connected interface. The development of the smartphone app and the data management system for the cloud-connected interface are described in detail in the Methods section. For simplicity, we include summary screenshots from the app and cloud-connected computer in Figure 6. The graph shows the presence of P, QRS, and T peaks, which are essential peaks for diagnosing cardiovascular problems. From the amplitude of the peaks and the R-R interval (RRI) on the mobile device screen, we infer heart rate (HR) and heart rate (HRV), which can be used for risk stratification. The overlap of R-wave fiducial points, as shown in Figure 6b, with the entire data set visible on the computer screen is an important indicator of HR variability. Finally, by acquiring the R-wave fiducial points, the RRI for each ECG signal (800 ms) between consecutive R peaks is calculated. This also verifies that a 50 Hz sampling rate is adequate for obtaining time-domain HRV parameters with reasonable accuracy. A long QT interval can predispose patients to life-threatening arrhythmias. Monitoring this abnormality is difficult and typically requires a 12-lead ECG system. The presence of a distinct T peak in a 3-lead ECG system can be helpful in understanding the QT interval. The mean QT interval from the present system is 160 ms. Hyperkalemia is a common cause of life-threatening arrhythmias in patients with cardiovascular disease, especially those with underlying renal failure. This disease is predicted using QRS widening and PR shortening. The QRS interval measured in the system is 60 ms, and the PR interval is 120 ms. Because the system is based on the bipolar leads of the Einthoven triangle, which are leads I, II, and III of the 12-lead ECG system, it is essential to conduct a comparative study with the three leads of the 12-lead DCG. A Welch Allyn Connex Cardio 12-lead ECG system was used, and the results are presented in Figure 6c. It is clear that the results are very similar to leads I and II.It is noteworthy to mention that limb leads (I, II, III, aVR, aVL, and aVF) are used to achieve ECG data of the anterior plane of the heart, while chest leads (V1–V6) are used to acquire ECG data of the horizontal plane of the heart.

[0097] This wearable 3-lead ECG system, which provides partial frontal data, is useful for home monitoring and can infer abnormalities early, which can then be further analyzed using a 12-lead ECG, thereby significantly enabling earlier intervention and better cardiovascular health management.

[0098] Exemplary Materials and Methods Wireless and BLE electronic device production The flexible printed circuit board used for the wireless BLE electronics for the cardiac monitoring device was obtained by patterning a commercially available DuPont Pyralux AP8535R substrate using an LPKF U4 UV laser system. Connections between the top and bottom circuit layers of the device were made using through-holes. Surface-mount components, including active components such as a BLE SoC (Dialog Semiconductor DA14531), a low-power ECG front-end (Analog Devices AD8232), a Toshiba TCR2DG28LF LDO, and a Panasonic CR1632 battery, as well as passive components such as resistors and capacitors in 0201 packages, were assembled using low-temperature soldering. Commercially available ECG electrodes (MikroElektronika MIKROE-2456) were used to attach the WSP to the skin and match the impedance between the device electrodes and the skin surface to achieve a better signal.

[0099] Firmware development to control sampling frequency and transmission power The study uses the Dialogue Semiconductors SmartBond TINY™ DA14531, a BLE solution for powering IoT devices. This SoC was chosen because it is currently one of the lowest power consumption Bluetooth 5.1 SoCs, which reduces the cost of adding BLE to wearable tag-based systems.

[0100] The specifications and full details of the SoC are provided on the respective company websites as described in Reference

[10] , which is incorporated herein by reference. 10 Further examples from companies of SoC usage are provided at the GitHub link in Reference

[11] , which is incorporated herein by reference. 11

[0101] The software development kit (SDK) provided by the company is very well written, and by using it the SoC can be programmed according to the sleep mode tutorial

[12] , which is incorporated herein by reference. 12 The SoC is configured to operate in an extended sleep mode to conserve battery life. In this mode, the radio, all peripheral, and system areas of the SoC are powered off, but the system random access memory (SRAM) remains powered on and retains data. Additionally, the SoC is equipped with a configurable transmit power level ranging from -19.5 dBm to +2.5 dBm, which is utilized in the power optimization study mentioned above. Finally, the direct reporting frequency is set according to the required sampling frequency.

[0102] Android app development for smartphones An Android application was created to collect data through the Bluetooth low-energy protocol. The application was developed in Android Studio using Java as the primary language. The standard Android BLE protocol was established to collect data through specific characteristics, which was then displayed on the screen using graphs. This data was also stored in the backend and later used to perform some simple analysis to extract useful information. Neurokit24 was used for this purpose to display some key information. This included finding the amplitudes of the P, Q, R, S, and T peaks, as well as displaying all the collective heartbeats in a single plot to analyze the differences in heartbeats between the different observations performed.

[0103] As a further example, a mobile application records and plots ECG data on a smartphone for real-time visual monitoring and transmits the data to a cloud-connected interface for remote access by healthcare professionals. This demonstration of a wireless patch with low-power operation and integrated with a cloud-connected interface method provides a significant step toward enabling unassisted home care in outpatient settings and preventative health management using devices without the significant constraints of battery and wired operation.

[0104] In a further example, the android / mobile application described above can be developed to also run on iOS devices.

[0105] Cloud-based Data Management The same process of data analysis is replicated on a computer as well. Since the data collected from the Android application is later moved online (to the "cloud"), the data is imported from an online cloud spreadsheet into a Python notebook and similar calculations are performed as in the steps above for the Android application. Some key insights again include finding the amplitudes of the P, Q, R, S, and T peaks and their intervals, and displaying the heartbeat of the aggregate data along with other useful information.

[0106] Finally, it should be understood that various changes, modifications, and / or additions may be made without departing from the spirit of the present invention as outlined herein.

[0107] References [1] Jeong, H. et al. Modular and Reconfigurable Wireless E‐Tattoos for Personalized Sensing. Advanced Materials Technologies 4, 1900117, doi:10.1002 / admt.201900117 (2019). [2] Cosoli, G., Spinsante, S., Scardulla, F., D'Acquisto, L. & Scalise, L. Wireless ECG and cardiac monitoring systems: State of the art, available commercial devices and useful electronic components. Measurement 177, 109243, doi:10.1016 / j.measurement.2021.109243 (2021). [3] Zulqarnain, M. et al. A flexible ECG patch compatible with NFC RF communication. Npj Flexible Electronics 4, doi:10.1038 / s41528-020-0077-x (2020). [4] Bayoumy, K. et al. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol 18, 581-599, doi:10.1038 / s41569-021-00522-7 (2021). [5] Li, C. et al. Design of biodegradable, implantable devices towards clinical translation. Nature Reviews Materials 5, 61-81, doi:10.1038 / s41578-019-0150-z (2019). [6] Jayaraman, P. P., Forkan, A. R. M., Morshed, A., Haghighi, P. D. & Kang, Y. B. Healthcare 4.0: A review of frontiers in digital health. WIREs Data Mining and Knowledge Discovery 10, doi:10.1002 / widm.1350 (2019). [7] Jurak, P. et al. Novel ultra-high-frequency electrocardiogram tool for the description of the ventricular depolarization pattern before and during cardiac resynchronization. J Cardiovasc Electrophysiol 31, 300-307, doi:10.1111 / jce.14299 (2020). [8] Malmivuo, J. & Plonsey, R. Bioelectromagnetism - Principles and Applications of ioelectric and Biomagnetic Fields. (1995). [9] Gargiulo, G. D., Bifulco, P., Cesarelli, M., Fratini, A. & Romano, M. Problems in Assessment of Novel Biopotential Front-End with Dry Electrode: A Brief Review. Machines 2, 87-98 (2014).

[10] SmartBond DA14530 and DA14531, https: / / www.dialogsemiconductor.com / products / bluetooth-low-energy / da14530-andda14531, (accessed on 12th of May, 2022).

[11] Dialog-semiconductor / BLE_SDK6_examples, https: / / github.com / dialogsemiconductor / BLE_SDK6_examples, (accessed on 12th of May, 2022)

[12] DA14531 / DA14585-586 Sleep mode tutorial, http: / / lpccs-docs.dialog semiconductor.com / DA14531_Sleep_Mode / index.html, (accessed on 12th of May, 2022).

Claims

1. 1. A device for monitoring cardiovascular activity in a patient, comprising: a. at least one power management unit for powering said device; b. an analog front-end unit for recording cardiac data; c) a data transmission unit for transmitting the recorded data; The device provides a means for recording and transmitting the cardiac data of the patient.

2. The power management unit a. a power supply; 10. The device of claim 1, further comprising: a. a low dropout regulator (LDO).

3. The device of claim 2 , wherein the power supply is selected from an additional or remote power source and / or a battery power source.

4. The device of claim 3 , wherein the remote power source is selected from a Wi-Fi, Bluetooth, cellular, or low-power wide area network power source.

5. 5. A device according to claim 3 or 4, wherein the device comprises an electromagnetic radiation receiver for receiving electromagnetic radiation and circuitry for deriving power for the device from the received electromagnetic radiation.

6. The analog front end unit comprises: a. at least three electrodes; b. an integrated instrumentation amplifier, and / or c) A device according to any one of claims 1 to 5, comprising a second order low pass filter.

7. The device of claim 6 , wherein the device comprises a positive terminal electrode, a negative terminal electrode, and a reference electrode.

8. 8. The device of claims 6 and 7, wherein each electrode comprises an adhesive.

9. 9. The device of claim 6, further comprising at least two resistors at the electrodes.

10. The data transmission unit an analog-to-digital converter; and b) A device according to any one of claims 1 to 9, comprising an antenna for wirelessly transferring digitised data.

11. 11. The device of claim 1, wherein the sampling of electrical activity is continuous or selective.

12. The device of claim 11 , wherein the sampling of electrical activity is selective.

13. The device of claim 1 , wherein the device is remotely controlled.

14. The device of claim 1 , wherein the device is activated and deactivated remotely.

15. The device of claim 14 , wherein the device includes a receiver that receives signals to control circuitry that activates and / or deactivates the sensor.

16. 16. The device of claim 1, wherein the thickness of the substrate of the device is between about 80 and 120 μm.

17. 17. The device of claim 16, wherein the thickness of the substrate is between about 90 and 110 μm.

18. 20. The device of claim 17, wherein the thickness of the substrate does not exceed about 101 μm.

19. 1. A method for monitoring cardiovascular activity in a patient, comprising: a. applying to said patient a device for monitoring cardiovascular activity, said device comprising: i. at least one power management unit for powering said device; ii. an analog front-end unit for recording cardiac data; iii. a data transmission unit for transmitting the recorded data; b. displaying the recorded data on a secondary device; an adhesive layer providing a means for maintaining contact between the electrode and the skin surface of the patient; the device performs high frequency sampling of cardiovascular events to achieve all required P, Q, R, S, and T peaks of the ECG signal; The method, wherein the device enables wireless communication with a secondary device.

20. 20. The method of claim 19, wherein the secondary device is selected from a computer, a smartphone, a smartwatch, a tablet, a touchscreen device, or any other suitable "smart device."

21. 1. A system for monitoring cardiovascular activity of a patient, comprising: a. a device for monitoring the cardiovascular activity of a patient, comprising: i. at least one power management unit for powering said device; ii. an analog front-end unit for recording cardiac data; iii. A device comprising a data transmission unit for transmitting the recorded data; b. a secondary device for receiving the recorded data.

22. 22. The system of claim 21, wherein the secondary device is selected from a computer, a smartphone, a smartwatch, a tablet, a touchscreen device, or any other suitable "smart device."

23. 1. A wireless cardiac sensor device, comprising: at least three electrodes mounted on a substrate in contact with the patient's skin over the heart for receiving electrical signals generated by the beating of the heart; a digital-to-analog converter for converting said signal into a digital form; and a wireless transmitter of said digital form of said signal.

24. 24. The wireless cardiac sensor device of claim 23, wherein the signals from the electrodes are provided to a filter before conversion to digital form.

25. 25. The wireless cardiac sensor device of claim 23 or 24, wherein the substrate is flexible to conform to contours of the skin.

26. 26. A wireless cardiac sensor device as described in any one of claims 23 to 25, wherein the electrodes are mounted on the substrate in a triangular shape that is smaller in size than the triangle formed between each of the shoulders and the midpoint between the bottom of each side of the rib cage.

27. 27. The wireless cardiac sensor device of claim 26, wherein the triangle of the electrodes is an equilateral triangle with side lengths between about 2 and 15 cm.

28. 27. The wireless cardiac sensor device of claim 26, wherein the triangle of the electrodes is an equilateral triangle with side lengths between about 3 and 12 cm.

29. 27. The wireless cardiac sensor device of claim 26, wherein the triangle of the electrodes is an equilateral triangle with side lengths between about 4 and 10 cm.

30. 30. The wireless cardiac sensor device of claim 22, wherein one of the electrodes is a positive terminal electrode, one of the electrodes is a negative terminal electrode, and another of the electrodes is a reference electrode.

31. 31. The wireless cardiac sensor device of claim 30, wherein, in use, the positive terminal electrode is oriented closest to the patient's right arm, the negative terminal electrode is oriented closest to the patient's left arm, and the reference electrode is oriented closest to the patient's left leg.

32. 1. A wireless cardiac sensor monitoring system, comprising: A monitoring device comprising: a. at least three electrodes mounted on a substrate in contact with the patient's skin over the heart for receiving electrical signals generated by the beating of the heart; b. a digital-to-analog converter for converting said signal into digital form; c. a monitoring device including a wireless transmitter of said digital form of said signal; a receiver of the transmitted signal configured to analyze the signal to identify features of interest and / or display a graph of the heart rate based on the signal.

33. 33. The wireless cardiac sensor monitoring system of claim 32, wherein the receiver of the transmission signal is a secondary device selected from a computer, a smartphone, a smartwatch, a tablet, a touchscreen device, or any other suitable "smart device."

34. 34. The wireless cardiac sensor monitoring system of claim 33, wherein the secondary device comprises a data module configured to receive, monitor, and / or analyze the cardiac data recorded by the device.

35. 1. A process for monitoring a patient, said process comprising: Providing a wireless cardiac sensor device according to any one of claims 1 to 31; b) contacting at least three electrodes mounted on the substrate with the patient's skin over the heart to receive electrical signals generated by the beating of the heart; c) converting said signal into a digital format; d) wirelessly transmitting said digital form of said signal.

36. 1. A process for monitoring a patient, said process comprising: Providing a wireless cardiac sensor device according to any one of claims 1 to 31; b) contacting at least three electrodes mounted on the substrate with the patient's skin over the heart to receive electrical signals generated by the beating of the heart; c) converting said signal into a digital format; d. wirelessly transmitting said digital form of said signal; e. receiving the transmission signal; f. analyzing the signal to identify features of interest and / or displaying a graph of the heartbeat tracing based on the signal.

37. 37. The process of claim 36, wherein the step of receiving the electrical signal (sampling period) occurs approximately every 18 to 30 ms.

38. 38. The process of claim 36 or 37, wherein the identified features of interest include P, Q, R, S and / or T peaks, RRI, PRI, QTI and / or QRSI.

39. 39. The process of any one of claims 36 to 38, wherein the wireless transmission has sufficient power to be received at a distance of at least about 0.5 to 10 meters.

40. 1. A device for monitoring cardiovascular activity in a patient, comprising: a. at least one power management unit for powering said device; b. an analog front-end unit for recording cardiac data; c) a data transmission unit for transmitting the recorded data; the device provides means for recording and transmitting the cardiac data of the patient; The device comprises: i. a power supply selected from additional or remote power sources and / or battery power sources; ii. A single (three-point) electrode for sampling; iii. An antenna for power harvesting to extend the life of the device and / or provide backup power access; iv. Means for wireless communication with a secondary device, and / or v. A device comprising one or more of the following elements: a BTLE, a Wi-Fi hub, and / or a means for connecting to a fall / motion IoT gateway.

41. 41. The device of claim 40, wherein the battery power source comprises a flat, stickable EcoCell and / or a rechargeable battery power source.

42. 41. The device of claim 40, wherein the power harvesting can occur via a BTLE hub or a fall / motion IoT gateway.

43. 41. The device of claim 40, wherein the device includes means for monitoring a patient for fall detection.

44. 41. The device of claim 40, wherein the electrodes have a triangular configuration.

45. 41. The device of claim 40, wherein the means for wireless communication with a secondary device allows for continuous real-time communication with the device.

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