CA3010634A1 - Fertility diagnostics monitoring system for fertility biomarker and related methods - Google Patents

Fertility diagnostics monitoring system for fertility biomarker and related methods Download PDF

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Publication number
CA3010634A1
CA3010634A1 CA3010634A CA3010634A CA3010634A1 CA 3010634 A1 CA3010634 A1 CA 3010634A1 CA 3010634 A CA3010634 A CA 3010634A CA 3010634 A CA3010634 A CA 3010634A CA 3010634 A1 CA3010634 A1 CA 3010634A1
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cervical mucus
led
medical device
fertility
temperature
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Maria Lorena H. Forcadilla
Mary Anne H. Forcadilla
Renato A. Forcadilla
Ernesto A. Forcadilla
Rafael Nelson Aboganda
Alex Pabayo
Reynaldo Cruz
Alexander Azucena
Paul Vincent Forcadilla
Charissa Rais
Marcin Skonieczny
Devlin Selkridge
Rishikesh Ghimire
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    • 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
    • A61B5/4318Evaluation of the lower reproductive system
    • A61B5/4331Evaluation of the lower reproductive system of the cervix
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/01Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0271Thermal or temperature sensors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

The present invention relates to the programming of a microprocessor to make two (2) genuine electronic sensors in direct contact with the vagina, sensing or actuating, to automate the natural birth control process. The stand-alone medical device measures the Body Basal Temperature (BBT) and detects the conditions and quality of cervical mucus in real-time -using LED lights and an audible sound to indicate infertile or fertile conditions. The stand-alone medical device is time critical, as it can only be used in the morning waking hours. However, when the stand-alone medical device is connected to computing devices via Bluetooth, it can be used as a vaginal probe in real-time before sexual intercourse. The computing device loaded with application software receives real-time, wireless data from the medical device and inputs from users. It also stores body parameters, and personal ovulation benchmarks to further analyze, consolidate, process data and display information on the fertility/infertility of users. A cloud-based software and Internet platform integrate ovulation data sent wirelessly from the computing devices onto digital records of users on health, exercise, stress level, sleep, and nutrition. The new Internet platform is named Family & Lifestyle Planner. The cloud-based software uses machine learning, Artificial Intelligence, and Big Data computing.

Description

ABSTRACT
The present invention relates to the programming of a microprocessor to make two (2) genuine electronic sensors in direct contact with the vagina, sensing or actuating, to automate the natural birth control process. The stand-alone medical device measures the Body Basal Temperature (BBT) and detects the conditions and quality of cervical mucus in real-time ¨
using LED lights and an audible sound to indicate infertile or fertile conditions. The stand-alone medical device is time critical, as it can only be used in the morning waking hours. However, when the stand-alone medical device is connected to computing devices via Bluetooth, it can be used as a vaginal probe in real-time before sexual intercourse. The computing device loaded with application software receives real-time, wireless data from the medical device and inputs from users. It also stores body parameters, and personal ovulation benchmarks to further analyze, consolidate, process data and display information on the fertility/infertility of users. A cloud-based software and Internet platform integrate ovulation data sent wirelessly from the computing devices onto digital records of users on health, exercise, stress level, sleep, and nutrition. The new Internet platform is named Family & Lifestyle Planner. The cloud-based software uses machine learning, Artificial Intelligence, and Big Data computing.
FERTILITY DIAGNOSTICS MONITORING SYSTEM FOR FERTILITY
BIO MARKER AND RELATED METHODS
CROSS REFERENCE TO RELATED APPLICATION
(01) This application claims priority to United States Provisional Patent No. 62/195373 - Fertility Detector, filed on July 22, 2015 FIELD OF THE INVENTION
(02) This invention relates to a fertility monitoring device adapted to measure Basal Body Temperature (BBT) with sensitive digital temperature, viscosity, and Infrared sensors detecting the conditions of cervical mucus and sending fertility data based on multiple inputs to another computing device.
Wage BACKGROUND OF THE INVENTION
(03) In the Philippines, 34% of married women (15-49 years old) used contraceptive methods such as condoms, contraceptive pills, hormonal injections and IUDs; 0.5% natural birth control methods;
and 16.7% traditional methods. While, 49.3% are currently not using any method. The Catholic Church is promoting natural birth control methods through family planning clinics. The Philippine Health and Reproductive Act of 2013 allows the government to purchase, distribute contraceptive products and educate the Filipinos about birth control. But access to reliable and accurate high-tech devices and methods of birth control are very much needed.
(04) Natural family planning methods without the use of medications or devices to control birth is practiced in the Philippines for many years. Natural family planning methods type of birth control like calendar and rhythm methods rely on observations about the woman's body and menstrual cycle. It also includes fertility awareness methods. However, using these methods requires personal discipline and clear understanding on how the methods work. The frustrating and time-consuming methods and the accuracy of determining the ovulation period deter many Filipino women from using them.
(05) Measuring the basal temperature is one fertility biomarker that has been effective to determine when women have ovulated.
Following ovulation, a woman's temperature rises by 0.4 to 1.0 degrees and remains up till next menstrual period. The temperature is lowest during the five days of ovulation where a woman is most fertile. But tracking the basal temperature is not accurate because of several factors. One is the use of mercury-based thermometer that is not sensitive enough to measure the slight shift of temperature usually at woman's waking hours in the morning. Second factors are the effect of body temperature flux, Wage room and ambient temperature to accurately measure the slight shift in basal temperature. Several US patents have been granted for inventions using Basal Body Temperature (BBT) to monitor fertility, among them are US Pat. No. 4,031,365 describing a system for continuously monitoring and displaying temperature to indicate ovulation activity. US Pat. No. 4,148,304 describes a system for determining the time of ovulation in an ear probe, which measures body temperature. US Pat. No. 4,151,831 describes a fertility indicator for measuring and detecting the body temperature with a timer for generating time ased signals, and a logic circuit connected to clock timer for selecting proper combinations of time-based signals. There are various types of temperature sensors such as vaginal probe, mouth probe and waist belt.
(06) Monitoring cervical mucus is the second fertility biomarker among fertility monitors on the market and patent granted. Cervical mucus monitoring is a method where cervical mucus condition is monitored each day. At the beginning of ovulation, the cervical fluid will go from dry to sticky to creamy like a lotion, and finally become like a raw egg white. This condition and quality of cervical mucus is when the woman is most fertile. The third fertility biomarker is Cervical Positioning. US Pat. No. 4,151,833 describes a method for detecting ovulation by measuring the water content of cervical mucus using a pellet made from water-swelling polymer.
US Pat. No. 4,685,471 uses cervical mucus alone to predict ovulation. US Pat. No. 5,240,010 describes a device for monitoring the temperature and changes in the characteristics of cervical mucus in the vagina.
(07) Various methods have been developed with medications, application software (fertility apps) and hardware to accurately monitor the two biomarkers, Basal Body Temperature (BBT) and conditions of cervical mucus. The method of combining temperature and the quality of cervical mucus is known as "Sympto-Thermal" method and is 99% accurate as contraception method when practiced perfectly. This is called evidence-based 3 !Page fertility-awareness method FAMBs (1 Am Board Fam. Med 2016;
29:508-511).
(08) The invention of birth control pills by Austrian-born American chemist in 1951, Dr. Carl Djerassi pioneered a social revolution on birth control. It brought women a revolutionary sense of freedom and choice. In Canada, the number of prescriptions for oral contraceptives has steadily dropped. Canadian pharmacies dispensed 1.17 million fewer prescriptions in 2015 than 2011 (QuintilesIMS). The decrease in the use of contraceptive pills is a shift in preferences among Canadian women as new alternatives such as estrogen-free and non-hormonal methods, IUDs and fertility tracking apps become available on the market. This trend follows a growing emphasis on natural health.
(09) For 60 years the contraceptive pills and hormonal injections dominated the birth control market in rich countries but are presently seeing an overall decline in the oral contraception market. Some women have become uncomfortable with putting synthetic hormones in their bodies. The World Health Organizations (WHO) has declared artificial hormones as a steroid, and therefore a carcinogen. A large-scale longitudinal study published in 2015 in the journal JAMA Psychiatry, part of American Medical Association network, suggests hormonal contraception could cause depression. The study analyzed the one million women study for 14 years in Denmark that confirmed hormonal contraception could cause depression. The pill's instructions for use list various risks and side effects, from PMS-like to decreased libido, migraine, an increased risk of breast cancer and blood clots.
(10) Despite the associated health risk, expensive price, and being a prescription drugs, the contraceptive pill is convenient to use. A
woman has to pop one pill a day for 30 days and is 99% effective for most women with perfect use. The effect is similar to injectable artificial hormones. The women are protected for unwanted pregnancy with twice-a-year injections. Unfortunately for Filipino women because of the price notwithstanding the health risks have 4IPage no access or cannot afford to use contraceptive pills and hormonal injections for birth control.
(11) Computer hardware programming separates the Fertility Diagnostics from the birth control systems, methods, and devices described and patents granted, to accurately determine the ovulation period. The program code (Figure 8), Arduino programming language (C++) on microprocessor that controlled the 2 digital sensors was developed based on the criteria of Family Practice Management in the US. It is a standardized set of 7 cycles of daily fertility observations, derived from real cycle data of ovulation benchmark and body parameters. The program code was also derived from the analysis of various fertility methods both hardware and software, artificial and natural, such as artificial hormones and biochemical, Fertility Apps, Rhythm methods, Lutenizing Hormone, Thermal Monitor, and Electrolyte Monitor.
Fertility Diagnostics hardware programming and reversed engineering enabled the device to be used as vaginal probe in real-time before sexual intercourse.
SUMMARY OF THE INVENTION
(12) A programmed stand-alone medical device that accurately detects fertility biomarkers such as Basal Body Temperature (BBT) and conditions of cervical mucus in real-time with 4 LED lights and sound alarm was invented. Within 10 seconds of vaginal insertion, a user will be able to know if she is fertile or not. The device also sends the wireless data of the measurement of temperature and conditions of cervical mucus via Bluetooth to computing devices like a mobile phone, tablet, laptop, and desktop computer for reactive computing. These devices are loaded with application software to receive, store, process fertility data in real-time and send the data wirelessly to the cloud-based Internet platform for integrated data processing related to health, fertility, exercise, stress level, sleep, and nutrition. The phone-based application software displays, records, and stores signals of Basal Body Temperature (BBT) and conditions of cervical mucus. It stores user 5[ Page inputs for profiling ovulation and personal fertility benchmark. The cloud-based software stores digital records of personal profile of users containing body parameters. It analyzes, interprets, and consolidates data and relays in digestible forms. The cloud-based platform contained users pre-set body parameters on ovulation, behavioural, dietary and lifestyle metrics.
CLAIMS OF THE INVENTION
1. The Fertility Diagnostics is a medical device for measuring the Basal Body Temperature (BBT) and detecting the condition and quality of cervical mucus to predict the ovulation period in real-time, comprises of:
(a) A digital sensor for measuring the Basal Body Temperature (BBT) and a cervical mucus sensor detecting the condition and quality of cervical mucus to determine fertility or infertility.
(b) It means the sensor measuring the Basal Body Temperature (BBT) by inserting the hygienic tubular device into the vagina is a one-wire sensor that uses digital protocol to quickly and accurately measure the temperature of the vagina in real-time with usable temperature range of -55 degree to 125 degree centigrade (-67F to +257F).
(c) It means the sensor for detecting the condition and quality of cervical mucus of a woman by inserting the hygienic tubular device into the vagina is a reflective Infrared sensor capable of detecting the condition, quality, and viscosity level of cervical mucus from a distance of 2mm to 10mm.
(d) The cervical mucus is scraped from the vagina and deposited in a mucus trap directly sensed by the Infrared sensor.
(e) Both signal output of temperature sensor and Infrared sensor are processed by a programmed microcontroller with 4 LED
lights and sound indicating the results: LED yellow will light if the user is not fertile and the LED green if semi-fertile. LED
white will illuminate with a buzzing sound to indicate fertile (two days) and LED red will light up with a buzzing sound to indicate user's fertility is certain (3 days). The lighting of LED red 61 Page

Claims (7)

CLAIMS OF THE INVENTION
1. The Fertility Diagnostics is a medical device for measuring the Basal Body Temperature (BBT) and detecting the condition and quality of cervical mucus to predict the ovulation period in real-time, comprises of:
(a) A digital sensor for measuring the Basal Body Temperature (BBT) and a cervical mucus sensor detecting the condition and quality of cervical mucus to determine fertility or infertility.
(b) It means the sensor measuring the Basal Body Temperature (BBT) by inserting the hygienic tubular device into the vagina is a one-wire sensor that uses digital protocol to quickly and accurately measure the temperature of the vagina in real-time with usable temperature range of -55 degree to 125 degree centigrade (-67F to +257F).
(c) It means the sensor for detecting the condition and quality of cervical mucus of a woman by inserting the hygienic tubular device into the vagina is a reflective Infrared sensor capable of detecting the condition, quality, and viscosity level of cervical mucus from a distance of 2mm to 10mm.
(d) The cervical mucus is scraped from the vagina and deposited in a mucus trap directly sensed by the Infrared sensor.
(e) Both signal output of temperature sensor and Infrared sensor are processed by a programmed microcontroller with 4 LED
lights and sound indicating the results: LED yellow will light if the user is not fertile and the LED green if semi-fertile. LED
white will illuminate with a buzzing sound to indicate fertile (two days) and LED red will light up with a buzzing sound to indicate user's fertility is certain (3 days). The lighting of LED red and buzzing sound means the synchronization of Basal Body Temperature and condition of cervical mucus have determined that the ovulation period has peaked. The real-time result is displayed on the LCD with character display of "Safe Sex" (not fertile) on LED yellow and green without sound alarm and "Unsafe Sex (Fertile) for LED white and red with sound alarm.
2. The Fertility Diagnostics is a medical device as mentioned in Claim No. 1 can be used as a portable non-wireless mode (stand-alone) and a wireless mode. In a wireless mode operation, the output of the medical device is the input for software processing installed on computing devices. The signal is transmitted via Bluetooth.
3. The Fertility Diagnostics is a medical device mentioned in Claims 1 and 2 where said outputs are measurement of the Basal Body Temperature (BBT) and detection of condition and quality of cervical mucus are displayed on various computing devices and data sent to the cloud.
4. The method of measuring the basal temperature and detecting the condition and quality of cervical mucus comprises the following steps:
(a) Gently insert the medical device into the vagina in the morning wake-up hours of the user for stand-alone, non-wireless mode and any time before sexual intercourse for wireless mode to determine fertile or infertile conditions.
(b) The output of temperature and cervical mucus sensors are the inputs to the microcontroller where data is processed, analyzed and results are displayed by the illumination of the LED lights, sound alarm, and text messages on LCD as mentioned in Claim No. 1(e). As recited in Claim No. 2, the processed data from programmed microcontroller in a wireless mode is transmitted via Bluetooth to computing devices.
5. As recited in Claim 4(b/c) the two outputs, basal temperature and condition of cervical mucus are relayed to the microcontroller for processing and transmitted in voltage signal for processing, analysis and interpretation by application software installed on computing devices.
6. The system of measurement, recording, storing, and analyzing the Basal Body Temperature (BBT) and condition of cervical mucus and displaying the results comprises of:
(a) A programmed microcontroller chip having RAM, ROM, CPU, and an ADC as mentioned in Claim No. 5 (b) Digital temperature sensor and Infrared sensor (c) Application software loaded on computing devices that store and display personal ovulation profile, benchmark, and body parameters.
7. The stand-alone medical device (non-wireless mode) which is time-critical that can only be used in a woman's morning waking hours can be reprogrammed after clinical testing so that it can be used in real-time before sexual intercourse.

(1) Tubular package housing the medical device circuit is made of clinically tested hygienic materials.
(2) A metallic tip that speed up the sensing of the Basal Body Temperature (BBT).
(3) The DS18B20 one-wire temperature sensor using digital protocol to measure the accurate basal temperature reading.
(4) A Reflective Infrared Sensor having two elements ¨ an IR LED and an IR
phototransistor capable to detect the accurate condition and quality of the cervical mucus.
(5) The Cervical Mucus trap with deposited mucus scraped from the vagina directly sensed by the Infrared sensor.
(6) The Bluetooth Module that wirelessly transmits in short ranges the data from the Fertility Diagnostics to external computing devices, particularly smartphone.
(7) Liquid Crystal Display (LCD) displays the text message of monitoring results.
(8) Yellow LED (8a) illuminates that user is not fertile Green LED (8b) illuminates that user is semi-fertile White LED (8c) illuminates that user is fertile Red LED (8d) illuminates that user is certainly fertile (9) The lithium ion coin battery, regulated at 5V D.C.
(10) The sliding battery holder for easy battery removal (11) The buzzer will make sound alarm when red and white LED is lighted an indication that the user is fertile (12) An ON/OFF touch switch works when touched and is completely flat to prevent unwanted switching (13) Mini-USB port an input for battery charging and external power FIGURE 2: Connection system of the invention (14) The Fertility Diagnostic device.
(15) Internet Cloud Web Services where data is automatically uploaded (16) The smartphone where real-time data from medical device is transmitted (17) The tablet computer where real-time data from medical device is transmitted.

(18) A laptop computer where real-time data from medical device is transmitted (19) A desktop computer where real-time data from medical device is transmitted (20) Various computing devices loaded with application software processing data transmitted from medical device via Bluetooth (21) The Infrared Sensor placed 2mm from cervical mucus trap FIGURE 3: The Cervical Mucus Trap (22) The cervical mucus trap where the mucus is deposited (22a) Cut-view of the vagina (22b) The medical device shown inserted into vagina (23) The cervical mucus scraper depositing the mucus into trap FIGURE 4: Fertility Diagnostics Block Diagram (24) The vagina, an elastic, muscular canal with a soft, flexible lining where the Fertility Diagnostics device is carefully inserted (25) One-wire temperature sensor DS18B20 measures accurately the basal temperature with a minimal amount of hardware and wiring. It sends accurate temperature readings directly to the microcomputer without the need of an analog to digital converter (26) A Reflective Infrared Sensor placed in a plastic casing with 2 elements ¨ an IR LED and IR phototransistor. The white and light coloured object will bounce light to be detected. Black and dark coloured object will absorb the IR light and cannot be detected. The detection distance to the object is approximately 2mm to 10mm.
(27) The Microcontroller is the Atmega328 microchip 8-bit AVR RISK-based microcontroller that is programmed to process the basal temperature and condition of cervical mucus of the device. The exact part number is ATMEGA328P-PU. The chip is powered by a 5V supply.
(28) Four (4) coloured Light Emitting Diodes (LED) is the device main indicators for basal temperature and condition of cervical mucus. LEDs are coloured red, white, green and yellow with minimum current of 0.4 mA.

(29) The 12C 1602 LCD module is a line 2 line by 16 characters display interface connected to the microcontroller displaying "Safe Sex"
(infertile) or "Unsafe Sex." (fertile).
(30) A piezo buzzer encapsulated in a cylindrical plastic coating with a hole on top surface for sound to propagate. The buzzer will make a buzzing sound when the red and white LED's lit, an indication that the user is fertile.
(31) Bluetooth module a transparent wireless communication sends the device real-time data to such external devices like smartphone or tablet.
(32) Rechargeable lithium battery, twice energy than conventional batteries, regulated and stabilized voltage at 5V.
(33) The Fertility Diagnostics application software designed to automate the natural birth control process.
(34) The add-on hardware and software (35) The real-time display on screen of external computing devices.
CA3010634A 2018-07-06 2018-07-06 Fertility diagnostics monitoring system for fertility biomarker and related methods Pending CA3010634A1 (en)

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CA3010634A CA3010634A1 (en) 2018-07-06 2018-07-06 Fertility diagnostics monitoring system for fertility biomarker and related methods

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Effective date: 20220411