This invention relates to maternal and foetal recorder to collect and analyse data and the method for collection and analysis of data with the use of maternal and foetal recorder which allow for ongoing monitoring of foetal development and parameters, especially in threatened pregnancies with high probability of miscarriage. Assessment of foetal status has always posed a considerable challenge in obstetrics. There are methods for anatomy assessment to help in intrauterine identification of developmental defects (ultrasonography, Doppler examination of a foetus), however it is not always possible to provide answers to all questions regarding foetus' well-being. Often well-being of a pregnant woman does not correspond to intrauterine foetal status, therefore it is necessary to use appropriate equipment to monitor it. Biophysiological diagnostics during intensive obstetric supervision is mainly based on cardiac function monitoring.

Foetal heart rate ranges from 120-180 bpm. Ongoing changes in the heart rate result from current behaviour of the foetus (rest, movement) as well as from psychophysiological status of the pregnant woman and location of women and foetus towards each other. Foetal heart rate may change frequently, even by 25 bpm in relation to the average value. The simplest device used to measure foetal heart rate is a stethoscope or an ear speaker with acoustic amplifier connected e.g. to a smartphone. It allows to listen and record changes of the heart rate along with development of the foetus. The primary advantage of this set include its simplicity and low price (several dozens of USD). Its disadvantages in turn include its low selectivity as it record all sounds reaching an earphone instead of only those which come from the heart rate. Therefore, such equipment is more like an interesting gadget than a diagnostic device.

There are cardiotocographic devices, the so-called CTG, to monitor foetal parameters which are used in maternity wards. Such devices have a form of a portable or stationary central unit equipped with electrode system, a printer and a speaker. Sometimes they are also equipped with a monitor showing a foetal heart rate. Portable CTG devices are additionally provided with a battery, but in such a case the device has the dimensions of a medium-sized briefcase and its portability is basically limited to rooms for pregnant women or to an ambulance. Electrotocograph's electrodes in older models of such devices are attached to the pregnant women's abdomen by a flexible belt pressing them to patient's body. Pressure on the mother's body is not indifferent for foetal health status, whereas long- lasting CTG examination, i.e. longer than 2.5 hours, poses a risk of complications, including miscarriage. Patient's discomfort due to prolonged immobility and stationary test is also significant. Additionally, as far as "Doppler" methods - such as CTG - are concerned, there is a need to use special gel which creates an intermediate layer between measurement head and skin. The gel must be used due to attenuation of an ultrasound signal by air layer present between face of the measurement head and patient's skin. Gel displaces the air from the boundary layer and thereby substantially improves acoustic contact between media which significantly reduces attenuation of the signal. It additionally decreases friction and facilitates moving the head on the patient's skin while searching for measurement signal.

More recent CTG devices are equipped with electrodes stuck to patient's abdomen which eliminates pressure on the uterus caused by belts but does not eliminate the need for a substantially fixed position in which pregnant woman must stay during the entire examination.

There are also fully portable devices which allow pregnant woman to function as usually. As in the case of more recent CTG devices, self-adhesive electrodes are stuck to patient's body and cooperate with a central unit which has the dimensions of average size mobile phone.

There is also a device according to ES2385619 which has at least two detectors to identify foetal heart rate and each detector contains at least two electrodes for detecting of ECG signals. A processor which is connected with the sensors (electrodes) is used to process signals received from each ECG detector and determines foetal heart rate. ECG signal processor has means for detecting heart rate of the mother determined after reaching of maximal ECG signals from detectors placed on mother's abdomen and means for determining pulse by identifying time intervals between each heart beat to determine mother's heart rate. Processor is configured to process signals from sensors, one of which is placed so that the electrode is located below the umbilical cord but before the pubic symphysis and the second sensor is placed below the pubic symphysis.

There is also an apparatus according to US2012150010 which detects uterine activity and has two input channels. The first one is a set of electric sensors (cutaneous electrodes) and the second one receives movement signals indicative of a movement of the maternal body. An output signal presents an electrohysterogram (EHG). There is also an apparatus according to GB2482758 for collecting foetal heart rate data and uterine activity data comprising means for receiving signals from sensors placed on the abdomen of a pregnant woman, electric signals indicative of foetal heart rate and uterine activity; means for process the above-mentioned signals to receive at least one parameter - at least pulse and at least one parameter related to uterine activity, as well as means for delivering output graphic or tabular form of at least one of the aforesaid foetal heart rate parameter and at least one uterine activity parameter per unit of time. Furthermore, the apparatus provides also an opportunity to obtain further foetal heart rate parameters, e.g. heart rate variability, pulse, RMSSD, time intervals, periods of contraction, the contraction strength and time delay of foetal heart rate.

There is also a device according to US4781200 with a central unit placed on belt with electrodes which has analytical subsystems which monitor the quality of signals received and if there are any disturbances in relation to normal range, they launch systems which inform a pregnant woman about the status beyond pre-programmed acceptable limits. Electrodes are placed in particular on abdominal belt and are acoustic electrodes (microphone, ECG sensors or bioimpedance).

There are also devices in which signals received by set of sensors are gathered or transmitted via a wireless network to be verified by a physician. Although all known devices precisely measure parameters, such as foetal heart rate and its mobility as well as uterine parameters, they must be analysed by a physician, because the vast majority of these devices known from the prior art does not include possible causes of deviations from the normal parameters, e.g. pregnant woman's movements, her body position, body temperature, etc. Additionally, even the devices which may on their own analyse the data gathered and are able to inform e.g. with an alarm about deviations of foetal vital functions, due to their construction, e.g. a device mentioned according to description of US4781200, the device itself may often interfere with the signal or discomfort the foetus and have negative impact on its vital signs.

Therefore, the aim was to develop a device and a method for data collection which will reflect foetal health status and be non-invasive and thus will allow to safely and correctly from the perspective of measurement methodology obtain data and if predetermined acceptable parameters are exceeded, they will send a message to a pregnant woman about immediate need to report to a physician. Additionally, the goal of the invention was to develop a device whose work would not be disturbed by external factors and to eliminate gels used with known devices to reduce such impact. At the same time, the invention's purpose was to create a device which would be able to constantly monitor foetal vital functions with no restrictions typical for Doppler (ultrasound) technology to 10 minutes per day due to harmful effect of ultrasound waves and 60 minutes per day in the case of CTG used in hospitals. These conditions are met by maternal and foetal recorder to collect and analyse data as well as method for collection and analysis of data with the use of maternal and foetal recorder according to the invention.

The invention specified that the maternal and foetal recorder to collect and analyse data has a main unit supplied from the internal source of energy, preferably a battery, at least one cable of a patient and at least one electrode attached to patient's body. Electrodes are connected to the main unit with at least one patient's cable. The main unit contains electronic components, preferably analog-to-digital converter, a processor, memory card, accelerometer, sound emitter, USB, SATA, battery as well as wireless connection module, preferably Bluetooth, at least one signalling diode, power button, standard ECG monitor connector, power connector and preferably a USB connector, place for a hanger and a clip to attach the device to the patient's clothes. Preferably, at least one electrode and in other construction example also a sound and temperature sensors are placed on the orthopaedic belt, preferably a lumbar one.

At least one electrode is an electrode which measures at least one type of signals among the following:

1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate)

2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position)

5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body

Preferably, the central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in at least 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

It is preferable if long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status. Central unit is additionally equipped with a part which prevents patient's cable and other cable, e.g. charger, from being connected with USB at the same time and this component is in form of a plug slidably connected to the housing in the area of both connectors or in other construction example such plug is a component fixedly connected with patient's cable and charger cable or data exchange cable. Preferably, the central unit has at least one built-in storage medium, preferably in the form of a memory card.

Preferably, at least five electrodes should be connected to patient's cable. Their connectors are permanently marked, in particular with numbers, letters or colours so that no mark is the same. Preferably, electrodes have an enlarged contact area with patient's body. Preferably, an external device to display foetal vital signs is connected through ECG monitor connector and/or USB. Preferably, an external device to display foetal vital signs is connected with Bluetooth. The device for displaying foetal vital parameters should preferably be in form of a personal computer. Preferably, data are presented at least in form of a diagram.

According to the invention, method for collection and analysis of data with the use of maternal and foetal recorder consists in that measurement electrodes connected with the main unit by patient's cable are placed on patient's body in the uterine area. Preferably, patient's abdominal skin should be moisturised before placing electrodes and top layer of the epidermis should be removed. Preferably, top layer of epidermis is removed with the use of tapes or a tape to remove the surface dead layer of the epidermis. After placing the electrodes on the patient's body, the data regarding the level of at least one following signal are collected and analysed:

1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate)

2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position) 5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body

Preferably, the central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in at least 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

It is preferable if long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status.

Maternal and foetal recorder to collect and analyse data as well as method for collection and analysis of data with the use of maternal and foetal recorder are presented on the drawing in Fig. 1 which shows schematically the device placed on patient's body; Fig. 2 presents orthopaedic belt with device connected to it according to the invention; Fig. 3 illustrates an exemplary graph of parameters gathered.

Example 1

The invention specified that the maternal and foetal recorder to collect and analyse data has a main unit 1 supplied from the internal source of energy - a battery, patient's cable 2 and set of electrodes 3 attached to patient's body. Electrodes E1-E5 are connected with the main unit 1 thought patient's cable 2. The main unit 1 contains electronic components: analog-to-digital converter, a processor, memory card, accelerometer, sound emitter, USB, SATA, battery as well as wireless connection module, preferably Bluetooth, a signalling diode, power button, standard ECG monitor connector, power connector and preferably a USB connector, place for a hanger and a clip to attach the device to the patient's clothes.

Electrodes measure at least one type of signals among the following: 1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate)

2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position)

5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body The central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

Long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status.

Central unit is equipped with a part which prevents patient's cable and other cable, e.g. charger, from being connected with USB at the same time and this component is in form of a plug slidably connected to the housing in the area of both connectors. The central unit has built-in storage medium in the form of a memory card.

Five electrodes should be connected to patient's cable. Their connectors are permanently marked so that no mark is the same. Electrodes have an enlarged contact area with patient's body.

An external device to display foetal vital signs is connected through patient's cable connector. An external device to display foetal vital signs is connected via Bluetooth. The device for displaying foetal vital parameters should preferably be in form of a personal computer and data are presented in form of a diagram. According to the invention, method for collection and analysis of data with the use of maternal and foetal recorder consists in that measurement electrodes connected with the main unit by patient's cable are placed on patient's body in the uterine area. Patient's abdominal skin should be moisturised before placing electrodes and top layer of the epidermis should be removed. Top epidermis layer is removed with the use of tapes or a tape to remove the surface dead layer of the epidermis.

After placing the electrodes on the patient's body, the data regarding the level of at least one following signal are collected and analysed:

1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate) 2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position) 5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body

Whereas the central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

Long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status.

Example 2

The invention specified that the maternal and foetal recorder to collect and analyse data has a main unit supplied from the internal source of energy - a battery, patient's cable and set of electrodes attached to patient's body. Electrodes are connected with the main unit thought patient's cable. The main unit contains electronic components: analog-to-digital converter, a processor, memory card, accelerometer, sound emitter, USB, SATA, battery as well as wireless connection module, preferably Bluetooth, a signalling diode, power button, standard ECG monitor connector, power connector and preferably a USB connector, place for a hanger and a clip to attach the device to the patient's clothes. Both electrodes and sound and temperature sensors are placed on the orthopaedic belt.

Electrodes measure at least one type of signals among the following:

1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate)

2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position)

5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body

The central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

Long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status.

Central unit is equipped with a part which prevents patient's cable and other cable, e.g. charger, from being connected with USB and this component is in form of a plug which is fixed with patient's cable and charger cable or data exchange cable.

The central unit has built-in storage medium in the form of a memory card. Five electrodes should be connected to patient's cable. Their connectors are permanently marked so that no mark is the same. Electrodes have an enlarged contact area with patient's body.

An external device to display foetal vital signs is connected through USB. An external device to display foetal vital signs is connected via Bluetooth. The device for displaying foetal vital parameters should preferably be in form of a personal computer and data are presented in form of a diagram.

According to the invention, method for collection and analysis of data with the use of maternal and foetal recorder consists in that measurement electrodes connected with the main unit by patient's cable are placed on patient's body in the uterine area. Patient's abdominal skin should be moisturised before placing electrodes and top layer of the epidermis should be removed. Top epidermis layer is removed with the use of tapes or a tape to remove the surface dead layer of the epidermis.

After placing the electrodes on the patient's body, the data regarding the level of at least one following signal are collected and analysed: 1. Electric signal of foetal heart rate (Holter measurement of foetal heart rate)

2. Electric signal of maternal heart rate (Holter measurement of maternal heart rate)

3. Mother's skin impedance (electric resistance of mother's skin), indirectly sweating and stress.

4. Mother's movement activity and body position (standing, supine position)

5. Contractive activity of the uterine muscle.

6. acoustic signal of foetal heart rate (foetal phonocardiography)

7. temperature of mother's body

Whereas the central unit has permanently recorded acceptable limits of at least electric signal of foetal heart rate corresponding to loss of pulse as well as tachycardia corresponding to the frequency of the primary foetal heart rate> 150/min (160) in 10-minute record, and bradycardia, i.e. the frequency of the primary action foetal heart rate <110/min which should trigger the alarm.

Long-term variability - oscillations (macrofluctuations) are measured and compared with standard values - fluctuations in heart foetal rate, changes of temporary foetal heart rate (decelerations or accelerations) fluctuating near average values lasting less than a minute and occurring at intervals of several seconds. Oscillations with no variability (silent oscillation acc. to Hammacher) - oscillation amplitude < 2 bpm and saltatory variability (saltatory oscillation) - oscillation amplitude > 25 bpm - are considered as the ones requiring an alarm. Additionally, it is preferable if decelerations, i.e. short-term decrease in foetal heart rate (> 15/min for 10 seconds or longer), are also recognised as an alarm-requiring status.