CN115643796A - ECG, heart and lung sound monitoring system with wireless earphone - Google Patents

Abstract

A heart activity measuring system with cardiopulmonary sound monitoring function is connected with earphones, such as wireless earphones or earplugs, and electrodes thereof are connected with the skin for measuring the heart activity by an electrocardiogram, ECG or EKG method. The device comprises a cardiorespiratory sensor, at least two electrodes, wherein a first electrode is in contact with the skin in the user's ear and a second electrode is in contact with the skin on the user's chest or back. The cardiopulmonary activity sensor may measure electrical signals generated by the heart muscle between at least two electrodes, sense sounds generated by the heart and lungs, and wirelessly transmit cardiopulmonary activity information to a host device, such as a smartphone or a smartwatch.

Description

ECG, heart and lung sound monitoring system with wireless earphone

Technical Field

The present disclosure relates generally to portable heart-lung activity monitors, portable electrocardiogram (ECG/EKG) monitoring systems, portable electronic recording systems, and the like. More particularly, the present disclosure relates to an apparatus that integrates a cardiopulmonary activity measurement sensor, a recording system, and an earphone.

Background

Exercise is an important factor in many people maintaining a healthy lifestyle. It has been found to be advantageous to track and record cardiopulmonary activity data, particularly during physical exercise. A number of devices are known which are designed to monitor the activity of the human heart. For example, the most common device is a heart rate monitor comprising a chest belt having two electrical contacts that should contact the user's chest and enable the heart rate monitor to measure the person's heart rate. Many people find this type of heart rate monitor inconvenient to use.

Other heart rate monitors involve optical or light-based technologies. These heart rate monitors typically include a light source and a light detector. Light emitted from the light source is irradiated to the blood vessel through the skin of the user, and the reflected light is sensed by the photodetector. The heart rate monitor further measures blood movement within the user's blood vessels to determine heart activity. Light-based heart rate monitors are typically integrated into wearable accessories, such as watches, wristbands, armbands, and the like. One well-known drawback of light-based heart rate monitors includes inconsistency in heart rate measurements, especially when the user is exercising.

Electrocardiographic devices have proven to be more reliable, but they are often bulky, inconvenient to carry, or require an additional device to be firmly secured to the user's chest. Electrocardiographic devices have also been found to be inconvenient for use in physical activities and daily life. Accordingly, there remains a need in the art for improved cardiac activity monitors that are more reliable, user friendly, and integrate with existing wearable devices, fashion accessories, and clothing.

SUMMARY

This section is provided to introduce various aspects of embodiments of the present disclosure in a simplified form that are further described in the example detailed description section below. 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. Various aspects of embodiments of the present disclosure are designed to overcome at least some of the deficiencies in the known prior art.

According to one aspect of the present disclosure, a device for cardiopulmonary activity monitoring is provided. The device is a device commonly referred to as a cardiopulmonary monitor or HLM that is integrated with or attached to existing wearable devices, fashion accessories, and clothing worn by a person. The cardiac monitoring sensor uses an electrocardiogram (ECG or EKG) method to connect at least two electrodes to the skin.

Wearable devices and accessories that may be integrated with the cardiac monitoring sensor include, but are not limited to: a headset that is brought into the ear, a bone conduction headset that is attached behind or in front of the ear, a single piece (mono) earplug, a two piece (stereo) earplug.

The cardiac monitoring system comprises at least one sensor, at least two electrodes connected to the skin of the human body, and at least one earpiece. The sensor with electrodes may be integrated or connected to existing equipment or accessories, or may be a stand-alone sensor device. The sensors detect electrical signals generated by the myocardium. At the same time, the sensor receives audible cardiopulmonary sounds through its microphone. The ECG signal and audible cardiopulmonary sounds are transmitted to a host device, such as a smartphone, watch, or other monitoring device commonly referred to as a host. The host computer separates the ECG signals from cardiopulmonary sounds, processes the ECG signals, calculates cardiac activity data as typical ECG waveform points: p, Q, R, S, T, interval between ECG waveform points, heartbeat, heart rate variability, and heart rate. Simultaneously, the host computer analyzes audible heart and breath sounds and calculates a breathing rate. In addition, the host is connected with at least one headset and receives sound information from a microphone built in the headset. The host compiles the ECG data, the cardiopulmonary sounds and the audio received by the earphones, and displays and stores the ECG signals, the cardiopulmonary sounds and the audio of the earphones into a digital audio file.

Additional objects, advantages and novel features of embodiments 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 drawings, or may be learned by production or operation of the embodiments. 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

Embodiments are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which like reference numerals refer to similar elements and in which:

FIG. 1 illustrates a logical block diagram of an HLM system;

FIG. 2 illustrates one embodiment of an HLM sensor;

FIG. 3 illustrates a cross-sectional view of one embodiment of an HLM sensor.

Fig. 4A shows a view of a female user showing one example of how the user may wear an HLM sensor;

fig. 4B shows a view of a male user showing one example of how the user may wear an HLM sensor;

FIG. 5A illustrates one embodiment of a headset connected with an HLM sensor;

FIG. 5B shows a side view of a user, showing one example of how the user wears a headset connected to an HLM sensor;

FIG. 5C illustrates a cross-sectional view of one embodiment of a headset connected with an HLM sensor;

FIG. 6A shows a cross-sectional view of another embodiment of a headset connected to an HLM sensor;

FIG. 6B shows a side view of an ear showing another example of how a user may wear a headset connected to an HLM sensor;

FIG. 7 illustrates in cross-section one embodiment of how a user may use an HLM sensor;

FIG. 8 shows a block diagram of user interaction with an HLM system;

fig. 9 illustrates a logical block diagram of an HLM application on a host.

Detailed description of exemplary embodiments

Introduction to

The following detailed description of the embodiments includes references to the accompanying drawings, which form a part hereof. The 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 figures illustrate illustrations according to exemplary embodiments. These exemplary embodiments, which are also referred to herein as "examples," are described in sufficient detail to enable those skilled in the art to practice the present subject matter. The embodiments may be combined, other embodiments may be utilized, or structural, logical, and operational changes may be made without departing from the scope of the claims. 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.

Various aspects of the embodiments will now be described with reference to a headset and device for cardiopulmonary activity monitoring. These headphones and devices may be implemented using electronic hardware, computer software, or any combination thereof. Whether such aspects of the disclosure are implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. For example, an element or any portion of an element or any combination of elements may be implemented by a "data processor" comprising 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 the various functions described in this disclosure. The data processor may execute software, firmware, or middleware (collectively referred to as "software"). The term "software" should be broadly interpreted as referring to instructions, instruction sets, code segments, program code, programs, subroutines, software components, applications, software packages, routines, subroutines, objects, executables, threads of execution, procedures, functions, etc., whether referred to in software, firmware, middleware, microcode, hardware description language, or by other names.

Thus, in one or more embodiments, the functions described herein may be implemented by hardware, software, or any combination thereof. If implemented in software, the functions may be stored on a non-transitory computer-readable medium or encoded as one or more instructions or code. Computer readable media includes computer storage media. A 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 random access memory, read only memory, electrically erasable programmable read only memory, magnetic disk memory, solid state memory, or any other data storage device, combinations of the above 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.

In this patent document, the terms "or" and "shall mean" and/or "unless otherwise indicated or clearly intended in the context of its use. The terms "a" and "an" should be taken to mean "one or more" unless specified otherwise or clearly inappropriate for use of the term "one or more". The terms "comprising," "including," "containing," and "containing" are interchangeable and are not intended to be limiting. For example, the term "including" should be interpreted as "including, but not limited to".

It should also be understood that the terms "first," "second," "third," and the like may be used herein to describe various elements. These terms are used to distinguish one element from another element, but do not imply that a sequence of elements is required. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present teachings. In addition, it will be understood that when an element is referred to as being "on" \8230; … "connected to" or "coupled to" another element, it can be directly on the other element, or connected or coupled to the other element, or intervening elements may be present. In contrast, when an element is referred to as being "directly on" \8230; … "directly connected to" or "directly coupled to" another element, there are no intervening elements present.

The term "host device" should be interpreted as any computing device or electronic device having data processing and data communication capabilities, including but not limited to a mobile device, a cellular telephone, a mobile telephone, a smartphone, an internet telephone, a user device, a mobile terminal, a tablet computer, a laptop computer, a desktop computer, a workstation, a thin client, a personal digital assistant, a multimedia player, a navigation system, a gaming console, a wearable computer, a smart watch, an entertainment system, an infotainment system, an in-vehicle computer, a cycle computer, or a virtual reality device.

The term "earpiece" should be construed as any device that may be placed in or near the outer ear of a user for the purpose of outputting an audio signal or noise reduction. The term "headset" shall also refer to any or all of the following, or shall be construed to mean that one or more of the following is an element of the "headset": headphones, earplugs, earphones, speakers, earmuffs, earplugs, hearing aids, and in-ear acoustic devices.

The term "headset" is to be understood as a device comprising only at least one earphone or a device comprising at least one earphone and a microphone. Thus, headphones can be made using either single headphones (mono) or dual headphones (binaural mono or stereo). The term "earpiece" as used herein refers to a pair of speakers or loudspeakers held close to the user's ears. Examples of headphones may be earmuffs, earhooks, earplugs, and in-ear headphones. In-ear headphones are small headphones, sometimes also referred to as earplugs, that are inserted into the ear canal or mounted in the outer ear. Although embodiments of the present disclosure are limited to wireless headsets or wireless headsets, those skilled in the art will appreciate that the same or similar embodiments may be implemented with wired headsets.

The term "heart activity" should be interpreted to mean any significant, natural or biological activity of the human heart, including heartbeat or cardiac electrical activity. The term "heart activity signal" should be interpreted as an analog signal representing the heart activity of the user. The term "heart activity data" should be interpreted as any digital data representing the heart activity of the user. Some examples of cardiac activity signals include, but are not limited to, electrocardiogram (ECG or EKG) signals, cardiac activity wave signals, or cardiac activity pulse signals. Some examples of cardiac activity data include, but are not limited to, heart rate, beats per minute, heart variability rate, heart rhythm, electrocardiogram (ECG or EKG) represented in digital form, or any other important or biological data related to cardiac activity.

The term "heart sound" should be interpreted as any sound produced by the heart in a frequency range below 20,000hz, including infrasound in the frequency range below 20 Hz. The term "lung sounds" should be interpreted as any sound produced by the lungs and airways breathing in a frequency range below 20,000hz, including infrasound in the frequency range below 20 hz.

As described above, various aspects of embodiments of the present disclosure provide a device for cardiopulmonary activity monitoring. In other words, embodiments of the present disclosure integrate or connect cardiopulmonary activity measurement sensors to the headset. The cardiorespiratory activity measurement sensor is typically configured to sense, detect or measure one or more heart activities of a user, generate cardiorespiratory activity data and transmit or cause transmission of the cardiorespiratory activity data to a host device, such as a smartphone or a smartwatch, for further processing, recording in memory or display.

The cardiopulmonary activity measurement sensor includes at least two electrodes configured to be directly connected to the skin of a user. In one embodiment, the first electrode is placed inside the ear, on the outer ear or in the ear canal and establishes a reliable electrical contact with the skin. The second electrode is in contact with the chest or back of the user.

In another embodiment, the cardiorespiratory activity measurement sensor is integrated with a headset or a third electrode. The third electrode is placed in the other ear of the user, on the outer ear or in the ear canal, in the same way as the first electrode, and establishes a reliable electrical contact with the skin.

The cardiopulmonary activity measurement apparatus may further include one or more sensors coupled to the electrodes and configured to measure electrical signals captured by the electrodes and produced by the myocardium, filter the ECG signals, process the ECG signals, calculate various cardiac data from the ECG signals, acquire cardiopulmonary sounds, and transmit the ECG signals, the cardiopulmonary sounds, to a host device.

Equipment structure

Referring now to the drawings, exemplary embodiments are described. The drawings are schematic illustrations of idealized example embodiments. Accordingly, example embodiments discussed herein should not be construed as limited to the particular illustrations presented herein, but rather these example embodiments may include deviations and differ from the illustrations presented herein.

Fig. 1 illustrates a block diagram representative of an example of a cardiac monitoring system 100, the cardiac monitoring system 100 including at least one HLM sensor 101, at least one host device 119, at least one wireless headset 123 for one ear, and optionally a second wireless headset 125 for the other ear. The host device 119 can be wirelessly connected to the HLM sensor 101, the headset 123, and the headset 125 simultaneously using bluetooth or a proprietary wireless protocol. The sensor 101 includes two logic subsystems, an audio subsystem and a cardiac monitoring subsystem or HrM subsystem. Both subsystems may operate independently and wirelessly interface with the host 119 to transmit audio signals and human cardiopulmonary activity characteristics.

In one embodiment, the configuration of the HrM subsystem includes two electrodes 103 and 104, an Analog Front End (AFE) 109, a radio Transmitter (TRX) 107, and a Battery (BAT) 121. In some embodiments, the HrM subsystem may also have a Modulator (MD) 110 and an Audio Codec (AC) 112. In another embodiment, the HrM subsystem may have a Microcontroller (MCU) 113, a data memory (DS) 117. The HrM subsystem may also have a third electrode 105.

The minimally configured audio subsystem includes at least one microphone 115, an Audio Codec (AC) 112, a radio Transmitter (TRX) 107, and a Battery (BAT) 121. In another embodiment, the audio subsystem may also have a Microcontroller (MCU) 113, a data memory (DS) 117. In another embodiment, the audio subsystem may also have an analog Amplifier (AMP) 114 with an input connected to a microphone 115 and an output connected to the Audio Codec (AC) 112. Analog Amplifier (AMP) 114 may be turned on or off by a user. The audio subsystem is intended to pick up sounds produced by the heart, lungs and airways through microphone 115. The sound is then transmitted to the AC112 and further to the host 119 via the TRX107 using standard audio channels commonly used in bluetooth accessories. The audio signal picked up by the microphone 115 may be transmitted to the AC112 in 2 ways: the unamplified signal and the amplified signal by AMP 114.

One of ordinary skill in the art will recognize that the partitioning of the HrM subsystem and the audio subsystem is for logical partitioning of different parts of the system only, and is not limited to components in each subsystem. In fact, some components are shared among all subsystems, and others are designated for use in one subsystem. The two subsystems may operate independently of each other as a whole. The logical interpretation of the division of the sensor 101 into two subsystems will be further clarified by the present disclosure.

In another embodiment, sensor 101 includes three electrodes 103, 104, and 105 connected to an Analog Front End (AFE) 109 by wires or conductive polymers. To measure the ECG signal, the electrodes 103 and 104 are used to generate a lead. Electrode 105 serves as a reference electrode commonly used in ECG measurement methods. The output of AFE109 is an amplified analog signal related to the ECG. The output of the AFE109 is passed to an analog input of a Microcontroller (MCU) 113 and a Modulator (MD) 110. The MCU113 processes the analog signals into digital form and calculates heart activity data. It stores the resulting data to a Data Storage (DS) 117, such as a flash memory. The MCU113 is connected to a wireless Transmitter (TRX) 107, such as a bluetooth or dedicated wireless transmitter.

The sensor 101 also includes at least one Audio Codec (AC) 112 and at least one microphone 115. The analog audio signal from the microphone 115 is processed by an Audio Codec (AC) 112 into a digital audio signal. Most Transmitters (TRX) 107 on the market, such as bluetooth, have built-in audio codecs. Thus, the blocks show the Transmitter (TRX) 107 and the Audio Codec (AC) 112 as separate components-only logical representations of them-they may be formed in one physical Integrated Circuit (IC) or microchip.

The output of AFE109 is also connected to Modulator (MD) 110. The MD110 modulates the analog ECG signal from the AFE109 and forwards the modulated signal to the AC112. The AC112 converts it to a digital audio format and forwards it to the Transmitter (TRX) 107 for wireless transmission to the host 119.MD110 may use different modulation methods. One approach is to use amplitude modulated carrier frequencies with time division. This method allows mixing the ECG signal from the AFE109 with the speech signal from the microphone 115 into one audio channel.

The purpose of the ECG signal modulation is to pass the analog ECG signal to the host computer through the standard microphone voice channel commonly used in wireless headsets without disturbing the audio signal. Since the human audible range uses a spectrum of 20Hz to 20,000hz, it makes sense to modulate the ECG signal with carrier frequencies above the audible range of 20,000hz. This method allows mixing the modulated ECG signal and the audio received from the microphone 115 into one audio channel. The mixing of the two signals and their digitization are performed in the codec AC112 and then transmitted to the host 119 via the TRX 107. The host 119 receives the digital audio stream and records it as a digital audio file using an available digital audio format (e.g., AAC, ALAC, FLAC, MP3, WAV, or other digital audio format). The ECG signal recorded in one file together with the speech signal will be further used for ECG analysis. The user may speak his own feelings or other observations while taking the ECG measurements. A physician, trained expert or Artificial Intelligence (AI) can use the narration of the user together with the ECG signal for detailed analysis of the cardiopulmonary activity.

Not all audio codecs support audio signal transmission frequencies above 20,000hz or 20 KHz. In fact, some bluetooth codecs limit audio frequencies to 16KHz or even 8KHz for a particular bluetooth audio profile. In this case, the modulator may be configured to use frequencies below 20 KHz. For example, if Audio Codec (AC) 112 has an audio frequency limit of 16KHz, then the carrier modulation frequency of MD110 may be set to be less than 16KHz. The AC112 mixes the signals from the microphone 115, amplifier 114 and MD110 into one audio signal, encodes it into a digital format and sends it to the host through the transmitter TRX 107. Host 119 receives the digital data and processes it into a mono audio stream.

In another embodiment, the HLM sensor 101 uses another method to transmit the ECG signal to the host 119. This can be achieved by using a dual microphone channel transmitter TRX 107. Some transmitters (e.g., bluetooth) are designed with two independent audio input channels for the two microphones. The speech signal from the microphone 115 is digitized by the codec AC112 and transmitted by the TRX107 using the first microphone channel. The modulated ECG signal from MD110 is digitized by codec AC112 and transmitted by TRX107 using the second microphone channel. The host 119 receives digital data with two microphone channels and processes it into one two-channel audio stream.

However, in another embodiment, the HLM sensor 101 transmits the ECG signal to the host 119 using a direct (non-modulated) method. The speech signal from the microphone 115 is digitized by the codec AC112 and transmitted by the TRX107 using the first microphone channel. The ECG signal from AFE109 passes through MD110 unmodified, then digitized by codec AC112, and transmitted by TRX107 using the second microphone channel. The host 119 receives digital data with two microphone channels and processes it into one two-channel audio stream.

Modern Integrated Circuits (ICs) may have multiple components, such as the MCU113, the transmitter 107, the data storage 117, and the audio codec 112 integrated into a single IC or microchip. The modulator MD110 may be implemented as microcontroller code or a library in the MCU 113. It is also possible to integrate all the components of the HLM sensor 101 into a single IC.

A Battery (BAT) 121 provides power to the sensor 101 and all its components. It may be a rechargeable battery or a disposable (non-rechargeable) battery. The transmitter TRX107 may wirelessly connect with the host 119 via a wireless transmitter 111 built into the host device, which has the same protocol as bluetooth or a proprietary wireless protocol. The host device 119 may be a mobile phone, a smart watch, a tablet, a computer, or any other device capable of receiving wireless signals, processing, displaying, storing, or relaying wireless signals to another device. The transmitter TRX107 may broadcast a signal to multiple host devices that may receive data simultaneously.

Illustrating a sensor embodiment

Fig. 2 illustrates one embodiment of an HLM sensor 200 for a wireless headset. The HLM sensor comprises a housing 201, a conductive bell-shaped cover 203 with an opening for a microphone 205, a connector 207 and an electrode lead 209, the electrode lead 209 comprising at least one first wire 215 connected to a conductive clip 219. In another embodiment, the electrode lead 209 comprises two wires, wherein the second wire 217 is connected to the conductive clip 221.

The clips 219 and 221 are made of a conductive material, such as a conductive polymer, metal cloth, or neodymium alloy. Clips 219 and 221 are made to facilitate clipping onto earphones 202 and 204. Clip 219 is connected to the right earpiece 202 and clip 221 is connected to the left earpiece 204. The clip 219 is connected to the first electrode input of the HLM sensor 103 by a wire 215, as shown in fig. 1. The clip 221 is connected to the third electrode input of the HLM sensor 105 by a wire 217 as shown in fig. 1. Both electrode input connections are located inside an HLM sensor housing 201, which is logically designated 101 in fig. 1.

As shown in fig. 1, the bell-shaped cover 203 is electrically connected to the second electrode 104. The bell 203 is made of a conductive material, such as a metal, metal alloy, metallized plastic, or conductive polymer. The opening of the microphone 205 in the bell-shaped cover 203 is used to receive sound from the chest or back of the user.

For better wearing options, the system may be equipped with a neck brace 223, the neck brace 223 being connected to the electrode wires 215 and 217 by sliding straps or rings 211 and 213, respectively. The purpose of the neck brace 223 with the slip ring is to establish a length of the brace such that it is located on or near the xiphoid process of the user's chest when the user wears the HLM sensor 201.

Fig. 2 is intended to show an overall view of the HLM sensor 200. The proportional dimensions of the housing 201, connector 207, wires 215 and 217, clips 219 and 221, earphones 202 and 204, and neck retainer 223 may not represent actual proportional dimensions of all of the elements shown.

Fig. 3 illustrates one embodiment of an HLM sensor by way of a cross-sectional view 300. The HLM sensor comprises: housing 301, bell cover 309, electrode lead 323 having leads connecting the sensor with the electrodes in the ear, printed Circuit Board (PCB) 307 having components logically represented within rectangle 101 as shown in fig. 1. This portion of fig. 3 depicts only the relevant components, not all of the components, in rectangle 101 shown in fig. 1.

Conductor 311 is connected to a first electrode, logically indicated as 103 in fig. 1. The wire 313 is electrically connected to the bell 309 at contact location 321. Bell 309 is made of metal, metal alloy, metallized plastic, or conductive polymer. Bell 309 represents the second electrode, logically 104 as shown in figure 1.

Lead 315 is connected to a third electrode, logically represented as 105 in fig. 1. The components 303 mounted on the PCB307 represent an Analog Front End (AFE), logically as shown at 109 in fig. 1. All 3 electrode lines 311, 313, and 315 are connected to the AFE303.

The bell 309 serves a dual purpose: one is the electrodes and the other is the diaphragm for a cardiorespiratory sound receiver. The bell 309 conducts current from the skin when placed on the user's chest or back and establishes a firm contact with the skin at its circumferential line 305. As a receiver of cardiopulmonary sounds, it works by blocking external noise when placed on the skin of the chest or back, and isolating the edge from other sounds at circumferential line 305. It receives sounds produced by the heart, lungs, and airways through opening 319.

Assembly 317 shows a microphone mounted on PCB307 and aligned with opening 319. The purpose of the microphone 317 is to receive audible sound from the heart and lungs when placed on the chest or back of the user. The microphone 317 may be turned on and off by the action of the user. The microphone 317 may be switched by the user to a different mode of operation: direct mode and amplification mode. These two modes of operation are also illustrated by the connection lines to AC112 in fig. 1. The direct mode is represented by a line from the microphone 115 to the AC112. The amplification mode is represented by the line through amplifier 114 to AC112. In the direct mode, the microphone receives the audio input and transmits it directly to the AC112. In the amplification mode, the audio input from the microphone 115 is amplified in the amplifier 114 and then transmitted to the AC112. The amplification mode is used to detect low amplitude sounds from the user's heart and lungs.

Examples of the use of HLM sensors with headphones

Fig. 4A shows a view of a female user showing one example of how the user wears the HLM sensor 400. In one embodiment, the HLM sensor 409 is placed on or near the chest, on or near the xiphoid process. The HLM sensor 409 may be clipped onto the bra so that it remains attached under the bra and establishes firm contact with the skin under the bra. A lead 413 connects the HLM sensor 409 with the electrode connector in the earpiece 401 of the right ear. A lead 405 connects the HLM sensor 409 with the electrode connector in the earpiece 403 of the left ear. In another embodiment, the wires 413 and 405 are hooked to the neck holder 415 with the help of the clips 411 and 407. The neck holder 415 is used to support the HLM sensor 409 at a fixed length and is placed on or near the xiphoid process. Each user can individually set the length of the neck holder 415 and then use it with the same length setting. In this way all recorded ECG data, heart sounds and lung sounds can be correctly compared, since the HLM sensor records ECG, heart sounds and lung sounds from the same location of the chest.

Fig. 4B shows a view of a male user showing one example of how the user wears the HLM sensor 420. The HLM sensor 431 is placed on the user's back between the thoracic vertebrae and the scapula. The HLM sensor 431 of the back can be pressed tightly against the skin by means of elastic bands which are closed or which surround the back and the chest. The HLM sensor 431 is connected to two leads 425 and 427 by wires 429. A wire 425 is connected to the electrode in the earpiece 423 of the left ear. The wires 427 connect to the electrodes in the earpiece 421 of the right ear.

In all embodiments shown in fig. 4A and 4B, the first electrode 103 as shown in fig. 1 is located inside the right ear headphone, the second electrode 104 as shown in fig. 1 is located on the chest or back of the user along with the HLM sensor, and the third electrode 105 as shown in fig. 1 is located inside the left ear headphone.

To detect an ECG signal, 2 electrodes are sufficient: the first electrode is located on the right ear with an earpiece and the second electrode is located on the chest or back with an HLM sensor. However, the third electrode located in the left earpiece serves as the reference electrode. The reference electrode in the left ear is used to drive a small current into the body to cancel out the electrical signals generated by other muscles or caused by the movement of these muscles and the whole body. The reference electrode in the left earphone can improve the quality of the ECG signal when the user is moving. The disclosed system is not limited to the use of only two or all three electrodes. It provides the user with a solution using two electrodes or a solution using three electrodes to reduce the lead wires to improve the ECG quality in motion.

Earphone example with clip-on electrode connector

Fig. 5A, 5B, and 5C illustrate one embodiment of a headset for use with the disclosed HLM sensor.

Fig. 5A illustrates one embodiment of a headset connected to an HLM sensor 500. The figure shows a front and back view of a headset with electrode wires 505 electrically connected to clip-on connectors 501 at locations 503. The clip connector 501 is made of metal or conductive polymer for establishing a reliable electrical connection with a ring 509 on the earphone stem. The cover 507 is intended to be placed in the external ear canal and establish a secure contact with the skin. The cover 507 is made of metal, metallized plastic, or conductive polymer, and is used to connect the in-the-ear electrode to the skin in the external auditory canal.

Fig. 5B shows a side view of a user showing one example of how the user wears headphones connected to the HLM sensor 520. The earphone 521 is located in the external auditory canal and the electrode wire 523 is clipped to the handle of the earphone. The electrode wire 523 is connected to an HLM sensor located on the back or chest of the user.

Figure 5C illustrates a cross-sectional view of one embodiment of a headset connected to an HLM sensor 540. A typical headset includes at least one speaker or driver 541, an electronic device with a battery 543. The headset may have at least one microphone 545.

The cover 547 (also shown as 507 in fig. 5A) is made of metal, metalized plastic, or a conductive polymer. The cover 547 is electrically connected to the inner wire 551 at location 549 by welding or mechanical connection so that the wire 551 can transmit the current picked up by the cover 547 from the skin to the ring 555 on the earphone stem. Ring 555 is made of metal, metallized plastic, or conductive polymer and is connected to lead 551 at location 553. Clip connector 557 (also shown as 501 in fig. 5A) is electrically connected to wire 561 at location 559. The clip connector 557 clips around the ring 555 and establishes a reliable electrical contact for the entire chain from the skin, via the cover 547, to the HLM sensor through the wires 561. The same design is also applicable to the second earpiece. The microphone 545 may be present in only one headset.

Other embodiments of connecting the electrode wires to the skin in the ear, electrically connecting the HLM sensor to the electrodes in the headset are also possible without departing from the spirit of the invention.

Earphone example with magnetic electrode connector

Fig. 6A, 6B, and 6C illustrate another embodiment of a headset for use with the disclosed HLM sensor.

Fig. 6A shows a cross-sectional view of another embodiment of a headset connected with an HLM sensor 600 using a magnetic connector. The headset typically includes at least one speaker or driver 605 and electronics with a battery 603. The headset may also have at least one microphone. The soft in-ear earplug 609 is intended to be placed in the ear canal. Soft in-ear earplugs are made of a conductive material, such as a conductive polymer, conductive latex or rubber. The mouthpiece 607 is designed to focus the audio sound from the driver 605 into the user's ear. The in-ear earplug 609 fits snugly over the mouth 607 of the tube. The nozzle 607 is made of a conductive material, such as metal, metallized plastic, or a conductive polymer. The nozzle 607 is electrically connected to the electrical wires 613 at location 611. The wire 613 is connected to the first magnet 617 inside the earphone housing 601. The first magnet 617 is electrically connected to the wire 613 at a location 615.

The second magnet 619 is attracted to the first magnet 617 by 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. Magnet 619 is electrically connected to electrode line 623 at location 621.

The magnets 617 and 619 are made of metal, woven metal or a neodymium alloy and electrically connect the HLM sensor to the skin inside the ear of the user via the electrode wire 623, the spout 607, the in-ear earpiece 609. The magnets 617 and 619 establish a reliable electrical connection by magnetic force and connect the electrode 103 shown in fig. 1 to the skin in the ear of the user.

In another embodiment, two earphones, one for each ear, may be used. The second earpiece has the same components as the first earpiece described above. The magnets 617 and 619 establish a reliable electrical connection by magnetic force and connect the electrode 105 shown in figure 1 to the skin in the ear of the user. The second earpiece may not contain a microphone.

Fig. 6B shows a side view of an ear showing another example of how a user wears a headset connected to the HLM sensor 630. When the user inserts earphone 631 into the ear, electrode wire 635 is connected to the skin of the ear through magnetic clip connector 633.

It will be apparent to those of ordinary skill in the art that other embodiments may connect the electrodes to the skin within the ear-electrically connecting the HLM sensor to the electrodes built into the headset without departing from the spirit of the invention.

Example of use of HLM sensor

Fig. 7 illustrates in cross-section view 700 one embodiment of how a user may use an HLM sensor. Not all of the components of the HLM sensor are described in detail in fig. 7. A detailed description of the components of the HLM sensor is shown in fig. 3. The HLM sensor 701 is placed on or near the xiphoid process of the chest, or between the thoracic vertebra and the scapula near the back of the user's skin 702, such that the bell 707 establishes firm contact with the skin around the lid edge 709. Cover 707 is made of metal, metal alloy, metallized plastic, or conductive polymer and is configured to receive electrical signals 717 generated by heart 715. The electrical signal 717 is transmitted to the AFE708 through contact with the skin 709 around the edge, the circumference of the cover 707. The cover 707 is electrically connected to the AFE708 by wires 704 having electrical contacts 706 located on the inner surface of the cover 707, logically as shown at 109 in fig. 1. The bell 707 is logically shown as the electrode 104 in fig. 1 at its contact surface with the skin 709. Electrical signals from the heart 717 are received by contact with the skin 709 at the perimeter, edge of the cover 707 and transmitted to the AFE708 through the electrical wires 704.

As described in detail in fig. 2 and 3, the two electrodes (logically shown as electrodes 103 and 105 in fig. 1) are connected to AFE708 by two wires within electrode lead 721.

An opening 703 in the bell 707 allows the microphone 705 to receive acoustic sound 719 generated by the heart 715 and acoustic sound 713 generated by the lungs and airway 711. The microphone 705 is isolated from other sounds by the sound-absorbing housing, picking up sounds only through the opening 703.

In another embodiment, the electrode 707 of the HLM sensor is made of a ring-shaped conductive material surrounding the microphone opening 703. A protective film may separate the microphone opening 703 from the skin 702.

It will be apparent to those of ordinary skill in the art that other embodiments may incorporate the electrodes 707 and microphone into one housing-electrically connecting the electrodes of one HLM sensor to the skin on the chest or back of the user, receiving sounds generated by the heart, lungs and airways of the user-without departing from the spirit of the invention.

Logic examples for HLM sensors in block diagrams

Fig. 8 shows a block diagram of user interaction with the HLM system 800. The HLM sensor 101, logically represented as part of the overall HLM system of fig. 1, also represented as 202 in fig. 2, comprises at least one host 119 and one headset 123. When the user wears the headset 202 for listening to music or speaking through a 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 lung sounds, the HLM sensor 201 needs to be placed on the chest or back, pressed against the skin 223 by means of clothing (such as a bra, shirt or special tie) and connected with at least one earphone 202 by means of electrode wires 215.

801-by default the sensor is in a dormant state. This is a low power consumption state to save battery. The sensor is configured to automatically turn on when it detects a current between the at least two electrodes. This can occur when a first electrode is connected to the earpiece in the ear, as shown in fig. 5A, 5D, 5C or 6A and 6B, and the other electrode is connected to the skin of the chest or back of the user, as shown in fig. 7. Once the HLM sensor is turned on, it begins to process ECG, heart and lung sounds simultaneously.

The 802-HLM sensor is connected to the host through a wireless connection such as bluetooth. It uses an available audio profile to transmit both ECG signals and cardiopulmonary sounds. In another embodiment, the sensors may operate independently without being connected to a host. It can also work with host wireless connections that are periodically lost or broken. When the HLM sensor is disconnected from the host, it stores all ECG signals, heart and lung sounds in a local data memory (DS) 117 with the help of the MCU113, as shown in fig. 1. When a connection is available, the stored data will be transferred to the host.

803-once a connection is established with the host, the HLM sensor modulates the ECG signal using one of the available modulation methods, mixes the modulated signal with the cardiopulmonary sounds, and transmits the mixed signal to the host.

804-when the microphone is in the amplification mode, the user can switch the HLM sensor to a special state to better detect low amplitude sounds produced by the heart, lungs, and airways. HLM sensors are equipped with push buttons or non-contact (e.g., capacitive or dynamic sensing) switches.

805-a user can interact with the HLM sensor through an application running on the host. An application on the host computer can receive voice instructions of the user through a microphone or a headset in the HLM sensor and instruct the HLM sensor to perform operations related to the user instructions. For example, the user may turn on the HLM sensor magnification mode by saying "zoom in" or the like. The host application converts the command to a digital control message that is sent to the HLM sensor instructing it to enter the amplify mode. Similarly, the user may say "normal" or the like to instruct the HLM sensor to return to normal mode.

The user may also instruct the HML application on the host computer to start recording ECG, cardiopulmonary sounds by saying "start recording", etc. Similarly, the user may stop recording by saying "stop recording" or the like.

806-when the user disconnects one of the electrodes from the skin or headset, the HLM sensor will detect and notify the host. The host application in turn notifies the user that one of the electrodes is open. If the user does so intentionally, the host may issue a command to the HLM sensor to shut it down after a period of time. The HLM sensor is then disconnected from the host and returns to a sleep (wait) state.

One of ordinary skill will recognize that the event streams depicted in the block diagrams are for illustrative purposes in one of many possible scenarios. The present disclosure is not limited to the one depicted in fig. 8.

Fig. 9 shows a logical block diagram of an HLM application on a host 900. The entire cardiac monitoring system is logically represented in fig. 1 and includes 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 headset 123. The host device 119 may also be wirelessly connected to the earphones 123 and 125. As shown in fig. 1, the host device 119 wirelessly receives audio data packets from the HLM sensor 101 via the built-in wireless transmitter 111. Meanwhile, the host device 119 may wirelessly receive the audio data packet through at least one headset 123 or 125 as shown in fig. 1. The HLM application on the host wirelessly receives audio streams from one headset 123 or 125 and from the HLM sensor. The HLM application processes the audio streams from the HLM sensor and the headset and acts in coordination with the HLM sensor.

The HLM application records all audio streams from the headphones and HLM sensor into one digital audio file. The digital audio files include voice audio from a microphone in the headset, heart and lung sounds, and ECG signals received from the HLM sensor. Such a single digital audio recording allows playback of the originally recorded audio stream at the same time as received, with the speech audio, heart and lung sounds synchronized with the ECG signal. This may provide a better diagnosis of cardiac and pulmonary activity. Some digital file formats, such as MP3, provide multi-channel (2-channel stereo or 4-channel) recording. In this case, the HLM application uses one channel (e.g., the left channel) for the speech audio, heart and lung sounds, and another channel (e.g., the right channel) for the ECG signal. In another embodiment, the speech audio is recorded in a first channel, the cardiopulmonary sounds are recorded in a second channel, and the ECG signals are recorded in a third channel. Further steps will describe one of many possible scenarios of HLM application logic.

901-the HLM application on the host device receives audio streams from the HLM sensor and at least one headset. The HLM application separates the ECG signal into another logical channel. It then mixes the speech audio received from the headphones and the heart and lung sounds received from the HLM sensor into one audio channel. The audio channel and the ECG channel are then processed in two parallel threads, one for each data stream or channel.

902-audio is recorded into one audio channel, such as the left channel in an MP3, WAV digital audio file, or other digital audio file format.

903 — demodulate the ECG signal into a raw ECG signal using the same demodulation method as used in the modulator MD110 shown in fig. 1.

904-the ECG signal is recorded to another channel, for example the right channel of the same digital audio file.

The 905-HLM application calculates vital ECG data from the ECG signal waveform, including but not limited to: p, Q, R, S and T amplitude positions and times, RR intervals, pulse, heart beat variability, atrial fibrillation preconditions, and other parameters.

The 906-HLM application interacts with the user on the data important for the calculated ECG. The HLM application informs the user of an abnormal situation, such as "possible preconditions for atrial fibrillation", by means of a voice message, requesting a medical doctor. "or" heart beat variation over average ", etc. The user may then ask the HLM application by voice questions about some other important data, such as "what is my average heart rate? "or" how to reduce my variability? ". The HLM application will attempt to use its logical capabilities in Artificial Intelligence (AI) to find an answer, or it may send this question to the cloud-based AI system over a wireless connection with the host device.

The user can instruct the HLM application to upload the ECG recording to the host device and cloud via voice commands. The host HLM application uploads the recording as directed and confirms to the user in a voice prompt. The headset may remain powered on and connected to the host for listening to music or making a phone call.

In another embodiment, the TRX107 shown in fig. 1, may have two independent microphone audio channels. The HLM sensor transmits heart and lung sounds through one microphone channel and ECG signals through the other microphone channel. In this case, step 901 simply forwards the audio channels of the heart and lungs to step 902 and the ECG signal channels to step 903. In addition, the ECG signal may be transmitted in raw, unmodulated form. In this embodiment, demodulation in step 903 becomes unnecessary and the logic proceeds to step 904.

Other design variations are possible that can utilize the disclosed invention to attach or integrate HLM sensors into wearable accessories or devices, where the electrodes are connected to the skin using the existing contact points of the wearable device with the skin. The above examples presented in fig. 1-9 are not limited to the described option of the wearable device or accessory being connected only to the electrodes. In accordance with the spirit of the invention, any headset can be enhanced by the disclosed cardiac monitoring sensor, wherein the first electrode is connected to the skin of the ear with the specific function of the headset. The second electrode may be in contact with the skin of the chest or back of the user. A third electrode connected to the skin of the other ear can be used as a reference electrode. All 2 or 3 electrodes are connected to an HLM sensor in order to measure heart activity using electrical signals obtained from both electrodes and to record cardiopulmonary sounds.

Thus, a device for cardiopulmonary activity monitoring has been described with different mounting options for the headset. Although embodiments have been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these example embodiments without departing from the broader spirit and scope of the application. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

Claims (30)

1. A system (100) for cardiac activity monitoring, the system (100) comprising:

a first electrode (103) configured to sense an electrical signal indicative of heart activity of a user at a first location of skin of the user;

a second electrode (104) configured to sense another electrical signal indicative of the cardiac activity of the user at a second location of the user's skin;

a Microcontroller (MCU) (113) configured to:

detecting a current between the first electrode and the second electrode;

processing the current to obtain an Electrocardiogram (ECG) signal; and

determining one or more cardiac activity parameters based on the ECG signal, the cardiac activity parameters including a PQRST complex in the ECG signal, a time interval between the PQRST complexes, a heart rate variability, and a probability of atrial fibrillation; and

a data storage configured to store the cardiac activity parameter.

2. The system as recited in claim 1, further comprising an acoustic sensor (115) configured to sense acoustic signals indicative of the cardiac and pulmonary activity of the user.

3. The system according to claim 2, further comprising a housing (201) for fixing the MCU (113), the data storage (117) and the acoustic sensor (115), wherein the housing (201) is configured to contact the skin of the user at one of the following positions: on the user's chest or on the user's back.

4. A system according to claim 3, wherein the first electrode (103) is attachable to a first earphone (123) and the second electrode (104) is integrated into the housing (201) such that the first electrode (103) and the second electrode (104) contact the skin of the user when the first earphone (123) is worn by the user.

5. The system of claim 4, further comprising:

a third electrode (105) attachable to a second earpiece (125) such that the third electrode (105) contacts the user's skin when the user wears the second earpiece (125), the third electrode (105) being used as a reference electrode in obtaining an ECG signal;

a first wire (215) for connecting the first electrode (103) to the housing (201) and the MCU (113); and

a second 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 retainer for retaining the first wire (215) and the second wire (223).

7. The system of claim 3, wherein:

the first electrode (103) is attachable to a first earphone (123) and connected to the housing (201) by a wire; and

the second electrode (104) is provided as a cover (309) made of an electrically conductive material, the cover (309) being mounted in the housing (201) and configured to contact the skin of the user.

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 signals to the host device (119): sensed acoustic signals and ECG signals.

9. The system according to claim 8, wherein said MCU (113) is configured to, prior to said transmitting:

detecting a current between the first electrode and the second electrode; and

in response to the detection, a connection is established 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 sends 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:

separating the digital signal into ECG data and audio data; and

determining one or more of the cardiac activity parameters based on the ECG data.

13. The system of claim 8, wherein the host device (119) is configured to:

receiving, via the acoustic sensor (115), a voice instruction of a user; and

in response to receiving the voice instruction, the MCU (113) is caused to perform one or more operations including starting an ECG measurement, completing the ECG measurement, and transmitting the ECG measurement.

14. The system of claim 13, further comprising a headset connected to the host device, wherein the host device (119) is configured to receive voice instructions of a user through the headset instead of the acoustic sensor (115).

15. The system of claim 14, wherein the host device (119) is configured to:

receiving a request from the headset to report ECG measurements from the user; and

in response to receiving the request, sending a voice message to the headset informing the user of the ECG measurement.

16. A method for cardiac activity monitoring, the method comprising:

detecting, by a Microcontroller (MCU) (113), a current between the first electrode (103) and the second electrode (104), wherein:

the first electrode (103) is configured to sense an electrical signal indicative of heart activity of the user at a first location of the skin of the user; and

the second electrode (104) is configured to sense a further electrical signal indicative of the cardiac activity of the user at a second location of the user's skin;

processing the current by the MCU (113) to obtain an Electrocardiogram (ECG) signal;

determining, by the MCU (113), one or more cardiac activity parameters based on the ECG signal, the cardiac activity parameters including PQRST complexes in the ECG signal, time intervals between the PQRST complexes, heart rate variability, and probability of atrial fibrillation; and

storing the cardiac activity parameter to a data store.

17. The method as recited in claim 16, further comprising sensing acoustic signals indicative of the cardiac and pulmonary activity of the user with an acoustic sensor (115).

18. The method according to claim 17, wherein the MCU (113), the data storage (117) and the acoustic sensor (115) are placed in a housing (201) for fixation, wherein the housing (201) is configured to contact the skin of the user at one of the following positions: on the user's chest or on the user's back.

19. The method of claim 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 the first electrode (103) and the second electrode (104) contact the skin of the user when the first earpiece (123) and the housing (201) are worn by the user.

20. The method of claim 19, wherein:

the obtaining of the ECG signal comprises processing a reference electrical signal from a third electrode (105), the third electrode (105) being attachable to a second earpiece (125) such that the third electrode (105) contacts the skin of the user when the second earpiece (125) is worn by the user;

the first electrode (103) is connected to the housing (201) and the MCU (113) by a first wire (215); and

the third electrode (104) is connected to the housing (113) and the MCU (113) by a second wire (217).

21. The method of claim 20, wherein the first wire (215) and the second wire (223) are secured to the user's neck by a neck retainer (223).

22. The method of claim 19, wherein:

the first electrode (103) is attachable to a first earphone (123) and connected to the housing (201) by a wire; and

the second electrode (104) is provided as a cover (309) made of an electrically conductive material, the cover (309) being mounted in the housing (201) and configured to contact the skin of the user.

23. The method of claim 18, further comprising transmitting, by the MCU (113) through a transmitter (107), to a host device (119), one or more of the following signals: the sensed acoustic signal and the ECG signal.

24. The method of claim 23, wherein prior to said transmitting, further comprising:

detecting, by the MCU (113), a current between the first electrode and the second electrode; and

-detection of information source, -establishing a connection between said transmitter (107) and said host device (119) by said MCU (113).

25. The method of claim 23, wherein the sensed acoustic signal and the ECG signal are transmitted separately using two separate channels.

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 cardiac activity parameters.

28. The method of claim 23, further comprising:

receiving, by the host device (119), voice instructions of the user via the acoustic sensor (115); and

in response to receiving the voice instruction, causing, by the host device (119), the MCU (113) to perform one or more operations including starting an ECG measurement, completing the ECG measurement, and sending the ECG measurement.

29. The method of claim 28, wherein the host device (119) is configured to receive voice instructions of a user via a headset instead of the acoustic sensor (115).

30. The method of claim 29, further comprising:

receiving, by the host device (119), a request from the headset to report ECG measurements; and

in response to receiving the result, sending, by the host device (119), a voice message to the headset informing the user of the ECG measurement result.

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