WO2018056777A2

WO2018056777A2 - Fetal well-being assessment device and control method thereof

Info

Publication number: WO2018056777A2
Application number: PCT/KR2017/010553
Authority: WO
Inventors: 안기훈; 김낙환; 박상현
Original assignee: 고려대학교 산학협력단; 안기훈
Priority date: 2016-09-26
Filing date: 2017-09-25
Publication date: 2018-03-29
Also published as: KR20180033621A; KR102175665B1; WO2018056777A3

Abstract

The present invention provides a fetal well-being assessment device (10) and a control method thereof, the device comprising: a pad module (2) including a fetal sensor unit (110) for sensing a fetal state and a fetal communication unit (120) for transmitting a fetal detection state signal of the fetal sensor unit (110) to the outside, the pad module being capable of being worn on a mother's abdomen; and a fetal state assessment module (100) including a communication unit (210) for communicating with the fetal communication unit (120) to receive the fetal detection state signal and a control unit (220) configured to calculate a fetal well-being index for checking whether or not the fetus is in good condition through a calculation process by a calculation unit (240) using the fetal detection state signal transmitted from the communication unit (210) and a preset data stored in a storage unit (230), assess the fetal well-being, and output the same through an output unit (250).

Description

Fetal Hi-Status Judgment Device and Its Control Method

The present invention relates to an apparatus and a control method thereof for detecting a fetal condition and determining the fetal well-being.

In order to check the health of the fetus through the ultrasound or ECG sensors are being examined.

However, whether or not fetal health according to the prior art is determined by a specialist through the examination equipment in the hospital, there is a problem that it is difficult to properly diagnose the fetal state in the case of mothers difficult to see the hospital due to remote residence or personal circumstances. More importantly, except for an average of 10 days, which is the number of visits to the hospital out of the total 280 days of pregnancy, if the fetus's health evaluation is neglected and the mother feels reduced fetuses, abnormal vaginal discharge or abdominal pain Only when there was a sign of special physical abnormalities in the body was found a specialist, it was difficult to respond to the condition of unstable fetal well-being.

In other words, even if the final diagnosis is made by a specialist, there is an increasing need for an apparatus capable of confirming whether a mother or a user should promptly consult a specialist.

Therefore, the present invention has been invented to solve the problems of the prior art, the object of the present invention is to make it easy for mothers and the like to check the well-being of the fetus to improve the bond with the fetus and cause continuous interest and interest In addition, the present invention provides a fetal well-being state determination device and a control method thereof, which enable prompt medical care in a situation where fetal well-being is suspected.

According to one aspect of the invention, the present invention includes a fetal sensor unit 110 for detecting the state of the fetus and includes a fetal communication unit 120 for transmitting a fetal detection state signal of the fetal sensor unit 110, the mother The pad module 2 wearable on the abdomen of the communication unit, the communication unit 210 receives the fetal detection state signal by communicating with the fetal communication unit 120, and the fetal detection state signal and the storage unit transmitted from the communication unit 210 Calculate the fetal well-being state index for checking whether the fetal well-being state through the calculation process through the calculation unit 240 using the preset data stored in the 230 and determine the well-being state of the fetus through the output unit 250 It provides a fetal well state determination apparatus 10 including a fetal state determination module 100 having a control unit 220 for controlling to output.

In the fetal well-being state determination device, the fetal sensor unit 110 is: an electrocardiogram sensor 111 that is disposed on the pad module and proximate to the mother's abdomen to detect the ECG signal of the fetus, and disposed on the pad module And an ultrasound sensor 113 disposed close to the mother's abdomen to detect fetal movement.

In the fetal well-being state determination device, the ECG sensor 111 includes: an ECG reference electrode 111a which is arranged around the mother's abdomen and outputs a reference electrode signal, and at least a portion of the ECG sensor 111 is in the mother's key direction. The electrocardiogram collecting electrode 111b may be disposed between the electrocardiogram reference electrodes 111a in the vertical plane projection.

In the fetal well-being state determination device, the control unit 220, fetal well-being index indicating the well-being state of the fetus using the fetal ECG signal and fetal movement signal detected by the fetal sensor unit 110 (X ) And the fetal wellness index (X) is:

And determine fetal condition by comparing fetal wellness index (X) with preset data stored in the storage unit 230, where r represents fetal heart rate per minute calculated from the ECG signal, and fetal nerve stability Indices (

) Is a fetal heart rate (r) per minute and a predetermined fetal heart rate change coefficient (stored in the storage unit 230) (

) Is calculated from the fetal nerve stability state, fetal acidosis index (

) Represents the fetal heart rate variation, and the fetal heart rate variation coefficient (Δv) preset in the storage unit 230 is a preset fetal heart rate change time (

) Divided by the maximum deviation (| r |) of fetal heart rate (r) per minute changed during) and the fetal acidosis index (

) Represents an auxiliary index for the heart rate variability of the fetus, and measures the number of occurrences of the prenatal fetal acidosis index Δcs, which is confirmed to be normal during the preset time tc, which is preset and stored in the storage unit 230. Normal fetal acidosis index (V) divided by the number of occurrences (c), fetal nerve development index (

Represents a fetal movement, and a predetermined fetal movement calculation time (preset stored in the storage 230)

May be divided by the number of fetal movements (m) that are predetermined as normal.

In the fetal well-being state determination device, the control unit 220 may calculate the ECG vector signal and the ECG signal magnitude from the ECG detection signal, and may check the position of the fetus from the ECG vector signal and the ECG signal magnitude.

In the fetal well-being state determination device, the pad module 2 is provided with a pad base (2b), the pad base (2b) has a plurality of pad unit (2a) including the fetal sensor unit 110 It may be removable.

According to another aspect of the present invention, the present invention includes a fetal sensor unit 110 for detecting the state of the fetus and includes a fetal communication unit 120 for transmitting the fetal detection state signal of the fetal sensor unit 110 to the outside. And a pad module (2) which can be worn on the mother's abdomen, the communication unit (210) communicating with the fetal communication unit (120) to receive a fetal detection state signal, and the fetal detection state signal transmitted from the communication unit (210). And a fetal well-being state index for checking whether the fetal well-being state is calculated through the calculation unit 240 using the preset data stored in the storage unit 230 and determining the well-being state of the fetus. Providing step (S1) for providing a fetal well condition determination apparatus 10 including a fetal state determination module 100 having a control unit 220 for controlling to output through the (S1), and the control unit 220 A sensing step (S10) in which the fetal sensor unit 110 detects a fetal state by applying a sensing control signal to the sensor unit 110, and the fetal ECG detected by the control unit 220 in the sensing step (S10). An evaluation step (S20) of evaluating the condition of the fetus based on the signal, the fetal motion signal, and the preset data, and an output evaluation step (S30) of outputting the evaluation result confirmed at the evaluation step (S20) to the outside. To provide a method of controlling the fetal well-being state determination device.

In the fetal well-being state control device control method, the fetal sensor unit 110: an electrocardiogram sensor 111 for detecting the ECG signal of the fetus is disposed in the pad module and close to the abdomen of the mother, and the pad module And an ultrasonic sensor 113 disposed close to the abdomen of the mother and detecting movement of the fetus, wherein the detecting step S10 includes: an electrocardiogram detection step in which the electrocardiogram sensor 111 detects an electrocardiogram of the fetus ( S11), and the ultrasonic sensor 113 may include a motion detection step (S13) for detecting the movement of the fetus.

In the fetal well-health determination device control method, the evaluation step (S20): the control unit 220, at least by using the fetal ECG signal and fetal movement signal detected by the fetal sensor unit 110, at least Fetal wellness index, which indicates the well-being of the fetus (

Judging and comparing the state of well-being of the fetus using a judgment index calculation step (S21) for calculating a judgment index including a) and a judgment index including a fetal wellness index (X) calculated in the judgment index calculation step (S21). An evaluation comparison step S23 may be included.

In the fetal well-health determination device control method, the determination index calculation step (S21) is: fetal heart rate per minute (r) calculated from the electrocardiogram signal and a predetermined fetal heart rate change amount that is pre-stored in the storage unit 230 Coefficient(

Fetal Nerve Stability Index, calculated from

) Shows the fetal nerve stability index (R) calculating step (S211) for calculating the fetal heart rate variation,

The fetal heart rate variability coefficient Δv preset in the storage unit 230 may be set to a preset fetal heart rate change time (

Fetal acidosis index, which is divided by the maximum deviation (| r |) of fetal heart rate (r) per minute changed during

Fetal acidosis index (V) calculating step (S213) and the secondary index for the fetal heart rate variance, which is calculated to be normal to be confirmed during the preset time (tc) stored in the storage unit 230 Fetal acidosis index, which is the number of occurrences of the predetermined fetal acidosis index (Δcs) divided by the measured normal fetal acidosis index (V) occurrence number (c)

) Fetal acidosis index (C) calculating step (S215) for calculating the fetus movement, and the predetermined fetal movement calculation time (preset stored in the storage unit 230)

Fetal nerve development index (△ m) divided by the number of fetal movements measured (m), which is preset as normal during

) Fetal nerve development index (M) calculating step (S217) and fetal nerve stability index (

) And fetal acidosis index (

) And fetal acidosis index (

) And fetal nerve development index (

Fetal wellness index (finally confirming the well-being state of the fetus from)

The fetal well-being index (X) calculating step (S219) may be calculated.

In the fetal well-being state control device control method, the evaluation comparison step (S23): using the determination index including the fetal wellness index (X) calculated in the determination index calculation step (S21) to determine the well-being state of the fetus In the case of judging the well-being state (S231) and the fetal well-being state is determined in the well-being state determination step (S231), non-good-bye type determination step of checking the type of non-good condition of the fetus using the determination index ( S233) may be included.

In the fetal well-being state determination device control method, the well-being state determination step (S231): a fetal wellness index comparison step (S2311) for checking whether the fetal wellness index (X) is within a preset range, and the The fetal wellness index comparison step (S2311) may include a fetal wellness state setting step (S2313) of setting the state of the fetus to a well state when the fetal wellness index (X) exists within a preset range.

In the fetal well-health determination device control method, the non-good morning type determination step (S233): the fetal nerve stability index (

) Is a fetal nerve stability determination step (S2331) to determine whether or not exists within a predetermined fetal nerve stability range, and the fetal nerve stability index (

) Is within the predetermined fetal neuronal stability range, the fetal acidosis index (

) Is a fetal acidosis judgment step (S2333) to determine whether or not present within the preset acidosis index range, and the fetal acidosis index (

) Is within the preset acidosis index range, the fetal acidosis index (

) Is a fetal acidosis secondary determination step (S2335) to check whether or not exists within the range of a predetermined acidosis index, and the fetal acidosis index (

) Is within the preset acidosis index range, the fetal nerve development index (

Fetal nerve development determination step (S2337) may be included to determine whether a) is within a preset fetal nerve development range.

In the method of controlling the fetal well-being state determination device, after the determination index calculation step (S21) is executed, the control unit 220 is a mode for checking whether or not the current execution mode is a location check mode for checking the position of the fetus When it is confirmed that the checking step (S22) and the mode executed in the mode checking step (S22) is the positioning mode, the positioning step (S24) for checking the position of the fetal maternal abdomen using the ECG signal It may further include.

In the fetal well-health determination device control method, the ECG signal vector confirmation step (S241) for confirming the ECG vector component from the ECG signal and the ECG signal vector confirmation step (S241) It may also include a position calculation step (S243) for calculating the position of the fetus from the ECG vector component.

In the fetal well-health judging device control method, the ECG signal vector checking step (S241) includes: a vector direction checking step (S2411) of checking a vector direction from the ECG signal to calculate an orientation of the fetal heart, and a mother's abdomen. And a vector size checking step (S2413) of checking the vector size from the ECG signal to reflect the fetal heart orientation in the direction across the back.

According to the present invention, it is possible to provide a fetal well-being state determination device that is worn on the mother's abdomen and guides the consultation of the fetus well or specialist through a simple detection.

1 and 2 are schematic state diagrams and block diagrams of an apparatus for determining fetal well condition according to an embodiment of the present invention.

3 to 9 are flowcharts of a control method of the fetal well-being state determination apparatus according to an embodiment of the present invention.

10 is a state diagram showing an arrangement state of the fetal sensor unit of the fetal well-being state determination apparatus according to an embodiment of the present invention.

11 and 12 are diagrams showing an electrocardiogram state according to the heart and posture of the fetus of the fetal well-being state determination apparatus according to an embodiment of the present invention.

13 to 14 are flowcharts illustrating a modified example of the fetal well-being state determination apparatus according to an embodiment of the present invention.

15 is a state diagram of a modified example of the fetal well-being state determination apparatus according to an embodiment of the present invention.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. First of all, in adding reference numerals to the components of each drawing, it should be noted that the same reference numerals are used as much as possible even if displayed on different drawings. In addition, in describing the present invention, when it is determined that the detailed description of the related well-known configuration or function may obscure the gist of the present invention, the detailed description thereof will be omitted.

The fetal well-being state determination apparatus 10 of the present invention is a device that detects the state of the fetus to determine the well-being state of the fetus, and also provides a control method of the fetal well-health determination device of the present invention.

First, the fetal well condition determination apparatus 10 of the present invention includes a pad module 2 and a fetal state determination module 200.

The paddle module 2 includes a fetal sensor unit 110 and a fetal communication unit 120. The fetal sensor unit 110 detects a fetal state, and detects and transmits a fetal state through detecting an ECG, a heart rate, and a movement of the fetus.

The pad module 2 is worn on the mother's abdomen, the pad module 2 is provided with a pad Velcro (3) to enable a ring fit to match the mother's body size. The pad module 2 may be based on a predetermined elastic material, and the fetal sensor unit 110 may be in close contact with the abdomen of the mother to more accurately detect the state from the fetus.

The fetal communicator 120 transmits the fetal state signal detected by the fetal detector 110 to the fetal state determination module 200. The communicator 210 communicates with the fetal communicator 120 to receive a fetal detection status signal. The fetal communicator 120 may be replaced with a simple signal line or a communication line when the pad module and the fetal state determination module are integrated as described below, or may be integrated with the communicator described below.

The fetal communication unit 120 may form a structure for transmitting a fetal state detection signal through an electrical connection with a cable, or in some cases, may form a signal transmission structure through a wireless without a separate cable. The wireless communication method is not limited to a specific method and may take various communication methods.

In the present embodiment, the pad module 2 has a configuration including a fetal communication unit 120 and a fetal detection unit 110. The pad module 2 signals the fetal sensor unit 110 and the fetal communication unit 120 to the side of the pad module 2. A separate fetal module controller (not shown) for processing and controlling may be provided, or various modifications may be possible, such as a single chip form in the fetal communication unit 120 to the fetal sensor unit 110.

The fetal state determination module 200 includes a communication unit 210 and a control unit 220, further includes a storage unit 230 and a calculation unit 240, and further includes an output unit 250. The communicator 210 communicates with the fetal communicator 120 to receive a fetal detection status signal. As described below, the communication unit 210 may be modified in various ways, such as when the pad module and the fetal state determination module are integrated, but may be replaced by a simple signal line or a communication line.

The controller 220 receives the fetal detection status signal transmitted from the communication unit 210. The control unit 220 makes electrical communication with the storage unit 230 and the operation unit 240, and the control unit 220 performs a calculation process through the operation unit 240 using preset data stored in the storage unit 230. You can run

The fetal state determination module 200 is implemented as a smartphone in this embodiment, without being limited thereto, the fetal state determination module 200 may be implemented as a module device used individually in a hospital or as a separate sound and alarm function device. Various modifications are possible, such as may be implemented. In addition, the fetal state determination module 200 is shown as being separated from the pad module in the present embodiment, but the present invention is not limited thereto, but the fetal state determination module and the pad module may form an integrated structure, in which case the communication unit is a simple signal. Various modifications are possible, such as being replaced by lines or wired communication lines.

More specifically, the fetal sensor unit 110 includes an electrocardiogram sensor 111 and an ultrasonic sensor 113. The ECG sensor 111 is disposed in the pad module 2 and is disposed in close proximity to the mother's abdomen to detect an ECG signal of the fetus.

In the present embodiment, the ECG sensor 111 includes an ECG reference electrode 111a and an ECG collection electrode 111b. The ECG sensor 111 may include one or more ECG sensors 111. ) May be provided in plurality. The plurality of ECG sensors 111 may extract an accurate fetal ECG signal by combining signals obtained at various positions through a substantially uniform arrangement.

The ECG reference electrode 111a surrounds the mother's abdomen and is disposed in plural and outputs a reference electrode signal. The ECG collection electrode 111b is disposed between the ECG reference electrodes 111a at least partially projected on a plane perpendicular to the mother's key direction (see FIGS. 1 and 10 (a) to (c)).

The electrical signal connected through the electrocardiogram reference electrode 111a and the electrocardiogram collection electrode 111b may be filtered and signal processed by the controller 220 to extract only the ECG signal of the fetus.

The ultrasonic sensor 113 is disposed in the pad module 2 and disposed close to the mother's abdomen to detect fetal movement. Ultrasonic sensor 113 may also be arranged in plurality, and by removing the noise generated by the operation of the mother through a predetermined filtering and signal processing to exclude the effect of the mother only fetal movement state signal corresponding to the movement of the fetus Can be extracted.

In more detail, the fetal state determination module 200 further includes a communication unit 210 and a control unit 220, and further includes a storage unit 230 and a calculation unit 240. The communication unit 210 may further include a fetal communication unit ( 120) a signal transmission may be achieved through a predetermined communication protocol with the side, and in some cases, a variety of selections may be made, such as transmission of an electrical communication signal through a cable.

The controller 220 processes the fetal state detection signal detected by the fetal sensor unit 110 through the fetal communication unit 120 and processes the fetal state detection signal transmitted through the communication unit 210 to determine the current fetal state. The controller 220 may include a filter unit and a signal processor as described above, and the controller 220 is connected to the storage unit 230 and the operation unit 240 to receive the fetal state detection signal and the storage unit 230. In this case, a determination control process for determining whether the fetus is in a normal state may be performed using the preset data stored in the control unit, and a control signal may be output through the output unit 250.

The storage unit 230 stores preset data, and controls the fetal state detection signal transmitted through the communication unit 210 via the fetal communication unit 120 and the fetal state detection signal detected by the fetal sensor unit 110. ) Can process and receive it and store it. According to the storage control signal of the control unit 220 may store the necessary data or withdraw the stored data.

The calculation unit 240 may perform a calculation process for determining the fetal state by using the fetal state detection signal and preset data according to the arithmetic control signal of the control unit 220. The calculation result through the calculator 240 may be stored in the storage 230 through the controller 220 or directly.

The output unit 250 may include a sound output unit 251 to an image output unit 253. The sound output unit 251 may be implemented as a speaker and may receive sound output control signals of the controller 220 and output sound / audio data included in preset data of the storage unit 230. That is, by outputting sound / voice data corresponding to the fetal state determined by the controller 220, the mother and the like can more easily and smoothly check the fetal state, so that follow-up measures can be more smoothly performed when necessary.

The image output unit 253 is implemented as a display, and the image output unit 253 may receive image output control signals from the controller 220 and output image data included in preset data of the storage unit 230. That is, the controller 220 may output image data corresponding to the fetal state determined by the controller 220 to visualize the mother for easier understanding.

Although the output unit 250 exemplifies the sound output unit and the image output unit, in some cases, it is also possible to implement a tactile signal output such as a vibration or an olfactory signal output such as a scent smell. Various modifications are possible in the range to be taken.

On the other hand, the control unit 220 of the fetal well-being state determination apparatus 10 of the present invention by using the fetal ECG signal and fetal movement signal detected by the fetal sensor unit 110, fetal well-being index indicating the fetal well-being state Calculate (X).

Here, fetal well-being index (X) can be expressed as follows.

In this case, r represents fetal heart rate per minute calculated from the ECG signal, and fetal nerve stability index (R) is a fetal heart rate r per minute and a preset fetal heart rate change coefficient pre-stored in the storage unit 230 (

It is calculated from) to represent the fetal nerve stability state, fetal nerve stability index (R) is expressed as follows.

In addition, fetal acidosis index (V) represents the heart rate variation of the fetus, fetal acidosis index (V) is expressed as follows.

The fetal acidosis index (V) is a fetal heart rate variation coefficient (Δv) preset in the storage unit 230, the preset fetal heart rate change time (

The maximum deviation (| r |) of fetal heart rate (r) per minute changed during

Fetal acidosis index (C) represents a supplemental index for heart rate variability of the fetus, and fetal acidosis index (C) is preset to be normal as confirmed during a preset time (tc) that is preset and stored in storage 230. The number of occurrences of fetal acidosis index (Δcs) divided by the measured number of normal fetal acidosis index (V) occurrences (c) is expressed as follows.

The fetal nerve development index (M) indicates fetal movements, and a preset fetal movement calculation time (preset stored in the storage 230)

The fetal movement incidence (△ m) divided by the measured number of fetal movements (m) is expressed as follows.

This preset fetal heart rate change coefficient (

), Preset fetal acidosis index (Vs), and preset fetal movement calculation time (

) Is included in the preset data stored in the storage 230. This operation process may be performed through an operation control signal for the operation unit 240 of the control unit 220.

The controller 220 determines whether or not the fetal wellness index X is in a state of fetal wellness by comparing with preset data stored in the storage 230.

In some cases, the fetal well-being state determination device 10 of the present invention may determine the position of the fetus to secure the fetal posture data. The control unit 220 of the fetal well-being state determination device 10 calculates the ECG vector signal and the ECG signal magnitude from the ECG detection signal. That is, as shown in FIGS. 11 and 12, the ECG signal of the fetus obtained from the ECG reference electrode 111a (see FIG. 10) and the ECG collection electrode 111b (see FIG. 10) is referred to as the ECG reference electrodes 111a and 10. ) And the ECG signal size and pattern change according to the ECG collection electrode 111b (see FIG. 10) and the fetal heart orientation. The electrical signals of various parts of the heart are measured by one electric signal through electric acceleration and deceleration, and can be formed as unit signals of electrocardiogram (P-QRS-T wave). Repeatedly, when the direction of the vector changes, the measurement signal changes, which can be used to identify changes in the position of the heart and to predict object movement. Arrows in FIG. 11 represent electrical signal vectors for the heart. The direction of deflection of the electrical signal obtained from the ECG sensor 111 is changed through the difference between the cardiac electrical signal vector and the orientation of the heart. By tracking the variation in the deflection direction of the electrical signal, the fetal heart position, ultimately the position and posture of the fetus can be collected, thereby obtaining the normal position and posture occupancy according to the fetal current position and fetal growth stage. It is possible to check whether or not.

In some cases, the pad module 2 may include a pad base 2b, and a plurality of pad units 2a including the fetal sensor unit 110 may be detachably attached to the pad base 2b.

That is, in the case of the initial state of the fetus and after the week is filled to some extent, a change in the position occupied by the fetus in the womb occurs and a plurality of fetal sensor units are used to detect the fetal state more accurately. It is also possible to take a structure that can be attached to additionally or necessary selectively according to the growth of the fetus by taking a detachable manner attached to them (Fig. 15).

Hereinafter, a control process of the fetal well condition determination apparatus 10 of the present invention will be described with reference to the accompanying drawings.

First, the providing step S1 is executed, and in the providing step S1, the fetal well-being state determination device 10 is provided. The fetal well condition determination apparatus 10 is replaced with the above description.

After the fetal well condition determining apparatus 10 is provided in the providing step S1, the detecting step S10 is executed. In the sensing step (S10), the control unit 220 transmits a detection control signal to the pad module 2 through the communication unit 210, and the fetal sensor unit 110 disposed in the abdomen of the mother through the fetal communication unit 120 is provided. The fetus detects the state of the fetus to generate a fetal detection state signal, and the fetal detection state signal is transmitted to the control unit 220 via the fetal communication unit 120 and the communication unit 210 again.

In this case, the fetal sensor unit 110 is disposed on the pad module as described above and placed close to the abdomen of the mother to detect the ECG signal of the fetus, and the pad module is disposed on the mother's abdomen An ultrasound sensor 113 is disposed in proximity to detect movement of the fetus, and the detecting step S10 includes an electrocardiogram detecting step S11 and a motion detecting step S13.

In the ECG detection step S11, the ECG sensor 111 detects the ECG of the fetus, and in the motion detection step S13, the ultrasound sensor 113 detects the movement of the fetus and is transmitted to the controller 220 through the fetal communication unit. . In some cases, after the step S13 is finished, the controller 220 compares the preset detection time ts included in the preset data stored in the storage shelf 230 with the elapsed detection time, and the detected elapsed time t is preset. If it is greater than the set detection time (ts), the detection state is terminated (S19), or the preset detection time (ts) is compared with the elapsed detection time (S15) so that the detection elapsed time (t) is equal to the preset detection time (ts). In the following case, the time may be incremented by Δt and the sensing steps of S11 and S13 may be repeated.

* Then, the control unit 220 executes the evaluation step (S20), the control unit 220 is based on the fetal ECG signal and fetal motion signal and the preset data stored in the storage unit 230 detected in the detection step (S10) Assess the condition of the fetus on the basis of

The evaluation step S20 includes a determination index calculation step S21 and an evaluation comparison step S23, and the evaluation state confirmed in the evaluation comparison step S23 is determined in the comparison result determination step S25, and the storage unit ( 230 may be stored.

In the determination index calculation step (S21), the control unit 220 uses the fetal ECG signal and the fetal motion signal detected by the fetal sensor unit 110, at least fetal well-being index indicating the fetal well-being state (

Calculate the judgment index including

In the evaluation comparison step (S23), the control unit 220 judges and compares the well-being state of the fetus using the determination index including the fetal well-being index (X) calculated in the determination index calculation step (S21).

More specifically, the determination index calculation step (S21) is a fetal nerve stability index (R) calculation step (S211), fetal acidosis index (V) calculation step (S213), fetal acidosis index (C) calculation step (S215) ), A fetal nerve development index (M) calculation step (S217), and a fetal wellness index (X) calculation step (S219).

In the fetal nerve stability index (R) calculation step (S211), the control unit 220 calculates the fetal heart rate r per minute calculated from the electrocardiogram signal and a preset fetal heart rate change amount coefficient pre-stored in the storage unit 230 (

Fetal Nerve Stability Index, calculated from

) Is calculated.

In the fetal acidosis index (V) calculation step (S213), the control unit 220 indicates the heart rate variation of the fetus, and sets the fetal heart rate variation coefficient Δv preset in the storage unit 230.

) Is calculated.

It shows an auxiliary index for the heart rate variation of the fetus, the fetal acidosis index (C) in the calculation step (S215) the control unit 220 is normal to be confirmed during the preset time (tc) that is stored in the storage unit 230 in advance Fetal acidosis index, which is the number of occurrences of the predetermined fetal acidosis index (Δcs) divided by the measured normal fetal acidosis index (V) occurrence number (c)

) Is calculated.

The fetal nerve development index (M) indicates fetal movement. In the fetal neural development index (M) calculation step (S217), the control unit 220 is a preset fetal movement calculation time (preset stored in the storage unit 230)

) Is calculated.

In the fetal wellness index (X) calculation step (S219), the control unit 220 is fetal nerve stability index (

) And fetal acidosis index (

) And fetal acidosis index (

) And fetal nerve development index (

) Is calculated.

Thereafter, the control unit executes an evaluation comparison step S23, and the evaluation comparison step S23 executes a well-being state determination step S231 and a no-hisday type determination step S233.

In the evaluation comparison step S23, the wellness state determination step S231 determines the wellness state of the fetus using a determination index including the fetal wellness index X calculated in the determination index calculation step S21.

When it is determined in the well state determination step (S231) that the fetal well-being state is not, in the non-good type determination step (S233), the control unit 220 checks the non-good state type of the fetus using the determination index.

More specifically, the well state determination step (S231) includes a fetal wellness index comparison step (S2311) and a fetal wellness state setting step (S2313).

In the fetal wellness index comparison step (S2311), the controller 220 determines whether the fetal wellness index X is within a preset range.

In the fetal wellness state setting step (S2313), the control unit 220 sets the state of the fetus to a wellness state when the fetal wellness index (X) exists within a preset range in the fetal wellness index comparison step (S2311).

The non-good type determination step (S233) includes a fetal nerve stability determination step (S2331), a fetal acidosis determination step (S2333), a fetal acidosis assistance determination step (S2335), and a fetal nerve development determination step (S2337).

In the fetal nerve stability determination step (S2331), the control unit 220 is a fetal nerve stability index (

) Is within the range of preset fetal nerve stability. A typical heart rate r per minute ranges from 110 to 160 and Δrs is set to a value of 50 in this embodiment, but this can vary depending on specifications.

In this embodiment, it is checked whether the fetal nerve stability index R is in the range between 0 and 1, and if the fetal nerve stability index R is not in the range between 0 and 1, the control flow is step S2332 Is transferred to the current fetal state is set to fetal nerve stabilization check step (S2332) to check whether or not fetal nerve stabilization.

Fetal Nerve Stability Index (

) Is within a predetermined fetal nerve stability range, that is, between 0 and 1 in the present embodiment, the fetal acidosis determination step (S2333), the control unit 220 is a fetal acidosis index (

) Is within the preset range of acidosis index.

As described above, the fetal acidosis index (V) is a fetal heart rate variation coefficient (Δv) preset in the storage unit 230, the predetermined fetal heart rate change time (

The maximum deviation (| r |) of fetal heart rate (r) per minute changed during In this example, the heart rate variance coefficient (Δv) was used as 10 before 32 weeks and 15 after 32 weeks.

In this example, it is checked whether the fetal acidosis index (V) exists in the range between 0 and 1, and if the fetal acidosis index (V) does not exist in the range between 0 and 1, the control flow is transferred to step S2334. The current state of the fetus is set to fetal acidosis check step (S2334) to confirm whether or not fetal acidosis.

Then, the fetal acidosis index (

) Is within the preset acidosis index range, the control unit 220 is the fetal acidosis secondary index (S2335)

) Is within the range of preset acidosis index. Fetal acidosis index (

) Is a normal fetal acidosis index (V) occurrence count (c) measured the number of occurrences of the fetal acidosis index (△ cs) that is determined to be normal to be confirmed during the preset time (tc) that is stored in the storage unit 230 in advance. The value of 2 was used in this example as the number of occurrences of the predetermined fetal acidosis index (Δcs).

In this embodiment, it is confirmed whether fetal acidosis index (C) is present at a value of 1 or less, and if fetal acidosis index (C) is not present at a value of 1 or less, the control flow is transferred to step S2336 to present The state of the fetus is set to check fetal nerve stability check step (S2336) to determine whether fetal acidosis.

Then, in the fetal nerve development determination step (S2337), the control unit 220 is fetal acidosis index (

) Is within the prenatal fetal nerve development range.

Fetal Nerve Development Index (

The fetal movement occurrence frequency (Δm) preset as normal is divided by the measured fetal movement frequency (m), and the fetal movement occurrence frequency (Δm) preset as normal is a value of 1 to 3 in this embodiment. This was used.

In this embodiment, it is checked whether the fetal nerve development index (M) is present at a value of 1 or less, and if the fetal acidosis index (C) is not present at a value of 1 or less, the control flow is transferred to step S2338 to present The condition of the fetus is set to fetal nerve development check step (S2338) to determine whether fetal nerve development.

If it is determined in step S2337 that the fetal neural development index (M) does not exist as a value less than or equal to 1, the controller 220 determines that there is an error in detecting or determining the current state of the fetus and checks the current state in an error checking step (S2339). Check with).

After the evaluation step is completed, the control unit 220 executes an output step (S30) for outputting the evaluation result confirmed in the evaluation step (S20) to the outside. In the output step (S30), the output method may be variously selected, such as sound / audio output or image output may be performed according to the type of the output unit 250 described above.

On the other hand, the control method of the fetal well-being state determination apparatus 10 of the present invention may further comprise the step of identifying the position of the fetus to utilize the position information of the fetus to determine the fetal well-being state. That is, as illustrated in FIGS. 13 and 14, the evaluation step S20 further includes a mode checking step S22 and a positioning step S24. After the determination index calculation step S21 is executed, in the mode confirmation step S22, the controller 220 checks whether the currently executed mode is a location checking mode for checking the position of the fetus.

When it is confirmed that the mode executed in the mode check step (S22) is the location check mode, in the location check step (S24), the control unit 220 checks the position of the fetal maternal abdomen using the ECG signal.

The positioning step S24 to be executed when the positioning mode is confirmed includes an ECG signal vector checking step S241 and a position calculating step S243.

In the ECG signal vector checking step S241, the controller 220 checks the ECG vector component from the ECG signal.

In step S243, the controller 220 calculates the position of the fetus from the ECG vector component calculated in the ECG signal vector checking step S241.

The ECG signal vector checking step S241 includes a vector direction checking step S2411 and a vector size checking step S2413. The vector direction checking step S2411 verifies the vector direction from the ECG signal to calculate the orientation of the fetal heart. The vector size checking step (S2413) checks the vector size from the ECG signal to reflect the fetal heart orientation in the direction across the mother's abdomen and back (see FIGS. 11 and 12).

By checking the vector direction and the vector size, the control unit 220 may compare the preset data of the storage unit 230 to check information on the current position and posture of the fetus and use it in the evaluation comparison step.

The above description is merely illustrative of the technical idea of the present invention, and those skilled in the art to which the present invention pertains may make various modifications and changes without departing from the essential characteristics of the present invention. As described above, the pad module and the fetal state determination module may take an individually separable configuration or may have an integrated configuration that is formed integrally, such as to facilitate the diagnosis of the condition through fetal detection and state determination. Various optional configurations are possible within the scope.

Therefore, the embodiments disclosed in the present invention are not intended to limit the technical idea of the present invention but to describe the present invention, and the scope of the technical idea of the present invention is not limited by these embodiments. The protection scope of the present invention should be interpreted by the following claims, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of the present invention.

Claims

A pad module (2) including a fetal sensor unit (110) for detecting a fetal state and a fetal communication unit (120) for transmitting a fetal detection state signal of the fetal sensor unit (110), and which can be worn on a mother's abdomen and,

By using the communication unit 210 to communicate with the fetal communication unit 120 receives the fetal detection state signal, and the fetal detection state signal transmitted from the communication unit 210 and the preset data stored in the storage 230. The fetus having a control unit 220 for controlling the output through the output unit 250 to calculate the fetal well-being state index to determine whether the fetal well-being state through the calculation unit 240 through the calculation process and to determine the well-being state of the fetus Fetal well state determination device 10 comprising a state determination module 100.
The method of claim 1

The fetal sensor unit 110:

An electrocardiogram sensor 111 disposed on the pad module and disposed close to the abdomen of the mother to detect an ECG signal of the fetus;

Fetal well-being state determination device (10) characterized in that it is disposed on the pad module and disposed close to the abdomen of the mother detects the movement of the fetus (113).
The method of claim 2,

The ECG sensor 111 is:

An electrocardiogram reference electrode 111a surrounding a mother's abdomen and arranged in a plurality, and outputting a reference electrode signal;

Fetal well state determination device (10), characterized in that at least a portion includes an electrocardiogram collection electrode (111b) disposed between the electrocardiogram reference electrode (111a) in a plane projection perpendicular to the mother's key direction.
The method of claim 3, wherein

The controller 220 calculates a fetal wellness index (X) representing a fetal wellness state by using an ECG signal and a fetal motion signal of a fetus detected by the fetal sensor unit 110, and calculates the fetal wellness index. (X) is:

The fetal wellbeing index (X) is compared with the preset data stored in the storage unit 230 to determine the state of the fetus,

Here, r represents fetal heart rate per minute calculated from the ECG signal,

Fetal Nerve Stability Index (
) Is a fetal heart rate (r) per minute and a predetermined fetal heart rate change coefficient (stored in the storage unit 230) (
Is calculated from) and represents the neuronal stability of the fetus,

Fetal acidosis index (
) Represents the fetal heart rate variation, and the fetal heart rate variation coefficient (Δv) preset in the storage unit 230 is a preset fetal heart rate change time (
Divided by the maximum deviation (| r |) of fetal heart rate (r) per minute changed during

Fetal acidosis index (
) Represents an auxiliary index for the heart rate variability of the fetus, and measures the number of occurrences of the prenatal fetal acidosis index Δcs, which is confirmed to be normal during the preset time tc, which is preset and stored in the storage unit 230. Normal fetal acidosis index (V) divided by the number of occurrences (c),

Fetal Nerve Development Index (
Represents a fetal movement, and a predetermined fetal movement calculation time (preset stored in the storage 230)
Fetal well-being state determination device 10, characterized in that divided by the number of fetal movements (m) measured by the predetermined number of fetal movement occurrence (△ m) during the normal.
The method of claim 4, wherein

The controller 220 calculates an electrocardiogram vector signal and an electrocardiogram signal magnitude from the electrocardiogram detection signal, and checks the fetal position of the fetus from the electrocardiogram vector signal and the electrocardiogram signal size. .
The method of claim 1,

The pad module 2 has a pad base 2b,

The pad base (2b) fetal well state determination device, characterized in that the plurality of pad unit (2a) including the fetal sensor unit 110 is removable.
A pad module including a fetal sensor unit 110 for detecting a state of a fetus and a fetal communication unit 120 which transmits a fetal detection state signal of the fetal sensor unit 110 to the outside, and which can be worn on a mother's abdomen ( 2) and a communication unit 210 communicating with the fetal communication unit 120 to receive a fetal detection state signal, and a preset setting stored in the fetal detection state signal and the storage unit 230 transmitted from the communication unit 210. Control unit 220 for calculating the fetal well-being state index to check whether the fetal well-being state through the calculation unit 240 through the calculation process using the data, and determines the well-being state of the fetus to output through the output unit 250 Providing step (S1) for providing a fetal well state determination device 10 comprising a fetal state determination module 100 having a;

A sensing step (S10) in which the control unit 220 applies a detection control signal to the fetal sensor unit 110 to detect the fetal state by the fetal sensor unit 110;

An evaluation step (S20) of the control unit 220 evaluating a fetal state based on the fetal ECG signal, the fetal movement signal, and the preset data detected in the detecting step S10;

Fetal well condition determination device control method comprising an output evaluation step (S30) for outputting the evaluation result confirmed in the evaluation step (S20) to the outside.
The method of claim 7, wherein

The fetal sensor unit 110: an electrocardiogram sensor 111 disposed on the pad module and disposed close to the mother's abdomen to detect an ECG signal of the fetus, and placed on the pad module and placed close to the mother's abdomen, the fetus Ultrasonic sensor 113 for detecting the movement of the,

The detecting step (S10) is:

An electrocardiogram sensor (S11) for detecting the ECG of the fetus by the ECG sensor 111;

Fetal well-being state control device control method characterized in that the ultrasonic sensor 113 comprises a motion detection step (S13) for detecting the movement of the fetus.
The method of claim 8,

The evaluation step (S20) is:

The control unit 220, by using the fetal ECG signal and fetal movement signal of the fetus detected by the fetal sensor unit 110, fetal well-being index indicating at least fetal wellness state (
A judgment index calculation step (S21) of calculating a judgment index including a),

Determination of fetal well-being state characterized in that it comprises an evaluation comparison step (S23) for judging and comparing the well-being state of the fetus using the determination index including the fetal wellness index (X) calculated in the determination index calculation step (S21) Device control method.
The method of claim 9,

The determination index calculating step S21 is:

The fetal heart rate r per minute calculated from the electrocardiogram signal and a preset fetal heart rate change coefficient prestored in the storage unit 230 (
Fetal Nerve Stability Index, calculated from
Calculating fetal nerve stability index (R) calculating step (S211),

The fetal heart rate variation is represented, and the fetal heart rate variation coefficient (Δv) preset in the storage unit 230 is set to the fetal heart rate change time (
Fetal acidosis index, which is divided by the maximum deviation (| r |) of fetal heart rate (r) per minute changed during
Calculating fetal acidosis index (V) calculating step (S213),

Normal fetus indicating the secondary index for the heart rate variation of the fetus, and the occurrence frequency (△ cs) of the fetal acidosis index preset as normal confirmed during the preset time (tc) stored in the storage unit 230 is measured. Fetal acidosis index, divided by the acidosis index (V) frequency of occurrence (c) (
Calculating fetal acidosis index (C) calculating step (S215),

Indicative of the movement of the fetus, the predetermined fetal movement calculation time (preset stored in the storage 230)
Fetal nerve development index (△ m) divided by the number of fetal movements measured (m), which is preset as normal during
Calculating fetal nerve development index (M) calculating step (S217),

Fetal Nerve Stability Index (
) And fetal acidosis index (
) And fetal acidosis index (
) And fetal nerve development index (
Fetal wellness index (finally confirming the well-being state of the fetus from)
Fetal well-being index (X) calculating step (S219) to calculate a) fetal well-being state control device control method.
The method of claim 10,

The evaluation comparison step (S23) is:

A well-being state determination step (S231) of judging the well-being state of the fetus by using the judgment index including the fetal well-being index (X) calculated in the determination index calculating step (S21);

If it is determined in the well-being state determining step (S231) is not fetal well-being state, fetal well-being comprising a non-good type determination step (S233) to check the type of non-good condition of the fetus using the determination index How to control the state judgment device.
The method of claim 11,

The well state determination step (S231) is:

A fetal wellness index comparing step (S2311) of checking whether the fetal wellness index (X) is within a preset range;

A fetus comprising a fetal well state setting step (S2313) of setting a fetal state to a well state when the fetal wellness index (X) exists within a preset range in the fetal wellness index comparing step (S2311) Hi state judgment device control method.
The method of claim 12,

The non-hello type determination step (S233) is:

Fetal nerve stability index (
Fetal nerve stability determination step (S2331) of checking whether or not exists within the preset fetal nerve stability range, and

Fetal nerve stability index (
) Is within the predetermined fetal neuronal stability range, the fetal acidosis index (
Fetal acidosis determination step (S2333) to determine whether or not exists within the preset acidosis index range,

Fetal acidosis index (
) Is within the preset acidosis index range, the fetal acidosis index (
Fetal acidosis secondary determination step (S2335) to determine whether or not exists within the range of the preset acidosis index, and

Fetal acidosis index (
) Is within the preset acidosis index range, the fetal nerve development index (
Fetal neural development judgment step (S2337) of determining whether or not to exist within the predetermined fetal nerve development range.
The method of claim 9,

After the determination index calculation step (S21) is executed, the control unit 220 checks whether the mode that is currently executed is a position checking mode for checking the position of the fetus (S22),

When it is confirmed that the mode executed in the mode check step (S22) is the positioning mode, further comprising a positioning step (S24) for confirming the position of the fetal maternal abdomen using the ECG signal How to control fetal wellness judgment device.
The method of claim 14,

An electrocardiogram signal vector confirming step (S241) in which the controller 220 identifies an electrocardiogram vector component from the electrocardiogram signal;

And a position calculating step (S243) of calculating a position of the fetus from the ECG vector component calculated in the ECG signal vector checking step (S241).
The method of claim 15,

The ECG signal vector checking step (S241) is:

A vector direction checking step (S2411) of checking a vector direction from the ECG signal to calculate an orientation of the fetal heart;

And a vector size checking step (S2413) of checking the vector size from the ECG signal so as to reflect the fetal heart orientation in the direction across the mother's abdomen and back.