Test magazine and method for using them

p0001The invention relates to a test magazine with two sandwich-wound, winding film strips between which receiving cells for test elements are kept, and a plurality of test elements each comprising a piercing unit for piercing into body tissue and a test unit for applying body fluid. The invention further relates to a method for processing such a magazine.

p0002Such test systems are intended to serve mainly diabetics for daily self-monitoring of blood glucose. More recent concepts provide a micron needle in conjunction with a test panel as a disposable system to produce a haute cue, to take out a small amount of blood using capillary forces, and to analyze this blood sample. With such an integrated system, the steps required are to be carried out simply and quickly in a largely automatic measuring sequence, even by lay persons. An important aspect is the miniaturization also with regard to a high integration of disposables in a small space in a handset.

p0003In this context, <patcit id="pcit0001" dnum="EP1360935A"><text>EP-A-1360935</text></patcit> Already proposed blister packs for test-integrated integrated testing elements comprising a sensor part and a lancing element protruding therefrom, but which, due to rigid frames with cup-shaped configurations, bring about disadvantages both during production and in use.

p0004The invention is based on the object of avoiding the disadvantages which have arisen in the prior art and also to provide improvements in that a high integration density and hygienic handling is possible.

p0005In order to achieve this object, the feature combinations given in the independent patent claims are proposed. Advantageous embodiments and further developments of the invention result from the dependent claims.

p0006The invention is based on the idea of ​​ensuring a high integration density and handling security for the test elements in two-dimensional cellular regions of a film package. Accordingly, the invention is characterized in that the piercing units and test units are arranged separately from one another in separate receiving cells. The cells can be realized simply by the intermediate region between the non-further developed film tapes. The separation also affords advantages in that the piercing elements can be independently pretreated, in particular sterilized and hydrophilized, without damage to the test chemistry, and that there is no danger in the lancing process

p0007Test chemicals enter the body. Moreover, this solution is distinguished by the possibility of a simple production, in particular by roll-to-roll production, wherein a particularly flat, winding configuration is possible.

p0008Advantageously, the piercing units and test units are arranged alternately or transversely thereto in pairs in the direction of the belt adjacent to each other in associated receiving cells.

p0009A particularly preferred embodiment provides for the piercing units in the associated receiving cells to be sterilized by irradiation preferably via a mask for shielding the test units.

p0010A production simplification is also achieved in that the foil tapes are connected to a test tape over their length, and that the test tape is cell-free by breakthroughs of the foil tapes with formation of the test units.

p0011In view of a long shelf life, it is also advantageous if a drying agent is incorporated in the receiving cells for the test units.

p0012A further aspect of the invention is that at least the piercing units can be removed from their respective receiving cell by transport means and moved into a completely separated working position from the film strips. In this way, a fully automatic process sequence is possible without hindrance by the magazine, whereby the hygienic disposal of spent units can also be easily solved.

p0013For a simple successive release of individual units, it is advantageous if the transport means comprise a tape pulling device for extending the film strips in different directions. This can be realized by the fact that the strip tensioning device has two deflection cylinders which are arranged at a lateral distance from one another and are rotatable or fixed in opposite directions at a dispensing point, and winding coils for the film strips arranged downstream of the deflection cylinders.

p0014In order to be able to further process the body fluid to be analyzed after the collection process, it is advantageous if the transport means for returning a puncture unit into an operative connection are formed with a test unit and / or disposal point located on the film tapes.

p0015A further improvement is achieved in that the transport means comprise a handling device for picking up and positioning a piercing unit released by pulling out the foil tapes at a dispensing point. In this case, it is advantageous if at least one of the foil tapes has positioning holes, in particular in the region of the receiving cells of the test units, for the engagement of the handling device.

p0016Individual sampling and handling is also suitable for integrated test elements, in which the piercing units are physically connected to the test units.

p0017A particularly preferred embodiment of the invention provides that at least one of the foil tapes is provided with a return structure for the preferably adhesive or clamping fixing of spent staking elements. In this way, a particularly simple disposal of contaminated units is possible.

p0018To increase the integration density, it is advantageous if the piercing units are arranged as flat material parts flat between the film strips. In this case, the foil tapes should be flat and should lie flat against the piercing units free of blisters or spatial projections.

p0019A further advantageous embodiment provides that the piercing units released at a dispensing point are dispensed back onto one of the foil tapes at a return point remote from it. Restrictions in the individual hand of the piercing units and, as the case may be, associated test elements are thereby further avoided.

p0020Advantageously, the piercing units have a capillary structure, preferably formed by a semi-indented channel, for collecting body fluids. A further improvement provides for the piercing units to be designed for transferring absorbed body fluid onto the test units.

p0021For the production of the cell structure it is favorable if the receiving cells are limited by line-shaped film connections, preferably welding or adhesive seams, between the film strips. A further improvement is achieved by the fact that the receiving cells are sealed by the film connections against one another and against the surrounding material.

p0022In order to facilitate the tearing open of the film pack, it is advantageous if the line-shaped film connections run obliquely to the longitudinal direction of the tape of the film strips.

p0023Advantageously, the piercing units are fixed in their associated receiving cell in a positionally fixed manner by means of form-locking or membrane-engaging film connections.

p0024It is also advantageous if at least one of the foil tapes has or forms a transparent measuring window for an optical measurement of the test units so that contactless scanning through the strip is possible.

p0025A high packing density can also be achieved in that the foil tapes with the test elements located therein are held in a zigzag fold as a folding package.

p0026Advantageously, the foil tapes with the test elements located therein are accommodated in a cassette. The test units can be designed specifically as reagent-coated detection fields for the detection of an analyte in the body fluid, in particular glucose.

p0027In a process-related aspect, the object mentioned at the outset is solved by the fact that the piercing units, if necessary in integrated test units, are individually released by pulling out the foil tapes, then moved into a working position removed from the associated receiving cell and subsequently re-stored on one of the film tapes.

p0028The invention is explained in more detail below with reference to the exemplary embodiments shown schematically in the drawing. Show it:<ul><li><figref idrefs="f0001">FIG</figref> A film magazine for blood glucose tests in a partial plan view;</li><li><figref idrefs="f0001">FIG</figref> A further film magazine or test magazine in a partial plan view;</li><li><figref idrefs="f0001">FIG</figref> The individual components of the film magazine <figref idrefs="f0001">FIG</figref> In an exploded view;</li><li><figref idrefs="f0002">FIGS. 4 and 5</figref> Further embodiments of film magazines in a top view;</li><li><figref idrefs="f0002">FIG</figref> 1 shows an embodiment with a bellows as a supply for test elements in a diagrammatic representation;</li><li><figref idrefs="f0003">FIG</figref> A test magazine in a magazine housing in a broken-away perspective view; and</li><li><figref idrefs="f0003">FIG</figref> A hand-held device for processing a test magazine <figref idrefs="f0003">FIG</figref>.</li></ul>

p0029The test magazines shown in the drawing comprise, as foil pack 10, two foil strips 12, 14 sandwiched with one another, between which receiving areas or cells 16 are exposed, in which test elements 18, 20 are provided for successive processing.

p0030How <figref idrefs="f0001">FIG</figref> , Test units 18 and test units 20, which are assigned in pairs, are provided as test elements, which are arranged separately from one another in separate receiving cells 16. In the exemplary embodiments shown, the piercing units 18 and test units 20 are arranged alternately in the direction of the belt. Also conceivable are arrangements which are laterally adjacent to each other or obliquely displaced transversely to the direction of the tape, or integrated combinations of test elements, in which the piercing units 18 are physically connected to the test units 20.

p0031The piercing units 18 are formed as flat shaped parts from a thin stainless steel plate and have, in the form of a micron needle, a distal piercing member 22 for piercing, for example, into the finger of a test person for blood production. The lancing member 22 is connected via a semi-opaque, groove-shaped capillary channel 24 to a holding area 26 for collecting and transferring blood. For this purpose, the piercing unit 18 concerned can be connected to an associated test unit 20 after the collecting process in such a way that the blood is applied to the collected blood in order to detect an analyte (glucose) contained therein in a single measurement. Detection can take place by means of a color reaction of the strip-shaped test units 20 and a photometric measurement in a manner known per se.

p0032The receiving cells 16 are kept as essentially two-dimensionally extended intermediate regions between the planar film strips 12, 14 in order to receive the test elements 18, 20 flat. The foil tapes 12, 14 thus remain free of blisters or tray-like formations in planar contact with the flat test elements, so that compact winding or space-saving folding is possible. For example, the piercing units 18 can have a surface dimension of 5 × 10 mm, so that even with a number of approximately 100 pieces an acceptable winding diameter is still achieved for use in a hand-held device.

p0033For the insulation and, if necessary, fixing of the test elements, the receiving cells 16 are delimited by linear connections 28 between the foil strips 12, In<figref idrefs="f0001">FIG</figref> A ladder-like structure consisting of welding or adhesive seams is provided for this purpose which ensures a material-tight sealing of the receiving cells 16 against one another and against the environment.

p0034By the separate arrangement, it is possible to sterilize the packaged piercing units 18 independently of the test units 20 by irradiation without damaging the sensitive test chemicals of the test units. This can take place via a shielding mask (not shown), which transmits an energetic radiation (X-ray or electron beam) only to the piercing units 18. Moreover, the separation makes it possible to hydrophilize the piercing units 18 for an effective liquid absorption by a surface treatment without having to take consideration for the test chemistry. A further advantage is that the chemicals used for the detection can not enter the body of the examiner during the lancing process.

p0035From the <figref idrefs="f0001">FIGS. 2 and 3</figref> An appropriate assembly of a tape package 10 with alternating piercing and testing units 18, 20 is obtained. The prefabricated piercing units 18 are enclosed between the bands 12, 14, the adhesive lines 28 arranged on the inner side of the band 12 delimiting the receiving cells 16. On the outside on the belt 14, a continuous test strip 30 is fixed by means of adhesive tape 32. The test strip 30 is exposed by breakthroughs 34 in the carrier band 14 in each second receiving cell 16 for the application of body fluid or blood, so that the separate test units 20 are thereby formed. With the multi-foil assembly described, high-throughput mass production is simplified from roll to roll.

p0036In the cell area of ​​the test units 20, desiccants 36 can also be contained as strip sections. Furthermore, positioning holes 38 are punched into the band 14 in these regions so that the piercing unit 18 can be accurately positioned after the collecting process, as will be explained in more detail below. It is particularly advantageous if, on one of the foil tapes 14, in particular linear or punctiform adhesive structures 40 permit a simple remagazineation of spent piercing units 18 or integrated test elements. It is also possible for additional detent points 42 to be provided in the cells of the piercing units 18 for their detachable mounting.

p0037The embodiments according to FIG <figref idrefs="f0002">FIGS. 4 and 5</figref> Show similar film packs 10, the same parts as described above being provided with the same reference symbols. Here, the connecting structure 28 between the belts 12, 14 lying on the width side is characterized by additional functions. On the one hand, by means of an engagement in recesses 44 of the piercing units and a peripheral abutment on support points 46, a secure fixation of the piercing units 18 is ensured. On the other hand, connecting seams 28 'which extend obliquely with respect to the longitudinal direction of the tape ensure that the strips 12, 14 can be torn open without the need for jacks without the need for force.

p0038<figref idrefs="f0002">FIG</figref> The provision of individual test elements or piercing units 18 from the film magazine 10 is illustrated in the illustrated embodiment. In the embodiment shown, the foil tapes 12, 14 with the test elements located therein are stored zigzag-shaped as a folding package 48. For a successive release of the piercing units 18, a tape pulling device 50 is provided in a housing (not shown) which comprises two winding bobbins 52, 54 for the film tapes 12, 14 as well as deflection rollers 58 arranged at a dispensing location 56 at a lateral distance from one another. Due to the tearing apart of the bands 12, 14 in the region of the deflection rollers 58, the piercing units 18 are released for further processing. In this case, the rotation of the winding coils 52, 54 is synchronized in order to keep the belts 12, 14 always tensioned.

p0039<figref idrefs="f0003">FIG</figref> Shows a preferred arrangement in a magazine housing 60 which is shown partially broken-away. The film package 10 is arranged there on a supply roller 62 from which the interconnected belts 12, 14 are pulled off via the deflection rollers 58 and are thereby torn apart with the test elements being released. After use, the test elements are returned to the inner side of the belt 12 at a return point 63, which is optionally removed from the lowered position 56, with adhesive strips 40 causing the retention. In this way, the consumed test elements 18 can be wound up on the reel 52 and thus simply disposed of.

p0040The test cartridge 64 described above can be used as a disposable article in a handset 66 as shown in FIG <figref idrefs="f0003">FIG</figref> Is simplified. Such a device 66 comprises all the operating means required for carrying out a glucose measurement, such as power supply 68, measuring and indicating electronics 70 and actuation system 72 for the handling of individual piercing units 18, which are discharged from the belt magazine 10, as well as a measuring optics 76. A handling device 74 is shown in the embodiment shown As part of the actuator system 72 to receive the elements 18 at the dispensing location 56, into a transversed lancing position remote from the strips 12, 14, to carry out the lancing movement via a housing opening and to bring it back onto the band 12 after blood collection. A non-contact optical measurement is then performed there by means of the measuring unit 76, in order subsequently to be able to display the determined result to the user. In this way, self-tests can also be carried out by a self-testing machine in a fully automatic measuring sequence, whereby a large number of tests are possible through the storage. The consumed cassettes 64 can be removed from the device 66 as a complete unit without having to be disposed of individually with blood-contaminated parts.