Test magazine and method for using them

Translation of description of equivalent WO 2005104948 A1

Testmagazin and method for processing

description

The invention relates to a test magazine sandwiched interconnected with two rollable foil strips between which recording cells are kept free for test elements, and a plurality of test elements, each having a lancing unit to insert or surfaces in body tissues and include a test unit for application of body fluid. The invention further relates to a method for processing such a magazine.

Such test systems are intended mainly for diabetics daily repeatedly performed blood glucose self-monitoring. Recent concepts envisage a microneedle connected prior to a test field as a single system (disposable) to generate a skin puncture, to remove a small amount of blood using capillary forces thereof and to analyze this blood sample. With such an integrated system are in a largely automated measuring process by laymen, the necessary steps can be made easily and quickly. An important aspect is the miniaturization in terms of high integration of disposables in a small space in a handset. In this context, already blister which, however, due to rigid frame were packagings for packing tightly integrated test elements pro- posed,

BESTATIGUNGSKOPIE bring with trough-shaped formations disadvantages both during manufacture and in use with it.

Proceeding from this, the present invention seeks to avoid that occurred in the prior art disadvantages and to provide improvements also to the effect that a high integration density and hygienic handling is possible.

To achieve this object, the feature combinations specified in the independent patent claims are proposed. Advantageous refinements and developments of the invention result from the dependent claims.

The invention is based on the idea to ensure a high integration density and handling security for the test elements in two-dimensional cellular areas of one foil bag. Accordingly, a first aspect of the invention is that the lancing units and test units are arranged separately from each other in separate recording cells. The cells can be simply by the intermediate area between see realize the not shaped foil bands. By separating and advantages are achieved in that the lancing elements independently pretreated without damage to the test chemical, in particular can be sterilized and rendered hydrophilic, and that during the lancing process there is no danger that Test chemicals enter the body. In addition, this solution is characterized by the possibility of simple manufacture in particular by roll-to-roll manufacturing, a particularly shallow, winding capable configuration is possible.

Advantageously, the lancing units and test units are alternately in the tape direction or transversely thereto in pairs adjacent to the associated receiving cells.

A particularly preferred embodiment provides that the lancing units are preferably sterilized in the associated receiving cells by irradiation through a mask for shielding the test units.

A manufacturing simplification is also achieved that the foil strips are connected along their length with a test strip, and that the test tape is released through openings in the foil tapes to form the test units cell by cell.

With a view to durability, it is also advantageous if in the host cells for Testeinhei- th a desiccant is incorporated.

Another aspect of the invention is that at least the lancing units can be removed by means of transport from their respective receiving cell and in a completely separate from the foil bands working posture position are movable. In this way, a fully automated process flow without obstruction by the magazine loading is possible, whereby the hygienic disposal of used units can be easily solved.

For a simple successive cropping of individual units, it is advantageous if the transport means comprise a Bandzugvorrichtung for pulling the foils ribbons in different directions. This can be realized that the two Bandzugvorrichtung arranged at a donation point at a lateral distance from each other in opposite directions rotating or stationary deflection roller and the Umlenkzylindern having Subordinated Aufwiekelspulen for film strips characterized.

To fluid easily process to be analyzed according to the summary task Körperflüs-, it is advantageous if the means of transport for returning a

Lancing unit are formed in an operative connection with one located on the foil tapes test unit and / or disposal site.

A further improvement is achieved in that the transport means comprise a handling device for picking up and positioning an exempted by pulling the film strips at a donation site lancing unit. It is advantageous if at least one of the foil tapes positioning in particular has in the region of the receiving cells of the test units for the engagement of the handling device.

The Single Collection and Handling is also suitable for integrated test elements in which the lancing units are connected to the test units as physically.

A particularly preferred embodiment of the invention provides that at least one of the foil strips is provided with a redemption structure for preferably adhesive or clamping fixation of used lancing elements. In this manner a particularly simple disposal of contaminated units is possible.

To increase the integration density, it is advantageous if the lancing units are arranged flat as flat material parts between the foil tapes. Here, the film strips should be flat and free rest of blisters or spatial formations flat against the lancing units.

A further advantageous embodiment provides that the Released at a donation site lancing units are zurückdispensiert at a remote therefrom return point on one of the foil strips. For restrictions in individual handling of lancing units and optionally related test elements be avoided. Advantageously, the lancing units have a preferably formed by a half-open channel capillary structure for collecting Körperflüssigkei. Another improvement provides that the lancing units are designed for the transfer of the recorded body fluid to the test units.

For the production of the cell structure, it is advantageous if the receiving cell connections by linienfδrmige Folienver-, preferably welded or glued seams are defined between the foil strips. A further improvement is achieved in that the receiving cell through the film connections against one another and are sealed tightly against the surrounding material.

In order to facilitate the tearing of the film package, it is advantageous if the linear foil connections extend obliquely to the tape longitudinal direction of the foil tapes.

Advantageously, the lancing units are fixed in position by a form-fitting umrandende or engaging in recesses film compounds in their assigned receiving cell fixed.

It is also advantageous if at least one of the foil tapes has or forms, so that a non-contact scanning by the tape is reciprocated by possible a transparent measuring window for an optical measurement of the test units. A high packing density let also be achieved that the foil strips are kept with the test elements therein in a zigzag fold as a folded package.

Advantageously, the foil bands are recorded with the test elements located therein in a cassette. The test units can specifically as with reagents coated detecting patches for detecting an A- nalyten in Korperflussigkeit, especially glucose be formed.

The invention is also a test apparatus for processing a test magazine mentioned.

In procedural terms, the aforementioned object is achieved in that the lancing units optionally exempted in conjunction integrated test units by pulling the film strips individually, then moved to a cell of the associated recording remote working position and then returned to a magazine back on one of the foil strips. It is particularly favorable when collected body fluid by means of the lancing units in the working position and subsequently transferred to the test units.

The following describes the invention based on the Ausfuhrungsbeispie- schematically shown in the drawing le explained in more detail. Show it:

Figure 1 is a film magazine for blood glucose testing in a sectional plan view.

Figure 2 shows a further film or test magazine in a sectional plan view.

3 shows the individual components of the film magazine of Figure 2 in an exploded view..;

Fig. 4 and 5 show further embodiments of film magazines in a sectional plan view;

Figure 6 shows an embodiment with a bellows as a supply for test elements in perspective view.

7 is a test magazine in a magazine housing in cutaway perspective view. and

Fig. 8 is a hand-held device for processing a test magazine according to Fig. 7.

The test magazines shown in the drawing comprehensive sen as a foil package 10 two sandwiched interconnected foil strips 12, 14, between which receiving spaces 16 cells kept or, in which test elements 18, 20 provided for the successive processing. As shown in FIG. 1, as the test elements pairwise associated lancing units and test units 18, 20 are provided which mezellen in separate recordings 16 are arranged separated from each other. In the illustrated embodiments, the lancing units and test units 18 20 are seen in the tape direction alternately arranged. Conceivable are also transverse to the band direction side by side or at an angle lying offset arrangements or integrated combinations of test elements, in which the lancing units are physically connected to the 18 test units 20th

The puncturing units 18 are formed as flat moldings from a thin stainless steel sheet and have a distal lancing member 22 for piercing, for example in the fingers of a test for blood collection in the form of a microneedle on. The lancing member 22 is a semi-open groove-shaped capillary channel 24 with a holding portion 26 for collecting and sharing blood connected to. For this purpose can be the lancing unit in question 18 after the collection process with an associated test unit 20 so bring in connection that this is applied to the collected blood to detect an analyte therein (glucose) in a one-time measurement. This shall be proved by a color reaction of the strip-shaped test units 20 and a photometric measurement in a conventional manner. For this purpose, at least one of the film strips 12, 14 are made as an optical window of a transparent material. The receiving cells 16 are two-dimensionally extended intermediate regions between the e- surrounded foil strips 12, 14 is kept free, the test elements 18, 20 receive as substantially flat. The foil strips 12, 14 thus remain free of blisters or trough-like formations in surface contact elements with the flat test, so that a compact space-saving or winding wrinkles is possible. For example, 18 may have a unit of area of ​​5 x 10 mm the lancing units, so that even when a total number of 100 pieces still an acceptable winding diameter is achieved for the use in a handheld device.

For the isolation and optionally fixing the test elements the receiving cells 16 are limited by line-shaped joints 28 between the foil strips 12, 14th In Fig. 1 this is a ladder-shaped structure made of welded or glued seams is provided which 16 provide a tight seal material of the receiving cells from each other and environment.

The separate arrangement, it is possible to use the packaged lancing units 18 independently of the Testein- units 20 to be sterilized by irradiation, without the chemicals sensitive test of the test units are damaged. This can be done through a resist mask, not shown, which transmits a high-energy radiation (X-ray or electron beam) only to the lancing units 18th Moreover, it is by the Separation possible, the lancing units 18 hydrophilizing for effective fluid intake by a surface treatment, without having to take into consideration the test chemical. A further advantage is that the chemicals used for the detection can not enter the body of the person being examined during the lancing process.

From FIGS. 2 and 3, an expedient As- results semblierung a band package 10 with alternating recessing and test units 18, 20. The prefabricated lancing units 18 are enclosed flat between the bands 12, 14, wherein the inner side is arranged on the tape 12 bond lines 18 receiving cells 16 limit. On the outside, on the belt 14 is a continuous strip 30 is fixed by means of adhesive tape 32nd The test strip 30 is formed by apertures 34 provides in the carrier tape 14 in each second receptacle cell 16 for the application of body fluid or blood released, so that in this way the separate test units 20 are formed. The described multi-film structure mass production in high throughput of role is easier to roll.

In the cell region of the test units 20 desiccant 36 can optionally also be present as a band portions. Furthermore, position in these areas onierungslδcher 38 punched in the tape 14, so that the lancing unit 18 after the collection process can be accurately positioned, as explained in more detail below tert is. It is particularly advantageous is when line- on the foil strips 14 in particular or punctate adhesive structures 40 a simple Remagazi- ordination spent lancing units allow 18 or inte- grated test elements. It is also possible that in the cells of the puncturing units 18 to the releasable holding sion additional locking points 42 are provided.

The embodiments of FIGS. 4 and 5 show similar before film packs 10, wherein like parts are provided with the same reference numerals as described above. Here, the connection structure is distinguished 28 between the broadside superimposed bands 12, 14 by additional functions. Firstly, a position firm fixation of the puncturing units 18 is ensured by engaging in recesses 44 of the lancing units and a peripheral system to support points 46th Secondly ensure obliquely to the tape lengthwise connecting seams 28 'for an up tearing the belts 12, 14 for the exemption of

Lancing units 18 without power peaks to enable smoothly.

Fig. 6 illustrates schematically greatly simplifies the deployment of individual test elements or lancing units 18 out of the film magazine 10. In the illustrated embodiment, the film strips 12, 14 with the test elements contained therein are zigzag-shaped stocked as a folded package 48th For successive exemption of lancing units 18 is in a housing, not shown, a Bandzugvorrichtung 50 is provided, the coils of two winding 52, 54 for the foil strips 12, 14 and these upstream, arranged at a dispensing location 56 laterally spaced from each other deflecting rollers 58 summarizes ura-. By tearing apart the bands 12, 14 in the region of the deflection rollers 58, the lancing units are exempted 18 for further processing. Here, the rotation of the winding reel 52, 54 synchronized to keep the belts 12, 14 is always tensioned. Such an arrangement may be as a dispenser also intended abzuspenden individual units 18, which are then used for example manually in a separate instrument.

Fig. 7 shows a preferred arrangement in a partially broken illustrated magazine housing 60. The film package 10 is there arranged on a supply roll 62, the interconnected bands 12, 14 deducted from the over the pulleys 58 and thereby torn apart under exemption of the test elements are , After use, the test elements are brought back to an optionally 56 remote from the position abgespendeten return point 63 back to the inside of the belt 12, in which adhesive strips 40 bring about the containment. In this way, the used test elements 18 can wound onto the spool 52 and are thus easily disposed of.

The test device 64 described above can be used as a disposable article in a handset 66, as is shown in simplified form in Fig. 8. Such a device 66 includes all the necessary for the implementation of a glucose measuring equipment as power supply 68, measuring and display electronics 70 and actuator 72 for the handling of individual, abgespendeter from the tape magazine 10 lancing units 18 and a measuring optical system 76. In the illustrated embodiment, a handling device 74 72 is provided as part of the actuator for receiving the elements 18 at the dispensing point 56, to be brought into a position remote from the belts 12, 14 positioned crossways puncturing position, to perform the lancing movement through a housing opening and bring back on the belt 12 after the blood collection. There is a non-contact optical measurement is made, to then display the determined result the user can by means of the measuring unit 76th In this way self-examinations may be performed in a fully automatic measuring sequence by laymen, with a large number of tests are possible by the magazine loading. The spent cartridge 64 can be taken as a complete unit from the unit 66, without the blood-contaminated parts should be disposed of separately.