DE102017208883A1 - Network-independent wireless thermometer for long-term use - Google Patents

Abstract

The invention relates to a network-independent radio thermometer for temperature measurement in a body opening for long-term use and a method for measuring the basal body temperature over a long period of time with the aid of the network-independent wireless thermometer according to the invention.

Description

Field of the invention

The invention relates to a network-independent radio thermometer for temperature measurement in a body opening for long-term use and a method for measuring the basal body temperature over a long period of time with the aid of the network-independent wireless thermometer according to the invention.

Background of the invention

It is known that during the course of the female cycle the body temperature changes due to hormones. One distinguishes between "low level" (temperature level between the end of menstruation and ovulation) and "high altitude" (temperature level between ovulation and menstruation beginning). During the high altitude, the temperature level is about 0.3 ° - 0.6 ° C above the low altitude. The change from low to high may take 72 hours - during which time ovulation takes place. The female egg cell can be fertilized for about 24 hours from this time.

The more accurately one can determine the time of ovulation, the safer a fertilization can be achieved or avoided. According to Knaus-Ogino, the woman's body temperature should be measured regularly with a thermometer. By regular measurement and recording of the body temperature then a statement about the ovulation time can be made.

As a fundamental problem turns out the fact that the human body temperature (even without pathological indications) is already generally fluctuating during the day, e.g. depending on the respective physical activity. The amplitude of these fluctuations, at 1.0 ° C, is well above the temperature difference between low and high. It should also be noted that at different body regions simultaneously measured temperatures differ by several degrees Celsius as well as in the repeatability.

One differentiates e.g. between surface temperature (armpit, forehead, wrist) and body core temperature (rectal, vaginal).

For the most reliable detection of the change from low to high, therefore, the body core temperature must be measured, and preferably at a time when it may be expected that, unaffected by physical activity, it is at a stable and reproducible level. This temperature is called the "basal body temperature" and corresponds to the temperature minimum (base) that occurs in the body during sleep.

Traditionally, in the temperature method, the core temperature is measured by thermometer at the end of each night's sleep, which must be stopped by alarm at the same time, and documented by means of graph paper as a temperature graph.

1. 1. Mit der allmorgendlichen Messung nach dem Wecken wird nicht die eigentliche Basaltemperatur gemessen, die sich nur nach einigen Stunden Schlaf, d.h. ohne jegliche körperliche Aktivität einstellt. Während der Aufwachphase steigt die Körperkerntemperatur tendenziell wieder an, besonders, wenn das Aufwecken per Wecker geschieht und körperliche Aktivität erforderlich ist (Aufrichten im Bett, Licht einschalten, Thermometer vom Nachttisch holen, Thermometer einführen) um die Messung überhaupt durchführen zu können.
2. 2. Die Messperson muss während des Messens absolut ungestört sein. Das Messergebnis wird mit zusätzlicher Ablenkung während der Messung immer ungenauer.
3. 3. Auch bei rektaler oder vaginaler Messung mit einem handelsüblichen Thermometer besteht die Gefahr, dass sich dessen Position während der Messung verschiebt, ggfs. während erneuten Einschlafens aus dem Rektum oder der Vagina gleitet.
4. 4. Es können Fehler beim Dokumentieren der Messwerte auf das Millimeterpapier passieren.
5. 5. Es können Fehler beim Auswerten der Messkurve entstehen.

While the temperature jump from low to high level indicates the ovulation time very reliably, the traditional procedure described above has a large number of sources of error in determining this temperature jump:

1. 1. The daily measurement after waking does not measure the actual basal body temperature, which only sets after a few hours of sleep, ie without any physical activity. During the recovery phase, the body core temperature tends to rise again, especially if the wake-up is on an alarm clock and physical activity is required (standing up in bed, switching on the light, getting the thermometer from the bedside table, inserting the thermometer) to be able to perform the measurement at all.
2. 2. The measuring person must be absolutely undisturbed during the measurement. The measurement result becomes increasingly inaccurate with additional distraction during the measurement.
3. 3. Even with rectal or vaginal measurement with a commercially available thermometer, there is a risk that its position shifts during the measurement, if necessary. Slips during re-falling from the rectum or the vagina.
4. 4. Errors can occur when documenting the measured values on the graph paper.
5. 5. Errors may occur when evaluating the measurement curve.

Furthermore, the application of this method is quite uncomfortable, requires a great deal of care and must be very disciplined in the morning routine built in order to produce useful results.

From the state of the art, so-called "ovulation computers" or "ovulation thermometers" are known, which simplify this procedure somewhat.

These are usually electronic thermometers with, depending on the equipment, built-in alarm, which is reminiscent of the measuring, a memory for several temperature values, an evaluation software for determining the Ovulation time, an indicator for current and older temperature values or the calculated ovulation time. Although these ovulation thermometers prevent errors in the documentation and evaluation of the temperature measured values, the problems described above (see points 1 to 3) in determining the basal body temperature persist.

As an improvement here are intravaginal thermometers, such as in the EP 2 567 680 B1 disclosed, which are worn intravaginally throughout the night's sleep and during this time at certain intervals (eg every 5 minutes) to measure and store the body core temperature. Typically, the recorded series of measurements of these sensors are read by means of a special reader. In some cases, this reader then simultaneously takes over the evaluation of the series of measurements for determining the real basal body temperature and the ovulation time. In other cases, the reader must be connected to another computer which will take care of the evaluation and display the results.

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

These intravaginal thermometers still have disadvantages in terms of comfort, usability and everyday usability. So the Ovulationsthermometer is the EP 2 567 680 B1 designed as a pessary and must be placed in a complex manner on the outer cervix.

The necessity of additional devices for reading the measured values makes the aforementioned solutions more expensive. In addition, some of the additional devices must be connected via USB cable to computers on which the corresponding driver and application software must be installed beforehand. In part, only one of the provider's websites allows you to view your own measured values on a smartphone or only with a single smartphone model series.

Significant drawbacks are that the mobility of these systems is very limited due to the need for ancillary equipment and that the sensors typically only last for only 1 year.

It is an object of the present invention to provide an ovulation thermometer which is improved in terms of the above-mentioned disadvantages.

Summary of the invention

1. (a) ein Single-Chip-Computer (SOC);
2. (b) einen Halbleiter-Temperatursensor;
3. (c) eine Kommunikationseinheit zur Signalübertragung nach dem BLE-Standard;
4. (d) einen Datenspeicher;
5. (e) eine Knopfzellenbatterie;

wobei der Temperatursensor und die Kommunikationseinheit über die Temperatur steuerbar sind, und
wobei das Funkthermometer zu Erfassung, Speicherung und Weitergabe von inkrementellen oder dekrementellen Temperaturwerten ausgelegt ist.In a first aspect, this object is achieved according to the invention in that a network-independent radio thermometer is provided for temperature measurement in a body opening for long-term use, with a hermetically sealed, substantially insertable into the body opening, plastic capsule, which contains:

1. (a) a single-chip computer (SOC);
2. (b) a semiconductor temperature sensor;
3. (c) a communication unit for signal transmission according to the BLE standard;
4. (d) a data store;
5. (e) a coin cell battery;

wherein the temperature sensor and the communication unit are controllable via the temperature, and
wherein the wireless thermometer is designed for detection, storage and transmission of incremental or decremental temperature values.

By design as a network-independent radio thermometer is a self-sufficient measuring unit that requires no charging with a corresponding charger. This makes the wireless thermometer particularly user-friendly, and less prone to error.

Since no battery or battery change under opening of the thermometer housing is required for the wireless thermometer, it can be factory provided as a hermetically sealed system and thus meet the high hygienic requirements for a measurement in body orifices.

Through a number of technical features, the inventors have succeeded in providing a thermometer for long-term use. A long-term use according to the invention is to be understood as use for at least one year, preferably at least two years and particularly preferably over three, four or even five years with daily measurement.

Thus, the use of a semiconductor temperature sensor allows accurate measurement with low power consumption. This sensor type also has a high long-term stability with regard to the temperature measurement.

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

Energy saving is also the signal transmission via Bluetooth Smart according to the BLE standard.

The controllability of the radio thermometer over the temperature not only a self-sufficient, independent of the user control and function-optimized activation is possible, but this controlled operation control also contributes to the minimization of power consumption.

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

All this makes it possible to use a commercially available coin cell battery to provide a wireless thermometer that can be used for many years with high precision and stability.

By using the Bluetooth Smart technology, the wireless thermometer can communicate with numerous receivers. Here in particular the use with a smartphone or tablet is possible, in which an application software, can be used as a so-called "App". This type of evaluation is particularly well received by the young people in question.

This makes it possible for the first time to simplify Knaus-Ogino's temperature measurement method at low cost so that it is accessible to a wide range of applications.

The invention in detail

According to the invention, the radio thermometer has the capability of storing the temperature measured values as increments or decrements relative to a base temperature and then also transmitting them by means of Bluetooth. This is possible because only measured values between 35.5 ° C and 40 ° C are relevant and therefore the increment values are significantly smaller than the absolute values of the measurement. In a preferred embodiment, the temperature of 35.5 ° C. is taken as the base value or offset value, and all other values are expressed as the difference to this value. On the one hand, the underlying must be so high that it is physiologically relevant, but also so low that only higher values than increments and no lower values than decrements are to be expected. Due to the increment or decrement storage and transmission, the length of the measurement series is shortened by approx. 50%.

In a further embodiment of the invention, the increments or decrements are not related to the base value (offset value) but to the respectively preceding value. Since the temperature difference of successive measurement times is very low or even zero, the measured values recorded here are significantly smaller, so that the length of the measurement series can be shortened by a further 50 to 62.5%.

According to the invention, the wireless thermometer has a coin-cell battery. This is preferably a lithium battery.

In a further embodiment, the battery has a power of between 0.1 and 2 watts, preferably between 0.2 and 1 watts, and more preferably about 0.5 watts.

The network-independent wireless thermometer according to the invention (also referred to below as "wireless thermometer") can be introduced into a wide variety of body openings and used there for temperature measurement. Examples include the mouth, the armpit, the rectum or the vagina called.

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

According to the invention, the wireless thermometer is designed for long-term use. The "long-term use" is defined according to the invention as an application in which the wireless thermometer with daily recording a series of measurements for at least 6 hours and daily transmission of the data use over a period of at least one year, preferably at least two years and more preferably of at least three, four or even five years.

In one embodiment of the invention, the plastic rasp of the wireless thermometer essentially consists of a plastic which has a body compatibility (biocompatibility) according to DIN ISO 10993-5: 2009. An "essentially" existing configuration with this plastic is to be understood in the context of the invention, an embodiment in which at least the outer, the body accessible surface consists of this plastic.

In a preferred manner, the biocompatible plastic here is selected from the group comprising polycarbonate, polyacrylate, polyester, polyethylene, polypropylene, polyacrylonitrile, acrylonitrile Butadiene-styrene copolymers (ABS) and mixtures thereof.

In the case of the ABS polymer, the proportions of the monomers used vary from 15-35% acrylonitrile, 5-30% butadiene and 40-60% styrene.

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

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

In one embodiment of the invention, the plastic capsule of the radio thermometer is a flattened over half its length circular cylinder, which is preferably hemispherical rounded at its cylindrical end and has at its flattened end an eyelet for receiving a pulling device. This makes the wireless thermometer easy and user-friendly to insert into the body opening. Due to the different configuration of the two ends a misorientation during insertion into the body opening is prevented. In addition, the wireless thermometer can be easily removed from the body opening through the eyelet in conjunction with a pulling device. By approaching standard menstrual pads, the user is instantly familiar with the application and feel of the wireless thermometer, resulting in increased compliance.

As a pulling device, a band or a cord can be used here expediently. Preferably, an annular silicone cord is used, which can be pulled to form a loop through the eyelet.

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

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

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 of 7 g.

In a further embodiment of the invention, in the wireless thermometer, the plastic capsule consists of a capsule housing and a capsule lid. It thus consists of a simple, only two-part capsule construction, which reduces the risk of impermeability and represents a cost-effective solution.

Preferably, the capsule housing with the capsule lid before use as a thermometer by bonding firmly and waterproof connected to each other. The connection of these two parts is done appropriately in the factory, so that only controlled closed, i. radio-controlled thermometers subjected to quality control are used.

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

1. (a) Eine Auflösung von mindestens 0,05 °C und bevorzugt von 0,01 °C im Bereich der Körpertemperatur;
2. (b) Abgabe einer digital umgesetzten Spannung über eine serielle Schnittstelle, die bevorzugt eine I²C-Schnittstelle ist;
3. (c) Eine Langzeitstabilität von weniger als 0,05°C/Jahr, bevorzugt von weniger als 0,01 °C/Jahr;
4. (d) Anwesenheit eines integrierten Mikrocontrollers, der die Messfehler des eigentlichen Halbleitersensors korrigiert;
5. (e) Fabrikseitige Kalibrierung mit Speicherung der Kalibrierdaten auf dem Temperatursensor-Chip in einem Permanentspeicher;
6. (f) ein durchschnittlicher Stromverbrauch von weniger als 200 nA pro Messung bei einer Messung pro Sekunde.

In a further embodiment of the invention, the semiconductor temperature sensor has at least one of the following properties:

1. (a) A resolution of at least 0.05 ° C and preferably 0.01 ° C in the range of body temperature;
2. (b) providing a digitally converted voltage via a serial interface, which is preferably an I ² C interface;
3. (c) a long-term stability of less than 0.05 ° C / year, preferably less than 0.01 ° C / year;
4. (d) presence of an integrated microcontroller which corrects the measurement errors of the actual semiconductor sensor;
5. (e) Factory calibration with storage of the calibration data on the temperature sensor chip in a non-volatile memory;
6. (f) an average power consumption of less than 200 nA per measurement at one measurement per second.

A resolution of 0.05 ° C in the range of body temperature is necessary in order to be able to measure the basal temperature sufficiently accurately for ovulation measurement. Preferably, the semiconductor temperature sensor according to the invention has a resolution of 0.01 ° C.

With a delivery of a digitally converted voltage via a serial interface, which is preferably an I ² C interface, efficient data transmission is possible.

Semiconductor sensors have a high long-term stability. Preferably, the semiconductor sensor has a long-term stability of less than 0.05 ° C / year, preferably less than 0.01 ° C / year. Only then is a very long, that is over several years extending operability of the wireless thermometer for measuring the vaginal basal body temperature. 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 is decreasing during long-term operation. The semiconductor temperature sensor thus has no voltage-dependent drifting.

By the presence of an integrated microcontroller, which corrects the measurement errors of the actual semiconductor sensor, a continuously high-precision temperature measurement is made possible.

In addition, a factory calibration of the temperature sensor with storage of the calibration data on the temperature sensor chip in a non-volatile memory contributes to the measurement accuracy.

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

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

The person skilled in semiconductor sensors with corresponding properties are known. Reference is made here, for example, to the I ² C temperature sensors from Silicone Laboratories Inc. (Austin, Texas USA), which include, inter alia, the high-precision temperature sensor Si7051, which can be used in a particularly preferred embodiment.

Conveniently, the electronic components of the wireless thermometer, such as data storage, Bluetooth LE transmission unit and control unit as a single-chip computer ("system-on-a-chip", SOC) are available. This allows a cost-effective, space-saving and energy-saving design.

In a preferred embodiment of the invention, in the wireless thermometer, the electronic components are mounted on a first printed circuit board preferably equipped on both sides, one of the edges of the first printed circuit board being in contact with the negative pole of the coin-cell battery via a second circular printed circuit board mounted perpendicularly thereto the connection to the positive pole of the battery is made via a U-shaped battery contact spring whose middle base is preferably arranged between the first and second printed circuit board. This embodiment is particularly space-saving and only allows a configuration as a small-sized tampon form.

In an alternative embodiment, in the wireless thermometer, the electronic components are mounted on a preferably printed on both sides, first circuit board, wherein one of the edges of the first circuit board as a slightly curved metallized edge is in direct contact with the negative pole of the coin-cell battery, and wherein the connection to the positive pole the battery is produced via a U-shaped battery contact spring whose middle base preferably engages in a recess metallized on the edge side of the printed circuit board. This is an additionally simplified embodiment in which it is possible to dispense with the second printed circuit board.

1. (a) Bereitstellen eines erfindungsgemäßen Funkthermometers in einem Ruhemodus;
2. (b) Einführen des Funkthermometers in eine Körperöffnung einer Frau, bevorzugt in die Vagina;
3. (c) Aufnehmen einer Temperaturmessreihe, bevorzugt über Nacht;
4. (d) Speicherung der Messdaten in einem Speicher des Funkthermometers;
5. (e) Entnehmen des Funkthermometers aus der Körperöffnung;
6. (f) Übertragen der Temperaturmessdaten mittels Bluetooth Smart an ein Empfangsgerät, das bevorzugt ein Smartphone oder ein Tablet ist;
7. (g) optionale Reinigung des Funkthermometers und Lagerung außerhalb der Körperöffnung;
8. (h) Wiederholung der Schritte (b) bis (g), bevorzugt täglich, zur Erhebung einer Langzeitmessreihe und Ermittlung relevanter Ereignisse im Menstruationszyklus wie Ovulationszeitpunkt, empfängnisfreie Phase oder fruchtbare Phase.

In a second aspect, the invention provides a method of measuring basal body temperature for ovulation determination, said method comprising the steps of:

1. (A) providing a wireless thermometer according to the invention in a sleep mode;
2. (B) inserting the wireless thermometer into a body opening of a woman, preferably in the vagina;
3. (c) recording a temperature measurement series, preferably overnight;
4. (d) storing the measurement data in a memory of the wireless thermometer;
5. (e) removing the wireless thermometer from the body orifice;
6. (f) transmitting the temperature measurement data by means of Bluetooth Smart to a receiving device, which is preferably a smartphone or a tablet;
7. (g) optional cleaning of the wireless thermometer and storage outside the body orifice;
8. (h) repetition of steps (b) to (g), preferably daily, to collect a long-term series of measurements and identify relevant events in the menstrual cycle such as ovulation time, non-fertile phase or fertile phase.

According to the invention the radio thermometer is temperature-dependent controlled, wherein the activation of the radio thermometer is induced starting from a resting state by the introduction into the body opening and the temperature increase caused thereby to a physiological value.

Preferably, the detection of the resting phase by a method in which the wireless thermometer in the sleep mode takes a time-controlled counter is incremented and after a predetermined counting time, which is preferably between 10 minutes and 60 minutes, more preferably between 15 and 45 minutes and particularly preferably 30 minutes, an energy-saving temperature measurement with low precision is performed, and the measurement result with the threshold of 35 , 5 ° C is maintained, while the sleep mode is maintained as long as a configurable number of consecutive readings, preferably at least two consecutive readings not exceeding 35.5 ° C. By this measuring method, the resting state is maintained in a simple and energy-saving manner until it is introduced into the body opening.

In an alternative embodiment, the wireless thermometer is placed in a "deep sleep mode" with extremely low power 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 radio thermometer for this "test measurement" when the set time is reached.

In a preferred embodiment, this external timer circuit is a system timer with an integrated MOSFET driver and 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 here.

1. (a) Es reduziert das Messintervall auf das für die Messreihe vorgesehene Messintervall, mit einer konfigurierbaren Reduktion, hierbei bevorzugt von 30 Minuten während der Ruhephase auf 5 Minuten während der Messreihe;
2. (b) Es erhöht die Messauflösung auf eine Auflösung von mindestens 0,05°C, wobei hier die Erhöhung der Auflösung bis zu einer für den Sensor maximalen Auflösung bevorzugt ist,
3. (c) Es speichert die Messwerte als Messreihe, wobei die Temperaturwerte als Inkremente ausgehend von einer Offset-Temperatur gespeichert werden.

According to the invention, the wireless thermometer is activated when it is inserted into the body orifice, insofar as a temperature measurement series is initiated. Preferably, the wireless thermometer performs the following three measures to initialize the measurement series with a configurable number of consecutive measured values of more than 35.5 ° C that can be set at least 2 times:

1. (a) It reduces the measurement interval to the measurement interval intended for the measurement series, with a configurable reduction, in this case preferably from 30 minutes during the rest phase to 5 minutes during the measurement series;
2. (b) It increases the measurement resolution to a resolution of at least 0.05 ° C., wherein here the increase of the resolution up to a maximum resolution for the sensor is preferred,
3. (c) It stores the measured values as a series of measurements, the temperature values being stored as increments from an offset temperature.

In a further embodiment, in the method according to the invention, the storage of the measurement data is implemented in a ring buffer, in which the oldest contents are overwritten, when the buffer is full and further elements are stored in the ring buffer. Thus, even with a lack of data transmission, the more recent data remains secure and can be used for the evaluation.

In a preferred embodiment, the memory is dimensioned so that it can accommodate about 30 or more series of measurements. Since the wireless thermometer is not worn during menstruation nor between ovulation and menstruation, it means that the wireless thermometer can collect data over a period of more than one month without the need for data transmission to the receiving device.

The temperature control of the radio thermometer according to the invention also includes the automatic detection of removal from the body opening with the two central sequences that 1.) the measurement series is completed and 2.) a data transmission is initiated.

In a preferred embodiment, this is done by a method in which the wireless thermometer after its removal from the body opening and a concomitant detection of a configurable, at least 2 amount of consecutive measured values below 35.5 ° C, the series of measurements is completed and the Bluetooth transmission unit the Availability of a completed measurement series is signaled (so-called "Advertising").

In a further embodiment, the data transmission takes place in a two-stage process, in which the device search for connection establishment takes place 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.

1. i. die Übertragungseinheit versucht, für eine kurze Zeitspanne von weniger als 1 min bevorzugt weniger als 30 sec und besonders bevorzugt für 10 sec mit hoher Sendeleistung, eine Verbindung mit einer Empfangseinheit aufzubauen;
2. ii. bei erfolgreichem Verbindungsaufbau überträgt die Verbindungseinheit die abgeschlossene(n) Messreihe(n) an die Empfangseinheit und die entsprechenden Daten werden aus dem Speicher des Funkthermometers gelöscht; oder
3. iii. bei erfolglosen Verbindungsaufbau wird für eine Zeitspanne von zwischen 30 s und 5 min, bevorzugt von zwischen 45 s und 2 min und insbesondere für 1 min die Sendeleistung der Übertragungseinheit reduziert oder ganz abgeschaltet,
4. iv. Iteration der Schritte i. und iii. mit einer konfigurierbaren Iterationsrate von bevorzugt zwischen 40 und 80 und besonders bevorzugt von 60;
5. v. bei nicht erfolgreichem Verbindungsaufbau nach Erreichen der konfigurierten Iterationsrate erfolgt das Abschalten der Sendeinheit bis zum Abschluss einer weiteren Messreihe.

In a preferred embodiment of the invention, the Bluetooth transmission unit carries out the following method steps for transmitting a completed measurement series:

1. i. the transmission unit attempts to connect to a receiving unit for a short period of time of less than 1 minute, preferably less than 30 seconds, and more preferably 10 seconds with high transmission power;
2. ii. If the connection is successful, the connection unit transmits the completed measurement series (s) to the receiving unit and the corresponding data are deleted from the memory of the wireless thermometer; or
3. iii. in the case of unsuccessful connection establishment, the transmission power of the transmission unit is reduced or completely switched off for a period of between 30 s and 5 min, preferably between 45 s and 2 min and in particular for 1 min,
4. iv. Iteration of steps i. and iii. with a configurable iteration rate of preferably between 40 and 80 and more preferably of 60;
5. v. If the connection is not successful after the configured iteration rate has been reached, the transmission unit is switched off until the conclusion of another series of measurements.

In a further embodiment, in the method according to the invention, only one measured value is given a time stamp in the measurement series for indicating the respective measurement times, and the remaining time points are defined by storing the measurement interval. This significantly reduces the data volume since not every measured value has to be timestamped.

To determine the real measuring time, the transmission time is also provided with a time stamp. As a result, the receiving device will determine the actual beginning of the measurement series by subtraction.

• • Batteriezustand;
• • Sendesignalstärke;
• • aktuelle Konfigurationsparameter des Funkthermometers;
• • Firmware Version des Funkthermometers
• • Universally Unique Identifier (UUID) des Funkthermometers

When transferring the data from the wireless thermometer to the receiving unit, further data can be transferred. These include, for example:

• • battery condition;
• • transmit signal strength;
• • current configuration parameters of the wireless thermometer;
• • Firmware version of the wireless thermometer
• • Universally Unique Identifier (UUID) of the wireless thermometer

In a further embodiment, the receiving unit can also, preferably with recourse to the cloud, carry out an updating of the software or specific configuration parameters.

In one embodiment of the invention, the receiving unit is authorized by reading a, the individual wireless thermometer associated barcodes or a two-dimensional code for recording series of measurements from this wireless thermometer.

Preferably, a 2D code is used here, which is particularly preferably a QR code. Such a 2D code can provide a high density of information for safe device detection at small measures. Such a 2D code may be mounted on the radio thermometer itself or the thermometer package. The 2D code, which is preferably a QR code, expediently contains a key with the aid of which the software of the receiving unit (preferably an "app") can retrieve the data from the cloud, which itself must automatically authenticate itself to the cloud server.

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

1. (a) ein Single-Chip-Computer (SOC);
2. (b) einen Halbleiter-Temperatursensor;
3. (c) eine Kommunikationseinheit zur Signalübertragung nach dem BLE-Standard;
4. (d) einen Datenspeicher;
5. (e) eine Knopfzellenbatterie;

wobei der Temperatursensor und die Kommunikationseinheit über die Temperatur steuerbar sind, und
wobei das Funkthermometer zu Erfassung, Speicherung und Weitergabe von inkrementellen oder dekrementellen Temperaturwerten ausgelegt ist.In a further aspect, the invention provides a network-independent radio thermometer for temperature measurement for long-term use, comprising:

1. (a) a single-chip computer (SOC);
2. (b) a semiconductor temperature sensor;
3. (c) a communication unit for signal transmission according to the BLE standard;
4. (d) a data store;
5. (e) a coin cell battery;

wherein the temperature sensor and the communication unit are controllable via the temperature, and
wherein the wireless thermometer is designed for detection, storage and transmission of incremental or decremental temperature values.

Such a wireless thermometer can be used advantageously for a variety of measurement purposes. So it can be used in devices where an accurate and simple temperature measurement over a long period of time is necessary.

Thus, such a thermometer can be used in the shipment of temperature-sensitive goods (food, pharmaceuticals) as a data logger to prove an uninterrupted cold chain.

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

Furthermore, it can be used in other biological systems, such as for measuring the breeding behavior of birds.

definitions

According to the invention, a configurable value is to be understood as meaning a value which can be freely configured, that is, in the context of the method, it is then possible to assume the arbitrarily preselected value given in each case in the configuration. This also explicitly includes dynamic configurability. This means that the configuration e.g. in response to the present test conditions can be adapted dynamically to these test conditions. For example, an intravaginal measurement series can only begin at a later point in time with a close-to-time temperature measurement, if the earlier measurements show that the basal temperature of the person concerned is only reached correspondingly late.

In the context of the invention, a "substantially rigid" plastic capsule is 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 has.

A "body opening" in the sense of the invention is an opening on a body of an animal or human. This includes body cavities such as the vagina, the rectum, the ear canal or the oral cavity as well as body cavities such as the armpit or the popliteal fossa as actual body openings.

According to the invention, the term "hermetically sealed" means a capsule which is sealed watertight. This prevents that body exudates and in particular body fluids such as sweat, urine or cervical fluid can penetrate into the interior of the capsule.

Bluetooth Low Energy (also called Bluetooth LE, BLE or Bluetooth Smart) is a wireless technology that allows devices in an environment of about 10 meters up to 500 m to be networked with newer versions. Compared to "classic" Bluetooth, Bluetooth Smart / BLE has significantly lower power consumption and lower costs for a similar range of communication. The corresponding Bluetooth versions are currently in use under the 4.x or 5.x specification.

list of figures

• 1 zeigt eine schematische Skizze eines erfindungsgemäßen netzunabhängigen Funkthermometers. Dargestellt ist das Funkthermometer in Aufsicht (oben links), in den beiden senkrecht zueinander stehenden Seitenansichten (unten links und unten rechts) und in perspektivischer Darstellung (oben rechts).
• 2 zeigt eine schematische Skizze der in dem netzunabhängigen Funkthermometer vorgesehenen elektronischen Komponenten. Dargestellt sind die Komponenten in Seitenansicht (links) und in perspektivischer Darstellung (rechts).
• 3 zeigt ein Flussdiagramm zur Darstellung des Messverfahrens.

These and other aspects of the invention are shown in detail in the figures as follows.

• 1 shows a schematic diagram of a network-independent wireless thermometer according to the invention. Shown is the radio thermometer in top view (top left), in the two mutually perpendicular side views (bottom left and bottom right) and in perspective view (top right).
• 2 shows a schematic diagram of the provided in the network wireless thermometer electronic components. Shown are the components in side view (left) and in perspective (right).
• 3 shows a flow chart for illustrating the measuring method.

Detailed description of the embodiments

1 1 shows a schematic sketch of a network-independent wireless thermometer according to the invention ( 1 ) as a cylindrical body ( 2 ) with hemispherical distal end ( 3 ) for easy insertion into the body opening and a flattened end ( 4 ), which is an eyelet ( 5 ) for receiving a pulling device (not shown).

In the 2 The electronic components provided in the capsule of the off-grid wireless thermometer are shown schematically in their arrangement. Here is a first circuit board ( 6 ) with an antenna ( 7 ), a temperature sensor ( 8th ), a capacitor ( 16 ), and with a printed circuit board of the BLE module ( 9 ) with shielding plate ( 9 ) and over an edge ( 11 ) to a second circular circuit board ( 12 ) soldered. This second circuit board is connected to the negative pole of the coin cell battery ( 13 ), wherein the connection to the positive terminal of the battery via a U-shaped battery contact spring ( 14 ) whose average basis ( 15 ) is arranged between the first and second circuit board.

In the 3 become the individual steps of the measurement and transmission process, as in the claims 11 and 13 described described. In the sub-step of data transmission, there are two alternative sequential steps. If the connection is established successfully with the receiving device (plus in the circle), data transfer to the receiving device takes place in the next step. If no connection can be established even after repeating 60 times (minus in a circle), the device is put back into idle mode.

Other variants of the invention and their execution will become apparent to those skilled in the art from the foregoing disclosure, the drawings and the claims.

Terms used in the claims, such as "comprising,""comprising,""including,""containing," and the like, do not exclude other elements or steps. The use of the indefinite article does not exclude a majority. A single facility can do the functions perform several mentioned in the claims units or devices. Reference signs indicated in the claims should not be regarded as limitations on the means and steps employed.

LIST OF REFERENCE NUMBERS

1

Network-independent wireless thermometer

2

Cylindrical capsule

3

Hemispherical distal end

4

flattened proximal end

5

Eyelet for pulling device

6

first circuit board

7

antenna

8th

temperature sensor

9

Shielding plate of the BLE module

10

PCB of the BLE module

11

Current-carrying edge of the first circuit board

12

Second circuit board

13

Coin-cell battery

14

Battery contact spring

15

Base of battery contact spring

16

capacitor

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 2567680 B1 [0012, 0014]

Claims (20)

Network-independent wireless thermometer for temperature measurement in a body opening for long-term use with a hermetically sealed, introduced into the body opening, substantially rigid plastic capsule containing: (f) a single-chip computer (SOC); (g) a semiconductor temperature sensor; (h) a communication unit for signal transmission according to the BLE standard; (i) a data store; (j) a coin cell battery; wherein the temperature sensor and the communication unit are controllable via the temperature, and wherein the wireless thermometer is designed for detection, storage and transmission of incremental or decremental temperature values. Mains-independent wireless thermometer according to Claim 1 , characterized in that the body opening is the ear, the rectum or the vagina. Mains-independent wireless thermometer according to Claim 1 or 2 , characterized in that the wireless thermometer with daily recording a series of measurements for at least 6 hours and daily transmission of the data allows a long-term use over a period of at least one year, preferably at least two years and more preferably at least three to five years. Mains-independent wireless thermometer according to Claim 1 to 3 , characterized in that the plastic capsule consists essentially of a plastic which is biocompatible according to DIN ISO 10993-5: 2009 and is selected from the group comprising polycarbonate, polyacrylate, polyester, polyethylene, polypropylene, acrylonitrile-butadiene-styrene copolymers ( ABS) and mixtures thereof. Network-independent radio thermometer according to one of the preceding claims, characterized in that the plastic capsule is a half-length flattened circular cylinder, which is preferably hemispherical rounded at its cylindrical end and at its flattened end has an eye for receiving a pulling device. Grid-independent radio thermometer 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 watertightly connected to each other before use as a thermometer by gluing, wherein for the bonding preferably a UV-curing cyanoacrylate adhesive is used. A mains-independent radio thermometer according to any one of the preceding claims, characterized in that the semiconductor temperature sensor has at least one of the following characteristics: (a) a resolution of 0.05 ° C in the range of body temperature; (b) providing a digitally converted voltage via a serial interface, which is preferably an I ² 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 which 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 power consumption of less than 200 nA per measurement at one measurement per second. Grid-independent radio thermometer according to one of the preceding claims, characterized in that the electronic components such as temperature sensor, data memory, Bluetooth LE transmission unit and control unit as a system-on-a-chip (SOC) are present. Grid-independent radio thermometer according to one of the preceding claims, characterized in that the electronic components are mounted on a preferably mounted on both sides, the first circuit board, wherein one of the edges of the first circuit board via a perpendicular thereto mounted second circular circuit board is in contact with the negative terminal of the button cell battery , and wherein the connection to the positive terminal of the battery is produced via a U-shaped battery contact spring whose middle base is preferably arranged between the first and second printed circuit board, Network-independent radio thermometer according to one of Claims 1 to 8th , characterized in that the electronic components are mounted on a, preferably bilaterally equipped, first circuit board, wherein one of the edges of the first circuit board as slightly curved metallized edge is in direct contact with the negative terminal of the coin cell battery, and wherein the connection to the positive terminal of the battery is produced via a U-shaped battery contact spring whose middle base preferably engages in an edge metallized recess of the circuit board. Method for measuring the basal body temperature for ovulation determination, comprising the following steps: (a) providing a network-independent wireless thermometer according to one of Claims 1 to 10 in a sleep mode; (B) inserting the wireless thermometer into a body opening of a woman, preferably in the vagina; (c) recording a temperature measurement series, 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 mobile phone, tablet or computer; (g) optional cleaning of the wireless thermometer and storage outside the body orifice; (h) repetition of steps (b) to (g), preferably daily, to collect a long-term series of measurements and identify relevant events in the menstrual cycle such as ovulation time, non-fertile phase or fertile phase. Method according to Claim 11 , characterized in that the wireless thermometer in the sleep mode according to step (a) increments a timed counter and after a configurable fixed count time, which is preferably between 10 minutes and 60 minutes, more preferably between 15 and 45 minutes and particularly preferably 30 minutes, an energy-saving Temperature measurement performs with low precision, and compares the measurement result with the threshold of between 35 and 36 ° C, wherein the sleep mode is maintained as long as not at least a number of consecutive measured values determined by configuration, which are preferably at least two consecutive measured values, over the Threshold. Method according to Claim 11 or 12 characterized in that the radio thermometer for initializing the series of measurements in step (c), for a configurable, at least 2, amount of consecutive measurements above the threshold between 35 and 36 ° C: i. reduces the measuring intervals; ii. the measurement resolution is increased and preferably maximized; iii. the measured values are stored as a series of measurements, the temperature values being stored as increments from an offset temperature or the preceding measured value. Method according to one of Claims 11 to 13 , characterized in that the storage of the data in step (d) is implemented in a ring buffer in which the oldest contents are overwritten, when the buffer is full and further elements can be placed in the ring buffer. Method according to one of Claims 11 to 14 , characterized in that the wireless thermometer after removal of the wireless thermometer in step (e) and detection of a configurable, at least 2 amount of consecutive measurements below the lying between 35 and 36 ° C threshold concludes the series of measurements and the Bluetooth transmission unit, the availability of a completed Measurement series signals (so-called "Advertising"). Method according to one of Claims 11 to 15 , characterized in that the Bluetooth transmission unit in step (f) performs the following method steps: i. the transmission unit attempts to connect to a receiving unit for a short period of time of less than 1 minute, preferably less than 30 seconds, and more preferably 10 seconds with high transmission power; ii. if the connection is successful, the connection unit transmits the completed measurement series (s) to the receiving unit and the corresponding data is deleted from the memory of the wireless thermometer; or iii. in the case of an unsuccessful connection setup, the transmission power of the transmission unit is reduced or completely switched off 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 more preferably of 60; v. If the connection is not successful after the configured iteration rate has been reached, the transmission unit is switched off until the conclusion of another series of measurements. Method according to one of Claims 11 to 16 , characterized in that in the measurement series for indicating the respective measurement times only one measurement contains a time stamp and the other times are defined by storing the measurement interval. Method according to one of Claims 11 to 17 , characterized in that the receiving unit is authorized by reading a, the individual radio thermometer associated barcode or a two-dimensional code for recording series of measurements from this wireless thermometer. Method according to one of Claims 11 to 18 , characterized in that the measurement data from the receiving unit in encrypted form in a database accessible via the Internet (so-called "cloud") stored and can be read out of this cloud again. Network-independent radio thermometer for temperature measurement for long-term use, comprising: (k) a single-chip computer (SOC); (I) a semiconductor temperature sensor; (M) a communication unit for signal transmission according to the BLE standard; (n) a data store; (o) a coin cell battery; wherein the temperature sensor and the communication unit are controllable via the temperature, and wherein the radio thermometer is designed for detection, storage and transmission of incremental or decremental temperature values.

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