FETAL HEART RATE MONITORING DEVICE AND METHOD OF CONTROLLING THEREOF

Abstract

The present document relates to a fetal heart rate monitoring device for monitoring a heart rate of a fetus. The device comprises a carrier that is attachable to a body, a fetal electrocardiographic sensor for providing an output signal, and a reference sensor for filtering the output signal. The device also comprises an actuator arrangement comprising a plurality of actuators distributed in an area around the fetal electrocardiographic sensor. Each actuator is configured for providing a haptic signal to the body. A controller communicatively connects to the fetal electrocardiographic sensor to receive the output signal, and to control the actuators for providing a haptic feedback signal to the body dependent on the output signal. The document also relates to a control method for such a device.

Claims

1. 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; an actuator arrangement comprising a plurality of actuators mounted on the carrier and distributed in an area around the at least one 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 to provide a haptic feedback signal to the human body dependent on the output signal.

2. The fetal heart rate monitoring device according to claim 1, wherein the controller is configured for determining a heart rate frequency based on the output signal received by the controller, and for providing the haptic feedback signal as a periodic signal having a periodicity corresponding to the determined heart rate frequency.

3. The fetal heart rate monitoring device according to claim 1, wherein the controller is configured for: determining a signal strength from the output signal received by the controller, and providing the haptic feedback signal dependent on the signal strength determined by the controller.

4. The fetal heart rate monitoring device according to claim 3, wherein the controller is configured for: individually controlling each actuator of the plurality of actuators for providing the haptic feedback signal, and selectively adapting for each respective actuator, of the plurality of actuators, an intensity of the haptic feedback signal provided via the actuator dependent on the signal strength determined by the controller.

5. The fetal heart rate monitoring device according to claim 4, wherein during a relative motion of the carrier on and across the human body, the controller receives one or more signal samples of the output signal and is configured for determining a signal strength from each of the signal samples, and wherein the controller is configured for providing, based on the signal strength from each of the signal samples and by selectively controlling one or more of the actuators, an indication of a direction in which a relative location of the carrier on the human body is to be changed for increasing the signal strength of the output signal received from the at least one fetal electrocardiographic sensor.

6. The fetal heart rate monitoring device according to claim 4, wherein the device further comprises: one or more auxiliary sensors for providing auxiliary output signals, and wherein the controller is configured for: determining an auxiliary signal strength from each of the auxiliary output signals, and providing, based on the auxiliary signal from each of the auxiliary output signals and by selectively controlling one or more of the actuators, an indication of a direction in which a relative location of the carrier on the human body is to be changed for increasing the signal strength of the output signal received from the at least one fetal electrocardiographic sensor.

7. The fetal heart rate monitoring device according to claim 3, wherein the 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 at least four actuators is located in a separate quadrant of the area.

8. The fetal heart rate monitoring device according to claim 6, wherein the controller is configured for providing, based on the determined signal strength, and where dependent on the auxiliary signal strengths, 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.

9. The fetal heart rate monitoring device according to claim 1, wherein the carrier comprises a flat bendable or flexible substrate material.

10. The fetal heart rate monitoring device according to claim 1, wherein the carrier is characterized by at least one of the group consisting of: the carrier is arranged for being adhered to a skin of the human body; the carrier is provided by a patch for attachment to the human body; the carrier is provided by a belt or cloth that may be attached around an abdominal region of the human body; and the carrier is arranged for supporting the fetal electrocardiographic sensor so as to be located on the human body on a belly thereof.

11. The fetal heart rate monitoring device according to claim 1, wherein the device includes printed electronics providing one or more of the group consisting of: the at least one fetal electrocardiographic sensor, the reference sensor, the actuator arrangement, the one or more the actuators of the actuator arrangement, the one or more electrical connections of the device, and one or more electrodes of the device.

12. The fetal heart rate monitoring device according to claim 1, wherein the device further comprises at least one ground electrode located between at least one of the fetal electrocardiographic sensors and the reference sensor.

13. 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; wherein the method comprises: 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 output signal received by the controller.

14. The method according to claim 13, further comprising: 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 signal strengths determined by the controller and by selectively controlling one or more of the actuators, an indication of a direction in which 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.

15. The method according to claim 13, further comprising: 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.

16. The fetal heart rate monitoring device according to claim 3, wherein the device comprises: a plurality of actuators comprising n actuators distributed in n sectors around the at least one fetal electrocardiographic sensor such that at least one actuator of the n actuators is located in a separate sector of the n sectors.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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:

[0021] FIG. 1 schematically illustrates a fetal heart rate monitoring device in accordance with an embodiment of the present invention;

[0022] FIG. 2 schematically illustrates control electronics for a fetal heart rate monitoring device in accordance with an embodiment of the present invention;

[0023] FIG. 3 schematically illustrates a fetal heart rate monitoring device in accordance with an embodiment of the present invention in use by a user.

DETAILED DESCRIPTION

[0024] FIG. 1 schematically illustrates a fetal heart rate monitoring device 1 in accordance with an embodiment of the present invention. The device comprises a carrier substrate 3 having thereon and integrated therein a plurality of components of the device. The carrier may be any kind of suitable carrier for the application, and suitable for being fixed relative to and in contact with the skin of a user. For example, the carrier 3 may comprise a patch having an adhering side that may be adhered to the skin, or a soft cloth that may be attachable by adhering patch sections or by one or more belts with quick-release connectors, clips, velcro or the like. The carrier 3 is preferably a flat carrier substrate that may be bendable or flexible to follow the contours of the contours of a user’s skin. The components on the carrier are preferably provided by printed electronics, which enable the whole to be embodied as a flat arrangement of parts. However, instead of or in addition to printed electronics, these components and any other parts that may be provided by printed electronics may also be provided using other types of flexible electronics, such as copper polyimide. For example, the carrier and its components may consist of functional layers: an arrangement of electrodes to be in contact with the skin, a carrier substrate layer, a printed electronics layer, and a cover layer. This is not essential though, as the skilled reader may appreciate, and certain layers may be integrated into a single layer, or alternatively the arrangement may not be embodied as a flat arrangement at all. For example, non-flat components that may have been selected to reduce the cost of manufacturing or selected because of reliability or accuracy, or for other reasons, may likewise be applied. In the above, although the electrodes are not illustrated, it is to be understood that the electrodes connect to the respective functional components in the upper layers or on the carrier 3 to provide a local connection with the skin. For example, each of the sensors may comprise an electrode (or be connected with an electrode) in touch with the skin to receive input signals. The actuators to be described do not necessarily require an electrode or functional part that is in touch with the skin, as will become apparent below, although of course this is not prohibited and in some cases being in contact with the skin may even be advantageous.

[0025] The fetal heart rate monitoring device 1 of FIG. 1 further comprises a fetal electrocardiographic sensor 5 (fECG sensor). A fECG sensor 5 is configured for sensing the small electrical impulses from the heart fetus and provide an output signal indicative of the sensed signal. This sensing technique is similar to regular ECG sensing, although a fECG is much more sensitive to enable picking up the much weaker cardiac signal from the fetus. Typically, because the fECG also picks up noise and other cardiac signals around (i.e. the cardiac signal of the mother), the fECG signal requires filtering in order to provide a strong enough fetal heart rate signal in the output signal to distinguish this from the disturbance. In the embodiment of FIG. 1, an optional reference sensor 13 is illustrated. The location of the reference sensor 13 is, in this embodiment, in the upper part of the carrier 3 which is closer to the heart of the mother. The reference sensor 13 is optional in the embodiment in the sense that it is not necessary that this reference sensor is additional to any optional auxiliary sensors present in the design. Here, in the embodiment of FIG. 1, auxiliary sensors 12 as will be described further down below, are present in the design and may be applied to also provide a reference signal for filtering. Hence, in the embodiment of FIG. 1, the reference sensor 13 may be a bit redundant and may thus be dispensed with. It has been included in the drawing for explanatory purposes though.

[0026] The carrier 3 of FIG. 1 is embodied as a patch having a central part 2 and a number of extremities 4. At the ends of each extremity 4, the patch bears an actuator 10 such that in total there are four actuators 10. The actuators 10 provide haptic feedback signals, as will be explained. The actuators are controlled using the control electronics 6, and are electrically and communicatively connected therewith. The device 1 further comprises auxiliary sensors 12. The auxiliary sensors 12 are further fetal electrocardiographic sensors providing auxiliary output signals. Furthermore, each of the extremities 4 includes an optional ground electrode 8 in touch with the skin. The ground electrode reduces the background noise in the fECG sensor 5 and the auxiliary sensors 12. The ground electrodes 8 are optional and may be absent in some embodiments. The patch being shown in FIG. 1 has a cross shape with four arms or extremities 4. The skilled person may appreciate that this shape is merely illustrative, and not essential. The patch may have an arbitrary shape or size, although must be large enough to allow bearing the components and spanning an area that is large enough so that a user is able to distinguish between the haptic feedback signals coming from different actuators 10. Naturally, the patch must be large enough to support all electrodes of the embodiment. Furthermore, the patch may be adhesive or otherwise treated such that it may easily adhere to the skin frequently in order to enable the patch to be removed and placed in a different location on the skin.

[0027] 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 FIG. 2 and will be explained below, are configured for receiving the output signal from the fECG sensor 5 and, dependent on the distinguished fetal heart rate signal, activate one or more or all of the actuators 10 to provide a haptic feedback signal. The actuators 10 may be configured for providing a vibrational signal, pressure signal or possibly a thermal signal, such as to provide a haptic feedback sensation to the user, i.e. the mother. The actuators 10 may be providing a periodic heart rate signal mimicking the fetal heart rate, i.e. having a periodic frequency that equals the fetal cardiac frequency.

[0028] 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.

[0029] 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 FIG. 1, directional signals may be given by the control electronics 6 by controlling the operation of actuators 10 selectively to provide the haptic signal via selected ones of the actuators 10. For example, by controlling the upper actuator 10 to provide a haptic feedback signal, the direction ‘up’ can be given.

[0030] An example of the above guiding method is schematically illustrated in FIG. 3. In FIG. 3, a pregnant mother 30 is schematically illustrated. The contours 32 schematically illustrate a belly of the user 30. In connection herewith, it is to be noted that although the present description frequently refers to the user’s belly as a desired location to place the device 1, this is not intended to be interpreted as limiting on the invention. The device may be placed anywhere on the body where a sufficiently strong fetal heart rate signal may be acquired. This may be on the belly, e.g. the abdominal region, such as an umbilical region, a right or left lumbar region, a hypogastrium region, or a right or left iliac region. However, this may likewise be from the side of the abdomen (hypochondriatic, lumbar or iliac regions) or the user’s back (e.g. the lumbar or dorsal parts). The device 1 illustrated in FIG. 3 will guide the user to a location where the fetal cardiac signal may be acquired best. This location is schematically depicted by heart 35, i.e. the assumed fetal heart position.

[0031] 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 FIG. 3 this is the lower-right direction). Correct placement of the device 1 over position 35, such that the location 35 more or less is located underneath or in the direct vicinity of fetal electrocardiographic sensor 5, will result in the haptic feedback signal 36 being provide through all actuators 10-1 to 10-4 equally. This will tell the user 30 that no further corrections are needed and that she can fix the device relative to the body in that location. When the fetus moves inside the uterus, the location where the haptic feedback is provided will likewise be adapted by the control electronics 6 by changing the intensity of the haptic feedback signal as it is provided by each individual actuator 10-1 to 10-4. Small changes may be indicated by subtle intensity differences between the different actuators 10-1 to 10-4. For example, if the fetus moves down, the intensity of actuator 10-3 may be increased and the intensity of actuator 10-1 may be decreased. If the location of the fetus moves considerably, the actuators 10 located farthest away from the new fetal location 35 may cease providing a haptic signal. For example, a situation as is illustrated in FIG. 3 may again be obtained, where only actuators 10-2 and 10-3 are operated to provide the haptic feedback signal 36. This will indicate to the user 30 that it may be time to change the location of device 1.

[0032] FIG. 2 schematically illustrates the control electronics 6 of a device 1 in accordance with an embodiment. The control electronics 6 at least comprises a power supply 18 and a processor 20. The processor 20 may communicatively be connected with an optional memory 25 for storing data, e.g. signal samples and other data, such as positional data or movement data. The processor 20 is further communicatively connected with an electrocardiographic sensor 5 and actuators 10. Furthermore, if present, the processor 20 is further communicatively connected with the auxiliary sensors 12. Additional electronic components may be present but are omitted from the drawing in order to not obscure the presentation and explanation of the invention with unnecessary details. However, to mention some of these additional components that may be present optionally, an accelerometer may for example be applied to guide measurement and recordation of movements.

[0033] 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.

[0034] 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.

[0035] 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.