DE102017010119A1 - Body fluid analyzer, analysis kit, method of analyzing body fluids using the analyzer, and methods of analyzing body fluids using the kit of analysis - Google Patents

Abstract

The present invention provides a body fluid analysis apparatus, an analysis kit, a body fluid analysis method using the analysis apparatus, and a body fluid analysis method using the analysis kit. The body fluid analyzer (1) comprises a container (2) adapted to receive body fluids and an analyzer (6), the container (2) having a passage (3) communicating with the analyzer (6). is connected, and by a closure device (9) is closed fluid-tight. According to the invention, the container (2) has an adapter (4) which is arranged in the passage opening (3) and which has at least one first attachment means (7). The analysis device (6) also has at least one section with at least one fastening means (8) which can be detachably connected to the first fastening means (7) of the adapter, wherein the closure device is arranged on or in the adapter (4).

Description

The invention relates to a body fluid analyzer, a kit of analysis, a method of analyzing body fluids using the analyzer, and a method of analyzing body fluids using the kit of analysis.

Sanitary facilities are known from the prior art, which have analysis devices to analyze urine can. This avoids that patients as usual practice a cup for urine intake or medical professionals need to handle the urine for analysis, where both groups may have skin contact with the urine or the cup may be contaminated, only to provide examples of sources of error in the analysis call.

The DE 10 2014 115 914 A1 describes a device for analyzing urine. There is a toilet bowl comprising a portion having an opening for collecting urine, via which a predetermined amount of urine is supplied to an analysis device outside the toilet bowl by means of a valve. After analysis by means of test strips, the residual urine is disposed of by a drainage device via the drain of the toilet bowl. After wetting, the test strip is evaluated optically and the data recorded is stored and made available for further evaluation.

DE 10 2010 061 035 B4 discloses a toilet with integrated measuring device for acquiring physiological data of a toilet user. In the toilet bowl a collecting device for the urine is hung, which is coupled to a Urinentnahleitung. This line leads between the upper edge of the toilet bowl and the underside of a toilet lid through to an analysis unit. The urine is analyzed there and returned in a parallel way back to the toilet bowl.

From the EP 0 278 631 A1 a toilet is shown, which has an opening in her toilet bowl, with the help of which urine can be collected. In the opening a valve for removal is arranged, which has a vertically movable, circular valve head, which is controlled by a control unit. Urine can be removed and sent to an analysis unit.

The DE 695 20 850 T2 describes a measuring device for analyzing urine, wherein a urine collecting part is disposed in a commode chair. This collecting part comprises a cover which covers an opening in the commode, whereby the cover can be opened electronically. The orifice is connected to a collection tube, which via a valve leads to a device for optically examining the urine sample taken.

In the US 5,073,500 A1 a toilet bowl is shown having in a front portion a bulge in which urine can be collected. Centrally in this bulge a narrow opening for discharging the urine is provided, wherein a valve is arranged in the discharge line. Downstream of the valve is an analysis device that can be supplied to the urine to make an optical analysis of the urine.

From the EP 0 292 311 Furthermore, a toilet with integrated urine analysis unit is known, in whose front wall area of the toilet bowl a collecting device is integrated. The collecting device is a tube with integrated metering valve and is screwed by a thread in the wall. A similar solution is in the EP 0 346 083 B1 disclosed.

Furthermore, from the EP 1 792 573 A1 a WC system for the evaluation of excrements known, wherein in a toilet bowl at a suitable position, a number of urine collection containers are arranged. Below these receptacles are openings in the wall of the toilet bowl, so that urine can be passed through these openings and via hoses to a measuring station in which the urine can be analyzed. Messrückstände are directed into the toilet drain.

The known from the prior art analysis devices are therefore complex and difficult to keep hygienic. Because the urine collection devices or urine supply lines to the respective analysis devices are firmly connected to the pelvis of the respective sanitary device, there are dead spaces in which urine may accumulate, which among other things may also influence subsequent analyzes. Based on this prior art, it is an object of the present invention to provide an improved analysis device that provides a correct and hygienic analysis of body fluids.

This object is achieved by a body fluid analysis device having the features of claim 1.

The further object of the improved analysis of body fluids is further solved by the analysis set having the features of claim 15.

The still further object of providing an optimized analytical method is provided by the method of analyzing body fluids using a method according to the invention Analysis device with the features of independent claim 19 solved.

Yet another object to provide a further improved analysis method is achieved by the method of analyzing body fluids using an analysis set according to the invention having the features of independent claim 20.

Further developments of the analysis device, the analysis set and the two analysis methods are set forth in the subclaims.

A first embodiment of the analyzer relates to a body fluid analyzer having an analyzer and a container adapted to receive body fluids. In this case, the container has a passage opening which is connected to the analysis device, and which can be closed fluid-tight by a closure device. According to the invention, the container has an adapter which is arranged in the passage opening and which has at least one first attachment means. The analysis device comprises at least one section with at least one second attachment means, which can be releasably connected to the first attachment means of the adapter. In this case, the closure device is arranged on or in the adapter.

The analysis device has a modular design, since the adapter can be used to connect various analysis devices in a modular manner; and it is simple in construction and has no or almost no dead spaces in which body fluids can collect undesirably, hence easy to clean and easy to keep hygienically clean.

Body fluids in the sense of the invention may be excrements, ie any excretion from the urinary tract (urine) and defecation from the gastrointestinal tract (stool). Further, stool in suspension, blood, sweat, vaginal secretions and saliva, etc. come into consideration. These are preferably human body fluids, but the use of the analysis device according to the invention for the examination of animal excreta is not excluded.

According to a further embodiment of the analysis device according to the invention, the closure device may be a cover made of transparent material. Preferably, glass, acrylic glass or another transparent, suitable plastic can be used. The body fluid can collect on the lid and then be examined from below by means of the analyzer. The analysis is clean and easy to perform. It may be provided that one edge boundary of the lid is slightly lowered, so that the lid is arranged just below the adapter flange, where "just" means a range of 0.1 to 2, preferably 0.5 to 1 mm. Thus, a sample receiving space can be formed which is easy to clean by operating the flush of the sanitary device and flushing collected body fluids away.

According to the invention, it is proposed to use a sanitary device from the group comprising urinals and toilets, preferably WCs, and bidets, which already have such a container to be used according to the invention, for example the toilet bowl. The sanitary device may further be any container or receptacle for receiving excrement. So seat or Hock toilets with and without flushing, vacuum disposal or chemical or biological wastewater disposal are possible. It may also be bidets, combinations of bidet and toilet or specially designed for excrement analysis containers or alternative containers.

In order to obtain the possibility of directly applying body fluid to the analysis device to be mounted under the closure device or of cleaning the closure device, the closure device or the cover may have opening and closing actuating means.

The invention may provide in a development that the opening and closing of the arranged on or in the adapter closure device can be controlled by a control unit. For this purpose, the control unit is operatively coupled to the closure device. The control unit may be part of the analysis device or be present separately, for example, be associated with the closure device and may have communication devices, such as a communication interface to a data processing unit.

In one embodiment of the analysis device, the adapter may be hollow cylindrical.

Furthermore, the adapter may have on its outer shell a sealing surface with a seal for sealing against the passage opening in the basin. In this case, a separate seal may be necessary. Preferably, a negatively mirrored sealing region can be provided, ie the seal abuts the part which is inserted into the passage opening. The type of seal that is to be applied between the sealing surface and the passage opening can be an annular seal or an adhesive bond or even a metal seal. Preferably, the adapter is an easy to edit Material chosen as an elastic plastic. Thus, the adapter may also consist of rubber or have this.

In order to fix the adapter in the passage opening, it has a flange on its front side facing the basin and has latching elements on its lateral surface. This allows the adapter to be installed firmly in the opening.

In order to be able to bring the analysis device into engagement with the adapter, it has a fastening section with which the analysis device is detachably connected. The used attachment between the two components is variable; the attachment portion may comprise a bayonet closure element, a snap closure element or a screw closure element, such as a thread. Other types of attachment are also possible.

The hollow cylindrical adapter forms in a preferred embodiment, a receiving space, which is also cylindrical, but in general can also have a different base. The receiving space in the adapter allows the analyzer to be fully or partially received. If the analysis device is transported or otherwise not used, a blind plug can be inserted into the receiving space of the adapter and closes the receiving space as a closure device in a fluid-tight manner.

A development of the analysis device can provide that the adapter has in its wall at least one receiving portion for receiving supply and discharge lines for body fluids, sensors or electrical lines. The adapter may also include means for liquid level measurement. For this purpose, there is a supply line in the wall of the adapter, which provides a fluidic connection to an electrical level sensor. This can be detected when body fluid penetrates into the receiving space of the adapter.

The adapter may include tempering elements such as a heating coil, and temperature sensors, in particular to achieve in the analysis of excrement, a heating of the respective sample.

In another embodiment, the analysis device can have a control unit with which it is operatively wired or wirelessly connected for control purposes. This can be done from the outside via suitable controls of the control unit - such as via touch screen or buttons. In a further variant, the control unit can also be connected to sensors. This is z. B. detected when the sanitary unit is used and then can automatically start an analysis by the analyzer. Furthermore, the control unit can also be operated by means of a mobile data processing unit, such. A mobile terminal such as a smartphone, tablet or other types of hand-held computers.

So that the analysis device can process the data recorded or evaluated by the analysis device, it can have a data processing unit. Alternatively, it may be operatively connected to a data processing unit, and for this purpose have the required communication facilities and interfaces. The analysis device preferably has a data processing interface for the wired or wireless connection of the data processing unit. The required components of the electronics can communicate with each other wired or wireless. For this purpose, the individual components provide for certain communication devices, such. B. near-field radio (including Bluetooth®, RFID), WLAN, etc. There are also wired interfaces possible, such as USB etc.

The analysis device may directly display a display unit for outputting the analysis result of the analysis device. Thus, when the data processing is completed in the analyzer, the dispensing can be done on a display, for example on the toilet lid, cistern or other suitable location in the sanitary facility's room or wall, such as the doctor's room a practice is attached. Alternatively, an external display unit may be wirelessly or wired connected to the analyzer. For this purpose, in turn, a mobile terminal, as described, suitable, and can take over the data processing of the acquired data and control of the entire analysis device in addition to the display. Preferably, a program, software or application (smartphone app) is provided which is specifically tailored to the analysis device used.

The invention may provide in a development that the analysis device has one or more attachment portion (s), which correspond to the attachment portion of the adapter. The analysis device may be dimensioned such that it can be partially or completely received in the receiving space of the adapter. For this purpose, the dimensions of the adapter, the analyzer and their attachment sections are matched.

The analysis device comprises measuring devices, such as a colorimeter, a spectrometer, or a spectroscope, and provides analysis means for the analysis of body fluids, which are selected from the group, in particular colorimetric, spectroscopic and chromatographic analysis methods and / or combinations thereof. So already known Anayseverfahren for testing for pregnancy, hormones, enzymes, tumor markers, inflammatory markers, etc. are performed. In addition to color changes on a colorimetric basis, it is also possible to test optically detectable parameters of the analytes which are based on reflection / transmission effects and the associated coefficients of the respective liquid. Optically detectable parameters may be, for example, values and concentrations of certain analytes, such as blood, erythrocytes, hemoglobin, glucose, ketone bodies, ascorbic acid, protein, leucocytes, nitrite, pH, bilirubin and urobilinogen. Furthermore, other analytes not listed here can be tested, especially with regard to clinical pictures or body conditions whose determination by urine samples is under development or is still being developed; in particular, improved pregnancy tests, cancer markers, diabetes markers etc. may be mentioned.

In one embodiment of the analysis device, the analysis device can be an opto-electronic detection device and can have a cover made of transparent material as the closure device. The lid is arranged in a range of 0.1 to 2 mm, preferably in a range of 0.5 to 1 mm, below the surface of the adapter flange, that a sample receiving space for a certain amount of excrement is formed, wherein the analysis device below the lid has at least one optical sensor for detecting an optically detectable parameter of the excrement.

Analytical devices for carrying out optical measurement methods, optoelectronic methods, for example spectroscopy, colorimetry, fluorimetry or phosphorescence analyzes, ultrasound or also magnetic measuring methods can be used. For this purpose, test strips, reagent carriers or even a so-called Lab-ona chip can be placed on the lid, wetted with excrements and analyzed by means of the analysis device.

Alternatively it can be provided that the analysis device is a spectrometer and also has a lid made of transparent material for insertion into the adapter. The lid closes with the surface of the container as far as possible and has a holding portion facing the interior of the container. At this holding section, a reagent carrier can be positioned so that it can be wetted with body fluid and changes in one or more test fields (in the sense that the contained reagent has reacted) can be optically detected by the analysis device. The spectrometer can have a monochromatic light source with output and input optics and, for example, be equipped with an infrared light source or a laser.

Possible reagent carriers which can be used with this variant are any types of reagent carriers or even test strips whose test fields undergo a visually detectable color change when they are wetted with excrement. The form of the reagent carrier is suitable if existing test fields or a test area does not exceed the area of the lid.

Accordingly, the analysis device is modularly or variably usable-depending on the parameters to be analyzed, a different, suitable analysis device can be selected and attached to the adapter, which can then optionally also be set up as interchangeable.

An analytical kit according to the invention may comprise an analyzer according to the invention and a reagent carrier for determining analytes in body fluids which is particularly suitable and has a base plate on which many test fields are equipped with one or more reagents for an analytical reaction with the analyte or analytes , In the center of the base plate, a handle is arranged, which extends out of the plane of the base plate. Through this handle, this reagent carrier is ideal for use with the analysis device, because the reagent can be positioned very well and accurately by the handle and comes the user's hand not at all with the container, such as a toilet bowl in contact.

An "analytical reaction" in the sense of the invention is any chemical reaction which serves to examine a substance sample for an analyte. In addition to color changes on a colorimetric basis, these are also optically detectable parameters of the analytes, which are based on reflection / transmission properties of the respective liquid. Thus, with the reagent carrier different values and concentrations of certain analytes, such as blood, erythrocytes, hemoglobin, glucose, ketone body, ascorbic acid, protein, leukocytes, nitrite, pH, values especially from urine such as albumin, citrulline, neopterin, methylmalonic acid (nitrostress) , 8-epi-prostaglandin, lactate, pyruvate (liver metabolism), amino acids, amylase (pancreas), pyridinoline (bone metabolism), vanillinmandelic acid, pyrroles, minerals such as zinc, heavy metals, bilirubin and urobilinogen from liquid samples. In particular, from stool may also contain analytes such as microbiome, alpha-1-antitrypsin, s-immunoglobulin A and germ counts and saliva DHEA, Progesterone, testosterone, cortisol, melatonin, oestradiol are being tested.

In addition, further, not yet listed analytes can be tested, especially with regard to clinical pictures or body conditions whose determination by urine samples are currently under development or are still being developed; in particular pregnancy tests, hormone tests, cancer and tumor markers, diabetes markers, micro RNA, drug tests, etc. are mentioned. In addition, analytes in other fluid samples, such as water samples can be tested to determine an environmental impact (in particular environmental analysis: aquaristics, swimming pool, building services, garden floors).

Liquid samples are understood to be high fluidity urine samples as well as semi-liquid samples such as low fluidity stool samples. In a preferred embodiment of the invention it is provided that the liquid sample is a urine sample. The main application of the invention is urinalysis. However, the reagent carrier according to the invention can also be used to analyze other fluids, such as blood, stool (in specific consistency), sweat, vaginal secretions or other body fluids.

This reagent carrier (hereinafter referred to as the preferred reagent carrier) which is proposed as being particularly suitable and which can be used with the analysis device according to the invention can have the following configurations:

The test fields can be arranged on the base plate of the reagent carrier along a geometric shape such as a circular path, a rectangle, a square, an oval. As a result, the test fields can be read particularly easily with the naked eye or by means of a suitable reading device or analysis device.

A base plate as a single or multi-layer round disc is proposed as preferred. The base plate may alternatively be rectangular, for example. Square, or triangular. Any geometric shape is conceivable which forms a suitable surface for test fields and the handle. In the case of a circular or circular shape, the test fields arranged on the circular path can be arranged at least along a part of the circumference of the disk, or along the entire circumference of the disk, the arrangement of the test fields being dependent on the test fields to be used.

The test fields can be of any desired shape and can be chosen as large as desired depending on the reagent and application used. Preferably, they are square, but in a further embodiment can also be rectangular or circular, wherein any arbitrary, technically meaningful geometric shape comes into question. For example, test fields for tests that require a predetermined amount of reagent and therefore require more area or volume may be larger than test fields for tests where a small amount of reagent is sufficient.

For most reagents and the carrier substrate per se, it is good if the reagent carrier is stored dry, so as not to be damaged. One of the test fields or a separate field on the base plate may therefore be provided as a moisture indicator to indicate whether the reagent carrier is still functional and can be used as intended with the analyzer. Such moisture indicators can be, for example, infrared sensitive test fields, or simply contain known moisture color indicators.

The base plate of the reagent carrier may have a carrier substrate, wherein preferably the carrier substrate is the uppermost layer having the test fields. It is also possible that the carrier substrate forms only one or more portions of the uppermost layer; it can also be part of the test fields. In this last case, the carrier substrate can rest on the base plate, have the shape of the test field and have as the uppermost layer the reagent of the test field. The test fields can be so well wettable or so moisturized that the reagent is well contacted with urine.

The carrier substrate can be made of the same material as the base plate or also of a material that is more absorbent than the base plate, such as paper, corn paper or fleece.

In the center of the reagent carrier may be present a recess which serves for attachment in the container of the analysis device.

The handle is an integral part of the reagent carrier because it contributes significantly to the hygienic ease of use. It may be formed by a strip having one or more kinks and, for example, having a V or W shape. Alternatively, the strip may have a bend, preferably a U-shape. The strip may have tabs disposed or truncated on both open ends of the V, W or U, the tabs being affixed to opposite locations of the recess, if any; in embodiments without the recess, the attachment of the tabs close to the center at opposite locations.

Alternatively, the handle may have an L-shape, wherein a tab on one side of the recess, if one is present (otherwise close to the center), attached, preferably glued, and the free end of the handle away from the base plate.

To save many reagent carriers space for use with the analyzer, it is proposed that the handle has a shape that allows many reagent carriers to be stacked on top of each other. Also for this purpose, the recess in the base plate is advantageous.

The test fields can be arranged on the same side of the base plate, on which the handle extends, in order to provide an optical inspection on the handle side. Alternatively, they may also be arranged on the side of the base plate which faces away from the handle.

Test fields of the reagent carrier are equipped with reagent (s) which react / react with the analyte in a physical or chemical, in particular colorimetric or chromatographic reaction. It is possible that the test fields all have the same reagent to obtain an accurate and statistically evaluable analysis, and it is also possible that each test field contains a different reagent to test different analytes in the liquid sample containing the reagent carrier wet. Furthermore, in addition to dry reagents bound by the test field, gels or similar substances can also be used for the test fields.

The base plate may have pre-colored reference fields which, for example, are suitably arranged in each case directly adjacent to the respective test field to be referenced. A test field can also be divided into two, one half being a test field with reagent and the other half being the pre-colored reference field. Thus, the reference fields can be accommodated on the base plate to save space.

For easy installation of the reagent carrier to the analysis device can be provided that the base plate has a position mark. Thus, the order of the test fields to be read or the starting point can be determined by means of the analysis device. The cursor may have any suitable shape, it may be a dash, a circle, any geometric shape or even a composite shape. It can be printed on, glued on or punched or cut out as a hole.

To identify the reagent carrier, the base plate can show a barcode of known type for transmitting information via the sampler or the reagent carrier. The bar code is visibly mounted on the top or bottom of the base plate and can be easily scanned by the analyzer of the analysis set. The information is to the reagent carrier itself, tests or durability. Furthermore, information about patients, specific treatments, hospitals, primary care physicians, associated pharmacies, etc. may be stored under an Internet page linked to the barcode or a database entry.

It can also be a freely determinable field provided on the base plate to which a sticker or label attached, preferably can be glued to provide the reagent with other (additional) information (personal information, etc.).

When used with the analyzer, the preferred reagent carrier is placed in a container of a sanitary device (toilet or bidet basin) and rinsed away after use. For this purpose, it is advantageous if the reagent carrier is made of a material that dissolves in the sewer system or finely shreds. Therefore, compositions of sanitary paper, in particular water-soluble paper compositions, or nonwovens or other biodegradable material, preferably corn paper, are suitable. The thickness of the paper may be adapted thereto, and is to be chosen so that the base plate or the handle is stable enough to wear the test fields or to be held by a user.

In a further embodiment of the analysis device, the container may have on its inside one or more fastening device (s) for releasably securing the reagent carrier in the basin. In this case, the fastening device is arranged at a predetermined position of the inside of the pelvis, which can be acted upon in normal use of the pelvis, eg. When urine, with urine. The attachment device may be a nose, a spike, a web, in particular a circular or part-circular web, and may be engaged with the recess or other recess or slot in the base plate of the reagent carrier. The shape and dimension of the nose or spine corresponds to the dimensions of the recess provided in the center of the base plate. The reagent carrier can also be attached to the container or the fastening device of the adapter by means of a suitable coating, an adhesive, a self-dissolving adhesive, a magnet, or a suction cup or other suitable fastening devices.

• - bei Benutzung der Sanitäreinrichtung benetzen Lassen des Deckels mit Körperflüssigkeit und damit Sammeln einer vorbestimmten Menge Körperflüssigkeit für die Analysevorrichtung;
• - Aktivieren der Analysevorrichtung und Analysieren der Körperflüssigkeit;
• - Erfassen der Analysenwerte und Ausgeben der Werte an die Datenverarbeitungseinheit bzw. die Anzeigeeinheit; und
• - nach erfolgter Analyse Wegspülen der Körperflüssigkeit auf dem Deckel.

For the analysis of body fluids, the following procedure can be carried out with the analysis device according to the invention:

• - in use of the sanitary device, allowing the lid to be wetted with body fluid and thereby collecting a predetermined amount of body fluid for the analyzer;
• Activating the analyzer and analyzing the body fluid;
• Detecting the analysis values and outputting the values to the data processing unit or the display unit; and
• - After analysis, rinse away the body fluid on the lid.

This allows a very simple analysis that is hygienic and easy for anyone to do.

• - Einsetzen des Reagenzträgers, dann erfolgt das
• - benetzen Lassen des Deckels mit Körperflüssigkeit und damit Sammeln einer vorbestimmten Menge Körperflüssigkeit für die Analysevorrichtung;
• - das Aktivieren der Analysevorrichtung und Analysieren der Körperflüssigkeit;
• - Erfassen der Analysenwerte und Ausgeben der Werte an die Datenverarbeitungseinheit bzw. der Anzeigeeinheit; und
• - nach erfolgter Analyse von dem Deckel Entfernen des Reagenzträgers samt Körperflüssigkeit.

The invention further comprises a method carried out for the analysis of excreta using the kit according to the invention. It starts with the

• - Inserting the reagent carrier, then that takes place
• - wetting the lid with body fluid and thereby collecting a predetermined amount of body fluid for the analyzer;
• activating the analyzer and analyzing the body fluid;
• Detecting the analysis values and outputting the values to the data processing unit or the display unit; and
• - After analysis of the cover, remove the reagent carrier together with body fluid.

Removing the reagent carrier comprises thereby that the reagent carrier can simply be rinsed away or, for example, can be removed from the container by means of a suitable gripping device for further (external) analysis or disposal. The aforementioned method enables simple and reproducible analysis of bodily fluids or excrements, without the risk that contamination of the analysis fluid paths could lead to a falsification of the measurement result.

Embodiments of the analysis device, as well as some of the advantages associated with these and other embodiments, will become apparent and better understood by the following detailed description with reference to the accompanying figures. Items or parts thereof that are substantially the same or similar may be provided with the same reference numerals. The figures are merely a schematic representation of an embodiment of the invention.

• 1 eine schematische Schnittansicht durch ein Becken einer Sanitäreinrichtung mit eingesetztem Adapter,
• 2 eine Schnittansicht des Adapters,
• 3 eine schematische Ansicht einer Ausführungsform der erfindungsgemäßen Analyseeinrichtung, angebracht im Becken einer Sanitäreinrichtung (Teilschnittansicht),
• 4 eine schematische Ansicht einer Ausführungsform des Analysensets, (Sanitäreinrichtung teilw. im Schnitt gezeigt),
• 5 eine schematische Ansicht eines bevorzugten Reagenzträgers, wie er in dem Analysenset verwendet werden kann,
• 6 eine weitere perspektivische Ansicht des Reagenzträgers, und
• 7 eine alternative Ausführungsform des Reagenzträgers.

Showing:

• 1 a schematic sectional view through a basin of a sanitary device with inserted adapter,
• 2 a sectional view of the adapter,
• 3 a schematic view of an embodiment of the analysis device according to the invention, mounted in the basin of a sanitary device (partial sectional view),
• 4 a schematic view of an embodiment of the analysis set, (sanitary device partially shown in section),
• 5 a schematic view of a preferred reagent carrier, as it can be used in the analysis set,
• 6 another perspective view of the reagent carrier, and
• 7 an alternative embodiment of the reagent carrier.

The device according to the invention relates to an analysis device 1 , the after 1 or 3 a basin 2 a sanitary device has. The basin 2 has a passage opening in a front area 3 into which the adapter 4 is used. The adapter 4 is in a longitudinal section in 2 shown; the hollow cylindrical shape comprises a receiving space 4 ' , Furthermore, the adapter has 4 a sealing surface 5 attached to a lateral surface of the adapter 4 is present. The sealing surface 5 forms an annular recess into which a gasket is inserted around the adapter 4 opposite the passage opening 3 seal. To the adapter 4 in the passage opening 3 To attach, the adapter has a flange 4 ' at his the basin 2 facing end face and has on its lateral surface locking elements 4 '" on. This can be the adapter 4 stuck in the opening 3 be installed.

Furthermore, the adapter has 4 on its end face, which in a mounting arrangement the pelvis 2 facing away, a first fastening means 7 , here screw holes. An analysis device 6 in the recording room 4 ' of the adapter 4 can be used, as is 3 shows, in turn, has fastening means 8th on that to the first fasteners 7 correspond. In the in 2 The illustrated case is the analyzer 6 fastened by screws, to which it has screw holes or -halterungen. The in the 3 shown analysis device 6 is based on optical methods and captures optically detectable parameters in the excrement to be investigated. For this purpose, the analysis device 6 suitable sensors, or electronic components.

So that the analyzer 6 is not polluted with excrement, is her a closure device 9 , a lid 9 , upstream. The lid 9 is made of transparent material, so that the optical components of the analyzer 6 clear view of this on the lid 9 to have lying or accumulating excrement. The lid 9 is arranged so that between flange 4 ' and one the pelvis 2 facing surface of the lid 9 a sample receiving area for excrements or a holding section or fastening device for a reagent carrier 101 is formed (eg for urine test strips). The lid 9 is in a range of 0.1 to 2 mm, preferably 1 mm from the end face of the adapter 4 lowered.

The analyzer 6 has a control unit 11 , a storage unit 16 as well as a communication interface 14 on. The control unit 11 controls the analysis operations in the analyzer 6 in accordance with predetermined parameters and stores acquired data on the storage unit 16 between. In 3 is shown that over the communication interface 14 by means of a wireless connection 15 (For example, WLAN or near-field radio link) data to an external data processing unit 12 can be sent. This data processing unit 12 evaluates the received data and outputs it appropriately on a display unit 13 out with the data processing unit 12 is firmly connected. The data processing unit 12 may be adapted to carry software, by means of which the electronic components of the analysis device 1 can be controlled.

In 4 is an analysis set 100 with analysis device 1 shown. In addition comes the reagent carrier 101 which is in the fastening device 103 of the lid 9 and can be kept there for the duration of use. The reagent carrier 101 has a holding tip 102 on, by means of the reagent carrier 101 in the fastening device 103 can be inserted. The fastening device 103 is through the lid 9 and the flange 4 ' of the adapter 4 formed in which the lid 9 is lowered in about 1 micron from the pelvic surface and from the flange 4 ' an edge is formed.

In 5 is the reagent carrier 101 shown having a circular base plate 104 which has in 5 with a total of ten square test fields 105 is equipped. The test fields 105 are on a circular path along the circumference of the base plate 104 arranged and are arranged along this circular path equidistant to each other. The base plate 104 extends in one plane e whose center Z the center of the base plate 104 forms. Downtown Z has the base plate 104 a recess A which has a substantially circular shape with two laterally attached rectangular pieces.

On the same surface, on which the test fields 105 is a barcode 107 among other things for the identification of the reagent carrier 101 or of the test stored thereon and a position mark 108 for detecting a starting point for analysis by means of a corresponding reader or the analysis device 6 intended.

The reagent carrier 101 has a handle 102 who in 4 and 6 is shown. The handle 102 is on the side of the base plate 104 arranged the test fields 105 facing away, and extends perpendicular to the plane e passing through the base plate 104 is defined. In 6 is shown that the handlebar 102 there is a crease in the middle, a kink in the middle 102 ' and vice versa is V-shaped. The open ends of the handle 102 are as tabs 102 ' are formed and are at opposite points of the recess A attached, in particular glued.

The test fields 105 are square-shaped, and are formed from a carrier substrate and a reagent which is designed for an analytical reaction with the analyte in the sample to be examined, wherein the reagent is the uppermost layer of the test field 105 forms. Examples are colorimetric or chromatographic test fields which have a reagent which corresponds to the respective liquid sample to be tested.

The handle 102 is dimensioned so that it can be held well by a user without the user having to use the test fields 105 touched. The recess A is sized at its lateral bulges to be at least one width of the strip of the grab handle 102 equivalent. This and due to the inverted V-shape of the handle 102 the reagent carrier can be stacked.

In 7 is an alternative form of the reagent carrier 101 shown, wherein the handle 102 is L-shaped and a tab 102 ' has, the side of the recess A is arranged. The free end of the handle 4 extends from the base plate 2 path.

To use the reagent carrier 101 can, how 4 shows, the reagent carrier 101 in a container 2 of the analysis set 100 be inserted. The container 2 is a basin of a sanitary device (for example, a toilet or bidet), on the inside of a fastening device 103 is provided. The fastening device 103 is circular and here has a bridge through the flange 4 ' of the adapter 4 is limited. The reagent carrier 101 can in this so formed receiving space be used and held so when the reagent carrier 1 urine is applied. The inner diameter of the flange 4 ' corresponds to the diameter of the base plate 104 so that the reagent carrier 101 held by the web, so that the reagent carrier 101 is not flushed away by wetting urine, but remains in place for the duration of an analysis. After use, the reagent carrier 101 simply flushed away by pressing the flush.

LIST OF REFERENCE NUMBERS

1

analyzer

2

container

3

Through opening

4

adapter

4 '

accommodation space

4 '

flange

4 ' "

locking elements

5

sealing surface

6

analyzer

7

First fastener adapter

8th

Fastener analysis device

9

closure device

11

control unit

12

Data processing unit

13

display unit

14

Communication Interface

15

Wireless connection

16

storage unit

100

The analysis set

101

reagent

102

handle

102 '

tabs

102 '

kink

103

Fastening device container

104

baseplate

105

test fields

107

barcode

108

bookmark

A

recess

e

level

Z

center

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

• DE 102014115914 A1 [0003]
• DE 102010061035 B4 [0004]
• EP 0278631 A1 [0005]
• DE 69520850 T2 [0006]
• US 5073500 A1 [0007]
• EP 0292311 [0008]
• EP 0346083 B1 [0008]
• EP 1792573 A1 [0009]

Claims (21)

Body fluid analysis device (1), comprising - a container (2) designed to receive body fluids, and - an analysis device (6), the container (2) having a passage opening (3) connected to the analysis device (2). 6), and which can be closed fluid-tight by a closure device (9), characterized in that - the container (2) has an adapter (4) which is arranged in the passage opening (3) and which has at least one first attachment means ( 7), the analysis device (6) has at least one section with at least one second attachment means (8) detachably connectable to the first attachment means (7) of the adapter, and wherein the closure device is disposed on or in the adapter (4) is. Analysis device (1) according to Claim 1 , characterized in that the closure device (9) is a lid (9) made of transparent material, and / or has actuating means for opening and closing. Analysis device (1) according to Claim 2 , characterized in that the opening and closing of the closure device (9) arranged on or in the adapter (4) can be controlled by a control unit (11) which is operatively coupled to the closure device (9). Analysis device (1) according to at least one of Claims 1 to 3 , characterized in that the container (2) is part of a sanitary device from the group comprising urinals and toilets, preferably WCs, and bidets. Analysis device (1) according to at least one of Claims 1 to 4 , characterized in that the adapter (4) - is hollow cylindrical and / or - on its outer jacket a seal (5) for sealing against the passage opening (3) in the basin (2). Analysis device (1) according to at least one of Claims 1 to 5 , characterized in that the adapter (4) has a fastening portion, with which the analysis device (6) is detachably connectable, wherein preferably the attachment portion comprises a bayonet closure element, a snap closure element or a screw closure element. Analysis device (1) according to at least one of Claims 1 to 6 , characterized in that the adapter (4) has - in its wall at least one receiving portion for receiving sensors and / or electrical lines, and / or - means for liquid level measurement, wherein in a wall of the adapter (4) has a feed line (10 ), which provides a fluidic connection to an electrical level sensor. Analysis device (1) according to at least one of Claims 1 to 7 , characterized in that the hollow cylindrical adapter forms a receiving space (4 ') for the analysis device (6) which is completely or partially receivable in the receiving space (4'). Analysis device (1) according to at least one of Claims 1 to 8th , characterized in that the analysis device (1) has a control unit (11) to which the analysis device (6) is connected by wire or wireless operation, wherein the analysis device (1) for processing and / or with the analysis device (6) evaluated data - a data processing unit (12) or - with a data processing unit (12) is operatively connectable, and / or that the analysis device (1) has a communication interface (14) for wired or wireless connection of the data processing unit (12). Analysis device (1) according to at least one of Claims 1 to 9 , characterized in that the analysis device (6) - a display unit (13) for output of analysis values, or - is connected to an external display unit wireless or wired. Analysis device (1) according to at least one of Claims 1 to 10 , characterized in that the analysis device (6) has at least one attachment portion that corresponds to the attachment portion of the adapter (4), and / or that the analysis device (6) has a holding portion that is positively connected to the receiving space of the adapter (4). is connectable. Analysis device (1) according to at least one of Claims 1 to 11 characterized in that the analyzer (6) is an optoelectronic detector and has a lid (9) of transparent material disposed in a range of 0.1 to 2 mm below the surface of an adapter flange (4 "), a sample receiving space is formed for a certain amount of excrement, wherein the analysis device (6) below the closure device (9) has at least one optical sensor for detecting an optically detectable parameter of the body fluid. Analysis device (1) according to Claim 12 , characterized in that the optoelectronic detection device comprises a colorimeter, a spectrometer, a spectroscope and / or combinations thereof. Analysis device (1) according to at least one of Claims 1 to 12 characterized in that the analyzer (6) is a spectrometer and has a lid (9) of transparent material for insertion into the adapter, which has a holding portion (103) facing the interior of the basin (2) of the sanitary device a reagent carrier (101) can be positioned on the holding section (103) in such a way that the reagent carrier (101) is wettable with body fluid and abuts the lid (9) in such a way that at least one change of at least one test field (105) is optically detectable, wherein the spectrometer has a monochromatic light source with output and input optics. An analysis set (100) comprising an analyzer and a reagent carrier (101) for determining analytes in body fluids, wherein the reagent carrier (101) comprises a base plate (104) on which a plurality of test fields (105) are arranged, the test fields ( 105) are equipped with at least one reagent which is designed for an analytical reaction with the analyte, characterized in that the analysis device has an analysis device (1) according to one of the Claims 1 to 14 is. Analysis set (100) to Claim 15 , characterized in that in the reagent carrier (101) in a center (Z) of the base plate (104) a handle (102) is arranged, which extends out of the plane (E) of the base plate (104). Analysis set (100) to Claim 16 , characterized in that - the test fields (105) on the base plate (104) of the reagent carrier (101) along a geometric shape are arranged, which is preferably a circular path, and the base plate (104) a single or multi-layer disc with a round Form is, wherein arranged on the circular path test fields (105) are arranged at least along part of the circumference of the disc, and / or - the base plate (104) has at least one carrier substrate, which is preferably a topmost layer, the test fields (105 ), or that the carrier substrate forms portions of a topmost layer and is part of the test fields (105), and / or that - in the center (Z) of the base plate (104) is present a recess (A), and / or - the handle (102) is formed by a strip having at least one kink (102 "and preferably having a V or W shape, or a bend, and preferably taking a U-shape with at both open ends of the V, W or U a adjacent or cut tabs (102 "), and wherein the tabs (102 ') at opposite points of the recess (A) are fixed, or only with one end near the center (Z) and / or adjacent to the recess (A ), preferably glued, is and whose free end extends away from the base plate as a handle (4) and / or - the test fields (105) are arranged on the same side of the base plate (104), on which the handle (102) extends to provide an optical inspection on the handle side, or the test fields (105) are arranged on the side of the base plate (103) which faces away from the handle (102). Analysis set (100) to Claim 16 or 17 , characterized in that the reagent carrier (101) consists of paper, in particular a water-soluble paper composition, a non-woven or a biodegradable material, preferably a corn paper. Analysis set (100) according to at least one of Claims 16 to 18 , characterized in that the container (2) on its inside for releasably securing the Reagenzträgers (101) at least one fastening device (103) which is arranged on the closure device (9) of the adapter (4), the intended use of the pelvis (2) urine is acted upon, and wherein the fastening device (103) is a nose, a mandrel and / or a web, in particular a circular or part-circular web and with the recess (A) or another recess or a slot in the base plate of the reagent carrier (101) can be brought into engagement. Method for analyzing body fluids using an analysis device (1) according to at least one of Claims 1 to 14 comprising the steps - When using the sanitary device wetting the lid (9) with excreta and thereby collecting a predetermined amount of body fluid for the analyzer (6); Activating the analysis device (6) and analyzing the body fluid, - acquiring the analysis values and outputting the values to the data processing unit (12) and / or the display unit (13); and - after analysis, rinsing away the body fluid on the lid (9). A method of analyzing body fluids using an analysis kit (100) according to at least one of Claims 15 to 19 comprising the steps of - inserting the reagent carrier (101), then - allowing the lid (9) to wet with body fluids and thereby collecting a predetermined amount of body fluid for the analyzer (6); Activating the analysis device (6) and analyzing the body fluid, - acquiring the analysis values and outputting the values to the data processing unit (12) and / or the display unit (13); and - after analysis, removing the reagent carrier (101) together with body fluid from the lid (9).

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