Patent Application
20230113978
The present invention is directed at a fetal heart rate monitoring device for monitoring a heart rate of a fetus, the device comprising: a carrier suitable for being attached to a human body; at least one fetal electrocardiographic sensor mounted on the carrier and configured for providing an output signal; at least one reference sensor for providing a reference signal for filtering the output signal to enable identifying a fetal heartrate therefrom. The invention is further directed at a method of controlling a fetal heart rate monitoring device.
Typically, if an expecting mother wants to experience the heart rate of her unborn baby, like an audible signal in an ultrasound echo, she needs to visit a professional healthcare facility. Alternatively or additionally, she can buy a commercially available fetal heartrate detection system that are nowadays available on the market. Such a system, which may be a handheld, belt or self-adhering bandage intended for fetal monitoring, requires proper positioning in order to obtain a (sufficiently strong) fetal heart rate signal. For professional healthcare employees this is a daily duty. Mothers to-be, however, may find this a more challenging task. Improper use of handheld, smart bandages or belts may then lead to confusion and dissatisfaction, or even worse, panic that something may be wrong if no proper signal can be achieved.
It is an object of the present invention to overcome the abovementioned disadvantages of conventional fetal heartrate detection systems, and to provide a fetal heart rate monitoring device that can be used also by unexperienced users to obtain a fetal heart rate signal from their unborn child.
To this end, there is provided herewith a fetal heart rate monitoring device for monitoring a heart rate of a fetus, the device comprising: a carrier suitable for being attached to a human body; at least one fetal electrocardiographic sensor mounted on the carrier and configured for providing an output signal; at least one reference sensor for providing a reference signal for filtering the output signal to enable identifying a fetal heartrate therefrom; wherein the device further comprises: an actuator arrangement comprising a plurality of actuators mounted on the carrier and distributed in an area around the fetal electrocardiographic sensor, wherein each actuator is configured for providing a haptic signal to the human body; and a controller communicatively connected to the at least one fetal electrocardiographic sensor for receiving the output signal, wherein the controller is arranged for controlling each of the plurality of actuators for providing a haptic feedback signal to the human body dependent on the received output signal.
The fetal heart rate monitoring device of the present invention is able, using the reference sensor in combination with the at least one fetal electrocardiographic sensor, to distinguish the relatively weak fetal heart rate signal from the background signal, and to provide direct haptic feedback to the user via the actuators. For example, the user may place the carrier of the fetal heart rate monitoring device on her belly and receive a haptic sensation via her skin in case the output signal contains the fetal heart rate signal. For example, the providing of a direct and real time haptic feedback signal via the skin makes it much more easy for a user to find the correct location where the fetal heart rate signal can be picked up. Alternatively, as we will further explain below, in certain embodiments direction may be provided via the haptic signal to move to the correct location where the fetal heart rate signal will be received stronger or is at its maximum strength.
Furthermore, the use of a haptic signal provided via the one or more actuators, makes the use of external feedback mechanisms – such as sound generators or Bluetooth connections to a mobile phone or other external device –obsolete. The monitoring device may therefore, in accordance with some embodiments, be completely self-contained, e.g. including a power supply (e.g. battery, solar panel, or charging element). Although a connection with an external element for these purposes is not needed, as may be appreciated any plugs, sockets or other means to facilitate a connection with an external device may in some embodiment nevertheless be present if deemed advantageous or desired for any additional purpose. For example, such a connection may be used for transferring time dependent fetal heart rate data that may be temporarily stored in the device, or to send or receive trigger signals to control certain device functions, or for some other purpose.
In accordance with some embodiments the controller is configured for determining a heart rate frequency from the received output signal, and for providing the haptic feedback signal as a periodic signal having a periodicity corresponding with the determined heart rate frequency. As may be appreciated, the direct haptic feedback, via the skin, of the fetal heart rate in an arbitrary or suitably selected periodic signal – the periodicity of which corresponds with the fetal heart rate frequency determined, will be comforting to the user and strengthen the user’s bond with the unborn baby.
In some embodiments, the controller is configured for determining a signal strength from the received output signal, and for providing the haptic feedback signal dependent on the determined signal strength. For example, the haptic feedback signal may be intensified in case the signal strength from the output signal (i.e. from the fetal heart rate signal found in the output signal) increases. This further enhances the ability of the user to find the location where the fetal heart rate may best be picked up, and further increases the level of comfort once the fetal heart rate signal has been found and is provided as feedback to the mother via the haptic signal.
In some of these embodiments, the controller is configured for individually controlling each of the actuators for providing the haptic feedback signal, and for selectively adapting for each respective actuator an intensity of the haptic feedback signal provided via the actuator dependent on the determined signal strength. By controlling the (intensity of) the haptic feedback provided by the individual actuators separately, it becomes possible to provide directions to the user via the haptic feedback signal.
For example, in certain embodiments, during a relative motion of the carrier on and across the human body, the controller may receive one or more signal samples of the output signal, wherein the controller is configured for determining a signal strength from each of the signal samples, and wherein the controller is configured for providing, based on the determined signal strength and by selectively controlling one or more of the actuators, an indication of a direction wherein a relative location of the carrier on the human body is to be changed for increasing the determined signal strength. The user, in this embodiment, is led by the haptic signals provided to move the carrier with the fetal electrocardiographic sensor towards a local maximum in received signal strength from the fetal heart rate signal detected. This is done on the basis of collected signal samples that are collected and (temporarily) stored while the carrier is being moved over and across the skin of the human body. The user will thereby be aided to quickly find a good location to pick up the heart rate.
In yet other of these embodiments, the device further comprises one or more auxiliary sensors for providing auxiliary output signals, and the controller is configured for determining an auxiliary signal strength from each of the auxiliary output signals, and for providing, based on the determined auxiliary signal strengths and by selectively controlling one or more of the actuators, an indication of a direction wherein a relative location of the carrier on the human body is to be changed for increasing the determined signal strength of the output signal received from the at least one fetal electrocardiographic sensor. As may be appreciated, instead of or in addition to the embodiment above, wherein history data of signal samples are used to determine a direction wherein the carrier may need to be moved to increase the signal, the auxiliary sensors of the present embodiment enable to provide multiple signal samples simultaneously and thereby enable to determine the direction without requiring history data. Thus, the user in these embodiments, upon placing the carrier on her skin, may immediately be directed towards the direction wherein the signal strength of the fetal heart rate signal increases. This makes it even more easy to find the fetal heart rate signal.
In various embodiments of the invention, the fetal heart rate monitoring device comprises at least four actuators distributed in the area around the at least one fetal electrocardiographic sensor such that at least one of the actuator is located in each quarter of the area. Having a minimum of four actuators, with at least one of them in each quarter of the area around the fetal electrocardiographic sensor, enables to provide simple directions via the haptic feedback signal, such as: up, down, left, and right. The four (or more) actuators with one of them in each quarter are a specific embodiment of the more general class of embodiments below, wherein, the fetal heart rate monitoring device comprises a plurality of actuators such as to comprise at least n actuators, wherein the area around the at least one fetal electrocardiographic sensor comprises an n number of sectors, such that at least one actuator is located in each one of the n number of sectors. For example, eight actuators in eight sectors enable to indicate directions such as: up, up-right, right, down-right, down, down-left, left, or up-left. In the embodiment with four quarters and (at least) four actuators, the directions: up-right, down-right, down-left, or up-left may of course be indicated by operating multiple actuators simultaneously to provide a haptic feedback signal.
In some embodiments, the controller is configured for providing, based on the determined signal strengths, and optionally (if applicable to the embodiment) the auxiliary signal strengths from the auxiliary sensors, an indication of a relative location of the heart of the fetus in the human body by selectively controlling the haptic signal of one or more of the actuators. By adapting the intensities of haptic feedback signal provided by the various actuators relative to each other, the location of the haptic sensation as perceived by the user may be changed. This may be done dependent on a determined expected relative location of the heart of the fetus (i.e. the projection thereof (nearest location) on the skin of the belly). Thereby, the user can sense the fetus movements in the uterus, and knows where about the fetus is located, i.e. in terms of the relative location on her belly.
In some embodiments, the carrier comprises a flat bendable or flexible substrate material. The carrier may be configured for being attached, at least temporarily, to the user’s body, e.g. by adhering or otherwise fixing. In various embodiments the carrier is arranged for being adhered to a skin of the human body. In some embodiments, the carrier is provided by a patch for attachment to the human body. In other embodiments, the carrier is provided by a belt or cloth that may be attached around an abdominal region of the human body. In some embodiments, the carrier is arranged for supporting the fetal electrocardiographic sensor such as to be located on the human body on a belly thereof. In particular, optionally, the carrier is arranged for supporting the fetal electrocardiographic sensor such as to be located in at least one of: an umbilical region, a right or left lumbar region, a hypogastrium region, or a right or left iliac region.
In some preferred embodiments, in the fetal heart rate monitoring device, one or more of: the at least one fetal electrocardiographic sensor, the reference sensor, the actuator arrangement, one or more the actuators of the actuator arrangement, one or more electrical connections of the device, or one or more electrodes of the device, are provided by printed electronics. In particular in combination with some of the above embodiments, e.g. the flat and bendable substrate and/or the patch that may be adhered, this provides an embodiment that may be worn underneath the user’s clothing such as to provide haptic feedback throughout the day.
In some embodiments, the fetal heart rate monitoring device further comprises at least one ground electrode located in between at least one of the fetal electrocardiographic sensors and the reference sensor. The additional ground electrode further enables to reduce the noise level in the output signal of the fetal electrocardiographic sensor. The ground electrode, however, is certainly not essential to the invention, and the invention may operate without the additional grounding electrode.
In accordance with a seconds aspect, there is provided a method of controlling a fetal heart rate monitoring device for monitoring a heart rate of a fetus located inside a human body, wherein the device comprises a controller, at least one fetal electrocardiographic sensor configured for providing an output signal to the controller, at least one reference sensor for providing a reference signal for filtering the output signal, and a plurality of actuators wherein each actuator is configured for providing a haptic signal to the human body; the method comprising a steps of: receiving, by the controller, the output signal from the at least one fetal electrocardiographic sensor; and providing, by controlling each of the plurality of actuators, a haptic feedback signal to the human body dependent on the received output signal. This method may be applied by a controller in a fetal heart rate monitoring device as described above in accordance with the first aspect.
In some embodiments, the method of the second aspect further comprises obtaining, by the controller, at least one of: one or more signal samples of the output signal of the at least one fetal electrocardiographic sensor, or one or more signal samples of auxiliary output signals provided by auxiliary sensors; determining, by the controller, one or more signals strengths from the signal samples; and providing, by the controller, based on the determined signal strengths and by selectively controlling one or more of the actuators, an indication of a direction wherein a relative location of the carrier on the human body is to be changed for increasing a signal strength of the output signal received from the at least one fetal electrocardiographic sensor.
In some embodiments, the method further comprises: obtaining, by the controller, at least one of: one or more signal samples of the output signal of the at least one fetal electrocardiographic sensor, or one or more signal samples of auxiliary output signals provided by auxiliary sensors; determining, by the controller, one or more signals strengths from the signal samples, and an expected relative location of the heart of the fetus in the human body; and providing an indication of the determined expected relative location of the heart of the fetus in the human body by selectively controlling the haptic signal of one or more of the actuators.
The invention will further be elucidated by description of some specific embodiments thereof, making reference to the attached drawings. The detailed description provides examples of possible implementations of the invention, but is not to be regarded as describing the only embodiments falling under the scope. The scope of the invention is defined in the claims, and the description is to be regarded as illustrative without being restrictive on the invention. In the drawings:
The fetal heart rate monitoring device 1 of
The carrier 3 of
In the device 1, the fECG sensor 5 provides an output signal that includes the fetal heart rate signal. This signal is filtered using the reference electrode 13 to enable distinguishing the fetal heart rate signal out of the disturbances provided by the mothers cardiac signal and noise signals. The control electronics, which are shown in
The haptic feedback signal provided by actuators 10 may be provided at a selected position, i.e. such that it is sensed at a certain position, by selectively controlling one or more of the actuators 10. This position dependency may be controlled by the controlling electronics dependent on e.g. the output signal from the fECG sensor 5 or on history data of signal samples that were acquired earlier. For example, the user may have moved the device 1 relative to her body and in contact with the skin, while at the same time signal samples of the output signal of sensor 5 were taken by the controller 20 which were temporarily stored in a buffer or memory 25. Preferably, the auxiliary signals from auxiliary sensors 12 are applied to monitor movements, i.e. changes in the relative position of the device 1 with respect to the user’s body. This may be achieved by performing e.g. triangulation on either the mother’s cardiac signal (using the mother’s heart as fixed reference point in the body) or the fetal cardiac signal (thereby assuming a temporary static position of the fetus while the device 1 is moved relative to the body, before being fixed thereto). The skilled person may appreciate that signals from other fixed references in or on the body may possibly be used in addition or alternatively. In principle, in certain embodiments, although this is somewhat cumbersome and therefore not the most advantageous solution, external signal sources may even be applied to generate a fixed reference signal, e.g. a further patch (separate from the device 1) with an electrode. In embodiments without auxiliary sensors 12, the main output signal from sensor 5 and for example signals from a motion sensor may be applied to either determine a relative position of the device 1 on the user’s body or to determine movement data. From this, directional instructions on how to move the device 1 relative to the body 30 may be derived. The above embodiments allow to store, in addition to the signal samples, positional data of the relative position of the device 1 relative to the body or movement data of movements that were made by the device 1 relative to the body.
From the historic signal samples, and e.g. after a signal strength determination by the controller (of the fetal cardiac signal strength), an expected relative location (or projection thereof on the skin of the belly) of the fetal’s heart may be determined (e.g. as the location of a local maximum in the fetal’s cardiac signal). The haptic feedback signal may be provided at or near this location, by selectively controlling one or more of the actuators 10 near this location, or by providing the haptic feedback signal via each of the actuators with a different signal intensity. Alternatively, the historic data may be used to guide the mother/user to move the patch to an optimal location for obtaining a strong heart rate signal. For example, based on the historic data, the haptic feedback signal via actuators 10 may be provided in a manner to guide the user to move the device 1 to the location where the best (i.e. strongest and/or least disturbed) output signal may be obtained from which the fetal heart rate signal may best be distinguished. For example, with four actuators 10 as depicted in
An example of the above guiding method is schematically illustrated in
The device 1 performs fetal heart rate signal measurements using the fetal electrocardiographic sensor 5 and the auxiliary sensors 12-1, 12-2, 12-3 and 12-4. From these measurements it can be determined that the fetal cardiac signal that origins from location 35, is best received via auxiliary sensors 12-2 and 12-3. The actuators 10-1, 10-2, 10-3 and 10-4, which are located close to the auxiliary sensors 12-1 to 12-4, are then operated to provide the haptic feedback signal 36 via actuators 10-2 and 10-3. The user 30 feels these haptic feedback signals 36 and intuitively interprets this as a direction to move the device 1 in the lower-left direction (in
The present invention has been described in terms of some specific embodiments thereof. It will be appreciated that the embodiments shown in the drawings and described herein are intended for illustrated purposes only and are not by any manner or means intended to be restrictive on the invention. It is believed that the operation and construction of the present invention will be apparent from the foregoing description and drawings appended thereto. It will be clear to the skilled person that the invention is not limited to any embodiment herein described and that modifications are possible which should be considered within the scope of the appended claims. Also kinematic inversions are considered inherently disclosed and to be within the scope of the invention. Moreover, any of the components and elements of the various embodiments disclosed may be combined or may be incorporated in other embodiments where considered necessary, desired or preferred, without departing from the scope of the invention as defined in the claims.
In the claims, any reference signs shall not be construed as limiting the claim. The term ‘comprising’ and ‘including’ when used in this description or the appended claims should not be construed in an exclusive or exhaustive sense but rather in an inclusive sense. Thus the expression ‘comprising’ as used herein does not exclude the presence of other elements or steps in addition to those listed in any claim. Furthermore, the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality. Features that are not specifically or explicitly described or claimed may be additionally included in the structure of the invention within its scope.
Expressions such as: “means for ...” should be read as: “component configured for ...” or “member constructed to ...” and should be construed to include equivalents for the structures disclosed. The use of expressions like: “critical”, “preferred”, “especially preferred” etc. is not intended to limit the invention. Additions, deletions, and modifications within the purview of the skilled person may generally be made without departing from the spirit and scope of the invention, as is determined by the claims. The invention may be practiced otherwise then as specifically described herein, and is only limited by the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20164220.4 | Mar 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/NL2021/050185 | 3/18/2021 | WO |
