CN118019485A - Apparatus and method for assessing and monitoring health risk of a subject - Google Patents
Apparatus and method for assessing and monitoring health risk of a subject Download PDFInfo
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Abstract
The present invention relates to medical technology. An apparatus for identifying and monitoring health risks comprising: a sensor in contact with and secured to the body of the subject; a measuring unit capable of converting signals from the sensor having different physical parameters into a form of corresponding measured values; a parameter-to-function conversion unit for converting each received signal containing the measured physiological parameter from a parameter signal to a functional signal having a standard format allowing correlation of the signals without further conversion; a signal correlation unit capable of identifying the presence of a risk and generating a corresponding alarm signal; a risk assessment unit capable of assessing risk and generating a signal containing an overall risk assessment (level); a display unit capable of converting the overall risk assessment (level) into a message for the wearer of the device and/or an expert monitoring the health of the wearer. A method of identifying and monitoring health risks is also contemplated.
Description
Technical Field
The present invention relates to medical equipment, in particular to devices and methods for assessing and monitoring the health risk of a subject and also for diagnosing the condition of the subject's organic tissue. The term "subject" as used herein is to be understood as a human subject or other living organic tissue wearing a personal device, in particular an animal subject (including mammalian subjects).
Background
Various methods are known in the art that are useful for assessing human health based on signals from various sensors.
Thus, according to international application W0200357025 of ipca 61 b 05/00 published 12/24/2003, a method of monitoring a patient for normal or abnormal physiological events by analyzing biomedical signals of the patient is known in the prior art. The biomedical signals to be analyzed were studied in the following manner. First, an unprocessed signal, for example an electrocardiogram signal using the corresponding electrode, is obtained. Second, adaptive segmentation of this signal is performed. In addition, some features are retrieved from such raw signals. Next, clustering of the time and waveform characteristics of the signals is performed. Finally, based on the obtained data, a medical interpretation of the clusters is performed.
Patent ep p 2156788 of IPC Α61 BETA 05/00 published 24 in 2 2010 discloses a method for measuring vital signs in time series. The vital parameters are continuously measured by the vital sign measurement module. The vital signs measurement module determines whether a person can drive the vehicle based on the health condition.
The method known in the prior art closest to the inventive method claimed in the present application is a method of detecting pathological fluctuations in physiological signals for diagnosing human diseases, as described in the application patent application US20100234748 published by 16/9/2010.
Known methods include performing a sliding window analysis to find sequences in the physiological signal data that correspond to amplitude-and duration-corrected versions of the template function within specified tolerances.
Disclosure of Invention
The technical effect to be achieved by the present invention is to improve the accuracy, reliability and timeliness of assessing a subject's health risk, and also to enhance the versatility of a tool useful for assessing said risk based on simultaneous measured heterogeneous physiological characteristics of the subject's organic tissue.
To achieve the above technical effects of the present invention, the inventors propose a device for assessing and monitoring health risk of a subject, the device comprising a sensor in contact with the subject's body and fastened thereto; a measurement block adapted to convert signals from a sensor sensing parameters of various physical properties into a class of values of a characteristic sensed by the sensor; a parameter and function conversion block adapted to convert each received signal having a measured physiological parameter from a parameter signal to a single form of a function signal so as to ensure their comparison without additional conversion; a signal comparison block adapted to evaluate the presence of a risk and to form a corresponding signal indicative of the presence of said risk; a risk assessment module adapted to assess risk and form a signal with a general risk assessment (level of risk); a display block adapted to convert the general risk assessment (level of risk) into a message addressed to a human subject wearing the device and/or to a health monitoring professional of the subject.
According to the invention, the claimed device has a sensor that can be fastened to the body of the subject in one of the following ways that are not harmful to the health of the subject: for example by means of a locking bracelet, a fixed patch or chest strap, or implantation.
In accordance with the present invention, the claimed device may be designed to be able to receive signals from piezoelectric sensors, photoelectric sensors, electrochemical sensors, and audio-visual sensors that provide a measurement of a physiological characteristic.
According to the invention, the claimed device may be designed to be able to receive signals wirelessly via wires or using a wireless data transmission protocol from a sensor directly mounted in the device housing and, if necessary, also from a sensor mounted outside the device housing.
According to the invention, the claimed device may be designed to be able to receive signals from sensors sensing parameters of various physical properties by means of a measurement block, a parameter and function conversion block, a signal comparison block and a risk assessment block.
In accordance with the present invention, the claimed apparatus may be designed to be capable of continuous, long-term health risk monitoring of a subject.
According to the invention, the claimed device has a display block, which may comprise a light indicator and/or a sound indicator and/or a screen.
In accordance with the present invention, the claimed device may communicate with a mobile gadget configured as a mobile phone, smart phone, tablet, laptop, or with a desktop PC.
The claimed apparatus for assessing and monitoring the health risk of a subject has the following functions:
long-term monitoring by continuous measurement of physiological characteristics (e.g. Heart Rate (HR), temperature, concentration of essential substances, and other parameters) by means of sensors in contact with the subject's body and fastened thereto;
-converting the parameters and functions of each measured hetero-signal into a homogeneous functional signal for subsequent comparison;
-comparison of homogeneous functional signals;
-assessing a health risk of the subject based on a set of established conditions associated with the health risk and indicative of a potential change in the subject's health;
-generating a message to inform a human subject and/or a health monitoring professional wearing the inventive device of certain health risks identified by the inventive device.
Furthermore, the present invention contemplates the availability of some additional functions that enable enhanced accuracy of subject health analysis:
Continuous self-checking of the operating conditions performed by the device of the invention (for example, checking whether the power supply is on and whether the sensor in contact with the subject's body is actually attached and fastened thereto);
Automatically correcting the signal containing the measured physiological characteristic (providing feedback during the measurement process);
Interaction with an external system to transfer data from the device for further processing.
The sensor, measurement block, parameter and function conversion block, signal comparison block, risk assessment block and display block may be structurally integrated to form a personal wearable device designed as a bracelet, for example.
If necessary, the sensor may be located outside the device housing to connect wirelessly with the bracelet via wires or using standard wireless data transmission protocols.
The overall combination of the essential features of the claimed apparatus for assessing and monitoring the health risk of a subject and the claimed method for assessing and monitoring the health risk of a subject has a direct impact on the accessibility of the claimed technical effect of the invention. The feature showing the presence of a sensor in the claimed device in contact with the subject's body and fastened thereto, and the feature of receiving a signal from said sensor containing the measured physiological characteristic, are key features of the present invention, and they ensure that the functionality of the device and the implementation of the claimed method achieve the claimed technical effect at the same time. The accuracy, reliability and operating efficiency of health risk assessment cannot be improved if no sensors are present in the claimed device, no signals are received from these sensors and they are not further converted in the manner described by the present invention. The versatility of health risk assessment tools is also increased mainly by having sensors in the claimed devices, by receiving signals from these sensors and by further conversion thereof.
Moreover, to achieve the above technical effect, the present invention proposes a method for assessing and monitoring the health risk of a subject, characterized by providing in advance a set of functional parameters, each set of functional parameters comprising a correlated threshold value of a critical physiological parameter and a combination of its temporal characteristics in terms of duration and periodicity, receiving from at least one sensor a signal comprising measured physiological characteristics together with collected retrospective data, each signal being converted into a signal having a single form, thereby ensuring that the signal is compared without additional conversion at given time intervals, wherein if this signal has reached a threshold value of a critical parameter value stored in one of a plurality of pre-formed sets of functional parameters, the signal adopts a value indicative of a risk factor for health of the subject, or if the threshold value has not been reached, then adopting a value indicative of a risk factor for health of the subject, and comparing the signals of the single form within the frame of each set of functional parameters, and when the values of the signals of the sets indicative of factors for health of the subject match each other, making a decision for health of the subject based on the plurality of decisions forming a general assessment of health condition, the device being fastened to a health of the human subject, or wearing the device for a health condition, the device being harmless to the health of the subject, or a long-term health of the human subject, and the device being wearing the device.
The inventive method for assessing and monitoring the health risk of a subject by means of the above-described apparatus for assessing and monitoring the health risk of a subject, comprising performing the following operations, may be described in detail as follows.
First, sets of functional parameters are provided in advance, each set comprising a combination of interrelated thresholds of key physiological parameters and their temporal characteristics in terms of duration and periodicity, to characterize a certain risk factor for the health of a subject. Furthermore, the selection of the key physiological parameters and their temporal characteristics in terms of duration and periodicity is based on verified medical data.
Each set of functional parameters is formed based on at least two parameters (time and at least one physiological parameter corresponding thereto) received from the sensor.
In addition, in order to ensure a continuous assessment and monitoring of the health risk of the subject, which risk assessment and monitoring is a continuous and sequential execution of all the operations constituting the method of the invention, in addition to the operations of pre-providing said set of physiological parameters, a signal containing the measured physiological characteristics is received from at least one sensor. The sensor provides a signal to be received which contains, inter alia, parameters such as Heart Rate (HR), sleep or wake state, type of human physical activity, energy expenditure and inflow, body hydration state (hydration state), sleep stage, stress level, glucose content in the intercellular fluid, but the parameters contained in the received signal are not limited to such a list.
Next, each signal is converted to a functional signal having a single form, ensuring that the signals are compared without additional conversion at given time intervals, wherein the signal assumes a value indicating the presence of a risk factor for the health of the subject if this signal has reached a threshold value of a key parameter value stored in one of the plurality of pre-formed functional parameters, or assumes a value indicating the absence of a risk factor for the health of the subject if the threshold value has not been reached. In other words, this enables the heterogeneous signal from the sensor to be converted into a single form for further comparison. It should be mentioned that one signal from the sensor gives as many homogeneous signals as different thresholds of the key physiological parameter corresponding to the signals in the set of functional parameters in its conversion into a single form of signal.
Furthermore, a particular value (e.g., arithmetic mean) of the signal from the sensor at a given time interval is determined before converting the signal from the sensor into a single form of signal.
In addition, when the sensor signal reaches a threshold value of the critical physiological parameter, the magnitude of the deviation of the sensor signal from the threshold value is stored, as well as the duration and periodicity of such deviation. Taking into account the magnitude of such deviations, the duration and periodicity of the deviations enables a more accurate determination of health while judging the presence of risk factors.
Then, the signals of the single form are compared within the framework of each set of functional parameters, and when the signal values of the set of risk factors indicative of the health of the subject match each other, a determination is made that a health risk has been identified, wherein corresponding signals are formed that such risk exists.
A set of conditions associated with the identified health risk and indicative of potential health changes is then generated.
The next step is to evaluate the risk based on the generated set of conditions to generally evaluate the health risk of the subject, wherein a signal corresponding to this evaluation is formed.
Finally, the human subject wearing the personal device and/or the professional performing the human health monitoring are accordingly informed by means of the display signal to show a general assessment (level) of risk on the display block of the device.
In the claimed method according to the invention, the external gadget may be selected from the group consisting of a mobile phone, a smart phone, a tablet computer or a desktop PC.
In the claimed method according to the invention, a set of functional parameters is provided in advance and a threshold value corresponding to such a set is specified. In the claimed method according to the invention, the sensor may be used as a source of a signal, in particular containing parameters such as Heart Rate (HR), sleep or wake state, type of human physical activity, energy expenditure and inflow, body hydration state, sleep stage, stress level, glucose content in the intercellular fluid, but the parameters contained in the received signal are not limited to such a list.
In the claimed method according to the invention, the current value of the signal from the sensor and the collected retrospective data are used before converting the signal from the sensor into a single form of signal.
In the claimed method according to the invention, a single homogeneous stream is formed from each received signal after it has been converted into a single form of signal.
In the claimed method according to the invention, for each set of functional parameters, one or more time windows may be used, to which the incoming data for each signal is related.
In the claimed method according to the invention, the length of each time window may be determined by a specific set of functional parameters.
In the claimed method according to the invention, it is possible to perform continuous monitoring of the technical condition of the device, automatic correction of the signal containing the measured physiological characteristic, in particular by providing feedback during the measurement process, interacting with an external system for data transmission.
In the claimed method according to the invention, the actions on the signals received from the sensors sensing the parameters of the various physical properties are divided into separate processing phases (signal conversion steps) and they are performed by the corresponding blocks of the inventive device.
Thus, by the overall combination of the essential features of the invention, a higher accuracy, a better reliability and a higher operating efficiency of the health risk assessment are ensured, as well as an enhanced versatility of the tool and the apparatus for implementing such assessment in the claimed method.
Drawings
Fig. 1 illustrates an embodiment of the claimed invention.
Fig. 2 shows a schematic diagram of the operations constituting the claimed method for assessing and monitoring the risk of the health of a subject.
Fig. 3 shows a general schematic of how a set of functional parameters is provided.
Fig. 4 shows a graph of converting a signal from a sensor containing a physiological parameter into a signal in a single form.
Figure 5 shows a graph of the results of comparing single form signals within the framework of the combination of signals for each of the provided sets of functional parameters and a graphical representation of certain risks to the health of the subject.
Fig. 6 shows an example of converting a signal containing physiological parameters into a signal in a single form.
Fig. 7 shows yet another example of converting a signal containing a physiological parameter into a signal in a single form.
Fig. 8 shows an example showing the core of converting a parameter signal into a functional signal prior to subsequent comparison, which conversion lays a foundation for the inventive method for assessing and monitoring the risk of the health of a subject.
Fig. 9 shows an example of a general algorithm for assessing risk.
Fig. 10 illustrates an example of risk assessment using a personal wearable device designed as a lockable bracelet.
Fig. 11 shows an example of an embodiment of the invention by using a personal wearable device based on analog and digital integrated circuits.
Detailed Description
Several embodiments are allowed for the inventive apparatus and method for assessing and monitoring the risk of a subject's health (fig. 1). Thus, a separate embodiment of the present invention may provide a personal wearable device designed to be equipped with a bracelet (I) with a sensor in contact with the subject's body and fastened thereto for use with a "bracelet-phone (tablet PC)" pair (II) or as part of a complex system of technical equipment (III) based on universal digital equipment.
A personal wearable device 1 (fig. 1) comprising a device for assessing and monitoring the risk of the health of a subject, mainly for measuring physiological parameters and informing the wearer of the device of the received values of such parameters. Currently, these devices are not intended to evaluate the risk of the health of a subject in considerable detail. Furthermore, these devices may operate as part of a complex system of technical equipment, and they may be linked with other wearable devices, e.g. a mobile phone (tablet) 2, in order to transfer data from the wearable device to the external device 3 for further processing (III).
The invention is implemented independently as a personal wearable device (fig. 1), for example as a bracelet designed to be equipped with a sensor (I), consisting of: a sensor (1) in contact with the subject's body and fastened thereto; a measurement block (2) that converts signals from sensors that sense parameters of various physical properties into a class of values of characteristics sensed by the sensors; a parameter and function conversion block (3) for converting each received signal with a measured physiological parameter from a parameter signal into a single form of a functional signal in order to ensure their comparison without the need for additional conversion; a signal comparison block (4) for assessing the presence of a risk and forming a corresponding signal indicative of the presence of said risk; a risk assessment block (5) for assessing risk and forming a signal with a general risk assessment (level of risk); and a display block (6) for converting the general risk assessment (level of risk) into a message addressed to a human subject wearing the device and/or to a health monitoring professional of the subject.
The key function of the claimed invention is to assess the risk of the health of a subject by means of sequential processing (1) of parameter signals sensed by one or several sensors having different physical properties based on purposeful parameter and function transformations (2) in the measurement block, performing the parameter and function transformations (3), comparing the signals (4) and assessing the risk (5).
The display block (5) is intended to convert said general risk assessment (level of risk) into a message addressed to the human subject wearing the device and/or to a health monitoring professional of the subject by means of a light indicator, a sound indicator and/or a screen.
Sequential processing of parameter signals in assessing the health risk of a subject means stepwise conversion of signals received from sensors into messages regarding the identified risk addressed to the human subject wearing the device and/or to the health monitoring professional of the subject. Five conversion steps were used: measurement, parameter and function conversion, signal comparison, risk assessment and display of assessment results. Each signal conversion is performed in a corresponding block of the inventive device. Fig. 2 shows the steps of converting signals received from sensors, the type of such signals and the graphical representation of the blocks constituting the device of the invention and corresponding to these signal conversions in the course of a health risk assessment.
Before starting the measurement procedure, sets (4) of functional parameters (designated "sets" on the drawings) are provided in advance (fig. 3), each set comprising a combination of interrelated thresholds of key physiological parameters and their temporal characteristics in terms of duration and periodicity, to characterize a certain risk factor for the health of the subject. Such parameters may include Heart Rate (HR), sleep or wake state, type of human physical activity, energy expenditure and inflow, body hydration state, sleep stages, stress level, glucose content in the intercellular fluid, but the parameters contained in the received signals are not limited to such a list.
The schematic diagram (on fig. 3) shows the process of providing the set 4 of functional parameters.
The set 4 of functional parameters reflecting a specific health state is understood as a correlated assumption about the possible health risk 5 identified for each risk Factor (FR) of the subject' S health, which can be identified from the signal S (P) obtained from the sensor containing the measured physiological characteristics in the form of the parameter P. In fact, each set of functional parameters 4 reflects assumptions about possible health risks when several parameters P are combined. Time is also one of the parameters, since the time characteristics in terms of duration and periodicity of the P-parameters should be considered when assessing health risk.
When combining several P parameters to form a hypothesis about a possible risk to human health, objective data that is accumulated in medicine and reflects causal relationships between diseases and previous patterns of changes in human physiological parameters P are used. Based on these data, key CP values for those parameters P are formed, which can be measured by means of the wearable personal device 1 (I, fig. 1).
An example of one such possible set 4 of functional parameters is shown in fig. 6. Using the Heart Rate Signal (HRS) as the signal P parameter S (P); the state in which the person is located, and this may be the parameter "calm" state, "walking" state, "running" state, and the parameter "time".
For each parameter in the set, assigning its threshold; thus, each parameter in the set is defined as a key physiological parameter.
For the embodiment of the invention shown in fig. 6, the threshold values are specified as follows:
for the key physiological parameter HRS, there is a pre-specified threshold HRS norm. The current value of the critical physiological parameter CP for the signal S of the parameter (HRS) is defined as
"S (HRS) >70% ×s (HRS norm)". That is, if the HRS monitoring results deviate by more than 70% from the established physiological parameter limits, the presence of some health risk factor, characterized by this parameter, is also recorded. That is, for this key physiological parameter, the threshold value may be specified in the form of a relative value as a fraction of the nominal value of this parameter;
the value of the threshold critical physiological parameter CP of the signal S for the parameter (type of activity), which indicates the presence of a risk factor, is established in any state other than the "running" state. That is, for a key physiological parameter that characterizes the type of activity of a subject, the presence of a certain risk factor is determined only if it belongs to a certain current state;
the value of the threshold critical physiological parameter CP of the signal S for the parameter (observation time), which indicates the presence of a risk factor, is estimated to be "2 minutes". That is, when a particular absolute value is reached, a risk factor is determined.
Fig. 7 shows another example, in which two sets 4 of functional parameters are used based on the same P-parameters. The set of functional parameters N is a set of examples shown in fig. 6. The set of functional parameters n+1 on the basis of the same P-parameters is associated with other assumptions about the potential risk of the subject's health. For the embodiment of the invention shown in fig. 7, the following thresholds are specified for this assumption:
for the key physiological parameter HRS, there is a pre-specified threshold HRS norm. The current value of the critical physiological parameter CP for the signal S of the parameter (HRS) is defined as
"S (HRS) >90% ×s (HRS norm)". That is, if the HRS monitoring results deviate by more than 90% from the established physiological parameter limits, the presence of some health risk factor, characterized by this parameter, is also recorded. That is, for this key physiological parameter, the threshold value may be specified in the form of a relative value as a fraction of the nominal value of this parameter;
the value of the threshold critical physiological parameter CP of the signal S for the parameter (type of activity), which indicates the presence of a risk factor, is established in any state other than the "running" state. That is, for a key physiological parameter that characterizes the type of activity of a subject, the presence of a certain risk factor is determined only if it belongs to a certain current state;
the value of the threshold critical physiological parameter CP of the signal S for the parameter (observation time), which indicates the presence of a risk factor, is estimated to be "0.1 minutes". That is, when a specific absolute value, namely "0.1 minutes", is reached, the risk factor is determined.
The example shown in fig. 7 shows that even for the same parameter combination, there may be several sets of functional parameters. The number of sets depends only on how much risk can be determined using the available sensor data.
The set of functional parameters is implemented in the device intended to be in the form of the amplitude of the voltage in the simplest case by presetting a threshold value for the critical physiological parameter, for example when it is necessary to use it in a threshold device analog input signal (fig. 11) (signal from sensor measuring HRS).
The set of functional parameters may also store temporal characteristics of key physiological parameters. A digital clock may be used for this purpose. For example, if HRS has a high frequency and is too long in duration, such signal values may be in a corresponding set.
Retrospective data of a subject's health observations may be either accumulated directly on the device or transmitted to an external system (device) for storage and subsequent processing for the purpose of continuous long-term risk monitoring. For this purpose, the possibility is provided of interacting with an external device selected from the group consisting of a mobile phone, a smart phone, a tablet, a laptop or a desktop PC.
The inventive method of assessing and monitoring the risk of a subject's health, as implemented in the present invention, is performed as follows (fig. 2).
A signal S (P) containing the measured physiological parameter P is received from one or both of the sensors 1 (fig. 2), e.g. from sensor 1 and sensor 2.
In addition, in the measurement block 2, the signals from the sensors with parameters of different physical properties are transformed into the form of values of the quantities measured by them, i.e. the signals take the form of parametric features.
Thereafter, in the parameter and function conversion block 3, each received parameter signal is converted into a single (hereinafter-binary) form of the function signal at given time intervals. In this case, the functional signal is determined to be "1" if the corresponding parameter signal reaches a threshold value of the key physiological parameter stored in one of the sets 4 (fig. 3) of preformed functional parameters, and to be "0" if the threshold value has not been reached yet.
Fig. 4 shows an example of such a transition of the condition signals S1 and S2. Thus, the limit of the critical physiological parameter is the threshold CP1, indicated by the dotted line, for the signal S1, and it is the threshold CP2 for the signal S2. If this value is exceeded at the output of the parameter and function conversion block 3 (fig. 2) at a given time interval, a "1" is recorded for signal CB1 or CB2, and if not, a "0" is recorded.
The method provides for determining a specific value (e.g., average value) of the signal from the sensor at time intervals of the input signal S for tuning for interference. Furthermore, the signal S containing the measured physiological parameter may be absent, for example due to sensor malfunction, the presence of disturbances in the signal transmission, and other objective reasons. In this case, the binary CB signal is not formed after the transition. An interruption in the signal transmission occurs as shown in fig. 4.
A next step (fig. 2) consists in comparing the binary signals within the framework of each set of functional parameters in the signal comparison block 4. At the output of the parameter and function block 3, a single stream of binary signals is formed. This particular conversion thus allows future comparisons of signals that were not comparable prior to conversion to binary form.
In this example we discuss the simplest binary form of comparison, namely "1" and "0". The threshold excess in the previous step may be stored in more digits, i.e. the excess value is stored. This allows for taking into account the value of the threshold value of the key signal value exceeding the physiological parameter and the duration of such exceeding when determining whether there is a health risk.
For each of the previously provided sets 4 of functional parameters (fig. 3), the functional binary signals are compared with each other and when the "1" values of the signals in the sets agree, a determination is made as to the presence of certain health risks. This operation is shown in fig. 5. The functional binary signals SB1, SB2, SB3 in this example are compared by AND logic within each set of functional parameters (i.e., set 1, set 2, AND set 3). If the current output value of each SB signal is "1" within the range of the functional parameter set, the output value is "1". If each SB signal has a value of "1" for the comparison time interval within the template, then the output will be "1". If there is even one "0", the output will be a "0". In this example, when comparing the first set to the third set, the output contains a "1", indicating that there is some health risk. If more than one set of functional parameters are triggered simultaneously, a plurality of conditions associated with a health risk and indicative of a potential change in the subject's health are identified. It should also be mentioned that the identified single condition may be indicative of several risks to the health of the subject.
Fig. 8 gives a general example showing the core of converting a parameter signal into a functional signal and its subsequent comparison, which lays the foundation for the inventive method for assessing and monitoring the risk of the health of a subject.
The text step (fig. 2) is to assess the risk of the subject's health and reflect the potential change in the subject's health based on the previously identified conditions associated with the risk, and is implemented in the risk assessment block 5. For example, algebra of binary logic may be used for qualitative assessment of risk formed by a device. Fig. 9 shows an example of a general scheme for such risk assessment.
With respect to the next step (fig. 2), the display block 6 of the inventive device for assessing and monitoring the risk of the health of a subject (e.g. using the bracelet-shaped personal wearable device 1 as shown in fig. 1) performs the conversion of said general assessment of risk (level of risk) into a message addressed to the human subject wearing said device and/or to the health monitoring professional of the subject, e.g. by means of a light indicator of a text message appearing on the display of the inventive device (fig. 10).
Medical example
As a practical example of a health risk assessment, here is an example of a signal from a wearable personal device containing time-functional parameters of stress and hydration levels measured in an observed 60 year old male. In a first stage of conversion into a binary signal, both the signal with the stress parameter and the signal with the hydration level (dehydration) parameter are compared with a critical physiological parameter value threshold and a signal for an excess time of both the signal with the stress parameter and the signal with the dehydration parameter. In the next stage, the signals in binary form have been compared within the framework of the functional parameter set. The following can be identified:
insufficient hydration increases stress;
long-term low hydration (dehydration).
Health monitoring indicates that the patient is dehydrated for a long period of time. With the doctor's appointment, after replacing one of the heart valves with an artificial heart valve 10 years ago, the last two years had taken antihypertensive drugs including diuretics, resulting in "blood clotting" caused by the dehydration condition. At the same time, insufficient hydration is accompanied by an increase in stress. The physician recognizes that the risks described in this example are critical to the life and health of the observed and opens new treatment options.
All of these situations suggest that there is an objective possibility of identifying human health risks.
Based on these data, a more general assessment of human health risk may be further considered. For example, these specified risks may be indicative of cardiovascular disease or metabolic disorder. Furthermore, the risk associated with stress and evidence of low hydration may indicate reduced fitness or reduced performance.
It should also be mentioned that, for example, an overall risk assessment of human health may be established as a representation of risk in the form of a risk list and its parameters, which are then analyzed by an expert, who makes general health and overall risk decisions for the individual. An automated system may also be established that will determine a more general risk for all or part of the risk data received based on the data received. This option is implemented through the interaction of the present invention with an external system (device) to transfer data from the wearable device for further processing.
Industrial applicability
The invention may be implemented as a personal wearable device, e.g. the device of the invention may be designed as a bracelet, or it may be part of a complex system consisting of pieces of technical equipment.
Fig. 11 shows an example of an embodiment of the invention provided as a personal wearable device designed as a wristband bracelet based on analog and digital ICs.
As an example, this particular figure refers to a method for identifying an HRS key value being exceeded, indicating the risk of cardiovascular disease (CVD) being present (risk 1), and a method for identifying a night-time enhanced HRS, indicating a risk of reduced adaptation of the subject's organic tissue (risk 2).
Thus, HRS sensors (e.g., optical pulsers) are positioned in the bracelet housing and in contact with the subject's body by locking the bracelet on the wrist, sending an electrical signal to a threshold device (comparator 1), where the signal is converted from a signal in analog form to a digital information signal. If the input analog signal has a value greater than a certain (threshold) voltage (critical HR value) that is preset as a critical functional signal for a first set (set 1) of functional parameters of the device (bracelet), a logic level signal equal to "1" is formed at the output of the threshold device. Furthermore, the signal from the logic element "lights up" the LED via a simple connection circuit (e.g., via a properly selected resistor). This indicates that a risk factor has been detected, i.e. that HR increases and thus, for example, the risk of CVD has been determined (risk 1). As an assumption of this risk, the second key parameter (time) is not considered in order to simplify the graphical representation.
In order to implement the inventive method for identifying night-time increased HR, additional elements with the inventive device are required, which are also positioned within the bracelet, since it is necessary to monitor two risk factors: increased HR and the type of activity of the subject "sleep".
Therefore, in order to determine the current time of day and measure the duration of the time interval in units smaller than one day (in our case, at night), we need a digital clock whose output generates a time signal that is distributed to two digital comparators (digital comparator 1 and digital comparator 2). Such comparators are widely used in measurement equipment, radio and wire communication and household appliances. For example, a digital clock with an alarm clock contains a digital comparator, wherein an audible signal is emitted when the current time coincides with a set time.
The first digital comparator is preset to 0 hours 0 minutes (alarm clock 1) to indicate the start of the night time and the second digital comparator is set to 6 hours 0 minutes (alarm clock 2) to indicate the end of the night time. 0 minutes (alarm clock 2), which indicates the end of the night time. These values refer to the second set (set 2) of functional parameters of the device (bracelet). When the condition alarm of each comparator is triggered, a logic level signal equal to "1" is formed at its output. Both signals are fed into a third digital comparator (digital comparator 3), where a logic level signal equal to "1" is formed at the output of the third digital comparator when "1" is present from the first comparator, and where a logic level signal equal to "0" is formed at the output of the third digital comparator when "1" is present from the second comparator. At each such switch, the first comparator and the second comparator change their output signals to be opposite until the next trigger of the conditional alarm clock. Thus, the device implements a key physiological parameter "night", which characterizes the type of conditional activity of the subject "sleep", i.e. it is determined that there is some risk factor only when belonging to this current state. To increase the reliability of activity type measurements, for example, sensors measuring the movement of the device in space, such as accelerometers, may additionally be used.
Considering that for the second method two risk factors should be considered, the signal from the threshold device (comparator 1), which means that there is a first factor when there is a "1" at its output, and the signal from the third digital comparator (digital comparator 3), which means that there is a second factor when there is a "1" at its output, are fed to the fourth digital comparator (digital comparator 4), where their comparisons are performed. If there are two signals at the input of the fourth comparator equal to "1" at the same time, a signal equal to "1" is also formed at its output, which means that there is a risk of the subject's organic tissue adaptation decreasing (risk 2). In this case, the signal from the logic element of the fourth digital comparator "lights up" the LED, similar to the first method.
The advantage of the present invention is its simplicity and versatility of implementation, enabling the risk of a subject's health to be assessed and monitored using any signal carrying any data about parameters and pieces of information of the subject's organic tissue condition.
Claims (26)
1. An apparatus for assessing and monitoring health risk of a subject, comprising: a sensor in contact with and secured to the subject's body; a measurement block adapted to convert signals from a sensor sensing parameters of various physical properties into a class of values of a characteristic sensed by the sensor; a parameter and function conversion block adapted to convert each received signal having a measured physiological parameter from a parameter signal to a single form of a function signal so as to ensure their comparison without additional conversion; a signal comparison block adapted to evaluate the presence of a risk and to form a corresponding signal indicative of the presence of said risk; a risk assessment block adapted to assess risk and form a signal with a general risk assessment; a display block adapted to convert the general risk assessment into a message addressed to a human subject wearing the device and/or a health monitoring professional of the subject.
2. The device according to claim 1, characterized in that the sensor is fastened to the subject's body in one of the following ways that are harmless to the subject's health, in particular by means of lockable bracelets, fixable patches or chest bands, or implantation.
3. The device of claim 1, wherein the device is configured to receive signals from piezoelectric sensors, photoelectric sensors, electrochemical sensors, and audio-visual sensors that provide a measurement of a physiological characteristic.
4. The device as claimed in claim 1, characterized in that the device is designed to be able to receive signals via wire or wireless data transmission from a sensor directly mounted in the device housing and, if necessary, also from a sensor mounted outside the device housing.
5. The device as claimed in claim 1, characterized in that the device is designed to be able to receive signals from the sensors sensing parameters of various physical properties by means of the measuring block, the parameter and function conversion block, the signal comparison block and the risk assessment block.
6. The device of claim 1, wherein the device is designed to be capable of performing continuous, long-term health risk monitoring of the subject.
7. Device according to claim 1, characterized in that the display block comprises a light indicator and/or an acoustic indicator and/or a screen.
8. The device of claim 1, wherein the device communicates with a mobile widget configured as a mobile phone, smart phone, tablet, laptop, or with a desktop PC.
9. The device of claim 1, wherein the parameter and function conversion block is adapted to convert each received signal having a measured physiological parameter from a parameter signal to a binary function signal.
10. The device of claim 1, wherein the risk assessment block is adapted to form a signal having a general level of risk, and the display block is adapted to convert the general level of risk into a message addressed to a human subject and/or health monitoring professional wearing the device.
11. A method for assessing and monitoring the health risk of a subject, characterized in that a set of functional parameters is provided in advance, each set of functional parameters comprising a correlated threshold value of a key physiological parameter and a combination of its temporal characteristics in terms of duration and periodicity, that a signal containing measured physiological characteristics is received from at least one sensor together with collected retrospective data, that each of the signals is converted into a signal having a single form, ensuring that the signal is compared without additional conversion at given time intervals, wherein if this signal has reached a threshold value of a key parameter value stored in one of the sets of the plurality of preformed functional parameters, then the signal takes a value indicative of a health risk factor for the subject, or if the threshold value has not been reached, then the signal of a single form is compared within the framework of each set of functional parameters, and that when the values of the signals of the sets of the signals indicative of the risk factor for the health of the subject match each other, a judgment of the risk of the health of the subject is made that there is a risk for the health of the subject based on a plurality of certain assessments forming a general assessment of the health condition, that it is fastened to a continuous device, or a human being carried out by a health-requiring device, or a health-of the subject is carried out by a health-device, a health-of which is secured by a human being in any of the condition, a health-requiring device, a health-is required device, a health-is a human being 10, a health-is secured device, and a health device is required has been required for a device.
12. The method of claim 11, wherein the external gadget is selected from the group consisting of a mobile phone, a smart phone, a tablet computer, and a desktop PC.
13. The method of claim 11, wherein the set of functional parameters is pre-provided and its corresponding threshold is established.
14. The method of claim 11, wherein each of the functional parameter sets comprises a combination of at least two parameters received from the sensor: time and at least one physiological parameter corresponding thereto.
15. The method of claim 11, wherein signals are received from sensors comprising parameters such as heart rate, sleep or wake state, type of human physical activity, energy expenditure and inflow, body hydration state, sleep stages, stress level, glucose content in intercellular fluid.
16. A method according to claim 11, characterized in that a specific value, e.g. an arithmetic mean, of the signal from the sensor at a given time interval is determined before converting the signal from the sensor into a signal of a single form.
17. The method of claim 11, wherein after each received signal is converted to a single form signal, a single homogeneous stream is formed from the single form signal.
18. The method of claim 11, wherein when the signal from the sensor reaches a threshold value of the key physiological parameter, storing a value of deviation of the signal from the sensor from the threshold value.
19. Method according to claim 11, characterized in that the magnitude of the deviation of the sensor signal from the threshold value and the duration and frequency of such deviation are taken into account when making the determination regarding the presence of health risks.
20. A method as claimed in claim 11, characterized in that one signal from the sensor gives, during its conversion into a signal of a single form, as many homogeneous signals as there are different thresholds of the key physiological parameter corresponding to that signal in the set of functional parameters.
21. The method of claim 11, wherein for each set of functional parameters, one or more time windows are used, with which the incoming data for each of the signals is related.
22. The method of claim 21, wherein the length of each time window is determined by a set of functional parameters.
23. A method as claimed in claim 11, characterized in that a continuous monitoring of the technical condition of the device is performed, the signal containing the measured physiological characteristic being automatically corrected, i.e. interacted with an external system for data transmission by providing feedback during the measurement process.
24. Method according to claim 11, characterized in that the actions performed on signals received from sensors sensing parameters having various physical properties are divided into processing stages and they are performed by corresponding blocks of the device of claim 1.
25. The method of claim 24, wherein the respective processing stage is a signal conversion step.
26. A method according to claim 11, characterized in that if a single binary form is selected when converting the parameter signal into a functional signal, a signal containing the measured physiological characteristic is received from at least one sensor, each received signal is converted into a binary form signal at given time intervals, wherein when this signal reaches a threshold value of a key parameter value stored in one of a plurality of pre-formed sets of functional parameters, the signal takes a "1" value, and if the threshold value has not been reached, the signal takes a "0" value, then the binary form signals are compared within the frame of each set of functional parameters and, if the "1" values of the set of functional parameters signal match each other, a determination is made that there is some risk regarding the health of the subject.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| RU2021123170A RU2786479C1 (en) | 2021-08-03 | Device and method for determination and monitoring of risks for health | |
| RU2021123170 | 2021-08-03 | ||
| PCT/RU2022/000247 WO2023014244A1 (en) | 2021-08-03 | 2022-08-02 | Device and method for identifying and monitoring health risks |
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| US4360029A (en) * | 1978-04-10 | 1982-11-23 | Johnson & Johnson | Automatic mean blood pressure reading device |
| US8615291B2 (en) * | 2009-03-13 | 2013-12-24 | National Institutes Of Health (Nih) | Method, system and computer program method for detection of pathological fluctuations of physiological signals to diagnose human illness |
| JP6511439B2 (en) * | 2013-06-04 | 2019-05-15 | プロテウス デジタル ヘルス， インコーポレイテッド | Systems, devices, and methods for data collection and outcome assessment |
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