Abstract:
A method of recording, storing, analyzing, and displaying changes in a woman&#39;s basal body temperature includes the steps of: (a) recording with an intelligent, preprogrammed thermometer the woman&#39;s orally-measured temperature; (b) storing in the thermometer the woman&#39;s temperature to create a stored temperature reading; (c) repeating steps (a) and (b); (d) analyzing inside the thermometer the significance of any changes in the stored temperature readings; and (e) displaying the changes in the woman&#39;s basal body temperature, and displaying an analysis of those changes, on the thermometer, and on any electronic device connected to the thermometer. In other features of the invention, steps (a) and (b) are repeated daily when the woman first awakes from her night&#39;s sleep, and the woman first inputs into the thermometer data about herself, including at least her year of birth, her height, her weight, her body mass index, and her current and past menstruation data.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application claims the benefit of provisional patent application Ser. No. 61/452,296, filed Mar. 14, 2011. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable. 
       THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    Not Applicable. 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0004]    Not Applicable. 
       BACKGROUND OF THE INVENTION 
       [0005]    (1) Field of the Invention 
         [0006]    The invention relates to methods and devices for measuring, analyzing, and displaying a woman&#39;s daily fertility status. 
         [0007]    (2) Description of Related Art (Including Information Disclosed Under 37 CFR 1.97 and 1.98) 
         [0008]    Measuring the “Basal Body Temperature” (“BBT”) is a known method of fertility calculation. However, in the past a woman had to put the self-measured data on a graph each time that she took her temperature; the calculation and analysis were done manually by her. This is time consuming; human error can not be excluded. Other natural family planning devices exist. Existing devices such as fertility monitors and ovulation predictors use indications such as BBT, saliva, mucous analysis, or the measurement of hormonal changes in salvia or urine to depict ovulation. 
         [0009]    Many monitoring methods have been patented, based on a wide variety of physical or chemical bodily changes believed to be indicative of the progress of the ovulation cycle. The following patents and patent applications are examples of such methods. 
         [0010]    U.S. Pat. No. 3,749,089 describes an instrument for monitoring ovulation including a dual electrode vaginal probe and monitoring device, for indicating the magnitude and polarity of the electriochemical response of vaginal fluids. 
         [0011]    U.S. Pat. No. 3,924,609 describes a test procedure and apparatus for determining low DC potentials for measurement and identification of the different phases as well as the fact of ovulation in adult mammalian females. 
         [0012]    U.S. Pat. No. 3,926,037, U.S. Pat. No. 3,928,423, U.S. Pat. No. 4,002,056, U.S. Pat. No. 4,013,066 and U.S. Pat. No. 4,059,986, describe devices for determining the properties (particularly surface tension) of bodily mucus as an indication of menstrual cycle phase. 
         [0013]    U.S. Pat. No. 3,986,494 and U.S. Pat. No. 4,010,738 describe a method of monitoring the concentration of volatile organic compounds having a molecular weight of between 50 and 350, found in vaginal secretions. 
         [0014]    U.S. Pat. No. 4,031,365 describes a system for continuously monitoring and displaying temperature to indicate ovulation activity. 
         [0015]    U.S. Pat. No. 4,036,212 describes a method of monitoring the progress of the ovulation cycle which comprises periodically determining the concentration of ATP in vaginal fluid. 
         [0016]    U.S. Pat. No. 4,119,089 describes a method for predicting and ascertaining the time of ovulation by monitoring the level of at least one volatile sulphur compound commonly occurring in mouth air. 
         [0017]    U.S. Pat. No. 4,148,304 describes a system for determining the time of ovulation in females including an ear probe which measures body temperature and a probe which measures body potential together with an electronic amplification circuit and indicating device which is capable of measuring small changes in temperature and body potential and providing a portable and, convenient device for determining time of ovulation. 
         [0018]    U.S. Pat. No. 4,151,831 describes a fertility indicator for measuring and detecting the body temperature of a human subject over a menstrual cycle, having a timer for generating time based signals, and a logic circuit connected to the clock timer and being responsible to the time based signals for selecting the proper combinations of the time based signals and for indicating the correct present time. There are various types of temperature sensors (vaginal probe, mouth probe, or waist belt) that can be used, coupled to a logic circuit for measuring the body temperature of the human subject. A solid state memory circuit having coded information command signals is coupled to the logic circuit for sequencing the logic circuit to take a plurality of temperature readings at a preset real time and to terminate the readings when the temperature has stabilized. A data storage circuit is provided for sequentially recording each of the stabilized temperatures that were measured, and a display circuit responsive to the solid state memory and data storage circuits, indicates the status of fertility of the subject during a menstrual cycle. There is also an alarm circuit coupled to, the logic circuit and it has a variable pitch responsive to the solid state memory circuit for indicating the time when the subject&#39;s temperature has to be taken. Lights or words can indicate the user&#39;s status. 
         [0019]    U.S. Pat. No. 4,151,833 describes a method for detecting ovulation by measuring the water content of the cervical mucus using a pellet made from a water-swellable polymer. 
         [0020]    U.S. Pat. No. 4,246,907 describes a method for predicting ovulation based on measuring every day throughout at least a substantial portion of the days of the menstrual cycle, the polarity of a direct current potential between at least two spaced apart portions of a woman&#39;s body. 
         [0021]    U.S. Pat. No. 4,465,077 describes a fertility computer having the ability to store information about a user&#39;s past menstrual cycle history, basal body temperature, and gynaecological disorders which; along with certain prediction indicators, is used to predict statistically when ovulation will occur. The information is processed in accordance with a pre-determined program which ascribes certain values to the parameters to predict the present fertility status of the user. 
         [0022]    U.S. Pat. No. 5,657,762 describes a method of monitoring the ovulation cycle of a female mammal, involving regular measurement of basal body temperature throughout a current ovulation cycle and occasional measurement of the level of at least one urinary component of significance in the cycle, the measurement of the urinary component being conducted at predetermined stages in the cycle to check that the level is consistent with a predicted level and thus confirm that the cycle as a whole is consistent with a prediction. 
         [0023]    U.S. Pat. No. 6,110,125 describes an indicating device for menstruation that includes: an ear-temperature measuring sensor to measure basal body temperatures of a user and output the measured values; a parameter-inputting means for inputting user-inputting parameters; a microprocessor for storing the basal body temperatures from the temperature measuring sensor, and storing the user-inputting parameters from the parameter inputting means, then using a mathematical method to estimate the user&#39;s monthly gynecophysiological factors in accordance, with the basal body temperatures and the user-inputting parameters; and a display means to display the user&#39;s monthly gynecophysiological factors estimated by the microprocessor. The indicating device for menstruation uses a mathematical method including weighting coefficients to estimate a user&#39;s monthly gynecophysiological factors more accurately. 
         [0024]    U.S. Pat. No. 6,861,079 describes a basal body temperature thermometer and a chart with instructions to confirm when and if ovulation will/did occur. Commercially available urinary chemical reagent strips are provided with instructions so as to predict/confirm if and when ovulation will occur. 
         [0025]    U.S. Pat. Application No. 20040081024 describes a wristwatch for taking the basal body temperature of a female and predicting her ovulation phase. The wristwatch has all of the following inside its case: a control circuit; a display; a memory; a timer; a battery; a wrist-temperature sensor, and a computer. 
         [0026]    U.S. Pat. Application No. 20070191729 describes a basal body temperature (“BBT”) measurement method which includes: measuring each distance to at least one ear canal area by emitting a pulse to a user&#39;s ear canal; measuring a body temperature in the ear canal area utilizing infrared rays; recognizing a first body temperature, corresponding to a first distance which satisfies a predetermined standard, as the user&#39;s eardrum temperature; and converting the eardrum temperature into the user&#39;s BBT. 
         [0027]    A device that separates the thermometer from data entry, data analysis, data storage, and data display, is currently sold in the United States by Valley Electronics LLC, in Eden, Md., (web page is http://www.lady-comp.com/en/) as the “Lady-Comp” device, which connects a temperature probe via an extendible, flexible cord to a hand-held device that accepts the temperature measurement, compares it with past temperature measurements, analyzes all the data, determines fertility status, and then displays that status. However, the thermometer must stay connected via its cord to the hand-held device, while measuring the woman&#39;s temperature. 
         [0028]    None of the systems described above uses a personal electronic device as a user interface in combination with an intelligent thermometer, which does all the calculations needed for the analysis of the female cycle, and which also displays the woman&#39;s fertility status. The only known existing systems using both a personal electronic device and an intelligent thermometer are of two types: first, a thermometer without cycle analysis combined with analysis application on the personal electronic device; and second, an intelligent preprogrammed thermometer with cycle analysis and readout capability. End user interaction (settings, editing menstruation recordings, etc.) is not intended to be done with the personal electronic device. The first type has the disadvantage that the temperature values have to be transferred manually to the personal electronic device, thus giving rise to possible mistakes, and is uncomfortable. The second type lacks the possibility to enter user information (Such as menstruation data) directly into the personal electronic device in a way that the consistency of data with the intelligent preprogrammed thermometer is assured. 
         [0029]    In light of the foregoing, a need remains for a system and method to allow the appraisal of a woman&#39;s menstrual cycle (i.e. corpus luteum insufficiency, anovulation, ovulation) through the use of a small oral thermometer which can analyze, store, and display fertility status, and then also communicate with a woman&#39;s personal electronic device, or personal digital assistant, such as a Blackberry, an iPod or some other such “smart” phone to store and display the fertility status. 
       BRIEF SUMMARY OF THE INVENTION 
       [0030]    An intelligent preprogrammed oral thermometer measures the basal body temperature to, track a woman&#39;s menstrual cycle to determine the fertile window. The thermometer is synced with a woman&#39;s personal electronic device using a software application to display the calculated fertility status. 
         [0031]    It is an object of the present invention to provide a compact and portable product package, which includes an intelligent thermometer, sync software, and application software, to be used with a personal electronic device to analyze and display a woman&#39;s daily fertility status. A secondary object of the invention is to allow the appraisal of a woman&#39;s menstrual cycle (i.e. corpus luteum insufficiency, anovulation, ovulation) through the use of a small oral thermometer which communicates with a woman&#39;s personal electronic device. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0032]    The novel features characteristic of the invention are set forth in the appended claims. However, the invention itself, as well as a preferred mode of use, and further objectives and advantages thereof, will best be understood by reference to the following detailed description, when read, in conjunction with the accompanying drawings in which the left-most significant digit(s) in the reference numerals denote(s) the first figure in which the respective reference numerals appear. 
           [0033]      FIG. 1A  is a schematic diagram of the intelligent preprogrammed thermometer of the present invention, equipped with a USB connection. 
           [0034]      FIG. 1B  is a schematic diagram of the intelligent preprogrammed thermometer of the present invention, equipped with a wireless connection. 
           [0035]      FIG. 2  illustrates various display screens on a woman&#39;s personal electronic device, when such device is loaded with the application software of the present invention. 
           [0036]      FIG. 3  is a schematic diagram of the intelligent preprogrammed thermometer connected by a USB cord to either a computer or a woman&#39;s personal electronic device. 
           [0037]      FIG. 4  is a schematic diagram of the intelligent preprogrammed thermometer connected wirelessly to either a computer or a woman&#39;s personal electronic device. 
           [0038]      FIG. 5  is a flow chart of the method that the system of the present invention uses to record, store, and analyze the BBT, and to display the significance of the BBT. 
           [0039]      FIG. 6  is a graph illustrating the fluctuation of a woman&#39;s BBT during her monthly cycle. 
           [0040]      FIG. 7  is a flow chart of the usual method of the actions that the user of the system of the present invention would take, and the responses of the system to those actions. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0041]    Referring now to  FIG. 1A , a thermometer  101  is a portable, digital, intelligent, pre-programmed thermometer. The thermometer  101  measures a female&#39;s basal body temperature (“BBT”). The thermometer  101  contains a battery  105 . An activation button  107  enables input of the first day of menstruation as it occurs in the user&#39;s female cycle, and allows the daily recordation of the BBT. The thermometer  101  includes a LED display  109  which indicates when measurement is successfully taken (about sixty seconds daily), and shows the actual daily fertile status of the user. In other embodiments, the display  109  can be replaced with, or accompanied by, either a light or an acoustic signal generator. The thermometer  101  has a resolution of 1/100 degrees Celsius. The thermometer  101  has a tip  111  which is designed to fit under a woman&#39;s tongue. The tip  111  includes a temperature sensor  113 . A cable  115  attaches at a first end to the thermometer  101  and at a second end to a USB connector  117 . 
         [0042]    The thermometer  101  has a microcontroller chip  103 . The microcontroller chip  103  contains the following items, hot shown in the drawings: a battery-backed volatile memory (“RAM”), a non-volatile memory (typically FLASH) for storing programs (plus an optional boot loader) and data (“ROM”), a CPU, an analog-to-digital converter (“ADC”), timers, a real-time clock with, an alarm function (with low power microcontrollers as MSP430 emulated by software), input lines for button(s) or optionally touch sense input pins, output lines for LED, sound, and/or displays (LCD, OLED or similar), and a voltage regulator. The microcontroller chip  103  is pre-programmed with temperature detection software, bio-mathematical forecasting software, synchronization recognition software, and application communication software. 
         [0043]    Referring now to  FIG. 1B , in an alternate embodiment of the thermometer  101 , instead of using, the cable  115 , the thermometer  101  is equipped with a wireless transducer chip  116  to enable wireless communication (for example, “Bluetooth”). 
         [0044]    The thermometer  101  can be used alone, or with a software application on the user&#39;s computer or other personal electronic device. The microcontroller chip  103  has enough storage capacity to store and display the female&#39;s fertile status. The necessary menstruation date can be input in three consecutive days by pressing the activation button  107  when menstruation occurs. The measurement of the BBT is taken daily, upon waking up, by putting the tip  111  under the tongue, and pressing the activation button  107 . The temperature can only be taken once a day, within the temperature reading time limit. The temperature reading time limit comprises 6 hours, beginning and ending three hours before and after the last temperature reading time. Temperature can be taken only once a day within the time, limit for taking the temperature. If the user is within the reading time limit, she can take her temperature, as indicated by the notification alert  109 . The alert  109  can be a light, a display, or an acoustic signal. The alert  109  indicates the end of measurement, and will show the fertile status of the actual day as either fertile, non fertile, or ovulation. 
         [0045]    Referring now to  FIG. 2 , application software  202  displays the results of the measurements taken, and the analysis done, by the thermometer  101 . The application software  202  generates a main screen  231 , which displays a welcome screen  230  and a footer navigation  240 , which defaults to the current time and the date of the last fertility status. The format of the time and date can be changed to the user&#39;s local time and date by using the input language of the user&#39;s private electronic device  301 , shown in  FIG. 3 . The footer navigation  240  contains the most used functions: a temperature reading, a fertility status, an alarm, and other settings. All functions of the footer navigation  240  are presented by an icon  246 . After a tap on the welcome screen  230 , a user data screen  232  allows the user to enter her year of birth, her height, her weight, and her body mass index (“BMI”). 
         [0046]    A display screen  233  presents the current temperature reading right after measurement. Using display screen  234 , past or current menstruation data can be entered. (Occurring menstruation data is a necessary input used to calculate the users cycle.) Menstruation must be entered three consecutive days during each cycle. A display screen  242  allows the user to adjust and activate an alarm time. A display screen  243  presents the fertility status of the next 24 hours, calculated by the thermometer  101 , and communicated to the application  202 . The display screen  243  displays the menstrual cycle day, the measured temperature, the date, and other necessary indications. A display screen  244  shows the user&#39;s menstrual graph, depicting ovulation day, fertility status, phases of the moon, temperature reading, date, and forecast. A display screen  245  presents an overview of the woman&#39;s individual cycle calendar. 
         [0047]      FIG. 3  and  FIG. 4  each illustrate the computing devices necessary to operate the thermometer  101  with the application software  202 .  FIG. 3  illustrates the use of the thermometer  101  with the USB connector  117 , connecting to either a personal computer.  301  or to a smart phone.  302 .  FIG. 4  illustrates the use of the thermometer  101  with the chip  116  to connect wirelessly to either a personal computer  301  (such as a tablet PC or a PC/Mac) or to a smart phone  302 . 
         [0048]    The application software  202  necessary for the operation of the thermometer  101  can be downloaded via an application software store or a website. The application software  202  works with either the personal computer  301  or the smart phone  302 . The thermometer  101  communicates and exchanges information (individual cycle and BBT data) with the application software  202 . The daily BBT measurements from the user are synchronized with the application software  202  in Degrees or Fahrenheit. Menstruation data, fertility status, cycle day, ovulation day and other detected cycle information are synchronized with the application software  202 . 
         [0049]    If the thermometer  101  connects via the USB  117  to a personal computer  301 , then the power supply can be derived from the personal computer  301 , and data transfer is possible at any time as long as there is a connection. On the other hand, if the thermometer  101  connects wirelessly via the chip  116 , then data transfer will only be possible if the smart phone  302  is active. This feature allows for minimized power consumption during standby. 
         [0050]    To extend battery life, in the preferred embodiment, the thermometer  101  goes into standby mode after sixty seconds with no user interaction or running a measurement. The recorded temperature and menstruation data, as well as the results of the cycle evaluation, are stored permanently and independently from the battery state. 
         [0051]    For connection via the USB connector  117 , a profile is used, which is commonly accepted (for example. HID, mass storage device or serial port interface). If the thermometer  101  is connected to a computer  301  that accepts the USB connector  117 , then power can be drawn from the computer  301 , and the thermometer  101  will act as “USB device”. If the USB connector  117  is capable to act as a “USB device” only, the thermometer  101  has to act as a USB-on-the-go host. 
         [0052]    The wireless (for example, Bluetooth) protocol may be implemented in a separate interface device inside the thermometer  101 , or integrated into the microcontroller chip  103 . 
         [0053]    Referring now to  FIG. 5 , the method is illustrated that the thermometer  101  uses to record, store, and analyze the BBT on the microcontroller chip  103 . In step  522 , the thermometer  101  starts measuring the temperature of the user. In step  523 , the microcontroller chip  103  waits for a stable temperature value. In step  524 , the user&#39;s cycle data (temperature) is saved and stored. The microcontroller chip  103  detects ovulation by the change of temperature and the input of the menstruation data. If applicable, in step  525 , the chip  103  requests menstruation input, and stores that input. Based on the recorded data in steps  524  and  525 , the chip  103  performs the following calculations. In step  532 , the chip  103  determines the beginning of a new cycle, based on the menstruation day that the user previously entered in step  525 , either using the application software  202 , or on the thermometer  101 . To achieve a definite detection of cycle start, dependent on the phase of the cycle, in step  542  the chip  103  determines whether three consecutive days of menstruation entry have occurred. If such has happened, then in step  552  the chip  103  calculates the statistics and stores them permanently. 
         [0054]    Referring back to step  532 , if a new cycle has hot started, or, if in step  542  the answer is also “no”, then in step  553  the chip  103  processes the information and calculates accordingly to detect fertile levels. In step  553  the chip  103  determines whether the day is a “safe” day for avoiding conception, that is, at the start of a cycle. If it is, then in step  561  the chip  103  displays “infertile” (green signal). If in step  553  the chip determines that the day is NOT a “safe” day for avoiding conception, then in step  554  the chip  103  determines whether the day is an intermediate day after a “safe” day, that is, an “uncertain” day. If the chip  103  determines that the day is an “uncertain” day for avoiding conception, then in step  562  it displays “uncertain” or “possibly fertile” (yellow signal). If in step  554  the chip  103  determines that the day is NOT an “uncertain” day for avoiding conception, then in step  555  it determines whether the day is a possibly fertile day. If in step  555  the chip  103  determines that the day is a possibly fertile day, them in step  563  it displays “fertile” (red signal). If in step  555  the chip  103  determines that the day is NOT a possibly fertile day, then in step  556  it determines whether the measured temperature denotes a significant temperature rise. If the temperature rise is of low significance, then in step  566  it displays “possibly fertile” (yellow signal). If the temperature rise is of high significance, then in step  566  it displays “infertile” (green signal). If in step  556  the chip  103  determines that the temperature rise is not significant, then in step  560  the chip  103  stores and evaluates the result. In step  560 , based on the day, of the cycle and the temperature readings, the chip  103  determines whether ovulation has already taken place in this cycle, and generates a display of fertility state. The chip  103  displays the result on the thermometer  101 , and also makes the display available via the application software  202  on the personal computer  301  or on the smart phone  302 . The actions in step  560  also occur after each of steps  561 ,  562 ,  563 , and  566 . 
         [0055]    The chip  103  uses several measures to get a failsafe handling of temperature recordings. First, in step  523 , temperature measurement is not finished until the value has, stabilized. If the temperature decreases significantly during the measurement, the value is not accepted until the temperature rises again to an acceptable value. This is because normally the basal body temperature will not significantly fall during the short period of measurement. Falling values thus are due to improper handling of the sensor  113 , breathing cold air, or similar influences which impede getting valid data. Another measure used to get a failsafe handling of temperature recordings is that temperature values are evaluated with statistical methods, and require a high significance for an accepted temperature rise. A third measure used to get a failsafe handling of temperature recordings is that the required level, of significance is adapted over the cycle to integrate the probabilities of temperature and day of cycle. 
         [0056]    The user has the possibility to correct her data (regarding menstruation and intercourse), using the application software  202  or the thermometer  101 , backwards for a limited number of days (three days, in the preferred embodiment). As soon as a new cycle start is definitely detected in step  542  and can&#39;t be erased again, a complete evaluation of the finished cycle takes place (exact determination of ovulation day, average temperature values for pre- and post-ovulation, checking if a corpus luteum insufficiency, (“CLI”) can be diagnosed or a monophase occurred) and the overall-statistics concerning the whole recorded data are updated. 
         [0057]      FIG. 6 . shows how the basal body temperature fluctuates in a woman&#39;s cycle. The menstrual cycle of a woman can be shorter (for example, 26 days) or longer (for example, 42 days) than the “average”. Temperature rises during ovulation by just 0.25 to 0.45 degree Celsius. The thermometer  101  detects this slight temperature increase. Temperature falls when menstruation starts. Pre-ovulatory phase temperature is lower. Post-ovulatory phase temperature is higher. 
         [0058]    Referring now to  FIG. 7 , the operation and use of the thermometer  103  is illustrated in a flowchart. The user of the thermometer  101  downloads the application software  202  from the inventor&#39;s website or an app store to a computer  301  or to a smart phone  302 . In step  720 , the application software  202  is opened and started. In step  721 , the Year, Month, Day, Time, BMI and past menstruation data (if applicable) are entered and displayed via the application software  202 , using the screens  231 ,  232 , and  234 . This is a one-time data entry. In step  722 , the user sets the wake up time using, the application software  202  and the screen  242 . In step  723 , the thermometer  101  is synced with the computer  301 , and information is exchanged. In step  724 , data is stored on the chip  103 . In step  725 , the alarm on the thermometer  101  sounds at the time entered via, the application software  202 . An optional feature allows the user to choose to be awakened by the smart phone  302 , as can be set via the application software  202 , using the screen  242 . In step  726 , the user stops the alarm by pressing the button  107  or by putting the end of the thermometer  101  containing the sensor  113  in her mouth. She then takes her temperature for about sixty seconds. In step  727 , an acoustic or light signal  109  informs the user that her temperature was taken. In step  728 , the chip  103  processes the data from the pre-entered data from the application software  202  and from the temperature just taken, and displays the fertility status of the next 24 hours. An optional feature allows the thermometer  101  to be synchronized with the application software  202  to display the fertility status and further cycle information, as shown in the display screens  243 ,  244 , and  245 . If menstruation occurs it can be so noted by the user, as shown in  FIG. 5 . 
         [0059]    The application software  202  and the thermometer  101  can be synchronized anytime. Cycle data information of the user can be exchanged between the application software  202  and the thermometer  101  whenever wanted. Valuable information about the user&#39;s menstruation cycle can be viewed using the application software  202  through either a computer  301  or a smart phone  302 .