WO2010099764A2

WO2010099764A2 - Method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions and arrangement for performing thereof

Info

Publication number: WO2010099764A2
Application number: PCT/CZ2010/000022
Authority: WO
Inventors: Jan Korec
Original assignee: Medetron S.R.O.; Cominfo, A.S.
Priority date: 2009-03-02
Filing date: 2010-02-26
Publication date: 2010-09-10
Also published as: EP2403399A2; NZ595391A; AU2010220701A1; CZ2009127A3; WO2010099764A3

Abstract

A method of recognizing the risk of preterm birth consisting in observing the uterine activity based on uterine contraction analysis characterized in that the uterine activity of a patient is monitored continually, in the context of her movement activity, whereas data obtained from this monitoring are simultaneously measured and stored in the mobile sensor module, compared and evaluated consequently by application software using filtration and analysis algorithms of measured data by a method enabling consequential detection of uterine contractions, their frequency and intensity, evaluation of their causes and severity level; and, as a result, the early risk diagnosis of preterm birth. An arrangement for performing the method is formed by the mobile sensor module (1), which can be connected via its connector (13) to a home station (2) connector (23), said home station can be connected-through a wireless communication GPRS modem (24) to the data storage (31) on the FTP-server (3); whereas the data storage (31) can be then connected to an Internet interface (41) of a computer (4), or connected directly by the USB module (25) to the USB module (42) of the computer (4).

Description

METHOD OF RECOGNIZING THE RISK OF PRETERM BIRTH CONSISTING IN OBSERVING THE UTERINE ACTIVITY BASED ON THE ANALYSIS OF UTERINE CONTRACTIONS AND ARRANGEMENT FOR PERFORMING THEREOF

Technical field

This invention deals with method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions and arrangement for performing thereof.

State of the art

Existing solutions were, more or less, limited only to uterine activity monitoring in terms of the uterine contraction evaluation in shorter isolated time intervals, generally in a specialist's office (gynecologist). For this purpose, instruments (especially tocodynamometers) in common type of construction were and are still used only during ambulatory check-ups in hospitals. Disadvantages of these instruments consist not only in their size, but also in the limitations in record time during the time of the patient is being investigated (maximum ϊ hour), or in the creation of artificial conditions during investigation, i.e. patient is inactive; lying on the back or on the side. These solutions can, indeed, for a certainty indicate a problem, but cannot provide a well-timed prevention, which can be ensured only by the continuous registration of uterine activity in the context of other important factors.

In European patent No. EP 0286731 a method and instrument for an external measurement of uterine contractions, especially for indication the risk of preterm birth, is described. The essence of the method consists in periodical sampling of number and intensity of uterine contractions. Sampled analogue signals are after a relevant strengthening converted into digital signals, which are subsequently stored and processed and, finally, depicted 'and/or handed over to the microprocessor. Within the measurement, measured values (responding the size and length of the contractions) are compared to a set threshold value and reference length of duration. Measured values above the threshold value and also included in the interval are saved with precision times. Then, the observation is repeated and a number of measured values saved during the predetermined time frame are set. If this number of values exceeds the number from previous set, an alarm signal is produced. The instrument includes central unit, main memory connected to the central unit by system bus, data register, one or more adapters and analogue gauging unit. This gauging unit contains measuring sensor, amplifier connected to a sensor output by means of low-passageway filter, eventually a comparator connected to its output. The amplifier output is connected via A/D transducer to an inner system bus. Besides that, at least another one two-way coupler is available as an adapter connected to a screen by an audiofrequency circuit.

In European patent No. EP 1161921 a uterine contractions detector and a development analyzer of contractions frequency are described. This method and instrument determines uterine contractions' frequency, analyses frequency data and generates graphical representation or set frequency in real time. The invention uses generally known methods of uterine activity detection. Uterine activity data are analyzed in order to specify the occurrence and frequency of contractions. Specified frequency of multiple time periods is displayed on mother/fetal screen in real time.

In European patent No. EP 1181890 a physiological events detector, especially detector for uterine contractions, is described. This method and instrument serves to physiological signal detection and for provision of event indication, which is related to the signal. The instrument includes input terminal, which is connected to the patient in order to obtain physiological signal, which shows at least one physiological event. The instrument also includes analytical module equipped with processor and software for control to set the occurrence of the event and to generate signal of its occurrence; and an indicator, which receives this signal and provides event indication in relationship to the signal. The method involves physiological signal obtaining, determining the origin of physiological event and signal generating in relationship to origination of this event.

Disclosure of the Invention

The aim of the invention is to create a complex system for effective risk of preterm birth prevention. The complex system is formed by the method of uterine activity observation based on the analysis of uterine contractions, which is designed to preterm birth prevention, together with the arrangement for performing the above mentioned method.

Introduced insufficiencies are eliminated to a great extent by the method of recognizing the risk of preterm- birth, according to this invention, the essence of which consists in continuous monitoring of patient's uterine activity, in context of her movement activity, whereas data obtained during the monitoring are measured and stored in the mobile sensor module at the same time, compared and evaluated consequently by the application software, which uses algorithms for filtration and measured data analysis; whereas determining method enables consequent uterine contractions detection, specifies their frequency and intensity, evaluates their causes and severity levels and, as a result,- recognizes early the risk of preterm birth.

The advantage is, in contrast to existing solutions, that the complex system, in agreement with invention, enables observation of the uterine activity virtually consecutively. It is also capable of running changes of patient's position and their dynamics monitoring, which can influence contractions abundance, their frequency, length and intensity. Obtained results are analyzed by the special application software and integrated with other important. information about patient and course of her gravidity at the same time to be displayed in explanatory print on the computer screen.

Indispensable advantage of the technique is a possibility of information integration from four available information sources (see further), analyze them together and then provide specialist - gynaecologist with an efficient complex tool for recognizing the risk of preterm birth as the best and the simplest way as possible.

The above mentioned four information sources (and also methods of data retrieval) are these:

1. continuous monitoring, recording and evaluation of uterine activity (e.g. exterior tocography technique)

2. the state of the cervix objective monitoring method (ultrasonic cervicometry)

3. regard to the environment and conditions of gravidity (diagnostic screening)

4. cervix score - observation of partial factors of pathological changes on cervix

Concrete realization of method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions, according to the invention, consists in creation of a new system of observing the uterine activity consisting of two integral components. First of them, the mobile autonomous "holter" type instrument, is designed for continuous non-invasive scanning and recording of uterine activity in the context of movement activity of the patient (potential mother), including accessories for re-charging and data transfer to user (specialist). The second one, the special analytical computer programme running on regular computer of the specialist, enables consecutive uterine contractions detection and determines their frequency and intensity. Programme can also evaluate their cause and relevance in the context of other relevant information (especially movement activity of the patient and values of cervix-score), whereby recognizing the risk of preterm birth can be reached. The essence of arrangement for performing the method of recognizing the risk of preterm birth consisting in observing the uterine activity in home background consists in the fact that the mobile sensor module, which saves measured data to the internal memory, is joinable via the home station's connector, which can be connected to data storage on FTP server by the wireless communication GPRS modem, whereas the data storage is accessible from the specialist's computer via Internet. The reason for FTP server usage is a permanent available connectivity, which can be promptly used both by home station and specialist's computer. In addition, FTP server disposes a great capacity for data holding including necessary safety protocols.

The essence of the arrangement for performing the method of recognizing the risk of preterm birth consisting in observing the uterine activity in hospitals consists in

'V ' mobile sensor modules, which saves measured data to the internal memory, joinable via connector to home station, which can be interconnected with the specialist's computer. This interconnection can be made directly by USB cable through USB interface or by local computer network via network interface (by a network cable or by the wireless communication Wi-Fi module).

For observation of the uterine activity is an advantage to have a mobile sensor module as a part of microprocessor, which is connected by double-ended buses to power supply unit, connector for connection to the home station, whereas a microprocessor bus is connected to the strain gauge, accelerometer, audible or LED alarm unit (indicating the state of mobile sensor module), and a marker button, which enables indication of subjective ^events (e.g. subjective contractions) by patient; all connected to the microprocessor bus-by double-ended buses.

It is advantageous, for data transfer to the central computer and for mobile sensor module attendance, that the home ^'station is formed by microprocessor connected by double-ended buses to power supply unit, connector for mobile sensor module connection, wireless communication modem, USB module, FLASH memory unit and audible or LED alarm unit.

The advantage of this arrangement, based on this invention, is the fact that the specialist is enabled to practically continuous monitoring of patients with indicated risk pregnancy. As soon as the common periodical investigation shows potential problem the specialist allots a mobile instrument to the patient and starts continuous distant monitoring. But it is not a real time_t monitoring - this is not necessary in this preventive phase - by default, once a day data download from the patient's instrument to the specialist's one is supposed. In case of need, the specialist can, indeed, require data update repeatedly during the day. The specialist has a special computer application programme (software), which processes and evaluates obtained data by the filtration and measured data analysis algorithms and enables visual graphical and numerical interpretation of obtained data and highlighting the potential risk factors.

The invention has these benefits:

- continuous data reading about the patient's uterine activity in correlation with her movement activity by mobile "Holter" type instrument fixed by an elastic belt to a patient's belly

- measured data transfer from the mobile instrument to the central database

- creating and maintaining 'the central database of all accessible relevant data about patient and her pregnancy

- management of entire records of pregnancy course (investigations, tests, laboratory results)

- automatic analysis of all available data (calculations of important parameters, nomograms)

- automatic diagnosis (definition of the risk of preterm birth based on the analysis)

- active signalization of risk situation (based on results of diagnostics)

- presentation of results in graphical and textual form on the screen, or on printer

The effect expected is oqtn financial savings in health service in the area of prenatal and subsequent care, and a significant ethical contribution to the area of mother and children care and also_;an increase in health care of citizens.

Brief Description of the Drawings

The principles of the inveiiuυu wm ue explained by virtue of drawings, where fig. 1 shows the engagement of mobile sensor module (MSM), fig. 2 represents the participation of home station module (DSM), fig. 3 describes the engaging of home system with linkage to the central workplace, fig. 4 relates to the connection of hospital system to the central workplace, fig. 5 depicts the application software and fig. 6 and 6b explains the algorithm for contraction detection. Description of the Preferred Embodiment

The method of recognizing 'the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contraction is related to the statistical proven connection (92%) between the uterine activity data and the risk of preterm birth, whereby offers a possibility of decrease of these cases.

The basis of this method is a 'continuous monitoring of patient's uterine activity in context to her movement activity, where obtained data are measured and stored in mobile sensor module 1 at the same time and then compared and evaluated by the application software 5, which uses filtration and measured data analysis algorithms. Determining is the method of objective observation of the state of the cervix enabling consequent uterine contractions detection, determining their frequency and intensity, evaluating their causes and severity levels and, as a result, recognizing the risk of preterm birth.

In the case of the method' of recognizing the risk of preterm birth consisting in observing the uterine activity another three methods are used, together with the one in the previous paragraph:

- method of objective monitoring of the state of the cervix (by ultrasonic cervicometry)

- method of regard to the environment and pregnancy conditions (diagnostic screening)

- method of so-called cervix score - monitoring of partial factors of pathological changes on cervix. During the measurement, penal points 0-1-2 are given to five quantitative characters of trfe^* cervix: o length, o permeability, o consistency, o placing in relation to .axis of small pelvis, o entering of pressing part of child.

Application software 5 for implementation execution processes, evaluates and interprets obtained data by algorithms 57 for filtration and measured data analysis. Data collection is proceeded from Other' information resources, mainly from the work form "Day view" 56, which shows¹ to tfte user (specialist) necessary information for early tendency of imminent preterm birth?. Necessary supporting data can be entered by other work forms (52 to 55), while the form "List of patients" 51_ is the initial for patient's choice and for handling with other forms.

Form "Patient's file" 52 contains basic data about patient (statistical in term of one gravidity), including the anamnesis.

Form "Investigation file" 53 collects data during the gravidity, which are potentially variable with a distinction into five categories: "Status praesens" (current state of the patient), "Midwifery findings',' (cervix score, ultrasonic cervicometry), "Serial diseases", "Pharmaceuticals" and "Laboratory investigations".

Form "Gravidity calendar" 54 is actually "plan" of entire gravidity course by weeks in the form of synoptic table with the possibility to complement weekly commentaries.

Form "Gravidity file" 55 summarizes the most important data about each patient's gravidity. ;•. ^' .

Application software 5 is^" the fundamental part of the invention by the view of specialist. For the self evaluatiόri^bf data obtained by monitoring the patient by the mobile instrument (holter), a work form (window) 56 "Day view" (see further) is used, which can be accessed directly from the patients' list. For a selected patient these data can be seen in the table "Day^vview" an evolution of important value criteria, i.e. frequency of objective contractions^; with distinction by relevancy and movement dynamic of the patient in conjunction with subjective contractions (according to the patient) and then with the cervix-score value. Each line represents one day of monitoring, where first line above responds with current (last) day of monitoring. Under the table a graphical visualisation of a day's contractions history is visible in the context of changes in patient's position with the possibility of detailed look in required parts of history (function "zoom").

Here you can see the work form design 56:

Meaning of single data in the table:

Week week of gravidity (virtually observed primarily since 24. week)

Date date of the measurement - at least during a part of a day ¹⁾

Monitoring time total time of patient monitoring during the day

0...24 graphical visualisation of measurement time periods during the day

Monitored criteria:

# Ko objective contractions frequency during the day - of all

# Km objective contractions.frequency during the day - with striking amplitude ²⁾

# Ks subjective contractions frequency during the day (according to markers from the patient)

Average T average duration of one contraction (< 1 min. / 1-3 min. / > 3 min. ) ³⁾ Vo K proportion of all contractions in total measurement duration ⁴⁾

% Km ... proportion of striking.²) ^'contractions in total measurement time ⁴⁾ CS cervix-score (the colour of background indicates excess of critical value during the week)

Legend:

¹⁾ For the directive day information, at least 6 hours of measuring during the day is required.

²⁾ Striking amplitude = limit exceeding of contraction maximum over its basal level, which is represented by the value of steady level.

³⁾ Contraction must be included in defined time interval "from - to", implicitly 0,5 - 5 minutes, and must have at least minimum amplitude.

⁴⁾ Numerically and graphically in %, where the maximum range of the numeral data's window for the graph corresponds for illustration not 100%, but only 20%, because the real proportion of contractions never exceeds 20%. Contractions proportion = sum of a contractions duration/total duration of measurement (within the day).

Graphical preview handling

Function "Zoom" - detailed preview of chosen part of curve:

Displays after delimitation of the curve section - the graph divides into two parts (see the demonstration below): upper contains the original overall day history (course), bottom enhanced a preview of curve section delimitated by oblong from total history.

Zoom function can be cancelled by clicking on the icon termination (x), which refreshes overall course in the bottom partpf ,the window. If we want to leave only the detailed preview in the lower part of the window, just click on the icon enlargement (D). Together with the function "zoom", changes of both scales are available as well as shifts, inserting and cancellation of markers, eventually a possibility to adjust curves (artefacts eliminations, etc.)

The advantage of this lay-out is a plasticity of what the user (specialist) see - day by day - development trends of contractions in relation to cervix-score value. The plasticity is reached by a combination of numerical and graphical expression of all of the important criteria.

Another very significant benefit is a rigorous distinction of contractions into two groups:

1. Contractions when the patient is in relative calmness

2. Contractions when the patient is moving

For a signalisation of a potential problem, contractions from first group have major importance. This fundamental distinction is enabled by usage of accelerometer in mobile sensor which enables registering of patient's position changes and allocates them to the contractions curve: '

As soon as any of criteria values increase and exceeds set limit for normal gravidity course, it is clearly signalled right in the default form, i.e. patient's list 51 and a further effective procedure is recommended. That means that immediately after launching the programme on^! the^' computer the user (specialist) see, which patient is coming to have potentially problem^' Those patients can be contacted without delay and take certain steps (another special investigations and tests, which results in medication, eventually hospitalization, etc.).

Arrangement for performing^" the method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions will be explained with several useful examples.

The basic version of arrangement for the home system is used for recognizing the risk of preterm birth consisting in observing the uterine activity with connection to the central workplace, which is shown in fig. 3. The arrangement in this embodiment is made by the mobile sensor module 1, which saves sense data to its internal storage and can be connected via its connector 13 to the home station's 2 connector 23. The home station 2 can be connected through a wireless communication GPRS modem 24 to the data storage 31 on the FTP-server 3; whereas the data storage 31 can be then connected to a computer 4 Internet interface 41., or can be connected directly by the USB module 25 to the computer 4 USB module 42.

Block engagement of the above-mentioned mobile sensor module 1 is shown in fig. 1. The arrangement in this embodiment is formed by a microprocessor H, which is interconnected by double-ended buses both to a power supply unit Λ2 and to a connector 13. The microprocessor;!! is interconnected via double-ended buses both to an accelerometer 14 and to the strain gauge 15; a FLASH memory unit 16, an audible or LED alarm unit IjJ, and a marker button 17 can be connected to the microprocessor bus H by double-ended buses. Mobile "Holter" type sensor 1 is made as a minimal size and weight ergonomic plastic case enabling easy fixing by belly belt and comfortable long-time wearing on the patient's body under the dress, without perceptible restraints in ordinary services.

Block engagement of above mentioned home station module 2 is shown in fig. 2. The arrangement in this embodiment is formed by a microprocessor 21, which is interconnected by double-ended buses to the power supply unit 22 and the connector 23. The microprocessor can be also connected, by double-ended buses, to the wireless communication GPRS modem 24^J, the USB module 25, the FLASH memory unit 26 and the audible or LED alarm unit 27. '* ^""^'

Another useful example of the arrangement is embodiment for hospital system intended for recognizing the risk'όf preterm birth consisting in observing the uterine activity with the connection to the central workplace (see fig. 4). The arrangement involves single mobile sensor modules 1 to N 1, which save sensed data to their FLASH memories 16, which can be connected by connectors 13 to the home station's 2 connector 23. The home station can be connected via wireless communication Wi-Fi interfaces 28 to the same type interface 43 of the computer 4, or interconnected directly by USB module 25 to computer 4 USB module 42.

" i -^■ r For obtaining the continuous information the fundamental information source is the method of continual monitoring, recording and evaluating of uterine activity. To measuring, recording and evaϊύafing the uterine activity an instrument with a portable mobile sensor module 1, and solid part formed by the home station module 2 is used. Registration of uterine activity is made by the strain gauge 15, which mechanically scans pressure on the patient's body, where the uterine activity is continuously carried. For position changes' registratipn^ah accelerometer 14 is used to derive current position of the patient including changes' dynamics by velocity vector in X, Y, Z coordinates. . ,. . ... 12

Mobile sensor module 1 is fixed by belt, which is its integral part, to the belly of a potential mother. Initial tension of the belt can be set to provide referential (calmness) belly pressure to the strain gauge ;15. During the uterine contraction is the strain gauge 15, sequenced in module 1, compressed between belly and belt and a periodical registration of pressure changes is happening.

Accelerometer 14 is operating at the same time registering the changes in positions of the mobile sensor -module 1 (the position of mother and child) in 3D and these changes are continuously dispatched to the registered pressure changes.

Mobile sensor module. l is equipped with a simple optical LED (eventually acoustic) indication 18 of self state: This enables the patient to verify easily module's functionality, its batteries level and initial tension of the belt. Mobile sensor module 1 also enables to indicate subjective events (patient records the time of the event by pressing the button 17). Subjective event is a standard subjective feel of contraction. This function enables post-comparison of contractions indicated subjectively by the patient and detected objectively bfthe instrument - see form "Day view" 56, criteria #Ko (frequency of objective contractions during the day - of all) and #Ks (frequency of subjective contractions during the day). ^

The mobile sensor 1 module's output are data determined to the further processing and evaluating. Transferring data to the distant central computer 4 uses firm part of the instrument - the home station 2, equipped with self FLASH memory 26 and needed communication interface,: which is formed by USB module 25 and wireless communication GPRS modem? 24JiVv-.

Connection between the "mobile sensor module 1 and the home station module 2 starts automatic data transfer from mobile sensor module's FLASH memory 16 to the home station's 2 FLASH memory- ^6, and battery charging in the power supply unit 12. After finishing this transfer, the home station 2 establishes connection with the FTP server 3 and, in case of success, sends data from" its FLASH memory 26 to the data storage 3_1, which is on the FTP server 3, where they stay ready for downloading to the central computer 4 by the specialist.

It is important to have functional data transfer form patient to specialist for every distance, which means that the⁹ technical solution, according to this invention, must support data communication via GSM network with the present use of Internet to store data on the FTP server 3.

The advantage of this solution is that the data download can be activated from the specialist workplace; patient just has to ensure insertion of her mobile sensor module λ to the home station module 2, equipped by own FLASH memory 26 and GPRS communication interface 24, in advance. Connection between the mobile sensor module 1 and the home station module 2 starts automatic data transfer from mobile sensor module's 1 FLASH memory 16 to home station module's 2 FLASH memory 26 and consequently to the data storage 31 on the FTP server 3, where they stay ready for transfer to the computer 4. Home station module 2 also provides battery charging in the power supply unit 12 of the mobile sensor module Y

The invention contains technical and software equipment for data transfer from the home station 2 at the patient's home across the data storage 3J. on the FTP server 3 to the specialist's computer 4. These activities can be suitably automated by planner, which runs data downloading subsequently from all of the instrument of currently monitored patients to the specialist's computer 4 at the stated time (ideally during night).

The invention also contains algorithms 57 for uterine contractions detection from obtained data. These algorithms involve combination of mathematical filters for removal of unwanted features (noise). Designed algorithms result from observation of pressure changes and following of partitions'with increase above steady level. Principles consist in observation of output level, when maximum level for set partition (0.5 minute) is marked as α (alpha). In the following partition, the alpha serves as a steady level indicator and entire values above this level signalizes possible contraction. If the output reaches values bigger than alpha for 0.5 minute's period, not more than 5 minutes, the partition is proclaimed as a contraction. If the change is not in this interval, the value of alpha is only updated according to the nearest interval.

Possible progress is described in more detail in the flow chart in the fig. 6 (a, b), when variable X[i] expresses sample time, Y[i] corresponding pressure value. Dividing samples to even and odd enables working with two values α (alpha) and thereby reaches superior results.

The invention contains algorithms tor complex data analysis of the patient's uterine activity and their visual representation in the context of other important criteria, which can be taken from other information resources (see methods 2 and 4 on pages 3 or 30) and complete them in the database of this software.

Self analysis consists in those steps:

1. Evaluation of daily data dose (per 24 hour or less - according to the specialist's instructions and preferences 'of the patient, but at least 6 hours), where every monitored day is represented* by one line in the table in work form "Day view" 56. Monitored criteria:

- Average length (duration)^'of the contraction

(basic distinction in the interval: < 1min. / 1-3 min. / > 3 min.)

- Number of contractions per hour: a) of all contractions (in the rest position - during displacement) b) only in striking contractions (in rest position - during displacement)

- Proportion of contractions in overall ones during controlled period (in %): a) of all contraction (in rest position - during displacement) b) only in striking contractions (in rest position - during the displacement)

- Predominant position of the patient during contractions: vertical - horizontal on the back - horizontal on the side

Those criteria are well-arranged to columns of mentioned table to monitor easily their trend day by day by the user (specialist). Besides that, when the increase of some of the criteria value exceeds set limit for normal pregnancy course, it is possible to signalize this fact directly in the default form, i.e. patients' list 51 and recommend further efficient procedure. 2. Complex evaluation of entire obtained data from the patient during the gravidity.

Statistics according to the set criteria:

- risk factors' weight in each week of gravidity - dynamics: expressed numerically (see table) and/or graphically (e.g. histogram)

/. week ... original week of pregnancy, when the specialist begins to monitor at least one of the risk factors (generally 20. week). n. week ... last week of gravidity, derived from the calendar generated for the patient (generally 42. week). Factors = quantifiable parameters obtained from all used methods, which are analyzed at least once a week. All criteria cited in step 1 and the cervix-score method belongs to those factors. Other quantifiable parameters are generally investigated with the periodicity longer than a week or by a single application and therefore have rather statistical and additional character.

Industrial applicability

The invention is applicable in every hospital specialized to gynaecology and midwifery, especially in particular clinics and clinics for risk gravidity.

List of correlation marks

1 mobile sensor module (MSM)

11 mobile sensor module's microprocessor

12 power supply unit

13 first connector

14 accelerometer

15 strain gauge

16 first FLASH memory

17 marker button

18 audible and LED alarm unit

2 home station module (DSM)

21 home station module's microprocessor

22 power supply unit

23 second connector

24 wireless communication GPRS modem

25 first USB connector

26 second FLASH memory

27 audible and LED alarm unit

28 first Wi-Fi interface

3 FTP server 31 data storage

4 computer (PC)

41 internet communication interface

42 second USB connector

43 second Wi-Fi interface

5 application software

51 form ,,List of patients + List of gravidity"

52 form ..Patient's file"

53 form ..Investigation file"

54 form ..Gravidity calendar"

55 form ..Gravidity"

56 form ,,Day view"

57 filtration and measured data analysis algorithms

Claims

PATENT CLAIMS

1. A method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions characterized in that the uterine activity of a patient is monitored continually, in the context of her movement activity, whereas data obtained from this monitoring are simultaneously measured and stored in the mobile sensor module and compared and evaluated consequently by the application software (5) using filtration and analysis algorithms of measured data by a method enabling consequential detection of uterine contractions, their frequency and intensity, evaluation of their causes and severity level; and, as a result, the early risk diagnosis of preterm birth.

2. An arrangement for performing the method according to claim 1 characterized by a mobile sensor module (1), which can be connected via its connector (13) to a home station's (2) connector (23), said home station (2) can be connected through a wireless communication GPRS modem (24) to the data storage (31) on the FTP-server (3); whereas the data storage (31) can be then connected to an Internet interface (41) of a computer (4), or can be connected directly by the USB module (25) to the USB module (42) of the computer (4).

3. An arrangement for performing the method according to claim 1 characterized by mobile sensor modules (1 to N), which can be connected by their connectors (13) to the home station's (2) connector (13), said home station (2) can be connected through the wireless communication Wi-Fi interface (28) to the same type interface (43) of a computer (4), or can be connected directly by the USB module (25) to the USB module (42) of the computer (4).

4. The arrangement according to claim 2 or 3 characterized in that the mobile sensor module (1) forms a microprocessor (11), which is interconnected by double- ended buses both to a power supply unit (12) and to a connector (13),whereas the microprocessor (11) is interconnected via double-ended buses both to an accelerometer (14) and to a strain gauge (15)? a FLASH memory unit (16), an audible or LED alarm unit (18), and a marker button' (17) is further connected to the bus of microprocessor (11) by double-ended buses.

5. The arrangement according" to claim 2 or 3 characterized in that the home station module (2) forms a microprocessor (21), which is interconnected by double- ended buses to the power supply unit (22) and connector (23), whereas the microprocessor is also connected, by double-ended buses, to the wireless communication GPRS modem (24); the USB module (25), the FLASH memory unit (26) and the audible or LED alarm unit.