HK1124118A - Test device for determining an analyte concentration - Google Patents

Description

Test device for determining an analyte concentration

Technical Field

The invention relates to a test device, in particular a portable test device, for determining at least one analyte concentration in a sample by means of a test element. The invention further relates to a test element for determining at least one analyte concentration in a sample using a test device according to the invention. Such a test device and test element are used in particular for measuring blood glucose concentrations.

Background

Blood glucose concentration monitoring is an important component of everyday life for diabetics. In this case, the blood glucose concentration must be determined quickly and reliably several times a day for appropriate medical measures to be taken. In order to no longer limit the daily life of the diabetic, corresponding mobile devices are often used, which can be transported easily and can be transported, so that, for example, the detection of the blood glucose concentration can be carried out at the workplace or also during off-hours.

Different mobile instruments exist on the market today, which function partly according to different diagnostic methods. Different diagnostic detection methods are used here, for example optical or electrochemical methods. One example of a commonly used method utilizes a special electrochemical test strip. These test strips are constructed, for example, in such a way that a given blood volume is transported to the electrode system by the capillary system of the test strip. For modern test strips a blood volume of about 1.5. mu.l is sufficient, partly also below 1. mu.l. For example, gold electrodes can be used as the electrode system, which are provided with a coating. The coating mostly comprises different enzymes and so-called neutralizing agents and serves to form charge carriers (for example in the form of oxidizing molecules) on the electrodes within the sample, the concentration of which depends on the blood glucose concentration. The concentration of such charge carriers can be determined by means of gold electrodes and suitable detection systems, for example by means of current-voltage detection, from which the blood glucose concentration can be finally deduced. An example of such an electrochemical test strip is shown in US 5,286,362.

Other detection principles may alternatively be used for the electrochemical detection method. For example, WO 01/48461 describes a light-conducting test strip for examining a sample, in particular a body fluid, in which a reaction system, when reacting with the sample, leads to an optically detectable change in a characteristic feature at a detection zone. This change can be evaluated by an evaluation device by means of a light guide incorporated into the test strip.

The test strip thus forms an important component of a portable diagnostic system. Typically, a diabetic patient requires about 5 to 7 such test strips per day. It is important here that the test strips are stored clean and dry in order not to detect blood glucose concentrations incorrectly due to contamination or moisture.

For this purpose, the test strips are generally stored in a corresponding container for removal from the test strip container by the user for testing and for introduction into a corresponding test meter. Such meters are known to the expert, for example for electrochemically determining the blood glucose concentration, and are described, for example, in US 2002/017823A 1 or WO 96/30752.

However, the test systems known from the prior art, in which the blood glucose concentration is determined by means of individual test strips (individual test strip systems), in which individual test strips are each inserted into a test device for testing, have a number of disadvantages in practice. Such systems require a large number of operating steps by the user or patient. The test strips must be removed from the corresponding storage device (e.g., test strip canister) and manually inserted into the meter. The respective test strips which are necessary for a reliable operation of such a single test strip system are therefore shaped to a relatively large extent for the patient, in particular an elderly patient or a child, in order to prevent the test strips from slipping out of the finger and being unusable for testing. However, increasing the test strip size leads to an increase in the space requirement of the detection system and enables fewer test strips to be accommodated in the respective receptacles. Furthermore, the material costs of the detection system increase due to this increased space requirement.

Furthermore, the manual handling of the test strip has the disadvantage of increasing the risk of contamination of the test strip. Manual removal of the test strip from the test strip container therefore results in the test strip being loaded with sweat or other soiling, which may adversely affect the corresponding detection. Another significant drawback is that the test strips remaining in the test strip container are exposed to atmospheric moisture each time the test strip container is opened, whereby the test strips used later removed from the test strip container may have different characteristics than the test strips initially removed.

To avoid the drawbacks of such single test strip systems, combined systems have been developed, particularly systems that combine test strip storage bins in addition to the test devices. These systems are constructed so that the test strips for testing are fed from the storage bin to the testing location. The detection can then be carried out directly after loading with the corresponding sample, for example a blood drop.

An example of such a combined system is described in WO 02/18940a 2. WO 02/18940a2 discloses a meter for detecting an analyte concentration in a fluid, which has a plurality of stacked sensors accommodated in a housing having an opening. The sensor can be electrically switched on and analyzed at the detection position. A transport element is rotatably received in the housing opening, and the measuring device has an elastic element which transports the individual sensors into the recesses of the transport element. If the transport member rotates, one sensor is transported to the detection position, respectively.

Another example of a combined system is shown in EP 1488736 a 1. In this system, diagnostic verification means in the form of a test strip are used, which is stored in a cassette. The cassette has a reading device for reading the test strip. An unused section of the test strip is pushed into the test position when the cassette lid is opened.

EP 1507143 a1 describes a combined analytical system which has a plurality of individually packaged analytical test elements contained in a stacked magazine. In order to detect the movement of a test element of such a package to an application position, the package is opened by a cutting device and the test element is pushed out of the package.

The combined system has significant advantages over conventional single test strip systems. Thus reducing many of the operational steps required for testing and also enabling the use of small, economical test parts. The loading of the test parts, in particular the test strips, with moisture or dirt is also significantly reduced.

However, the combination systems known from the prior art also have disadvantages, in particular, which impair the use as portable instruments and reduce the acceptance by the patient. One important drawback is that the integration of the system results in a relatively large structural size of the instrument. For many combination systems, for example, relatively bulky elastic systems are therefore required, which enable a corresponding transport of the test strip system. Furthermore, the combined system is often motor-driven, which leads to additional space requirements. Rather than a motor-driven combination system, requires additional clamping devices, which in many cases, in turn, affects the operation of the elderly patient or child. Furthermore, the motor drive or the complicated manual drive significantly increases the production costs of the system. The electric drive system additionally has the disadvantage that powerful batteries are required for the electric machine, which are expensive and have to be replaced frequently. These cells also lead to an additional increase in the structural volume. Another disadvantage of the complex systems known from the prior art is that they often have sensitive structural parts on their surface, which can be easily damaged mechanically, for example when transported in a pocket, moisture can enter the device, and/or their function can be adversely affected by dirt.

Object of the invention

The object of the present invention is to provide a test device for determining at least one analyte concentration in a sample, in particular a liquid sample, by means of at least one test element, which avoids the disadvantages of the test devices known from the prior art. Furthermore, corresponding test elements are to be provided, which can be used with the test device according to the invention.

Description of the invention

This object is achieved by the invention having the features of the independent claims. Advantageous developments of the invention are characterized in the dependent claims. The wording of all claims is made the content of this description by this reference.

A test device for determining at least one analyte concentration in a sample by means of a test element is proposed. In particular, this can be a sugar measurement, in particular a blood sugar measurement and/or a cholesterol measurement and/or a coagulum measurement. However, other analytical concentrations or, correspondingly, other analyses, for example pH measurements or similar chemical analyses or measurements, can alternatively or additionally be obtained. An immunoassay or the like can also be carried out, for example, by means of the test device. The sample may in particular be a liquid sample, such as blood, urine, saliva or stool. But other forms of sample, such as a gas sample, are also contemplated. Furthermore, instead of analyzing the concentration, it is also possible to merely infer the presence or absence of an analyte, which is to be included according to the invention.

The test device should have a housing which has a closed state and an open state. The housing can be designed in particular such that it can be opened manually by the user. In particular, the housing can be designed to be pushed or opened. For example, the housing can have a substantially hexahedral shape with a fold-out axis, wherein the housing can be folded out along the fold-out axis, whereby the housing lower part and the housing upper part are angled relative to one another, for example at right angles, in the folded-out state. In the closed state, the housing lower part and the housing upper part lie flat against one another, wherein the surfaces which bear the housing lower part and the housing upper part against one another are no longer accessible from the outside. This is achieved, for example, in that the surface of the housing lower part which bears against the housing upper part in the closed state of the housing is sealed by the housing, for example, for protecting this surface and components arranged on and/or in this surface (for example, displays, operating components, test strips, etc.) from environmental influences, for example from atmospheric moisture, dirt or mechanical influences. These systems are known from the prior art, for example, for mobile telephones. However, other opening devices according to the invention, such as a pusher mechanism, are also conceivable.

The feature according to the invention that the housing can be opened is a distinct advantage compared to known systems according to the invention. In particular, the design of the housing in such a way that it can be opened allows the sensitive components to be placed in a region of the housing that is accessible only in the opened or opened state of the housing.

The test device also has a storage device for receiving at least one test element, wherein the storage device has at least one storage position for the test element. At least one test element is formed by a strip-shaped test element. The storage device has a storage case, preferably a replaceable storage case, which itself has a plurality of cavities. The strip-shaped test elements are accommodated in the cavities substantially parallel to one another. In particular, the test elements can be stored individually in the individual cavities of the storage device. In contrast to many devices known from the prior art, for example from WO 02/18940a2, this extended configuration of the storage device ensures that the remaining test elements remaining in the storage device remain unaffected when the test elements are removed. In addition, the storage device can have a drying mechanism for ensuring a dry and clean storage of the test elements. Drying means may therefore be incorporated in one or more cavities of the storage device. Alternatively or additionally, drying means can be incorporated into other hollow spaces or into the walls of the storage device, in particular the storage box. Alternatively or additionally, the test element itself can also have a drying means, i.e. a section which can receive moisture, for example.

The test device according to the invention furthermore has a measuring device which is designed in such a way that at least one analyte concentration can be determined by means of at least one test element. Such measuring devices are known to the expert and are therefore not described here. In particular the form of the measuring device depends on the test element used, and its possible extension is described in more detail below. For example, at least one measuring position can have contacts for contacting at least one test element.

The test device also has a feed device. The dispensing device has means for transporting at least one test element from at least one storage position to at least one measuring position when the housing is opened. In this context, the term "open" of the housing is to be understood to mean, in particular, that parts which are hidden in the closed state, such as surfaces, along which the lower housing part and the upper housing part rest against one another, and operating parts (display, operating buttons, test strip storage compartment) which are arranged on these surfaces, are accessible. For example, this may be understood as pushing or flipping the housing open. The test strip outlet is preferably also contacted here, for example by releasing an outlet slot or the like when the housing is opened. Other forms of "touch-to-part" may be included within the concept "open".

In particular, the at least one test element can be released and/or can be transported from the at least one storage position to the at least one measuring position by opening the housing. For example, the effort required for the user to open the housing can be used to transport the test element. The force exerted on the housing when the housing is opened can be transmitted to the at least one test element, for example, by a corresponding mechanical device, for example, a lever device.

It is particularly advantageous here if the transport of the at least one test element by the dispensing device comprises a rotational movement of the test element about a rotational axis. In particular, it is possible to provide at least one test element with a longitudinal extent, for example a longitudinal axis of a test strip, wherein the test element is advantageously rotated about a rotational axis perpendicular to the longitudinal axis of the test element during transport from at least one storage position to at least one measuring position. It is thereby possible to provide the giving device with such a rotation axis. For example, the axis of rotation can pass through at least one test element.

Alternatively or additionally, the test element can be transported from the at least one storage position to the at least one measuring position by means of another type of movement, for example a translational movement. This makes it possible, for example, to push a test strip into a measuring position when the housing is opened. Combinations of motion patterns, such as translational-rotational motion, can also be implemented.

The test device according to the invention has a number of advantages over other combined test devices known from the prior art. In particular, the opening function of the housing, for example, the opening of the housing, enables convenient test devices to be obtained which exhibit particular robustness. The housing can thus be designed such that in the closed state of the housing only the non-sensitive parts of the test device are accessible from the outside. For example, the housing can be provided on its outer side with a smooth dirt-repellent surface which prevents dirt and moisture from entering the test device. However, it is also possible to alternatively provide various operation members, such as various operation buttons or display members, on the outer surface of the housing. However, it is advantageous to make important and particularly sensitive functional parts of the test device accessible only in the open state of the housing. In particular, the test device can be designed such that the operating buttons, display elements and other functional elements of the test device are accessible in the folded-open state.

The test device also has a high degree of imperviousness, since it can be embodied flat and can therefore be carried unobtrusively. No disturbing motor or reducer noise is generated when using the test device, since the motor can be dispensed with. The system cost of the test device is relatively low because costly structural components such as motors, large batteries, etc. can be eliminated. The material costs, in particular for the consumable, are relatively low, since smaller test elements can be used.

Furthermore, the extended design of the test device according to the invention significantly increases the operational safety compared to the combination systems known from the prior art. In order to prepare the determination of the analyte concentration, for example a blood glucose concentration measurement, the test device need only be opened, for example flipped open. It is no longer necessary to clamp the transport device or to operate the motor by means of a corresponding push button. This ensures in particular that patients with limited motor-operated capability, in particular elderly patients or children, can also safely operate the test device.

A further significant advantage of the development of the test device according to the invention is that the overall size of the test device can be significantly reduced in comparison with known test devices. Neither a complex and bulky clamping device or transport device for the test elements nor complex and bulky motors and bulky and expensive batteries are required for the test device according to the invention. In particular, the test element is rotated about an axis for bringing the test element from the storage position into the measuring position, which extended configuration enables a space-saving implementation of the test device. It is also ensured overall that the test device according to the invention is in an advantageous manner a robust, easy-to-operate and economical mobile instrument for use, which can also be operated easily by patients with limited motor-operated capability. This fulfils the so-called "family care thoughts" and reduces the costs of the health system.

The test device according to the invention can be additionally improved by various modifications. In particular, it is possible for the storage device to have one or more storage containers. For example, a replaceable bin. Such storage bins may be obtained by a patient through a pharmacy or a pharmacy and loaded into a testing device, for example. Here, it may be a disposable storage container or a reusable storage container. For example, an electronic memory or other form of information carrier can also be integrated into the exchangeable storage case, so that even when a new storage case is inserted into the test device, information specific to the loading can be transmitted to the test device via the test elements contained in the storage case. Such so-called "non-explicit coding" systems are known from the prior art.

It is particularly advantageous if the storage device, for example a storage box, has a perforable film, for example a film, for protecting the at least one test element from atmospheric moisture and dirt (sealing). This development of the invention is particularly advantageous in combination with the development according to the invention, in which the storage device has a separate cavity for each test element. Each cavity can thereby be closed by such a perforable membrane. For example, the dispensing device and/or the at least one test element can be designed such that the film is perforated when the at least one test element is transported from the at least one storage position to the at least one measuring position when the housing is opened. For example, at least one test element has a sharp edge or corner for this purpose. In particular, the perforation can be achieved by a rotational movement of the at least one test element, during which, for example, sharp corners of the at least one test element are pressed against the film for such a long time that the film is perforated and the test element is transported through the film to the measuring position.

In addition, the test device according to the invention can be further developed such that, when the housing is closed, the at least one test element is returned from the at least one measuring position to the at least one storage position. In particular, this transport can also be effected by a dispensing device which can have a corresponding mechanism for this transport. For example, a rotation of the at least one test element can still be used for this transport. This development of the invention ensures that used test elements, which are stored in a particularly hygienic manner there, do not have to be removed. It is not necessary to handle each test element separately. Thereby improving the judiciousness of use.

The invention can also be further developed with a decoupling mechanism which decouples the opening of the dispensing device and the testing device according to the wishes of the user. This can be achieved, for example, in a manner known to the skilled worker by simply uncoupling the drive (for example, a gear connected to the housing and a gear connected to the dispensing device). For example, the housing can be opened, but the test element is not present, if the user desires and specifies this (for example by pressing a decoupling button). This allows a user to open the housing, for example, for reading out electrical measurement results, for example, from the memory of the test device, without using the test element. Alternatively, the housing can be designed such that it can be opened only when a test element is present.

In principle, the test device can be designed such that a single test element is transported to the measurement position when the test device is opened. However, it is also possible to select a plurality of test elements to be transported simultaneously to the measuring position. But preferably a single test element is used.

In order to ensure that a fresh, i.e. not used, test element is used each time the housing is opened, the test device may additionally have a selection device. This selection device can be designed such that a test element which is not currently used is selected each time the housing is opened. For example, the test elements can be arranged parallel to one another in a row, for example in a single cavity, wherein the selection device executes a step in the direction of the next test element not currently used each time the housing is opened. The selection device can be moved further at the location of a cavity, for example.

In principle, a test device according to the invention with a plurality of test elements and a test principle can be used. The expert is familiar with this detection principle from the prior art. Thus, for example, optical measuring methods can be used, for example, for optically determining the cholesterol content in blood or urine, such methods being known, for example, from DE 69815207T 2. Alternatively or additionally, however, an electrochemical test element can also be used, as already described above in the measurement of blood glucose concentration and known, for example, from US 5,286,362. In particular, such a test element can advantageously be a test strip.

In connection with the test device according to the invention, a test element is proposed according to the invention, which can interact with a dispensing device of the test device. For this purpose, the test element according to the invention has at least one connecting device for connecting the test element to the dispensing device. This connecting means may be, for example, a hook which engages into a corresponding recess in the dispensing device. It is particularly preferred, however, for the test element according to the invention to have an opening for the passage of the shaft of the dispensing device. The opening can be, for example, a circular or angular opening in the interior of the test element, or it can also be an opening provided on the edge of the test element, for example a cutout in the edge of the test element (preferably the test strip). In this way, the test element can be rotated by the shaft for the purpose of transferring the test element from the storage position into the measuring position.

The test element according to the invention can furthermore be designed in such a way that it has a capillary system for transporting the liquid sample from the application point to the measurement point. The test element can be designed, for example, in such a way that it has an opening for the shaft, which opening is arranged, for example, in the center of the test element or at the edge of the test element. Furthermore, the test element can have an application point and electrode contacts on opposite ends. In particular, the test device can be designed such that, when the housing is opened, the test element is rotated by the dispensing device from the storage position into the measuring position, so that the application position can be reached by the user and at the same time the measuring electrodes of the test element engage in the contacts of the test device. The test element is thereby automatically electrically connected when it is transported to the measuring position.

The test device according to the invention and the test element according to the invention can be used by a patient, for example, in the following manner, wherein the method steps described below are not necessarily limited to the described sequence. The patient carries the test device in the closed position in the desired transport container or pocket. For taking a measurement, for example for measuring blood glucose concentration, the patient removes the test device from the pocket and opens the housing of the test device. This opening can be effected, for example, by simple opening or an additional actuation of an actuating element is required for opening. For example, the test device can have an opening button which must be actuated in order to open the test device. In this way, unintentional opening of the test device can be prevented.

A test element, for example a test strip, is automatically transported to the measuring position by opening the test device. In this case, the test element can be electrically contacted, for example. The test device may also be designed such that it is automatically activated when the housing is opened. Such activation of the test device may, for example, comprise switching on a computer, for example a microcomputer integrated in the measuring device. In addition, corresponding menus can be automatically made available to the user on a display element, for example a display. The housing may be configured such that the computer is automatically disconnected again when the testing device is closed.

During which the patient provides a corresponding sample. Such sample provision may for example comprise the generation of a drop of blood, for example by means of a spear system known to the skilled person. The patient applies the test sample to the test element. The analyte concentration in the sample is then determined automatically or by patient initialization (e.g. by pressing a corresponding measuring button). The analysis concentration can be displayed on a display unit and/or stored in a data memory of a microcomputer, for example. Alternatively or additionally, for example, the analyte concentration can be added to a database and the data processing can be continued accordingly.

The patient then closes the housing of the test device, wherein the used test elements are returned to the storage position, for example. The test device can then be stored in the transport device, for example in a pocket. The acquired data, for example data including the analyte concentration, can alternatively or additionally also be passed on to other analyzers, for example to other computer systems, or made available to the physician for further evaluation.

Examples

The following describes embodiments of the present invention in detail with the aid of examples. The invention is not limited to the embodiments shown. Embodiments are schematically illustrated in the drawings. In the various figures, identical reference symbols designate identical or functionally corresponding parts. In the drawings:

figure 1A shows a first preferred embodiment of a testing device according to the invention in a closed state,

figure 1B shows the test device according to figure 1A during opening,

figure 1C shows the open state of the test device according to figure 1A,

figure 2A shows a second embodiment of the testing device in a closed state,

figure 2B shows the testing device of figure 2A in an open state,

figure 3 shows an embodiment of a test strip storage bin for use in a test device according to the present invention,

figure 4A shows a first embodiment of a test strip according to the present invention,

figure 4B shows a second embodiment of a test strip according to the present invention,

figures 5A to 5E show an embodiment of an exemplary method process for transporting a test strip from a storage position to a measurement position when the test device is opened,

fig. 6A to 6D illustrate an embodiment of a selection device for selecting one test strip from the storage bin.

Fig. 1A to 1C show a first preferred exemplary embodiment of a test device 110 according to the present invention for determining a blood glucose concentration. Fig. 1A shows the closed state of the test device 110, fig. 1B shows the test device 110 during opening and fig. 1C shows the open state of the test device 110.

The test device 110 includes a housing 112 having a housing lower member 114 and a top cover 116 (housing upper member). The housing lower part 114 and the top cover 116 are connected to one another along a hinge 118, the hinge 118 simultaneously serving to transmit forces. This force transmission ensures that the force used for opening the cover 116 can simultaneously be used in the housing lower part 114 for rotating the test strip (see below).

In the closed state shown in fig. 1A, the housing 112 has a closed smooth surface. The cover 116 and the housing lower part 114 are adapted to one another by their shape in such a way that only a narrow separating plane 120 is created, through which impurities in the form of dirt and water cannot substantially enter the interior of the testing device 110. In this case, an upwardly pointing console 122 is formed on the housing lower part 114, which can be grasped by the thumb of the hand, for example, during opening of the housing 112. A release button 124 is provided on the console 122. This release button 124 may have a purely mechanical function, in particular releasing the opening of the housing 112 by pressing the release button 124. Alternatively or additionally, the release button may have an electrical function, for example by activating or initializing a measuring circuit and/or a microcomputer in the test device 110 when the release button 124 is actuated.

Inside the housing 112, a control surface 126 is located inside the top cover 116 and a measuring surface 128 is located inside the housing lower part 114. The control surface 126 has a display member in the form of a display 130 and a plurality of operating buttons 132. By actuating the pushbutton 132, for example, a measurement and/or a menu function of the test device 110 can be initiated. The analysis concentration may be displayed digitally, for example, on display 130. The test device 110 can function in general, for example, in a manner similar to known test devices available on the market.

A storage box 134 in the form of a grid is embedded in the measuring surface 128 in the housing lower part 114. The storage box 134 is exchangeably formed and has a plurality of cavities 135, in which test strips 136 are accommodated parallel to one another. The storage bin, and in particular the cavity 135, may additionally contain a drying mechanism (not shown in fig. 3) that protects the test strips 136 contained within the cavity 135 from atmospheric moisture. An example of such a storage bin 134 is shown in fig. 3. A thin film in the form of a lacquer film 138 is arranged over each cavity 135. The storage box 134 also has a pivot axis 140, about which the individual test strips 136 are rotatably supported.

When the housing 112 of the test device 110 is opened (see fig. 1B), a test strip 136 is rotated about the rotational axis 140 by a dispensing device (not shown). The sealing film 138 of the associated cavity 135 is interrupted or penetrated by the test strip 142 of the test strip 136. In the fully open state of the housing 112 (see fig. 1C) the test strip 136 is in the correct use and measurement position. It is also possible to choose to orient the test strip 136 differently for the purpose of using the sample and/or the measurement, for example, in a separate application position and measurement position. It is also conceivable to transport the housing 112 first to an application position after opening and then to add the measurement position after the sample application has been completed, for example by releasing the measurement position by reclosing the housing 112. Importantly, the test strip's application point 150 (see below, FIGS. 4A and 4B) is accessible for sample application to the patient at the application location.

The test strip 136, aligned in the application and measurement position shown in fig. 1C, is in electrical communication with contacts (not shown, see, e.g., reference numeral 176 in fig. 5A) of the testing device 110, whereby electrochemical measurements can be made.

The storage bin 134 shown in fig. 3 is constructed of a grid for, for example, 10, 25, 50 or more test strips 136. The number of test strips 136 is limited to the size of the testing device 110. A storage bin length of about 40mm is required for 50 test strips 134. Test strips according to the present invention are shown by way of example in fig. 4A and 4B, which can be loaded into a storage bin 134 according to the embodiment of fig. 3. In the preferred embodiment shown in fig. 4A, the test strip 136 has an aperture 144 in its center for passing through the rotational axis 140 (see fig. 3). One notch 146 is located on the edge of the test strip 136 in the embodiment of the test strip 136 shown in FIG. 4B. Both the aperture 144 and the notch 146 enable the test strip 136 to be rotated about the rotational axis 140 of the storage bin 134 from a (horizontal) storage position to a (vertical, see fig. 1C) measurement position.

The test strip in the embodiment according to fig. 4A and 4B is an electrochemical measurement strip for blood glucose concentration measurement according to the above description. The test strip 136 is formed by a longitudinally extending rectangle and has an electrode contact 148 on one end and an application point 150 for applying a drop of blood on the other, opposite end. Blood is transported from the application point 150 to the interior of the test strip 136 by a capillary system 152. Where the blood contacts the measuring electrodes 154, which are in turn connected to the electrode contacts 148. In the measuring position (shown in fig. 1C), the electrode contacts 148 are connected to corresponding contacts of the test device 110, so that the blood glucose concentration can be determined electrochemically.

The housing 112 of the test device 110 includes an electronic evaluation device in addition to the presentation device for transporting the test strip 136 to the measurement position (see fig. 1B and 1C). This electronic evaluation device is used to evaluate the test strip 136 by electrochemical measurements. Such evaluation circuits are known to the expert. The evaluation circuit may also comprise a microcomputer which can be operated, for example, by means of operating buttons 132. The microcomputer can control the evaluation program accordingly and for example comprise a data memory.

In the embodiment of the testing device 110 shown in fig. 1A to 1C, the display 130 and the operating buttons 132 are combined in the operating plane 126 of the top cover 116 located on the inside. As described above, opening the housing 112, for example, may automatically serve to turn on the testing device 110. Alternatively or additionally, this may be accomplished by an unlock button 124 (which may also be implemented by an "on/off button"). After use of the testing device 110, i.e., particularly after completion of a blood glucose concentration measurement, the patient closes the housing 112 by closing the cap 116. Where the test strip 136 is automatically transferred back into its cavity 135. The test strip 136 may also optionally be removed and disposed of manually. The test device 110 may also optionally be automatically turned off when the housing 112 is closed, thereby preventing the test device 110 from inadvertently remaining on. This saves in particular electrical energy.

An alternative embodiment 110 to that of fig. 1A to 1C is shown in fig. 2A and 2B, which has a similar function. A storage tank 134, such as the one according to the embodiment of fig. 3, is still incorporated within the housing 112. The storage bin 134 still has a cavity 135 into which an electrochemical test strip 136 is inserted. These test strips 136 are still constructed similarly to the embodiment of fig. 4A or 4B.

In contrast to the exemplary embodiment according to fig. 1A to 1C, the exemplary embodiment according to fig. 2A and 2B has no operating surface located inside, although it has a measuring surface 128 located inside the housing 112. Instead, in this embodiment, the operating surface 126 having the display 130 and the operating buttons 132 is placed on the surface of the top cover 116. Optionally, functions (not shown) in the form of display elements and/or operating elements can also be arranged on the inner side 156 of the cover.

The function of the test device 110 according to the exemplary embodiment in fig. 2A and 2B can be achieved, for example, in that the patient opens the housing 112 and applies a drop of blood 158 to the test strip 136. The housing 112 is then closed again, whereby the measurement is automatically started or carried out or the electrical measurement results are evaluated, wherein the results can also be read out by the display 130 when the housing 112 is closed.

Fig. 5A to 5E schematically show the dispensing of a test strip 136 by a dispensing device 160 according to the invention when the housing 112 of a test device 110, as shown, for example, in fig. 1A to 1C, is opened. Fig. 5A to 5E show sectional views of the lower housing part 114 of the test device 110 parallel to the hinge 118 (i.e. perpendicular to the longer axis of the housing 112). The housing 112 is not shown in fig. 5A to 5E for simplicity.

The dispensing device 160 interacts with the storage container 134, for example, according to fig. 3. A number of test strips 136, in this embodiment test strips 136 according to the embodiment of fig. 4A, are housed in the storage bin 134. The test strip 136 has an electrode contact 148 on one end and an application point 150 on the opposite end for applying a drop of blood 158. The test strips 136 furthermore each have an aperture 144 through which the pivot axis 140 is guided. The housing lower part 114 of the test device 110 is designed in such a way that it has a receptacle for receiving the end of the rotary shaft 140. This receiving body is not shown in fig. 5A to 5E. The rotary shaft 140 is thus, for example, an integral component of the storage container 134, wherein the ends of the rotary shaft 140 are positioned or inserted into the respective receptacles of the housing 112 when a new storage container 134 is inserted into the housing 112 of the testing device 110. Thereby allowing each test strip 136 to be rotatably supported about a rotational axis 140.

The test strip 136 is transported from the storage position (fig. 5A) to the measurement position (fig. 5E) by the dispensing device 160. Here, the test strip 136 is in the storage position shown in fig. 5A when the housing 112 is closed (see fig. 1A), and the test strip 136 is in the measuring position shown in fig. 5E when the housing 112 is opened (see fig. 1C). In the storage position shown in fig. 5A, the test strip 136 is received within the cavity 135. While in the measuring position shown in fig. 5E the test strip 136 is rotated by 90 deg. compared to the storage position of fig. 5A, with the electrode contacts 148 pointing downwards and the application point 150 pointing upwards.

For this purpose, the dispensing device 160 has a dispensing housing 162 which is arranged inside the storage tank 134. A gear wheel 164 having a rotational axis is rotatably supported perpendicular to the drawing plane inside the given housing 162. This gear 164 is driven by a transmission (not shown) through the hinge 118 of the testing device 110 and rotates in a counterclockwise direction when the housing 112 is opened.

Furthermore, the dispensing device 160 has a transport arm 166, which is bent at a right angle. Within the drive range 168, the conveying arm 166 interacts with the gear wheel 164 in such a way that the conveying arm 166 is moved to the right in fig. 5A by the gear wheel 164 when the housing 112 is opened.

In the rest position of the closed housing 112, which is shown in fig. 5A and represents the test device 110, the upwardly directed pressure region 170 of the conveying arm 166 rests against the bottom of the storage bin 134. In an upwardly directed pressing region 170, the transport arm 166 is guided in the dispensing housing 162 of the dispensing device 160 by means of a pin 172 and a curved slot 174.

As soon as the housing 112 of the testing device 110 is slightly opened, the pressing area 170 of the transport arm 166 begins to be pressed into the storage bin 134 (see fig. 5B to 5E). In this case, the contact areas 170 each engage exactly one cavity 135 of the storage box 134, wherein a test strip 136 is just pushed out of the storage box 134. For this purpose, the storage box 134 can have, for example, above and below each cavity 135A corresponding pierceable film 138 (see fig. 3, not shown in fig. 5A to 5E). This membrane can be pierced by the edge of the test strip 136 and/or by the pressure zone 170 of the transport arm 166. If the housing 112 is opened, the transfer arm 166 is moved to the right in fig. 5A to 5E via the gear 164 over a drive range 168, thereby moving the pressing area 170 upward into the storage box 134. The storage container 134 is supported by the dispensing device 160 in such a way that the pressure-exerting region 170 acts on the test strip 136 to the right of the axis of rotation 140. Thereby rotating the test strip 136 counterclockwise in the view shown in fig. 5A-5E.

Furthermore, the dispensing device 160 in this exemplary embodiment according to fig. 5A to 5E has contacts 176 for contacting the test strip 136. These contacts 176 are connected to the measurement circuit of the test device 110. A measuring circuit, not shown, makes it possible to evaluate the test strip 136 using electrochemical measuring methods known to the expert from the prior art. It is for example possible to let this measuring circuit comprise a circuit for performing current-voltage measurements or capacitive measurements. The contacts 176 are fixed to the dispensing housing 162 of the dispensing device 160 in such a way that the contacts 176 contact the electrode contacts 148 of the test strip 136 in the measuring position shown in fig. 5E. For example, the contacts 176 can have corresponding clamping devices, into which the test strips 136 are pressed by the dispensing device 160, in particular by the transport arm 166. In this way, a safe and reliable electrical contact can be established between the electrode contact 148 and the contact 176.

Due to the curved slot 174, the contact pressure region 170 of the conveying arm 166 describes (fig. sequence 5A to 5E) a curved path, for example an arc, when it is opened. This arc is moved in the opposite direction by the pressing area 170 when the housing 112 is closed (fig. sequence 5E to 5A). The contact area 170 bears against the test strip 136 via a chamfer 178, as a result of which the test strip 136 is forced to rotate in the clockwise direction when the housing 112 is closed. The used test strip 136 is thereby moved back from the measuring position (fig. 5E) into the storage position (fig. 5A) after use of the test strip 136.

The dispensing device 160 shown in fig. 5A to 5E has a mechanism for dispensing exactly one test strip 136 from the storage bin 134. Depending on the position of the dispensing device 160 below the defined cavity 135 of the storage bin 134, the test strip 136 located in the corresponding cavity 135 is transferred into the measuring position (see fig. 5E).

It is contemplated that the testing device 110 may include a mechanism that includes a defined cavity 135 that selects the storage bin 134. Examples of such selection means 180 are schematically shown in different views in fig. 6A to 6D. Fig. 6A shows a perspective partial view of the closing cap 116, fig. 6B shows a perspective partial view of the opening cap 116, fig. 6C shows a side view of the closing cap 116 and fig. 6D shows a side view of the opening cap. Fig. 6A to 6C are to be observably explained together.

The dispensing device 160 is supported according to the exemplary embodiment described above in fig. 5A to 5E on two shafts 182, 184, namely a drive shaft 182 and a slide shaft 184, which form part of the selection device 180. The drive shaft 182 is connected to the gear 164 of the setting device 160 and drives this gear. The slide shafts 184 pass through the corresponding slide shaft holes 186 of the dispensing casing 162, whereby the dispensing apparatus 160 can be slid on the slide shafts 184. The stop position of the dispensing device 160 on the top side (i.e. on the right in fig. 6A to 6D) is given by a stop 188 which is fixedly connected to the housing lower part 114 and which at the same time also fixes the top-side end of the sliding shaft 184. The opposite end of the sliding shaft 184 is fixed inside a fixing body 190.

The selection device 180 furthermore has a drive unit 192. The drive unit 192 itself has a transverse shaft 194, which is supported on two lateral fastening bodies 196 and extends perpendicularly to the shafts 182, 184. Two rollers 198 and a balance 200 are fixed to the transverse shaft 194. The transverse shaft 194 is prestressed by a spring (not shown). The drive unit 192 also has a pivot lever 202 with a release lever 204. This release lever 204 is connected to the unlock button 124 (see, e.g., fig. 1A). If release lever 204 is operated, rocker 202 temporarily releases balance 200, thereby allowing this spring-driven balance to just continue to move around the setting (corresponding to the teeth on balance 200).

A spring band (not shown in the figures) is wound around the drum 198, which in turn is connected to the dispensing device 160. As the wobbler 200 rotates, the roller 198 is also rotated, thereby winding the spring band around the roller. This causes the dispensing device 160 to move in the direction of movement, i.e., to the left in fig. 6A to 6D.

The positioning of each balance 200, i.e. each time the release lever 204 is operated, achieves a determined movement of the setting device 160 for each step. The storage bin 134 is provided on the dispensing device 160 as described above. The balance 200 and the deceleration by roller 198 are designed such that each step of movement controls the position of exactly one cavity 135 in the forward direction. This allows the dispensing device 160 to continue to feed in one cavity 135 each time it is positioned.

The drive shaft 182 is coupled to a gear transmission 208 of the top cover 116 via an angular transmission 206 (see fig. 6C and 6D). The gear 208 is in turn mounted on a cover mount 210, which is fixedly connected to the housing lower part 114, so that the opening movement of the cover 116 relative to the housing lower part 114 can be achieved. At the same time, the cover 116 is biased against the housing lower part 114 in the direction of the opening movement by a spring (not shown). In the closed state of the housing 112 (fig. 6A and 6C), the cover 116 is secured by a latch (not shown) which prevents the cover 116 from being flipped open by the cover. The top cover 116 can only be released by operating the unlocking button 124 and can be opened by spring force actuation. However, when the cover 116 is opened, the drive shaft 182 is rotated by the angle drive 206, which in turn drives the gear 164 of the dispensing device 160, whereby the test strips 136 are dispensed from the storage bin 134 by the transport arm 166.

In summary, the process of presenting one test strip 136 from the storage bin 134 consists of the following steps. The user operates the unlock button 124 of the housing 112. In this case, the setting-out device 160 is positioned further with exactly one cavity 135 by releasing the lever 204 and the balance 200. While the flip-open top cover 116 is released and actuated by spring force by operating the unlock button 124. The measuring can be carried out in that the toothed wheel 164 of the dispensing device 160 is actuated by the drive shaft 182, so that the dispensing device 160, via the transport arm 166, transports exactly one test strip 136 into the application and measuring position shown in fig. 5E.

List of reference numerals

110 testing device

112 outer casing

114 lower part of housing

116 Top cover

118 hinge

120 interface

122 operating table

124 unlock button

126 control surface

128 detection surface

130 display

132 operating button

134 storage box

135 cavity

136 test strip

138 lacquered film

140 rotating shaft

142 test strip

144 aperture

146 notch

148 electrode contact

150 point of application

152 capillary system

154 detection electrode

156 inside the top cover

158 blood drop

160 giving device

162 to give a shell

164 Gear

166 transfer arm

168 drive range

170 range of pressing

172 guide pin

174 curved slot

176 contact

178 chamfer

180 selection device

182 drive shaft

184 sliding shaft

186 sliding shaft hole

188 stop

190 fixed body

192 drive unit

194 horizontal axis

196 side fixing body

198 roller

200 balance wheel

202 rocker

204 release lever

206 degree angle drive

208 gear transmission

210 roof fixing body

212 direction of motion

Claims (15)

1. A test device (110) for determining at least one analyte concentration in a sample by means of at least one test element (136) has

-a housing (112), wherein the housing (112) has a closed state and an open state;

-a storage device (134) for accommodating at least one test element (136), wherein the storage device (134) has at least one storage position for the test element (136);

-a measuring device, wherein the measuring device is designed to determine at least one analyte concentration by means of at least one test element (136); and

-a dispensing device (140, 160), wherein the dispensing device (140, 160) has means for transporting at least one test element (136) from at least one storage position to at least one measuring position when the housing (112) is opened,

it is characterized in that the preparation method is characterized in that,

-at least one test element (136) is formed by a strip-shaped test element (136), wherein the storage device (134) has a storage box (134), preferably a replaceable storage box (134), wherein the storage box (134) has a plurality of cavities (135), wherein the strip-shaped test elements (136) are accommodated in the cavities (135) substantially parallel to one another.

2. The testing device (110) of claim 1, wherein the housing (112) is flip-open.

3. The testing device (110) according to one of the two preceding claims, characterized in that the dispensing device (140, 160) has a rotational axis (140) for rotating the at least one test element (136) from the at least one storage position into the at least one measuring position.

4. The testing device (110) according to one of the preceding claims, characterized in that the storage device (134) has at least one film (138) which can be perforated by at least one test element (136) and which serves to protect the test element (136) against atmospheric moisture and dirt.

5. The testing device (110) according to one of the preceding claims, wherein the storage device (134) additionally has at least one drying mechanism for reducing the moisture of the air.

6. The testing device (110) according to any of the preceding claims, wherein the drying mechanism is incorporated into at least one of the following components: in at least one cavity (135) in the storage device (134); in at least one test element (136); in at least one storage tank (134).

7. The test device (110) according to one of the preceding claims, wherein at least one measuring position has a contact (176) for contacting at least one test element (136).

8. The testing device (110) according to one of the preceding claims, characterized in that the dispensing device (140, 160) has means (140, 166) for transporting the at least one test element (136) from the at least one measuring position to the at least one storage position when the housing (112) is closed.

9. The test device (110) as claimed in one of the preceding claims, additionally having a selection device (18), wherein the selection device (180) is designed to select unused test elements (136) each time the housing (112) is opened.

10. The test device (110) as claimed in one of the preceding claims, additionally comprising a decoupling mechanism, wherein the decoupling mechanism is designed to prevent at least one test element (136) from being transported by a user from at least one storage position to at least one measuring position by the dispensing device (140, 160) when the housing (112) is opened when the decoupling mechanism is actuated.

11. The testing device (110) according to any of the preceding claims, wherein the measuring device has means for performing at least one of the following measurements: sugar measurements, in particular blood glucose measurements; measuring cholesterol; measuring coagula; and (4) performing immunity measurement.

12. Storage bin (134) having at least one test element (136) for determining at least one analyte concentration in a sample, wherein the storage bin (134) is designed for use in a test device (110) according to one of claims 1 to 11, wherein the at least one test element (136) is designed as a strip-shaped test element (136) and has at least one connecting device (144, 146) for connecting the test element (136) to a dispensing device (140, 160), characterized in that the storage bin (134) has a stack of a plurality of stacked pockets (135), wherein the strip-shaped test elements (136) are accommodated in the pockets (135) parallel to one another.

13. A bin (134) as claimed in the preceding claim, characterised in that the connecting means (144; 146) has at least one opening (144; 146) for the passage of a rotatable shaft (140).

14. The storage case (134) of either of the above two claims, wherein the test element (136) is a test element (136) for electrochemically determining at least one analyte concentration.

15. The storage tank (134) of any one of the three preceding claims, wherein at least one test element (136) has a capillary system (152) for transporting the liquid sample from the application location (150) to the measurement location (154).