Test magazine and method for using them

[0001] The invention relates to a test magazine, with two interleaved, wrapped film strips between which free retaining cells for test elements are left, and with a large number of test elements that comprise a puncturing unit for tissue puncturing and a test unit for fluid supply, respectively the political system. In addition, the invention relates to a method for processing such a magazine.

[0002] Such test systems should primarily serve diabetics in order to carry out daily self-monitoring on a daily basis regarding blood sugar levels. Newer solutions provide a microneedle in combination with the test field as a one-time system (Disposable

- the element available) to produce a skin puncture, draw a small amount of blood using capillary forces and subject this blood sample to analysis. With the help of such an integrated system it should be possible to carry out easily and quickly, also by a layman, the necessary stages to a large extent the automatic measurement process. An important aspect is miniaturization, also in relation to the high integration of available elements, in a small space in a hand-held device.

[0003] Therefore, in EP-A-1360935, blister packs have already been proposed for test elements integrated in the package, comprising a sensor part and a lancing element protruding therefrom, which due to the rigid frame with molded elements having the shape of a tub , cause inconvenience, both during manufacture and when using test elements.

[0004] Proceeding from the above, the task underlying the invention is to eliminate the drawbacks of the prior art and to develop such improvements that high component density and hygienic handling are possible.

[0005] To solve this task, combinations of features have been proposed as set out in the independent claims. Preferred embodiments and developments of the invention result from the dependent claims.

[0006] The invention is derived from the idea of ​​providing high packing density and reliable handling of test elements in cell-shaped, two-dimensional areas of the film packaging. Accordingly, the invention consists in that the puncturing units and test units are arranged as separated from each other in separate retaining cells. The cells can be shaped simply by means of an intermediate area between the non-shaped film strips. The separation also provides the advantages that the puncturing elements can be pre-treated independently, without damaging the test chemical reagents, especially they can be sterilized and they can be given features that facilitate fluid access, and that there is no danger during the puncturing process that

[0007] test chemical reagents will enter the body. At the same time, this solution is characterized by the possibility of easy manufacture, especially production from roll to roll, while it is possible to obtain a particularly flat construction, suitable for winding.

[0008] Preferably, the puncturing units and test units are arranged alternately in the direction of the strand, or transversely thereto, in the associated locating cells in adjacent pairs.

[0009] A particularly advantageous embodiment provides that the puncturing units are sterilized in the associated retaining cells by irradiation, preferably via a mask, to cover the test units.

[0010] Production simplification is achieved due to the fact that the film strips are connected along their entire length with the test strip, and that thanks to the cut out of the film strips, the test strip is made available, cell by cell, to form test units.

[0011] Due to the long stability, it is advantageous if a desiccant is embedded in the retaining cells for the test units.

[0012] A further aspect of the invention is that at least the puncturing units are taken by means of transport from their respective locating cell and moved to a working position separated from the test strips. In this way, a completely automated course of action is possible, without hindering storage, and the problem of hygienic disposal of used units can also be solved easily.

[0013] For easy, successive access to individual units, it is advantageous if the transport means have a band tensioning device for stretching the film bands in different directions. This can be accomplished due to the fact that the band tensioning device has two rotating in opposite directions or stationary steering rollers, located at the dosing site, sideways apart from each other, and winding spools for film bands, located behind the guide rollers.

[0014] In order that after the collection process it is possible to easily further process the body fluid under analysis, it is advantageous if, in order to retract the lancing unit into the working connection, the transport means are shaped with a test unit located on the film strips and / or to the place waste disposal.

[0015] A further improvement is obtained due to the fact that the transport means have handling devices for gripping and positioning the lancing unit made available by stretching the film bands at the dispensing location. It is advantageous here if at least one of the film bands has positioning holes, especially in the area of ​​the test cells retaining cells, for meshing the handling device.

[0016] Single withdrawal and handling is also suitable for integrated test elements in which the lancing units are physically connected to the test units.

[0017] According to a particularly preferred embodiment of the invention, it is provided that at least one of the film bands is provided with a receiving structure, preferably for adhesive or clamping.

Determining used lancing elements. In this way, it is particularly easy to remove infected units.

[0018] In order to increase the packing density, it is advantageous if the lancing units, as parts of flat material, are arranged in a flat manner between the film webs. In this case, the film strands are shaped in a flat manner and adhere evenly to the puncturing units, in a manner free of bubbles or spatial shapes.

[0019] A further preferred embodiment provides that the lancing units, made available at the dispensing site, are withdrawn from dispensing at a distant return position to the film web. Thus, restrictions on the handling of individual lancing units and possibly associated test elements have been eliminated.

[0020] Preferably, the lancing units have a capillary structure for collecting body fluid, preferably formed by means of a semi-open channel. A further improvement provides that the puncturing units are intended to transfer the received body fluid to the test units.

[0021] For the production of the cell structure, it is advantageous if the retaining cells are limited by linear film joints, preferably welded or glued joints between the film strips. A further improvement is achieved due to the fact that the retaining cells are sealed by a direct permanent connection by means of foil joints relative to each other and to the environment.

In order to facilitate the tearing of the foil packaging, it is advantageous if the linear foil joints run obliquely with respect to the longitudinal direction of the film bands.

[0023] Preferably, the puncturing units are fixed in position in their associated retaining cell through foil joints, surrounding with a shaped closure or into recesses.

[0024] It is also advantageous if at least one of the film bands has, or creates, a transparent measuring window for optical metering of the test units so that contactless analysis through the band is possible.

[0025] The high packing density can be achieved by the fact that the film webs with the test elements therein are kept ready, in the form of a zigzag fold, as a folded packet.

[0026] Preferably, the film webs with the test elements therein are fixed in a cassette. Test units can be shaped as detection fields, covered with a layer of reagents, for the detection of analyte in the body fluid, especially glucose.

[0027] With regard to the method, the task mentioned at the outset is solved by the fact that the puncturing units, optionally in combination with integrated test units, are made available individually by stretching the film bands, then they are moved to a working position, distant from the associated fixing cell, and then again stored on one of the film bands.

[0028] In the following, the invention is explained in more detail on the basis of the embodiments shown schematically in the drawing. The figure shows:

EP 1742575 B1

Fig. 1 a foil magazine for testing blood glucose, in a fragmentary top view;

Fig. 2 a further foil or test magazine, in a fragmentary view;

Fig. 3 exploded the individual components of the foil magazine according to Fig. 2;

Figs. 4 and 5 further embodiments of foil magazines, in a fragmentary view;

Fig. 6 a perspective view of the embodiment with a corrugated bellows as a reserve for test elements;

Fig. 7 a test magazine in a magazine housing, in a broken away perspective view; and

Fig. 8 a hand-held tool for processing the test magazine according to Fig. 7.

[0029] The test magazines shown in the drawing contain, as the foil packet 10, two interconnected strips of foil between which areas or retaining cells 16 are left, in which test elements 18, 20 are available for successive processing.

[0030] As it results from Fig. 1, puncturing units 18 and test units 20 arranged in pairs are provided as test elements, which are arranged as separated from each other in separate retaining cells 16. In the illustrated embodiments, puncturing units 18 and units test 20, viewed in the direction of the band, are staggered. Arrangements or integrated combinations of test elements are also possible, lying sideways, side by side, transverse to the direction of the strand or with an oblique adjustment, in which the lancing units 18 are physically connected to the test units 20.

[0031] The puncture units 18 are formed as flat bodies of thin alloy sheet and have a distal puncture element 22 in the form of a microneedle, for puncturing, for example, the finger of a test person, to obtain a blood sample. Through a semi-open capillary channel 24 in the form of a groove, the lancing element 22 is connected to the attachment area 26 for collecting and transferring blood. For this purpose, after the collection process, the given lancing unit 18 can be connected to the associated test unit 20 in such a way that it is fed with the collected blood, in order to detect its single analyte (glucose) during a single measurement. Detection can be accomplished in a known manner by the color reaction of test strip units and photometric measurement. For this purpose, at least one of the film bands 12.14 can be made, as an optical window, of transparent material.

[0032] The retaining cells 16 are shaped as substantially two-dimensional stretched intermediate areas between the flat film bands 12,14 to receive the test elements 18,20 in a flat position. Thus, when flat adhering to the test elements, the film strips 12.14 are free from bubbles and tub-like shapes, making it possible to wind in a compact manner or fold in a space-saving manner. For example, lancing units may have surface dimensions of 5 x 10 mm, so that even in

In the case of an amount of about 100 pieces, an acceptable roll diameter is still obtained for use in a hand-held device.

[0033] In order to separate and optionally determine the test elements, the fixing cells 16 are limited by means of linear connections 28 between the film bands 12,14. To this end, a ladder structure of welded or glued joints is provided in Fig. 2, which provides a direct non-detachable sealing of the locating cells 16 to each other and to the environment.

[0034] Thanks to the separate placement, it is possible to sterilize the packed lancing units 18 by irradiation, independent of the test units 20, without damaging the sensitive test reagents of the chemical test units. This can be accomplished through a protective mask not shown, which transmits energy-rich radiation (x-rays or electron beams) only to the puncturing units

18. In addition, thanks to the separation, by surface treatment, it is possible to provide lancet units with 18 features to facilitate fluid access, for efficient fluid intake, without having to consider test chemicals. A further advantage is that the chemical reagents used for detection cannot penetrate the puncturing process into the test subject's body.

[0035] Figures 2 and 3 show the preferred assembly of the band package of the band package 10 with alternating lancing and test units 18.20. The prefabricated puncturing units 18 are included, in a flat arrangement, between the strips 12,14, whereby the adhesive lines 28, located from the inside on band 12, limit the locating cells 16. From the outside, band 14 is fixed by means of adhesive tape 32 continuous test strip 30. Through the cutouts 34 in the carrier band 14, the test strip 30 is provided in every second retaining cell 16 for supplying body fluid or blood, thereby creating separate test units 20. By means of the multi-film construction described, mass production with high throughput capacity is simplified. rolls on a roll.

[0036] In the area of ​​the cells of the test units 20 desiccants 36 can be arranged, possibly also as band segments. In addition, positioning holes 38 are cut out in these areas in the band 14 so that, after the collection process, the lancing unit 19 can be positioned exactly, as will be explained in more detail below. It is particularly advantageous if, on one of the film strips 14, especially the linear or point adhesive structures 40 allow easy re-storage of used lancing units 18 or integrated test elements. It is also possible that additional retaining points 42 are provided in the cells of the puncturing units 18 for detachable attachment.

[0037] Embodiments of Figures 4 and 5 show similar foil packages 10, with identical parts as described above being provided with the same markers. In this case, the connecting structure 28 between the 12,14 bands lying side by side on top of each other is characterized by additional functions. First, thanks to the meshing of the choices

In the puncturing units and by adhering from the edge side to the support locations 46, it is ensured that the puncturing units 18 are fixed in a stable position. Secondly, the joining joints 28 ', extending obliquely to the longitudinal direction of the strand, provide the possibility of tearing the strands 12.14, in a push-free manner, to provide lancet units 18, without increasing the force.

[0038] In Fig. 6, the preparation of individual test elements 18 or puncturing units in a foil magazine 10 is clearly schematically simplified. In the embodiment shown, the film strips 12,14 with the test elements contained therein are stored in the form of a zigzag as folding packet 48. In order to provide lancet units 18, a band tensioning device 50 is located in a housing not shown, which includes two winding spools 52,54 for film strips 12,14 and return rollers 58 located in front of them disposed at the dispensing location 56 at a lateral distance from each other . By means of tearing the 12.14 bands in the area of ​​the return rollers 58, lancing units 18 are made available for further processing. The rotation of the winding spools 52.54 is synchronized to keep the 12.14 strings constantly under tension. Such a system, as a dispenser, can also be designed for dispensing individual units 18, which are then placed, for example, manually in a separate measuring device.

In Fig. 7, a preferred arrangement is shown in the magazine housing 60 shown in a partial selection. The foil packet 10 is in this case arranged on a roll 62 with a unwinding supply, from which interconnected bands 12 are unwound through the return rollers 58, 14 and are torn apart, releasing the test elements. After use, the test elements in the return position 63, possibly remote from the dispensed position 56, are retracted onto the inner surface of the band 12, the adhesive strips 40 causing retention. In this way, used test elements 18 are wound onto a spool 52 and thus easily removed as waste.

[0040] The test cassette 64 described above can be used in hand-held device 64 as a disposable article, as is simplified in Fig. 8. Such device 66 has all the technical means necessary to perform glucose measurement, such as energy supply 68, measuring and display electronics 70 and actuating systems 72 for manipulating separate lancing units 18 dispensed from the band magazine 10, and optical measuring system 76. In the embodiment shown, the handling device 74 forms part of the actuation system 72 to fix the elements 18 at the dispensing location 56, to place in an oblique puncture position away from the bands 12,14, to carry out the puncturing movement through the opening in the housing, and after the blood re-positioning on band 12. There, a non-contact optical measurement is carried out using the measuring unit 76 to subsequently allow the user to indicate the detected result. In this way, it is possible to carry out independent tests by a layman in a completely automated measurement process, thanks to which storage is possible to place

A large number of tests. Used cartridges 64 can be removed from the instrument 66 as a complete unit, without the need for single removal of blood contaminated parts.