ANALYSIS SYSTEM INCLUDING A TOOTHBRUSH

Description

[0001] The present invention relates to an analysis system comprising a toothbrush (100) with a brush head according to claim 1.

[0002] US Pat. No. 6,623,698 B discloses a device for detecting blood sugar, pregnancy, HIV, and the like. This toothbrush uses one or more interchangeable toothbrush heads. The heads have integrated sensors.

[0003] The sensors are either optical or electrical sensors. The document discloses a time-sequential measurement with a first time phase in which saliva collection and measurement takes place, followed by a second time phase in which only tooth brushing takes place.

[0004] Although this publication and the associated technology have been known for some time, a product based on it has not yet achieved commercial success. One possible reason could be the type of sensors in the brush. If biosensors with a short lifespan of several days were used in the aforementioned brush head, the replacement intervals for the brush head would be very short.

[0005] Other relevant prior art documents are US 2012 / 322 023 A1, DE 11 2012 003 494 T5, US 2016 / 374609 A1 and US 2014 / 310900 A1.

[0006] On the other hand, special attention must be paid to hygiene in dentistry.

[0007] Furthermore, some sensors are no longer reliable after a short period of use, usually even after a single use.

[0008] Based on this, the object of the present invention is to provide a toothbrush which has a brush head with an integrated and replaceable sensor unit.

[0009] The present invention solves this problem by an analysis system having the features of claim 1.

[0010] A brush head of a toothbrush has one or more means for mechanically cleaning the teeth. These are described below in a preferred embodiment as a plurality of bristles for cleaning the teeth. Typically, these bristles are arranged along a front side.

[0011] However, it is also possible within the scope of the present invention to use one or more other means for mechanically cleaning teeth, alternatively or in addition to the aforementioned bristles. This means or these means can comprise, among other things, a sponge, a cushion, one or more microfiber structures, or one or more vibrating elements. Accordingly, the brush with microfiber structures is then a textile brush with textile instead of bristles, a sponge brush with a sponge structure instead of bristles, or a vibrating brush with one or more vibrating elements.

[0012] The following description is based on the preferred embodiment with the bristles, although other means can of course also be used as described.

[0013] Furthermore, the brush head has a sensor arrangement that serves to monitor the health of a user. Within the context of the present invention, health refers to the presence and concentration of pathogens, such as viruses, fungi, and / or bacteria, as well as the presence of carcinomas, cardiovascular diseases, stomach ulcers, reflux, diabetes, or even the fertility status, e.g., impending ovulation, or the pregnancy status of a user. The above list is not exhaustive; further examples may be added.

[0014] Health monitoring can be achieved, among other things, by measuring pathogens such as the concentration of bacteria, viruses, etc., or by detecting the body's defense reactions, such as the detection of antibodies. Other measurements, such as temperature and / or conductivity, can also be used alone or in combination with other measured data to monitor health.

[0015] Health monitoring can optionally and preferably be carried out using a personalized health profile created while healthy, e.g., during a doctor's visit. Changes in measurements can then be continually compared with this health profile.

[0016] In contrast to the previous state of the art, the sensor unit is replaceably mounted on or in the brush head of the toothbrush. The sensor unit can be part of a sensor assembly, which can also be designed to be replaceable.

[0017] The brush head itself can be replaceable and attached to the handle of a toothbrush or permanently attached to the toothbrush. Typically, a brush head needs to be replaced after more than one month, for example, every three to four months. The sensor unit or sensor assembly should preferably be replaced after every measurement or after a few measurements.

[0018] The sensor arrangement has several different sensor units.

[0019] When replacing the sensor assembly, multiple sensor units can be replaced simultaneously. Other sensor units may be permanently attached to the brush head and / or handle of the toothbrush, meaning they cannot be replaced.

[0020] The sensor unit can be arranged on the side of the brush head, on the back or between the bristles, similar to a sieve.

[0021] The use of a disposable sensor unit and, particularly preferably, a disposable sensor arrangement enables, for example, a one-time, metered release of an indicator, e.g., an indicator dye or biomarker, to the aforementioned sensor unit. The same applies to pH measurement. The sensor unit or sensor arrangement can then be replaced. Therefore, the sensor unit and / or sensor arrangement need not be particularly robust for reuse, but can be implemented in a miniaturized design.

[0022] In the event that reagents or the sensor unit as a whole are consumed and / or destroyed during the measurement, interchangeability is particularly advantageous.

[0023] Advantageous embodiments of the brush head are the subject of the subclaims.

[0024] Advantageously, the brush head can have a so-called sensor adapter, in particular a one-, two-, or three-way adapter (three-way connector) for connecting the replaceable sensor unit or the replaceable sensor arrangement, e.g. a biosensor, to the brush head.

[0025] The brush head can preferably have an electrical interface with contacts, in particular in the form of spherical, preferably gold-plated, contact elements arranged as a matrix. The matrix can have a linear 1-dimensional arrangement or be designed as a 2-dimensional matrix. The matrix is ​​preferably sealed against liquids, including saliva, with a corresponding IP class, e.g. IP67. So-called BGA contacts (ball grid array) are preferably provided as contact elements. In addition to or alternatively to the aforementioned BGA contacts, pins and / or lamellae can also be provided. In total, several connector / interface contacts, preferably in the form of BGA contacts, pins and / or lamellae, can thus be provided.

[0026] The brush head, in particular the sensor unit or the sensor arrangement, can have at least one reservoir and / or a supply line for delivery substances, in particular biomarkers, e.g., functional molecules, binding substances, e.g., binding ligands, and / or indicator compounds, e.g., luminophores, in particular fluorophores. Binding ligands can form a bond with other molecules in the saliva and with the sensor surface. Corresponding ligand-receptor interactions and the corresponding binding molecules are known from the field of ELISA tests (enzyme-linked immunosorbent assays) and can also be used as binding ligands within the scope of the present invention.

[0027] It is advantageous if the sensor unit, or particularly preferably the sensor arrangement comprising a plurality of sensor units, is designed as a thin-layer or thin-film sensor unit or arrangement, or as a sensor chip. This miniaturizes the sensor arrangement, and the brush head only needs to provide a small amount of space for the sensor arrangement or the sensor unit. Alternatively or additionally, the sensor arrangement can be formed additively and / or subtractively using a microtechnology process, for example, using lithography, soft lithography, 3D printing, printing, screen printing, and / or stereolithography.

[0028] The sensor arrangement can advantageously comprise at least two, preferably at least three, sensor units for determining at least two material properties of saliva, preferably three material properties of saliva, in particular at least one physical material property and at least one chemical, biochemical, and / or biological material property. A tendency toward disease development can be derived from the determined material properties.

[0029] The sensor arrangement may comprise a first sensor unit for determining a voltage-equivalent measured value of the medium or the saliva, in particular a resistance value of the medium or a conductivity value of the medium. The first sensor unit is configured to perform an impedance measurement of the saliva at one or more frequencies and / or frequency bands.

[0030] In particular, the first sensor unit can determine an electrical impedance value, whereby the impedance values ​​can preferably be determined across multiple frequencies and / or frequency bands. The DC resistance is included in the impedance as a DC value. The effective resistance R is the frequency-independent, real part of the complex impedance Z(f)=R+jX(f). Coated electrodes and electrolytes lead to complex impedances of biosensors due to their capacitive properties (charging of electrodes, electrode surfaces, insulation, permittivity of electrolyte / body fluids). A temporal (dynamic) voltage and / or current measurement and / or a charge measurement (Coulomb) could also be used to determine the voltage-equivalent resistance value. A model-based determination of the aforementioned quantities can also be performed.

[0031] The sensor arrangement advantageously has at least one second sensor unit for determining the pH value of saliva.

[0032] The sensor arrangement also includes a third sensor unit, which is configured as a biosensor. An electric brush head is typically used for extended periods of time, e.g., 30-80 days, which is not a realistic application period for biosensors with coated electrodes or optical sensors. The measurements lose accuracy, stability, specificity, and selectivity, and can become unusable after just a few days.

[0033] In a preferred embodiment of the invention, the biosensor is designed as a hormone, enzyme, peptide, and / or protein sensor, including an antigen and / or antibody sensor, and particularly preferably as a lactate sensor, a glucose sensor, a GABA sensor, an IgA sensor, a lysozyme sensor, an IgG sensor, an IgM sensor, an IL-6 sensor, a CRP sensor, a Tnf-a sensor, and / or an alpha macroglobulin sensor. These compounds are indicators of periodontitis, periodontitis, diabetes, and / or cardiovascular diseases. Alternatively or additionally, the biosensor can be designed as one or more sensors for detecting metabolites of diseases.

[0034] Disease-causing bacteria can be understood as bacteria that cause periodontitis and / or caries, particularly Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, and Aggregatibacter actinomycetemcomitans, which are associated with aggressive periodontitis. These bacteria produce detectable metabolites. However, metabolites of other diseases, such as viruses such as SARS-CoV or influenza viruses, as well as other pathogens that cause colds or oropharyngeal carcinomas, can also be measured. Various pathogens such as bacteria, viruses, and fungi, especially mold, are also detectable.

[0035] Preferably, the third sensor unit or further sensor units can detect different metabolites or analytes per clinical picture in order to exclude an incorrect measurement (a so-called "false negative").

[0036] The sensor arrangement and / or an individual sensor unit can be arranged in a form-fitting or force-fitting manner on the side of the brush head facing away from the bristles, for example by clamping, locking and / or pressing.

[0037] Furthermore, a mechanical and / or electrical interface can be provided, e.g., incorporating the aforementioned adapter. A locking mechanism can be provided between the sensor arrangement and / or the sensor unit and the brush head at this point, so that replacement is only possible after actuating the locking mechanism.

[0038] During signal processing, raw signals or raw data can preferably be processed with a sufficiently high sampling rate – preferably in the range of 10 to 1000 Hz and over longer periods of time, preferably of at least one minute. The time period can also be more than 4 minutes, and the sampling can be dependent on the condition of the toothbrush. If, for example, a sampling is performed during ultrasonic wave treatment with an electric toothbrush, a different time period can be selected in the idle state than in the mode in which the vibrations are active (to avoid the interference of vibrations on the SU measurement). In the case of sampling during active vibrations, advanced signal processing (DSP) methods can also be used to filter out or compensate for the interference, so that interference is introduced or compensated.For this purpose, disturbances can be estimated or determined and the signals can be compensated and / or adapted as in a feedforward disturbance compensation scheme (known from control engineering) or adaptive noise canceller (known from DSP - Digital Signal Processing: Adaptive Noise Canceller from Widrow, Echo Cancellers, adaptive LMS Filter) scheme.

[0039] The replaceable sensor unit with biosensors will provide electrochemical signals according to the developed redox reactions, which are preferably specifically designed for the target biomarker biosensors. Since this unit should provide measurement values ​​reliably (with appropriate precision and stability), preferably over multiple measurements and / or several days, advanced signal processing methods are advantageous.

[0040] Many current electrochemical biosensors typically require preconditioning in a suitable solution for time intervals of 10-30 minutes prior to measurement.

[0041] Alternatively or additionally, the sensor arrangement may also comprise electro-optical sensors by means of which a change in fluorescence or a spectral change or a change in the refractive index (RI index / refractive index) can be detected.

[0042] In this application, preconditioning in the application cycles can be shortened or, advantageously, can be omitted. Preconditioning may be easier to implement with a device that has an exchange station, but more difficult without one, such as with an electronic toothbrush without a corresponding exchange or charging station, i.e., as a standalone SU unit. However, preconditioning can also be advantageously avoided by applying one or a combination of several DSP methods. These can also be used for further product functionality, such as detecting the state of biosensors - dry vs. wetted with saliva, detecting good signal quality vs. poor signal quality, for example, detecting intermediate states in which the SU unit is not sufficiently wetted with saliva, or detecting movements that cause interference.

[0043] Another part of the invention is a toothbrush.

[0044] The toothbrush can advantageously have a control and / or evaluation unit which is equipped to acquire data, in particular raw data, during the measurement of the saliva by the sensor unit with a sampling rate of 10-1000 Hz.

[0045] The control and / or evaluation unit can also be equipped to acquire data, in particular raw data, during the measurement of the saliva by the sensor unit in a sampling interval of at least 3 to 500 seconds.

[0046] Furthermore, the toothbrush has a radio module for data transmission with an external device for data processing and determining a health status.

[0047] The radio module can be part of an electronic module, which can also include a measurement module. The electronic module can contain one or more ASICs as application-specific integrated circuits.

[0048] In addition, the toothbrush can have a module for inductive power transmission, which is preferably arranged in the handle of the toothbrush.

[0049] Furthermore, an analysis system is provided, comprising the toothbrush described above and an external device for data processing, wherein raw signals are transmitted from the toothbrush to the external device and wherein the external device has a data memory on which a computer program product for data analysis is stored, wherein the computer program product is designed for data analysis of the data determined by the sensor unit, preferably according to one or more DSP methods (method of digital data processing or digital signal processing), in order to determine a state of health.

[0050] A method for operating the analysis system according to the invention comprises a data analysis and has the following steps: a) Sampling of electrochemical signals, in particular amperometric signals at different potentials and / or voltametric signals at different currents, and / or impedance signals over a measurement period at a predetermined sampling rate

[0051] The preferred measurement duration and sampling rate have been described previously. b) Detection and classification of sensor element states with regard to the "humidification state" based on the determined electrochemical signals and / or impedances

[0052] In a preferred embodiment, the aforementioned detection can be performed by an impedance measurement. The following values ​​were detected in a frequency range between 500 Hz and 100 kHz. The values ​​may vary with frequency. Saliva: typical range: 0.6-1 kOhm. Saliva with water: 1-1.6 kOhm. Water alone will show much higher values, as it is not as conductive. Values ​​of 3-8 kOhm are assumed for tap water. Toothpaste in saliva reduces the impedance values ​​to 0.2-0.5 kOhm. The reduction depends on the composition of the toothpaste and the amount used; the more toothpaste, the greater the reduction in the impedance values.

[0053] Thus, the impedance measurement described above can be used to detect the following conditions: water via sensors (complete or partial moistening of the sensors), water-saliva mix, saliva, saliva with toothpaste c) Evaluation of amplitudes and changes in the electrochemical signals and / or impedances and in particular the associated redox reactions and / or capacitive transients in order to analyze the saliva with regard to the user's state of health

[0054] The evaluation can be carried out in particular by an evaluation unit comparing the actual value and the target value, whereby predefined data sets for the evaluation are stored in a data memory of the evaluation unit, e.g. in so-called lookup tables.

[0055] It is particularly advantageous if, in step c), the sampled electrochemical signals are decomposed and / or filtered into a useful component and one or more interfering components of the signal, wherein the useful component represents or correlates with the redox reaction component of the signal, which is relevant for determining the concentration of the biomarker. The correlation can, for example, be linear or exponential or the like.

[0056] The method, in particular following step c) or before step a), may comprise at least one of the following further steps: d) sampling electrochemical signals after conditioning and / or stabilization in a provided reference solution; and / or e) repeating measurements to combine information from multiple measurements, preferably to improve precision, improve the signal-to-noise (S / N) ratio, and / or compensate for interference.

[0057] Furthermore, a replacement station for replacing the brush head can be provided, comprising a replacement chamber, wherein the brush head can be inserted at least partially into the replacement chamber, and wherein the replacement station has a storage arrangement with a plurality of separable sensor arrangements and / or sensor units and a loading unit for loading the brush head within the replacement chamber. The replacement chamber is open at least on one side to allow the brush head to be inserted.

[0058] Loading can be done automatically or manually. Many different options are possible for exchange stations. For example, the exchange station can be the size of a tabletop or a small, manually operated station. Especially in the latter case, the station can be powered by a battery or other portable power storage device, such as a rechargeable battery.

[0059] Furthermore, the exchange station can advantageously have a radio module, e.g. a wireless transmitting and receiving unit, for bidirectional wireless data exchange, in particular with an external computer or server or a cloud application.

[0060] An exchange station can optionally have sensors that evaluate saliva samples collected by the brush head. For this purpose, the exchange station can have one or more fluid lines for flushing a measuring chamber into which the saliva sample is introduced, as well as one or more fluid lines for adding reagents to the measuring chamber, and a measuring and evaluation unit that evaluates the measured values ​​recorded by the sensors of the exchange station. The measuring chamber can also simultaneously serve as the exchange chamber. Via a mechanism, preferably a mechanism as described above, the toothbrush, in particular its bristles, or its cushion, sponge, or other material, can also release an active ingredient.

[0061] A further concept of the present disclosure is that the station does not replace sensor units or sensor arrangements, but rather, as a storage station, merely performs an analysis of saliva collected by the toothbrush. This collection of saliva occurs via a suction mechanism within the toothbrush. This saliva is then delivered to the measuring chamber and analyzed within the measuring chamber by at least partially replaceable sensors arranged for this purpose.

[0062] The exchange station can advantageously have a charging station, e.g. a charging connection point, for charging the toothbrush.

[0063] Furthermore, the exchange station can have a collection and / or evaluation unit for reading out sensor data from the used sensor arrangement and / or for calibration or for reading in sensor data for the sensor arrangement to be fitted.

[0064] It is advantageous if the exchange station and the toothbrush have at least one transmitting module, in particular a transmitting and receiving module, for exchanging acquired sensor data with an external data processing unit. This could be, for example, a Bluetooth module, an NFC module, an RFID module, a LoRa module, a 5G module, or the like.

[0065] In the case of the transmitting and receiving module or an additional receiving module, bidirectional data exchange can take place.

[0066] The exchange station can have a module for wireless energy transfer, e.g., through inductive power transmission. This module can also transmit data, so that the module can advantageously also function as a transmitter and / or receiver. A module for wireless energy transfer can also be additionally included in the toothbrush handle and / or toothbrush head.

[0067] This allows various data to be read from the toothbrush, the sensor array, or the respective replaceable sensor unit. This includes, for example, calibration data, UDI data (i.e., a serial number or other data for identifying the toothbrush and / or the sensor array and / or the sensor unit), configuration data, and, of course, sensor data, such as measured values ​​or measurement conditions. QAM, FSK, or PSK can also be used for data transmission.

[0068] Data exchange preferably occurs bidirectionally between the exchange station and the brush head. For this purpose, the brush head or toothbrush can be equipped with a microcontroller, preferably with an EEPROM (electrically erasable programmable read-only memory). The brush head or toothbrush can also be equipped with another non-volatile RAM memory. This memory can be located in an optional ASIC chip, separately in the microcontroller, or in other electronic components of the brush head or toothbrush.

[0069] The exchange station can have additional optional units that expand the analysis options and / or the usability of the toothbrush. Furthermore, measurement conditions and electronic or device states can be set and monitored. For example, the exchange station can have a recognition unit that recognizes the identity of the toothbrush or the associated user and adjusts the settings individually for that person. For this purpose, the toothbrush has a marking, e.g., a QR code or similar.

[0070] An evaluation unit provided in the exchange station or in the toothbrush can be designed to carry out a method for operating the toothbrush to monitor the health status of a user or patient, in particular with regard to the development of periodontitis, the method comprising the following steps: I. Equipping the brush head of the toothbrush with a new sensor arrangement and / or sensor unit, in particular in the exchange station; II. Inserting the brush head into the oral cavity and bringing the sensor arrangement and / or sensor unit into contact with saliva; this consumes the sensor arrangement and / or sensor unit. Consumption can occur, in particular, after just one contact. III. Generating sensor data to determine at least two, preferably at least three, material properties of the saliva and IV. Removing a consumed sensor arrangement and / or sensor unit and reading the data, in particular within the exchange station.

[0071] Some of the steps, e.g. step III and IV can be performed simultaneously. In step I, calibration of the sensor units can also be performed optionally and advantageously.

[0072] Of course, it is also possible to determine only one or more material properties as a sum, whereby the material properties can be sum parameters that can be determined based on a model. It is also possible to determine only the change in the material properties. This also falls under the aforementioned step III. Furthermore, additional biomarkers from external devices can be processed and, in particular, included in the sum parameter. A typical example of this is the data from the AppleHealth Vital Signs program.

[0073] After performing step II of the method, an indicator module can indicate that the sensor assembly is worn out and must be replaced to repeat the method. However, the use of the indicator module is not mandatory when performing the method. The indicator can be provided acoustically, visually (e.g., via an LED indicator or a display, e.g., a display on the device itself or on a mobile device such as a smartphone), or through vibrations.

[0074] Furthermore, a device for monitoring the health status, in particular with regard to the development of periodontitis, periodontitis, diabetes or cardiovascular diseases in a user can be provided, comprising a toothbrush with a device for taking saliva from a patient and a station with a measuring chamber for receiving the sucked-in saliva, wherein at least one sensor unit or a sensor arrangement comprising at least one sensor unit is arranged within the measuring chamber and wherein the sensor unit or the sensor arrangement is arranged interchangeably within the measuring chamber. In this case, the station is not an exchange station for exchanging the sensor arrangement or sensor unit on the brush head, but rather the sensor unit or sensor arrangement is arranged within the measuring chamber or exchange chamber. In this case, the toothbrush is used only as a means of transport for contact with the patient's saliva.The generation of measurement data therefore does not take place in the patient’s mouth, but only within the ward.

[0075] It is particularly advantageous in this concept if the measuring chamber has a supply, in particular a magazine, of unused sensor units or sensor arrangements and has an exchange mechanism, e.g. a removal and assembly machine, for exchanging a used sensor unit or sensor arrangement with a new sensor unit or sensor arrangement from the supply or the magazine.

[0076] The device for removing saliva in the toothbrush can preferably be designed as a suction device and, for example, comprise a suction pump and / or dispensing pump, e.g. for transporting and administering liquids.

[0077] In an advantageous variant of the method, the sensor assembly is worn out after performing step II of the method and must preferably be replaced to repeat the method. This variant is usually described as "single-use."

[0078] Furthermore, the use of the eBrush head serves to monitor the health status of a user, in particular the concentration of viruses, bacteria in the body, the state of inflammation in the body, the risk of diabetes and / or cancer, the risk of cardiovascular disease and / or the fertility cycle.

[0079] The invention will be explained in more detail below using an exemplary embodiment with the aid of figures. Modifications of the exemplary embodiment are also mentioned and can be understood as isolated features. Fig. 1 schematic representation of a brush head of a toothbrush; Fig. 2 schematic representation of an arrangement comprising an exchange station and the brush head of the Fig. 1 ; Fig. 3 schematic representation of a second embodiment of a brush head; Fig. 4 another view of the brush head of the Fig. 3 ; Fig. 5 schematic representation of a third embodiment of a brush head; Fig. 6 enlarged view of the Fig. 5 ; Fig. 7 schematic representation of a section of a fourth embodiment variant in modification of the variant of the Figs. 5 and 6 Fig. 8Complete view of the variant of the Fig. 7 ; Fig. 9 schematic representation of a fifth embodiment of a brush head; Fig. 10 further view of the brush head of the Fig. 9 ; Fig. 11 simplified exploded view of the variant of the Figs. 9 and 10 ; Fig. 12 schematic representation of a sixth embodiment of a segment of a brush head.

[0080] Fig. 1 shows a brush head 1 of a toothbrush 100. In this case, it is the brush head 1 of an electric toothbrush. It can, of course, also be a toothbrush without an electric drive for moving the brushes and / or without an ultrasonic generator. In this case, a power supply unit is required, but this only operates the sensor units, in particular the bio- and electrosensors, possibly transmitting and / or receiving modules, and possibly an evaluation unit.

[0081] The brush head 1 has a plurality of bristles 2 on the front and a replaceable sensor arrangement 3 comprising a plurality of sensor units on the back. The sensor arrangement 3 is designed as a flexible plastic film or as a chip on a plastic substrate and comprises at least a first sensor unit 4 for determining the pH value of the measuring medium. This is preferably a disposable sensor unit, in particular for single use. The sensor unit can be designed in particular as a thin-layer and / or thin-film sensor unit or as another form of sensor unit based on microtechnology, e.g. as an MEMS unit. Other variants for designing a corresponding sensor unit include 3D printing, pad printing, lithography or screen printing.

[0082] Furthermore, the brush head 1 can have a sensor adapter, in particular a one-, two-, or three-way adapter for connecting the replaceable sensor arrangement 3, which, however, Fig. 1 is arranged below the sensor arrangement and is therefore hidden.

[0083] Typical thin-film sensor units for measuring pH include carbon electrodes doped with ruthenium dioxide. Such pH electrodes are described as disposable sensors for single use, for example, by Koncki et al. in "Disposable screen-printed pH electrode for determination of anticholinesterase activity" (p. 139 ff., Biosensors for Direct Monitoring of Environmental Pollutants in Field).

[0084] Other pH thin-film sensors with pH electrodes based on ISFET technology are also known from various applications. An example of a pH sensor design with a reference electrode and an additional electrode is described, for example, in DE 10 2011 085 747 A1.

[0085] AT186493 A, AT 184692 A and DE 10 2006 022 290 also disclose pH sensors based on thin-film technology or thick-film technology with electrode layers, in particular conductive and semiconductive layers made of different materials or sensor chips.

[0086] The design of the first sensor unit is not necessarily limited to the two electrodes shown. For example, the sensor unit can preferably be designed as a potentiostat arrangement with a working electrode, a reference electrode, and a counter electrode.

[0087] The use of a so-called 3-electrode cell is also possible within the scope of the present invention, whereby in a particularly preferred embodiment, a fourth and possibly additional electrodes can be used in the sensor units for disturbance detection and disturbance compensation. In a signal processing process performed by an evaluation unit, disturbance compensation for noise reduction can be performed.

[0088] The aforementioned sensor unit or the aforementioned pH sensors and the associated electrical lines and connections can preferably be arranged on or in a flexprint circuit board or a flexible film.

[0089] A pH sensor measuring range of between 1 and 13, preferably between 3 and 8, is recommended for this application. Saliva is known to be neutral to slightly alkaline, so the aforementioned measuring range is ideal for this application. It is also advantageous if the sensor unit 4 itself has a temperature sensor (not shown in detail) for determining the medium temperature. If this lies outside a predetermined measuring range, in particular between 33 and 37.5 °C, e.g. due to ice, tea or the like, an error message can be output for the measurement indicating that the temperature in the throat is outside a predetermined specification range, or it can be an indication of a physiological change, e.g. pregnancy, illness or reaction, e.g. immune reaction, due to an elevated temperature or fever above 38.5 °C.Temperature measurement over days can also be beneficial for monitoring health status, including a personalized profile and / or determining the fertility cycle, e.g. for contraception or fertility testing.

[0090] The maximum extension of the aforementioned sensor unit in one spatial direction can preferably be between 4 and 8 mm. Preferably, the sensor unit can have a spatial dimension of less than 150 mm 2 , particularly preferably between 50 and 120 mm 2 .

[0091] The thickness of the sensor unit can be less than 4 mm, preferably 2 mm or less. Particularly preferably, the respective sensors can be arranged, in particular printed, on a film as a substrate.

[0092] The sensor unit, as a film, can preferably be replaced after a maximum of 15 uses, preferably a maximum of 10 uses.

[0093] The individual sensors of a sensor unit can be round, whereby at least one or some of the sensors can have a diameter between 1-3 mm.

[0094] A control and / or evaluation unit (not shown) integrated into the toothbrush (in the brush head or brush handle) can be equipped to acquire data, particularly raw data, during the measurement of saliva by the sensor unit 4, 5, 8 at a sampling interval of at least 3 to 500 seconds. However, a measurement duration of less than 20 seconds is advantageous, for example, 5 seconds.

[0095] Furthermore, the sensor arrangement 3 comprises a second sensor unit 5, preferably a thin-layer or thin-film sensor unit, for determining a voltage or a voltage-equivalent measured variable. The second thin-film sensor unit comprises an electrode pair consisting of two electrodes 6 and 7 for determining said measured variable, such as the conductivity of the measuring medium, the impedance of the measuring medium, the current intensity or the voltage, or a respective drop between the electrodes. Impedance measurement at one or more frequencies is particularly preferred, for example frequency ranges from 0.1 to 100, from 100 to 5000 Hz, and from 1 kHz to 10 kHz, possibly even higher.

[0096] Instead of the two electrodes 6 and 7, a potentiostat or a three-electrode arrangement can also be provided as the sensor unit 5. An impedance measurement can be used, for example, to measure biomarkers such as TNF-α or other biomarkers.

[0097] This second sensor unit 5 is also spaced at a short distance of less than 1 cm, preferably less than 5 mm, particularly preferably less than 3 mm, from the first sensor unit 4. Since the composition of the medium in the oral cavity can change, this short distance is preferred, so that the sensor units essentially analyze saliva of the same composition.

[0098] The sensor assembly 3 also has a third sensor unit 8. The third sensor unit 8 comprises a measuring cell and a reference cell for determining the concentration of a chemical compound in saliva. The chemical compound that can be determined can be, for example, the lactate or glucose content. The measuring range of a glucose sensor is between 0.1 and 1 mM. The measuring range of a lactate sensor is between 0.025 and 0.5 mM.

[0099] Further variants of sensors for the third sensor unit 8 include enzyme sensors, peptide sensors, protein sensors or sensors for detecting cells.

[0100] A third sensor unit can be configured as a GABA sensor (gamma-aminobutyrate acid), an IgA (immunoglobulin A), IgG, IgM, CRP, and / or a lysozyme sensor. This third sensor unit detects the concentration of at least one chemical compound, thereby enabling the presence of other diseases that would otherwise interfere with the measurement of the first and second sensor units to be detected. A typical sensor for detecting the aforementioned variables is, for example, an electrochemical sensor, an optical sensor, or one or more suitable coated biosensors.

[0101] The brush head also allows for the determination of the presence and concentration of anaerobic and / or aerobic bacteria or individual classes of the aforementioned bacteria, e.g., by measuring the concentration of their degradation products and / or metabolites, and allows for an assessment of the state of the immune system. By appropriately combining the above-mentioned sensors and detecting or failing to detect bacterial metabolites, a viral infection can be determined. This is especially true when infection values ​​or infection criteria are met and detected, but bacterial metabolites are not detected.

[0102] In the preferred version of the Fig. 1 the brush head 1 has a mechanical interface 9 for detachable connection to a handle 101, in particular a drive device of an electric toothbrush 1.

[0103] Fig. 2shows a preferred variant of a replacement station 10 for replacing the sensor arrangement 3 on the back of the brush head 1. However, other variants of replacement stations 10 are also possible within the scope of the present invention.

[0104] The exchange station 10 comprises an exchange chamber 11, into which the brush head 1 can be inserted. In this exchange chamber, the used sensor arrangement 3' is separated and provided with a new sensor arrangement 3'. This new sensor arrangement can be separated as a discrete section of a storage arrangement 13, e.g. a film roll or a magazine, by a separating device 12. Subsequently, the brush head 1 can be loaded. In the case of Fig. 1The separating device 12 is advantageously also the assembly device in a compact design. However, it is also possible for both of the aforementioned devices to be arranged separately. The assembly device can remove the used sensor arrangement 3' in a first step, e.g., by suction or magnetic detachment or the like, and can assemble the new sensor arrangement 3 in a second step.

[0105] A reservoir 17 for storing the used sensor arrangements 3 is provided below the exchange chamber. As an alternative to the film roll, a magazine with several chips can also be arranged in the exchange station 10, whereby the chips do not necessarily have to be flexible.

[0106] The exchange station 10 can also have an integrated charging station 14 in which the handle of the electric toothbrush can be charged, in particular inductively.

[0107] In an optional readout and / or evaluation unit 15, the sensor data from the used sensor assembly 3 can be read out and, if necessary, evaluated. The sensor assembly can be read out to store the sensor data. The read-out sensor data can then be transferred to an external data processing unit, e.g., a dentist's database or a computer.

[0108] For this purpose, the exchange station 10 has at least one transmitter module 16, in particular a transmitter and receiver module, for wireless connection to the data processing unit. If the transmitter module 16 is designed as a transmitter and receiver module or if a receiver module is provided in addition to the transmitter module 16, a software update of the evaluation unit 15 can also be performed. Suitable technologies for data transmission include, for example, 5G, LoRA, BT, NFC, via a hub or a mobile device, or directly via a base station (LoRA, or 5G or 4G / cat-M, LTE Cat M1).

[0109] It is of course also possible that the data determined by the sensor arrangement 3 are not only transmitted in the exchange station 10, but that data transmission already takes place through the toothbrush 100.

[0110] The exchange chamber 11 can be flooded with a cleaning medium and / or water for cleaning the brush head. If the exchange chamber 11 is also used as a measuring chamber, it can be flushed to ensure the most consistent measuring conditions possible. Reagents can also be added to the measuring chamber.

[0111] If the toothbrush 100 has a supply of a toothbrush or mouthwash medium, the exchange station 10 can have a storage space for said toothbrush or mouthwash medium and can supply this to the toothbrush 100, for example via the charging station 14 for filling the toothbrush 100.

[0112] Alternatively, the toothpaste can be applied directly to the bristles of the toothbrush via the exchange station.

[0113] Furthermore, the exchange chamber 11 or a chamber fluidically connected to the exchange chamber 11 can have a sensor arrangement, e.g., for optical measurement. An extraction device can optionally be provided for transferring the fluid into the additional chamber.

[0114] The saliva adhering to the brush head 2 can be diluted and / or limited to a predefined volume, e.g., the chamber volume, and then measured optically, electrochemically, or physically. For this purpose, a supply line for delivery substances, e.g., functional molecules, binding substances, e.g., binding ligands, and / or indicator compounds, e.g., luminophores, in particular fluorophores, can be provided, a light source for emitting light to excite the indicator compound with at least one wavelength, and a receiving unit for measuring the received light. Accordingly, fluorescence spectroscopic analysis, UV-Vis spectroscopic analysis, and other optical analysis methods using optical sensors can be applied.

[0115] It may happen that the toothbrush or cleaning agent interferes with individual measurements. Therefore, it is advisable to perform a reference measurement without saliva from time to time. This allows the evaluation unit to quantify the amount of toothbrush or cleaning agent used in the saliva when measuring a saliva sample after toothbrushing and to compensate for the resulting interference in the measurement signal. This can be done alternatively or additionally using a model based on stored parameters, using non-parametric model-based methods, or by population counting, e.g., of bacteria.

[0116] Alternatively, this reference measurement can also be omitted, e.g. if the respective analysis method is insensitive to interference or if the same toothbrushing or cleaning medium is always used, for which the manufacturer has already stored a data set in the data memory of the evaluation unit for the purpose of measuring value compensation.

[0117] The assessment of general health, and specifically oral health within the oral cavity, can be performed individually for each user or by estimating it based on an average value. In the former case, the health status must be determined by a physician, and following the examination, a reference measurement must be taken and stored for comparison with the data obtained by the toothbrush.

[0118] In addition to the preferred field of application of early detection of periodontitis (e.g. by measuring IgA), other dental diseases (e.g. by measuring GABA) or caries (e.g. by measuring Lactobacillus), the present invention can also be used for the early detection of individual cancers and / or pregnancy, e.g. by determining the folic acid content.

[0119] Further applications of early detection, which can also be detected within the scope of the present invention, are carcinomas, cardiovascular applications, heart attacks, viral diseases, autoimmune diseases, infectious diseases, gastroesophageal reflux disease, arteriosclerosis, sciatica, breathing difficulties, in particular caused by respiratory diseases, chronic obstructive pulmonary diseases, Alzheimer's disease, multiple sclerosis, general oral health conditions, diabetes, oxygen uptake, cancer, arthritis and / or malnutrition, in particular obesity.

[0120] In addition to early detection, the subject matter of the present application can also be used to monitor nutrition during pregnancy. Due to the additional nutritional needs of the unborn child, pregnant women are regularly tested for levels of iron, folic acid, and the like. The composition of saliva can provide information about whether the daily requirement for individual nutrients has already been met and is being maintained.

[0121] It is also possible to monitor a patient's medication in this way. For example, a saliva sample from the patient before medication can serve as a reference.

[0122] An advantageous application of the brush head includes monitoring the medication intake by the user (patient adherence / patient compliance monitoring), e.g. in diabetes.

[0123] Here, for example, the glucose levels should be within a target range, which in more severe cases can only be achieved by regularly taking insulin or GLP-1 inhibitors or similar oral medications that lower blood sugar levels (GLP inhibitors such as Semaglutide from Novo Nordisk).

[0124] By analyzing time series of biosensor data, one can also detect not only whether, but also when, the patient has taken their medication. If the patient does not take their medication, other values ​​will be measured, either completely or partially outside the desired range. The range or target range can be defined, for example, as a range between 70 and 150 mg / dL, which represents normal glucose levels before and after meals.

[0125] The Fig. 2The station shown is designed as an exchange station. In a variant of the invention not shown, it is also possible to arrange the sensor arrangement of the brush head of the toothbrush in the station, in particular in a measuring chamber of the station. With this concept, however, the saliva must be transferred from the oral cavity into the station. For this purpose, the toothbrush can, for example, have a suction device which removes saliva from the oral cavity in a first operating mode. In an optional second operating mode, the suction device can have a blow-out function in order to release the sucked-in saliva into the measuring chamber and measure it there.

[0126] Furthermore, the brush head or in particular the exchange station can have additional sensors which make it possible to detect individual components of a toothpaste, a mouthwash or other compositions for oral care and to correct the measured values ​​of the saliva based on this detection.

[0127] The exchange station or the other station can also have a dispensing device for a predetermined type and quantity of a composition for oral care, e.g., for application to a toothbrush. This composition can be stored as a data set with regard to the concentration of its components, e.g., in the data memory of an evaluation unit.

[0128] Further versions of a toothbrush can be found in the Figures 3-11 shown.

[0129] The variant of a toothbrush head 20 made of Figs. 3 and 4has a base body 23 from which bristles 24 with an average bristle length l protrude. Bristles 24 of different bristle lengths can be provided, wherein the average bristle length refers to the mean value of all bristles.

[0130] For reasons of better insertion into the mouth, the base body 23 can have a lower height than the bristle length 1b. The bristle length 1b and the height of the base body 23 add up to the total height of the brush head.

[0131] Furthermore, the base body 23 has an insertion slot 21 for receiving a plate-shaped sensor unit. The plate-shaped sensor unit is protected from mechanical damage by the base body 23 on its two main surfaces. For this purpose, the base body 23 has a cover segment 22 on the top, starting from the position of the bristles 24. The sensor unit can be inserted into the insertion slot 21 on an end face 26 of the toothbrush 20, said end face being arranged on a side of the toothbrush opposite a brush neck attachment 25.

[0132] The length l of the insertion slot 21 in the insertion direction R is preferably at least 30%, particularly preferably at least 50%, of the length of the brush head in the insertion direction.

[0133] The height h of the insertion slot 21 is preferably between 3 and 30% of the height of the base body 23.

[0134] The variant of a toothbrush 20 from Figs. 3 and 4 has a base body 23 from which bristles 24 with an average bristle length l protrude. Bristles 24 of different bristle lengths can be provided, wherein the average bristle length refers to the mean value of all bristles.

[0135] For reasons of better insertion into the mouth, the base body 23 can have a lower height than the bristle length 1b. The bristle length 1b and the height of the base body 23 add up to the total height of the brush head.

[0136] Furthermore, the base body 23 has an insertion slot 21 for receiving a sensor arrangement in the form of a plate-shaped, replaceable sensor unit. The plate-shaped sensor unit is protected from mechanical damage by the base body 23 on its two main surfaces. For this purpose, the base body 23 has a cover segment 22 on its upper side, starting from the position of the bristles 24. The sensor unit can be inserted into the insertion slot 21 on an end face 26 of the toothbrush 20, said end face being arranged on a side of the toothbrush opposite a brush neck attachment 25.

[0137] The length l of the insertion slot 21 in the insertion direction R is preferably at least 30%, particularly preferably at least 50%, of the length of the brush head in the insertion direction.

[0138] The height h of the insertion slot 21 is preferably between 3 and 30% of the height of the base body 23.

[0139] In a further variant of the present invention in Figs. 5 and 6 A brush head 30 also has a base body 31 and protruding bristles 32. The rear surface of the brush head opposite the bristles has a contact surface 33 and sensor receptacles 34, 35, and 36 embedded therein. These receptacles allow the saliva to penetrate and position itself during the measurement - which is advantageous when the saliva contact is too brief. The saliva can enter the receptacles and there make contact with the specific sensors and be held. For additional improved support of the sensor unit, a partially or completely circumferential edge 37 can be arranged laterally of the contact surface 33 and protruding from it, so that the sensor unit does not protrude from the toothbrush and allows the sensor unit to be guided and secured during insertion. This spoon variant is available in Figs. 7 and 8 shown.

[0140] Fig. 9-11 has a further variant of a toothbrush head 40, which in analogy to Figs. 3 and 4 a base body 41, an insertion slot 43 for inserting a sensor unit 42, and a cover segment 47. In contrast to the variant of the Figs. 3 and 4 The cover segment 47 has openings 45 for storing saliva. The saliva can pass through the openings 45 and be directed to the respective sensor elements of the sensor unit 43.

[0141] The cover can be removable or rotated away to allow cleaning and drying of the biosensor surface with water and under air.

[0142] Other components and features of the toothbrush head shown in the figures are functionally analogous to the Figs. 3 and 4 to understand.

[0143] While the sensor unit in Fig. 3-11 is flat, shows Fig. 12A variant of a brush head 50 with a sensor unit 51 as a lateral attachment to the base body of a brush head. The sensor unit 51 can be part of a larger sensor arrangement, whereby only the sensor unit 51 is replaceable and the other sensors of the sensor arrangement can be arranged non-replaceably in the brush head. Such non-replaceable sensors can be, for example, a temperature sensor or a conductivity sensor, impedance sensors, potentiometric sensors, etc. The replaceable sensors 55 are embedded in the body of the sensor unit 51, which has a stop surface 56 on the edge of the sensor array 53 for adaptation to the base body. This variant also features a recess 54 for better collection of saliva, as well as an edge-side projection 52 for the same purpose.

[0144] Alternatively, it is also possible to insert a plate-like or foil-like replaceable insert as a sensor unit into the recess 54.

[0145] The features of individual design variants can be advantageously combined with one another. The arrangement of the sensor unit on a plane that is recessed relative to the edge area to collect saliva is particularly preferred (see Fig. Fig. 8 ).

[0146] The sensor unit is particularly preferably designed as a film and can also preferably be wetted with saliva from one or more sides, preferably completely or at least over the contact area of ​​all sensors.

[0147] The sensor unit can be placed or inserted from the side or from above.

[0148] The electrical contacts between the brush head and the sensor unit are preferably located in a part of a support surface for the sensor unit that is closest to the brush handle.

[0149] Drilling is not necessary, but may be provided to collect saliva.

[0150] Another aspect is the realization that the influence of toothpaste, toothpaste foam, or even mouthwash significantly interferes with the measurement process. Therefore, the measurement should ideally be taken before the actual brushing process. To avoid excessive interference with daily routines, brushing can begin early and the toothpaste applied after the measurement time, e.g., 5 seconds.

[0151] Alternatively or additionally, a measurement can also be taken after brushing teeth and rinsing the mouth with a calibration rinse.

[0152] A method for operating an analysis system comprising the toothbrush and an external device for data processing. The device can be, for example, a server, a computer, a mobile phone, a tablet, and / or the aforementioned exchange station.

[0153] Raw signals, e.g. impedance measurements, voltage equivalent signals or the like, are transmitted from the toothbrush to the external device.

[0154] The external device has a data memory on which a computer program product for data analysis is stored, wherein the computer program product is designed for data analysis of the data determined by the sensor unit, preferably according to one or more DSP methods, in order to determine a state of health.

[0155] The said data analysis comprises, according to the method, at least the following steps: a) Sampling of electrochemical signals and / or impedances b) Detection and / or classification of states of the sensor element with regard to the humidification state of a sensor element or individual sensors of the humidification element based on the determined electrochemical signals and / or impedances c) Evaluation of amplitudes and changes in the electrochemical signals and / or impedances in order to analyze the saliva with regard to the patient's state of health.

[0156] The humidification status can indicate complete or partial (insufficient) humidification. However, other conditions, such as the presence of toothpaste and the concentration of saliva in water, can also be indicated. This makes it possible to determine the concentration of saliva and compensate for interfering factors such as toothpaste when measuring and evaluating health status.

[0157] One possibility for detecting the aforementioned conditions is the detection of signal changes, time constants of exponential factors and / or signal variance calculation (ripple monitoring).

[0158] When evaluating amplitudes in step c), it is advantageous to decompose the raw signals or electrochemical signals to analyze the useful component of the respective signal and / or to compensate for interference components.

[0159] The decomposition can be carried out using exponential models, which can be designed, for example, as exponential decays or exponential processes or as first order exponential step responses, in particular of the 1-exp(-t) type.

[0160] Another form of decomposition can be achieved by classifying signals and signal changes based on temporal patterns (signal processing in the time domain) or features in the frequency domain.

[0161] Furthermore, a decomposition is carried out by classifying signals based on the course of derivatives of signals and / or as a rate of change and / or as one or more approximate derivatives.

[0162] After decomposing signals into different components (signal decomposition), deriving signal features / characteristics based on this decomposition can then be used to improve estimates of concentrations and / or to derive more precise calibration curves.

[0163] The separation of various interfering components from the useful component of the electrochemical signal or impedance, i.e., the reaction component of the corresponding electrochemical reaction, can alternatively or advantageously be achieved using the Cottrel equation or other similar models of a physical and / or mathematical nature. The useful signal is then of interest for determining the concentration of indicators, particularly biomarkers, which, individually or possibly together with other measured values, can provide information about the health status of the toothbrush user. The biomarkers can be detected by specific biosensors.

[0164] The method may also include sampling electrochemical signals after conditioning and / or stabilizing the sensor unit in a provided reference solution. This sampling can preferably be performed after step c), e.g., upon initial use of the toothbrush, or before step a).

[0165] The sampling of signals after conditioning and / or stabilization can advantageously be initiated or detected in combination by a trigger or sensor, preferably a conductivity or impedance sensor, which detects the presence of the reference solution and / or saliva and / or indicates the end of a conditioning period. The trigger can preferably perform the measurement based on the detected state or state transition.

[0166] Furthermore, in particular following step c), one or more repetitions of measurements may be carried out in order to combine the information from several measurements, preferably in order to improve the precision, to improve the signal-to-noise (S / N signal-to-noise) ratio towards the signal and / or to compensate for interference.

[0167] The sampling of electrochemical signals, especially amperometric signals at different potentials, can take several seconds or minutes.

[0168] The detection and classification of "dry" vs. "ventilated after humidification" vs. "fully humidified" states and the corresponding transitions can be performed as described above.

[0169] This detection advantageously enables an assessment of the reliability of the measurements carried out by the biosensor and the other sensors and the resulting health status.

[0170] The evaluation of the decay of electrochemical signals or impedances allows conclusions to be drawn about redox reactions and capacitive transients within the oral cavity.

[0171] The toothbrush, in particular the sensor arrangement, can, as described above, have a temperature sensor. The temperature measurement can be averaged over several days to obtain a reference body temperature. Furthermore, a sudden increase in temperature, e.g., in the case of fever, can be detected, as can a gradually increasing and / or periodically recurring temperature increase. This can be advantageous, for example, for determining the fertility cycle, e.g., as part of health monitoring or in addition to it.

[0172] Optionally or additionally, the toothbrush may have a dosing device for dispensing substances for the treatment of diseases, particularly in the oral cavity, and / or for stimulating the immune system.

[0173] These can be specifically prescribed by a doctor, with the toothbrush serving as a dosing device. Particularly in the case of diseases in the oral area, such as gingivitis, the toothbrush can be used to apply a corresponding medication precisely and, combined with a mechanically assisted massage during dosing, through the bristles, e.g. on the gums. The dosage or the amount of medication delivered can be adjusted by the doctor or the patient using the toothbrush. In the case of the doctor, this can have special access authorization for corresponding sub-programs, e.g. via a Bluetooth transponder or a code or the like, which prevents access to doctor-specific sub-programs of the toothbrush. Alternatively or additionally, a program or program setting for the dosage can be stored remotely or via a data storage device, e.g.USB stick, to the toothbrush or the exchange station.

[0174] Optionally, a reference fluid can be used to condition the sensors. Water, for example, with a defined ion content, can be used for this purpose. This reference fluid, also called conditioning fluid, resets the sensors in the sensor array to an initial value.

[0175] In addition, one or more calibration fluids can be used with one or more conductivities defined differently than the reference fluid. This allows the measurement accuracy to be checked and, if necessary, readjusted after a certain period of time using the calibration fluid(s).

[0176] The reference liquid and at least one calibration liquid can be part of the analysis system.

[0177] The sensor array and the brush head can be designed as replaceable and disposable items. The sensor array advantageously allows for both the detection and monitoring of a health condition. In selected cases of a disease, the type of disease and / or its severity or intensity can also be determined.

[0178] Multidimensional biomarkers can be used. Ideally, toothbrush handling should be such that its signals are collected and / or recorded at least once daily. The data can then be stored over several days, weeks, or months, etc., to identify long-term trends. List of reference symbols

[0179] 1Brush head 2Bristles 3Sensor assembly 3Used sensor assembly 4Second sensor unit 5First sensor unit 6Electrode 7Electrode 8Third sensor unit 9Mechanical interface 10Exchange station 11Exchange chamber 12Separation device 13Foil roll 14Charging station 15Read-out and / or evaluation unit 16Transmitter module 17Reservoir 20Toothbrush head 21Insertion slot 22Cover segment 23Main body 24Bristles 25Brush neck attachment 26End face 30Brush head 31Main body 32Bristles 33Contact surface 34Sensor receptacle 35Sensor receptacle 36Sensor receptacle 37Rim 40Toothbrush head 41Main body 42Sensor unit 43Insertion slot 45Openings 47Cover segment 50Brush head 51Sensor unit 52Protrusion 53Sensor array 54Recess 55Sensors lb Bristle length lLength of insertion slot hHeight of insertion slot RInsertion direction 100Toothbrush 101Handle

Claims

1. Analysis system, comprising a toothbrush (100) with a brush head (1, 20, 30, 40, 50), having at least one mechanical cleaning agent for cleaning the teeth and a plurality of sensor units (4, 5, 8, 42, 51) for monitoring the state of health of a user, wherein the brush head (1, 20, 30, 40, 50) has a first sensor unit (5) for performing an impedance measurement of the saliva with one or more frequencies and / or frequency bands, wherein the brush head (1, 20, 30, 40, 50) has at least one second sensor unit (4) for determining the pH value and / or the temperature of saliva, and wherein the brush head (1) has a third sensor unit (8), wherein the third sensor unit (8) is designed as a biosensor and wherein the third sensor unit (8) is arranged in an exchangeable manner on or in the brush head (1, 20, 30, 40, 50) and has an external device for data processing, wherein the toothbrush comprises a radio module for data transmission to the external device for data processing to determine a state of health, so that raw signals can be transmitted from the toothbrush to the external device, and wherein the external device comprises a data memory on which a computer program product for data analysis is stored, wherein the computer program product is designed for analyzing the data determined by the sensor unit designed as a biosensor, preferably according to one or more DSP methods, for determining a state of health, wherein the data analysis comprises the following steps: a. sampling impedances over a measurement period at a predetermined sampling rate; b. detecting and classifying states of the sensor units (4, 5, 8, 42, 51) with regard to the moisture state of the sensor units (4, 5, 8, 42, 51) on the basis of the impedances determined; and c. evaluating amplitudes and / or changes in the impedances, and in particular the associated redox reactions and / or capacitive transients, in order to analyze the saliva with regard to the state of health of the user, wherein, on the basis of the impedances determined, the presence of toothpaste and the concentration of saliva in water are detected in addition to the humidification state.

2. Analysis system according to claim 1, characterized in that the brush head, in particular the third sensor unit (4, 5, 8, 42, 51), has a reservoir and / or a supply line for dispensing additive substances, e.g. functional molecules, binding agents, e.g. binding ligands, and / or indicator compounds, e.g. luminophores and / or biomarkers, in particular fluorophores.

3. Analysis system according to one of the preceding claims, characterized in that the first sensor unit (5) is designed to determine a voltage-equivalent measured value of the saliva in the form of a resistance value of the saliva or a conductivity value of the saliva.

4. Analysis system according to one of the preceding claims, characterized in that the biosensor is designed as a lactate sensor, glucose sensor, IgA sensor, IgM sensor, IgG sensor, CRP sensor, IL-6 sensor, lysozyme sensor, TNF-a sensor, alpha-macroglobulin sensor and / or as a sensor for detecting metabolites, in particular bacteria causing periodontitis and / or caries, preferably from Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and / or Aggregatibacter actinomycetemcomitans associated with aggressive periodontitis, and / or as a GABA sensor for determining a concentration of the aforementioned compounds.

5. Analysis system according to one of the preceding claims, characterized in that the toothbrush (100) has a handle (101) and the brush head (1, 20, 30, 40, 50), as well as a mechanical interface (9) for detachably connecting the brush head (1, 20, 30, 40, 50) to the handle (101).

6. Analysis system according to one of the preceding claims, characterized in that the toothbrush (100) has a control and / or evaluation unit, which is equipped to record data, in particular raw data, during the measurement of saliva by the sensor unit (4, 5, 8, 42, 51) at a sampling rate of 10-1000 Hz.

7. Analysis system according to claim 6, characterized in that the control and / or evaluation unit is equipped to record data, in particular raw data, during the measurement of saliva by the sensor unit (4, 5, 8, 42, 51) in a measurement period of at least 3 to 500 seconds.