EP3484354A1 - Système de dispositif portable unique pour mesurer la pression artérielle - Google Patents

Système de dispositif portable unique pour mesurer la pression artérielle

Info

Publication number
EP3484354A1
EP3484354A1 EP17828364.4A EP17828364A EP3484354A1 EP 3484354 A1 EP3484354 A1 EP 3484354A1 EP 17828364 A EP17828364 A EP 17828364A EP 3484354 A1 EP3484354 A1 EP 3484354A1
Authority
EP
European Patent Office
Prior art keywords
sensor
waveform
pulse
ecg
user
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP17828364.4A
Other languages
German (de)
English (en)
Other versions
EP3484354A4 (fr
Inventor
Milan RAJ
Bryan Mcgrane
Roozbeh Ghaffari
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MC10 Inc
Original Assignee
MC10 Inc
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 MC10 Inc filed Critical MC10 Inc
Publication of EP3484354A1 publication Critical patent/EP3484354A1/fr
Publication of EP3484354A4 publication Critical patent/EP3484354A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02125—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/33—Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1102—Ballistocardiography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist

Definitions

  • the present disclosure relates generally to blood pressure monitoring. More particularly, aspects of this disclosure relate to using a single sensor attached to a body to measure blood pressure by determining pulse arrival time.
  • Integrated circuits are the cornerstone of the information age and the foundation of today's information technology industries.
  • the integrated circuit a.k.a. "chip” or “microchip,” is a set of interconnected electronic components, such as transistors, capacitors, and resistors, which are etched or imprinted onto a semiconducting material, such as silicon or germanium.
  • Integrated circuits take on various forms including, as some non-limiting examples, microprocessors, amplifiers, Flash memories, application specific integrated circuits (ASICs), static random access memories (SRAMs), digital signal processors (DSPs), dynamic random access memories (DRAMs), erasable programmable read only memories (EPROMs), and programmable logic.
  • Integrated circuits are used in innumerable products, including computers (e.g., personal, laptop and tablet computers), smartphones, flat-screen televisions, medical instruments, telecommunication and networking equipment, airplanes, watercraft and automobiles.
  • wearable devices have given rise to new methods of acquiring, analyzing, and diagnosing medical issues with patients, by having the patient wear a sensor that monitors specific characteristics.
  • wearable devices have been created within the sports and recreational fields for the purpose of monitoring physical activity and fitness. For example, a user may don a wearable device, such as a wearable running coach, to measure the distance traveled during an activity (e.g., running, walking, etc.), and measure the kinematics of the user's motion during the activity.
  • One example of a body function that is desirable to monitor is blood pressure and more specifically, to monitor resting and ambulatory blood pressure continuously over an extended period of time.
  • An adequate blood pressure level is necessary for blood to travel from the heart around the body.
  • a blood pressure that is too low (hypotension) may lead to inadequate blood flow, or hypoperfusion, of critical organs.
  • a blood pressure level that is too high (hypertension) may, over time, have detrimental health effects on organs such as the heart (myocardial infarction), the brain (stroke, hemorrhage), and kidneys (renal failure).
  • traditional blood pressure measurement methods such as using an external cuff that constricts around a patient's arm cannot provide continuous monitoring of blood pressure.
  • Pulse Arrival Time is the time it takes the pressure wave generated by the heart to travel a predefined point along a peripheral artery.
  • the Pulse Arrival Time can be determined as the time difference between the time an electrical pulse signal (e.g., an ECG signal) of the heart is detected and the time that the resulting mechanical impulse of the pressure wave is detected along the peripheral artery. Knowing PAT, and the distance between the two points of measurement, one can determine the Pulse Wave Velocity (PWV). Knowing the basic properties of the blood vessel wall, and the PWV, one can calculate the mean pressure exerted on the wall along the arterial path, and thus obtain blood pressure.
  • PAT Pulse Arrival Time
  • PWV Pulse Wave Velocity
  • the PWV and the basic properties of the vessel wall can be pre-determined constants and incorporated in a function based on the PAT to determine blood pressure.
  • the basic properties of the vessel wall can be determined empirically by measuring the blood pressure using a traditional blood pressure cuff to calibrate the sensor. Previous techniques to measure PAT required two sensors, one at the heart and another at a remote location. However, the use of two separate devices requires time synchronization with a high level of precision. Further additional sensors add to the expense of the blood pressure measurement.
  • an attachable sensor device for sensing a pulse arrival time.
  • the sensor device includes an ECG sensor in contact with the skin of a user to measure an ECG waveform.
  • a pulse sensor is in contact with the skin of the user to measure a pulse waveform.
  • a controller receives the ECG waveform from the ECG sensor and the pulse waveform from the pulse sensor to determine a pulse arrival time based on a pulse detected from the ECG waveform and the pulse detected from the pulse waveform.
  • the system includes a wearable sensor device attached to a location on the body remote from the heart.
  • the sensor device includes an ECG sensor and a pulse sensor.
  • a controller receives an ECG waveform from the ECG sensor and a pulse waveform from the pulse sensor to determine a pulse arrival time.
  • the controller is operative to determine the blood pressure based on the determined pulse arrival time and the distance between the location and the heart.
  • Another example is a method of measuring blood pressure with an attachable sensor device.
  • a sensor device including an ECG sensor and a pulse sensor is attached to a location on the skin of a user. Blood pressure is measured for a calibration value. A distance from the location to the heart is input. An ECG waveform and a pulse waveform is measured at the location. A pulse arrival time is determined based on the ECG waveform, pulse waveform and input distance from the location to the heart. Blood pressure is determined based on the pulse arrival time and calibration value.
  • FIG. 1 shows a system for a single wearable sensor for sensing blood pressure of a user
  • FIG. 2 is a block diagram of the wearable sensor device in FIG. 1;
  • FIG. 3 is a graph showing the sampled ECG signal of the sensor device and the sampled PPG signal of the sensor device in FIG. 1;
  • FIG. 4A is a top view of an example of the single wearable sensor in FIG. 1 and highlights the specific features and components used to enable the system of FIG. 2;
  • FIG. 4B is a bottom view of an example of the single wearable sensor in FIG. 1 and highlights the skin-facing optical sensor used in FIG. 2;
  • FIG. 5 is a flow diagram showing the process of measuring blood pressure in the system in FIG. 1;
  • FIG. 6 is a graph showing an ECG signal, a PPT signal and a seismocardiogram (SCG) signal;
  • FIG. 7 A is a graph showing a sampled ECG waveform and a SCG waveform.
  • FIG. 7B is a close up view of the waveforms in FIG. 7A.
  • FIG. 1 shows a user 100 that has attached at least one wearable sensor device such as a wearable sensor device 110 for the purpose of obtaining pulse arrival time to determine blood pressure.
  • the wearable sensor device 110 only has to be attached at a location that is near a blood vessel such as an artery or a capillary bed.
  • the wearable sensor device 110 can be remotely located from the heart of the user 100 but in sufficient proximity to measure heart signals and identify features such as the R-wave of the ECG waveform or the aortic opening feature of the SCG waveform from the heart beat. Only a single sensor device is needed to determine the blood pressure in this example.
  • Example locations may include the wearable sensor 110 on the mid left shoulder, a wearable sensor 112 on the lower left shoulder, a wearable sensor 114 on the left arm and a wearable sensor 116 on the left arm.
  • the locations of the wearable sensors 110, 112, 114 and 116 shown in Fig. 1 are for illustration only.
  • blood pressure can be determined by sensing two or more signals as single location on the body, for example, using only a single wearable sensor.
  • the wearable sensors can be positioned in many other locations, such as, the right shoulder, arm, wrist, foot, neck, or thigh, etc. near a blood vessel and where the sensor can detect the PPG, ECG and/or SCG signals from the body.
  • the wearable sensor device such as one of the sensor devices 110, 112, 114, and 116 are in communication with a smart device such as a user device 130.
  • the user device 130 can be a computing device such as a smart phone, a tablet, a laptop or desktop computer, a personal digital assistant or a network of computers (e.g., a cloud or a cluster).
  • the user device 130 allows programming and control of the sensor devices 110, 112, 114 and 116.
  • the sensor devices 110, 112, 114, and 116 are used for non-invasive blood pressure monitoring, they can have other measurement and sensing functions in relation to the user 100.
  • the time data from the sensor device such as one of the sensor devices 110, 112, 114 and 116 associated with the sensed pulses may be uploaded to a cloud storage server 160 periodically and analyzed by applications running on the cloud application server 162 using postprocessing techniques. The user may access these applications or the output of the applications by accessing the cloud server 162 such as through a website.
  • any of the sensors 110, 112, 114 and 116 may be used to capture blood pressure related data to determine pulse arrival time.
  • the user device 130 determines blood pressure measurements based on the collected pulse arrival data. Alternatively, the determination of blood pressure measurements may be performed on one of the sensors 110, 112, 114, and 116 or on the cloud application server 162 based on pulse arrival data.
  • FIG. 2 shows an example of a wearable sensor device 200 such as the sensor device 110 in FIG. 1 in accord with aspects of the present disclosure.
  • the wearable device 200 can provide conformal sensing capabilities, providing mechanically transparent close contact with a surface (such as the skin or other tissues or organs of the body) to provide measurement and/or analysis of physiological information from the user 100.
  • the wearable device 200 senses, measures, or otherwise quantifies the motion of at least one body part of a user in proximity to the wearable device 200 (e.g., the sensors in the wearable device 200 can detect the motion of the body part, either directly or indirectly).
  • the wearable device 200 senses, measures, or otherwise quantifies the temperature of the environment of the wearable device 200, including, for example, the skin and/or body temperature at or adjacent to the location that the wearable device 200 is coupled to the body of a user.
  • the wearable device 200 senses, measures, or otherwise quantifies other characteristics and/or parameters of the body (e.g., human or animal body) and/or surface of the body, including, for example, electrical signals associated with cardiac activity (e.g., ECG), electrical signals associated with muscle activity (e.g., electromyography (EMG)), changes in electrical potential and impedance associated with changes to the skin (e.g., galvanic skin response), electrical signals of the brain (e.g., electroencephalogram (EEG)), bioimpedance monitoring (e.g., body-mass index, stress characterization, and sweat quantification), and optically modulated sensing (e.g., photoplethysmography (PPG) and pulse-wave velocity), and the like.
  • ECG cardiac activity
  • EMG electromyography
  • EEG electromyography
  • EEG electromyography
  • bioimpedance monitoring e.g., body-mass index, stress characterization, and sweat quantification
  • PPG photoplethysmography
  • the wearable device 200 described herein can be formed as a patch.
  • the patch can be flexible and/or stretchable, and can include stretchable and/or conformal electronics and conformal electrodes disposed in or on a flexible and/or stretchable substrate.
  • the wearable device 200 can be rigid but otherwise attachable to a user.
  • the wearable device 200 can include portions that are stretchable and/or conformable and portions that are rigid.
  • the wearable device 200 can be any device that is wearable on a user, such as coupled to the skin of the user, to provide measurement and/or analysis of physiological information of the user.
  • the wearable device can be adhered to the body by adhesive, held in place against the body by tape or straps, or held in place against the body by clothing.
  • the wearable device 200 of FIG 2 can include at least one processor 201 and one or more associated memory storage modules 203.
  • the wearable device 200 can further include one or more sensors, such as an accelerometer 205 and/or a temperature sensor 213 and/or an optical sensor 217.
  • the wearable device 200 can optionally include one or more wireless transceivers, such as transceiver 207, for communicating with other sensor devices such as the master sensor device 110 or other computing devices such as the user device 130 in FIG. 1.
  • the wearable device 200 can also include a power source 209 that provides power for the components of the wearable device 200.
  • the wearable device 200 can be configured to draw power from a wireless connection or an electromagnetic field (e.g., an induction coil, an NFC reader device, microwaves, and light).
  • an electromagnetic field e.g., an induction coil, an NFC reader device, microwaves, and light.
  • the processor 201 can be a controller that is configured to control the wearable device 200 and components thereof based on computer program code. Thus, the processor 201 can control the wearable device 200 to measure and quantify data indicative of temperature, motion and/or other physiological data, and/or analyze such data indicative of temperature, motion and/or other physiological data according to the principles described herein.
  • the memory storage module 203 can be configured to save the generated sensor data (e.g., the time when a pulse in blood flow is sensed, accelerometer 205 information, temperature sensor 213 information, or other physiological information, such as ECG, EMG, etc.) or information representative of acceleration and/or temperature and/or other physiological information derived from the sensor data. Further, according to some embodiments, the memory storage module 203 can be configured to store the computer program code that controls the processor 201. In some implementations, the memory storage module 203 can be volatile and/or non-volatile memory. For example, the memory storage module 203 can include flash memory, static memory, solid state memory, removable memory cards, or any combination thereof. In certain examples, the memory storage module 203 can be removable from the wearable device 200.
  • the memory storage module 203 can be local to the wearable device 200, while in other examples the memory storage module 203 can be remote from the wearable device 200.
  • the memory storage module 203 can be internal memory of a smartphone such as the user device 130 in FIG. 1 that is in wired or wireless communication with the wearable device 200, such as through radio frequency communication protocols including, for example, WiFi, Zigbee, Bluetooth®, medical telemetry and near-field communication (NFC), and/or optically using, for example, infrared or non-infrared LEDs.
  • the wearable device 200 can optionally communicate (e.g., wirelessly) with a user device 130 such as a smartphone via an application (e.g., program) executing on the smartphone.
  • the sensor data (e.g., including data generated by sensor and data derived from the sensor data), including the temperature information, the acceleration information, and/or the other physiological information (e.g., ECG, EMG, etc.), can be stored on the memory storage module 203 for processing at a later time.
  • the wearable device 200 can include more than one memory storage module 203, such as one volatile and one non-volatile memory storage module 203.
  • the memory storage module 203 can store the sensor generated information indicative of motion (e.g., acceleration information), temperature information, physiological data, or analysis of such information indicative of motion, temperature, physiological data according to the principles described herein, such as storing historical acceleration information, historical temperature information, historical extracted features, and/or historical locations.
  • the memory storage module 203 can also store time and/or date information about when the information was received from the sensor.
  • the functionality of the wearable device 200 can be implemented based on hardware, software, or firmware or a combination thereof.
  • the memory storage module 203 can include computer program code in the form of software or firmware that can be retrieved and executed by the processor 201.
  • the processor 201 executes the computer program code that implements the functionality discussed below with respect to determining the on-body status of the wearable device 200, the location of the wearable device 200 on a user, and configuring functionality of the wearable device 200 (e.g., based on the on-body status and sensed location).
  • one or more other components of the wearable device 200 can be hardwired to perform some or all of the functionality.
  • the power source 209 can be any type of rechargeable (or single use) power source for an electronic device, such as, but not limited to, one or more electrochemical cells or batteries, one or more photovoltaic cells, or a combination thereof.
  • the cells can charge one or more electrochemical cells and/or batteries.
  • the power source 209 can be a small battery or capacitor that stores enough energy for the device to power up and execute a predefined program sequence before running out of energy, for example, an NFC or RFID based sensing device.
  • the wearable device 200 can include one or more sensors, such as the accelerometer 205, a temperature sensor 213, electrical contacts 215 (e.g., electrical contacts or electrodes), and/or an optical sensor 217.
  • one or more of the sensors such as accelerometer 205, the optical sensor 217 and/or electrical contacts 215, can be separate components from the wearable device 200. That is, the wearable device 200 can be connected (by wire or wirelessly) to each sensor (e.g., accelerometer 205, temperature sensor 213, electrical contacts 215, and optical sensor 217). This enables the wearable device 200 to sense conditions at one or more locations that are remote from the wearable device 200.
  • the wearable device 200 can include one or more integral sensors in addition to one or more remote sensors.
  • the accelerometer 205 measures and/or generates acceleration information indicative of a motion and/or acceleration of the wearable device 200, including information indicative of a user wearing, and/or body parts of the user wearing, the wearable device 200.
  • the accelerometer 205 within the wearable device 200 can include a 3- axis accelerometer that generates acceleration information with respect to the x-axis, the y-axis, and the z-axis of the accelerometer based on the acceleration experienced by the wearable device 200.
  • the wearable device 200 can include three independent accelerometers (not shown for illustrative convenience) that each generate acceleration information with respect to a single axis, such as the x-axis, the y-axis, or the z-axis of the wearable device 200.
  • the wearable device 200 can include an inertial measurement unit (IMU) that measures the velocity, the orientation, and the acceleration using a combination of one or more accelerometers, gyroscopes, and magnetometers.
  • IMU inertial measurement unit
  • the accelerometer 205 can be any motion sensing element or combination of elements that provides acceleration information.
  • the accelerometer 205 includes a detection range of ⁇ 4 times the force of gravity (Gs). However, the range can vary, such as being ⁇ 10 Gs or ⁇ 2 Gs. Further, the accelerometer 205 can have a sampling rate of 50 hertz (Hz) such that each second the accelerometer 205 generates 150 points of acceleration information, or 50 points within each axis. However, the sampling rate can vary, such as being 10 Hz to 250 Hz.
  • one or more sensors of the wearable device 200 such as the accelerometer 205, can include a built-in temperature sensor, such as the temperature sensor 211 within the accelerometer 205.
  • the temperature sensor 211 within the accelerometer 205 can be used to calibrate the accelerometer 205 over a wide temperature range and to measure the temperature of the area of the body that the accelerometer 205 is coupled to.
  • Other temperature sensors included with other device components can also be used.
  • other subcomponents or elements of the wearable device 200 can include one or more microelectromechanical system (MEMS) components within the wearable device 200 that is designed to measure motion or orientation (e.g., angular-rate gyroscope, etc.).
  • MEMS microelectromechanical system
  • the wearable device 200 can include a discrete temperature sensor, such as the temperature sensor 213 which can be positioned in a different location from the wearable device 200.
  • the wearable device 200 can use the temperature information detected by the temperature sensor 211 and/or the temperature sensor 213 according to various methods and processes. For purposes of convenience, reference is made below to the temperature sensor 211. However, such reference is not limited to apply only to the temperature sensor 211, but applies to any one or more temperature sensors within or connected to the wearable device 200.
  • the electrical contacts 215 can be formed of conductive material (e.g., copper, silver, gold, aluminum, a hydrogel, conductive polymer, etc.) and provide an interface between the wearable device 200 and the skin of the user 100, for receiving electrical signals (e.g., ECG, EMG, etc.) from the skin.
  • the electrical contacts 215 can include one or more electrical contacts 215, such as two electrical contacts 215, electrically connecting the skin of the user 100 to an amplifier circuit that can be part of an analog front end circuit 216, to amplify and condition electrical signals (e.g., ECG, EMG, etc). With two electrical contacts 215, one contact can be electrically configured as a positive contact and the other contact can be electrically configured as a negative contact. However, in some aspects, there may be more than two electrical contacts, such as four electrical contacts 215 (e.g., two positive and two negative electrical contacts), six electrical contacts 215, etc.
  • the optical sensor 217 can measure the photoplethysmography (PPG) signal when placed on the skin's surface, allowing for the monitoring of various biometrics including, but not limited to, heart rate, respiration, and blood oxygen measurements.
  • the optical sensor 217 can include one or more light emitters that can emit red, green, infrared light or a combination thereof and one or more optical transducers (e.g., photodiode, CCD sensors). Using the one or more optical transducers, the optical sensor 217 can sense the wavelength of the reflected light. In this example, the optical sensor 217 illuminates the skin and the reflected light changes intensity based on the concentration of oxygen in a blood vessel such as an artery or a capillary bed.
  • PPG photoplethysmography
  • a pulse can be detected as a change in the amount of the reflected light due to a change in the concentration of oxygen in a blood vessel and thus the reflected light detected by the optical sensor 217.
  • sensors can be included on the wearable device 200 to detect the pulse such as the accelerometer 205, a pressure sensor, a strain gauge sensor or an acoustic sensor to measure the mechano-acoustic signatures of the pulse.
  • the wearable device 200 can include one or more additional components without departing from the spirit and scope of the present disclosure.
  • Such components can include a display (e.g., one or more light-emitting diodes (LEDs), liquid crystal display (LCD), organic light-emitting diode (OLED)), a speaker, a microphone, a vibration motor, a barometer, a light sensor, a photoelectric sensor, or any other sensor for sensing, measuring, or otherwise quantifying parameters and/or characteristics of the body.
  • the wearable device 200 can include components for performing one or more additional sensor modalities, such as, but not limited to, hydration level measurements, conductance measurements, and/or pressure measurements.
  • the wearable device 200 can be configured to, or include one or more components that, perform any combination of these different types of sensor measurements, in addition to the accelerometer 205 and temperature sensor 211.
  • the primary purpose of the temperature sensor 211 is for calibrating the accelerometer 205. Accordingly, the temperature sensor 211 does not rely on direct contact to an object to detect the temperature. By way of example, the temperature sensor 211 does not require direct contact to the skin of a user when coupled to the user to determine the skin temperature. For example, the skin temperature affects the temperature information generated by the wearable device 200 without direct contact between the temperature sensor 211 and the skin. Accordingly, the temperature sensor 211 can be fully encapsulated and, therefore, be waterproof for greater durability. The thermal conductivity of the encapsulating material can be selected to control the ability of the temperature sensor 211 to detect the temperature without direct contact.
  • a user's blood pressure can be measured using the wearable sensing device 200.
  • the form factor of the wearable device 200 allows positioning and repositioning of the sensor devices at different locations on the body of the user 100 in order to achieve the highest quality of data.
  • the sensor device 110 placed on the shoulder of the user 100 in FIG. 1 is set in an electrocardiogram (ECG) sensing mode in order to receive ECG signals and determine the time-point of a pulse signal feature (e.g., associated with the R-wave) in the ECG from the heart of the user 100.
  • ECG electrocardiogram
  • the sensor device 110 can also capture the time-point of the pulse associated with the pressure-wave of the pulse using a photoplethysmography (PPG) sensor or accelerometer.
  • the pulse arrival time can then be determined from the ECG waveform and the pulse arrival (e.g., using the PPG signal data) at the location of the sensor device 110.
  • the wearable device 200 can provide high quality ECG and PPG data as it conforms to the body and is coupled to the skin of the user 100 without bands or other fastening devices placing pressure on the arterial wall which would alter the measurement. This tight coupling also reduces the motion artifacts.
  • the accelerometer 205 can be used to cancel out noise seen by the PPG sensor.
  • a method of blood pressure measurement based on pulse arrival time using the sensor devices such as the wearable device 200 may be employed.
  • the concept for the measurement of pulse arrival time relies on the use of both the analog front-end (AFE) amplifier 216 in conjunction with electrodes 215 and a PPG sensor such as the optical sensor 217 in a location that is distal from a subject's heart (e.g. upper shoulder, wrist, leg, etc.).
  • AFE analog front-end
  • PPG sensor such as the optical sensor 217 in a location that is distal from a subject's heart (e.g. upper shoulder, wrist, leg, etc.).
  • PAG Pulse Arrival Time
  • This data has correlation to a subject's blood pressure and requires only one device as the salient sensing modalities are completely integrated into the wearable device 200.
  • ECG electrocardiogram
  • PPG photoplethysmography
  • FIG. 3 is a graph 300 showing a visualization of the data streams from the sensor device 110 attached on the shoulder of the user 100 in FIG. 1.
  • a first trace 310 is the output of the ECG sensed from the electrodes 215 of the sensor device 110.
  • the ECG of the sensor device 110 is sampled at 250 Hz and digitized to 16 bits.
  • a second trace 320 is the PPG output of the optical sensor 217 of the sensor device 110.
  • the optical sensor is sampled at 400 Hz at 18 bits.
  • An electrical wave is detected at a first time point 322 on the first trace 310.
  • a pulse pressure wave is detected at a second time point 324 (e.g., the foot of the pressure pulse - FPP) on the second trace 312. As shown in FIG. 3, the time difference between the two time points 322 and 324 constitute the pulse arrival time 326 between the heart and the shoulder of the user 100 in FIG. 1 through the artery.
  • This time difference is the PAT metric and, if the distance from the sensing location to the heart is known, the Pulse Wave Velocity (PWV) metric can be calculated as:
  • PWV can be used with mathematical models or functions to compute blood pressure.
  • one model that can be used is the Moens-Korteweg and Hughes equations, which model the PWV dependence on the blood vessel's characteristics and a blood vessel's elasticity dependence on pressure, respectively.
  • E Young's modulus of elasticity of the vessel wall
  • h the vessel wall thickness
  • R vessel radius
  • p the blood density
  • E 0 the nominal Young's modulus of elasticity
  • ⁇ the nominal Young's modulus of elasticity
  • P the effective blood pressure
  • the user 100 wears the sensor device 110 and enables the ECG/PPG recording feature via a smart device such as the user device 130 such as by a Bluetooth low energy (BLE) signal.
  • the user may visualize the ECG and PPG waveforms in real time based on data received from the sensor device 110 using the display on the user device 130.
  • the user device 130 then makes a determination regarding the quality of the PPG waveform and, if it determines the quality is low, the user device 130 can automatically adjust the parameters of the PPG sensor of the sensor device 110 to improve the signal quality.
  • the user device 130 sends commands via a BLE signal to adjust the PPG sensor parameters such as the LED output power, duty cycle, color (wavelength frequency), sampling rate, and LED on off time to improve signal quality of the optical sensor for PAT measurement.
  • the system can be calibrated.
  • the user device 130 instructs the user to be seated and wear a blood pressure cuff to measure blood pressure for calibration purposes.
  • the blood pressure cuff system can conform to ISO 81060-2 or similar to ensure accuracy of the calibration procedure.
  • the goal of this procedure is to calibrate out the features of the Moens- Korteweg and Hughes equations relating to blood vascular characteristics (i.e., E, h, and R). This results in a persistent calibration as these parameters are constant on a time scale much longer than changes in blood pressure.
  • the user After the blood pressure cuff calibration measurement is complete, the user stores this value in the memory of the user device 130 as variable, BPCA L, S ITTIN G .
  • the user device 130 sends a BLE command to the sensor device 110 to record ECG and PPG waveforms for 30 seconds.
  • the data from the waveforms is sent to the user device 130 via a BLE signal and the user device 130 starts to calculate the PAT based on detected features of the waveforms shown in FIG. 3.
  • the user is instructed to input the approximate distance between the sensor device 110 and the heart, allowing the user device 130 to calculate the value, PWVS ITTIN G- This value serves as the initial calibration point for PWV against blood pressure.
  • the distance between the sensor device 110 and the heart may also be determined from tables stored in the user device 130 reflecting the estimated distance between the location of the sensor and the heart based on the height, weight, age and other biometric measurements of a user that are input to the user device 130. The distance may also be determined automatically by use of the sensor device 110 or other sensors.
  • the user device 130 can also instruct the user to stand up to calculate another calibration point. Similar to the above procedure, the user must take a blood pressure calibration measurement using the cuff and input this value as BP C A L, S T A NDIN G- The smart device 130 then sends a BLE command to the sensor device 110 to record ECG and PPG waveforms for 30 seconds and, using the same distance input by the user, calculates PWVS T AN DI NG- Using the two cuff-based calibration points BPCAL,SITTING and BPCAL,STANDING and the associated PWV data, the user device 130 can calculate the constant parameters of the Moens-Korteweg and Hughes equations. This results in a fully defined mathematical model that can determine blood pressure for any PWV determined by the user device 130 from the pulse arrival time derived from the ECG and PPG waveforms.
  • FIG. 4A is a top view of the wearable sensor device 110 and FIG. 4B is a bottom view of the wearable sensor device 110 in FIG. 1.
  • the bottom of the wearable sensor device 110 is in contact with the skin of the user.
  • the wearable sensor device 110 includes a number of islands 410, 412, 414, 416, 418, and 420 as well as a battery 422.
  • the islands 410, 412, 414, 416, 418, and 420, and the battery 422 are coupled together by flexible conductive interconnections 424. In this manner, the wearable sensor device 110 can be in conformal contact and flex with movements of a user's skin.
  • the islands 410, 412, 414, 416, 418, and 420 can be used to mount different components (e.g., integrated circuits) on the top surface of the wearable sensor device 110 as shown in FIG. 4A.
  • a flash memory chip 430 is mounted on the island 410
  • a microcontroller 432 is mounted on the island 412
  • a power management integrated circuit 434 is mounted on the island 414.
  • the memory chip 430 in this example can be a 64 MB memory chip that is part of the memory storage module 203 in FIG. 2.
  • a flexible tab 436 can be attached to another island 438.
  • the island 438 can hold an optical sensor integrated circuit 440.
  • the flexible tab 436 can be folded over to allow the optical sensor integrated circuit 440 to be positioned on the bottom of the island 414 in order to be in contact with the user's skin.
  • a motion sensor 6-axis internal measurement (IMU) integrated circuit 446 can be mounted on the island 416 that may be used for the accelerometer 205 shown in FIG. 2, a heart rate sensor integrated circuit 448 can be mounted on the island 418, and various electronic support components 450 can be mounted on the island 420.
  • IMU 6-axis internal measurement
  • the bottom of the islands 410 and 416 and the battery 422 can include four or more electrodes 460 to be in contact with the skin.
  • the electrodes 460 can be electrically connected (e.g., either directly or through an amplifier) to the heart rate sensor integrated circuit 448.
  • the electrodes 460 may be included as parts of other islands or in other locations on the islands other than those shown in FIG. 4B.
  • the electrodes 460 constitute the electrical contacts 215 in FIG. 2.
  • the battery 422 and the power management integrated circuit 434 constitute the power source 209 in FIG. 2.
  • the microcontroller 432 is an onboard nRF51822 system on chip manufactured by Nordic Semiconductor that performs the functions of the processor 201 and transceiver 207 in FIG. 2.
  • the heart rate sensor integrated circuit 448 is an ADS 1191 manufactured by Texas Instruments and can be an integrated part of the processor 201 in FIG. 2.
  • the optical sensor integrated circuit 440 is a MAX30101 manufactured by Maxim Integrated to record the PPG waveform from the user's skin and serves as the optical sensor 217 in FIG. 2. As the optical sensor 440 needs to face the skin for proper signal acquisition, the component can be populated on the island 438 that is attached to the island 416 by the flexible tab 436.
  • the flexible tab 436 is folded once at manufacturing, resulting in the skin-facing optical sensor shown in FIG. 4B.
  • the optical sensor 440 can be mounted on the skin- facing side of one of the islands.
  • the heart rate sensor integrated circuit 448 makes electrical contact with the subject's skin via electrodes 460 on the skin-facing side of the device as shown in FIG. 4B. With both these sensors facing the skin, the sensor device 110 is able to capture both ECG and PPG waveforms using a common system clock.
  • the timing precision is a function of the digital bus speed set by the microcontroller 432 and supporting hardware. This level of timing precision is more than enough for blood pressure applications, where the limit can be as high as 5 milliseconds.
  • the data can be transmitted to a smart device or equivalent such as the user device 130 in FIG. 1 via the BlueTooth® Low-Energy (BLE) radio for additional processing.
  • BLE BlueTooth® Low-Energy
  • the algorithm used to process the data by the user device 130 will conform to the diagram outlined in FIG. 3. The algorithm will identify the salient points of the respective waveforms and compare the time difference between them.
  • FIG. 5 is a flow diagram of the process of measuring blood pressure in the system shown in FIG. 1.
  • Handshaking is performed between the user device 130 and the sensor device 110 (500).
  • the handshaking involves sending identification information for the sensor device 110 and a MAC address to the user device 130.
  • the user device 130 sets initial configuration data such as the location of the sensor device 110 on the body, the sampling rate and applicable storage parameters (502).
  • the sensor device 110 can continuously (or periodically) send the output of the ECG signal received from the electrical contacts 215 in FIG. 2 to the user device 130 (504).
  • the output of the ECG signal can include one or more samples (e.g., 2, 3, 4, 5, 10, 20, or more samples) associated with a particular timestamp.
  • the optical sensor on the sensor device 110 can also continuously (or periodically) send an output PPG signal to the user device 130 that can include one or more samples (e.g., 2, 3, 4, 5, 10, 20, or more samples) associated with a particular timestamp (506).
  • the user device 130 receives the ECG output waveform signal and the PPG output waveform signal from the sensor device 110.
  • the user device 130 determines whether the quality of the PPG waveform is sufficient (508). If the quality of the PPG waveform is low (e.g., features, such as the foot, of the PPG waveform are not discernible), the user device 130 adjusts the parameters of the optical sensor to improve the signal quality (510).
  • the PPG output waveform is then checked again to determine if the PPG waveform is sufficient (508). If the quality of the PPG waveform is still not above a predefined threshold, the user can be instructed to reposition the sensor device 110 on the body. If the quality of the PPG waveform is sufficient, calibration data is input in the form of a blood pressure measurement from a cuff device while standing and sitting (512). Based on the calibration data, the user device 130 determines the constant parameters for blood pressure determination (514).
  • the user device 130 senses the pulse based on the PQRS waves detected in the ECG waveform (516). The user device records the timestamp associated with the ECG waveform when the pulse is sensed. The user device 130 senses the pulse based on sensing a foot of the PPG signal from the optical sensor output waveform when the pressure wave reaches the location of the sensor device (518). The user device 130 records the timestamp associated with the PPG signal when the pulse is sensed. The pulse arrival time can be determined by the user device 130 based on the timestamps from the R-wave of the ECG waveform and the foot of the PPG signal from the PPG waveform (520). As shown in FIG.
  • the foot of the PPG waveform can be determined by determining a maximum first derivative of the waveform and determining the point of the tangent to the maximum first derivative.
  • the blood pressure can be determined from the pulse arrival time by the user device 130 (522).
  • the determined blood pressure can be stored in the memory of the user device 130 (524).
  • the process described in FIG. 5 is a real time determination of blood pressure by the user device 130. Some or all of the operations described above may be performed by the sensor device 110. Alternatively, the timestamp data and respective signals may be transmitted to the cloud server 162 and some or all of the above operations may be performed by the cloud server 162. Alternatively, the sensor device 110 can store the waveform data and transmit the stored data periodically to the user device 130 for measurement of the blood pressure at a delayed time.
  • the above described examples allow the use of a single sensor device to continuously, and non-invasively measure blood pressure from a subject without the persistent use of a blood pressure cuff.
  • the use of a single patch mitigates the need for advanced network techniques, such as time synchronization across multiple devices, to generate accurate measurements.
  • the sensor device decribed in FIGs. 1, 2 and 4A-4B has flexibility and mechanical compliance to the human body to allow for tight adhesion to the skin, giving high-fidelity ECG and PPG waveforms. This feature of the system allows for unobtrusive, comfortable use to the end user, enabling more frequent measurements that can help physicians better characterize their patients' vascular health through daily life.
  • an accelerometer such as the accelerometer 205 of the wearable sensor device 200 shown in FIG. 2 can be used to detect and measure a biometric signal known as a seismocardiogram (SCG).
  • SCG seismocardiogram
  • the SCG signal can be detected and recorded by the accelerometer 205 of the wearable sensor device 200, for example, due to the tight mechano-acoustic coupling of the wearable sensor device 200 to the skin (or other organ) that enables the device to sense mechano-acoustic waveforms that propagate from the internal organs of the body to the surface of the skin.
  • the SCG waveform can be more reliable than measurement of the ECG for sensors that are attached at points in the body that are relatively far from the heart or chest of the patient.
  • FIG. 6 is a diagram showing a ECG waveform 600, a SCG waveform 602 and a blood pressure waveform 604 during a time period of a heartbeat.
  • the salient features of the SCG waveform 602 correlate well to the characteristics of the heart and its pumping action as displayed with the ECG waveform 600.
  • FIG. 6 shows a Q point 610, an R point 612 and a S point 614 on the ECG waveform 600.
  • the SCG waveform 602 demonstrates an aortic opening point 620 that shows when blood from the left ventricle is ejected from the heart through the aortic valve.
  • the BP waveform 604 includes a foot of the pressure pulse (FPP) point 624 that defines the onset of systole in the pressure pulse waveform.
  • FPP pressure pulse
  • the ECG waveform 600 may define a Pre-ejection Period (PEP) time 630 between the Q-point 610 and the AO point 620.
  • PEP Pre-ejection Period
  • a Pulse Arrival Time (PAT) 632 is shown between the R point 612 and the FPP point 624.
  • a Pulse Transit Time (PTT) 634 is shown between the AO point 620 and the FPP point 624
  • the important aspects of the cardiac cycle can be determined.
  • the Aortic Opening (AO) feature is the point when blood from the left ventricle ejects from the heart through the aortic valve, signifying the initial onset of blood propagating through the body. Knowing this point in time gives a more complete picture of the relationship between the mechanical and electrical characteristics of the heart, leading to insights about the difference between Pulse Arrival Time (PAT), Pulse Transit Time (PTT), and PEP (Pre-ejection Period).
  • PAT Pulse Arrival Time
  • PTT Pulse Transit Time
  • PEP Pre-ejection Period
  • FIG. 7A is a graph of the amplitude of output waveforms from the sensor device 110, attached to the left shoulder of the user 100 as shown in FIG. 1, plotted against time.
  • FIG. 7A shows an ECG waveform 700 from the output of the analog front end (AFE) circuitry connected to the electrodes 215 of the sensor device 110.
  • AFE analog front end
  • the ECG data from the sensor in the sensor device 110 can be sampled at 250 Hz and digitized to 16 bits and the ECG waveform 700 is derived from the ECG data.
  • FIG. 7A also shows a SCG waveform 702 taken from the accelerometer of the sensor device 110.
  • the 7B is a close up view of the ECG waveform 700 and the SCG waveform 702.
  • the ECG waveform 700 includes various valleys 710 that correspond to R-wave of the ECG signal.
  • the SCG waveform 702 includes various peaks 712 that correspond to AO feature points.
  • the integration of the SCG waveforms with accompanying ECG and PPG waveforms gives a holistic picture of the dynamics of the vascular system.
  • a motion-based sensor such as the accelerometer in combination with bio-potential (e.g., ECG) and/or optical (e.g., PPG) recording capabilities in a remote sensor such as the sensor device 110 in FIG. 1 provides significant advantages over other systems that cannot record all three sensing modalities from a common location.
  • the main advantage is that it can be used to negate the PEP time from an overall PAT calculation.
  • the PAT measurement may take into account mechanical processes of the heart that do not relate to blood propagation through the vasculature (e.g., left ventricular isovolumic contraction), a true PTT measurement ignores these processes and highlights only blood flow through the vasculature.
  • a measured PEP time can be used by the system to quantify (and eliminate) the time associated with the mechanical process of the heart moving blood around through its chambers (i.e., atria and ventricles), leading to a more precise PTT value.
  • the Q-R interval time can be determined from the peaks of the Q-wave and the R-wave and the Q-R interval time can be subtracted from the PEP time to identify the portion of the PEP time that is included in the PAT measurement.
  • the portion of the PEP time can be subtracted from the PAT measurement to more accurately determine the PTT measurement.
  • the improved PAT calculation will be solely based on the dynamics of blood flow through the vasculature and not from the electro-mechanical dynamics of the heart.
  • the aforementioned methods include at least those steps enumerated above. It is also within the scope and spirit of the present disclosure to omit steps, include additional steps, and/or modify the order of steps presented herein. It should be further noted that each of the foregoing methods can be representative of a single sequence of related steps; however, it is expected that each of these methods will be practiced in a systematic and repetitive manner.

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Abstract

La présente invention concerne un système de détection de la pression artérielle chez un utilisateur. Le système comprend un dispositif de capteur portable fixé à un emplacement sur le corps distant du cœur. Le dispositif de capteur peut comprendre un capteur d'accéléromètre (ou acoustique), un capteur ECG et/ou un capteur PPG. Un dispositif de commande reçoit des formes d'onde SCG, ECG et PPG depuis les capteurs pour déterminer un temps d'arrivée d'impulsion, un temps de transit d'impulsion et une période de pré-éjection. Le dispositif de commande est fonctionnel pour déterminer la pression artérielle sur la base du temps d'arrivée d'impulsion déterminé et de la distance entre le dispositif de capteur et le cœur.
EP17828364.4A 2016-07-12 2017-07-12 Système de dispositif portable unique pour mesurer la pression artérielle Withdrawn EP3484354A4 (fr)

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