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WO2010128863A1 - A device for recording events relating to parents of infants and pregnant women - Google Patents

A device for recording events relating to parents of infants and pregnant women Download PDF

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Publication number
WO2010128863A1
WO2010128863A1 PCT/NO2010/000163 NO2010000163W WO2010128863A1 WO 2010128863 A1 WO2010128863 A1 WO 2010128863A1 NO 2010000163 W NO2010000163 W NO 2010000163W WO 2010128863 A1 WO2010128863 A1 WO 2010128863A1
Authority
WO
WIPO (PCT)
Prior art keywords
logger
digital
colic
button
events
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NO2010/000163
Other languages
French (fr)
Inventor
Sophie Lund Aaserud
Håvard HARSTAD
Bjørn MEDHUS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LOGGIT AS
Original Assignee
LOGGIT AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LOGGIT AS filed Critical LOGGIT AS
Publication of WO2010128863A1 publication Critical patent/WO2010128863A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT 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
    • G16H40/60ICT 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
    • G16H40/63ICT 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 local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7282Event detection, e.g. detecting unique waveforms indicative of a medical condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient; User input means
    • A61B5/7475User input or interface means, e.g. keyboard, pointing device, joystick
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/022Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/43Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343Pregnancy and labour monitoring, e.g. for labour onset detection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7275Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Definitions

  • the present invention relates to a device for logging events during pregnancy as well as to the logging of infant-related events on said device.
  • Parents of an inconsolable child use a lot of resources and energy to find out why the child is crying, and to ascertain whether or not their child meets the definition of colic with respect to for how long the child is crying. They also try out most of the more or less recommended pieces of advice to relieve the child's pain. Often, however, the parents are left with more questions than answers after having tried most of the recommendations and products/services available.
  • the apparatus keeps track, systematizes, and provides predictability and control, which in turn brings about confidence and a feeling of being in command.
  • the present invention relates to a digital logger for logging fetal development during pregnancy and for infant-related events embedded in a device comprising: input/output units, special buttons for event registration, non-volatile memory for storing events, and an operating system for hardware and software management.
  • FIG. 1 shows a typical development environment for the digital logger unit according to an aspect of the present invention
  • Fig. 2 shows a general flow chart of the screen display functionality according to an aspect of the present invention
  • Fig. 3 shows a flow chart of a fall-asleep registration screen display according to an aspect of the present invention
  • Fig. 4 shows a flow chart of an awakening screen display according to an aspect of the present invention
  • Fig. 5 shows a flow chart of a feeding time screen display according to an aspect of the present invention
  • Fig. 6 shows a flow chart of a diaper change screen display according to an aspect of the present invention
  • Fig. 1 shows a typical development environment for the digital logger unit according to an aspect of the present invention
  • Fig. 2 shows a general flow chart of the screen display functionality according to an aspect of the present invention
  • Fig. 3 shows a flow chart of a fall-asleep registration screen display according to an aspect of the present invention
  • Fig. 4 shows a flow chart of an awakening screen
  • FIG. 7 shows a flow chart of a start crying screen display according to an aspect of the present invention
  • Fig. 8 shows a flow chart of a stop crying screen display according to an aspect of the present invention
  • Fig. 9 shows a flow chart for an sickness screen display according to an aspect of the present invention
  • Fig. 10 shows a flow chart of a fever registration screen display according to an aspect of the present invention
  • Fig. 11 shows a flow chart of a medicine screen display according to an aspect of the present invention
  • Fig. 12 shows a flow chart of a weight logging according to percentile model screen display according to an aspect of the present invention
  • FIG. 13 shows a flow chart of a vaccine registration screen display according to an aspect of the present invention
  • Fig. 14 shows a flow chart of a pregnancy overview screen display according to an aspect of the present invention
  • Fig. 15 shows a flow chart of a colic crying screen display according to an aspect of the present invention
  • Fig. 16 shows a flow chart of an alarm function screen display according to an aspect of the present invention
  • Fig. 17 shows a flow chart of a data logger setup screen display according to an aspect of the present invention
  • Fig. 18 shows a component diagram of software components of the data logger application according to an aspect of the present invention
  • FIG. 19 shows a state diagram of the data logger application according to an aspect of the present invention
  • Fig. 20 shows a state diagram of percentile scheme functionality according to an aspect of the present invention
  • Fig. 21 shows a state diagram of medicine functionality according to an aspect of the present invention
  • Fig. 22 shows a state diagram of pregnancy functionality according to an aspect of the present invention
  • Fig. 23 shows a state diagram of alarm functionality according to an aspect of the present invention
  • Fig. 24 shows a state diagram for setup functionality according to an aspect of the present invention.
  • digital logger digital recorder, data logger unit, digital log, and logger unit are to be understood as a digital logger for logging events during pregnancy as well as for logging infant-related events according to the present invention.
  • the logger unit of the present invention may be implemented as a palmtop embedded unit comprising the functionality as set out above. It will also typically be able to communicate with external units such as a PDA and personal computers for displaying data, and/or for further processing of data, for charging batteries, and also for the backup of data.
  • external units such as a PDA and personal computers for displaying data, and/or for further processing of data, for charging batteries, and also for the backup of data.
  • a need for overview and objective facts may arise in a meeting with the doctor or maternal and child health centre. Given the digital log, you will know, for example, when the child has had the fever and how high the fever has been recently. As the digital log may allow the possibility of comparing collected data and graphs relating to sleep, food, crying, and so on, parents will much easier see if there could be an underlying explanation to why the child is crying when it does.
  • the digital log is a practical solution to all the information tired parents are trying to remember in order to keep track of the diurnal rhythm of the child. Anything mothers and fathers are trying to remember, in order to know when to do what, are stored in the digital log.
  • the digital logger systematizes and shows you that in what you experience as chaos, a pattern may exist. Seeing the pattern will give you a higher degree of predictability, bringing along a feeling of confidence.
  • the digital log according to the present invention may be a digital logger which through simple keystrokes is able to record the crying, digestion, sleeping, and eating pattern of a baby.
  • a running counter tells you when the child was last fed, and for how long he has been asleep.
  • the logger may have functions for indicating or mathematically calculating colic probability as well as for revealing crying patterns, fever and sickness history, medication, vaccinating program, and development.
  • the digital log according to the present invention may be a personal pregnancy calendar. Typically, it will include a clock and an alarm function for the notification of eating times, medication, etc.
  • the functions may typically be selected according to a pattern that is intuitive for today's parents. That is, the user interface may typically be recognizable for persons that are familiar with mobile phones, PDAs, hand-held music players, and similar devices.
  • the data may be entered using arrow buttons in lists and menus or by way of an alphabetic and numerical keypad.
  • the digital log according to the present invention may be provided with a visual output device such as a display, enabling the display of information from the period shown in a table or graph.
  • twins and premature babies For parents of twins and premature babies, it is completely necessary to keep track of when and how often, and in some cases how much, the children eat and when they are sleeping. Premature children commonly require frequent and regular meals, also through the night. Also, the growth rate of twins and premature babies are monitored more closely than the one for children born at term.
  • the digital log according to the present invention - a personal digital pregnancy calendar
  • the digital logger When the digital logger is in pregnancy mode, on a daily basis, it will inform the user on what is going on in the stomach of the expectant mother. When expectant mother is 5.4?? days pregnant, it will report that today, the baby's heart is making its first heartbeats. It will tell the expectant parents that the eyelashes are fully developed, that the fingernails appear before the toenails. All such information is based on a database that begins the "running period" when the user registers that a pregnancy period has started. It calculates the expected date of birth when the user enters the date for the first day of the last menstrual period together with the cycle length. Alternatively, it bases the information on the term calculated by the doctor.
  • the user may log the blood pressure, weight, as well as other important milestones and aspects of the pregnancy. Every day, it will inform how far the expectant mother has come in the pregnancy and how many days remain to the expected day of birth.
  • data may be uploaded through a computer, PDA, or similar application. Typically, this may be accomplished via a simple interface such as USB or similar interface.
  • the unit receiving the data may systematize the information further, and maintain graphs and tables of weekly and monthly development.
  • the digital logger could be connected to an Internet server for the transfer of data.
  • the growth of the child is logged in a percentile scheme in accordance with the WHO model - the same model which is frequently used by the public health institutions and public health care in general.
  • the digital log may be incorporated in a system comprising one or more docking stations. One such station could, for example, be located next to the child's bed, and another is connected to a computer via a USB cable or a similar suited interface.
  • the logger unit may include one or more of the following I/O units: Special buttons Joystick Display
  • the users of the data logger unit according to the present invention will be able to click on one set of special buttons to register various events.
  • one click will be sufficient to register the event, regardless of the state in which the digital log is as long as it is switched on.
  • one or more of the special buttons may appear as single buttons having multiple functions.
  • the following special buttons will be clickable: Fall asleep
  • the unit may comprise a joystick capable of generating the following events:
  • the logger unit is assumed to include a processor, preferably comprising a MMU so that it will be possible to run an operating system.
  • the logger unit will have a USB interface so as to be easily connectable to a local PC.
  • the USB interface will be used for transferring information from the logger unit to the application on the local PC.
  • the logger unit may serve as a USB unit (slave) whereas the local PC may serve as a USB host (master).
  • connecting the logger unit to the PC will be accomplished in the same manner as when connecting a USB memory stick to the PC.
  • a USB connection to the logger unit would make it possible to recharge the batteries of the digital logger unit through the USB port of a PC, if desirable.
  • the folder containing the event file stored on the logger unit is uploaded to the local file system on the local PC.
  • An application on the local PC copies the file from the logger unit to the hard disk of the PC.
  • the new file that has been transferred replaces any previously transferred files.
  • the application running on the local PC may then present the data from the file on the PC display device.
  • the local PC application will implement the following main functionalities:
  • the application is able to add a file back to the logger unit. In this manner, the application may serve as a backup unit for the logger unit.
  • the logger unit will be equipped with a visual output device such as a display with associated hardware. The screen display functionality may be controlled, for example, by algorithms as they appear in the flow charts of Figs. 2-16.
  • the main menu as shown on the screen may typically present the user for the following options:
  • the users may select from the menu options using the joystick.
  • the data logger unit typically will be provided with a power save mode. For example, if the user does not make use of the joystick or clicks on any of the buttons during a given time period to, the data logger unit could return to the main menu, if not already in that menu. If still nothing happens within a further time period ti, the logger unit may enter a standby mode. In standby mode, it is a goal that that the logger unit consumes as little power as possible. Thus, the display could be put in a power save mode and the users would only see a digital clock on the display, for example.
  • the clock is continuously moving across the screen, preventing the clock from permanently burning into the display screen.
  • the logger unit exits standby mode when the user moves the joystick or clicks on one of the special buttons. If the parents are moving the joystick, the logger will enter the main menu. If one of the special buttons is selected, the logger will enter directly into the registration screen display for the event associated with that special button.
  • the logger unit will be provided with flash memory or another suitable non-volatile memory of a size sufficient to store the software components needed.
  • flash memory must be supported by the chosen operating system.
  • the digital logger must have enough RAM to be able to run the operating system and application from the RAM.
  • all software components will be located in the flash memory.
  • a boot loader will be the first software to start after the power is switched on. This software must be run from the flash memory. The boot loader will unpack the kernel of the operating system and the RAM disk from flash to RAM. It is technically possible to run parts of or the entire application from flash memory.
  • the logger unit needs a real-time clock in order to keep track of the current time and date when the unit is switched off.
  • the time with a one second N resolution, is stored in a suitable format, such as number of seconds since Epoch.
  • An alarm is stored as an event with a future trigger time. When an alarm has expired, the alarm event can be deleted from the event log.
  • an alarm sound will be played and a screen picture will appear showing information on the alarm.
  • the user responds to the alarm by touching the joystick, whereupon the logger unit will return to the screen picture shown before the alarm appeared. If the logger unit was the screen saver mode prior to the alarm event, it will return directly to screen saver mode. If the user were registering a wakeup event when the alarm appeared, they will be able to continue this registration after the alarm has been responded to.
  • the digital logger unit needs a loudspeaker or a similar device for communicating an alarm. It may be a prerequisite that this sound unit is supported by an integrated operating system.
  • the operating system may be comprised of the following main components:
  • Kernel Basic functionality, possibly with adaptations to the selected processor, if necessary.
  • the logger unit may ha a kernel including the necessary adaptations (patches).
  • Graphical window system A graphical user interface that is specially adapted for embedded units.
  • the data logger unit will store data over time, and the table below shows what dynamic information the logger unit needs to store in an event log. This information must not be lost if the unit is switched off or the battery is emptied.
  • Exemplary software components that may run on the data logger and the manner in which they intercommunicate can be seen in Fig. 18.
  • the data logger unit according to the present invention may use the following device drivers:
  • a driver for the user-defined button 28 Handles the interface to the special buttons. This driver must be a character device driver. • A driver for the joystick 29: Handles the interface to the joystick. This driver must be a character device driver.
  • a USB driver 30 Handles the USB interface to the local PC. This is a standard device driver included with most operating systems.
  • a driver for the flash memory 32 Handles the flash memory interface. This is a standard driver included with most operating systems.
  • a loudspeaker driver 31 Handles the interface to the loudspeaker or other audio hardware.
  • the various drivers communicate with the data logger application via operating system devices. With each of the drivers except from flash memory driver 32, the data logger application 20 will communicate directly with the desired devices 28-31. Between the logger and flash driver 32, another abstraction layer is provided by way of an event handling library 27.
  • the event handling library 27 provides the following interface to the data logger application 20:
  • a function for locating the last n events of a particular type is a function for locating the last n events of a particular type.
  • a function for locating all events of a particular type within a given time period is a function for locating all events of a particular type within a given time period.
  • the event handling library 27 uses flash driver 32 to add or retrieve information to/from the flash memory.
  • the data logger application 20 could typically be implemented as a state machine.
  • the state machine will passively await one of the following events:
  • Fig. 19 The overall state machine of the digital logger is described in Fig. 19. This figure shows an overview of all possible states without indicating any sub- states.
  • the individual sub-states are shown in Figs. 20-24, of which Fig. 20 shows a percentile scheme functionality state diagram, Fig. 21 shows a medicine functionality state diagram, Fig. 22 shows a pregnancy functionality state diagram, Fig. 23 shows an alarm functionality state diagram, and Fig. 24 shows a setup functionality state diagram.
  • a characteristic of colic is that the child has crying spells at about the same time of the day, several days a week.
  • the rule of thumb is that the child is crying for three or more hours each day three or more days a week during three or more weeks.
  • the classical scenario is that the child starts crying in the afternoon and calms down in the evening. If the child feels happy, eats, and sleeps outside the crying spells, one may generally assume that the child suffer from what is known as baby colic.
  • Colic usually appears when the child is two or three weeks old and generally disappears when the baby becomes three months old.
  • a step-by-step method is used. In the logger unit, this is, naturally, carried out in an automatically. The user only enters external events such as start crying, stop crying and so on.
  • T ⁇ d ⁇ t _ end - 1 _start [eq. 1]
  • the likelihood of colic, P(d), for each day is calculated. If the child has cried for less than 2 hours during a day, the colic likelihood value for this day equals 0. If the child has cried for more than 2 hours, the colic likelihood of this day is larger than 1 , increasing proportionally with the number of crying hours.
  • the formula for calculating the colic likelihood, P(d), for day d is as follows: P ( d > ° if T(d) ⁇ 2
  • the factors (-14/3) and 7/3 is chosen so as to make the colic likelihood equal to 1.0 in the case of 3 hours of crying 3 days a week during 3 weeks.
  • the digital log When parents log the baby's crying, the digital log will flash a "near colic symbol", as well as a contact doctor/health care centre symbol, when the accumulated crying approaches the colic definition threshold. That is, in this example, when P is between 0.8 and 1.5. If the number of hours the baby has cried reaches/exceeds the colic definition, a colic symbol will flash on the screen together with the contact doctor/health centre symbol. As the parents also record when the child sleeps, eats, and poops, patterns indicating whether or not the crying may be related to colic can be easily revealed. In addition, parents may also log remedial actions such as acupuncture or other recommended measures for easing the colic pain of the child. In that case, the digital logger of the present invention will reveal whether or not the measures have any effect on the crying pattern of the child.
  • the digital log are able to indicate colic patterns, and provides vulnerable and exhausted parents of colic children with a predictability that helps them through a tough time. It also systematizes other basal needs and remedial actions (sleep, food, and digestion, as well as any cases of acupuncture, chiropractic, mothers' diets, etc.) thus revealing reasons why a baby is crying.
  • the boot loader may be the first software running after power-up. It is responsible for initializing necessary hardware and starting the other software.
  • Flash Memory area in which the content is preserved even if the power is switched off.
  • Local PC A PC that may run one of the operating systems Linux, Mac OS X, or Windows. Has a
  • USB connection that may be connected to the
  • the local PC may also be used for viewing the information transferred through an application.
  • Mac OS X Operating system that may be used on the local PC.
  • RAM Random Access Memory Memory area in which the content is lost if the power is switched off.
  • UML Unified Modeling Language Standard modeling language used for specifying software systems.

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Abstract

The present invention relates to a digital logger for logging fetal development during pregnancy and for infant-related events embedded in a device comprising: input/output units, special buttons for registering events, non-volatile memory for storing events, and an operating system for controlling hardware and software.

Description

A DEVICE FOR RECORDING EVENTS RELATING TO PARENTS OF INFANTS
AND PREGNANT WOMEN
Field of the invention
[0001] The present invention relates to a device for logging events during pregnancy as well as to the logging of infant-related events on said device.
Background of the invention
[0002] Maternal and child health centres experience a huge rush of parents struggling to establish good routines for their children and to "find the pattern" in a busy working day. The fundamental need for control, routines, and safety of any parent may not have changed significantly as time has passed, but certainly the parents' level of ambition and the technological development have.
[0003] For many people, the anxiety inherent in becoming a parent for the first time is much larger than expected. Consequently, maternal and child health centres experience a massive rush of parents asking for help to establish good routines for their child.
[0004] Parents of an inconsolable child use a lot of resources and energy to find out why the child is crying, and to ascertain whether or not their child meets the definition of colic with respect to for how long the child is crying. They also try out most of the more or less recommended pieces of advice to relieve the child's pain. Often, however, the parents are left with more questions than answers after having tried most of the recommendations and products/services available.
[0005] Also, during pregnancy, many expectant parents want to know more about the various pregnancy stages and whether everything is normal, both out of curiosity and of fear that everything is not as it should be.
[0006] Today, no standards or methods exist that address the above challenges and problems.
[0007] However, maternal and child health centres may recommend parents feeling insecure about their routines to maintain a journal containing different colour codes showing when their child is sleeping, crying, and eating. With that, they will get a view of the situation. [0008] The best advice the doctors and maternal and child health centre have for parents of a colic child is that the family should plan so as to get through this period in a best possible manner. Summary of the invention [0009] According to the present invention, a digital log, personal pregnancy calendar, and colic detector for parents of infants are provided. [0010] The apparatus of the present invention makes it easier to see a pattern, to implement routines based on the habits of a child, as well as to establish a secure setting for a family. The apparatus keeps track, systematizes, and provides predictability and control, which in turn brings about confidence and a feeling of being in command. [0011] In particular, the present invention relates to a digital logger for logging fetal development during pregnancy and for infant-related events embedded in a device comprising: input/output units, special buttons for event registration, non-volatile memory for storing events, and an operating system for hardware and software management. [0012] These and further advantages of the present invention will be apparent from the appended independent claims. [0013] Particularly advantageous embodiments will be apparent from the dependent claims. Brief description of the drawings [0014] To facilitate the understanding of the invention, in the following discussion, reference will be made to the accompanying drawings, in which: [0015] Fig. 1 shows a typical development environment for the digital logger unit according to an aspect of the present invention, [0016] Fig. 2 shows a general flow chart of the screen display functionality according to an aspect of the present invention, [0017] Fig. 3 shows a flow chart of a fall-asleep registration screen display according to an aspect of the present invention [0018] Fig. 4 shows a flow chart of an awakening screen display according to an aspect of the present invention, [0019] Fig. 5 shows a flow chart of a feeding time screen display according to an aspect of the present invention, [0020] Fig. 6 shows a flow chart of a diaper change screen display according to an aspect of the present invention, [0021] Fig. 7 shows a flow chart of a start crying screen display according to an aspect of the present invention, [0022] Fig. 8 shows a flow chart of a stop crying screen display according to an aspect of the present invention, [0023] Fig. 9 shows a flow chart for an sickness screen display according to an aspect of the present invention, [0024] Fig. 10 shows a flow chart of a fever registration screen display according to an aspect of the present invention, [0025] Fig. 11 shows a flow chart of a medicine screen display according to an aspect of the present invention, [0026] Fig. 12 shows a flow chart of a weight logging according to percentile model screen display according to an aspect of the present invention, [0027] Fig. 13 shows a flow chart of a vaccine registration screen display according to an aspect of the present invention, [0028] Fig. 14 shows a flow chart of a pregnancy overview screen display according to an aspect of the present invention, [0029] Fig. 15 shows a flow chart of a colic crying screen display according to an aspect of the present invention, [0030] Fig. 16 shows a flow chart of an alarm function screen display according to an aspect of the present invention, [0031] Fig. 17 shows a flow chart of a data logger setup screen display according to an aspect of the present invention, [0032] Fig. 18 shows a component diagram of software components of the data logger application according to an aspect of the present invention, [0033] Fig. 19 shows a state diagram of the data logger application according to an aspect of the present invention, [0034] Fig. 20 shows a state diagram of percentile scheme functionality according to an aspect of the present invention, [0035] Fig. 21 shows a state diagram of medicine functionality according to an aspect of the present invention, [0036] Fig. 22 shows a state diagram of pregnancy functionality according to an aspect of the present invention,
[0037] Fig. 23 shows a state diagram of alarm functionality according to an aspect of the present invention,
[0038] Fig. 24 shows a state diagram for setup functionality according to an aspect of the present invention.
Detailed description of the invention
[0039] In the following, the present invention will be described in more detail with reference to the accompanying drawings.
[0040] Unless clearly expressed otherwise, the terms digital logger, digital recorder, data logger unit, digital log, and logger unit are to be understood as a digital logger for logging events during pregnancy as well as for logging infant-related events according to the present invention.
[0041] Typically, the logger unit of the present invention may be implemented as a palmtop embedded unit comprising the functionality as set out above. It will also typically be able to communicate with external units such as a PDA and personal computers for displaying data, and/or for further processing of data, for charging batteries, and also for the backup of data.
[0042] A need for overview and objective facts may arise in a meeting with the doctor or maternal and child health centre. Given the digital log, you will know, for example, when the child has had the fever and how high the fever has been recently. As the digital log may allow the possibility of comparing collected data and graphs relating to sleep, food, crying, and so on, parents will much easier see if there could be an underlying explanation to why the child is crying when it does.
[0043] The digital log is a practical solution to all the information tired parents are trying to remember in order to keep track of the diurnal rhythm of the child. Anything mothers and fathers are trying to remember, in order to know when to do what, are stored in the digital log. When you need to view the overall picture, then load the information up to a computer by way of a USB connector and software. The digital logger systematizes and shows you that in what you experience as chaos, a pattern may exist. Seeing the pattern will give you a higher degree of predictability, bringing along a feeling of confidence.
[0044] Typically, the digital log according to the present invention may be a digital logger which through simple keystrokes is able to record the crying, digestion, sleeping, and eating pattern of a baby. One click on a fall-sleep button when the child has fallen asleep and one click on the awakening button register the sleeping periods. A single click before and after each breastfeeding session register when and how frequent the baby eats. The same applies for diaper change. One click when crying starts and one click when crying ends register the crying pattern, and notify you on a possible colic condition with the child. A running counter tells you when the child was last fed, and for how long he has been asleep.
[0045] The logger may have functions for indicating or mathematically calculating colic probability as well as for revealing crying patterns, fever and sickness history, medication, vaccinating program, and development.
[0046] In addition, the digital log according to the present invention may be a personal pregnancy calendar. Typically, it will include a clock and an alarm function for the notification of eating times, medication, etc. The functions may typically be selected according to a pattern that is intuitive for today's parents. That is, the user interface may typically be recognizable for persons that are familiar with mobile phones, PDAs, hand-held music players, and similar devices. Typically, the data may be entered using arrow buttons in lists and menus or by way of an alphabetic and numerical keypad. Optionally, the digital log according to the present invention may be provided with a visual output device such as a display, enabling the display of information from the period shown in a table or graph.
Premature babies
[0047] To parents of twins, parents of premature and children, the area of utility for the digital logs is obvious. In the case of premature and twin babies, the need for good routines regarding food and sleep is particularly important. They are more closely followed up by the maternal and child health centres with respect both to growth (percentile scheme), development, and sickness. The digital log will significantly facilitate the daily routine for this group.
[0048] For parents of twins and premature babies, it is completely necessary to keep track of when and how often, and in some cases how much, the children eat and when they are sleeping. Premature children commonly require frequent and regular meals, also through the night. Also, the growth rate of twins and premature babies are monitored more closely than the one for children born at term.
The digital log according to the present invention - a personal digital pregnancy calendar
[0049] When the digital logger is in pregnancy mode, on a daily basis, it will inform the user on what is going on in the stomach of the expectant mother. When expectant mother is 5.4?? days pregnant, it will report that today, the baby's heart is making its first heartbeats. It will tell the expectant parents that the eyelashes are fully developed, that the fingernails appear before the toenails. All such information is based on a database that begins the "running period" when the user registers that a pregnancy period has started. It calculates the expected date of birth when the user enters the date for the first day of the last menstrual period together with the cycle length. Alternatively, it bases the information on the term calculated by the doctor.
[0050] The user may log the blood pressure, weight, as well as other important milestones and aspects of the pregnancy. Every day, it will inform how far the expectant mother has come in the pregnancy and how many days remain to the expected day of birth.
[0051] In an embodiment of the present invention, data may be uploaded through a computer, PDA, or similar application. Typically, this may be accomplished via a simple interface such as USB or similar interface. The unit receiving the data may systematize the information further, and maintain graphs and tables of weekly and monthly development.
[0052] Additionally, in an embodiment, it could be possible to connect the digital logger to an Internet server for the transfer of data. [0053] The growth of the child is logged in a percentile scheme in accordance with the WHO model - the same model which is frequently used by the public health institutions and public health care in general. [0054] The digital log may be incorporated in a system comprising one or more docking stations. One such station could, for example, be located next to the child's bed, and another is connected to a computer via a USB cable or a similar suited interface. [0055] It would be advantageous to provide the digital logger with a key lock option.
Exemplary hardware
[0056] The logger unit may include one or more of the following I/O units: Special buttons Joystick Display
• USB port Loudspeaker
[0057] At any time, the users of the data logger unit according to the present invention will be able to click on one set of special buttons to register various events. Advantageously, one click will be sufficient to register the event, regardless of the state in which the digital log is as long as it is switched on. It is understood that one or more of the special buttons may appear as single buttons having multiple functions. Typically, the following special buttons will be clickable: Fall asleep
• Awakened Food
• Diaper Start crying Stop crying
• Happy
[0058] In addition, the unit may comprise a joystick capable of generating the following events:
• Up Down
• Left
• Right
Enter (for example, pressing the joystick inward)
[0059] The logger unit is assumed to include a processor, preferably comprising a MMU so that it will be possible to run an operating system.
[0060] In one embodiment, the logger unit will have a USB interface so as to be easily connectable to a local PC. The USB interface will be used for transferring information from the logger unit to the application on the local PC. The logger unit may serve as a USB unit (slave) whereas the local PC may serve as a USB host (master). In this manner, connecting the logger unit to the PC will be accomplished in the same manner as when connecting a USB memory stick to the PC. Also, a USB connection to the logger unit would make it possible to recharge the batteries of the digital logger unit through the USB port of a PC, if desirable. The folder containing the event file stored on the logger unit is uploaded to the local file system on the local PC. An application on the local PC copies the file from the logger unit to the hard disk of the PC. The new file that has been transferred replaces any previously transferred files. The application running on the local PC may then present the data from the file on the PC display device.
[0061] Typically, the local PC application will implement the following main functionalities:
• Fetch file from the Digital Logger Unit View a list of all events contained in a file
View a graphic representation of crying and sleeping history View a graphic representation of the percentile scheme. [0062] A further advantageous function would be that the application is able to add a file back to the logger unit. In this manner, the application may serve as a backup unit for the logger unit. [0063] Advantageously, the logger unit will be equipped with a visual output device such as a display with associated hardware. The screen display functionality may be controlled, for example, by algorithms as they appear in the flow charts of Figs. 2-16.
[0064] The main menu as shown on the screen may typically present the user for the following options:
1. Sickness
2. Fever
3. Medicine
4. Percentile scheme
5. Vaccines
6. Pregnancy
7. Crying
8. Alarms
9. Setup
[0065] According to one aspect of the invention, the users may select from the menu options using the joystick.
[0066] The data logger unit typically will be provided with a power save mode. For example, if the user does not make use of the joystick or clicks on any of the buttons during a given time period to, the data logger unit could return to the main menu, if not already in that menu. If still nothing happens within a further time period ti, the logger unit may enter a standby mode. In standby mode, it is a goal that that the logger unit consumes as little power as possible. Thus, the display could be put in a power save mode and the users would only see a digital clock on the display, for example. Advantageously, the clock is continuously moving across the screen, preventing the clock from permanently burning into the display screen.
[0067] The logger unit exits standby mode when the user moves the joystick or clicks on one of the special buttons. If the parents are moving the joystick, the logger will enter the main menu. If one of the special buttons is selected, the logger will enter directly into the registration screen display for the event associated with that special button.
[0068] Advantageously, the logger unit will be provided with flash memory or another suitable non-volatile memory of a size sufficient to store the software components needed. Such flash memory must be supported by the chosen operating system. Additionally, the digital logger must have enough RAM to be able to run the operating system and application from the RAM. At boot time, all software components will be located in the flash memory. Typically, a boot loader will be the first software to start after the power is switched on. This software must be run from the flash memory. The boot loader will unpack the kernel of the operating system and the RAM disk from flash to RAM. It is technically possible to run parts of or the entire application from flash memory.
[0069] The logger unit needs a real-time clock in order to keep track of the current time and date when the unit is switched off. The time, with a one second N resolution, is stored in a suitable format, such as number of seconds since Epoch. An alarm is stored as an event with a future trigger time. When an alarm has expired, the alarm event can be deleted from the event log.
[0070] Typically, the following two timed alarms may appear in the logger application:
Wake up alarm Medication alarm
[0071] In either case, an alarm sound will be played and a screen picture will appear showing information on the alarm. The user responds to the alarm by touching the joystick, whereupon the logger unit will return to the screen picture shown before the alarm appeared. If the logger unit was the screen saver mode prior to the alarm event, it will return directly to screen saver mode. If the user were registering a wakeup event when the alarm appeared, they will be able to continue this registration after the alarm has been responded to.
[0072] The digital logger unit needs a loudspeaker or a similar device for communicating an alarm. It may be a prerequisite that this sound unit is supported by an integrated operating system.
[0073] The table below shows en estimate of the memory usage (i.e. use of RAM and flash memory). It is assumed that the operating system and a dedicated software application are stored in the flash memory, and loaded into RAM before execution. Exemplary software applications will be provided in the section dealing with software. In the following, the application in the context of the digital log is to be understood as the data logger application as it appears in Figs.18-24.
Table 1 : Memory usage
Figure imgf000012_0001
Software and exemplary operating systems with an operating system description. [0074] By using an operating system, an abstraction layer is added between the application and hardware. This will make the application more flexible and as least as possible bound to the hardware architecture. The hardware architecture adaptations will then mainly be located in the operating system.
[0075] The operating system may be comprised of the following main components:
Kernel: Basic functionality, possibly with adaptations to the selected processor, if necessary. The logger unit may ha a kernel including the necessary adaptations (patches).
Graphical window system: A graphical user interface that is specially adapted for embedded units.
[0076] The data logger unit will store data over time, and the table below shows what dynamic information the logger unit needs to store in an event log. This information must not be lost if the unit is switched off or the battery is emptied.
Table 2: Data to be stored for each event
Figure imgf000013_0001
[0077] In the case of a child for which an average of 50 events are logged each day during a period of 5 years, this will this require a storage area of:
[0078] 50 events/day* (5*365 days) * 8 byte / event = 730 000 byte = 713 Kb.
[0079] In the calculations, the fact that some descriptive text could be stored together with the event has not been taken into account. Even when a descriptive text is included, however, the amount of data involved will be small and there will be no problem retaining all the data that has been stored for a child in the logger unit.
[0080] Exemplary software components that may run on the data logger and the manner in which they intercommunicate can be seen in Fig. 18. For example, the data logger unit according to the present invention may use the following device drivers:
A driver for the user-defined button 28: Handles the interface to the special buttons. This driver must be a character device driver. • A driver for the joystick 29: Handles the interface to the joystick. This driver must be a character device driver.
• A USB driver 30: Handles the USB interface to the local PC. This is a standard device driver included with most operating systems.
• A driver for the flash memory 32: Handles the flash memory interface. This is a standard driver included with most operating systems.
• A loudspeaker driver 31 : Handles the interface to the loudspeaker or other audio hardware.
[0081] The various drivers communicate with the data logger application via operating system devices. With each of the drivers except from flash memory driver 32, the data logger application 20 will communicate directly with the desired devices 28-31. Between the logger and flash driver 32, another abstraction layer is provided by way of an event handling library 27. The event handling library 27 provides the following interface to the data logger application 20:
A function for adding a new event.
A function for locating the last n events of a particular type.
A function for locating all events of a particular type within a given time period.
The event handling library 27 uses flash driver 32 to add or retrieve information to/from the flash memory.
[0082] The data logger application 20 could typically be implemented as a state machine. The state machine will passively await one of the following events:
Joystick
Special button (user-defined button)
Time event (Timeout)
[0083] The overall state machine of the digital logger is described in Fig. 19. This figure shows an overview of all possible states without indicating any sub- states. The individual sub-states are shown in Figs. 20-24, of which Fig. 20 shows a percentile scheme functionality state diagram, Fig. 21 shows a medicine functionality state diagram, Fig. 22 shows a pregnancy functionality state diagram, Fig. 23 shows an alarm functionality state diagram, and Fig. 24 shows a setup functionality state diagram.
[0084] From the figures, it is seen that the above design is carried out as a hierarchical state machine. This is only one exemplary embodiment, and the state machine may also be implemented having a flat structure.
Calculating possible colic
[0085] Somewhere between 15 and 20 percent of all children less than three months of age suffer from colic. The term originates from the Latin word colon and means stomach pains. It is not known with certainty why many babies suffer colic pain in their first living months, but the physicians believe it may be because the intestinal system has not yet been fully developed.
[0086] A characteristic of colic is that the child has crying spells at about the same time of the day, several days a week. The rule of thumb is that the child is crying for three or more hours each day three or more days a week during three or more weeks. The classical scenario is that the child starts crying in the afternoon and calms down in the evening. If the child feels happy, eats, and sleeps outside the crying spells, one may generally assume that the child suffer from what is known as baby colic.
[0087] Colic usually appears when the child is two or three weeks old and generally disappears when the baby becomes three months old.
[0088] In the following, an exemplary colic calculation is shown. It should be noted that the calculations are not exact, which is accounted for by the logger unit of the present invention in that cases of doubt are actually reported as cases of doubt.
[0089] The table below shows input and output parameters of the logger unit and hence parameters used for calculating likelihood of colic in the example.
Table 3
Figure imgf000015_0001
Figure imgf000016_0001
[0090] Exemplary threshold values for colic probability are listed in the table below.
Table 4
Figure imgf000016_0002
[0091] In the exemplary colic likelihood calculation, a step-by-step method is used. In the logger unit, this is, naturally, carried out in an automatically. The user only enters external events such as start crying, stop crying and so on.
[0092] Step i
[0093] First, all crying periods are summed up day by day. That is, the formula below is used for each individual day, and a new parameter d is used for each day. For example, for a five day period, there will be five T(d) values, for a three week period, there will be 21 T(d) values, and so on. The sum of all crying periods for day d, is T(d):
T{d) = ∑ t _ end - 1 _start [eq. 1]
[0094] Step 2
[0095] The likelihood of colic, P(d), for each day is calculated. If the child has cried for less than 2 hours during a day, the colic likelihood value for this day equals 0. If the child has cried for more than 2 hours, the colic likelihood of this day is larger than 1 , increasing proportionally with the number of crying hours. The formula for calculating the colic likelihood, P(d), for day d is as follows: P(d> ° if T(d) < 2
Figure imgf000017_0001
[0096] The factors (-14/3) and 7/3 is chosen so as to make the colic likelihood equal to 1.0 in the case of 3 hours of crying 3 days a week during 3 weeks.
[0097] Step 3
[0098] The colic likelihood for a period of n days is calculated. In the example, a maximum of 21 days is assumed, but the apparatus is by no means limited thereto.
[0099] First, an average colic likelihood for all days is calculated. Then, the result is multiplied with a factor increasing with the number of days of crying. In this manner, the reliability of the colic likelihood calculation will increase when the crying periods have been measured over several days. If only measurements for a few days are available, the uncertainty will be larger and thus the likelihood of colic will be lower.
[00100] The colic likelihood for a period of n days then becomes:
42 n ^ [eq. 3]
[00101] When parents log the baby's crying, the digital log will flash a "near colic symbol", as well as a contact doctor/health care centre symbol, when the accumulated crying approaches the colic definition threshold. That is, in this example, when P is between 0.8 and 1.5. If the number of hours the baby has cried reaches/exceeds the colic definition, a colic symbol will flash on the screen together with the contact doctor/health centre symbol. As the parents also record when the child sleeps, eats, and poops, patterns indicating whether or not the crying may be related to colic can be easily revealed. In addition, parents may also log remedial actions such as acupuncture or other recommended measures for easing the colic pain of the child. In that case, the digital logger of the present invention will reveal whether or not the measures have any effect on the crying pattern of the child.
[00102] The digital log are able to indicate colic patterns, and provides vulnerable and exhausted parents of colic children with a predictability that helps them through a tough time. It also systematizes other basal needs and remedial actions (sleep, food, and digestion, as well as any cases of acupuncture, chiropractic, mothers' diets, etc.) thus revealing reasons why a baby is crying.
Numbering designation of the drawings
10 The data logger unit according to the present invention
11 Local computer/PC
12 Development computer/PC
13 Communication link between the development computer and the data logger unit of the present invention, e.g. a RS232 connection.
20 Data logger application
21 User-defined button character device.
22 Joystick character device
23 USB device
24 Loudspeaker device
25 Flash memory block device
26 Event handling
27 Event handling library
28 Device driver for user-defined button
29 Device driver for joystick
30 USB driver
31 Loudspeaker driver
32 Device driver for flash memory Abbreviations and definitions
CVS Concurrent Version System
I/O Input/Output
HTML HyperText Markup Language MMU Memory Management Unit
MPL Mozilla Public License USB Universal Serial Bus Boot loader The boot loader may be the first software running after power-up. It is responsible for initializing necessary hardware and starting the other software.
Flash Memory area in which the content is preserved even if the power is switched off.
Linux Exemplary operating system that may be used on the local PC
Local PC A PC that may run one of the operating systems Linux, Mac OS X, or Windows. Has a
USB connection that may be connected to the
Digital Logger Unit to fetch data. The local PC may also be used for viewing the information transferred through an application.
Mac OS X Operating system that may be used on the local PC.
RAM Random Access Memory. Memory area in which the content is lost if the power is switched off.
UML Unified Modeling Language. Standard modeling language used for specifying software systems.
Development PC PC used for software development. Windows Operating system that may be used on the local PC.

Claims

Claims
1. A digital logger (10) for logging fetal development during pregnancy and for infant-related events embedded in a device characterized in that it comprises: a. input/output units, comprising special buttons for registering events, b. non-volatile memory for storing events, and c. an operating system for controlling hardware and software.
2. The digital logger (10) of claim 1 , characterized in that the input/output units further comprises: a joystick, display, USB port, and a loudspeaker.
3. The digital logger of claim 1 , characterized in that the special buttons comprise the following functional buttons: a fall-asleep button, awakening button, food button, diaper change button, cry start button, cry stop button, and happy button.
4. The digital logger of claim 1 , characterized in that the logger comprises a processor.
5. The digital logger of claim 2, characterized in that the joystick is capable of generating the following events shown on a display: up, down, left, right, and enter.
6. The digital logger according one or more of claims 1-5, characterized in that the logger further includes at least an alarm unit.
7. The digital logger according to one or more of claims 1-6, characterized in that the logger at least comprises a real-time clock.
8. The digital logger according to one or more of claims 1-6, characterized in that the logger comprises an algorithm for calculating likelihood of colic, the algorithm comprising the steps of carrying out the following calculations:
T(d) = ∑t_end-t_start d a. calculate T(d) b. P(d) for day d is given by:
P(d>° if T(d) < 2
v 3J 3 if T(d) >= 2 c. the likelihood of colic for a period of n days then becomes:
Figure imgf000021_0001
9. The digital logger of claim 8, characterized in that if P has a value between 0.8 and 1.5, a colic alarm will be issued by the digital logger.
PCT/NO2010/000163 2009-05-04 2010-05-03 A device for recording events relating to parents of infants and pregnant women Ceased WO2010128863A1 (en)

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