INDEPENDENT WIRELESS THERMOMETER FOR LONG-TERM USE

Description

Field of the invention

[0001] The invention relates to a mains-independent radio thermometer for measuring temperature in a body opening for long-term use and to a method for measuring basal body temperature over a longer period of time using the mains-independent radio thermometer according to the invention. Background of the invention

[0002] It is known that body temperature changes due to hormones throughout the female cycle. A distinction is made between "low" (temperature level between the end of menstruation and ovulation) and "high" (temperature level between ovulation and the onset of menstruation). During the high, the temperature level is approximately 0.3°–0.6°C higher than the low. The transition from low to high can last 72 hours – during this time, ovulation occurs. The female egg can be fertilized for approximately 24 hours from this point onward.

[0003] The more accurately the time of ovulation can be determined, the more reliably fertilization can be achieved or avoided. According to Knaus-Ogino, a woman's body temperature should be measured regularly with a thermometer. By regularly measuring and recording body temperature, a prediction of the time of ovulation can be made.

[0004] A fundamental problem is the fact that human body temperature (even without pathological indications) generally fluctuates throughout the day, e.g., depending on the respective physical activity. The amplitude of these fluctuations, at 1.0 °C, is significantly higher than the temperature difference between low and high altitudes. Furthermore, it should be noted that temperatures measured simultaneously in different body regions differ by several degrees Celsius and also in repeatability.

[0005] A distinction is made, for example, between surface temperature (armpit, forehead, wrist) and core body temperature (rectal, vaginal).

[0006] To detect the transition from low to high sleep as reliably as possible, core body temperature must be measured, preferably at a time when it can be expected to be at a stable and reproducible level, unaffected by physical activity. This temperature is called "basal body temperature" and corresponds to the minimum (base) temperature that occurs in the core of the body during sleep.

[0007] Traditionally, the temperature method involves measuring core body temperature every morning at the end of a night's sleep, which must be interrupted by an alarm clock at the same time each day, using a fever thermometer and documenting it as a temperature graph on graph paper.

[0008] While the temperature jump from low to high indicates the time of ovulation very reliably, the traditional procedure described above contains a number of sources of error in determining this temperature jump: 1. The daily morning measurement after waking up does not measure the actual basal body temperature, which only occurs after a few hours of sleep, i.e. without any physical activity. During the waking phase, the core body temperature tends to rise again, especially if the person is woken up by an alarm clock and physical activity is required (sitting up in bed, turning on the light, getting the thermometer from the bedside table, inserting the thermometer) in order to even take the measurement. 2. The person taking the measurement must be completely undisturbed during the measurement. The measurement result becomes increasingly less accurate with additional distractions during the measurement. 3. Even with rectal or vaginal measurements using a commercially available thermometer, there is a risk that the position of the thermometer will shift during the measurement and possibly slip out of the rectum or vagina while falling asleep again. 4. Mistakes can occur when documenting the measurements on graph paper. 5.Errors may occur when evaluating the measurement curve.

[0009] Furthermore, the application of this method is quite uncomfortable, requires a high degree of care and must be incorporated into the morning routine in a very disciplined manner in order to achieve useful results.

[0010] So-called "ovulation computers" or "ovulation thermometers" are known from the state of the art and simplify this procedure somewhat.

[0011] These are usually electronic thermometers with, depending on the features, a built-in alarm to remind you to take your temperature, a memory for multiple temperature readings, analysis software for determining the time of ovulation, a display of current and previous temperature readings, or the calculated time of ovulation. While these ovulation thermometers prevent errors in documenting and evaluating temperature readings, the problems described above (see points 1 to 3) in determining basal body temperature remain.

[0012] As an improvement, intravaginal thermometers, such as those disclosed in EP 2 567 680 B1, are proposed. These thermometers are worn intravaginally throughout the night and measure and store core body temperature at specific intervals (e.g., every 5 minutes). Typically, the recorded series of measurements from these sensors are read out using a special reader. In some cases, this reader simultaneously evaluates the series of measurements to determine the actual basal body temperature and the time of ovulation. In other cases, the reader must be connected to another computer, which performs the evaluation and displays the results.

[0013] Typically, temperature sensors are powered by rechargeable batteries, which then need to be regularly recharged, for example, by the reader or a power supply, to ensure that the sensor can record the next nightly series of measurements.

[0014] These intravaginal thermometers still have disadvantages in terms of comfort, usability, and suitability for everyday use. For example, the ovulation thermometer in EP 2 567 680 B1 is designed as a pessary and requires a complex procedure for placing it on the external cervix.

[0015] The need for additional devices to read the measured values ​​increases the cost of the aforementioned solutions. Furthermore, some of the additional devices must be connected to computers via USB cables, requiring the appropriate driver and application software to be installed. In some cases, viewing one's own measured values ​​on a smartphone or only on a specific smartphone model series requires a provider's website.

[0016] Significant disadvantages are that the mobility of these systems is very limited due to the need for additional equipment and that the sensors typically have a lifetime of only 1 year.

[0017] US 2016 / 213354 A1 describes a wireless thermometer according to the preamble of claim 1, for measuring temperature in a body orifice for long-term use, comprising a circuit board, a temperature sensor, a communication unit capable of Bluetooth transmission, and a data memory. Activation of this wireless thermometer can be induced by temperature changes.

[0018] The wireless thermometer covered by US 2016 / 213354 A1 is capable of detecting and recording temperature variations, but these are stored as distinct temperature values, which requires a lot of storage space. This results in high transmission speeds and thus high energy consumption.

[0019] It is an object of the present invention to provide an ovulation thermometer which is improved with regard to the disadvantages listed above. Summary of the invention

[0020] In a first aspect, this object is achieved according to the invention by providing a network-independent radio thermometer for measuring temperature in a body opening according to claim 1.

[0021] Designed as a mains-independent wireless thermometer, it's a self-contained measuring unit that doesn't require charging. This makes the wireless thermometer particularly user-friendly and less prone to errors.

[0022] Since the wireless thermometer does not require changing the battery or rechargeable battery while opening the thermometer housing, it can be provided as a hermetically sealed system at the factory and thus meets the high hygienic requirements for measuring in body openings.

[0023] Through a number of technical features, the inventors have succeeded in providing a thermometer for long-term use. Long-term use according to the invention is understood to mean use for at least one year, preferably at least two years, and particularly preferably for three, four, or even five years with daily measurements.

[0024] The use of a semiconductor temperature sensor allows for accurate measurement with low power consumption. This type of sensor also exhibits high long-term stability with regard to temperature measurement.

[0025] By using a special semiconductor temperature sensor with innovative signal processing and innovative analog design, the semiconductor temperature sensor has a high resolution over both a wide temperature range and a wide voltage range.

[0026] According to the invention, the increments or decrements are not related to the base value (offset value), but to the respective previous value. Since the temperature difference between consecutive measurement points is very small or even zero, the measured values ​​recorded are significantly smaller, so that the length of the measurement series can be shortened by a further 50 to 62.5%.

[0027] Signal transmission via Bluetooth Smart according to the BLE standard also saves energy.

[0028] The ability to control the wireless thermometer via temperature not only enables autonomous, user-independent and functionally optimized activation, but this controlled operation also contributes to minimizing power consumption.

[0029] The acquisition, storage and transmission of incremental or decremental temperature data significantly reduces the data volume, so that not only longer measurement series can be stored, but also the transmission time of the energy-intensive radio transmission can be reduced.

[0030] All this makes it possible to provide a wireless thermometer with a standard button cell battery that can be used continuously for several years with high precision and measurement stability.

[0031] Using Bluetooth Smart technology, the wireless thermometer can communicate with numerous receiving devices. This is especially useful with smartphones or tablets, where application software, known as an "app," can be used. This type of analysis is particularly popular among the young users concerned.

[0032] This makes it possible for the first time to simplify the Knaus-Ogino temperature measurement method at low cost so that it is accessible for widespread use. The invention in detail

[0033] According to the invention, the wireless thermometer is capable of storing temperature measurements as increments or decrements relative to a base temperature and then transmitting them via Bluetooth. This is possible because only measurements between 35.5°C and approximately 40°C are relevant, and therefore the increment values ​​are significantly smaller than the absolute measurement values. In a preferred embodiment, the temperature of 35.5°C is used as the base value or offset value, and all further values ​​are expressed as the difference from this value. The base value must be high enough to be physiologically relevant, but also low enough that only higher values ​​can be expected as increments and no lower values ​​as decrements. Storing and transmitting incremental or decremental values ​​reduces the length of the measurement series by approximately 50%.

[0034] In a preferred embodiment, the electronic components are mounted on a first printed circuit board, preferably populated on both sides, wherein one of the edges of the first printed circuit board, as a slightly curved metallized edge, is in direct contact with the negative pole of the button cell battery, and wherein the connection to the positive pole of the battery is established via a U-shaped battery contact spring, the central base of which preferably engages in a metallized recess of the printed circuit board on the edge side.

[0035] According to the invention, the wireless thermometer has a button cell battery. This is preferably a lithium battery.

[0036] In a further embodiment, the battery has a power of between 0.1 and 2 watts, preferably between 0.2 and 1 watt and particularly preferably about 0.5 watts.

[0037] The inventive, network-independent wireless thermometer (hereinafter also referred to as "wireless thermometer") can be inserted into a wide variety of body orifices and used there to measure temperature. Examples include the oral cavity, armpit, rectum, or vagina.

[0038] In a preferred embodiment, the wireless thermometer is used to measure basal body temperature and can therefore preferably be used in the rectum and especially in the vagina.

[0039] According to the invention, the wireless thermometer is designed for long-term use. "Long-term use" is defined according to the invention as a use in which the wireless thermometer, with daily recording of a series of measurements over at least six hours and daily transmission of the data, enables use over a period of at least one year, preferably at least two years, and particularly preferably at least three, four, or even five years.

[0040] In one embodiment of the invention, the plastic capsule of the radio thermometer consists essentially of a plastic that has a body compatibility (biocompatibility) according to DIN ISO 10993-5:2009. In the context of the invention, a "substantially" existing design with this plastic is understood to mean a design in which at least the outer surface accessible to the body consists of this plastic.

[0041] Preferably, the biocompatible plastic is selected from the group comprising polycarbonate, polyacrylate, polyester, polyethylene, polypropylene, polyacrylonitrile, acrylonitrile-butadiene-styrene copolymers (ABS) and mixtures thereof.

[0042] For the ABS polymer, the proportions of the monomers used vary from 15-35% acrylonitrile, 5-30% butadiene and 40-60% styrene.

[0043] Most preferably, the capsule consists of a mixture of 80% ABS polymer, 10% polycarbonate and 10% rubber.

[0044] As a hermetically sealed structure, the plastic capsule can be easily cleaned with water and / or liquid disinfectants.

[0045] In one embodiment of the invention, the plastic capsule of the wireless thermometer is a circular cylinder that is flattened over half its length and is preferably hemispherically rounded at its cylindrical end and has an eyelet at its flattened end for receiving a pulling device. This makes the wireless thermometer easy and user-friendly to insert into the body orifice. The different design of the two ends prevents misorientation during insertion into the body orifice. In addition, the eyelet in conjunction with a pulling device allows the wireless thermometer to be easily removed from the body orifice. Because the shape is similar to conventional menstrual tampons, the user is immediately familiar with the use and wearing comfort of the wireless thermometer, which results in increased compliance.

[0046] A band or cord can be used as a pulling device. A ring-shaped silicone cord is preferred, which can be pulled through the eyelet to form a loop.

[0047] In one embodiment, the capsule has a length of less than 60 mm, preferably less than 50 mm, particularly preferably between 35 and 50 mm and in particular 47 mm.

[0048] In a further embodiment, the capsule has a diameter of less than 25 mm, preferably less than 20 mm, particularly preferably between 12 and 16 mm and in particular 14 mm at its thickest point.

[0049] The radio thermometer expediently has a total weight of less than 15 g, preferably less than 10 g, particularly preferably a total weight of between 6 and 8 g and in particular 7 g.

[0050] In a further embodiment of the invention, the plastic capsule of the wireless thermometer consists of a capsule housing and a capsule lid. This represents a simple capsule structure consisting of only two parts, which reduces the risk of leaks and represents a cost-effective solution.

[0051] Preferably, the capsule housing and the capsule lid are firmly and watertightly bonded together by adhesive prior to use as a thermometer. The connection of these two parts is carried out in a suitable manner at the factory, ensuring that only wireless thermometers that have been subjected to controlled sealing (i.e., quality control) are used.

[0052] In one embodiment, a UV-curing cyanoacrylate adhesive is preferably used for bonding. These are biocompatible adhesives with high bond strength.

[0053] In a further embodiment of the invention, the semiconductor temperature sensor has at least one of the following properties: (a) A resolution of at least 0.05 °C and preferably 0.01 °C in the body temperature range; (b) Output of a digitally converted voltage via a serial interface, which is preferably an I2 C interface; (c) A long-term stability of less than 0.05 °C / year, preferably less than 0.01 °C / year; (d) Presence of an integrated microcontroller that corrects the measurement errors of the actual semiconductor sensor; (e) Factory calibration with storage of the calibration data on the temperature sensor chip in a non-volatile memory; (f) An average current consumption of less than 200 nA per measurement at one measurement per second.

[0054] A resolution of 0.05 °C in the body temperature range is necessary to be able to measure the basal temperature with sufficient accuracy for ovulation measurement. In Preferably, the semiconductor temperature sensor according to the invention has a resolution of 0.01 °C.

[0055] Efficient data transmission is possible by supplying a digitally converted voltage via a serial interface, which is preferably an I2 C interface.

[0056] Semiconductor sensors have high long-term stability. InPreferably, the semiconductor sensor has a long-term stability of less than 0.05°C / year, more preferably less than 0.01°C / year. Only this ensures a very long usability of the wireless thermometer for measuring vaginal basal temperature, i.e., over several years. The semiconductor temperature sensor according to the invention has the advantage of maintaining its measuring capability, and in particular its resolution, even when the voltage decreases during long-term operation. The semiconductor temperature sensor thus exhibits no voltage-dependent drift.

[0057] The presence of an integrated microcontroller, which corrects the measurement errors of the actual semiconductor sensor, enables continuous, high-precision temperature measurement.

[0058] In addition, factory calibration of the temperature sensor with storage of the calibration data on the temperature sensor chip in a permanent memory contributes to the measurement accuracy.

[0059] By using a corresponding miniaturized semiconductor temperature sensor, the measurement can be performed with an average power consumption of less than 200 nA per measurement (at one measurement per second).

[0060] In In a preferred embodiment, the semiconductor temperature sensor (also called "bandgap" temperature sensor) has all of the features (a) to (f) listed above.

[0061] Semiconductor sensors with corresponding properties are known to those skilled in the art. Reference is made, for example, to the I2 C temperature sensors from Silicone Laboratories Inc. (Austin, Texas, USA), which include, among other things, the high-precision temperature sensor Si7051, which can be used in a particularly preferred embodiment.

[0062] The electronic components of the wireless thermometer, such as the data storage, Bluetooth LE transmission unit, and control unit, are conveniently implemented as a single-chip computer ("System-on-a-chip"; SOC). This enables a cost-effective, space-saving, and power-efficient design.

[0063] InIn a preferred embodiment of the invention, the electronic components of the wireless thermometer are mounted on a first circuit board, preferably populated on both sides. One of the edges of the first circuit board is in contact with the negative pole of the button cell battery via a second circular circuit board mounted perpendicularly thereto. The connection to the positive pole of the battery is established via a U-shaped battery contact spring, the central base of which is preferably arranged between the first and second circuit boards. This configuration is particularly space-saving and enables a design as a compact tampon shape.

[0064] In an alternative embodiment of the wireless thermometer, the electronic components are mounted on a first circuit board, preferably populated on both sides. One of the edges of the first circuit board, as a slightly curved metallized edge, is in direct contact with the negative terminal of the button cell battery. The connection to the positive terminal of the battery is established via a U-shaped battery contact spring, the central base of which preferably engages in a metallized recess on the edge of the circuit board. This is an additionally simplified design in which the second circuit board can be omitted.

[0065] In a second aspect, the invention provides a method for measuring basal body temperature for ovulation determination, said method comprising the following steps: (a) Providing a wireless thermometer according to the invention in a rest mode; (b) Inserting the wireless thermometer into a body orifice of a woman, preferably into the vagina; (c) Recording a series of temperature measurements, preferably overnight; (d) Storing the measurement data in a memory of the wireless thermometer; (e) Removing the wireless thermometer from the body orifice; (f) Transmitting the temperature measurement data via Bluetooth Smart to a receiving device, which is preferably a smartphone or a tablet; (g) Optionally cleaning the wireless thermometer and storing it outside the body orifice; (h) Repeating steps (b) to (g), preferably daily, to collect a long-term series of measurements and determine relevant events in the menstrual cycle such as the time of ovulation, the non-conception phase, or the fertile phase.

[0066] According to the invention, the wireless thermometer is controlled in a temperature-dependent manner, whereby the activation of the wireless thermometer is induced from a resting state by insertion into the body opening and the resulting temperature increase to a physiological value.

[0067] Preferably, the detection of the rest phase is carried out by a method in which the radio thermometer increments a time-controlled counter in rest mode and, after a predetermined counting time, which is preferably between 10 minutes and 60 minutes, more preferably between 15 and 45 minutes and especially preferably 30 minutes, an energy-saving temperature measurement with low precision is carried out and the measurement result is compared with the threshold value of 35.5°C, wherein the rest mode is maintained as long as a configurable number of consecutive measured values, which preferably corresponds to at least two consecutive measured values, do not exceed 35.5°C. This measuring method maintains the rest state in a controlled manner in a simple and energy-saving manner until insertion into the body orifice.

[0068] In an alternative embodiment, the wireless thermometer is put into a "deep sleep mode" with extremely low energy consumption. Instead of the counter described above, the energy-saving measurement for detecting a position in the body cavity can also be initiated by a power-saving external timer circuit, which reactivates the wireless thermometer for this "test measurement" when the set time is reached.

[0069] In a preferred embodiment, this external timer circuit is a system timer with an integrated MOSFET driver and a consumption in the nanoampere range. In a specific embodiment, the TPL5110 "Nano-power system timer for power gating" from Texas Instruments (Dallas, TX, USA) is used.

[0070] According to the invention, the wireless thermometer, which is in standby mode, is activated upon insertion into the body orifice, insofar as a series of temperature measurements is initiated. To initiate the series of measurements, the wireless thermometer preferably performs the following three steps when a configurable number of consecutive measurements exceeding 35.5°C (at least two) is reached: (a) It reduces the measurement interval to the measurement interval intended for the measurement series, with a configurable reduction, preferably from 30 minutes during the rest phase to 5 minutes during the measurement series; (b) It increases the measurement resolution to a resolution of at least 0.05°C, whereby increasing the resolution up to a maximum resolution for the sensor is preferred, (c) It stores the measured values ​​as a measurement series, with the temperature values ​​being stored as increments starting from an offset temperature.

[0071] InIn a further embodiment, the method according to the invention implements the storage of the measurement data in a ring buffer, in which the oldest contents are overwritten when the buffer is full and additional elements are stored in the ring buffer. Thus, even if data transmission is interrupted for a longer period, the more recent data remains saved and can be used for evaluation.

[0072] In In a preferred embodiment, the memory is dimensioned to accommodate approximately 30 or more series of measurements. Since the wireless thermometer is not worn during menstruation, nor between ovulation and menstruation, this means that the wireless thermometer can collect data over a period of more than one month without the need to transmit data to the receiving device.

[0073] The temperature control of the wireless thermometer according to the invention also includes the automatic detection of the removal from the body opening with the two central consequences that 1.) the series of measurements is completed and 2.) a data transmission is initiated.

[0074] In In a preferred embodiment, this is done by a method in which the radio thermometer, after its removal from the body opening and the associated detection of a configurable number of consecutive measured values ​​below 35.5°C, completes the series of measurements and signals the availability of a completed series of measurements to the Bluetooth transmission unit (so-called "advertising").

[0075] In a further embodiment, the data transmission takes place in a two-stage process in which the device search for establishing a connection is carried out only in a short period of time with high transmission power and then iteratively starts a new attempt after a rest period with reduced or no activity.

[0076] In a preferred embodiment of the invention, the Bluetooth transmission unit carries out the following method steps for transmitting a completed series of measurements: i. the transmission unit attempts to establish a connection with a receiving unit for a short period of time of less than 1 minute, preferably less than 30 seconds and particularly preferably for 10 seconds, with high transmission power; ii. if the connection is successfully established, the connection unit transmits the completed measurement series(s) to the receiving unit and the corresponding data are deleted from the memory of the radio thermometer; or iii. if the connection is unsuccessful, the transmission power of the transmission unit is reduced or switched off entirely for a period of between 30 seconds and 5 minutes, preferably between 45 seconds and 2 minutes and in particular for 1 minute, iv. iteration of steps i. and iii. with a configurable iteration rate of preferably between 40 and 80 and particularly preferably 60; v.If the connection cannot be established successfully after the configured iteration rate has been reached, the transmitter unit is switched off until another series of measurements has been completed.

[0077] In a special embodiment, after completing a measurement series, the sensor activates its Bluetooth transmitter for 10 seconds to signal the availability of a new measurement series to the smartphone app via "Bluetooth advertising." The 10-second Bluetooth advertising is also referred to as an "advertising burst."

[0078] If the smartphone app does not initiate a connection with the sensor within these 10 seconds, the sensor will generate further advertising bursts at intervals of 1 minute each - but a maximum of 60 intervals in total (i.e., one hour).

[0079] The number of advertising bursts will be referred to as "Z[AB]" in the following. In the scenario described above, Z[AB] is therefore "60".

[0080] Repeating the advertising bursts offers the user a "grace period" of up to one hour, during which they can discover that their smartphone is not within range of the sensor, or is not switched on, etc., and can, if necessary, remedy the situation so that the current series of measurements can still be delivered in a timely manner.

[0081] Z[AB] is decremented with each advertising burst. If no data transmission has occurred by the time the grace period expires (Z[AB] = 0), a timeout occurs. During a timeout, the sensor terminates its advertising burst engagement until a new measurement series is available, thus setting Z[AB] back to 60.

[0082] Normally (i.e.: when the switched on smartphone with activated app is within Bluetooth range) the smartphone app initiates the connection setup with the sensor already within the first advertising burst.

[0083] It may happen that the sensor is used daily for several days (or weeks) without the recorded measurement series being able to be delivered, for example because there is no smartphone within Bluetooth range for a longer period of time (e.g. vacation without a smartphone, smartphone loss, smartphone defect, etc.).

[0084] In these cases, 60 unsuccessful advertising bursts occur after each recorded measurement series. For a 10-day vacation, this would result in 600 advertising bursts. The power consumption per advertising burst is significant. Under normal conditions, 600 advertising bursts are sufficient for 600 days (i.e., with approximately 15 measurement series per month, > 3 years).

[0085] As a solution for these cases, the following two embodiments are proposed, which can be used either separately or combined with each other: In a first embodiment, the Z[AB] is reduced if a predetermined number of advertising bursts fail. For example, instead of a "grace period" of 1 hour with 60 advertising bursts at 1-minute intervals, the advertising bursts can be reduced to 10.

[0086] Additionally, the intervals between one advertising burst and the next can be successively extended, e.g., from 1 to 2 to 3 to 5 to 10 to 20 to 45 to 90 to 180 to 360 minutes. In this example, with 10 advertising bursts (Z[AB] = 10), the total grace period is almost 12 hours (714 minutes = 1 + 2 + 3 + 5 + 10 + 20 + 45 + 90 + 180 + 360).

[0087] In this embodiment, both Z[AB] and the intervals can be suitably optimized according to requirements.

[0088] In a second embodiment, the timeout is changed, i.e., the number of unsuccessful advertising bursts, which then leads to a termination ("timeout") of the advertising burst series. The sensor maintains a counter for consecutive timeouts (hereinafter referred to as "Z[TO]"). The previously described number of advertising bursts ("Z[AB]") depends on Z[TO]: If Z[TO] exceeds a certain threshold (e.g., 3 timeouts in a row), Z[AB] is set to 3, for example ("vacation mode"); otherwise, to 10 (see above). After each measurement series successfully delivered to the smartphone, the sensor sets Z[TO] to "0" (ZERO).

[0089] In a further embodiment of the method according to the invention, only one measured value in the measurement series receives a timestamp to indicate the respective measurement times, while the remaining times are defined by saving the measurement interval. This significantly reduces the data volume, since not every measured value needs to be timestamped.

[0090] To determine the true measurement time, the transmission time is also timestamped. This allows the receiving device to determine the actual start of the measurement series by calculating the difference.

[0091] When transferring data from the wireless thermometer to the receiver unit, additional data may be transmitted. These include, for example: Battery status; transmission signal strength; current configuration parameters of the wireless thermometer; firmware version of the wireless thermometer; Universally Unique Identifier (UUID) of the wireless thermometer

[0092] In a further embodiment, the receiving unit can also update the software or certain configuration parameters, preferably by using the cloud.

[0093] In one embodiment of the invention, the receiving unit is authorized to record series of measurements from this radio thermometer by reading a barcode or a two-dimensional code assigned to the individual radio thermometer.

[0094] A 2D code is preferably used here, which is particularly preferably a QR code. Such a 2D code can provide a high information density for secure device identification despite its small dimensions. Such a 2D code can be applied to the wireless thermometer itself or the thermometer packaging. The 2D code, which is preferably a QR code, expediently contains a key with which the software of the receiving unit (preferably an "app") can retrieve the data from the cloud. To do so, the software must automatically authenticate itself with the cloud server.

[0095] In a further embodiment, the measurement data from the receiving unit are stored in encrypted form in a database accessible via the Internet (so-called "cloud") and can be read out again from this cloud.

[0096] In a further aspect, the invention provides a mains-independent wireless thermometer for temperature measurement for long-term use, comprising: (a) a single-chip computer (SOC); (b) a semiconductor temperature sensor; (c) a communication unit for signal transmission according to the BLE standard; (d) a data memory; (e) a button cell battery; wherein the temperature sensor and the communication unit are controllable via the temperature, and wherein the radio thermometer is designed to record, store and transmit incremental or decremental temperature values.

[0097] In a further aspect, the invention provides a method for determining basal body temperature, the method comprising the following steps: (a) Providing a series of temperature measurements of a female human body recorded overnight during the sleep phase with a measurement interval of between 2 and 10 minutes, and preferably of 5 minutes, wherein this series of temperature measurements has preferably been created using a radio thermometer according to the invention and / or a method according to the invention; (b) Determining that time range of 15 to 25 minutes and preferably of 20 minutes in the series of temperature measurements from step (a) which lies 20 to 90 minutes before the end of the series of measurements defined by waking up and has the lowest temperature amplitude as the difference between the highest and lowest temperature values ​​measured in this time range; (c) Determining the basal body temperature by calculating the mean value, preferably as an arithmetic mean or central value (median) based on the temperature measurements of the time range determined in step (b).

[0098] The temperature method is about detecting the time of the hormonally induced temperature jump from low to high in the female cycle - this is about 0.5°C.

[0099] In the human body, temperature fluctuations exceeding 0.5°C can occur even within a day, depending on physical activity.

[0100] The temperature method works more reliably the less the measured body temperature is influenced by non-hormonal factors. Therefore, it is traditionally measured with a fever thermometer at the same time each morning after a night's sleep.

[0101] One of the relevant advantages of the present invention in this regard is that, instead of a single measurement after a night's sleep, temperature measurements are taken at certain intervals (e.g., 5 minutes) throughout the night in order to create a series of temperature measurements.

[0102] The quality of the evaluation with regard to the accuracy of determining the time of ovulation then continues to depend on the respective calculation method or evaluation algorithm. The method or algorithm is designed to identify a representative temperature value from the respective nightly measurement series, which is then incorporated into the monthly / cycle curve to determine the time of ovulation.

[0103] In this context, the literature often refers to "basal body temperature"—the lowest temperature that occurs (e.g.) during this sleep phase. However, in our practice, defining basal body temperature as a nighttime minimum is not optimal, as it is often an "outlier," i.e., a singular minimum.

[0104] As the inventors discovered, focusing on temperature measurements taken approximately 30 minutes before waking allows for improved determination of basal body temperature. However, this does not eliminate the fundamental problem mentioned above (the risk of singular extremes).

[0105] Here, the three-step procedure described above provides a decisive improvement in that a time range of about 20 minutes in length with the lowest temperature amplitude in the time approximately 20 - 90 minutes before waking is sought in the nighttime temperature curve and the temperature mean of this time range is defined as the basal temperature.

[0106] The theoretical background is that a) a low temperature amplitude indicates low physical activity in this sleep phase and b) the risk of singular extremes is reduced

[0107] In a further aspect, the invention provides a method for determining basal body temperature, the method comprising the following steps: (a) Providing a temperature measurement series of a female human body recorded overnight during the sleep phase with a measurement interval of between 2 and 10 minutes, and preferably of 5 minutes, wherein this temperature measurement series has preferably been created using a radio thermometer according to the invention and / or a method according to the invention; (b) Dividing the temperature measurement series into segments S1, S2, S3 ...SN of equal length, preferably from 5 minutes to 60 minutes; (c) Forming the respective temperature mean values ​​M1, M2, M3, ...MN for the segments S1, S2, S3 ...SN , based on the temperature measurements of the respective segments, preferably as an arithmetic mean or central value (median); (d) carrying out steps (b) to (c) for further temperature measurement series recorded in subsequent nights according to step (a), which series have preferably been created every night; whereby the segment duration and the method of calculating the mean value have been retained; (e) creating N monthly cycle curves by plotting the respective temperature mean values ​​M1 , M2 , M3 ,..MN over time; (f) determining the monthly cycle curve which, of the N cycle curves, shows the smallest standard deviation or variance in the monthly temperature course; . wherein preferably the nightly temperature measurement series are aligned in time before the segment formation in step (b) taking into account similar temperature progression patterns or the circadian temperature rhythm, and the position of the segments S1, S2, S3 ...SN is determined not only by the actual measurement time but also by a start time defined by the aligned measurement series.

[0108] As the inventor discovered, the predefined method delivers even better results. It divides the nighttime temperature curves into segments of equal length (e.g., 5-60 minutes) and determines their mean temperature (e.g., in the form of the arithmetic mean or median).

[0109] A series of measurements recorded approximately between 1:00 a.m. and 7:00 a.m. is "broken down" into 6–724 segments, each of whose mean temperature values ​​initially yields 6–72 monthly cycle curves. Using suitable methods, such as regression or AI pattern recognition, which can be statistical, syntactical, or neural network-based, the cycle curve that best represents the hormonally determined monthly temperature pattern during the cycle is determined.

[0110] As a result, this method "dampens" or eliminates singular extremes in the monthly temperature curve and simultaneously exposes the significance of the hormonally induced temperature jump at the time of ovulation. Various statistical methods are suitable for further processing with regard to detecting the time of ovulation (see regime change models, etc.).

[0111] Preferably, the nighttime temperature curves (before segmentation) are temporally aligned, e.g. taking into account similar temperature patterns or circadian rhythms (so-called alignment).

[0112] Such a wireless thermometer can be used advantageously for a wide variety of measurement purposes. For example, it can be used in devices that require accurate and simple temperature measurement over a long period of time.

[0113] Such a thermometer can be used as a data logger to prove an uninterrupted cold chain when shipping temperature-sensitive goods (food, pharmaceuticals).

[0114] In another possible application, the wireless thermometer can also be used in buildings to create a networked, "intelligent" home ("smart home") and can, for example, further reduce energy costs.

[0115] Furthermore, it can be used in other biological systems, for example to measure the breeding behavior of birds. Definitions

[0116] According to the invention, a configurable value is understood to be a value that can be freely configured, i.e., within the scope of the method, it can assume any preselected value given in the configuration. This also explicitly includes dynamic configurability. This means that the configuration can be dynamically adapted to the existing test conditions, for example in response to these test conditions. For example, an intravaginal series of measurements can only begin at a later point in time with closely spaced temperature recording if the earlier measurements show that the basal temperature is only reached correspondingly late in the person in question.

[0117] For the purposes of the invention, a "substantially rigid" plastic capsule is understood to mean a plastic capsule in which the plastic has a hardness according to DIN ISO-2039-1:2003-6 of at least 75 MPa, preferably of at least 90 MPa and particularly preferably of at least 95 MPa.

[0118] A "body orifice" within the meaning of the invention is an opening on the body of an animal or human. This includes actual body orifices such as the vagina, rectum, ear canal, or oral cavity, as well as body recesses such as the armpit or the back of the knee.

[0119] According to the invention, the term "hermetically sealed" refers to a capsule that is sealed watertight. This prevents bodily excretions, particularly body fluids such as sweat, urine, or cervical fluid, from penetrating the interior of the capsule.

[0120] Bluetooth Low Energy (also known as Bluetooth LE, BLE, or Bluetooth Smart) is a wireless technology that allows devices to connect within a range of approximately 10 meters to 500 meters in newer versions. Compared to "classic" Bluetooth, Bluetooth Smart / BLE offers significantly lower power consumption and lower costs over a similar communication range. The corresponding Bluetooth versions are currently in use under the 4.x or 5.x specifications. Short description of the illustrations

[0121] These and other aspects of the invention are shown in detail in the figures as follows. Fig. 1 shows a schematic sketch of a mains-independent wireless thermometer according to the invention. The wireless thermometer is shown in plan view (top left), in two perpendicular side views (bottom left and bottom right), and in perspective (top right). Fig. 2 shows a schematic sketch of the electronic components provided in the mains-independent wireless thermometer. The components are shown in side view (left) and in perspective (right). Fig. 3 shows a flowchart illustrating the measurement process. Detailed description of the implementation examples

[0122] Fig. 1 shows a schematic sketch of a mains-independent radio thermometer (1) according to the invention as a cylindrical body (2) with a hemispherical distal end (3) for easy insertion into the body opening and a flattened end (4) which has an eyelet (5) for receiving a pulling device (not shown).

[0123] In the Fig. 2 The electronic components provided in the capsule of the mains-independent radio thermometer are shown schematically in their arrangement. A first circuit board (6) is equipped with an antenna (7), a temperature sensor (8), a capacitor (16), and with a circuit board of the BLE module (9) with shielding plate (9) and is soldered via an edge (11) to a second circular circuit board (12). This second circuit board is connected to the negative pole of the button cell battery (13), with the connection to the positive pole of the battery being established via a U-shaped battery contact spring (14), the central base (15) of which is arranged between the first and second circuit boards.

[0124] In the Fig. 3The individual steps of the measurement and transmission method are presented as described in claims 11 and 13. The data transmission sub-step includes two alternative follow-up steps. If a connection is successfully established with the receiving device (plus in a circle), the next step is data transmission to the receiving device. If no connection can be established even after 60 repetitions (minus in a circle), the device is put back into sleep mode.

[0125] Further variants of the invention and their implementation will become apparent to the person skilled in the art from the preceding disclosure, the figures and the patent claims.

[0126] Terms used in the claims such as "comprise," "have," "include," "contain," and the like do not exclude further elements or steps. The use of the indefinite article does not exclude a plurality. A single device may perform the functions of multiple units or devices recited in the claims. Reference numerals indicated in the claims are not to be construed as limitations on the means and steps employed. List of reference symbols

[0127] 1Grid-independent wireless thermometer 2Cylindrical capsule 3Hemispherical distal end 4Flattened proximal end 5Eyelet for pulling device 6First circuit board 7Antenna 8Temperature sensor 9Shielding plate of the BLE module 10PCB of the BLE module 11Live edge of the first circuit board 12Second circuit board 13Button cell battery 14Battery contact spring 15Base of the battery contact spring 16Capacitor

Claims

1. Off-line radio thermometer (1) for temperature measurement in a body opening for long-term use with a hermetically sealed, into the body opening insertable, essentially stiff plastic capsule, containing a coin cell battery (13) and as electronic components: (a) a single-chip computer; (b) a semiconductor temperature sensor (8); (c) a communication unit for signal transmission; (d) a data storage; where the temperature sensor (8) and the communication unit can be controlled via the temperature, so that the activation of the radio thermometer (1) for recording a series of temperature measurements is induced starting from a idle state by the insertion into the body opening and the resulting temperature increase to a physiological value, and involves the automatic detection of the extraction from the body opening with the two central consequences that 1.) the measurement series is completed and 2.) a data transmission is initiated, characterized in that the communication unit is configured for signal transmission according to the BLE standard, and the radio thermometer (1) designed is for measuring, storing and transmitting of incremental or decremental temperature values, and where the increments or decrements are related to a base value or to the immediately preceding value.

2. Off-line radio thermometer (1) according to claim 1, characterized in that the electronic components are mounted on a - preferably on both sides populated - first printed circuit board (6), whereby one of the edges of the first printed circuit board (6) has direct contact with the negative terminal of the coin cell battery (13) as a slightly curved metallized edge, and the connection to the positive terminal of the battery is established via a U-shaped battery contact spring (14), the central base (15) of which preferably engages in a cutout in the printed circuit board (6) which is metallized on the edge side.

3. Off-line radio thermometer (1) according to claim 1 or 2, characterized in that the body opening is the ear, the rectum or the vagina.

4. Off-line radio thermometer (1) according to claim 1 to 3, characterized in that with daily recordings of a series of measurements over at least 6 hours and daily transmissions of the data, the radio thermometer (1) enables long-term use over a period of at least one year, preferably of at least two years and particularly preferably of at least three to five years.

5. Off-line radio thermometer (1) according to one of the preceding claims, characterized in that the plastic capsule consists of a capsule housing and a capsule lid, which are firmly and water-tightly connected to one another by gluing before being used as thermometers, wherein a UV-curing cyanoacrylate adhesive is preferably used for the bonding.

6. Off-line radio thermometer (1) according to one of the preceding claims, characterized in that the semiconductor temperature sensor (8) has at least one of the following properties: (a) a resolution of 0.05° C. in the body temperature range; (b) delivery of a digitally converted voltage via a serial interface, which is preferably an I2C interface; (c) a long-term stability of less than 0.05° C. / year, preferably less than 0.01° C. / year; (d) presence of an integrated microcontroller that corrects errors the measurement of the actual semiconductor sensor; (e) factory-side calibration with storage of the calibrator data on the temperature sensor chip in a permanent storage; (f) an average power consumption of less than 200 nA per measurement at at one measurement per second.

7. Off-line radio thermometer (1) according to one of the preceding claims, characterized in that the electronic components such as data storage, Bluetooth LE transmission unit and control unit are present as a single-chip system.

8. Method for measuring the basal temperature for ovulation determination, which comprises the following steps: (a) providing an off-line radio thermometer (1) in a idle mode, comprising: a single-chip computer; a semiconductor temperature sensor (8); a communication unit for signal transmission according to the BLE standard; a data storage; a coin cell battery (13); wherein the temperature sensor (8) and the communication unit are controllable via temperature, and wherein the radio thermometer (1) is designed for recording, storing and transmitting incremental or decremental temperature values, providing an off-line radio thermometer (1) in accordance with one of claims 1 to 7; (b) inserting the radio thermometer (1) into a woman's body opening, preferably into the vagina; (c) recording a series of temperature measurements, preferably overnight; (d) storing of the measurement data as incremental or decremental temperature values in a storage of the radio thermometer (1); (e) taking the radio thermometer (1) out of the body opening; (f) transmitting the temperature measurement data as incremental or decremental temperature values by means of Bluetooth Smart to a receiving device which is preferably a mobile phone, tablet or computer; (g) optional cleaning of the radio thermometer (1) and storage outside the body opening; (h) repeating of steps (b) to (g), preferably daily, for the collection of a long-term measurement series to determine relevant events in the menstrual cycle such as ovulation time, non-conception phase or fertile phase.

9. Method according to claim 8, characterized in that the radio thermometer (1) in idle mode increments a time-controlled counter according to step (a) and, after a configurable set counting time, which is preferably between 10 minutes and 60 minutes, particularly preferably between 15 and 45 minutes and especially preferably 30 minutes, performs an energy-saving temperature measurement with low precision and compares the measurement result with the threshold value between 35 and 36°C, where the idle mode is maintained as long as at least a number of consecutive measurements, defined by configuration, preferably at least two consecutive measurements, are above the threshold value.

10. Method according to claim 8 or 9, characterized in that the radio thermometer (1) for initializing the measurement series in step (c), performs after a configurable number of at least 2 consecutive measured values above the threshold value between 35° and 36° C. the following steps: I. it reduces the measurement intervals; li. it increases and preferably maximizes the measurement resolution; lii. it stores the measured values as a measurement series, whereby the temperature values are stored as increments starting from an offset temperature or the preceding measured value.

11. Method according to one of claims 8 to 10, characterized in that the storage of the data in step (d) is implemented as a ring buffer, in which the oldest contents are overwritten when the buffer is full so that further elements can be stored in the ring buffer.

12. Method according to one of claims 8 to 11, characterized in that the radio thermometer (1), after removal of the radio thermometer (1) in step (e) and detection of a configurable number of at least 2 consecutively measured values below the threshold value lying between 35 and 36°C, completes the series of measurements and signals the availability of a completed series of measurements to the Bluetooth transmission unit.

13. Method according to one of claims 8 to 12, characterized in that the Bluetooth transmission unit in step (f) performs the following methodic steps: i. the transmission unit attempts to establish a connection with a receiving unit for a short period of time of less than 1 min preferably less than 30 sec and particularly preferably for 10 sec with high transmission power; ii. if the connection is successfully established, the connection unit transmits the completed series(es) of measurements to the receiving unit and the corresponding data are deleted from the memory of the radio thermometer (1); or iii. if the connection is unsuccessful, the transmission power of the transmission unit is reduced or switched off completely for a period of between 30 s and 5 min, preferably between 45 s and 2 min and in particular for 1 min, iv. Iteration of steps i. and iii. with a configurable iteration rate of preferably between 40 and 80 and particularly preferably 60; v. if the connection is not successfully established after the configured iteration rate is reached, the transmission unit is switched off until a further series of measurements has been completed.

14. Method according to one of claims 8 to 13, characterized in that, for specifying the respective measurement times, only one measurement value of the measurement series contains a time stamp and the other times are defined by storing the measurement interval.