EP-4740850-A2 - APPARATUS FOR DETERMINING A PHYSIOLOGICAL CONDITION OF BABIES AND INFANTS

EP4740850A2EP 4740850 A2EP4740850 A2EP 4740850A2EP-4740850-A2

Abstract

The invention relates to a portable device (200) designed to be worn on the body of a child (300), wherein the child is a baby or toddler. The device comprises: • one or more sensors (412, 414, 416) for recording several vital parameters of the child, wherein the vital parameters include at least heart rate, oxygen saturation, and respiratory rate; and • an evaluation software (408) configured to predict at least one current or future physiological state of the child as a function of the heart rate, oxygen saturation, and respiratory rate measured by the sensors; and • an interface (403, 404) for transmitting the prediction result regarding at least one physiological condition to a user's mobile telecommunications device (302) and/or to a server computer system

Inventors

WUNDERLICH, Dr. Nadine
WUNDERLICH, Björn

Assignees

Lilio Health GmbH

Dates

Publication Date: 20260513
Application Date: 20220527

Claims (15)

Portable device (200), - wherein the portable device is designed to be worn on the body of a child (300), wherein the child is a baby or toddler; - the device includes: • one or more sensors (412, 414, 416) for recording several vital parameters of the child, wherein the vital parameters include at least heart rate, oxygen saturation, and respiratory rate; and • an evaluation software (408) configured to predict at least one current or future physiological state of the child as a function of the heart rate, oxygen saturation, and respiratory rate measured by the sensors; and • an interface (403, 404) for transmitting the prediction result regarding at least one physiological condition to a user’s mobile telecommunications device (302) and/or to a server computer system.
The portable device according to claim 1, - where at least one physiological condition is a state of increased risk of sudden infant death syndrome (SIDS), - where the evaluation software is configured to use at least the heart rate, oxygen saturation, and respiratory rate as input to predict the presence of an increased risk of sudden infant death syndrome.
The portable device according to claim 2, wherein the evaluation software is configured to predict the presence of an increased risk of sudden infant death as a function of one or more further parameters, wherein the one or more further parameters comprise: - the child's skin temperature; - the ambient temperature; and/or - the ambient humidity.
The device according to one of the previous claims, - wherein the sensors include a photoplethysmographic sensor, here referred to as PPG sensor (412), - the evaluation software is designed to derive the child's heart rate, oxygen saturation, and respiratory rate from the signals recorded by the PPG sensor and to provide this information as input to the evaluation software.
The device according to one of the previous claims, - wherein the one or more sensors comprise a sensor for detecting at least one blood parameter of the child, wherein the at least one blood parameter is in particular a methemoglobin concentration and/or a carboxyhemoglobin concentration and/or a CO2 concentration in the child's blood, wherein the sensor for detecting the blood parameter may in particular be configured as the PPG sensor according to claim 4; - where the evaluation software is trained to use at least one blood parameter as an additional input parameter in order to reduce the false positive rate of the prediction of the increased risk of sudden infant death by the evaluation software.
The device according to one of the previous claims, - wherein the device includes at least one sensor for determining at least one further vital parameter and/or environmental parameter or an interface for receiving the further vital parameter and/or environmental parameter from an external sensor, wherein the at least Another environment parameter is selected from a group comprising: • the CO2 concentration of the ambient air, • Video data of the child, in particular video data from an infrared camera; • Acoustic data captured by a microphone; and • Movement data that characterizes the child's movement activity; - where the evaluation software is trained to use at least one additional vital parameter and/or environmental parameter as an additional input parameter to predict the presence of an increased risk of sudden infant death.
The portable device according to one of the preceding claims, - where at least one of the vital signs sensors is designed to measure the child's blood glucose concentration in a non-invasive manner; - wherein the evaluation software is designed to predict a further physiological state in the form of a current or future feeling of hunger in the child as a function of at least the measured blood glucose concentration, and/or to predict a future point in time when the feeling of hunger will occur; - wherein in particular the sensors include a photoplethysmographic sensor, here referred to as PPG sensor (412), and wherein the evaluation software is designed to derive the child's blood glucose concentration from the signals recorded by the PPG sensor, in addition to the child's heart rate, oxygen saturation and respiratory rate, and to provide at least the blood glucose concentration as input for the prediction of hunger.
The device according to one of the previous claims, - the evaluation software is designed to detect the current or future presence of a physiologically problematic condition in the child, • if at least one vital parameter value is outside a predefined normal range; and/or • if a pattern of values of several vital parameters is detected which indicates a current or future problematic physiological condition of the child, whereby the pattern can also be detected if all vital parameters are individually within their normal range; and - wherein the evaluation software is trained to send a message regarding the predicted problematic physiological condition to the mobile telecommunications device (302) and/or the server computer system in response to the detection of the currently or in the future existing physiologically problematic condition.
The device according to one of the previous claims, - wherein the evaluation software is trained to selectively detect the current or future presence of a physiologically problematic condition in the child that requires immediate intervention, wherein this physiologically problematic condition includes in particular the increased risk of sudden infant death syndrome; and - to forward at least some of the vital parameters or interim prediction results measured or derived by the portable device to the server computer system via a network to enable it to predict physiological conditions and/or calculate a refined final prediction, especially of physiological conditions that do not require immediate intervention.
The device according to one of the preceding claims, wherein the device (200) is a bracelet or band worn on the ankle or leg; - wherein in particular the sensors comprise one or more pressure sensors designed to detect the contact pressure of the device on the child's body, and wherein the evaluation software is designed to recognize, based on the measured contact pressure, whether the contact pressure is within a predefined permissible contact pressure range within which the one or more sensors for detecting vital signs can function correctly, and wherein the evaluation software is designed to issue a warning via a signaling element of the device (200) to the user and/or via the interface to the telecommunications device if the measured contact pressure is outside the permissible contact pressure range; and/or - wherein the evaluation software is designed to prevent the measurement of vital parameters by the one or more sensors until the contact pressure is again within the permissible contact pressure range.
The device according to one of the preceding claims, wherein the device is configured to, - only if the evaluation software detects the current or future presence of a physiologically problematic condition, in particular an increased risk of sudden infant death syndrome and/or a feeling of hunger, or the presence of a vital or environmental parameter in a health-critical value range, to send a message to the user device; and - otherwise, automatically save the recorded vital parameters and optionally recorded environmental parameters without sending a message.
The portable device according to one of the preceding claims, - wherein the portable device comprises one or more environmental parameter sensors selected from a group including: • a thermometer used to measure the ambient temperature; • a measuring device for measuring ambient humidity; • Gases, especially CO2 ; • UV sensor for detecting a cumulative UV radiation dose, in particular a daily cumulative UV radiation dose; - and/or wherein the sensors of the portable device for recording vital parameters include further sensors selected from a group comprising: • Accelerometer to detect the position (supine, prone) of the child; • Temperature sensor for measuring skin temperature; • a microphone to capture ambient sounds and/or sounds from the child; • Video camera, especially a thermal imaging camera;
The portable device according to one of the preceding claims, wherein the prediction software includes at least one predictive model for predicting the at least one physiological state, wherein the at least one predictive model is a model generated by a machine learning method based on a training data set.
System comprising the portable device according to any of the preceding claims and one or more of the following additional components: - the portable telecommunications device, wherein user software is instantiated on the portable telecommunications device, the user software being interoperable with the evaluation software and configured to display the prediction results received from the portable device via the interface to the user and/or to enable the user to configure the evaluation software; and/or - the server computer system; and/or - a base station to which one or more external sensors are connected for measuring the child's vital parameters or environmental parameters of the child's environment; and/or - one or more of the external sensors, in particular a video camera, in particular a thermal imaging video camera.
Method for providing a portable device (200) for monitoring the physiological condition of a child, comprising: - Providing (102) a training data set comprising multiple data sets, wherein in each data set at least one physiological state of the child is stored linked to vital parameters of the child, wherein the vital parameters include at least the heart rate, the oxygen saturation, and the respiratory rate; - Performing (104) a machine learning procedure on the training data to generate at least one predictive model (520, 620), wherein the model is trained to predict the physiological state of the child based on at least the heart rate, oxygen saturation, and respiratory rate; - Installation (106) of evaluation software (408) comprising at least one predictive model (410, 520, 620) on the portable device, wherein the device is designed to be worn on the body of a child (300), wherein the child is a baby or toddler, and wherein the device comprises: • one or more sensors (412, 414, 416) for recording several vital parameters of the child, wherein the vital parameters include at least the heart rate, oxygen saturation, and respiratory rate, wherein the evaluation software is configured to use the at least one predictive model for predicting the physiological state based on the heart rate, oxygen saturation, and respiratory rate recorded by the sensors; and - an interface (403, 404) for transmitting a prediction result regarding at least one physiological condition to a user's mobile telecommunications device (302) and/or to a server computer system.

Description

Area The present invention relates to a device for determining the physiological state of a baby or toddler, which is worn on the child's body and contains several sensors. State of the art Various devices and sensor systems for monitoring the vital parameters of newborns and infants are known in the state of the art. In a specifically medical context, e.g., in a neonatal unit or intensive care unit of a hospital, these devices are often characterized by high precision in detecting particularly life-threatening physiological conditions. However, The sensor systems used for this purpose are often very expensive, and correctly attaching them to the child's body requires time, experience, and often a large number of complex and bulky devices. These devices, designed for neonatal intensive care units, are therefore unsuitable for monitoring the physiological status of children in a home environment by the child's parents. In the home environment, there are now several options available for parents to monitor at least some physiological conditions of their children using relatively simple means. The patent application US2016324466A1 This describes a method, device, and system for the local and monitoring of environmental risk factors for sudden infant death syndrome (SIDS). The device is used to monitor the sleep environment of newborns and infants at home by a parent or other caregiver. The device is placed near the infant's face and monitors, for example, the CO2 content of exhaled air and the infant's sleeping position. In particular, sleeping position and whether the head is covered by bedding are considered risk factors, as these can obstruct the airways and impair breathing. Blood parameters are not monitored. The patent application US2018000405A1 The report discloses a system and methods for health monitoring. The system records various vital parameters of the mother during the postpartum period, as well as various parameters of the newborn, such as fetal heart rate and oxygenation. However, it does not describe the use of machine learning methods to predict physiological parameters, particularly not for detecting an increased risk of sudden infant death syndrome (SIDS) or for recognizing hunger. The patent application US 2020/0060590 A1 This describes a baby monitor consisting of a sensor unit and a receiver unit. The sensor unit contains various sensors, a processing unit, and a transmitter unit. The processing unit The transmitter unit processes the raw data measured by the sensors, specifically formatting it. The transmitter then sends the formatted data to the receiver unit. The sensor unit is attached to the baby's foot and contains sensors for measuring heart rate, blood oxygen saturation, and movement. Heart rate and oxygen saturation are measured using pulse oximetry. The receiver unit (but not the sensor unit) analyzes the received data and triggers an alarm if necessary. Many state-of-the-art devices used to monitor vital signs in the home environment have several problems. They often contain only a few sensors, as a larger number of sensors is often difficult to integrate into clothing or accessories worn by babies and toddlers due to limited space. The small number of sensors also often results in a limited data set and poor-quality predictions based on it. Furthermore, adding more sensors would often significantly increase the device's cost. Another problem with some state-of-the-art devices is that the measurement data alone is often of limited use to users. A change in respiratory rate or a reduced oxygen concentration can have various causes, meaning these values alone do not allow parents to determine whether a problem exists. Summary The invention is based on the objective of providing an improved device for detecting physiological conditions in a baby or toddler, which does not have the aforementioned problems or has them to a lesser extent. The problems underlying the invention are each solved by the features of the independent claims. Embodiments of the invention are specified in the dependent claims. The embodiments listed below can be freely combined with one another, provided they are not mutually exclusive. In one aspect, the invention relates to a wearable device. The wearable device is designed to be worn on the body of a child. The child is a baby or toddler. The device comprises: one or more sensors for recording several vital parameters of the child, wherein the vital parameters include at least heart rate, oxygen saturation, and respiratory rate; and an evaluation software configured to predict at least one current or future physiological state of the child as a function of the heart rate, oxygen saturation, and respiratory rate measured by the sensors; and an interface for transmitting the prediction result regarding at least one physiological condition to a user's mobile telecommunications device and/or to a server computer system. This can be advantageous because the a