FETAL MONITORING DEVICE AND METHOD FOR MONITORING A HEALTH CONDITION OF A FETUS

TECHNICAL FIELD

[0001] The subject matter disclosed herein relates to monitoring a health condition of a fetus. More specifically relates to, a fetal monitoring device for monitoring a health condition of a fetus using an ultrasound technique and assisting a user in positioning the fetal monitoring device.

BACKGROUND OF THE INVENTION

[0002] Fetal monitoring involves evaluating the health condition of a fetus using a fetal monitoring device. The fetal monitoring device determines the heart rate of the fetus so as to determine if this is within a prescribed limit. This device may need to be positioned on a subject i.e., mother's body to monitor the heart rate. The heart rate may be presented in the form of an audio waveform or a value in a display unit. The heart rate is reviewed by a medical expert to determine the fetus health condition. Some fetus may have increased risk of fetal heart problems. Therefore the fetus may need to be monitored time to time. However fetal monitoring during labor delivery is even more critical and complex. Due to the motion of the fetus or descending movement of the fetus during this period, the health condition of the heart may vary and hence constant monitoring is required. In addition the position of the fetus needs to be also determined. In such instances the position of the fetal monitoring device on the subject need to be changed based on the fetus movement. As the fetus moves there will be a variation in the audio waveform associated with the heart rate leading to a high probability of missing the heart rate of the fetus. Further due to any positioning error, the fetal monitoring device may misjudge the heart rate of the subject as the heart rate of the fetus thereby leading to incorrect monitoring of the health condition. Misjudgment of the heart rate may be more probable when the maternal heart rate is higher than normal for example the maternal heart rate is above 100 beats per minute (BPM).

[0003] Monitoring the fetal heart rate may be dependent on a physical structure of the patient as well. So if the patient is obese or has high body mass index (BMI) then monitoring the fetal heart rate may be difficult and repositioning the fetal monitoring device to sense the fetal heart rate may be complex and nearly impossible.

[0004] Thus there is a need for a fetal monitoring device capable of monitoring a health condition of the fetus and assisting a user in positioning the fetal monitoring device.

BRIEF DESCRIPTION OF THE INVENTION

[0005] The above-mentioned shortcomings, disadvantages and problems are addressed herein which will be understood by reading and understanding the following specification.

[0006] In an embodiment a fetal monitoring device for monitoring a health condition of a fetus is disclosed. The fetus monitoring device includes a sensing unit having an imaging sensor configured to capture blood flow information of a heart of the fetus. The sensing unit also includes a doppler sensor configured to monitor heartbeat rate of the fetus. A processor receives the blood flow information and the heartbeat rate and generates an image of the heart embedded with the blood flow information.

[0007] In an embodiment a method of monitoring a health condition of a fetus in a subject is disclosed. A sensing unit is placed on the subject to monitor the health condition. Initially one or more of an imaging sensor and a doppler sensor of the sensing unit is selectively activated. The imaging sensor monitors blood flow information and the doppler sensor monitors the heart beat rate. The blood flow information and the heart beat rate are then utilized for generating an image of a heart. The image of the heart is embedded with the blood flow information.

[0008] Various other features, objects, and advantages of the invention will be made apparent to those skilled in the art from the accompanying drawings and detailed description thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIGURE 1 is schematic illustration of a fetal monitoring device used for monitoring a subject in accordance with an embodiment;

[0010] FIGURE 2 is a schematic illustration of the fetal monitoring device 100 for monitoring the health condition of the fetus in accordance with an embodiment;

[0011] FIGURE 3 is a schematic illustration of an exemplary system architecture of the fetal monitoring device in accordance with an embodiment;

[0012] FIGURE 4 is a schematic illustration of a display unit of the fetal monitoring device;

[0013] FIGURE 5 illustrates a flow diagram of a method of monitoring a health condition of a fetus in a subject in accordance with an embodiment; and

[0014] FIGURE 6 illustrates a flow diagram of a method of assisting positioning of a fetal monitoring device on a subject in accordance with an embodiment.

DETAILED DESCRIPTION OF THE INVENTION

[0015] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments that may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical and other changes may be made without departing from the scope of the embodiments. The following detailed description is, therefore, not to be taken as limiting the scope of the invention.

[0016] As discussed in detail below, embodiments of the invention include a fetal monitoring device for monitoring a health condition of a fetus. The fetus monitoring device includes a sensing unit having an imaging sensor configured to capture blood flow information of a heart of the fetus. The sensing unit also includes a doppler sensor configured to monitor heartbeat rate of the fetus. A processor receives the blood flow information and the heartbeat rate and generates an image of the heart embedded with the blood flow information.

[0017] FIG. 1 is a schematic illustration of a fetal monitoring device 100 used for monitoring a subject 102 i.e., a patient in accordance with an embodiment. The fetal monitoring device 100 may be an ultrasound monitoring device. The fetal monitoring device 100 comprises a sensing unit that may be positioned on the subject 102. The sensing unit may include a plurality of sensors for monitoring a health condition of a fetus present in the subject 102. The health condition may be monitored by determining multiple health parameters of the fetus. The health parameters may include heart beat rate, umbilical cord and artery information and blood flow information. As the fetus moves or descends particularly during the delivery period the sensing unit may need to be repositioned on the body for monitoring the health condition. More specifically the sensing unit may need to be moved on the body for receiving heart beat rate of the fetus.

In an embodiment the sensing unit may be a handheld device capable of being moved on a body of the subject 102. However it may be envisioned that the sensing unit may have any other configuration for conveniently positioning on the subject's body. The sensing unit may be repositioned by a user for example, a medical expert or any medical practitioner who examines the health of the fetus.

[0018] FIG. 2 is a schematic illustration of the fetal monitoring device 100 for monitoring the health condition of the fetus in accordance with an embodiment. The fetal monitoring device 100 includes a sensing unit 104 that may be positioned on the subject's body to monitor the health parameters of the fetus. For example the sensing unit 104 may be used to determine heart beat rate of the fetus. The sensing unit 104 includes a doppler sensor 106 and an imaging sensor 108. The doppler sensor 106 detects the heart beat rate
of the fetus. The doppler sensor 106 may be activated when the sensing unit 104 is positioned on the subject's body. The doppler sensor 106 may include multiple transducers capable of capturing the heart beat rate. In an embodiment the doppler sensor 106 may include nine transducers. The doppler sensor 106 may operate at a range of 1.13 MHz to 1.19 MHz. The detected heart beat rate is processed by a processor 110 to present an audible simulation of the heart beat to the user i.e., audible sound waves. The heart beat rate may be presented in the form of a value for example, heart beats per minute (BPM). In another embodiment the heart beat rate may be presented in the form of audio waveforms. The user may review the heart beat rate and reposition the sensing unit 104 on the subject's body when there is a variation in the heart beat rate. For example, when the fetus moves during labor delivery a doppler sensor of the sensing unit positioned on the subject's body may not be able to capture the heart beat rate of the fetus due to a current position on the fetus. This may be due to a limited range of detection capability of the doppler sensor and hence may need to be repositioned for receiving the heart beat rate. So the user views the heart beat variation and manually repositions the sensing unit so as to receive the heart beat which may be a trial and error method.

[0019] In such situations it will be convenient to have an image that shows the fetal heart. To this end when a variation in the heart beat rate is detected, the processor 1110 may activate the imaging sensor 108. In an embodiment the user may activate the imaging sensor 108. The imaging sensor 108 captures fetal heart image and other health parameters such as blood flow information. The blood information may include but not limited to presence of blood flow and blood flow rate in the blood vessels of the fetus. In an embodiment the imaging sensor 108 may be an ultrasonic sensor. The ultrasonic sensor may include multiple ultrasonic transducers that may be capable of capturing an image of the heart and the blood flow information from the fetus. The ultrasonic sensors may be arranged in the form of an array. The ultrasonic transducers may operate at a range of 5 MHz to 20 MHz. The ultrasonic transducers to be included in the imaging sensor 108 may be determined based on various focusing parameters that may be required. The focusing parameters may include but not limited to, field of view, depth of resolution, penetration capability on the subject's body, beam steering angle, beam pitch,
and beam frequency. The fetal monitoring device 100 may provide facilities for adjusting the focusing parameters of the imaging sensor 108. The focusing parameters may be adjusted based on user inputs received through an input device (not shown in FIG. 2). The input device may be a touch screen user interface.

[0020] Different types of ultrasonic transducers may be used and they include for example sector type transducers, convex type transducers and linear type transducers. A sector type transducer may have less foot print on the subject's body and a broad field of view. This transducer may have other properties such as but not limited to a broad field of view at depth, large beam steering angle and fine pitch. Now in the case of the convex type transducers, the transducers may have maximum field of view and, depth for resolution and penetration in the subject's body. Moreover the convex type transducers may have large aperture and large pitch with limited steering. If the imaging sensor 108 includes convex type transducers then they are arranged in a curved array manner so as to achieve a large field of view at depth. Finally the linear type transducers may have high resolution, shallow depth, less beam steering and high beam frequency. If these transducers are present in the imaging sensor 108 then they may be arranged in a flat array manner with a large field of view. The linear type transducers may be used for capturing images of small portions of the subject's anatomy.

[0021] The imaging sensor 108 and the doppler sensor 106 may be arranged in a manner such that a single sensing unit such as the sensing unit 104 includes both these sensors. The processor 110 may be able to selectively activate one or more of these sensors for detecting the health condition of the fetus. The selective activation may be performed in response to detecting a variation in a health parameter for example the heart beat rate. In an embodiment the imaging sensor 108 may be activated when the heart beat rate of fetal heart reaches below a threshold value. Thus the heart beat rate value represents a low heart beat rate indicating a defect in the fetal heart. In another embodiment the imaging sensor 108 may be activated when the heart beat rate ranges above a threshold value. Here the value of the heart beat rate indicates a high heart beat rate again showing a defect in the fetal heart. These threshold values may be pre-stored in
the fetal monitoring device 100. In an embodiment the threshold values may be set by the user.

[0022] Moreover a variation in the heart beat rate may indicate that the detected heart beat rate is associated with the subject for example mother. In an embodiment the fetal monitoring device 100 may present an alarm signal informing the user about incorrect detection of the subject's heart beat rate. In all these instances the processor 110 processes the heart image and the blood flow information, to present them to the user through a display unit. The displayed image may include the blood flow information embedded on the heart image. The blood flow information in the image facilitates the user in repositioning the sensing unit 104 more precisely on the subject's body. Moreover the image also facilitates the user in identifying double count and half counts associated with the heart. The double count refers to a situation when a fetal monitoring device displays a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other and if the heart rate is below for example 120 bpm. Whereas the half count relates to a scenario in which the fetal monitoring device may only recognize every second beat resulting in a halved rate for a limited time when the fetal tachycardia is for example above 180 bpm and when some interference exists from breathing or maternal arteries. If the actual FHR is above the maximum limit of the monitor for example 240 bpm, the fetal monitoring device may consider this as half-count. This halving step is accompanied by an abrupt switch of the trace to exactly half a prior baseline value. This switch may simulate a FHR deceleration called as a "false deceleration". The image generated also helps the user to determine pen lifts and understand the current scenario and reposition the sensing unit 104. The pen lift is the period when the fetal monitoring device does not provide any fetal heart rate information. This is explained in detail in conjunction with FIG. 3 and FIG. 4.

[0023] Now referring to FIG. 3 depicting a schematic illustration of an exemplary system architecture of a fetal monitoring device 100 in accordance with an embodiment. The system architecture illustrates the imaging sensor 108 and the doppler sensor 106 of the sensing unit 104. During operation of the fetal monitoring device 100, the doppler
sensor 106 may generate doppler signals that may be transmitted to the subject's body. The doppler signals may be transmitted in the form of burst signals. The doppler signals reflect and are received from the fetus, organs of the fetus and subject's body at the doppler sensor 106. A logic unit 300 monitors these signals and determines timings of the transmitted doppler signals and the received signals. The received signals are amplified by an amplifier 302 and subsequently send to a signal processing unit 304. The signal processing unit 304 demodulates and filters the amplified signals. Subsequently the signals from the signal processing unit 304 are transmitted to an analog to digital convenor (ADC) 306. The ADC 306 digitizes these signals. Thereafter frequency of the digitized signals is increased for example doubled and channelized through an audio amplifier and finally transmitted through a speaker (not shown in FIG. 3) of the fetal monitoring device 100. The user can hear the digitized signals and change the position of the sensing unit 104 on the subject's body.

[0024] When there is a variation in digitized signals such as, a change in frequency of the digitized signals or change in strength of the digitized signals, then the imaging sensor 108 is activated. The variation in the digitized signals is determined by a digital signal processor 308. The digital signal processor 308 may use a digital signal processing method for analyzing the digitized signals to determine signal to noise ratio of the received signals. The digital signal processor 308 informs the doppler sensor 106 regarding variation in the digitized signals. This information is received at a logic unit 310 and processed to activate the imaging sensor 108. The logic unit 310 instructs a beam former 312 to form multiple beams of ultrasonic signals using the ultrasonic transducers. A transmit pulser 314 assists the beam former 312 and the ultrasonic transducers in generating the ultrasonic signals. More specifically the transmit pulser 314 generates short, large amplitude electric pulses of controlled energy, which are converted into short ultrasonic signals when applied to the ultrasonic transducers.

[0025] The ultrasonic signals transmitted to the fetus and the subject's body are reflected and received as echoed signals. The echoed signals are received by a detector 316 and processed. The processed signals may be send to a scan convertor 318 for
generating an image of the fetus heart along with the blood flow information which is then transmitted to the ADC 306. The processed signals may also include information associated with various health parameters of the fetus. The ADC 306 and the digital signal processor 308 processes the image and the blood flow information to provide an image of the fetus heart with the blood flow information embedded thereon. A display unit 320 may be used to display the image of the fetal heart with the blood flow information. The display unit 320 may also display information associated with other health parameters. The display unit 320 may be controlled by a digital controller 322.

[0026] As illustrated in FIG. 4 the display unit 320 may display the image of the fetal heart with the blood flow information indicated with a color code. Numerous types of color codes may be used for depicting the blood flow information. For example, a blood flow in a heart blood vessel may be indicated in red color. However it may be contemplated that various other techniques may utilized for presenting the blood flow information may be presented on the image of fetal heart in various other embodiments. The display unit 320 may also display the health parameters of the fetus in the form readings for example, fetal heart beat rate (FHR). The displayed image is reviewed by the user and thereafter position of the sensing unit 104 may be changed. The position of the sensing unit 104 is changed only if there is a variation in the heart beat rate and the blood flow rate, non-availability of visuals of the fetal heart, or any change in other health parameters values. Thus the image facilitates the user for conveniently and accurately positioning the sensing unit 104 to monitor the fetal health condition due to the critical time period of labor delivery.

[0027] In an example, the display unit 320 may display a fetal heart image. The display unit 320 may also depict blood flow rate in a blood vessel in the fetal heart as a numerical value and with a color code. The blood flow with the color code may be embedded on the fetal heart image. In case the blood flow rate value is indicated as low and an intensity of the color of the blood flow is low then this indicates less blood flow in the blood vessel representing a defect in the fetal heart. In another instance the display unit 320 may present a blurred image of the fetal heart and the blood flow in the blood
vessel may not be visible. This indicates that the sensing unit 104 is not receiving the health parameter information from the fetal heart and hence needs to be repositioned. The fetal monitoring device 100 may generate an alarm signal for notifying the user of such situations. The user may then reposition the sensing unit 104 from the current position of the subject's body to a new position to receive the health parameter information from the fetal heart.

[0028] Turning now to FIG. 5 illustrating a flow diagram of a method 500 of monitoring a health condition of a fetus in a subject in accordance with an embodiment. The health condition may be determined based on the various health parameters associated with the fetal heart. As explained in conjunction with FIG. 1, the health parameters may include heart beat rate, umbilical cord and artery information and blood flow information. The sensing unit of the fetal monitoring device may be used for monitoring the health parameters of the fetal heart. The sensing unit positioned on the subject's body may include a doppler sensor and an imaging sensor. At step 502 the doppler sensor and the imaging sensor may be selectively activated. The doppler sensor may be activated and may be continuously monitoring the health parameters of the fetal heart. The doppler sensor may send and receive signals indicating a health parameter such as, heart beat rate of the fetal heart. When a variation in the heart beat rate is detected then the imaging sensor is activated. In this instance the doppler sensor may continue to monitor the heart beat rate. The imaging sensor may monitor blood flow information associated with blood vessels of the fetal heart at step 504. The blood flow information may include but not limited to presence of blood flow and blood flow rate in the blood vessels of the fetus. In an embodiment the imaging sensor may include multiple ultrasonic transducers. These ultrasonic transducers send ultrasonic signals to the subject's body so that the signals are received by the fetus. The ultrasonic signals reflected from the fetus include the heart beat rate information and the blood flow information in the fetal heart.

[0029] These reflected ultrasonic signals are then processed to generate an image of the heart embedded with the blood flow information at step 506. The image may depict
the fetal heart and the blood flowing through blood vessels of the fetal heart. In an embodiment the blood flow information may be depicted using a color code. In case the blood flow rate value is indicated as low and an intensity of the color associated with the blood flow is low then this indicates that less blood flow in the blood vessel showing a defect in the fetal heart. In another instance a blurred image of the fetal heart may be displayed and the blood flow in the blood vessel may not be visible. This indicates that the sensing unit is not receiving the health parameter information from the fetal heart due to the fetal movement during labor delivery.

[0030] Now referring to FIG. 6 illustrating a flow diagram of a method 600 of assisting positioning of the fetal monitoring device on the subject in accordance with an embodiment. At step 602 the doppler sensor and the imaging sensor may be selectively activated. The doppler sensor may be activated and may be continuously monitoring the health parameters of the fetal heart. The doppler sensor may send and receive signals indicating a health parameter such as, heart beat rate of the fetal heart. When a variation in the heart beat rate is detected then the imaging sensor is activated. In this instance the doppler sensor may continue to monitor the heart beat rate. The imaging sensor may monitor blood flow information associated with blood vessels of the fetal heart at step 604. The blood flow information may include but not limited to presence of blood flow and blood flow rate in the blood vessels of the fetus. In an embodiment the imaging sensor may include multiple ultrasonic transducers. These ultrasonic transducers send ultrasonic signals to the subject's body so that these signals are received by the fetus. The ultrasonic signals reflected from the fetus include the heart beat rate and the blood flow information in the fetal heart.

[0031] These reflected ultrasonic signals are processed to generate an image of the heart embedded with the blood flow information at step 606. The image may depict the fetal heart and the blood flowing through blood vessels of the fetal heart. In an embodiment the blood flow information may be depicted using a color code. In case the blood flow rate value is indicated as low and an intensity of the color associated with the blood flow is low then this indicates that less blood flow in the blood vessel showing a
defect in the fetal heart. In another instance a blurred image of the fetal heart may be displayed and the blood flow in the blood vessel may not be visible. This indicates that the sensing unit is not receiving the health parameter information from the fetal heart due to the fetal movement during labor delivery.

[0032] The variation of the health parameters of the fetal heart such as the heart beat rate variation and the blood flow information assists the user in positioning the sensing unit on the subject's body at step 608. The heart beat variation may be measured with respect to one or more threshold values. These threshold values represent threshold heart beat rates indicating a low heart beat rate and a high heart beat rate. In an instance the variation in the heart beat rate may also indicate that the heart beat rate detected may be associated with the subject's heart i.e. mother's heart. Thus the images of the heart assists the user in precisely evaluating the scenario and repositioning the sensing unit for receiving information associated with the health parameters of the fetal heart.

[0033] The methods 500 and 600 can be performed using a processor or any other processing device. The method steps can be implemented using coded instructions (e.g., computer readable instructions) stored on a tangible computer readable medium. The tangible computer readable medium may be for example a flash memory, a read-only memory (ROM), a random access memory (RAM), any other computer readable storage medium and any storage media. Although the method of monitoring a health condition of a fetus and the method of assisting positioning of the fetal monitoring device on the subject are explained with reference to the flow chart of FIG. 5 and FIG. 6, other methods of implementing the method can be employed. For example, the order of execution of each method steps may be changed, and/or some of the method steps described may be changed, eliminated, divide or combined. Further the method steps may be sequentially or simultaneously executed for managing an infrastructure in the virtual environment.

[0034] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any computing system or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims,
and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language 01 the claims.

[0035] Referral Numerals:

We Claim:

1. A fetal monitoring device for monitoring a health condition of a fetus, wherein the
fetal monitoring device comprises:

a sensing unit comprising,

an imaging sensor configured to capture blood flow information of a heart of the fetus;

a doppler sensor configured to monitor heartbeat rate of the fetus; and a processor for receiving the blood flow information and the heartbeat rate and generating an image of the heart embedded with the blood flow information.

2. The fetal monitoring device of claim 1, wherein the imaging sensor comprises a plurality of ultrasonic transducers.

3. The fetal monitoring device of claim 1, wherein the processor is capable of selectively activating at least one of the imaging sensor and the doppler sensor.

4. The fetal monitoring device of claim 1, wherein the processor is capable of:
detecting a variation in the heartbeat rate with respect to at least one threshold value; and
activating the imaging sensor based on the variation in the heartbeat rate.

5. The fetal monitoring device of claim 4, wherein the processor is capable of disabling the imaging sensor based on the variation in the heart beat rate.

6. The fetal monitoring device of claim 4, wherein the processor is capable of activating the imaging sensor in response to a user input.

7. The fetal monitoring device of claim 1 further comprising a display unit for presenting at least one of the image of the heart, the heartbeat rate, health parameters and the blood flow information.

8. The fetal monitoring device of claim 1 further comprises a memory for storing at least one of the blood flow information, the heartbeat rate and the image of the heart.

9. A method of monitoring a health condition of a fetus in a subject, the method comprising:

selectively activating at least one of an imaging sensor and a doppler sensor of a sensing unit positioned on the subject;

monitoring blood flow information of a heart of the fetus using the imaging sensor and heart beat rate using the doppler sensor; and

generating an image of the heart embedded with the blood flow information.

10. The method of claim 9 further comprises detecting a variation in the heart beat rate with respect to at least one threshold value, wherein the imaging sensor is activated based on the variation in the heart beat rate.

11. The method of claim 10 further comprises disabling the imaging sensor based on the variation in the heart beat rate.

12. The method of claim 9 further comprises presenting at least one of the image of the heart, the heartbeat rate, health parameters and the blood flow information.

13. A method for assisting positioning of a fetal monitoring device on a subject, the fetal monitoring device capable of monitoring a health condition of a fetus, the method comprising:

selectively activating at least one of an imaging sensor and a doppler sensor of a sensing unit, wherein the sensing unit is comprised in the fetal monitoring device;

monitoring blood flow information of a heart of the fetus using the imaging sensor and heart beat rate using the doppler sensor;

generating an image of the heart embedded with the blood flow information; and

presenting a variation in the heart beat rate with respect to at least one threshold value, wherein the variation in heart beat rate assists a user to position the sensing unit on the subject.

14. The method of claim 13 further comprising presenting at least one of the image of the heart, the heartbeat rate, health parameters and the blood flow information to the user.