Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
  • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
  • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
  • A61B5/4356—Assessing uterine contractions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
  • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
  • A61B5/0011—Foetal or obstetric data
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
  • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
  • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
  • A61B5/033—Uterine pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
  • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
  • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

• 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.
• 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.
• at least another one two-way coupler is available as an adapter connected to a screen by an audiofrequency circuit.
• 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.
• a physiological events detector especially detector for uterine contractions.
• 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.
• 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.
• 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.
• Concrete realization of method of recognizing the risk of preterm birth consisting in observing the uterine activity based on the analysis of uterine contractions consists in creation of a new system of observing the uterine activity consisting of two integral components.
• 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.
• 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.
• 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.
• 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 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:
• 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.
• 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
• fig. 6 and 6b explains the algorithm for contraction detection.
• 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.
• cervix score monitoring of partial factors of pathological changes on cervix.
• 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 shows 1 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.
• 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.
• a work form (window) 56 “Day view” (see further) is used, which can be accessed directly from the patients' list.
• Day v view 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.
• 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").
• 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.
• 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: '
• 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.
• FIG. 1 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 ⁇ 2 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.
• GPRS modem 24 J the wireless communication GPRS modem 24 J
• the USB module 25 the FLASH memory unit 26 and the audible or LED alarm unit 27.
• 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.
• the fundamental information source is the method of continual monitoring, recording and evaluating of 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.
• 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 ⁇ 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 ⁇ (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.
• 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.
• the invention is applicable in every hospital specialized to gynaecology and midwifery, especially in particular clinics and clinics for risk gravidity.
• MSM mobile sensor module
• DSM home station module

Applications Claiming Priority (2)

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• 2009
  • 2009-03-02 CZ CZ20090127A patent/CZ2009127A3/cs unknown
• 2010
  • 2010-02-26 AU AU2010220701A patent/AU2010220701A1/en not_active Abandoned
  • 2010-02-26 NZ NZ595391A patent/NZ595391A/xx not_active IP Right Cessation
  • 2010-02-26 EP EP10729686A patent/EP2403399A2/de not_active Ceased
  • 2010-02-26 WO PCT/CZ2010/000022 patent/WO2010099764A2/en active Application Filing

Patent Citations (2)

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