WO2021188018A2 - Ecg, heart and lungs sound monitoring system with wireless earphones - Google Patents

Ecg, heart and lungs sound monitoring system with wireless earphones Download PDF

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Publication number
WO2021188018A2
WO2021188018A2 PCT/RU2021/050067 RU2021050067W WO2021188018A2 WO 2021188018 A2 WO2021188018 A2 WO 2021188018A2 RU 2021050067 W RU2021050067 W RU 2021050067W WO 2021188018 A2 WO2021188018 A2 WO 2021188018A2
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WIPO (PCT)
Prior art keywords
electrode
user
ecg
heart
signal
Prior art date
Application number
PCT/RU2021/050067
Other languages
French (fr)
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WO2021188018A3 (en
Inventor
Vladimir Savchenko
Original Assignee
Vladimir Savchenko
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vladimir Savchenko filed Critical Vladimir Savchenko
Priority to CN202180034974.XA priority Critical patent/CN115643796A/en
Publication of WO2021188018A2 publication Critical patent/WO2021188018A2/en
Publication of WO2021188018A3 publication Critical patent/WO2021188018A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/33Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332Portable devices specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6803Head-worn items, e.g. helmets, masks, headphones or goggles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00Instruments for auscultation
    • A61B7/003Detecting lung or respiration noise

Definitions

  • This disclosure generally relates to portable heart and lungs activity monitors, portable electrocardiography (ECG/EKG) monitoring systems, portable electronic sound recording systems and the like devices. More particularly, this disclosure relates to an apparatus which integrates a heart and lungs activity measuring sensor, a sound recording system and earphones.
  • ECG/EKG portable electrocardiography
  • Heart rate monitor including a chest belt having two electrical contacts which should contact the chest of a user and enable the heart rate monitor to measure a human heart rate. This type of heart rate monitor is found to be inconvenient to use by many individuals.
  • These heart rate monitors typically include a light source and a light detector. A light is shined from the light source, directed through a skin of the user to a blood vessel, and the reflected light sensed by the light detector. The heart rate monitor further measures a blood motion within a vessel of the user to determine heart activity.
  • the light-based heart rate monitors are typically integrated into wearable accessories such as watches, wrist bands, arm bands, and the like.
  • One well known drawback of the light-based heart rate monitors includes inconsistency in heart rate measurement, especially when the user is in motion.
  • Electrocardiography devices have been proven to be more reliable but they are typically bulky, non-portable, or require an extra device tightly attached to a chest of the user.
  • the electrocardiography devices were also found to be inconvenient to use in sporting activities and everyday life. Accordingly, there is still a need in the art to improve heart activity monitors, make them more reliable, user friendly and integrated with existing wearable devices, fashion accessories and garment.
  • an apparatus for heart and lungs activity monitoring is a device commonly called a heart and lungs monitor or HLM which is integrated into or attached to existing wearable accessories, fashion accessories and garment worn by a human.
  • the heart monitoring sensor uses electrocardiogram (ECG or EKG) method with at least two electrodes attached to a skin.
  • the wearable devices and accessories which can be integrated with the heart monitoring sensor include but not limited to: headsets with in-ear headphones, bone-conducting headphones attached behind the ear or in front of the ear, a single piece (mono) earbud, a dual-piece (stereo) earbuds.
  • the heart monitoring system consist of at least one sensor, at least two electrodes connected to the skin of a human and at least one earpiece.
  • the sensor with electrodes could be integrated into or connected to an existing device or accessory or be a stand-alone sensor device.
  • the sensor detects electrical signal generated by the heart muscles.
  • the sensor receives audible heart and lung sounds on its microphone.
  • the ECG signal and audible heart and lungs sounds are transmitted to a host device such as a smartphone, a watch or other monitoring device commonly called a host.
  • the host separates ECG signal from heart and lungs sounds, processes the ECG signals, calculates heart activity data such as typical ECG waveform points: P, Q, R, S,
  • T intervals between ECG waveform points, heartbeat, heart rate variability and heart rhythm and other heart activity parameters.
  • the host analyzes audible heart and breathing sounds and calculates breathing rate.
  • the host is connected to at least one earpiece and receives audible information from a microphone built into the earpiece. The host compiles ECG data, heart and lungs sound with an audio received from an earpiece, displays and stores the ECG signal with the heart and lungs sounds and an audio from earpiece into one digital audio file.
  • FIG. 1 illustrates a logical block diagram of the HLM system
  • FIG. 2 illustrates one embodiment of the HLM sensor
  • FIG. 3 illustrates one embodiment of the HLM sensor in cross-sectional view
  • FIG. 4A shows a view of a female user illustrating one example how the user can wear the HLM sensor
  • FIG. 4B shows a view of a male user illustrating one example how the user can wear the HLM sensor
  • FIG. 5A illustrates one embodiment of an earpiece with connection to the
  • FIG. 5B shows a side view of a user illustrating one example how a user can wear an earpiece connected with the HLM sensor
  • FIG. 5C illustrates a cross-sectional view of one embodiment of an earpiece with connection to the HLM sensor
  • FIG. 6A illustrates a cross-sectional view of another embodiment of an earpiece with connection to the HLM sensor
  • FIG. 6B shows a side view of an ear illustrating another example how a user can wear an earpiece connected with the HLM sensor
  • FIG. 7 illustrates one embodiment how a user can use the HLM sensor in cross-sectional view
  • FIG. 8 a block diagram illustrating user’s interaction with the HLM system
  • FIG. 9 a block diagram illustrating the logic of the HLM application on the host.
  • headset and apparatus for heart and lungs activity monitoring.
  • These headset and apparatus may be implemented using electronic hardware, computer software, or any combination thereof. Whether such aspects of this disclosure are implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system.
  • an element, or any portion of an element, or any combination of elements may be implemented with a “data processor” that includes one or more microprocessors, microcontrollers (MCUs), Central Processing Units (CPUs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), programmable logic devices (PLDs), state machines, gated logic, discrete hardware circuits, and other suitable hardware configured to perform various functions described throughout this disclosure.
  • the data processor may execute software, firmware, or middleware (collectively referred to as “software”).
  • the term “software” shall be construed broadly to mean instructions, instruction sets, code, code segments, program code, programs, subprograms, software components, applications, software applications, software packages, routines, subroutines, objects, executables, threads of execution, procedures, functions, etc., whether referred to as software, firmware, middleware, microcode, hardware description language, or otherwise.
  • the functions described herein may be implemented in hardware, software, or any combination thereof. If implemented in software, the functions may be stored on or encoded as one or more instructions or code on a non-transitory computer-readable medium.
  • Computer-readable media includes computer storage media. Storage media may be any available media that can be accessed by a computer.
  • such computer-readable media can comprise a random-access memory, a read-only memory, an electrically erasable programmable read-only memory, magnetic disk storage, solid state memory, or any other data storage devices, combinations of the aforementioned types of computer- readable media, or any other medium that can be used to store computer executable code in the form of instructions or data structures that can be accessed by a computer.
  • first, second, third, and so forth can be used herein to describe various elements. These terms are used to distinguish one element from another, but not to imply a required sequence of elements. For example, a first element can be termed a second element, and, similarly, a second element can be termed a first element, without departing from the scope of present teachings.
  • the term “host device” shall be construed to mean any computing or electronic device with data processing and data communication capabilities, including, but not limited to, a mobile device, cellular phone, mobile phone, smart phone, Internet phone, user equipment, mobile terminal, tablet computer, laptop computer, desktop computer, workstation, thin client, personal digital assistant, multimedia player, navigation system, game console, wearable computer, smart watch, entertainment system, infotainment system, vehicle computer, bicycle computer, or virtual reality device.
  • the term “earpiece” shall be construed to mean any device that can be placed into or near an outer ear of a user for purposes of outputting audio signals or noise reduction purposes.
  • the term “earpiece” shall also mean any or all of the following, or shall be construed to mean that one or more of the following is an element of the “earpiece”: a headphone, an earbud, an earphone, an ear speaker, an ear pod, an ear insert, hearing aid device, and in-the-ear acoustic device.
  • the term “headset” shall be construed to mean a device that comprises at least one headphone only or a device that comprises at least one headphone and a microphone.
  • a headset can be made with either a single-earpiece (mono) or a double-earpiece (mono to both ears or stereo).
  • headphones is used herein to mean a pair of speakers or loudspeakers maintained close to a user’s ears. Examples of headphones can circum-aural, supra-aural, earbud, and in-ear headphones.
  • In-ear headphones are small headphones, sometimes also called earbuds, which are inserted in the ear canal or fitted in the outer ear.
  • heart activity shall be construed to mean any vital, natural or biological activity of a human heart including heart beats or heart electrical activity.
  • heart activity signal shall be construed to mean an analog signal characterizing a heart activity of a user.
  • heart activity data shall be construed to mean any digital data characterizing a heart activity of a user.
  • heart activity signal include, but not limited to, an electrocardiogram (ECG or EKG) signal, heart activity wave signal, or heart activity impulse signal.
  • heart activity data include, but not limited to, a heart rate, a heart beats per minute, a heart variability rate, a heart rhythm, an electrocardiogram (ECG or EKG) represented in digital form or any other vital or biometrical data associated with heart activity.
  • ECG electrocardiogram
  • heart sound shall be construed to mean any sounds produced by the heart in the range below 20,000 Hz frequency, including infra-sounds below 20 Hz frequency range.
  • lungs sound shall be construed to mean any sounds produced by the lungs and airways as a result of breathing in the range below 20,000 Hz frequency, including infra-sounds below 20 Hz frequency range.
  • the aspects of embodiments of this disclosure provide an apparatus for heart and lungs activity monitoring.
  • the embodiments of this disclosure integrate or connect a heart and lungs activity measuring sensor to an earpiece.
  • the heart and lungs activity measuring sensor is generally configured to sense, detect, or measure one or more heart activities of the user, generate heart and lungs activity data and transmit or cause transmitting the heart and lungs activity data to a host device such as a smart phone or a smart watch for further processing, recording in a memory, or displaying.
  • the heart and lungs activity measuring sensor comprise at least two electrodes which are configured to directly connect to a skin of a user.
  • first electrode is placed inside an ear, on a concha or in an auditory canal and establishes a reliable electrical contact with the skin.
  • the second electrode provides a contact on the chest or back of the user.
  • a third electrode In another embodiment of the heart and lungs activity measuring sensor integrated into an earpiece a third electrode.
  • the third electrode is positioned inside the other ear of the user in the same way as the first electrode, on a concha or in an auditory canal and establishes a reliable electrical contact with the skin.
  • the heart and lungs activity measuring apparatus can further comprise one or more sensors coupled to the electrodes and configured to measure electrical signals captured by electrodes and generated by heart muscles, filter the ECG signal, process this ECG signal, calculate various heart data from ECG signal, capture heart and lungs sound and transmit ECG signal, heart and lungs sound to a host device.
  • FIG. 1 illustrates a block diagram representing an example of the heart monitoring system 100 which is comprised of at least one HLM sensor 101, at least one host device 119, at least one wireless earpiece 123 for one ear and optionally a second wireless earpiece 125 for the other ear.
  • the host device 119 can be wirelessly connected to HLM sensor 101, to earpiece 123 and to earpiece 125 simultaneously using Bluetooth or proprietary wireless protocol.
  • the sensor 101 comprised of two logical subsystems, audio subsystem and heart monitoring subsystem or HrM subsystem. Both subsystems can function independently and in wireless connection to a host 119 for the purpose of transmitting audio signals and human heart and lungs activity characteristics.
  • HrM subsystem is comprised of 2 electrodes 103 and 104, an analog front end (AFE) 109, a wireless transmitter (TRX) 107 and a battery (BAT) 121.
  • AFE analog front end
  • TRX wireless transmitter
  • BAT battery
  • HrM subsystem could also have a modulator (MD) 110 and an audio codec (AC) 112.
  • HrM subsystem could have a microcontroller (MCU) 113, a data storage (DS) 117.
  • HrM subsystem could also have a third electrode 105.
  • Audio subsystem in a minimal configuration comprised of at least one microphone 115, an audio codec (AC) 112, a wireless transmitter (TRX) 107 and a battery (BAT) 121.
  • the audio subsystem could also have a microcontroller (MCU) 113, a data storage (DS) 117.
  • MCU microcontroller
  • DS data storage
  • the audio subsystem could also have an analog amplifier (AMP) 114 connected with its input to a microphone 115 and as an output to audio codec (AC) 112.
  • the analog amplifier (AMP) 114 could be turned on an off by the user.
  • the audio subsystem is intended to pick sounds produced by the heart, lungs and airways via a microphone 115.
  • the audio signal picked by a microphone 115 could be transmitted to AC 112 in 2 ways: non-amplified and amplified signal via AMP 114.
  • HrM subsystem and audio subsystem is used only for logical division of different parts of the system and is not limiting to components in each subsystem. In fact, some components are shared between all subsystems, other components are designated for use in one subsystem. Both subsystems could function independently from each other and as a whole unit. The logical explanation of division the sensor 101 into two subsystems will be apparent further from this disclosure.
  • the sensor 101 is comprised of three electrodes
  • Electrodes 103 and 104 are used to create one lead for the purpose of measuring ECG signals.
  • the electrode 105 serves as a reference electrode as commonly used in ECG measuring method.
  • the output of the AFE 109 is an amplified analog signal related to ECG.
  • the output of the AFE 109 is passed to an analog input of microcontroller (MCU) 113 and to a modulator (MD) 110.
  • MCU 113 processes the analog signal into digital form and calculates heart activity data. It stores the resulting data to a data storage (DS) 117 like a flash memory.
  • MCU 113 is connected to a wireless transmitter (TRX) 107 like Bluetooth or proprietary wireless transmitter.
  • the sensor 101 also contains at least one audio codec (AC) 112 and at least one microphone 115. Analog audio signal from a microphone 115 processed by audio codec (AC) 112 into digital audio signal.
  • AFE 109 The output of AFE 109 is also connected to a modulator (MD) 110.
  • MD modulator
  • the MD 110 modulates analog ECG signal from AFE 109 and forwards modulated signal to AC 112.
  • AC 112 transforms it into a digital audio format and forwards it to a transmitter (TRX) 107 for wireless transmission to a host 119.
  • the MD 110 can use different modulation methods.
  • One method is using a carrying frequency with time-divided amplitude modulation. This method allows mixing ECG signal from AFE 109 with a voice signal from a microphone 115 into one audio channel.
  • ECG signal modulation The purpose of ECG signal modulation is to pass the analog ECG signal to the host without interfering with an audio signal via a standard microphone voice channel commonly used in wireless earphones. Since the human audible range uses spectrum from 20 Hz to 20,000 Hz it makes sense to modulate ECG signal using carrying frequency above audible range of 20,000 Hz. This method allows to mix modulated ECG signal and audio received from a microphone 115 into one audio channel. The mixing of both signals and its digitizing is performed in a codec AC 112 and then transmitted via TRX 107 to the host 119. The host 119 receives digital audio stream and records it into one digital audio file using available digital audio format such as AAC, ALAC, FLAC, MP3, WAV or other digital audio format.
  • the ECG signal recorded together with a voice signal in one file is used further for ECG analytics.
  • the user can narrate its own feelings or other observations at the exactly the same time as ECG measurement is performed.
  • This user’s narrative together with ECG signal could be used by a physician, trained specialist or artificial intelligence (AI) for detailed analytics of heart and lungs activity.
  • AI artificial intelligence
  • the modulator can be set to use frequencies below 20 KHz.
  • audio codec (AC) 112 has 16 KHz audio frequency limit then the carrying modulating frequency for MD 110 could be set to less than 16 KHz.
  • the AC 112 mixes signals from a microphone 115, from an amplifier 114 and from MD 110 into one audio signal, codes it into a digital format and sends via a transmitter TRX 107 to the host.
  • the host 119 receives digital data and processes it as a mono audio stream.
  • the HLM sensor 101 uses another method transmitting ECG signal to the host 119. It can be achieved by using two-microphone- channel transmitter TRX 107. Some transmitters, like Bluetooth are designed to have two independent audio input channels for two microphones.
  • the voice signal from a microphone 115 is digitized by the codec AC 112 and transmitted by TRX 107 using first microphone channel.
  • the modulated ECG signal from MD 110 is digitized by the codec AC 112 and transmitted by TRX 107 using second microphone channel.
  • the host 119 receives digital data with two microphone channels and processes it as a two- channel audio stream.
  • the HLM sensor 101 uses direct (non- modulated) method transmitting ECG signal to the host 119.
  • the voice signal from a microphone 115 is digitized by the codec AC 112 and transmitted by TRX 107 using first microphone channel.
  • the ECG signal from AFE 109 passed through MD 110 without modification, then digitized by the codec AC 112 and transmitted by TRX 107 using second microphone channel.
  • the host 119 receives digital data with two microphone channels and processes it as a two-channel audio stream.
  • Modern integrated circuits can have several components like MCU
  • a modulator MD 110 could be implemented as a microcontroller code or library in MCU 113. It is also possible to have all components of the HLM sensor 101 integrated into a single IC.
  • the battery (BAT) 121 provides power for the sensor 101 and all its components. It can be a rechargeable or a single use (non-rechargeable) battery.
  • the transmitter TRX 107 can be wirelessly connected to a host 119 via a wireless transmitter 111 built into the host device with the same protocol like Bluetooth or proprietary wireless protocol.
  • the host device 119 can be a mobile phone, a smartwatch, a tablet, a computer or any other device capable of receiving wireless signals, processing, displaying, storing or rebroadcasting them to another device.
  • the transmitter TRX 107 can broadcast signals to multiple host devices which can receive the data at the same time.
  • FIG. 2 illustrates one embodiment of the HLM sensor 200 for use with wireless earbuds.
  • the HLM sensor is comprised of a housing 201, an electrically conductive bell-shaped cover 203 with an opening for a microphone 205, a connector 207 and an electrode cable 209 containing at least one, the first electrical wire 215 connected to electrically conductive clip 219.
  • the electrode cable 209 contains two electrical wires, where the second electrical wire 217 connected to electrically conductive clip 221.
  • the clips 219 and 221 are made from an electrically conductive materials like conductive polymers, metals, metallic or neodymium alloys.
  • the clips 219 and 221 are made for easy clipping to earbuds 202 and 204 respectively.
  • the clip 219 connects to the right earbud 202 and the clip 221 connects to the left earbud 204.
  • the clip 219 is connected via an electrical wire 215 to the first electrode input of the HLM sensor 103 as illustrated in FIG. 1.
  • the clip 221 is connected via an electrical wire 217 to the third electrode input of the HLM sensor 105 as illustrated in FIG. 1. Both electrode input connections are located inside the HLM sensor housing 201 which is logically represented as 101 in FIG. 1.
  • the bell-shaped cover 203 is electrically connected to the second electrode 104 as illustrated in FIG. 1.
  • the bell-shaped cover 203 is made from an electrically conductive material such as a metal, metallic alloy, metal plated plastic or a conductive polymer.
  • the opening for a microphone 205 in the bell-shaped cover 203 intends for receiving sounds from a chest or a back of the user.
  • the system could be equipped with a neck holder 223 connected to the electrode wires 215 and 217 with a sliding ties or rings 211 and 213 respectively.
  • the purpose of the neck holder 223 with sliding rings is to establish certain length of the holder so when a user is wearing the HLM sensor 201 it is located on or near xiphistemum on a chest of a user.
  • FIG. 2 is intended for illustrating overall picture of the HLM sensor 200.
  • the proportional dimensions of the housing 201, the connector 207, wires 215 and 217, clips 219 and 221, earbuds 202 and 204, and the neck holder 223 may not represent the real proportional dimensions of all elements in the illustration.
  • FIG. 3 illustrates one embodiment of the HLM sensor in cross-sectional view 300.
  • the HLM sensor comprises of: the housing 301, a bell-shaped cover 309, an electrode cable 323 with wires connecting the sensor with electrodes in the ear and a printed circuit board (PCB) 307 with the components logically represented inside the rectangle 101 as illustrated in FIG. 1.
  • PCB printed circuit board
  • the wire 311 is connected to the first electrode logically represented as
  • the wire 313 is electrically connected to the bell-shaped cover 309 at a contact position 321.
  • the bell-shaped cover 309 is made from a metal, a metallic alloy, metal plated plastic or electrically conductive polymer.
  • the bell-shaped cover 309 represents the second electrode logically illustrated as 104 in FIG.L [0059]
  • the wire 315 is connected to the third electrode logically represented as
  • the component 303 mounted on PCB 307 represents an analog front end (AFE) logically illustrated as 109 in FIG. 1. All 3 electrode wires 311, 313 and 315 are connected to AFE 303.
  • AFE analog front end
  • the bell-shaped cover 309 serves dual purpose: one is the electrode, the other is a diaphragm for heart and lungs sound receptacle.
  • the bell-shaped cover 309 conducts electrical current from the skin when places of the chest or back of the user and establishes a firm contact with the skin at its circumference line 305.
  • As a receptacle for heart and lungs sounds it works by blocking outside noise when placed on a skin of a chest or back and seals the edges from other sounds at circumference line 305. It receives the sounds generated by the heart, lungs and airways via an opening 319.
  • Component 317 illustrates a microphone mounted on PCB 307 and aligned with an opening 319.
  • the purpose of the microphone 317 is to receive audible sounds from heart and lungs when placed on a chest or back of the user.
  • the microphone 317 can be turned on and off by the user’s action.
  • the microphone 317 can be switched by the user into different modes of operation: direct mode and amplified mode. These two modes of operation are also illustrated by the connection lines to AC 112 in FIG. 1.
  • Direct mode is represented with a straight line from microphone 115 to AC 112.
  • Amplified mode is represented with a line via amplifier 114 to AC 112.
  • In a direct mode the microphone receives audio input and transmits it directly to AC 112.
  • an amplified mode the audio input from a microphone 115 is amplified in amplifier 114 and then transmitted to the AC 112.
  • the amplified mode is used to detect a low amplitude sound from the heart and lungs of the user.
  • FIG. 4A shows a view of a female user illustrating one example how the user can wear the HLM sensor 400.
  • the HLM sensor 409 is positioned on a chest, on or near xiphistemum.
  • the HLM sensor 409 could be clipped to the bra so it remains attached under a bra and establishes a firm contact with the skin under the bra.
  • the wire 413 connects the HLM sensor 409 with an electrode connector in the earpiece 401 of the right ear.
  • the wire 405 connects the HLM sensor 409 with an electrode connector in the earpiece 403 of the left ear.
  • the wires 413 and 405 are hooked with a help of clips 411 and 407 to the neck holder 415.
  • the neck holder 415 is used to support the HLM sensor 409 at a fixed length and positioned on or near xiphistemum. Each user can set the length of neck holder 415 individually and then use it with the same length setting. This way all recorded ECG data, heart and lungs sounds could be properly compared since the HLM sensor is recording ECG, heart and lungs sounds from the same location on a chest.
  • FIG. 4B shows a view of a male user illustrating one example how the user can wear the HLM sensor 420.
  • the HLM sensor 431 is positioned on user’s back, between thoracic vertebrae and scapula.
  • the HLM sensor 431 on the back could be held tightly pressed against the skin with a help of tight closing or an elastic tie around the back and the chest.
  • the HLM sensor 431 connected via cord 429 with two wires 425 and 427.
  • Wire 425 is connected to an electrode in the earpiece 423 in the left ear.
  • Wire 427 is connected to an electrode in the earpiece 421 in the right ear.
  • the second electrode 104 as illustrated in FIG. 1 is positioned with the HLM sensor on user’s chest or back and the third electrode 105 as illustrated in FIG. 1 is positioned inside the left ear earpiece.
  • the third electrode positioned in the left earpiece is used as a reference electrode.
  • the reference electrode in the left ear is used to drive a small electrical current into the body to offset electrical signals created by other muscles or caused by motion of these muscles and the whole body.
  • the reference electrode in the left earpiece can improve the quality of ECG signal when the user is in motion.
  • the disclosed system is not limited to using only two or all three electrodes. It provides options for the user to have less wires using a two-electrode solution or use a three- electrode solution to improve ECG quality in motion.
  • FIG. 5A, FIG. 5B and FIG. 5C illustrate one embodiment of an earpiece for use with the disclosed HLM sensor.
  • FIG. 5 A illustrates one embodiment of an earpiece with connection to the
  • the illustration shows front and back view of one earpiece with an electrode wire 505 electrically connected to a clip-on connector 501 at a position 503.
  • the clip-on connector 501 is made from a metal or an electrically conductive polymer and used to establish a reliable electrical connection with a ring 509 on the stem of the earpiece.
  • the cover 507 is intended to be positioned in a concha of the ear and establish a reliable contact with the skin.
  • the cover 507 is made from a metal, metal plated plastic or an electrically conductive polymer and serves a purpose of the in-ear electrode connected to a skin in concha of the ear. [0068] FIG.
  • FIG. 5B shows a side view of a user illustrating one example how a user can wear an earpiece connected with the HLM sensor 520.
  • the earpiece 521 is position in the concha of the ear with an electrode wire 523 clipped to the stem of the earpiece.
  • the electrode wire 523 is connected to the HLM sensor positioned on the back or chest of the user.
  • FIG. 5C illustrates a cross-sectional view of one embodiment of an earpiece with connection to the HLM sensor 540.
  • a typical earpiece consists of at least one speaker or driver 541, an electronic assembly with a battery 543.
  • An earpiece may have at least one microphone 545.
  • the cover 547 also illustrated as 507 in FIG. 5A, is made from a metal, metal plated plastic or an electrically conductive polymer.
  • the cover 547 is electrically connected at position 549 to the internal wire 551 with soldering or mechanical connection so the wire 551 can transmit electrical current picked by the cover 547 from the skin to the ring 555 on the stem of the earpiece.
  • the ring 555 is made from a metal, metal plated plastic or an electrically conductive polymer and connected with the wire 551 at a position 553.
  • a clip-on connector 557 also illustrated as 501 in FIG. 5A, is electrically connected to the wire 561 at the position 559.
  • the clip-on connector 557 clips around the ring 555 and establishes a reliable electrical contact for the whole chain from the skin, via the cover 547, to the HLM sensor via wire 561.
  • the same design is also applied for the second earpiece.
  • the microphone 545 may be present only in one earpiece.
  • FIG. 6A and FIG. 6B illustrate another embodiment of an earpiece for use with the disclosed HLM sensor.
  • FIG. 6A illustrates a cross-sectional view of another embodiment of an earpiece with connection to the HLM sensor 600 using a magnetic connector.
  • An earpiece typically consists of at least one speaker or driver 605 and an electronic assembly with a battery 603.
  • the earpiece may also have at least one microphone.
  • the soft in-ear insert 609 is intended to be positioned inside the ear canal.
  • the soft in-ear insert is made from an electrically conductive material like an electrically conductive polymer, an electrically conductive latex or rubber.
  • the nozzle 607 is designed to funnel the audio sound from the driver 605 to the ear of a user.
  • the in-ear insert 609 fits snugly over the nozzle 607.
  • the nozzle 607 is made from an electrically conductive material like a metal, a metal plated plastic or an electrically conductive polymer.
  • the nozzle 607 is electrically connected at a position 611 with an electrical wire 613.
  • the electrical wire 613 is connected to a first magnet 617 positioned inside the earpiece housing 601.
  • the first magnet 617 is electrically connected to a wire 613 at a position 615.
  • the second magnet 619 is attached to the first magnet 617 with a magnetic force. Both magnets are polarized in such a way that they attract each other on one side and repel each other on the other side.
  • the magnet 619 is electrically connected to the electrode wire 623 at a position 621.
  • Both magnets 617 and 619 are made from a metal, metallic or neodymium alloys and serve a purpose of electrically connecting HLM sensor via an electrode wire 623, the nozzle 607, the in-ear insert 609 to the skin inside the ear of a user.
  • the magnets 617 and 619 establish a reliable electrical connection with help of a magnetic force and connect electrode 103 illustrated in FIG. 1 to the skin in the ear of a user.
  • two earpieces could be used, one for each ear.
  • the second earpiece has the same components as the first one described above.
  • the magnets 617 and 619 establish a reliable electrical connection with help of a magnetic force and connect electrode 105 illustrated in FIG. 1 to the skin in the ear of a user.
  • the second earpiece may not contain a microphone.
  • FIG. 6B shows a side view of an ear illustrating another example how a user can wear an earpiece connected with the HLM sensor 630.
  • the electrode wire 635 is connected via a magnetic clip connector 633 to the skin of the ear.
  • FIG. 7 illustrates one embodiment how a user can use the HLM sensor in cross-sectional view 700.
  • FIG. 7 does not describe all components of the HLM sensor in details.
  • the detailed description of components of the HLM sensor are illustrated in FIG. 3.
  • the HLM sensor 701 is positioned on or near xiphisternum on a chest, or between thoracic vertebrae and scapula on a back adjacent to the skin 702 of a user so that the bell-shaped cover 707 establishes a firm contact with the skin around cover’s edge 709.
  • the cover 707 is made from a metal, a metallic alloy, a metal plated plastic or an electrically conductive polymer and serves a purpose of receiving electrical signal 717 generated by the heart 715.
  • the electrical signal 717 transmitted via a contact with a skin 709 around the edges, the circumference of the cover 707 to the AFE 708.
  • the cover 707 is electrically connected to the AFE 708, logically illustrated as 109 in FIG. 1, via an electrical wire 704 with an electrical contact 706, which is located on the inside surface of the cover 707.
  • the bell-shaped cover 707 at its contact surface with the skin 709 is logically illustrated as an electrode 104 in FIG. 1.
  • the electrical signal from the heart 717 is received via the contact with the skin 709 at around the edges, the circumference of the cover 707 and transmitted through the electrical wire 704 to AFE 708.
  • Electrodes 103 and 105 The two electrodes, logically illustrated as electrodes 103 and 105 on FIG.
  • AFE 708 are connected to AFE 708 via two electrical wires inside the electrode cable 721 as described in details in FIG. 2 and FIG 3.
  • the opening 703 in the bell-shaped cover 707 allows the microphone 705 to receive acoustic sound 719 produced by the heart 715 and acoustic sound 713 produced by the lungs and airways 711.
  • the microphone 705 is isolated from other sounds with a sound absorbing enclosure, picking the sounds only through the opening 703.
  • the HLM sensor’s electrode 707 is made from an electrically conductive material in form of a ring around the microphone opening 703.
  • a protective membrane could separate microphone opening 703 from the skin 702.
  • HLM sensor 701 combining electrode 707 and microphone into one enclosure without deviating from the spirit of this invention - electrically connecting one HLM sensor’s electrode to a skin on a chest or back of a user and receiving sounds produced by the user’s heart, lungs and airways.
  • FIG. 8 a block diagram illustrating user’s interaction with the HLM system 800.
  • the HLM sensor 101 is logically represented as part of an overall HLM system in FIG. 1, consisting of at least one host 119 and one earpiece 123, also illustrated as 202 in FIG. 2.
  • the HLM sensor 201 is turned off and may not be worn at all.
  • the HLM sensor 201 When the user wants to measure and record ECG, heart or lungs sound the HLM sensor 201 need to be placed on a chest or back, firmly adjacent to a skin with a help of piece of clothing like a bra, a shirt or a special tie 223, and be connected to at least one earpiece 202 with a help of electrode wire 215.
  • the sensor by default is in a state of hibernation. This is a low-power state to save the battery.
  • the sensor is configured to turn on automatically when it detects an electrical current between at least two electrodes. This happens when the first electrode is connected to an earpiece in the ear as illustrated in FIG. 5A, FIG. 5D, FIG.
  • Bluetooth uses one of the available audio profiles to transmit heart and lungs sound with ECG signal simultaneously.
  • the sensor can work independently form being connected to the host. It can also work with a wireless connection to the host periodically lost or disconnected. While HLM sensor is disconnected from the host it stores all ECG signal, heart and lungs sound in a local data storage (DS) 117 with a help of MCU 113 as illustrated in FIG. 1. The stored data is transmitted to the host when the connection becomes available.
  • DS local data storage
  • the HLM sensor modulates ECG signal with one of the available modulation methods, mixes modulated signal with heart and lungs sound and transmits mixed signal to the host.
  • HLM sensor 804 - user can switch the HLM sensor into a special state when microphone is in amplified mode for better detection of low amplitude sound produced by the heart, lungs and airways.
  • HLM sensor is equipped with a button or contactless (e. g. capacitive or motion detection) switch.
  • [0089] 805 - user can interact with the HLM sensor through an application running on the host.
  • the application on the host can receive a voice request from a user via a microphone in HLM sensor or an earpiece and instruct the HLM sensor to execute an action associated with user’s request.
  • the user can request to turn HLM sensor amplified mode by saying “amplify” or the like.
  • the host application translates this request into a digital control message to HLM sensor requesting it to turn into an amplified mode.
  • the user can say “normal” or the like requesting HLM sensor to turn back to a normal mode.
  • ECG, heart and lungs sound by saying “start recording” or the like.
  • user can stop recording by saying “stop recording” or the like.
  • the HLM sensor detects it and notifies the host.
  • the host application in turn notifies the user that one of the electrodes is disconnected. If the user did it intentionally then the host issues a command to the HLM sensor to turn off after a certain period of time. The HLM sensor then disconnects from the host, and goes back into hibernation (waiting) state.
  • FIG. 9 a block diagram illustrating the logic of the HLM application on the host 900.
  • the overall heart monitoring system is logically represented in FIG. 1 and consist of at least one HLM sensor 101 wirelessly connected to a host device 119.
  • the host device 119 may also be wirelessly connected to at least one earpiece 123.
  • the host device 119 may also be wirelessly connected to both earpieces 123 and 125.
  • the host device 119 wirelessly receives audio data packets from the HLM sensor 101 via a built- in wireless transmitter 111 as illustrated on FIG. 1.
  • the host device 119 can wirelessly receive audio data packets from at least one earpiece 123 or 125 as illustrated on FIG. 1.
  • the HLM application on the host wirelessly receives audio streams from one earpiece 123 or 125 and from HLM sensor.
  • the HLM application processes audio streams from HLM sensor and an earpiece and coordinates actions with HLM sensor.
  • HLM application records all audio streams from earpiece and HLM sensor into one digital audio file.
  • the digital audio file includes a voice audio from a microphone in the earpiece, the heart and lungs sound and an ECG signal received from HLM sensor.
  • This single digital audio record allows for a playback of the originally recorded audio stream with the same timing as it was received, where a voice audio, heart and lungs sound synchronized with the ECG signal. This allows for a better diagnosis of heart and lungs activity.
  • Some digital file formats, like MP3 provide multi channel (2 channel -stereo or 4 channel -quadro) recording.
  • the HLM application uses one channel, (e.g. left channel) for a voice audio, heart and lungs sound, and another channel (e.g. right channel), for ECG signal.
  • the voice audio is recorded in the first channel
  • heart and lungs sound is recorded in the second channel
  • ECG signal is recorded in the third channel.
  • the HLM application on the host device receives audio streams from HLM sensor and at least one earpiece.
  • the HLM application separates ECG signal into another logical channel. It mixes then the voice audio received from an earpiece and audio with heart and lungs sound received from HLM sensor into one audio channel. Then the audio channel and ECG channel are processed in two parallel threads, one for each stream of data or a channel.
  • the audio is recorded into one audio channel, e.g. the left channel in a digital audio file in MP3, WAV or another digital audio file format.
  • the ECG signal is recorded into another channel, e.g. the right channel of the same digital audio file.
  • the HLM application calculates vital ECG data from ECG signal waveform, including but not limited to: P, Q, R, S and T amplitude position and time,
  • RR interval pulse
  • heart beat variability atrial fibrillation precondition and other parameters.
  • HLM application interacts with the user about calculated ECG vital data.
  • HLM application notifies the user about abnormalities in a voice message, e.g. “Possible pre-condition for atrial fibrillation. Seek medical attention.” or “a heartbeat variability above your average” or the like. Then the user can audibly ask HLM application questions about some other vital data like “What is my average heart rate?” or “What to do to reduce my variability?”.
  • the HLM application will try to find answers using its own logical capacity in artificial intelligence (AI) or it can pass this question to the cloud-based AI system via a wireless connection to the host device.
  • AI artificial intelligence
  • the user can instruct the HLM application via a voice command to upload the ECG recording to a host device and to the cloud.
  • Host HLM application uploads the recording as instructed and confirms it to the user in a voice prompt.
  • the earpiece can remain powered and connected to the host for the purpose of listening to music or talking on a phone.
  • TRX 107 illustrated in FIG. 1 could have two separate microphone audio channels.
  • HLM sensor transmits heart and lungs sound via one microphone channel and ECG signal via another microphone channel.
  • step 901 performs simply forwarding heart and lungs audio channel to step 902 and ECG signal channel to step 903.
  • the ECG signal can be transmitted in original, non- modulated form.
  • the de-modulation in step 903 becomes unnecessary and the logic proceeds to step 904.
  • FIG. 1 through FIG. 9 are not limited to only the described wearable devices or accessories and electrode connection options.
  • any earpiece can be enhanced with the disclosed heart monitoring sensor where the first electrode is connected to the skin of the ear using specific features of an earpiece.
  • the second electrode could be in contact with the skin on the chest or back of the user.
  • a third electrode connecting to the skin of another ear can be used as a reference electrode. All 2 or 3 electrodes are connected to the HLM sensor with a purpose to measure heart activity using electrical signals obtained from two electrodes and recording heart and lungs sound.

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Abstract

A heart activity measurement system with heart and lungs sound monitoring is coupled with an earpiece such as a wireless earphone or earbud with electrodes connected to a skin for the purpose of measuring heart activity using electrocardiogram, ECG or EKG method. The apparatus consists of a heart and lungs sensor, at least two electrodes, where the first electrode is in contact with a skin within the ear of the user and the second electrode is in contact with a skin on a chest or a back of the user. The heart and lungs activity sensor can measure electrical signals generated by heart muscles between at least two electrodes, sense the sound generated by heart and lungs and transmit heart and lungs activity information wirelessly to a host device such as a smartphone or a smartwatch.

Description

ECG, HEART AND LUNGS SOUND MONITORING SYSTEM WITH
WIRELESS EARPHONES
TECHNICAL FIELD
[0001] This disclosure generally relates to portable heart and lungs activity monitors, portable electrocardiography (ECG/EKG) monitoring systems, portable electronic sound recording systems and the like devices. More particularly, this disclosure relates to an apparatus which integrates a heart and lungs activity measuring sensor, a sound recording system and earphones.
DESCRIPTION OF RELATED ART
[0002] Athletic activity is an important factor for many individuals in maintaining a healthy lifestyle. It was found to be advantageous to track and record heart and lungs activity data especially during a physical exercise. There are known many devices designed to monitor an activity of human heart. For example, a most common device is a heart rate monitor including a chest belt having two electrical contacts which should contact the chest of a user and enable the heart rate monitor to measure a human heart rate. This type of heart rate monitor is found to be inconvenient to use by many individuals.
[0003] Other heart rate monitors involve an optical or light-based technology.
These hart rate monitors typically include a light source and a light detector. A light is shined from the light source, directed through a skin of the user to a blood vessel, and the reflected light sensed by the light detector. The heart rate monitor further measures a blood motion within a vessel of the user to determine heart activity. The light-based heart rate monitors are typically integrated into wearable accessories such as watches, wrist bands, arm bands, and the like. One well known drawback of the light-based heart rate monitors includes inconsistency in heart rate measurement, especially when the user is in motion.
[0004] Electrocardiography devices have been proven to be more reliable but they are typically bulky, non-portable, or require an extra device tightly attached to a chest of the user. The electrocardiography devices were also found to be inconvenient to use in sporting activities and everyday life. Accordingly, there is still a need in the art to improve heart activity monitors, make them more reliable, user friendly and integrated with existing wearable devices, fashion accessories and garment.
SUMMARY
[0005] This section is provided to introduce aspects of embodiments of this disclosure in a simplified form that are further described below in the section of Detailed Description of Example Embodiments. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The aspects of embodiments of this disclosure are designed to overcome at least some drawbacks existing known in the art.
[0006] According to one aspect of this disclosure, there is provided an apparatus for heart and lungs activity monitoring. The apparatus is a device commonly called a heart and lungs monitor or HLM which is integrated into or attached to existing wearable accessories, fashion accessories and garment worn by a human. The heart monitoring sensor uses electrocardiogram (ECG or EKG) method with at least two electrodes attached to a skin.
[0007] The wearable devices and accessories which can be integrated with the heart monitoring sensor include but not limited to: headsets with in-ear headphones, bone-conducting headphones attached behind the ear or in front of the ear, a single piece (mono) earbud, a dual-piece (stereo) earbuds.
[0008] The heart monitoring system consist of at least one sensor, at least two electrodes connected to the skin of a human and at least one earpiece. The sensor with electrodes could be integrated into or connected to an existing device or accessory or be a stand-alone sensor device. The sensor detects electrical signal generated by the heart muscles. At the same time the sensor receives audible heart and lung sounds on its microphone. The ECG signal and audible heart and lungs sounds are transmitted to a host device such as a smartphone, a watch or other monitoring device commonly called a host. The host separates ECG signal from heart and lungs sounds, processes the ECG signals, calculates heart activity data such as typical ECG waveform points: P, Q, R, S,
T, intervals between ECG waveform points, heartbeat, heart rate variability and heart rhythm and other heart activity parameters. At the same time the host analyzes audible heart and breathing sounds and calculates breathing rate. In addition, the host is connected to at least one earpiece and receives audible information from a microphone built into the earpiece. The host compiles ECG data, heart and lungs sound with an audio received from an earpiece, displays and stores the ECG signal with the heart and lungs sounds and an audio from earpiece into one digital audio file.
[0009] Additional objects, advantages, and novel features of the examples will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following description and the accompanying drawings or may be learned by production or operation of the examples. The objects and advantages of the concepts may be realized and attained by means of the methodologies, instrumentalities and combinations particularly pointed out in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS [0010] Embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:
[0011] FIG. 1 illustrates a logical block diagram of the HLM system;
[0012] FIG. 2 illustrates one embodiment of the HLM sensor;
[0013] FIG. 3 illustrates one embodiment of the HLM sensor in cross-sectional view;
[0014] FIG. 4A shows a view of a female user illustrating one example how the user can wear the HLM sensor;
[0015] FIG. 4B shows a view of a male user illustrating one example how the user can wear the HLM sensor;
[0016] FIG. 5A illustrates one embodiment of an earpiece with connection to the
HLM sensor;
[0017] FIG. 5B shows a side view of a user illustrating one example how a user can wear an earpiece connected with the HLM sensor;
[0018] FIG. 5C illustrates a cross-sectional view of one embodiment of an earpiece with connection to the HLM sensor;
[0019] FIG. 6A illustrates a cross-sectional view of another embodiment of an earpiece with connection to the HLM sensor;
[0020] FIG. 6B shows a side view of an ear illustrating another example how a user can wear an earpiece connected with the HLM sensor;
[0021] FIG. 7 illustrates one embodiment how a user can use the HLM sensor in cross-sectional view; [0022] FIG. 8 a block diagram illustrating user’s interaction with the HLM system;
[0023] FIG. 9 a block diagram illustrating the logic of the HLM application on the host.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
Introduction
[0024] The following detailed description of embodiments includes references to the accompanying drawings, which form a part of the detailed description. Approaches described in this section are not prior art to the claims and are not admitted to be prior art by inclusion in this section. The drawings show illustrations in accordance with example embodiments. These example embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the present subject matter. The embodiments can be combined, other embodiments can be utilized, or structural, logical and operational changes can be made without departing from the scope of what is claimed. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined by the appended claims and their equivalents.
[0025] Aspects of embodiments will now be presented with reference to a headset and an apparatus for heart and lungs activity monitoring. These headset and apparatus may be implemented using electronic hardware, computer software, or any combination thereof. Whether such aspects of this disclosure are implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. By way of example, an element, or any portion of an element, or any combination of elements may be implemented with a “data processor” that includes one or more microprocessors, microcontrollers (MCUs), Central Processing Units (CPUs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), programmable logic devices (PLDs), state machines, gated logic, discrete hardware circuits, and other suitable hardware configured to perform various functions described throughout this disclosure. The data processor may execute software, firmware, or middleware (collectively referred to as “software”). The term “software” shall be construed broadly to mean instructions, instruction sets, code, code segments, program code, programs, subprograms, software components, applications, software applications, software packages, routines, subroutines, objects, executables, threads of execution, procedures, functions, etc., whether referred to as software, firmware, middleware, microcode, hardware description language, or otherwise.
[0026] Accordingly, in one or more embodiments, the functions described herein may be implemented in hardware, software, or any combination thereof. If implemented in software, the functions may be stored on or encoded as one or more instructions or code on a non-transitory computer-readable medium. Computer-readable media includes computer storage media. Storage media may be any available media that can be accessed by a computer. By way of example, and not limitation, such computer-readable media can comprise a random-access memory, a read-only memory, an electrically erasable programmable read-only memory, magnetic disk storage, solid state memory, or any other data storage devices, combinations of the aforementioned types of computer- readable media, or any other medium that can be used to store computer executable code in the form of instructions or data structures that can be accessed by a computer.
[0027] For purposes of this patent document, the terms “or” and “and” shall mean “and/or” unless stated otherwise or clearly intended otherwise by the context of their use. The term “a” shall mean “one or more” unless stated otherwise or where the use of “one or more” is clearly inappropriate. The terms “comprise,” “comprising,” “include,” and “including” are interchangeable and not intended to be limiting. For example, the term “including” shall be interpreted to mean “including, but not limited to.”
[0028] It should be also understood that the terms “first,” “second,” “third,” and so forth can be used herein to describe various elements. These terms are used to distinguish one element from another, but not to imply a required sequence of elements. For example, a first element can be termed a second element, and, similarly, a second element can be termed a first element, without departing from the scope of present teachings. Moreover, it shall be understood that when an element is referred to as being “on” or “connected” or “coupled” to another element, it can be directly on or connected or coupled to the other element or intervening elements can be present. In contrast, when an element is referred to as being “directly on” or “directly connected” or “directly coupled” to another element, there are no intervening elements present.
[0029] The term “host device” shall be construed to mean any computing or electronic device with data processing and data communication capabilities, including, but not limited to, a mobile device, cellular phone, mobile phone, smart phone, Internet phone, user equipment, mobile terminal, tablet computer, laptop computer, desktop computer, workstation, thin client, personal digital assistant, multimedia player, navigation system, game console, wearable computer, smart watch, entertainment system, infotainment system, vehicle computer, bicycle computer, or virtual reality device.
[0030] The term “earpiece” shall be construed to mean any device that can be placed into or near an outer ear of a user for purposes of outputting audio signals or noise reduction purposes. The term “earpiece” shall also mean any or all of the following, or shall be construed to mean that one or more of the following is an element of the “earpiece”: a headphone, an earbud, an earphone, an ear speaker, an ear pod, an ear insert, hearing aid device, and in-the-ear acoustic device.
[0031] The term “headset” shall be construed to mean a device that comprises at least one headphone only or a device that comprises at least one headphone and a microphone. Thus, a headset can be made with either a single-earpiece (mono) or a double-earpiece (mono to both ears or stereo). The term “headphones” is used herein to mean a pair of speakers or loudspeakers maintained close to a user’s ears. Examples of headphones can circum-aural, supra-aural, earbud, and in-ear headphones. In-ear headphones are small headphones, sometimes also called earbuds, which are inserted in the ear canal or fitted in the outer ear. Although the embodiments of this disclosure are limited to wireless headphones or wireless headset, those skilled in the art would appreciate that the same or similar embodiments can be implemented with wired headphones.
[0032] The term “heart activity” shall be construed to mean any vital, natural or biological activity of a human heart including heart beats or heart electrical activity. The term “heart activity signal” shall be construed to mean an analog signal characterizing a heart activity of a user. The term “heart activity data” shall be construed to mean any digital data characterizing a heart activity of a user. Some examples of heart activity signal include, but not limited to, an electrocardiogram (ECG or EKG) signal, heart activity wave signal, or heart activity impulse signal. Some examples of heart activity data include, but not limited to, a heart rate, a heart beats per minute, a heart variability rate, a heart rhythm, an electrocardiogram (ECG or EKG) represented in digital form or any other vital or biometrical data associated with heart activity.
[0033] The term “heart sound” shall be construed to mean any sounds produced by the heart in the range below 20,000 Hz frequency, including infra-sounds below 20 Hz frequency range. The term “lungs sound” shall be construed to mean any sounds produced by the lungs and airways as a result of breathing in the range below 20,000 Hz frequency, including infra-sounds below 20 Hz frequency range.
[0034] As outlined above, the aspects of embodiments of this disclosure provide an apparatus for heart and lungs activity monitoring. In other words, the embodiments of this disclosure integrate or connect a heart and lungs activity measuring sensor to an earpiece. The heart and lungs activity measuring sensor is generally configured to sense, detect, or measure one or more heart activities of the user, generate heart and lungs activity data and transmit or cause transmitting the heart and lungs activity data to a host device such as a smart phone or a smart watch for further processing, recording in a memory, or displaying.
[0035] The heart and lungs activity measuring sensor comprise at least two electrodes which are configured to directly connect to a skin of a user. In one embodiment first electrode is placed inside an ear, on a concha or in an auditory canal and establishes a reliable electrical contact with the skin. The second electrode provides a contact on the chest or back of the user.
[0036] In another embodiment of the heart and lungs activity measuring sensor integrated into an earpiece a third electrode. The third electrode is positioned inside the other ear of the user in the same way as the first electrode, on a concha or in an auditory canal and establishes a reliable electrical contact with the skin.
[0037] The heart and lungs activity measuring apparatus can further comprise one or more sensors coupled to the electrodes and configured to measure electrical signals captured by electrodes and generated by heart muscles, filter the ECG signal, process this ECG signal, calculate various heart data from ECG signal, capture heart and lungs sound and transmit ECG signal, heart and lungs sound to a host device.
Apparatus Architecture
[0038] Referring now to the drawings, exemplary embodiments are described.
The drawings are schematic illustrations of idealized example embodiments. Thus, the example embodiments discussed herein should not be construed as limited to the particular illustrations presented herein, rather these example embodiments can include deviations and differ from the illustrations presented herein.
[0039] FIG. 1 illustrates a block diagram representing an example of the heart monitoring system 100 which is comprised of at least one HLM sensor 101, at least one host device 119, at least one wireless earpiece 123 for one ear and optionally a second wireless earpiece 125 for the other ear. The host device 119 can be wirelessly connected to HLM sensor 101, to earpiece 123 and to earpiece 125 simultaneously using Bluetooth or proprietary wireless protocol. The sensor 101 comprised of two logical subsystems, audio subsystem and heart monitoring subsystem or HrM subsystem. Both subsystems can function independently and in wireless connection to a host 119 for the purpose of transmitting audio signals and human heart and lungs activity characteristics.
[0040] In one embodiment the configuration of HrM subsystem is comprised of 2 electrodes 103 and 104, an analog front end (AFE) 109, a wireless transmitter (TRX) 107 and a battery (BAT) 121. In some embodiment HrM subsystem could also have a modulator (MD) 110 and an audio codec (AC) 112. Yet in another embodiment HrM subsystem could have a microcontroller (MCU) 113, a data storage (DS) 117. HrM subsystem could also have a third electrode 105.
[0041] Audio subsystem in a minimal configuration comprised of at least one microphone 115, an audio codec (AC) 112, a wireless transmitter (TRX) 107 and a battery (BAT) 121. In another embodiment the audio subsystem could also have a microcontroller (MCU) 113, a data storage (DS) 117. Yet in another embodiment the audio subsystem could also have an analog amplifier (AMP) 114 connected with its input to a microphone 115 and as an output to audio codec (AC) 112. The analog amplifier (AMP) 114 could be turned on an off by the user. The audio subsystem is intended to pick sounds produced by the heart, lungs and airways via a microphone 115. Then the sounds transmitted to AC 112 and further to the host 119 via TRX 107 using a standard audio channel commonly used in Bluetooth accessories. The audio signal picked by a microphone 115 could be transmitted to AC 112 in 2 ways: non-amplified and amplified signal via AMP 114.
[0042] A person with ordinary skills in the art would realize that the division into
HrM subsystem and audio subsystem is used only for logical division of different parts of the system and is not limiting to components in each subsystem. In fact, some components are shared between all subsystems, other components are designated for use in one subsystem. Both subsystems could function independently from each other and as a whole unit. The logical explanation of division the sensor 101 into two subsystems will be apparent further from this disclosure.
[0043] In another embodiment the sensor 101 is comprised of three electrodes
103, 104 and 105 which are connected via electrical wires or electrically conductive polymers to an analog front end (AFE) 109. Electrodes 103 and 104 are used to create one lead for the purpose of measuring ECG signals. The electrode 105 serves as a reference electrode as commonly used in ECG measuring method. The output of the AFE 109 is an amplified analog signal related to ECG. The output of the AFE 109 is passed to an analog input of microcontroller (MCU) 113 and to a modulator (MD) 110. MCU 113 processes the analog signal into digital form and calculates heart activity data. It stores the resulting data to a data storage (DS) 117 like a flash memory. MCU 113 is connected to a wireless transmitter (TRX) 107 like Bluetooth or proprietary wireless transmitter.
[0044] The sensor 101 also contains at least one audio codec (AC) 112 and at least one microphone 115. Analog audio signal from a microphone 115 processed by audio codec (AC) 112 into digital audio signal. Most transmitters (TRX) 107 available on the market, like Bluetooth have built-in audio codecs. Therefore, the blocks illustrating transmitter (TRX) 107 and audio codec (AC) 112 shown as separate components are just their logical representation and could be constructed in one physical integrated circuit (IC) or a microchip.
[0045] The output of AFE 109 is also connected to a modulator (MD) 110. MD
110 modulates analog ECG signal from AFE 109 and forwards modulated signal to AC 112. AC 112 transforms it into a digital audio format and forwards it to a transmitter (TRX) 107 for wireless transmission to a host 119. The MD 110 can use different modulation methods. One method is using a carrying frequency with time-divided amplitude modulation. This method allows mixing ECG signal from AFE 109 with a voice signal from a microphone 115 into one audio channel.
[0046] The purpose of ECG signal modulation is to pass the analog ECG signal to the host without interfering with an audio signal via a standard microphone voice channel commonly used in wireless earphones. Since the human audible range uses spectrum from 20 Hz to 20,000 Hz it makes sense to modulate ECG signal using carrying frequency above audible range of 20,000 Hz. This method allows to mix modulated ECG signal and audio received from a microphone 115 into one audio channel. The mixing of both signals and its digitizing is performed in a codec AC 112 and then transmitted via TRX 107 to the host 119. The host 119 receives digital audio stream and records it into one digital audio file using available digital audio format such as AAC, ALAC, FLAC, MP3, WAV or other digital audio format. The ECG signal recorded together with a voice signal in one file is used further for ECG analytics. The user can narrate its own feelings or other observations at the exactly the same time as ECG measurement is performed. This user’s narrative together with ECG signal could be used by a physician, trained specialist or artificial intelligence (AI) for detailed analytics of heart and lungs activity.
[0047] Not all audio codecs support audio signal transmission frequencies above
20,000 Hz or 20 KHz. In fact, some Bluetooth codecs limit the audio frequency to 16KHz or even 8KHz for a special Bluetooth audio profile. In this case the modulator can be set to use frequencies below 20 KHz. For example, if audio codec (AC) 112 has 16 KHz audio frequency limit then the carrying modulating frequency for MD 110 could be set to less than 16 KHz. The AC 112 mixes signals from a microphone 115, from an amplifier 114 and from MD 110 into one audio signal, codes it into a digital format and sends via a transmitter TRX 107 to the host. The host 119 receives digital data and processes it as a mono audio stream.
[0048] In another embodiment the HLM sensor 101 uses another method transmitting ECG signal to the host 119. It can be achieved by using two-microphone- channel transmitter TRX 107. Some transmitters, like Bluetooth are designed to have two independent audio input channels for two microphones. The voice signal from a microphone 115 is digitized by the codec AC 112 and transmitted by TRX 107 using first microphone channel. The modulated ECG signal from MD 110 is digitized by the codec AC 112 and transmitted by TRX 107 using second microphone channel. The host 119 receives digital data with two microphone channels and processes it as a two- channel audio stream.
[0049] Yet, in another embodiment the HLM sensor 101 uses direct (non- modulated) method transmitting ECG signal to the host 119. The voice signal from a microphone 115 is digitized by the codec AC 112 and transmitted by TRX 107 using first microphone channel. The ECG signal from AFE 109 passed through MD 110 without modification, then digitized by the codec AC 112 and transmitted by TRX 107 using second microphone channel. The host 119 receives digital data with two microphone channels and processes it as a two-channel audio stream.
[0050] Modern integrated circuits (IC) can have several components like MCU
113, Transmitter 107, data storage 117 and audio codec 112 integrated into a single IC or a microchip. A modulator MD 110 could be implemented as a microcontroller code or library in MCU 113. It is also possible to have all components of the HLM sensor 101 integrated into a single IC.
[0051] The battery (BAT) 121 provides power for the sensor 101 and all its components. It can be a rechargeable or a single use (non-rechargeable) battery. The transmitter TRX 107 can be wirelessly connected to a host 119 via a wireless transmitter 111 built into the host device with the same protocol like Bluetooth or proprietary wireless protocol. The host device 119 can be a mobile phone, a smartwatch, a tablet, a computer or any other device capable of receiving wireless signals, processing, displaying, storing or rebroadcasting them to another device. The transmitter TRX 107 can broadcast signals to multiple host devices which can receive the data at the same time.
Example Illustrating one Sensor Embodiment [0052] FIG. 2 illustrates one embodiment of the HLM sensor 200 for use with wireless earbuds. The HLM sensor is comprised of a housing 201, an electrically conductive bell-shaped cover 203 with an opening for a microphone 205, a connector 207 and an electrode cable 209 containing at least one, the first electrical wire 215 connected to electrically conductive clip 219. In another embodiment the electrode cable 209 contains two electrical wires, where the second electrical wire 217 connected to electrically conductive clip 221.
[0053] The clips 219 and 221 are made from an electrically conductive materials like conductive polymers, metals, metallic or neodymium alloys. The clips 219 and 221 are made for easy clipping to earbuds 202 and 204 respectively. The clip 219 connects to the right earbud 202 and the clip 221 connects to the left earbud 204. The clip 219 is connected via an electrical wire 215 to the first electrode input of the HLM sensor 103 as illustrated in FIG. 1. The clip 221 is connected via an electrical wire 217 to the third electrode input of the HLM sensor 105 as illustrated in FIG. 1. Both electrode input connections are located inside the HLM sensor housing 201 which is logically represented as 101 in FIG. 1.
[0054] The bell-shaped cover 203 is electrically connected to the second electrode 104 as illustrated in FIG. 1. The bell-shaped cover 203 is made from an electrically conductive material such as a metal, metallic alloy, metal plated plastic or a conductive polymer. The opening for a microphone 205 in the bell-shaped cover 203 intends for receiving sounds from a chest or a back of the user.
[0055] For better wearing options the system could be equipped with a neck holder 223 connected to the electrode wires 215 and 217 with a sliding ties or rings 211 and 213 respectively. The purpose of the neck holder 223 with sliding rings is to establish certain length of the holder so when a user is wearing the HLM sensor 201 it is located on or near xiphistemum on a chest of a user.
[0056] FIG. 2 is intended for illustrating overall picture of the HLM sensor 200.
The proportional dimensions of the housing 201, the connector 207, wires 215 and 217, clips 219 and 221, earbuds 202 and 204, and the neck holder 223 may not represent the real proportional dimensions of all elements in the illustration.
[0057] FIG. 3 illustrates one embodiment of the HLM sensor in cross-sectional view 300. The HLM sensor comprises of: the housing 301, a bell-shaped cover 309, an electrode cable 323 with wires connecting the sensor with electrodes in the ear and a printed circuit board (PCB) 307 with the components logically represented inside the rectangle 101 as illustrated in FIG. 1. This section of FIG. 3 describes not all but only relevant components from the rectangle 101 illustrated in FIG. 1.
[0058] The wire 311 is connected to the first electrode logically represented as
103 in FIG.l. The wire 313 is electrically connected to the bell-shaped cover 309 at a contact position 321. The bell-shaped cover 309 is made from a metal, a metallic alloy, metal plated plastic or electrically conductive polymer. The bell-shaped cover 309 represents the second electrode logically illustrated as 104 in FIG.L [0059] The wire 315 is connected to the third electrode logically represented as
105 in FIG.L The component 303 mounted on PCB 307 represents an analog front end (AFE) logically illustrated as 109 in FIG. 1. All 3 electrode wires 311, 313 and 315 are connected to AFE 303.
[0060] The bell-shaped cover 309 serves dual purpose: one is the electrode, the other is a diaphragm for heart and lungs sound receptacle. The bell-shaped cover 309 conducts electrical current from the skin when places of the chest or back of the user and establishes a firm contact with the skin at its circumference line 305. As a receptacle for heart and lungs sounds it works by blocking outside noise when placed on a skin of a chest or back and seals the edges from other sounds at circumference line 305. It receives the sounds generated by the heart, lungs and airways via an opening 319.
[0061] Component 317 illustrates a microphone mounted on PCB 307 and aligned with an opening 319. The purpose of the microphone 317 is to receive audible sounds from heart and lungs when placed on a chest or back of the user. The microphone 317 can be turned on and off by the user’s action. The microphone 317 can be switched by the user into different modes of operation: direct mode and amplified mode. These two modes of operation are also illustrated by the connection lines to AC 112 in FIG. 1. Direct mode is represented with a straight line from microphone 115 to AC 112. Amplified mode is represented with a line via amplifier 114 to AC 112. In a direct mode the microphone receives audio input and transmits it directly to AC 112. In an amplified mode the audio input from a microphone 115 is amplified in amplifier 114 and then transmitted to the AC 112. The amplified mode is used to detect a low amplitude sound from the heart and lungs of the user.
Examples Illustrating the Use of the HLM sensor with a headset [0062] FIG. 4A shows a view of a female user illustrating one example how the user can wear the HLM sensor 400. In one embodiment the HLM sensor 409 is positioned on a chest, on or near xiphistemum. The HLM sensor 409 could be clipped to the bra so it remains attached under a bra and establishes a firm contact with the skin under the bra. The wire 413 connects the HLM sensor 409 with an electrode connector in the earpiece 401 of the right ear. The wire 405 connects the HLM sensor 409 with an electrode connector in the earpiece 403 of the left ear. In another embodiment, the wires 413 and 405 are hooked with a help of clips 411 and 407 to the neck holder 415. The neck holder 415 is used to support the HLM sensor 409 at a fixed length and positioned on or near xiphistemum. Each user can set the length of neck holder 415 individually and then use it with the same length setting. This way all recorded ECG data, heart and lungs sounds could be properly compared since the HLM sensor is recording ECG, heart and lungs sounds from the same location on a chest.
[0063] FIG. 4B shows a view of a male user illustrating one example how the user can wear the HLM sensor 420. The HLM sensor 431 is positioned on user’s back, between thoracic vertebrae and scapula. The HLM sensor 431 on the back could be held tightly pressed against the skin with a help of tight closing or an elastic tie around the back and the chest. The HLM sensor 431 connected via cord 429 with two wires 425 and 427. Wire 425 is connected to an electrode in the earpiece 423 in the left ear. Wire 427 is connected to an electrode in the earpiece 421 in the right ear.
[0064] In all embodiments illustrated in FIG. 4A and FIG 4B the first electrode
103 as illustrated in FIG. 1 is positioned inside the right ear earpiece, the second electrode 104 as illustrated in FIG. 1 is positioned with the HLM sensor on user’s chest or back and the third electrode 105 as illustrated in FIG. 1 is positioned inside the left ear earpiece.
[0065] To detect ECG signal is sufficient to have 2 electrodes: the first electrode in the right ear with an earpiece and the second electrode on a chest or back with the HLM sensor. However, the third electrode positioned in the left earpiece is used as a reference electrode. The reference electrode in the left ear is used to drive a small electrical current into the body to offset electrical signals created by other muscles or caused by motion of these muscles and the whole body. The reference electrode in the left earpiece can improve the quality of ECG signal when the user is in motion. The disclosed system is not limited to using only two or all three electrodes. It provides options for the user to have less wires using a two-electrode solution or use a three- electrode solution to improve ECG quality in motion.
Example of an Earpiece with a Clip-on Electrode Connector [0066] FIG. 5A, FIG. 5B and FIG. 5C illustrate one embodiment of an earpiece for use with the disclosed HLM sensor.
[0067] FIG. 5 A illustrates one embodiment of an earpiece with connection to the
HLM sensor 500. The illustration shows front and back view of one earpiece with an electrode wire 505 electrically connected to a clip-on connector 501 at a position 503. The clip-on connector 501 is made from a metal or an electrically conductive polymer and used to establish a reliable electrical connection with a ring 509 on the stem of the earpiece. The cover 507 is intended to be positioned in a concha of the ear and establish a reliable contact with the skin. The cover 507 is made from a metal, metal plated plastic or an electrically conductive polymer and serves a purpose of the in-ear electrode connected to a skin in concha of the ear. [0068] FIG. 5B shows a side view of a user illustrating one example how a user can wear an earpiece connected with the HLM sensor 520. The earpiece 521 is position in the concha of the ear with an electrode wire 523 clipped to the stem of the earpiece. The electrode wire 523 is connected to the HLM sensor positioned on the back or chest of the user.
[0069] FIG. 5C illustrates a cross-sectional view of one embodiment of an earpiece with connection to the HLM sensor 540. A typical earpiece consists of at least one speaker or driver 541, an electronic assembly with a battery 543. An earpiece may have at least one microphone 545.
[0070] The cover 547, also illustrated as 507 in FIG. 5A, is made from a metal, metal plated plastic or an electrically conductive polymer. The cover 547 is electrically connected at position 549 to the internal wire 551 with soldering or mechanical connection so the wire 551 can transmit electrical current picked by the cover 547 from the skin to the ring 555 on the stem of the earpiece. The ring 555 is made from a metal, metal plated plastic or an electrically conductive polymer and connected with the wire 551 at a position 553. A clip-on connector 557, also illustrated as 501 in FIG. 5A, is electrically connected to the wire 561 at the position 559. The clip-on connector 557 clips around the ring 555 and establishes a reliable electrical contact for the whole chain from the skin, via the cover 547, to the HLM sensor via wire 561. The same design is also applied for the second earpiece. The microphone 545 may be present only in one earpiece.
[0071] Other embodiments are possible for connecting electrode wire to the skin in the ear without deviating from the spirit of this invention, electrically connecting HLM sensor to an electrode in the earpiece.
Example of an Earpiece with a Magnetic Electrode Connector [0072] FIG. 6A and FIG. 6B illustrate another embodiment of an earpiece for use with the disclosed HLM sensor.
[0073] FIG. 6A illustrates a cross-sectional view of another embodiment of an earpiece with connection to the HLM sensor 600 using a magnetic connector. An earpiece typically consists of at least one speaker or driver 605 and an electronic assembly with a battery 603. The earpiece may also have at least one microphone. The soft in-ear insert 609 is intended to be positioned inside the ear canal. The soft in-ear insert is made from an electrically conductive material like an electrically conductive polymer, an electrically conductive latex or rubber. The nozzle 607 is designed to funnel the audio sound from the driver 605 to the ear of a user. The in-ear insert 609 fits snugly over the nozzle 607. The nozzle 607 is made from an electrically conductive material like a metal, a metal plated plastic or an electrically conductive polymer. The nozzle 607 is electrically connected at a position 611 with an electrical wire 613. The electrical wire 613 is connected to a first magnet 617 positioned inside the earpiece housing 601. The first magnet 617 is electrically connected to a wire 613 at a position 615.
[0074] The second magnet 619 is attached to the first magnet 617 with a magnetic force. Both magnets are polarized in such a way that they attract each other on one side and repel each other on the other side. The magnet 619 is electrically connected to the electrode wire 623 at a position 621.
[0075] Both magnets 617 and 619 are made from a metal, metallic or neodymium alloys and serve a purpose of electrically connecting HLM sensor via an electrode wire 623, the nozzle 607, the in-ear insert 609 to the skin inside the ear of a user. The magnets 617 and 619 establish a reliable electrical connection with help of a magnetic force and connect electrode 103 illustrated in FIG. 1 to the skin in the ear of a user.
[0076] In another embodiment two earpieces could be used, one for each ear. The second earpiece has the same components as the first one described above. The magnets 617 and 619 establish a reliable electrical connection with help of a magnetic force and connect electrode 105 illustrated in FIG. 1 to the skin in the ear of a user. The second earpiece may not contain a microphone.
[0077] FIG. 6B shows a side view of an ear illustrating another example how a user can wear an earpiece connected with the HLM sensor 630. When a user inserts the earpiece 631 inside the ear the electrode wire 635 is connected via a magnetic clip connector 633 to the skin of the ear.
[0078] It is apparent to a person with ordinary skills in the art that other embodiments are possible for connecting an electrode to the skin in the ear without deviating from the spirit of this invention - electrically connecting HLM sensor to an electrode built into an earpiece.
Example Illustrating the Use of the HLM sensor
[0079] FIG. 7 illustrates one embodiment how a user can use the HLM sensor in cross-sectional view 700. FIG. 7 does not describe all components of the HLM sensor in details. The detailed description of components of the HLM sensor are illustrated in FIG. 3. The HLM sensor 701 is positioned on or near xiphisternum on a chest, or between thoracic vertebrae and scapula on a back adjacent to the skin 702 of a user so that the bell-shaped cover 707 establishes a firm contact with the skin around cover’s edge 709. The cover 707 is made from a metal, a metallic alloy, a metal plated plastic or an electrically conductive polymer and serves a purpose of receiving electrical signal 717 generated by the heart 715. The electrical signal 717 transmitted via a contact with a skin 709 around the edges, the circumference of the cover 707 to the AFE 708. The cover 707 is electrically connected to the AFE 708, logically illustrated as 109 in FIG. 1, via an electrical wire 704 with an electrical contact 706, which is located on the inside surface of the cover 707. The bell-shaped cover 707 at its contact surface with the skin 709 is logically illustrated as an electrode 104 in FIG. 1. The electrical signal from the heart 717 is received via the contact with the skin 709 at around the edges, the circumference of the cover 707 and transmitted through the electrical wire 704 to AFE 708.
[0080] The two electrodes, logically illustrated as electrodes 103 and 105 on FIG.
1, are connected to AFE 708 via two electrical wires inside the electrode cable 721 as described in details in FIG. 2 and FIG 3.
[0081] The opening 703 in the bell-shaped cover 707 allows the microphone 705 to receive acoustic sound 719 produced by the heart 715 and acoustic sound 713 produced by the lungs and airways 711. The microphone 705 is isolated from other sounds with a sound absorbing enclosure, picking the sounds only through the opening 703.
[0082] I another embodiment the HLM sensor’s electrode 707 is made from an electrically conductive material in form of a ring around the microphone opening 703. A protective membrane could separate microphone opening 703 from the skin 702.
[0083] It is apparent to a person with ordinary skills in the art that other embodiments are possible for constructing HLM sensor 701 combining electrode 707 and microphone into one enclosure without deviating from the spirit of this invention - electrically connecting one HLM sensor’s electrode to a skin on a chest or back of a user and receiving sounds produced by the user’s heart, lungs and airways.
Example of the Logic of HLM sensor in Block Diagram [0084] FIG. 8 a block diagram illustrating user’s interaction with the HLM system 800. The HLM sensor 101 is logically represented as part of an overall HLM system in FIG. 1, consisting of at least one host 119 and one earpiece 123, also illustrated as 202 in FIG. 2. When the user wears an earpiece 202 for the purpose of listening to music or talking via microphone the HLM sensor 201 is turned off and may not be worn at all. When the user wants to measure and record ECG, heart or lungs sound the HLM sensor 201 need to be placed on a chest or back, firmly adjacent to a skin with a help of piece of clothing like a bra, a shirt or a special tie 223, and be connected to at least one earpiece 202 with a help of electrode wire 215.
[0085] 801 - the sensor by default is in a state of hibernation. This is a low-power state to save the battery. The sensor is configured to turn on automatically when it detects an electrical current between at least two electrodes. This happens when the first electrode is connected to an earpiece in the ear as illustrated in FIG. 5A, FIG. 5D, FIG.
5C or FIG. 6 A and FIG. 6B, and the other electrode is connected to a skin on a chest or back of the user as illustrated in FIG 7. Once the HLM sensor is turned on it starts processing ECG, heart and lungs sound simultaneously.
[0086] 802 - the HLM sensor connects to the host via wireless connection like
Bluetooth. It uses one of the available audio profiles to transmit heart and lungs sound with ECG signal simultaneously. In another embodiment the sensor can work independently form being connected to the host. It can also work with a wireless connection to the host periodically lost or disconnected. While HLM sensor is disconnected from the host it stores all ECG signal, heart and lungs sound in a local data storage (DS) 117 with a help of MCU 113 as illustrated in FIG. 1. The stored data is transmitted to the host when the connection becomes available.
[0087] 803 - once connection to the host is established the HLM sensor modulates ECG signal with one of the available modulation methods, mixes modulated signal with heart and lungs sound and transmits mixed signal to the host.
[0088] 804 - user can switch the HLM sensor into a special state when microphone is in amplified mode for better detection of low amplitude sound produced by the heart, lungs and airways. HLM sensor is equipped with a button or contactless (e. g. capacitive or motion detection) switch.
[0089] 805 - user can interact with the HLM sensor through an application running on the host. The application on the host can receive a voice request from a user via a microphone in HLM sensor or an earpiece and instruct the HLM sensor to execute an action associated with user’s request. For example, the user can request to turn HLM sensor amplified mode by saying “amplify” or the like. The host application translates this request into a digital control message to HLM sensor requesting it to turn into an amplified mode. Similarly, the user can say “normal” or the like requesting HLM sensor to turn back to a normal mode.
[0090] User can also request an HML application on the host to start recording
ECG, heart and lungs sound by saying “start recording” or the like. Similarly, user can stop recording by saying “stop recording” or the like.
[0091] 806 - when user disconnects one of the electrodes from the skin or an earpiece the HLM sensor detects it and notifies the host. The host application in turn notifies the user that one of the electrodes is disconnected. If the user did it intentionally then the host issues a command to the HLM sensor to turn off after a certain period of time. The HLM sensor then disconnects from the host, and goes back into hibernation (waiting) state.
[0092] A person with an ordinary skill would realize that the described flow of events in a block diagram is used for illustration purpose for one of the many possible scenarios. The current disclosure does not limit it to one scenario described in FIG. 8. [0093] FIG. 9 a block diagram illustrating the logic of the HLM application on the host 900. The overall heart monitoring system is logically represented in FIG. 1 and consist of at least one HLM sensor 101 wirelessly connected to a host device 119. The host device 119 may also be wirelessly connected to at least one earpiece 123. The host device 119 may also be wirelessly connected to both earpieces 123 and 125. The host device 119 wirelessly receives audio data packets from the HLM sensor 101 via a built- in wireless transmitter 111 as illustrated on FIG. 1. At the same time the host device 119 can wirelessly receive audio data packets from at least one earpiece 123 or 125 as illustrated on FIG. 1. The HLM application on the host wirelessly receives audio streams from one earpiece 123 or 125 and from HLM sensor. The HLM application processes audio streams from HLM sensor and an earpiece and coordinates actions with HLM sensor.
[0094] HLM application records all audio streams from earpiece and HLM sensor into one digital audio file. The digital audio file includes a voice audio from a microphone in the earpiece, the heart and lungs sound and an ECG signal received from HLM sensor. This single digital audio record allows for a playback of the originally recorded audio stream with the same timing as it was received, where a voice audio, heart and lungs sound synchronized with the ECG signal. This allows for a better diagnosis of heart and lungs activity. Some digital file formats, like MP3 provide multi channel (2 channel -stereo or 4 channel -quadro) recording. In this case the HLM application uses one channel, (e.g. left channel) for a voice audio, heart and lungs sound, and another channel (e.g. right channel), for ECG signal. In another embodiment the voice audio is recorded in the first channel, heart and lungs sound is recorded in the second channel and ECG signal is recorded in the third channel. Further steps are describing one of many possible scenarios of HLM application logic.
[0095] 901 - The HLM application on the host device receives audio streams from HLM sensor and at least one earpiece. The HLM application separates ECG signal into another logical channel. It mixes then the voice audio received from an earpiece and audio with heart and lungs sound received from HLM sensor into one audio channel. Then the audio channel and ECG channel are processed in two parallel threads, one for each stream of data or a channel.
[0096] 902 - The audio is recorded into one audio channel, e.g. the left channel in a digital audio file in MP3, WAV or another digital audio file format.
[0097] 903 - The ECG signal is de-modulated into the original ECG signal using the same demodulation method as it was used in the modulator MD 110 illustrated in FIG. 1.
[0098] 904 - The ECG signal is recorded into another channel, e.g. the right channel of the same digital audio file.
[0099] 905 - The HLM application calculates vital ECG data from ECG signal waveform, including but not limited to: P, Q, R, S and T amplitude position and time,
RR interval, pulse, heart beat variability, atrial fibrillation precondition and other parameters.
[00100] 906 - The HLM application interacts with the user about calculated ECG vital data. HLM application notifies the user about abnormalities in a voice message, e.g. “Possible pre-condition for atrial fibrillation. Seek medical attention.” or “a heartbeat variability above your average” or the like. Then the user can audibly ask HLM application questions about some other vital data like “What is my average heart rate?” or “What to do to reduce my variability?”. The HLM application will try to find answers using its own logical capacity in artificial intelligence (AI) or it can pass this question to the cloud-based AI system via a wireless connection to the host device.
[00101] The user can instruct the HLM application via a voice command to upload the ECG recording to a host device and to the cloud. Host HLM application uploads the recording as instructed and confirms it to the user in a voice prompt. The earpiece can remain powered and connected to the host for the purpose of listening to music or talking on a phone.
[00102] In another embodiment TRX 107 illustrated in FIG. 1 could have two separate microphone audio channels. HLM sensor transmits heart and lungs sound via one microphone channel and ECG signal via another microphone channel. In this case step 901 performs simply forwarding heart and lungs audio channel to step 902 and ECG signal channel to step 903. Also, the ECG signal can be transmitted in original, non- modulated form. In this embodiment the de-modulation in step 903 becomes unnecessary and the logic proceeds to step 904.
[00103] Other design variation with the HLM sensor attached to or integrated into wearable accessories or devices with electrodes connected to a skin using wearable’s existing points of contact with the skin can be utilized using the disclosed invention. The above examples presented in FIG. 1 through FIG. 9 are not limited to only the described wearable devices or accessories and electrode connection options. In the spirit of this invention any earpiece can be enhanced with the disclosed heart monitoring sensor where the first electrode is connected to the skin of the ear using specific features of an earpiece. The second electrode could be in contact with the skin on the chest or back of the user. A third electrode connecting to the skin of another ear can be used as a reference electrode. All 2 or 3 electrodes are connected to the HLM sensor with a purpose to measure heart activity using electrical signals obtained from two electrodes and recording heart and lungs sound.
[00104] Thus, an apparatus for heart and lungs activity monitoring have been described with different mounting options to earpiece. Although embodiments have been described with reference to specific example embodiments, it will be evident that various modifications and changes can be made to these example embodiments without departing from the broader spirit and scope of the present application. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.

Claims

1. A system (100) for heart activity monitoring, the system (100) comprising: a first electrode (103) configured to sense, at a first location of skin of a user, an electrical signal indicative of a heart activity of the user; a second electrode (104) configured to sense, at a second location of the skin of the user, a further electrical signal indicative of the heart activity of the user; a microcontroller (MCU) (113) configured to: detect an electric current between the first electrode and the second electrode; process the electric current to obtain an electrocardiograph (ECG) signal; and determine, based on the ECG signal, one or more of heart activity parameters, the heart activity parameters including PQRST complexes in ECG signal, time intervals between the PQRST complexes, a heart rate, a heart rate variability, and a probability of atrial fibrillation; and a data storage configured to store the heart activity parameters.
2. The system of claim 1, further comprising an acoustic sensor (115) configured to sense an acoustic signal indicative of the heart activity and a lung activity of the user.
3. The system of claim 2, further comprising a housing (201) for holding the MCU (113), the data storage (117), and the acoustic sensor (115), wherein
23
SUBSTITUTE SHEETS (RULE 26) the housing (201) is configured to touch the skin of the user at one of the following locations: on a chest of the user or on a back of the user.
4. The system of claims 3, wherein the first electrode (103) is attachable to a first earpiece (123) and the second electrode (104) is integrated into the housing (201), such that when the user wears the first earpiece (123), the first electrode (103) and the second electrode (104) touch the skin of the user.
5. The system of claim 4, further comprising: a third electrode (105) attachable to a second earpiece (125), such that when the user wears the second earpiece (125), the third electrode (105) touches the skin of the user, the third electrode (105) being used as a reference electrode in the obtaining ECG signal; a first electrical wire (215) for connecting the first electrode (103) to the housing (201) and the MCU (113); and a second electrical wire (217) for connecting the third electrode (105) to the housing (201) and the MCU (113).
6. The system of claim 5, further comprising a neck holder to hold the first electrical wire (215) and the second electrical wire (223).
7. The system of claim 3, wherein: the first electrode (103) is attachable to a first earpiece (123) and connected to housing (201) via an electrical wire; and the second electrode (104) is carried out as a cover (309) made of electrically conductive material, the cover (309) being installed in the housing (201) and configured to touch the skin of the user.
24
SUBSTITUTE SHEETS (RULE 26)
8. The system of claim 2, further comprising a transmitter (107) and a host device (119), wherein the MCU (113) is configured to transmit, via the transmitter (107), one or more of the following: the sensed acoustic signal and the ECG signal to the host device (119).
9. The system of claim 8, wherein the MCU (113) is configured to, prior to the transmitting to: detect an electric current between the first electrode and the second electrode; and in response to the detection, establish a connection between the transmitter (107) and the host device (119).
10. The system of claim 8, wherein the sensed acoustic signal and the ECG signal are transmitted separately using two separate channels.
11. The system of claim 8, wherein the MCU (113) combines the sensed acoustic signal and the ECG signal into a digital signal and transmits the digital signal to the host device (119) via a single channel.
12. The system of claim 11, wherein the host device (119) is configured to run an application to: separate the digital signal into ECG data and audio data; and determine, based on the ECG data, one or more of the heart activity parameters.
13. The system of claim 8, wherein the host device (119) is configured to: receive voice commands of the user via the acoustic sensor (115); and
25
SUBSTITUTE SHEETS (RULE 26) in response to receiving the voice commands, cause the MCU (113) to perform one or more operations including starting ECG measurement, finishing the ECG measurement, and transmitting results of the ECG measurement.
14. The system of claim 13, further comprising earpieces connected to the host devices, wherein the host device (119) is configured to receive the voice commands of the user via the earpieces instead of the acoustic sensor (115).
15. The system of claim 14, wherein the host device (119) is configured to: receive, form the earpieces, a request from the user for reporting results of ECG measurement; and in response to the receiving the request, send a voice message to the earpieces, the voice message informing the user of the results of ECG measurement.
16. A method for heart activity monitoring, the method comprising: detecting, by a microcontroller (MCU) (113), an electric current between a first electrode (103) and a second electrode (104), wherein: the first electrode (103) is configured to sense, at a first location of a skin of a user, an electrical signal indicative of a heart activity of the user; and the second electrode (104) configured to sense, at a second location of the skin of the user, a further electrical signal indicative of the heart activity of the user; processing, by the MCU (113), the electric current to obtain an electrocardiograph (ECG) signal;
26
SUBSTITUTE SHEETS (RULE 26) determining, by the MCU (113) and based on the ECG signal, one or more of heart activity parameters, the heart activity parameters including PQRST complexes in the ECG signal, time intervals between the PQRST complexes, a heart rate, a heart rate variability, and a probability of atrial fibrillation; and storing the heart activity parameters to a data storage.
17. The method of claim 16, further comprising sensing, by an acoustic sensor (115), an acoustic signal indicative of the heart activity and a lung activity of the user.
18. The method of claim 17, wherein the MCU (113), the data storage (117), and the acoustic sensor (115) are arranged in a housing (201) for holding, wherein the housing (201) is configured to touch skin of the user at one of the following locations: on a chest of the user or on a back of the user.
19. The method of claims 18, wherein the first electrode (103) is attachable to a first earpiece (123) and the second electrode (104) is integrated into the housing (201), such that when the user wears the first earpiece (123) and the housing (201), the first electrode (103) and the second electrode (104) touch the skin of the user.
20. The method of claim 19, wherein: the obtaining of the ECG signal includes processing a reference electrical signal from a third electrode (105), the third electrode (105) attachable to a second earpiece (125), such that when the user wears the second earpiece (125), the third electrode (105) touch the skin of the user;
27
SUBSTITUTE SHEETS (RULE 26) the first electrode (103) is connected by a first electrical wire (215) to the housing (201) and the MCU (113); and the third electrode (104) is connected to the housing (113) and the MCU (113) by a second electrical wire (217).
21. The method of claim 20, wherein the first electrical wire (215) and the second electrical wire (223) are secured to a neck of the user by a neck holder (223).
22. The method of claim 19, wherein: the first electrode (103) is attachable to a first earpiece (123) and connected to a housing (201) via an electrical wire; and the second electrode (104) is carried out as a cover (309) made of electrically conductive material, the cover (309) being installed in the housing (201) and configured to touch the skin of the user.
23. The method of claim 18, further comprising transmitting, by the MCU (113) and via a transmitter (107), one or more of the following: the sensed acoustic signal and the ECG signal to a host device (119).
24. The method of claim 23, further comprising, prior to the transmitting: detecting, by the MCU (113), an electric current between the first electrode and the second electrode; and in response to the detection, establishing, by the MCU (113), a connection between the transmitter (107) and the host device (119).
25. The method of claim 23, wherein the sensed acoustic signal and the ECG signal are transmitted separately using two separate channels.
28
SUBSTITUTE SHEETS (RULE 26)
26. The method of claim 23, further comprising: combining, by the MCU (113), the sensed acoustic signal and the ECG signal into a digital signal; and transmitting, by the MCU (113), the digital signal to the host device (119) via a single channel.
27. The method of claim 26, further comprising: separating, by an application of the host device (119), the digital signal into ECG data and audio data; and determining, by the application of the host device (119) and based on the ECG data, one or more of the heart activity parameters.
28. The method of claim 23, further comprising: receiving, by the host device (119), voice commands of the user via the acoustic sensor (115); and in response to receiving the voice commands, causing, by the host device (119), the MCU (113) to perform one or more operations including starting ECG measurement, finishing the ECG measurement, and transmitting results of the ECG measurement.
29. The method of claim 28, wherein the host device (119) is configured to receive the voice commands of the user via earpieces instead of the acoustic sensor (115).
30. The method of claim 29, further comprising: receiving, by the host device (119), form the earpieces, a request from the user for reporting results of ECG measurement; and
29
SUBSTITUTE SHEETS (RULE 26) in response to the receiving the results, sending, by the host device (119), a voice message to the earpieces, the voice message informing the user of the results of ECG measurement.
30
SUBSTITUTE SHEETS (RULE 26)
PCT/RU2021/050067 2020-03-16 2021-03-13 Ecg, heart and lungs sound monitoring system with wireless earphones WO2021188018A2 (en)

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Publication number Priority date Publication date Assignee Title
US11298064B1 (en) * 2014-02-18 2022-04-12 Orbital Research Inc. Head-mounted physiological signal monitoring system, devices and methods
US20180296105A1 (en) * 2015-06-19 2018-10-18 Michael Blake Wearable physiological monitoring and notification system based on real-time heart rate variability analysis
US20170039358A1 (en) * 2015-08-07 2017-02-09 Fitbit, Inc. Transaction prevention using fitness data
US10547702B2 (en) * 2016-11-07 2020-01-28 Cable Television Laboratories, Inc. Internet protocol over a content-centric network (IPoC)

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