WO2018029560A1 - System and method for the monitoring of vital parameters. - Google Patents

System and method for the monitoring of vital parameters. Download PDF

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Publication number
WO2018029560A1
WO2018029560A1 PCT/IB2017/054570 IB2017054570W WO2018029560A1 WO 2018029560 A1 WO2018029560 A1 WO 2018029560A1 IB 2017054570 W IB2017054570 W IB 2017054570W WO 2018029560 A1 WO2018029560 A1 WO 2018029560A1
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WO
WIPO (PCT)
Prior art keywords
person
alarm signal
vital parameters
mobile device
heart rate
Prior art date
Application number
PCT/IB2017/054570
Other languages
French (fr)
Inventor
Sabrina Menghini
Original Assignee
Inmm S.R.L.
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 Inmm S.R.L. filed Critical Inmm S.R.L.
Publication of WO2018029560A1 publication Critical patent/WO2018029560A1/en

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/60—ICT specially adapted for the handling or processing of medical references relating to pathologies

Definitions

  • This invention relates to a system and a method for the biomedical monitoring of the vital parameters of a person (or monitored subject).
  • the system is applicable in the continuous monitoring of vital parameters in agreement with medical reference staff, based on the different categories of subjects to be monitored, the activities carried out and the contexts which the system can be used in; more specifically, the system can be used to control patients with intellectual and relational disabilities (such as autism) or other disorders, people who practise sports (mountaineering, canoeing, swimming, etc), categories of workers at high risk for accidents and rescue workers such as the fire service, speleologists or military personnel.
  • intellectual and relational disabilities such as autism
  • people who practise sports mountaineering, canoeing, swimming, etc
  • rescue workers such as the fire service, speleologists or military personnel.
  • WO2014/1 16968A1 discloses a system and a method providing support for operators in dealing with patients in emergency situations.
  • Patent document WO2010/132617A2 discloses a system for controlling and monitoring the vital parameters of a subject via a biomedical device; more specifically, the system comprises a biomedical device in contact with the subject and configured to detect vital parameters, a mobile device used to impart to the biomedical device a procedure for monitoring the vital parameters, collecting the vital parameters detected and transmitting the vital parameters, and a server for collecting the vital parameters received from the mobile device.
  • the biomedical device detects the vital parameters only after receiving specific instructions from the mobile device; this is evidently a drawback in that it always requires an external command and may be subject to malfunctioning of the mobile device, especially disadvantageous in cases where the vital parameters of a subject need to be monitored continuously. Further, no provision is made for sending an alarm signal to the subject if the vital parameters exceed predetermined threshold values, which means the subject has no way of knowing their health conditions in real time. Moreover, the system does not associate the vital parameters detected with information regarding position, or geographical location, useful for rescuing the subject in the event of a distress situation.
  • Patent document WO201 1/034881 A1 discloses a patient monitoring system including sensorized equipment (with a plurality of electrodes of a digital ECG system), which is worn by the patient, and a processing system connected by a cable to the sensorized equipment.
  • sensorized equipment with a plurality of electrodes of a digital ECG system
  • processing system connected by a cable to the sensorized equipment.
  • the aim of this invention is to provide a system and a method for the biomedical monitoring of the vital parameters of at least one subject to overcome the above mentioned disadvantages of the prior art.
  • the aim of this invention is to provide a system and a method for the biomedical monitoring of parameters (preferably vital parameters) capable of preventing danger situations or allowing prompt action to be taken should such situations arise.
  • Another aim of this disclosure is to provide a system and a method for the biomedical monitoring of vital parameters capable of monitoring and controlling the physiological data of two or more subjects simultaneously, both in real time and on a historical basis using stored data.
  • a further aim of this disclosure is to propose an integrated hardware device worn by the subject to be monitored to implement the system.
  • a yet further aim of this disclosure is to propose an electronic processor program - for example, an application for smart phones - which allows implementing the above mentioned system using the hardware of one of the smart phones.
  • This method for the biomedical monitoring of vital parameters of a person comprises the following steps:
  • the person's monitoring data including signals representing the person's heart rate and blood oxygen saturation;
  • processing includes comparing the vital parameters with predetermined reference values stored in a data bank (having storage capacity);
  • the alarm may be displayed;
  • heart rate and blood oxygen saturation shall not in any way be construed as a limitation to these parameters, in the sense that other parameters can be detected and monitored, in particular vital parameters, but more in general, biomedical parameters, or parameters relating to the state of the subject's health.
  • the step of detecting is carried out by a sensor worn by the person.
  • the step of deriving is carried out by an electronic element connected (by a cable and by a wireless communication system) to the sensor (which preferably has processing and storage capabilities).
  • the monitoring data (comprising at least the person's vital parameters) are communicated to a remote server.
  • the monitoring data are communicated by a mobile device.
  • the mobile device may be a mobile phone or a piece of dedicated hardware.
  • the mobile device may be separate from the electronic element and be communicating therewith (for example, through a wireless communication system).
  • the mobile device may include the electronic element which, in this case, is integrated in the same hardware.
  • the step of processing is carried out by the remote server (but might also be carried out by the mobile device).
  • the step of generating the alarm signal is carried out by the (remote) server, !n such case, an embodiment is envisaged wherein the alarm signal is received by the mobile device.
  • the step of transmitting an alert to the person is carried out by the mobile device (but might also be carried out by the electronic element (if distinct from the mobile device).
  • the step of generating the alarm signal is carried out by the server (preferably for the relatively more complex calculations) and possibly also by the mobile device (preferably for the relatively more simple calculations).
  • the alarm signal generated by the server is then transmitted to the person by the mobile device (or by the electronic element, if distinct from the mobile device).
  • Transmitting the alarm signal to the monitored person includes displaying, and/or acoustically alerting to, contents representing the alarm signal.
  • Such displaying and/or acoustic alerting may be performed by the mobile device (or possibly by the electronic element, if distinct from the mobile device).
  • data exchange between the sensor (or sensors) which derives (derive) the vital parameters of the person and the mobile device and/or the server occurs by wireless communication.
  • the data exchanged between the sensor (or sensors) which derives (derive) the vital parameters of the person and the mobile device and/or the server are uniquely correlated with the monitored person (for example, by an identification code uniquely assigned to the person).
  • Different types of alarm signals including voice signals, can be generated.
  • a first alarm signal is generated in response to heart rate and/or oxygen saturation exceeding at least a first reference value.
  • a second alarm signal is also generated in response to the heart rate and/or oxygen saturation and/or other parameters detectable by the sensors exceeding at least a second reference value, where the second reference value is greater than the first reference value (in the sense that it defines a more restrictive condition which implies the occurrence of the condition based on the first reference value but not vice versa).
  • the monitoring data also include an acceleration parameter, representing the person's movement, and/or a position parameter representing the person's position.
  • the position parameter indicates the subject's position (at any time), with the possibility of displaying (on a remote computer or on a display of the mobile device) a map representing the person's geographical location and movements, !n such case, at least one alarm signal may be generated also as a function of the acceleration parameter.
  • the mobile device includes a satellite positioning system (GPS) and an accelerometer.
  • GPS satellite positioning system
  • accelerometer an accelerometer
  • a third alarm signal is generated in response to the concurrent occurrence of a first condition, linked to the exceeding of a reference value by the heart rate and/or oxygen saturation (and/or other parameters), and a second condition, linked to the acceleration parameter and/or the position parameter.
  • a (fourth) alarm signal is generated in response to a comparison between a curve of at least one parameter selected from the vital parameters and a corresponding predetermined reference curve; in practice, this alarm signal takes into account a curve over time of one or more of the parameters monitored (for example, the vital parameters).
  • the step of transmitting the alert to the person occurs according to one or more of the following types of alert:
  • the alerts (a), (b), (c) or (d) are transmitted according to a predetermined logic.
  • transmission of the alert to the person occurs in mode (a) in response to the first alarm signal; transmission of the alert to the person occurs in mode (b) in response to the second alarm signal. Transmission of the alert to the person may occur according to different embodiments. In one embodiment, it occurs in mode (c) in response to the third alarm signal; according to another aspect, transmission of the alert to the person occurs in mode (d) in response to the fourth alarm signal.
  • a (fifth or sixth) alarm signal is generated in response to a failure to acknowledge the alert (d) produced by the fourth alarm signal, within a predetermined safety time interval.
  • This disclosure also provides a system for biomedical monitoring of vital parameters of a person.
  • the system comprises at least one sensor (that is, one or more sensors) wearable by the person and configured to detect signals representing the person's heart rate and blood oxygen saturation (other parameters detectable by other biomedical sensors are not excluded).
  • the sensor wearable by the person might have a probe connectabie to one ear, finger or temple of the person or to the person ' s chest (to name a few examples).
  • the system also comprises an electronic element connected to the sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation.
  • the system includes a mobile device comprising a memory unit, a processor and an Internet connection, communicating with the electronic element to receive the person's vital parameters and store them at least temporarily in the memory unit.
  • the mobile device may be separate from the electronic element or it may incorporate it, that is to say, integrate it in its own hardware and software.
  • the mobile device may be a piece of dedicated hardware or a mobile phone provided with suitable software.
  • the system includes a server having a data bank containing predetermined reference values at least for the vital parameters.
  • the server is configured to receive from the mobile device the person's monitoring data, including the signals representing the person's heart rate and blood oxygen saturation.
  • the server is programmed to process the monitoring data.
  • the server is programmed to compare the vital parameters derived by the electronic element with the corresponding reference values.
  • the server is programmed to generate at least one alarm signal as a function of the processing.
  • the server is programmed to transmit the at least one alarm signal as a function to the mobile device.
  • the mobile device is programmed to transmit an alert to the person as a function of the alarm signal generated.
  • the mobile device includes a display. In one embodiment, the mobile device includes a sound player. In one embodiment, the mobile device is programmed to activate a visual and/or sound and/or vocal alert (depending on the type of alert in response to receiving the at least one alarm signal from the server (preferably according to a predetermined logic, such as, for example, the logic described above).
  • This disclosure also provides an object (in a possible embodiment, a helmet) wearable by a person.
  • the object comprises a body (in the case of the helmet, a shell) structured in such a way that it can be worn.
  • the object includes at least one sensor wearable by the person (to be in contact with the person's head, fingers or chest) and configured to detect signals representing the person's heart rate and blood oxygen saturation.
  • the object comprises an electronic element connected to the at least one sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation.
  • the object includes an electronic device, fixed to the shell to constitute a mobile device, and comprising a memory unit, a processor and an Internet connection.
  • the electronic device (or mobile device) is configured to receive the person's vital parameters from the electronic element and to store them in the memory.
  • the electronic device (or mobile device) is programmed to transmit at least the vital parameters to a remote server to receive from the remote server at least one alarm signal and to generate an alert for the person as a function of the alarm signal.
  • This disclosure also provides a processor program comprising a software for performing the following steps:
  • the person's monitoring data including (amongst other possible parameters) the person's vital parameters representing the person's heart rate and blood oxygen saturation;
  • a mobile device comprising a memory unit, a processor and an Internet connection.
  • the program is, in one or more possible embodiments, configured to perform one or more other steps of the method described in this disclosure.
  • the disclosure also relates to a storage medium containing the processor program.
  • the disclosure also relates to a downloadable data flow representing the processor program.
  • the system and method for the biomedical monitoring of parameters proposed in this disclosure allow, in at least one example embodiment, generating alarm notifications ("alarm") each time the parameters detected by one or more of the sensors applied to the subject to be monitored fail outside predetermined safety ranges set for each parameter and for data aggregated therewith; the alarm notifications are viewable in real time both by the subject being monitored and by an operator at a remote station responsible for controlling the subject.
  • alarm alarm notifications
  • the system and method for the biomedical monitoring of parameters proposed in this disclosure also allow, in at least one example embodiment, generating alarm notifications as a function of each category of the vital parameters detected and of the acceleration detected, the alarm notification being differential based on a predetermined value by which at least one of the subject's threshold and acceleration values is exceeded,
  • the system comprises:
  • At least one electronic element configured to interact with the at least one wearable electronic sensor and to receive and process the vital parameters received from the at least one wearable electronic sensor and to transmit these vital parameters;
  • At least one mobile device comprising a display; the at least one mobile device being configured to interact with the at least one electronic element, having access to a memory to store the vital parameters transmitted by the at least one electronic element and a processor programmed to process and transmit the vital parameters received;
  • the data bank contains a plurality of threshold values assigned to each category of the vital parameters
  • the at least one mobile device comprises a data exchange interface configured to receive from the server an alarm notification viewable on the display in real time by the at least one subject and viewable in real time also by an operator in charge, using the browser, when at least one of the threshold values assigned to each category of vital parameters of each subject is exceeded.
  • the biomedical monitoring system allows:
  • alarm each time the values defected fall outside predetermined safety ranges set for each parameter and for data aggregated therewith;
  • the alarm being viewable on a PC or other suitable device to allow personnel in charge to monitor the activities of the subject, even from a remote station;
  • the biomedical monitoring system comprises: at least one wearable electronic sensor, at least one electronic element, at least one mobile device and a server.
  • the at least one wearable electronic sensor is adapted to detect the subject s vital parameters and to make the data available in real time through a Bluetooth connection, and is configured to communicate the information collected (being provided with a data exchange module).
  • the wearable electronic sensor worn by the subject can be applied to garments or clothing accessories (such as caps or hats, headbands and wristbands) or to personal protection devices (such as helmets, earmuffs and working gloves) to monitor the subject's vital parameters.
  • the wearable electronic sensor can be applied to any part of the subjects body with high capillary density, to detect heart rate and oxygen saturation; further, the wearable electronic sensor continuously sends the parameters detected to the mobile device through a wireless Bluetooth protocol.
  • the at least one electronic element is configured to interact with the at least one wearable electronic sensor and is adapted to receive and process the vital parameters received from the at least one wearable electronic sensor; preferably the at least one electronic element comprises an accelerometer and a satellite positioning device (GPS) to integrate the vital parameters detected, received from the at least one wearable sensor, with acceleration and geographical position (which, for convenience of description, are included without distinction under "vital parameters”.
  • the at least one electronic element is also configured to transmit the aforementioned vital parameters to the mobile device.
  • the at least one mobile device for example a tablet or a smart phone, or other electronic device of the type known as "smart device", is connectabie wireiessiy to the at least one electronic element to continuously receive from the electronic element the vital parameters detected, store them in a memory and/or communicate them.
  • the devices can cooperate with each other independently, with the aim of simultaneously monitoring one subject each, supported by the system, by a communications infrastructure and by a control and supervision station,
  • the vital parameters of a subject are stored in the memory of the mobile device or in a remotely accessible data bank (supported by an adequate communications infrastructure).
  • the data bank resides in a server which defines a control and supervision station.
  • the mobile device can send the data to the server through a 3G or WiFi connection, based on availability. If the network connection is not available, the data are temporarily stored locally in the mobile device (offline mode) and then transmitted automatically as soon as the connection becomes available again. This possibility allows monitoring sessions as much as several hours long to be recorded offline without losing any data. The actual duration of a session depends on the available space on the mobile device.
  • the displaying and transmitting application is developed in the native code of the mobile device it is installed in.
  • the device When the values of the parameters of the monitored subject exceed certain predetermined thresholds, the device allows displaying notifications for the user (on the display of the mobile device) at different severity levels. Specifically, in online mode, the notifications are sent to the server, whereas in offline mode, only the user is notified and only when certain thresholds are exceeded.
  • the server collects the vital parameters of all the monitored subjects and displays them in organized graphical interfaces accessible through a common browser both from a PC and from an Android or iOS tablet.
  • the server also comprises a data bank containing a plurality of codes for identifying the operators.
  • the mobile device receives the operator's identification code (when the operator logs in or is authenticated).
  • the server allows the following operational flows to be carried out:
  • an object of this invention is an electronic processor program comprising instructions which are executable by a mobile device and an electronic processor and which, when executed by the mobile device and the electronic processor, allow the mobile device and the electronic processor to implement the method.
  • a yet further object of this invention is an integrated hardware device to embody the system.
  • the hardware includes an embedded wearable computational device provided with suitable sensors, which collects information regarding the patient's health and the surrounding environment and which can communicate this information, after processing it if necessary.
  • the biomedical monitoring system allows monitoring and controlling the physiological data of two or more subjects simultaneously, both in real time and on a historical basis using stored data. More specifically, the system is capable of generating alarm notifications ("alarm") each time the parameters detected fail outside predetermined safety ranges set for each parameter and for data aggregated therewith; the alarm notifications are viewable in real time both by the subject being monitored and by an operator at a remote station responsible for controlling the subject.
  • alarm alarm notifications
  • the biomedical monitoring system is to all intents and purposes a self-contained system. In one embodiment, however, this monitoring system might be integrated in a system (and method) for aiding an operator in an emergency situation involving a patient, made according to one or more of the features described in Italian patent document No. 102015000047210 in the name of the present Applicant and incorporated herein by reference, with a view to increasing the amount of information and data on the tag associated with the patient.
  • This disclosure also makes available (within the scope of protection) an electronic element (connected to the at least one sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation) having one or more of the features described in this disclosure.
  • this description provides an interface element obtained by means of a software program and, if necessary, also hardware elements.
  • this interface is placed between the mobile device (or the tag) and the server (which acts as a hub) to manage communications between the mobile device and the server.
  • the interface element is configured to perform the following actions:
  • the hardware of the interface element might include communication interfaces of the different channels, which might not already be present in the mobile device (mobile phone or tablet)
  • the functions are limited to tracing and selecting the communication channels which are compatible with the hardware available in the mobile device.
  • the interface element is programmed to process the data to be transmitted in order to adapt the amount of data to the band and type of channel available, or selected.
  • the system might include the interface element. It is understood, however, that this description is also extended to the interface element as such. Brief description of the drawings
  • Figure 2 illustrates the system of Figure 1 in a first variant embodiment of it
  • Figure 3 illustrates the system of Figure 1 in a second variant embodiment of it.
  • the system is configured to allow an operator to remotely monitor the vital parameters of a subject to be controlled.
  • the system is also configured to allow the same operator, or other operators, to store, process and modify the vital parameters in such a way as to make up an archive containing historical data; this allows creating a health profile for the subject and modifying specific threshold values, thereby improving the degree of reliability with which the parameters detected at any given instant might be associated with a possible health problem suffered by the subject.
  • dynamically modifying the threshold values of each subject based on the vital parameters detected in the past avoids having to send alarm notifications and/or rescue workers and means unless it is really necessary.
  • Diagram 1 Layout of physical media of the biomedical monitoring system
  • the system of this disclosure comprises a mobile device which allows the monitored subject to receive alarm notifications, when necessary, if the vital parameters detected exceed predetermined threshold values.
  • the system of this disclosure comprises a wearable electronic sensor adapted to continuously detect the vital parameters of a subject to be monitored. Also, the wearable electronic sensor is configured to continuously transmit the vital parameters detected to an electronic element.
  • the vital parameters were selected as a function of the possibility of being defected by at least one sensor; the vital parameters detected by the wearable electronic sensor are the subject's heart rate and blood oxygen saturation.
  • the system of this disclosure comprises an electronic element connectable to the sensor and adapted to transmit to the mobile device the vital parameters detected by the wearable electronic sensor.
  • the electronic element also allows tracking the subject's position and acceleration (when necessary, indicating very sudden movements in the case of acceleration values which are too high for the subject to support).
  • the system of this disclosure also comprises a server.
  • the server records the vital parameters of the different subjects (in a data bank) and allows the parameters to be displayed. Differentia! alarm notifications based on each vital parameter are sent to the mobile device (held by the subject), indicating by how much each threshold value is exceeded, since the server is in communication with the mobile device through a remote connection. More specifically, comparing the vital parameters with corresponding predetermined threshold values allows identifying the subject's health conditions.
  • each parameter varies according to use conditions (sports persons, persons with our without disabilities, labourers, etc.) and is defined by dedicated clinical studies. However, since the parameters are strictly connected with the subject's physical state, they are modelled on the results and statistics derived from each use,
  • This disclosure also provides a processor program comprising software for performing the steps of the method (with the exception of detections which might be managed independently of the software) according to the disclosure (comprising one or more of the features or steps described).
  • the processor program is configured to perform the steps of the method when run on the mobile device of the system and on the server according to this disclosure (comprising one or more of the features or steps described).
  • diagram 2 shows the following
  • BTD - BlueTooth Device a generic sensor for capturing the vital parameters of the monitored subject and which communicates with the smart phone via Bluetooth.
  • BTC -- BlueToofhConnector a software module for capturing data from Bluetooth in continuous mode. It connects up to the mobile device which is already configured in Android and captures data systematically at fixed periodic intervals.
  • BL - Business Logic a software component which manages the operating logic of the application and which has the following functions:
  • DB - Mobile DataBase a database for temporarily storing data in the mobile device, used like a memory and to historicize data locally in cases where connectivity with the server is down. Used like a temporary memory and to historicize data locally so it can be used locally when connectivity with the server is down.
  • SYNC - Synchronizer a software component which replicates the data stored on the mobile device onto the server in real time.
  • DATA-M - Mobile DataAccess an architectural module for managing access to the DataBase on mobile app in uniform and controlled manner.
  • WEB App - Web Application an application developed to display the data aggregately and to manage the operator's functions.
  • CONF - Configuration manager a component for managing system configuration (mobile device side).
  • ALARM - Alarm Notifier a component which manages alarm notifications from the server.
  • the system allows identifying the physical state of the monitored subject, detecting situations of distress and, depending on the level of danger, generating a different type of alarm displayable by the subject on the display of the mobile device.
  • Each alarm has a different alerting policy, based, for example, on changing colours, pop-up messages or sound alerts, depending on the severity level:
  • Diagram 3 schematically represents the operating logic of a preferred embodiment of the biomedical monitoring system.
  • Diagram 3 Schematic representation of the operating logic of a preferred embodiment of the biomedical monitoring system.
  • the electronic element is integrated in the mobile device. This is different from the embodiment illustrated in Diagram 2, where the electronic element and the mobile device are not integrated in a single piece of hardware.
  • Diagram 4 schematically represents the operating logic of a preferred embodiment of the biomedical monitoring system.
  • iagram 4 Schematic representation of the operating logic of a further preferred embodiment of the biomedical monitoring system.
  • the wearable electronic sensor, the electronic element and the mobile device are integrated in a singie piece of dedicated hardware.
  • a device which is wearable by a subject for the biomedical monitoring the subject's vital parameters where the wearable electronic sensor, the electronic element and the mobile device are integrated in a single piece of dedicated hardware which can be conveniently applied to a garment or a clothing accessory or a personal protection device (for example, a safety helmet).
  • Diagram 6 schematically represents a device which is wearable by a subject for the biomedical monitoring of the subject's vital parameters.
  • This disclosure also provides a method for biomedical monitoring of vital parameters (heart rate, blood oxygen saturation, acceleration, geographical position) of at least one subject, comprising the following steps:
  • This description also provides a data storage device (for example a CD- ROM or other mass storage medium) readable by a computer and containing the above mentioned computer program.
  • a data storage device for example a CD- ROM or other mass storage medium
  • This description also provides a data flow downloadable onto a computer and representing the above mentioned computer program.
  • biometric (vital) parameters detectable by the sensors of the system and usable in the step of processing (by means of one or more diagnostic algorithms), attention is drawn to the following.
  • the system detects (preferably in real time) at least the person's heart rate and blood oxygen saturation, that is to say, the system detects the person's monitoring data, including signals representing the person's heart rate and blood oxygen saturation.
  • the diagnostic algorithms include criteria based on a comparison of the values defected for these parameters with corresponding predetermined reference values. These diagnostic algorithms are based on a combination of the parameters including at least the heart rate (Fc) and the (peripheral) blood oxygen saturation (Sp02).
  • the diagnostic algorithms use, in combination with the heart rate (Fc) and the (peripheral) blood oxygen saturation (Sp02), at least one further parameter: and that is, the intensity of pulsation.
  • the signal representing the "intensity of pulsation" parameter is derived by analysing an amplitude of a signal measured by the sensor 3; the sensor 3 might be a pulsimeter, which is a sensor designed to measure heart rate (Fc) and (peripheral) blood oxygen saturation (Sp02).
  • the electronic element 3 (the TAG wearable by the monitored person) is programmed to periodically and automatically update the result of performing the step of processing (for example, the diagnostic algorithm).
  • the wearable electronic appliance 3 (TAG) is, consequently, also programmed to automatically update an alert transmitted to the person as a function of the result of performing the step of processing.
  • the processor of the electronic element 3 uses, for the processing, the updated values of the parameters measured by the sensors fixed to the person the wearable electronic element 3 is associated with.

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Abstract

A method for biomedical monitoring of a person's vital parameters, comprises the following steps: detecting in real time the person's monitoring data, including signals representing the person's heart rate and blood oxygen saturation; deriving the person's vital parameters, representing the person's heart rate and blood oxygen saturation; processing the monitoring data, where processing includes comparing the vital parameters with predetermined reference values stored in a data bank; generating at least one alarm signal as a function of the processing; transmitting an alert message, including a voice message to the person as a function of the alarm signal generated.

Description

SYSTEM AND METHOD FOR THE MONITORING OF VITAL
Technical field
This invention relates to a system and a method for the biomedical monitoring of the vital parameters of a person (or monitored subject).
In particular, the system is applicable in the continuous monitoring of vital parameters in agreement with medical reference staff, based on the different categories of subjects to be monitored, the activities carried out and the contexts which the system can be used in; more specifically, the system can be used to control patients with intellectual and relational disabilities (such as autism) or other disorders, people who practise sports (mountaineering, canoeing, swimming, etc), categories of workers at high risk for accidents and rescue workers such as the fire service, speleologists or military personnel.
Known in the prior art are biomedical monitoring systems and methods which allow detecting the vital parameters of a subject.
WO2014/1 16968A1 discloses a system and a method providing support for operators in dealing with patients in emergency situations.
These solutions, however, do not allow effective biomedical monitoring of a person's vital parameters in order to generate alarm signals which can prevent danger situations or to take prompt action should such situations arise.
Patent document WO2010/132617A2 discloses a system for controlling and monitoring the vital parameters of a subject via a biomedical device; more specifically, the system comprises a biomedical device in contact with the subject and configured to detect vital parameters, a mobile device used to impart to the biomedical device a procedure for monitoring the vital parameters, collecting the vital parameters detected and transmitting the vital parameters, and a server for collecting the vital parameters received from the mobile device.
This system has several disadvantages, however. Firstly, the biomedical device detects the vital parameters only after receiving specific instructions from the mobile device; this is evidently a drawback in that it always requires an external command and may be subject to malfunctioning of the mobile device, especially disadvantageous in cases where the vital parameters of a subject need to be monitored continuously. Further, no provision is made for sending an alarm signal to the subject if the vital parameters exceed predetermined threshold values, which means the subject has no way of knowing their health conditions in real time. Moreover, the system does not associate the vital parameters detected with information regarding position, or geographical location, useful for rescuing the subject in the event of a distress situation.
Patent document WO201 1/034881 A1 discloses a patient monitoring system including sensorized equipment (with a plurality of electrodes of a digital ECG system), which is worn by the patient, and a processing system connected by a cable to the sensorized equipment. This solution, however, although it is suitable for hospitalized patients, has the disadvantage of not allowing effective monitoring of patients not confined to a limited space.
Disclosure of the invention
The aim of this invention is to provide a system and a method for the biomedical monitoring of the vital parameters of at least one subject to overcome the above mentioned disadvantages of the prior art.
More specifically, the aim of this invention is to provide a system and a method for the biomedical monitoring of parameters (preferably vital parameters) capable of preventing danger situations or allowing prompt action to be taken should such situations arise. Another aim of this disclosure is to provide a system and a method for the biomedical monitoring of vital parameters capable of monitoring and controlling the physiological data of two or more subjects simultaneously, both in real time and on a historical basis using stored data.
A further aim of this disclosure is to propose an integrated hardware device worn by the subject to be monitored to implement the system.
A yet further aim of this disclosure is to propose an electronic processor program - for example, an application for smart phones - which allows implementing the above mentioned system using the hardware of one of the smart phones.
These aims are fully achieved by the system, method, program and appliances forming the object of this invention and as characterized in the appended claims.
This method for the biomedical monitoring of vital parameters of a person (or, more generally speaking, of biomedical parameters, that is, parameters relating to the state of the person's health), comprises the following steps:
- detecting in real time the person's monitoring data, including signals representing the person's heart rate and blood oxygen saturation;
- deriving the person's vital parameters, representing the person's heart rate and blood oxygen saturation;
- processing the monitoring data, where processing includes comparing the vital parameters with predetermined reference values stored in a data bank (having storage capacity);
- generating at least one alarm signal as a function of the processing; in one embodiment, the alarm may be displayed;
- transmitting an alert to the person as a function of the alarm signal generated.
There is also a step of pre-alerting the monitored person and/or the control station as a function of the alarm signal generated.
Reference in this patent document to heart rate and blood oxygen saturation shall not in any way be construed as a limitation to these parameters, in the sense that other parameters can be detected and monitored, in particular vital parameters, but more in general, biomedical parameters, or parameters relating to the state of the subject's health. The step of detecting is carried out by a sensor worn by the person.
The step of deriving is carried out by an electronic element connected (by a cable and by a wireless communication system) to the sensor (which preferably has processing and storage capabilities).
In one embodiment, the monitoring data (comprising at least the person's vital parameters) are communicated to a remote server. In one embodiment, the monitoring data are communicated by a mobile device. The mobile device may be a mobile phone or a piece of dedicated hardware.
In one embodiment, the mobile device may be separate from the electronic element and be communicating therewith (for example, through a wireless communication system).
In another embodiment, the mobile device may include the electronic element which, in this case, is integrated in the same hardware.
In one embodiment, the step of processing is carried out by the remote server (but might also be carried out by the mobile device).
In this embodiment, the step of generating the alarm signal (or alarm signals) is carried out by the (remote) server, !n such case, an embodiment is envisaged wherein the alarm signal is received by the mobile device.
In a possible embodiment, the step of transmitting an alert to the person (as a function of the alarm signal) is carried out by the mobile device (but might also be carried out by the electronic element (if distinct from the mobile device).
In this embodiment, the step of generating the alarm signal (or alarm signals) is carried out by the server (preferably for the relatively more complex calculations) and possibly also by the mobile device (preferably for the relatively more simple calculations). The alarm signal generated by the server is then transmitted to the person by the mobile device (or by the electronic element, if distinct from the mobile device).
Transmitting the alarm signal to the monitored person (who is wearing the sensors configured to derive the vital parameters) includes displaying, and/or acoustically alerting to, contents representing the alarm signal. Such displaying and/or acoustic alerting may be performed by the mobile device (or possibly by the electronic element, if distinct from the mobile device).
In one embodiment, data exchange between the sensor (or sensors) which derives (derive) the vital parameters of the person and the mobile device and/or the server occurs by wireless communication.
In one embodiment, the data exchanged between the sensor (or sensors) which derives (derive) the vital parameters of the person and the mobile device and/or the server are uniquely correlated with the monitored person (for example, by an identification code uniquely assigned to the person). Different types of alarm signals, including voice signals, can be generated. In a possible embodiment, a first alarm signal is generated in response to heart rate and/or oxygen saturation exceeding at least a first reference value. In one embodiment, there are one or more reference thresholds, consisting of corresponding reference values for heart rate; similarly, there are one or more reference thresholds, consisting of corresponding reference values for blood oxygen saturation.
!n a possible embodiment, a second alarm signal is also generated in response to the heart rate and/or oxygen saturation and/or other parameters detectable by the sensors exceeding at least a second reference value, where the second reference value is greater than the first reference value (in the sense that it defines a more restrictive condition which implies the occurrence of the condition based on the first reference value but not vice versa).
In a possible embodiment, the monitoring data also include an acceleration parameter, representing the person's movement, and/or a position parameter representing the person's position. The position parameter indicates the subject's position (at any time), with the possibility of displaying (on a remote computer or on a display of the mobile device) a map representing the person's geographical location and movements, !n such case, at least one alarm signal may be generated also as a function of the acceleration parameter.
In this embodiment, the mobile device includes a satellite positioning system (GPS) and an accelerometer.
In this case, also a third alarm signal is generated in response to the concurrent occurrence of a first condition, linked to the exceeding of a reference value by the heart rate and/or oxygen saturation (and/or other parameters), and a second condition, linked to the acceleration parameter and/or the position parameter.
!n a possible embodiment, (also) a (fourth) alarm signal is generated in response to a comparison between a curve of at least one parameter selected from the vital parameters and a corresponding predetermined reference curve; in practice, this alarm signal takes into account a curve over time of one or more of the parameters monitored (for example, the vital parameters).
In a possible embodiment, the step of transmitting the alert to the person occurs according to one or more of the following types of alert:
a) activating a visual alert viewable by the person on a wearable device worn by the person;
b) activating a sound alert played by the wearable device worn by the person;
c) activating a prolonged sound alert played by the wearable device worn by the person and switched off only when the person acknowledges the alert;
d) activating an alert (for example vocal) perceivable by the person by means of the wearable device worn by the person. Preferably, the alerts (a), (b), (c) or (d) are transmitted according to a predetermined logic.
In a possible embodiment, transmission of the alert to the person occurs in mode (a) in response to the first alarm signal; transmission of the alert to the person occurs in mode (b) in response to the second alarm signal. Transmission of the alert to the person may occur according to different embodiments. In one embodiment, it occurs in mode (c) in response to the third alarm signal; according to another aspect, transmission of the alert to the person occurs in mode (d) in response to the fourth alarm signal.
In a possible embodiment, a (fifth or sixth) alarm signal is generated in response to a failure to acknowledge the alert (d) produced by the fourth alarm signal, within a predetermined safety time interval.
This disclosure also provides a system for biomedical monitoring of vital parameters of a person.
The system comprises at least one sensor (that is, one or more sensors) wearable by the person and configured to detect signals representing the person's heart rate and blood oxygen saturation (other parameters detectable by other biomedical sensors are not excluded). The sensor wearable by the person might have a probe connectabie to one ear, finger or temple of the person or to the person's chest (to name a few examples). The system also comprises an electronic element connected to the sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation.
In one embodiment, the system includes a mobile device comprising a memory unit, a processor and an Internet connection, communicating with the electronic element to receive the person's vital parameters and store them at least temporarily in the memory unit.
The mobile device may be separate from the electronic element or it may incorporate it, that is to say, integrate it in its own hardware and software. The mobile device may be a piece of dedicated hardware or a mobile phone provided with suitable software.
!n one embodiment, the system includes a server having a data bank containing predetermined reference values at least for the vital parameters. In one embodiment, the server is configured to receive from the mobile device the person's monitoring data, including the signals representing the person's heart rate and blood oxygen saturation. In one embodiment, the server is programmed to process the monitoring data. In one embodiment, the server is programmed to compare the vital parameters derived by the electronic element with the corresponding reference values. In one embodiment, the server is programmed to generate at least one alarm signal as a function of the processing. In one embodiment, the server is programmed to transmit the at least one alarm signal as a function to the mobile device.
The mobile device is programmed to transmit an alert to the person as a function of the alarm signal generated.
In one embodiment, the mobile device includes a display. In one embodiment, the mobile device includes a sound player. In one embodiment, the mobile device is programmed to activate a visual and/or sound and/or vocal alert (depending on the type of alert in response to receiving the at least one alarm signal from the server (preferably according to a predetermined logic, such as, for example, the logic described above).
This disclosure also provides an object (in a possible embodiment, a helmet) wearable by a person.
The object comprises a body (in the case of the helmet, a shell) structured in such a way that it can be worn.
The object includes at least one sensor wearable by the person (to be in contact with the person's head, fingers or chest) and configured to detect signals representing the person's heart rate and blood oxygen saturation. The object comprises an electronic element connected to the at least one sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation.
The object includes an electronic device, fixed to the shell to constitute a mobile device, and comprising a memory unit, a processor and an Internet connection. The electronic device (or mobile device) is configured to receive the person's vital parameters from the electronic element and to store them in the memory. The electronic device (or mobile device) is programmed to transmit at least the vital parameters to a remote server to receive from the remote server at least one alarm signal and to generate an alert for the person as a function of the alarm signal.
This disclosure also provides a processor program comprising a software for performing the following steps:
- acquiring in real time the person's monitoring data, including (amongst other possible parameters) the person's vital parameters representing the person's heart rate and blood oxygen saturation;
- transmitting the monitoring data to a remote server so that the monitoring data can be processed by comparing the vital parameters with respective predetermined reference values stored in a data bank;
- receiving at least one alarm signal generated by the server as a function of the processing;
- transmitting an alert to the person as a function of the alarm signal generated, when the software is run on a mobile device comprising a memory unit, a processor and an Internet connection.
The program is, in one or more possible embodiments, configured to perform one or more other steps of the method described in this disclosure.
The disclosure also relates to a storage medium containing the processor program.
The disclosure also relates to a downloadable data flow representing the processor program.
Thus, the system and method for the biomedical monitoring of parameters proposed in this disclosure allow, in at least one example embodiment, generating alarm notifications ("alarm") each time the parameters detected by one or more of the sensors applied to the subject to be monitored fail outside predetermined safety ranges set for each parameter and for data aggregated therewith; the alarm notifications are viewable in real time both by the subject being monitored and by an operator at a remote station responsible for controlling the subject.
The system and method for the biomedical monitoring of parameters proposed in this disclosure also allow, in at least one example embodiment, generating alarm notifications as a function of each category of the vital parameters detected and of the acceleration detected, the alarm notification being differential based on a predetermined value by which at least one of the subject's threshold and acceleration values is exceeded,
!n a possible embodiment, the system comprises:
- at least one wearable electronic sensor worn by the subject and configured to detect the subject's heart rate and blood oxygen saturation;
- at least one electronic element configured to interact with the at least one wearable electronic sensor and to receive and process the vital parameters received from the at least one wearable electronic sensor and to transmit these vital parameters;
- at least one mobile device, comprising a display; the at least one mobile device being configured to interact with the at least one electronic element, having access to a memory to store the vital parameters transmitted by the at least one electronic element and a processor programmed to process and transmit the vital parameters received;
- a server containing a data bank and being in communication with the mobile device through a local or remote connection, the server being configured to receive, store and process the vital parameters transmitted by the mobile device;
- a browser configured to display the data contained in the server; the system being characterized in that:
- the data bank contains a plurality of threshold values assigned to each category of the vital parameters;
- the at least one mobile device comprises a data exchange interface configured to receive from the server an alarm notification viewable on the display in real time by the at least one subject and viewable in real time also by an operator in charge, using the browser, when at least one of the threshold values assigned to each category of vital parameters of each subject is exceeded.
The biomedical monitoring system allows:
- creating an identification record of the subject to be monitored containing information useful for better defining the subject;
- monitoring the vital parameters of the monitored subjects in agreement with reference medical staff, taking into account the different types of activities carried out and continuously tracking the route followed by each subject;
- generating alarm notifications ("alarm") each time the values defected fall outside predetermined safety ranges set for each parameter and for data aggregated therewith;
- communicating the alarm in real time, the alarm being viewable on a PC or other suitable device to allow personnel in charge to monitor the activities of the subject, even from a remote station;
- carrying out a quick rescue operation in cases considered serious and an ex post analysis of the places and/or situations which led to the change in the psycho-physical conditions of the subject, so as to be able to adopt corrective measures.
The biomedical monitoring system according to this disclosure comprises: at least one wearable electronic sensor, at least one electronic element, at least one mobile device and a server.
More specifically, the at least one wearable electronic sensor is adapted to detect the subject s vital parameters and to make the data available in real time through a Bluetooth connection, and is configured to communicate the information collected (being provided with a data exchange module). Preferably, the wearable electronic sensor worn by the subject can be applied to garments or clothing accessories (such as caps or hats, headbands and wristbands) or to personal protection devices (such as helmets, earmuffs and working gloves) to monitor the subject's vital parameters. In a preferred embodiment, the wearable electronic sensor can be applied to any part of the subjects body with high capillary density, to detect heart rate and oxygen saturation; further, the wearable electronic sensor continuously sends the parameters detected to the mobile device through a wireless Bluetooth protocol.
The at least one electronic element is configured to interact with the at least one wearable electronic sensor and is adapted to receive and process the vital parameters received from the at least one wearable electronic sensor; preferably the at least one electronic element comprises an accelerometer and a satellite positioning device (GPS) to integrate the vital parameters detected, received from the at least one wearable sensor, with acceleration and geographical position (which, for convenience of description, are included without distinction under "vital parameters". The at least one electronic element is also configured to transmit the aforementioned vital parameters to the mobile device.
The at least one mobile device, for example a tablet or a smart phone, or other electronic device of the type known as "smart device", is connectabie wireiessiy to the at least one electronic element to continuously receive from the electronic element the vital parameters detected, store them in a memory and/or communicate them. The devices can cooperate with each other independently, with the aim of simultaneously monitoring one subject each, supported by the system, by a communications infrastructure and by a control and supervision station,
Preferably, the vital parameters of a subject are stored in the memory of the mobile device or in a remotely accessible data bank (supported by an adequate communications infrastructure). For example, the data bank resides in a server which defines a control and supervision station. More specifically, the mobile device can send the data to the server through a 3G or WiFi connection, based on availability. If the network connection is not available, the data are temporarily stored locally in the mobile device (offline mode) and then transmitted automatically as soon as the connection becomes available again. This possibility allows monitoring sessions as much as several hours long to be recorded offline without losing any data. The actual duration of a session depends on the available space on the mobile device.
The displaying and transmitting application is developed in the native code of the mobile device it is installed in.
When the values of the parameters of the monitored subject exceed certain predetermined thresholds, the device allows displaying notifications for the user (on the display of the mobile device) at different severity levels. Specifically, in online mode, the notifications are sent to the server, whereas in offline mode, only the user is notified and only when certain thresholds are exceeded.
The server collects the vital parameters of all the monitored subjects and displays them in organized graphical interfaces accessible through a common browser both from a PC and from an Android or iOS tablet.
The server also comprises a data bank containing a plurality of codes for identifying the operators. The mobile device receives the operator's identification code (when the operator logs in or is authenticated).
More specifically, the server allows the following operational flows to be carried out:
- Login of operator in charge using personal credentials.
- Recording of subjects to be monitored
- Creating and starting a monitoring session.
- Displaying the vital parameters in real time as continuous-display scalar values (numbers), animated icons and graphs. Any parameters out of threshold are indicated using different colours and different alerting policies, based on the severity of the alarm.
- Displaying the data on a map, indicating the route followed by the subject and the values detected.
- Displaying the historical data for each monitoring session and each subject.
Also an object of this invention is an electronic processor program comprising instructions which are executable by a mobile device and an electronic processor and which, when executed by the mobile device and the electronic processor, allow the mobile device and the electronic processor to implement the method. A yet further object of this invention is an integrated hardware device to embody the system.
The hardware includes an embedded wearable computational device provided with suitable sensors, which collects information regarding the patient's health and the surrounding environment and which can communicate this information, after processing it if necessary.
The biomedical monitoring system allows monitoring and controlling the physiological data of two or more subjects simultaneously, both in real time and on a historical basis using stored data. More specifically, the system is capable of generating alarm notifications ("alarm") each time the parameters detected fail outside predetermined safety ranges set for each parameter and for data aggregated therewith; the alarm notifications are viewable in real time both by the subject being monitored and by an operator at a remote station responsible for controlling the subject.
The biomedical monitoring system according to this disclosure is to all intents and purposes a self-contained system. In one embodiment, however, this monitoring system might be integrated in a system (and method) for aiding an operator in an emergency situation involving a patient, made according to one or more of the features described in Italian patent document No. 102015000047210 in the name of the present Applicant and incorporated herein by reference, with a view to increasing the amount of information and data on the tag associated with the patient. This disclosure also makes available (within the scope of protection) an electronic element (connected to the at least one sensor and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation) having one or more of the features described in this disclosure. According to another aspect, this description provides an interface element obtained by means of a software program and, if necessary, also hardware elements.
In functional terms, this interface is placed between the mobile device (or the tag) and the server (which acts as a hub) to manage communications between the mobile device and the server.
The interface element is configured to perform the following actions:
- tracing (identifying) and verifying the available transmission channels; - selecting the fastest transmission channel;
- adapting to the selected transmission channel the information packets to be transmitted.
These actions are carried out in real time.
In a possible embodiment, the hardware of the interface element might include communication interfaces of the different channels, which might not already be present in the mobile device (mobile phone or tablet)
Without the additional hardware, the functions are limited to tracing and selecting the communication channels which are compatible with the hardware available in the mobile device.
Whatever the case, the interface element is programmed to process the data to be transmitted in order to adapt the amount of data to the band and type of channel available, or selected.
In one embodiment, the system might include the interface element. It is understood, however, that this description is also extended to the interface element as such. Brief description of the drawings
These and other features will become more apparent from the following detailed description of preferred embodiments illustrated purely by way of non-limiting example in the accompanying drawings, in which:
- Figure 1 schematically represents the system according to this disclosure;
- Figure 2 illustrates the system of Figure 1 in a first variant embodiment of it;
- Figure 3 illustrates the system of Figure 1 in a second variant embodiment of it.
Detained description of preferred embodiments of the invention
In a possible embodiment, the system according to this disclosure is configured to allow an operator to remotely monitor the vital parameters of a subject to be controlled. The system is also configured to allow the same operator, or other operators, to store, process and modify the vital parameters in such a way as to make up an archive containing historical data; this allows creating a health profile for the subject and modifying specific threshold values, thereby improving the degree of reliability with which the parameters detected at any given instant might be associated with a possible health problem suffered by the subject. In practice, dynamically modifying the threshold values of each subject based on the vital parameters detected in the past avoids having to send alarm notifications and/or rescue workers and means unless it is really necessary.
Below is a description of the hardware components of one possible embodiment of the system according to this disclosure.
Figure imgf000018_0001
Diagram 1 : Layout of physical media of the biomedical monitoring system The system of this disclosure comprises a mobile device which allows the monitored subject to receive alarm notifications, when necessary, if the vital parameters detected exceed predetermined threshold values.
The system of this disclosure comprises a wearable electronic sensor adapted to continuously detect the vital parameters of a subject to be monitored. Also, the wearable electronic sensor is configured to continuously transmit the vital parameters detected to an electronic element.
An analysis of the main emergency topics, both for the health conditions of a subject and for the medical aid provided in the event of accidents at the workplace, crossed with health guidelines made it possible to establish which parameters are the first indicators of health problems and to establish whether these are fixed or change over time and according to the clinical picture. The vital parameters were selected as a function of the possibility of being defected by at least one sensor; the vital parameters detected by the wearable electronic sensor are the subject's heart rate and blood oxygen saturation.
The system of this disclosure comprises an electronic element connectable to the sensor and adapted to transmit to the mobile device the vital parameters detected by the wearable electronic sensor. The electronic element also allows tracking the subject's position and acceleration (when necessary, indicating very sudden movements in the case of acceleration values which are too high for the subject to support). The system of this disclosure also comprises a server. The server records the vital parameters of the different subjects (in a data bank) and allows the parameters to be displayed. Differentia! alarm notifications based on each vital parameter are sent to the mobile device (held by the subject), indicating by how much each threshold value is exceeded, since the server is in communication with the mobile device through a remote connection. More specifically, comparing the vital parameters with corresponding predetermined threshold values allows identifying the subject's health conditions. Further, continuous use of the system allows the vital parameters of each subject to be dynamically modelled on their state of health. Each parameter varies according to use conditions (sports persons, persons with our without disabilities, labourers, etc.) and is defined by dedicated clinical studies. However, since the parameters are strictly connected with the subject's physical state, they are modelled on the results and statistics derived from each use,
This disclosure also provides a processor program comprising software for performing the steps of the method (with the exception of detections which might be managed independently of the software) according to the disclosure (comprising one or more of the features or steps described).
Figure imgf000019_0001
Diagram 2: Software architecture of the system
!n particular, the processor program is configured to perform the steps of the method when run on the mobile device of the system and on the server according to this disclosure (comprising one or more of the features or steps described).
More in detail, diagram 2 shows the following
BTD - BlueTooth Device: a generic sensor for capturing the vital parameters of the monitored subject and which communicates with the smart phone via Bluetooth.
BTC -- BlueToofhConnector: a software module for capturing data from Bluetooth in continuous mode. It connects up to the mobile device which is already configured in Android and captures data systematically at fixed periodic intervals.
BL - Business Logic: a software component which manages the operating logic of the application and which has the following functions:
1 . Data integration from BTC and Accelerometer and GPS.
2. Data formatting.
3. Writing of data to DB.
DB - Mobile DataBase: a database for temporarily storing data in the mobile device, used like a memory and to historicize data locally in cases where connectivity with the server is down. Used like a temporary memory and to historicize data locally so it can be used locally when connectivity with the server is down.
SYNC - Synchronizer: a software component which replicates the data stored on the mobile device onto the server in real time.
DATA-M - Mobile DataAccess: an architectural module for managing access to the DataBase on mobile app in uniform and controlled manner.
WEB App - Web Application: an application developed to display the data aggregately and to manage the operator's functions.
CONF - Configuration manager: a component for managing system configuration (mobile device side). ALARM - Alarm Notifier: a component which manages alarm notifications from the server.
In a possible embodiment, the system allows identifying the physical state of the monitored subject, detecting situations of distress and, depending on the level of danger, generating a different type of alarm displayable by the subject on the display of the mobile device.
There are various types of alarms:
- alarm as a function of the physical parameters (oxygen saturation/heart rate) with independent thresholds;
- alarm as a function of the subject's acceleration (motionless/in motion) in a defined time interval;
- alarm as a function of aggregate physical values;
- alarm as a function of the subject's interaction with the wearable system in a defined time interval.
Each alarm has a different alerting policy, based, for example, on changing colours, pop-up messages or sound alerts, depending on the severity level:
- Low severity: unintrusive notification,
- Medium severity: intrusive notification which pre-alerts to possible danger if the values detected do not return to within predetermined threshold values.
- High severity: unignorabie notification which defines the need to check and, if necessary, come to the aid of, the subject.
Diagram 3 schematically represents the operating logic of a preferred embodiment of the biomedical monitoring system.
Figure imgf000022_0001
Diagram 3: Schematic representation of the operating logic of a preferred embodiment of the biomedical monitoring system.
More specifically, in the embodiment illustrated, the electronic element is integrated in the mobile device. This is different from the embodiment illustrated in Diagram 2, where the electronic element and the mobile device are not integrated in a single piece of hardware.
Diagram 4 schematically represents the operating logic of a preferred embodiment of the biomedical monitoring system.
Figure imgf000022_0002
iagram 4: Schematic representation of the operating logic of a further preferred embodiment of the biomedical monitoring system.
More specifically, in the embodiment illustrated, the wearable electronic sensor, the electronic element and the mobile device are integrated in a singie piece of dedicated hardware. Thus provided is a device which is wearable by a subject for the biomedical monitoring the subject's vital parameters, where the wearable electronic sensor, the electronic element and the mobile device are integrated in a single piece of dedicated hardware which can be conveniently applied to a garment or a clothing accessory or a personal protection device (for example, a safety helmet). More in detail, Diagram 6 schematically represents a device which is wearable by a subject for the biomedical monitoring of the subject's vital parameters.
This disclosure also provides a method for biomedical monitoring of vital parameters (heart rate, blood oxygen saturation, acceleration, geographical position) of at least one subject, comprising the following steps:
- detecting one or more vital parameters of the at least one subject to be monitored;
- comparing the one or more vital parameters detected with respective predetermined thresholds;
- deriving the state of health of the at least one subject based on the one or more vital parameters detected;
characterized in that it comprises a step of notifying an alarm to the at least one subject when at least one of the threshold values assigned to each category of vital parameters of each subject is exceeded.
This description also provides a data storage device (for example a CD- ROM or other mass storage medium) readable by a computer and containing the above mentioned computer program.
This description also provides a data flow downloadable onto a computer and representing the above mentioned computer program.
With regard to the biometric (vital) parameters detectable by the sensors of the system and usable in the step of processing (by means of one or more diagnostic algorithms), attention is drawn to the following.
In one embodiment of it, the system detects (preferably in real time) at least the person's heart rate and blood oxygen saturation, that is to say, the system detects the person's monitoring data, including signals representing the person's heart rate and blood oxygen saturation.
In this embodiment, the diagnostic algorithms include criteria based on a comparison of the values defected for these parameters with corresponding predetermined reference values. These diagnostic algorithms are based on a combination of the parameters including at least the heart rate (Fc) and the (peripheral) blood oxygen saturation (Sp02).
In one embodiment, the diagnostic algorithms use, in combination with the heart rate (Fc) and the (peripheral) blood oxygen saturation (Sp02), at least one further parameter: and that is, the intensity of pulsation. The signal representing the "intensity of pulsation" parameter is derived by analysing an amplitude of a signal measured by the sensor 3; the sensor 3 might be a pulsimeter, which is a sensor designed to measure heart rate (Fc) and (peripheral) blood oxygen saturation (Sp02).
It should be noted that the electronic element 3 (the TAG wearable by the monitored person) is programmed to periodically and automatically update the result of performing the step of processing (for example, the diagnostic algorithm). In one embodiment, the wearable electronic appliance 3 (TAG) is, consequently, also programmed to automatically update an alert transmitted to the person as a function of the result of performing the step of processing.
At each update, the processor of the electronic element 3 uses, for the processing, the updated values of the parameters measured by the sensors fixed to the person the wearable electronic element 3 is associated with.

Claims

1 . A method for biomedical monitoring of a person's vital parameters, comprising the following steps:
- detecting in real time the person's monitoring data, including signals representing the person's heart rate and blood oxygen saturation;
- deriving the person's vita! parameters, representing the person's heart rate and blood oxygen saturation;
- processing the monitoring data, where processing includes comparing the vital parameters with predetermined reference values stored in a data bank;
- generating at least one alarm signal as a function of the processing;
- transmitting an alert to the person as a function of the alarm signal generated,
2. The method according to claim 1 , wherein the at least one alarm signal includes a first alarm signal generated in response to the heart rate and/or oxygen saturation exceeding at least a first reference value.
3. The method according to claim 2, wherein the at least one alarm signal includes a second alarm signal generated in response to the heart rate and/or oxygen saturation exceeding at least a second reference value, where the second reference value is greater than the first reference value, 4. The method according to any one of the preceding claims, wherein the monitoring data also include an acceleration parameter, representing the person's movement, and/or a position parameter representing the person's position, and wherein the alarm signal is generated also as a function of the acceleration parameter and/or of the position parameter. 5. The method according to claim 4, wherein the at least one alarm signal includes a third alarm signal generated in response to the concurrent occurrence of a first condition, linked to the exceeding of a reference value by the heart rate and/or oxygen saturation, and a second condition, linked to the acceleration parameter and/or the position parameter.
8. The method according to any one of the preceding claims, wherein the at least one alarm signal includes a fourth alarm signal generated in response to a comparison between a curve of at least one parameter selected from the vital parameters and a corresponding predetermined reference curve,
7. The method according to any one of the preceding claims, wherein the step of transmitting the alert to the person occurs according to one or more of the following types of alert:
- activating a visual alert viewable by the person on a wearable device worn by the person;
- activating a sound alert played by the wearable device worn by the person;
- activating a prolonged sound alert played by the wearable device worn by the person and switched off only when the person acknowledges the alert.
8. A system (1 ) for biomedical monitoring of vital parameters of a person, comprising:
- at least one sensor (2) wearable by the person and configured to detect signals representing the person's heart rate and blood oxygen saturation; - an electronic element (3) connected to the at least one sensor (2) and configured to receive and process the signals in order to derive the person s vital parameters, representing the person's heart rate and blood oxygen saturation;
- a mobile device (4) comprising a memory unit, a processor and an Internet connection, communicating with the electronic element (3) to receive the person's vital parameters and store them at least temporarily in the memory unit;
- a server (6) having a data bank containing predetermined reference values at least for the vital parameters, configured to receive from the mobile device the person's monitoring data, including the signals representing the person's heart rate and blood oxygen saturation, and programmed to process the monitoring data to compare the vital parameters derived by the electronic element with the corresponding reference values, to generate at least one alarm signal as a function of the processing and to transmit the at least one alarm signal to the mobile device,
wherein the mobile device (4) is programmed to transmit an alert to the person as a function of the alarm signal generated,
9. The system according to claim 8, wherein the mobile device includes a display (5) and/or a sound player, and wherein the mobile device is programmed to activate a visual and/or sound alert in response to receiving the at least one alarm signal from the server.
10. The system according to claim 8 or 9, wherein the server is programmed to generate a first alarm signal in response to the heart rate and/or oxygen saturation exceeding at least a first reference value.
1 1 . The system according to any one of claims 8 to 10, wherein the mobile device (4) includes a satellite positioning system (GPS) and an accelerometer, wherein the monitoring data also include an acceleration parameter, representing the person's movement, and a position parameter representing the person's position, and wherein the server is programmed to generate a third alarm signal in response to the concurrent occurrence of a first condition, linked to the exceeding of a reference value by the heart rate and/or oxygen saturation, and a second condition, linked to the acceleration parameter and/or the position parameter.
12. The method according to any one of claims 8 to 1 1 , wherein the server is programmed to generate a fourth alarm signal in response to a comparison between a curve of at least one parameter selected from the vital parameters and a corresponding predetermined reference curve stored in the data bank.
13. The system according to any one of claims 8 to 12, wherein the electronic element (3) is built into the mobile device (4) and wherein the mobile device (4) is a piece of dedicated hardware or a mobile telephone.
14. A helmet wearable on a person's head, comprising:
- a shell which is shaped to be fitted over the head;
- at least one sensor (2) wearable by the person and configured to detect signals representing the person's heart rate and blood oxygen saturation; - an electronic element (3) connected to the at least one sensor (2) and configured to receive and process the signals in order to derive the person's vital parameters, representing the person's heart rate and blood oxygen saturation;
- an electronic device (4) fixed to the shell to constitute a mobile device and comprising a memory unit, a processor and an Internet connection and configured to receive from the electronic element (3) the person's vital parameters and store them in the memory unit, and programmed to transmit at least the vital parameters to a remote server to receive from the remote server at least one alarm signal and to generate an alert for the person as a function of the alarm signal.
15. A processor program comprising a software for performing the following steps:
- acquiring in real time the person's monitoring data, including the person's vital parameters representing the person's heart rate and blood oxygen saturation;
- transmitting the monitoring data to a remote server so that the monitoring data can be processed by comparing the vital parameters with respective predetermined reference values stored in a data bank;
- receiving at least one alarm signal generated by the server as a function of the processing;
- transmitting an alert to the person as a function of the alarm signal generated.
when the software is run on a mobile device comprising a memory unit, a processor and an Internet connection.
PCT/IB2017/054570 2016-08-11 2017-07-27 System and method for the monitoring of vital parameters. WO2018029560A1 (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011034881A1 (en) * 2009-09-15 2011-03-24 Sotera Wireless, Inc. Body-worn vital sign monitor
US20140228649A1 (en) * 2012-07-30 2014-08-14 Treefrog Developments, Inc. Activity monitoring

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011034881A1 (en) * 2009-09-15 2011-03-24 Sotera Wireless, Inc. Body-worn vital sign monitor
US20140228649A1 (en) * 2012-07-30 2014-08-14 Treefrog Developments, Inc. Activity monitoring

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