Classifications

• • G—PHYSICS
  • G08—SIGNALLING
  • G08B—SIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
  • G08B21/00—Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
  • G08B21/02—Alarms for ensuring the safety of persons
  • G08B21/04—Alarms for ensuring the safety of persons responsive to non-activity, e.g. of elderly persons
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• • 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
  • A61B5/6802—Sensor mounted on worn items
  • A61B5/681—Wristwatch-type devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/02—Operational features
  • A61B2560/0204—Operational features of power management
  • A61B2560/0209—Operational features of power management adapted for power saving
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/02—Operational features
  • A61B2560/0266—Operational features for monitoring or limiting apparatus function
  • A61B2560/0271—Operational features for monitoring or limiting apparatus function using a remote monitoring unit
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
  • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/021—Measuring pressure in heart or blood vessels
• • 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 for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/024—Measuring pulse rate or heart rate
  • A61B5/02438—Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Measuring 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 or mobility of a limb
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S128/00—Surgery
  • Y10S128/903—Radio telemetry

Definitions

• the present invention is of a method and device for measuring at least one physiological parameter of a subject at the wrist, preferably for extracting clinically useful information thereof. More specifically, the present invention is of a device which may be worn at the wrist of the subject with a strap or other fastening article, and which may then be used to monitor the subject through measurement of the physiological parameter.
• non-invasive monitoring of a human subject could be very useful as part of the overall health maintenance of the human subject, and could be used in order to detect a deterioration in the physiological condition of the subject before a concomitant deterioration in the health of the subject becomes noticeable.
• adverse physiological conditions which could be detected with regular non-invasive monitoring include but are not limited to excessive weight gain or less; arrhythmia and other heart conditions; incipient diabetes in the form of improper glucose metabolism; and loss of lung capacity or other problems with respiration.
• Heart rate and blood pressure are important factors in determining the state of a person's health and the physical condition of a person's body in response to physical or emotional stress. Periodic monitoring of these physical parameters is particularly important for individuals having cardiac disease and/or lowered cardiac functioning, or high blood pressure. However, physically healthy individuals may also wish to periodically monitor their heart rate and blood pressure in stressful situations, for example when engaging in strenuous exercise.
• the equipment In order to support regular monitoring of human subjects in their normal environment, such as in the home and at the office for example, the equipment must be non-invasive and easy to use. The equipment would then be able to monitor at least one physiological parameter of the user, without requiring the user to perform any complicated actions and/or to operate complex devices. Indeed, it would be highly preferred for the equipment to be incorporated as part of the regular daily living routine of the subject, since the requirement for any additional or special actions on the part of human subject is likely to result in decreased compliance. In addition, the equipment should be robust yet inexpensive.
• Such a device incorporates a wristband to attach a physiological sensor to the wrist of the subject.
• a wristband device to attach a physiological sensor to the wrist of the subject.
• a number of different types of such wristband devices are available, most of which are intended to be used as stand-alone devices to provide information about the subject's own physical condition, mainly for heart rate and blood pressure.
• Most of these devices obtain such measurements by using an inflating cuff, which is bulky and awkward for the subject.
• Wrist-mounted heart rate monitors are known to the art and have been disclosed, for example, in the patent to Orr et al, U.S. Patent No. 3,807,388, wherein the duration of a heart beat is measured by counting electrical pulses recurring at a known frequency. The duration of the heartbeat is then related to a particular average heart beat rate.
• the disclosed measurement system does not directly measure the heart rate and, therefore, is subject to inaccuracies of measurement due to the instability of heart beat duration over brief intervals of time.
• a blood pressure measuring device is disclosed in the patent to Petzke et al, U.S. Patent No. 3,926,179, in which a probe is applied adjacent to the radial artery of a wrist.
• a pressure-sensitive transducer on the probe generates electrical signals corresponding to the blood pressure pulses of the radial artery.
• the electrical pulses are applied to analog circuitry that generates a systolic signal corresponding to the integrated voltage at the peak of the electrical pulse signal and a diastolic signal corresponding to the voltage at the low point of the pulse signal.
• the analog device of Petzke et al requires a substantial amount of power to operate and, therefore, is not suitable for use in a small, compact stand-alone device for being worn on the wrist.
• a blood pressure and a heart rate measuring wrist watch is also disclosed in the patent to Broadwater, U.S. Patent No. 4,331,154, in which a digital watch is employed to measure systolic and diastolic blood pressure as well as heart rate.
• the band of the watch supports a piezoelectric transducer that is held in contact with the wrist adjacent to the radial artery when a switch on the band is activated.
• the absolute values required for this method to evaluate blood pressure cause the device to be subject to inaccurate readings, since the tissues of the hand and wrist may be expected to expand and contract according to such factors as the time of day, and the condition of the external environment such as the atmospheric pressure. Such expansion or contraction may cause different degrees of tension on the wrist-mounted device, which is therefore not suitable for use without daily calibrations.
• Other wrist-mounted devices are for wireless panic alarm systems, mainly for elderly people who live alone. These devices are usually shaped as a wristband or a pendant. Whenever the user becomes distressed, the user presses a panic button located on the device. The device then sends a digitally coded wireless message to a gateway device located nearby, usually in the same room, by using a unidirectional wireless data communication link. The gateway device then contacts a manually operated contact center, for example with a land based or cellular telephone connection. A particular identifier for the user is usually sent first, after which the human operator is allowed to talk to the user through a speaker and to listen through a sensitive microphone located within the gateway.
• none of the above systems contains any physiological measurement device within, in order to learn about the current physiological status of the user.
• the operator at the call center learns about the user's condition only by speaking with the user. However, this is only possible if the user is actually able to speak. High levels of background noise may also prevent the user from being heard by the microphone of the gateway device.
• the background art does not teach or suggest a device which can conveniently, non-intrusively and autonomously measure one or more physiological parameters, in order to extract medical information such as heart rate, breathing rate and blood pressure, and which may be worn on the wrist of the user.
• the background art also does not teach or suggest such a wrist-mounted device, which can measure such parameters and then send the information to a contact center or other location containing medical personnel.
• the background art also does not teach or suggest such a wrist-mounted device which is compact, non-invasive, and light.
• the present invention overcomes these deficiencies of the background art by providing a wrist-mounted device for measuring at least one physiological parameter of the user.
• the present invention enables such a measurement to preferably be transformed into medical information about the user, and/or displays the results on a LCD display.
• the term "physiological parameter” refers to the signal which is received from the sensor
• the term “medical information” refers to the information which may be extracted or otherwise obtained by analyzing this signal and/or a combination of signals. Such information may then optionally be sent to medical personnel (for example at a contact monitoring center) and/or to a remote server, through a gateway device.
• the gateway device preferably communicates with the wrist-mounted device of the present invention through a wireless communication channel.
• the present invention has the option to display the medical information to the user on a local LCD display, such that the user is optionally and preferably able to read the result locally.
• medical information which may be extracted from the measured physiological parameter or parameters include, but are not limited to: heart rate; regularity in heart rate; breathing rate; arrhythmia of the heart (if any), as well as the general rhythm and functioning of the heart; blood pressure; presence of abnormal body movements such as convulsions for example; body position; general body movements; body temperature; presence and level of sweat; oxygen saturation in the blood; and glucose levels in the blood.
• the present invention may measure other parameters that may affect the subject's physical condition, including but not limited to ambient temperature and humidity, lighting conditions, smoke or other material in the air, distance from home etc.
• the present invention also features an alarm signal for being transmitted through the gateway device in order to indicate an emergency or otherwise dangerous situation for the user.
• the alarm signal may optionally be transmitted according to a manual action of the user, such as pressing a "panic button" for example.
• the gateway Upon receipt of the manually activated alarm signal, the gateway would preferably initiate immediately a call to a human operated call center. Then the device would preferably automatically collect one or more current measurements of physiological parameters of the user. These measurements may be sent directly to the gateway, or alternatively may be analyzed in order to compute the medical information of the user before sending the results to the gateway. The human operator would then preferably be able to assess the user's medical condition from the received information.
• the alarm signal is transmitted automatically upon measurement of one or more physiological parameters of the user, even if the user is unable to press the panic button.
• the alarm signal may be given to the user, additionally or alternatively, for example by sounding an audible alarm, more preferably from the wrist-mounted device itself.
• the device of the present invention also monitors, at least periodically or continuously, one or more physiological parameters of the user. Continuous monitoring would more easily enable the device to transmit the alarm signal if one or more physiological parameters are determined to be outside of predefined criteria, which may represent such medical information as unstable or excessive heart rate, or very high or low blood pressure.
• the wrist- mounted device features one or more sensors attached to a wristband or other fastening article.
• the sensor(s) may optionally be connected to a microprocessor, optionally by a wire but alternatively through a wireless connection.
• the microprocessor may optionally also be located within the wristband, or otherwise attached to the wristband.
• the sensor(s) may optionally support automatic collection of the measurement of the at least one physiological parameter, while the microprocessor is able to execute one or more instructions for extracting medical information about the user from such measurement(s).
• the microprocessor more preferably operates a software program to process and analyze the data which is collected, in order to compute medical information.
• the extracted information optionally also with the raw data, is then preferably transferred to the previously described gateway device.
• the gateway device may optionally relay such information to a remote server, which more preferably is able to provide such information to medical personnel, for example as part of a contact center. Therefore, continuous monitoring of the medical information and/or physiological parameters of the user may optionally and more preferably be made, enabling better medical care for the user.
• a device for measuring at least one physiological parameter of a subject comprising: (a) a fastening article for being fastened to a wrist of the user; (b) at least one sensor for measuring at least one physiological function of the user, the sensor may be in contact with at least a portion of the wrist and the sensor being attached to the fastening article; and (c) a processor for receiving a signal from the sensor and for converting at least one measurement to form the at least one physiological parameter.
• the data may be stored on a non-volatile memory for being downloaded later by the user or by an operator.
• a system for measuring at least one physiological parameter of a subject comprising: (a) a device for measuring the at least one physiological parameter, comprising: (i) a fastening article for being fastened to a wrist of the user; (ii) a sensor for measuring at least one physiological parameter of the user, the sensor being in contact with at least a portion of the wrist and the sensor being attached to the fastening article; (iii) a communication unit for at least transmitting data; and (b) a gateway device for receiving the transmitted data for being monitored.
• a method for monitoring a physiological parameter of a user comprising: providing a device for monitoring the physiological parameter, the device being attached to at least a portion of the user at a pulse point of the user; monitoring the physiological parameter through the pulse point; and if a level of the physiological parameter of the user is outside of an expected range, transmitting an alarm.
• a device for measuring at least one physiological parameter of a subject comprising: (a) a fastening article for being fastened to a wrist of the user; (b) a piezoceramic sensor for measuring at least one physiological parameter of the user at a pulse point of the wrist and the sensor being attached to the fastening article; and (c) a processor for receiving a signal from the sensor and for converting the at least one measurement to form medical information.
• microprocessor includes, but is not limited to, general- purpose microprocessor, a DSP, a micro-controller or a special ASIC designed for that purpose.
• the method of the present invention could be described as a process for being performed by a data processor, and as such could optionally be implemented as software, hardware or firmware, or a combination thereof.
• a software application could be written in substantially any suitable programming language, which could easily be selected by one of ordinary skill in the art.
• the programming language chosen should be compatible with the computational device (computer hardware and operating system) according to which the software application is executed. Examples of suitable programming languages include, but are not limited to, Visual Basic, Assembler, Visual C, standard C, C++ and Java. BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic block diagram of a system according to an exemplary embodiment of the present invention
• FIG 2 shows an exploded view of an exemplary device
• FIG 3 describes a general state flow diagram
• FIG 4 describes a bi-directional message format between the device and the gateway;
• FIG 5 shows an exploded view of an exemplary device with ECG option;
• FIG. 6 is an exploded view of an exemplary device, which illustrates the installation of a SpO2 sensor.
• the present invention is of a wrist-mounted device for measuring at least one physiological parameter of the user.
• the present invention enables such a measurement to preferably be transformed into medical information about the user.
• Such information may then optionally be sent to medical personnel (for example at a contact monitoring center) and/or to a remote server, through a gateway device.
• the gateway device preferably communicates with the wrist-mounted device of the present invention through a wireless communication channel.
• Examples of medical information which may be extracted from the measured physiological parameter or parameters include, but are not limited to: heart rate; regularity in heart rate; breathing rate; arrhythmia of the heart (if any), as well as the general rhythm and functioning of the heart; blood pressure; presence of abnormal body movements such as convulsions for example; body position; general body movements; body temperature; presence and level of sweat; oxygen saturation in the blood; and glucose levels in the blood.
• the present invention also features an alarm signal for being transmitted through the gateway device in order to indicate an emergency or otherwise dangerous situation for the user.
• the alarm signal may optionally be transmitted according to a manual action of the user, such as pressing a
• panic button for example.
• the alarm signal is transmitted automatically upon measurement of the one or more physiological parameters of the user, preferably even if the user is unable to press the panic button.
• the alarm signal may be given to the user, additionally or alternatively, for example by sounding an audible alarm, more preferably from the wrist-mounted device itself.
• An exemplary embodiment of the present invention may measure also parameters that may affect the subject's physical condition, including but not limited to ambient temperature and humidity, lighting conditions, smoke and/or other material in the air, distance from home etc.
• the gateway Upon receipt of the manually/automatically activated alarm signal, the gateway would preferably initiate immediately a call to a human operated call center. Then the device would preferably automatically collect one or more current physiological measurements of the user. These measurements may be sent directly to the gateway, or alternatively may be analyzed in order to compute the medical parameters of the user before sending the results to the gateway. The gateway may also analyze the measurement, for example when the measurements are transferred directly to the gateway. The human operator, at the medical center, would then preferably be able to assess the user's medical condition from the received information. It should be noted that the terms "medical center” and "call center” are used interchangeably herein.
• the device of the present invention may also monitor, at least periodically but more preferably continuously, the value or condition of one or more physiological parameters of the user. Continuous monitoring would more easily enable the device to transmit the alarm signal if measurements of one or more physiological parameters are collected and analyzed by the microprocessor to form medical information, which then could be determined to be above predefined criteria, such as unstable heart rate, or very high or low blood pressure, for example.
• the wrist-mounted device features one or more sensors attached to a wristband or other fastening article.
• the sensor(s) are preferably connected to a microprocessor, optionally by a wire but alternatively through a wireless connection.
• the microprocessor may optionally also be located within the wristband, or otherwise attached to the wristband.
• the sensor(s) preferably support automatic collection of at least one physiological measurement; more preferably, the microprocessor is able to execute one or more instructions for extracting clinically useful information about the user from such measurement(s).
• the microprocessor more preferably operates a software program to process and analyze the data which is collected, in order to compute medical information.
• the extracted medical information optionally also with the raw data, is then preferably transferred to the previously described gateway device.
• the gateway device then preferably relays such information to a remote server, which more preferably is able to provide such information to medical personnel, for example as part of a contact center. Therefore, continuous monitoring of the physiological parameters of the user may optionally and more preferably be made, enabling better medical care for the user.
• the disclosure does not describe a device which has the functionality according to the present invention, but the disclosed method is generally useful for determining blood pressure from an external measurement of pressure from the pulse through the skin of the subject.
• the principles and operation of a device and method according to the present invention may be better understood with reference to the drawings and the accompanying description.
• FIG. 1 is a schematic block diagram of a system according to the present invention.
• a system 100 features a wearable device 101 to be worn by a user, preferably as a wrist-mounted device, for example by being attached with a wristband or other fastening article to the wrist of the user.
• Device 101 features at least one physiological sensor 102 for measuring at least one physiological parameter of the user.
• the function of an exemplary sensor 102 is described in greater detail below.
• the device 101 may optionally feature a vibration sensor 123, preferably a piezoceramic sensor, which is not in direct contact with the skin of the user.
• Sensor preferably a piezoceramic sensor
• sensor 123 measures the movement of the wrist.
• the output of sensor 123 can be used by a processing unit 103 to capture the movement of the wrist and to recover some noise received by sensor 102, which is caused by such movement.
• Device 101 may include additional ambient sensors 130 or additional measuring routines for measuring other parameters.
• device 101 may optionally have a humidity sensor for measuring the ambient humidity.
• An exemplary humidity sensor may be the Humidity Gauge manufactured by Honeywell.
• processing unit 103 may optionally include internal RAM and nonvolatile program memory (not shown). Also processing unit 103 may optionally include an extended data memory 105 located externally to processing unit 103. Processing unit 103 preferably executes at least one instruction for processing the data obtained by sensor 102.
• Extended memory component 105 is preferably an electrically erasable nonvolatile external memory component. Examples of such a memory component include but are not limited to FM24CL64-S (Ramtron, USA), with 64Kbit of fast access read/write serial memory for storing temporary data related to the sampled physiological parameter.
• Device 101 may optionally feature a real time clock 117 in order to provide an accurate time and date for each measurement, as device 101 can optionally store a few measurements before transmitting such data and/or information to a gateway device 110, as described in greater detail below. Stored data and/or information may also optionally be used for such applications as reminding the subject to take medication, perform a prescheduled measurement, and so forth.
• An A/D converter 109 with multiple inputs is also optionally and preferably present if sensor 102 is an analog sensor, in order to convert the analog signal to a digital signal.
• Device 101 preferably features an internal communication unit 104, for at least unidirectional, but more preferably bi-directional, communication with gateway device 110.
• Gateway device 110 may feature a communication unit 107.
• Communication unit 104 may optionally communicate with communication unit 107 through a wire or alternatively through a wireless communication link 121.
• gateway device 110 is located relatively close to the user and hence to device 101, for example by being located at the user's premises.
• gateway device 110 could optionally be installed in the home of the user.
• Gateway device 110 also optionally and preferably features a controller 108 for controlling functions of gateway device 110, such as communication with device 101 for example.
• Gateway device 110 preferably communicates with a remote server 114 through a data link 120, which could optionally be a direct dial-up modem connection with DTMF coding or TCP/IP using regular LAN or dial-up modem connection to an ISP, for example.
• data link 120 may optionally be a wired or wireless link, for example through a cellular telephone and/or land-based telephone system, or a combination thereof.
• Remote server 114 may be controlled by a system administrator 112, which may be a person (for manual operation) or a software program (for automatic operation), or a combination thereof. Remote server 114 also preferably features a database 113 for storing data received from gateway device 110.
• Device 101 may also feature a manually operated panic alarm button 116 to be manually activated by the user, for example if the user is in distress.
• Device 101 may also optionally feature a LED display 118, for example in order to indicate of alert activation or a low battery level.
• Physiological sensor 102 is preferably part of a sensor assembly. Without the intention to limit in any way, the following discussion centers on such a physiological sensor 102, which contains a piezoceramic transducer for generating an electrical signal, having amplitude corresponding to the magnitude of applied pressure. Therefore, if at least a portion of the transducer is located adjacent to, and in physical contact with, an area of the wrist where blood pressure pulses may be detected, the transducer generates electrical pressure pulses corresponding to the detected blood pressure pulses. Each of the electrical pressure pulses preferably defines a maximum voltage over a systolic interval and a minimum voltage over a diastolic interval.
• piezoceramic sensor is used as a pressure transducer according to a preferred embodiment of the invention, it should be appreciated that other transducers known to the art may be employed without departing from the spirit of the invention. Examples of such sensors include but are not limited to piezoelectric transducers, resistive strain gauges and pressure sensor made of fiber-optic techniques.
• the piezoceramic transducer is desirable for the present invention since the transducer measures the direct effect of the pressure exerted within the radial artery, while other transducers, for example resistive strain gauges, measure secondary effects such as the strain forces that are applied at the surface of the skin due to the expansion of the radial artery. Piezoceramic transducers are also cheaper than piezoelectric transducers but still produce a high-quality signal.
• the analog output of sensor 102 is first preferably treated by an analog front-end 119, which more preferably contains analog selector to select the appropriate sensor followed by an analog filter (not shown).
• this analog filter preferably has a cutoff of about 20Hz, a linear phase response, a flat amplitude response up to 10Hz and an amplification of about 3 for acquiring the full spectrum of a typical blood pressure pulse.
• the filtered signal then enters A/D converter 109.
• Processing unit 103 preferably controls the operation of A/D converter 109.
• A/D converter 109 starts sampling the filtered analog signal of sensor 102 from analog front-end 119, preferably at a rate controlled by processing unit 103. This rate is optionally and more preferably 80 samples per second as to over sample the data by a factor of 4 to maintain a good quality sampled signal.
• A/D converter 109 preferably transfers the analog data into a digital coded word, optionally at resolution of 10 bits per sample, for example.
• An exemplary measuring period may be about 30 seconds in which data is gathered at processing unit 103.
• Processing unit 103 preferably operates a software program for examining the validity of the sampled data, in order to determine whether the data contains some indications of legitimate physiological data (such as of a blood pressure pulse of an artery) or alternatively whether the data contains only noise or poor readings.
• A/D converter 109 preferably starts sampling the signal again in order to obtain data for measurement. This process preferably continues until the software determines that sufficient valid data has been collected or after a few successive rejections (usually after 3 times).
• the software program preferably performs an algorithm for calculating some medical parameters from the sampled data, such as the calculation of systolic and diastolic blood pressure using a method as disclosed in US Patent No. 4,418,700, which is hereby incorporated by reference as if fully set forth herein.
• the calculated parameters are then preferably stored in memory 105.
• the data stored in memory 105 is preferably transmitted to gateway device 110 periodically, or alternatively or additionally after manual operation of panic button 116.
• the calculated parameters are also optionally and preferably displayed on a local LCD display 124, so the user can view the last medical results locally.
• data for all medical parameters that are sent to remote server 114 are sent according to a security protocol for maintaining the privacy of the user.
• the software program preferably performs another algorithm for generating an alert if the medical parameters have values beyond or otherwise outside of the normal expected values.
• device 101 preferably features a two-way communication link as shown for link 121, for establishing more reliable communication with gateway device 110.
• Examples of communication units 104, 107 include but are not limited to an RF401 UHF transceiver (Nordic), which operates in the universal ISM band (433.92Mhz), an infrared transceiver, and a "Bluetooth" protocol enabled-transceiver operating bi- directionally in the 2.4GHz band.
• Device 101 preferably has its own unique identifier, stored in non-volatile data storage, more preferably in memory 105.
• gateway device 110 Each time device 101 sends a wireless message to gateway device 110, device 101 also preferably sends the unique identifier to gateway device 110, although optionally the identifier may be sent only periodically, for example once per day. Gateway device 110 also preferably sends a message to a particular device 101 by including the device identifier in the message, thereby specifying which such device should receive the message.
• device 101 preferably has its own real time clock 117.
• real time clock 117 is preferably used to provide a time tag for each set of results. This time tag is very important for continuous monitoring of the user for long periods of time. By examining the data recorded over of the user for long period of time, a change or alteration in the health condition of the user may be detected.
• Real time clock 117 may optionally be implemented by separate hardware such as RTC8564 (EPSON, US) for example, or alternatively by a software program for operation by processing unit 103.
• the output of real time clock 117 may be displayed on one of displays 118 or 124 for displaying the date and time.
• Device 101 may also optionally feature a watchdog 115, which monitors the function of device 101. If the end of a watchdog time period is reached, device 101 is assumed to have a fault in its operation, and a master reset is preferably initiated automatically.
• Device 101 also preferably features a power source such as a battery 106, which powers device 101.
• a power source such as a battery 106
• suitable batteries include but are not limited to the silver oxide coin battery model 386 (Panasonic, Japan) having 150mAh in capacity with a pulse burst of 75mA for a short period of time (about 5 sec for each pulse).
• Battery 106 optionally and preferably contains enough energy to power the device for more than one year of operation without being replaced.
• Figure 2 shows an exploded view of an exemplary device according to Figure 1.
• the device features sensor 102, shown with the preferred but exemplary implementation of a piezoceramic sensor as previously described.
• the device also optionally and preferably features battery 106, and a push button 316 (for optional implementation of the panic button of the device of Figure 1).
• Battery 106 may optionally be replaced with a plurality of smaller batteries (not shown).
• the device preferably features a processor 314 (which may optionally be similar or identical to the processing unit of the device of Figure 1.
• the components of the device are preferably held by a case 306.
• sensor 102 is in physical contact with an anvil 300 via a protrusion 302.
• Protrusion 302 is welded, optionally by a laser, on one side to the center of anvil 300 and on the other side to the center of sensor 102.
• Anvil 300 is pressed against the skin of the wrist of the subject (not shown), more preferably at a pulse point.
• Anvil 300 may optionally be a rigid disk made for example of polymer, or optionally a metal, such as gold plated copper or stainless steel, for example. Of course, any other type of suitable material, or combinations of materials, may also optionally be used.
• Anvil 300 therefore collects and integrates the pressure waves, which are associated with each pulse of the blood of the subject, from the area below anvil 300.
• This pressure is preferably transferred from the center of anvil 300 to the center of sensor 102 via protrusion 302.
• Sensor 102 then emits voltage to form a signal, preferably according to a linear output.
• the present invention may measure the blood pressure pulse without blocking the blood flow in the artery.
• This signal is then received by processor 314, which preferably extracts medical information from the measurement of the physiological parameter.
• Processor 314 optionally and preferably features a crystal oscillator 312, for stabilizing the internal clock of processor 314.
• Processor 314 may communicate with the real time clock of the device (not shown). Also not shown are the extended memory, transceiver (communication unit), A/D converter and analog front end of the device.
• Processor 314, oscillator 312 and push button 316 are all preferably mounted on a PCB board 308.
• PCB board 308 is then preferably sandwiched between battery
• Device cover 304 preferably features a soft portion, which may be rubber for example, for enabling the user to locate and depress the panic push button through push button 316.
• An o-ring 310 is preferably used for waterproof sealing between cover 304 and the case 306 of the device.
• Anvil 300 then is held between sensor 102 and the skin of the user (not shown), for example.
• sensor 102 and anvil 300 could optionally be located in the wristband for affixing the device to the wrist of the user (not shown).
• Figure 3 is a state flow chart of the operation of the device.
• the software preferably makes some initializations using default values.
• the software preferably triggers a watchdog function shown as a "Watchdog” process, and then enters a sleeping mode for saving battery life, shown as a "Sleep" process.
• the device is assumed to have a fault in its operation, and a master reset is preferably initiated automatically.
• the device is preferably "woken up” according to one of three triggers. First, the device is preferably woken up when the user presses a panic button manually. This process is shown by the "Alarm” state. The device then preferably immediately starts a transmission to the gateway device, containing a distress indication and the device identifier. Then the device enters a receiving mode for a few seconds, waiting for acknowledge (ACK) from the gateway device. This process is shown as a "TX RX" state.
• a repeated message is initiated. Additional transmissions are initiated, if necessary. However, if after a predefined number of repeated times an acknowledge message is not received, an error message is stored within a log and no more tries are made. More preferably an indication LED starts blinking for a few seconds, optionally with an audible alarm. Then, the process returns to the "Sleep" state.
• the process After receiving acknowledge, the process turns to "Supervise” state, where the device collects data from its sensors, preferably calculates some medical information concerning the current physiological status of the user. Then, the device turns into "Tx/Rx” state, where the device transmits a message containing the identifier, and the calculated medical parameters. And if the received ACK contains no commands the device returns to the "Sleep” state, otherwise the device does the command and sends an ACK to the gateway. The gateway returns an ACK with another command to continue or without a command to terminate this process. After doing the last command the device returns to the "Sleep" state.
• an external real time clock signals the device to execute an automatic check. Then, the process enters "Supervise” state as discussed in the above paragraph, only that this time for saving battery life, the device initiate the "Tx Rx” process only once for a few successive times sending all the accumulated data in one transmission. Then, the device preferably enters a "Sleep” state unless the measured parameters exceed a predefined threshold at least once, but preferably for a few successive measurements. In this case, the device initiates an automatic alarm entering the "Alarm” state, if the device has permission to do so, as previously described.
• the device When a timer for a supervise process has been running or after an alarm, the device preferably exercises an automatic check as described above, and after that initiates a transmission to the gateway device including all the data collected after the last transmission. Then the device preferably waits for acknowledge, preferably repeating the transmission again if not receiving such an acknowledge message. In the acknowledge message, a command for the device can be stored. In such a case the device performs this command and then the device sends an acknowledge message to the gateway device. This process may optionally continue until an acknowledge message without a command is received, after which the device preferably returns to sleep mode.
• the device exit "Sleep” mode if of technical reasons a technician wants to change the operation software, the device enters "Boot Loader” state where a new software is loaded “on the fly” without a need to disconnect the batteries.
• Other exemplary embodiment may use additional routines and modes, such as a mode that verifies whether the user is in the user's premises for example. This mode is optionally initiated every few minutes and transmit acknowledge to the gateway. The gateway waits for those signals and if in a certain window of time, for example 30 minutes, an acknowledgment has not been received, the gateway calls the medical center and reports that the user is missing.
• Figure 4 describes an exemplary message format for exchanging messages between the device and the gateway device. Every message preferably starts with a preamble STX byte (hex 7E), followed by a byte which contains the number of bytes in the current message, and three bytes of address, followed by a command byte and its corresponding data bytes. This is followed by two bytes of CRC and an ETX byte (hex 7B).
• STX byte hex 7E
• a byte which contains the number of bytes in the current message and three bytes of address, followed by a command byte and its corresponding data bytes. This is followed by two bytes of CRC and an ETX byte (hex 7B).
• the message is a variable length message with strong error detection and correction method for enhanced communication reliability.
• Each message optionally and preferably contains a low battery indication, if necessary.
• a repeated message is preferably transmitted for a predefined number of times, such as 20 times for example, after which the device preferably enters a sleeping mode if no answer is received.
• an acknowledge message is preferably returned by the gateway device and vise versa.
• This message may also contain a command for the device encoded in the CMD byte within the message.
• Commands could optionally include, but are not limited to, one or more of the following:
• the device may optionally contain a Battery OK/Battery Low indication for the battery situation. This signal preferably appears three months before the battery finishes, enough time to ask the user to replace the battery.
• the device preferably sends also all the medical data stored in its memory with that message.
• the device preferably returns an acknowledge message with a 3 bit message serial number to the gateway device, in order to fulfill a full handshake between the two. If the gateway device does not receive acknowledge from the device within a few seconds, the gateway device preferably sends its transmission message again with the same serial number. The message may even be repeated a few times, each time waiting for acknowledge. If acknowledge is not received, a logbook is updated with an error message, and more preferably an indication LED is turned on for error indication.
• Figure 5 shows an exploded view of a device 500 according to exemplary embodiments of the present invention.
• device 500 may optionally measure other activities of the body including but not limited to ECG, tonus activity, temperature and the SpO2 (oxygen saturation in the blood) value in the blood of the user, for example.
• Device 500 in Figure 5 may be similar to an expanded wristwatch in shape, where bottom anvil 510 is the section which lies flat against the wrist. This forms the base of device 500 whose center is lower case 550. All other components are built onto lower case 550, culminating at the top with face-plate 557, upon which are mounted a number of additional components including sensors.
• Sensor 540 is optionally and preferably attached to lower case 550 of device
• Each arc 530 and 531 preferably has a vertical portion and a horizontal portion.
• the horizontal portion is preferably placed between sensor
• the vertical portions of arcs 530 and 531 are preferably affixed into an appropriate slot in lower case 550 of device 500.
• Lower case 550 may optionally have one or more electrical boards 554 and 556 that comprise the electrical circuitry, which is disclosed in conjunction to in Fig.
• a vibration sensor (an accelerometer) may optionally be connected to one of boards 554 or 556.
• Device 500 is preferably covered by a top cover 557, that optionally and more preferably has two electrodes 560 and 561, SpO2 sensor 566 and optionally a single push panic button 558 that is preferably pressed by the user upon commencement of a measurement period, or if the wearer presses panic button 558 .
• panic button 558 Pressing the flexible portion 563 within top cover 557 causes panic button 558 to be pushed, and preferably initiates an automatic process within device 500.
• gateway 110 (see Figure 1) as to whether the user is already in a conference with the call center. If device 500 is found to be in a conference with the center, then device 500 may optionally start a measuring thread.
• device 500 preferably initiates the panic thread.
• the panic thread starts by establishing a connection with the call center via gateway 110 ( Figure 1).
• device 500 preferably initiates the measuring thread and transmits a set of results to gateway 110.
• Gateway 110 optionally and preferably stores those results and upon establishing the connection with the call center, gateway 110 transmits the results to the call center.
• the panic thread starts upon pressing activation push button 558 for long period of time (e.g. above few seconds, 5, 6 etc.), thereby initiating a call to medical center.
• pressing activation push button 558 for a short period of time for example shorter than a second, starts an automatic measuring thread.
• the measuring thread optionally and preferably starts by scanning the available sensors 102 for a first sensor 102 that produces a valid signal (see Figure 1).
• a valid signal is defined as a signal that meets predefined requirements including but not limited to, one or more of the signal amplitude being within a certain range, frequency being within a certain range and so forth.
• the valid signal is processed by the appropriate analog front-end 119 and processing unit 103 (see Figure 1).
• the medical information is preferably transferred to gateway 110, after which device 500 enters into Sleeping mode.
• device 500 may inform the user that a measuring process is initiated. Upon terminating the measurements, the results are sent to the remote server 114 (FIG. 1) via gateway 110.
• Two bands 574 and 576 are optionally connected to lower case 550 and are preferably used to fasten the device to the wrist of the user.
• the long band 576 may optionally have a flexible conductive wire (not shown) which functions as an antenna, and which is connected to the transmitter of the communication unit 104, inside device 500, while the far end of long band 576 may comprise temperature sensor 580 connected by pair of wires (not shown) to the internal circuitry, both of which are described in greater detail below.
• Device 500 may optionally be used to measure blood pressure pulse using piezoceramic transducer 540 to generate an electrical signal.
• the amplitude of the electrical signal from piezoceramic transducer 540 corresponds to the magnitude of pressure applied thereto.
• Piezoceramic transducer 540 may be a common piezoceramic buzzer, made of PZT material, and may optionally and additionally be used as a common buzzer, which receives the alarm signals from processing unit 103 (see figure 1) and produces the alarm sound.
• the alarm sound is generated by forcing voltage over piezoceramic transducer 540, which then buzzes for the duration of the alarm signal.
• the exemplary sensor for sensing blood pressure pulse preferably comprises three elements: anvil 510, protrusion 520 and piezoceramic transducer 540.
• Protrusion 520 is preferably welded, optionally by a laser, on one side to the center of anvil 510 and on the other side to the center of piezoceramic transducer 540.
• Anvil 510 is pressed against the skin of the wrist of the subject (not shown), more preferably at a pulse point.
• Anvil 510 may optionally be a rigid disk or other structure, made for example of polymer, or optionally a metal, such as gold plated copper or stainless steel, for example. Of course, any other type of suitable material, or combinations of materials, may also optionally be used.
• Anvil 510 therefore collects and integrates the pressure waves, which are associated with each pulse of the blood of the subject, from the area of skin below anvil 510. This pressure is preferably transferred from the center of anvil 510 to the center of piezoceramic transducer 540 via protrusion 520. Piezoceramic transducer 540 then emits voltage to form a signal, preferably according to a linear output. Protrusion 520 preferably is able to focus the input pressure, therefore increasing the output signal of piezoceramic transducer 540.
• transducer 540 generates electrical pulses corresponding to the detected blood pressure pulses.
• Each of the electrical pressure pulses preferably defines a maximum voltage over a systolic interval and a minimum voltage over a diastolic interval.
• the electrical signal from transducer 540 is preferably amplified by analog front end 119 and transferred via A/D converter 109 to processing unit 103 (see figure 1).
• Processing unit 103 processes the digital signal and may deliver a plurality of medical information based on the measurement of blood pressure pulse including but not limited to heart rate, regularity in heart rate, breathing rate, arrhythmia of the heart (if any), general rhythm and functioning of the heart as well as the blood pressure amongst others.
• Device 500 optionally and preferably features two conductive areas 560 and
• anvil 510 preferably has a conductive area 515, which preferably sits adjacent to the skin of the user.
• conductive area 515 may cover the whole of anvil 510, a non-limiting example of which is constructing anvil 510 of metal.
• Each of conductive areas 560, 561 and 515 is preferably electronically connected, as one of the sensors 102, to an analog front-end 119 ( Figure 1).
• Conductive areas 560, 561 and 515 may optionally and preferably be made of metal, polymer coated with a conductive layer or any other conductive material including but not limited to gold plated copper. Conductive areas 560, 561 and 515 form three electrodes that may be used for measuring electrochemical activity of the user's body (e.g. ECG, or tonus activity). This activity measures the effects of electricity on chemical and biological activities in the body, and is referred to hereinafter as electrochemical activity.
• ECG electrochemical activity
• the user has to touch, simultaneously, the two conductive areas 560 and 561 with the user's second hand, for example with two fingers, to form three measuring points including the skin portion, on the first hand, that is adjacent to conductive area 515.
• the three electronic signals from conductive areas 560, 561 and 515, are transferred to analog front-end 119 ( Figure 1).
• Analog front-end 119 extracts the ECG analog signal from the three signals by using the signal of one electrode as a reference and amplifying the differential voltage between the other two electrodes.
• the ECG analog signal is then transferred to A/D converter 109 and from there the digital ECG signal is transferred to processing unit 103 ( Figure 1).
• Analyzing the analog signal to extract the ECG signal may be done by electrical circuits that are known in the art. Additional medical information may be determined from the ECG signal. For example, information about breathing rate may be processed based on methods that are described in the prior art.
• An exemplary method is disclosed in the following article: "Derivation of Respiration Signals from Multi lead ECGs". By George B. Moody, Roger G. Mark, Andrea Zoccola and Sara Mantero. This article originally appeared in Computers in Cardiology 1985, vol. 12 pp. 113-116 (Washington, DC: IEEE Computer Society Press), which is hereby incorporated by reference as if fully set forth herein.
• PWTT Pulse Wave Transit Time
• A/D converter 109 may be integrated into processing unit 103.
• Processing unit 103 processes the ECG signal and generates medical information such as, but not limited to, heart rate, regularity in heart rate, breathing rate, arrhythmia of the heart (if any), as well as the general rhythm and functioning of the heart for example.
• the medical information is then transferred to the call center via gateway 110 ( Figure 1).
• Device 500 may optionally be used for measuring the oxygen saturation in the blood (SpO2) by using SpO2 sensor 566.
• Sensor 566 optionally and preferably has two light sources, optionally by two LEDs (light Emitting Diode) and a photoelectric detector for example. One of the LEDs emits in the infrared band and the other emits in the red band.
• FIG. 6 is a system diagram of an exemplary method of placement of SpO2 sensor 566 in faceplate 557 (of device 600).
• the two LEDs and the photoelectric detector (not shown here) of SpO2 sensor 566 are optionally installed over platform 568 which is supported by flexible support 630.
• Support 630 may optionally be any material which can absorb and exert pressure, including but not limited to a spring, piece of rubber, a sponge, flexible wing and so forth.
• Support 630 is locked in a niche 615 in faceplate 557.
• the edge of niche 615 is optionally and preferably surrounded by material 620, which is more preferably flexible and opaque.
• Material 620 may optionally be any flexible opaque substance including but not limited to rubber, sponge, flexible wings and so forth.
• Processing unit 103 instructs the current drivers in analog front-end 119 ( Figure 1), which is associated with sensor 566, to force current through the LEDs alternately in sensor 566.
• the reflected light from the finger is received by the photo detector, which converts the photons into electronic signal.
• the electronic signal is fed, as one of sensors 102, to analog front end 119.
• Analog front-end 119 processes the analog signal and transfers the processed analog signal to A/D converter 109 ( Figure 1).
• the digital signal is transferred to processing unit 103 ( Figure 1), which processes the digital signal and generates the SpO2 figure. This information is then transferred to the call center via gateway 110 ( Figure 1).
• the signal that is collected from the SpO2 sensor may also optionally be used for producing other heart related information.
• processing the signal that reflects the intensity of the reflected IR light may produce information such as heart rate, PWTT, irregularity of heart rate etc.
• device 500 may optionally have a temperature sensor 580 which is installed at the far end of long band 576.
• Temperature sensor 580 preferably includes a thermistor located in a metal cup and is connected via two flexible conductive wires (not shown) that run along the band into the lower case of device 500. The two wires are connected as one of sensors 102 ( Figure 1) to analog front-end 119.
• Analog front-end 119 converts the changes in the resistance of the thermistor into an electrical signal with magnitude proportional to the temperature of the user.
• the analog signal is converted into digital signal by A/D Converter 109 and transferred to processing unit 103.
• Processing unit 103 converts the digital signal into temperature information and sends this temperature information via gateway 110 to the call center.
• Temperature sensor 580 is preferably installed in a protected solid housing.
• the solid housing may optionally be made of polymer, metal, gum or any material able to provide the necessary properties.
• To start measuring the temperature of the user device 500 is optionally removed from the user's hand and sensor 580 is preferably pressed against the user's armpit (not shown).
• each of the verbs, "comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

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