HK1105569B - Test magazine - Google Patents

Description

Test box

Technical Field

The invention relates to a test cartridge having two wraparound foil strips connected to one another in a sandwich manner and having a plurality of test elements, between which a receiving chamber for the test elements remains, and the test elements each comprise a lancing unit for lancing body tissue and a test unit for loading body fluid. The invention also relates to a method of using such a test cartridge.

Background

The test system is mainly used for self-checking blood sugar of diabetics many times every day. More recent proposals provide a microneedle (disposable) as a disposable system in combination with a test zone for creating a skin perforation from which a small amount of blood is withdrawn by capillary suction and the blood sample is analysed. With such an integrated system, even laypersons can easily and quickly carry out the necessary steps in a largely automated test sequence. An important aspect is that the disposable is designed to be miniaturized in view of the large number of disposables integrated in the narrow space of the hand-held instrument. In this case, foil bags for firmly packed integrated test elements have been proposed since long, but these have disadvantages both in terms of production and in terms of use due to their rigid frame and the trough-like depression.

Disclosure of Invention

Starting from this, the object of the invention is to avoid the disadvantages of the prior art and to improve it in such a way that a high integration density can be achieved and operation can be carried out hygienically.

To solve this object, combinations of features specified in the independent claims are proposed. Preferred embodiments and developments of the invention are obtained in the dependent claims.

The invention is based on the basic idea of ensuring a high integration density and operational safety for the test elements in the two-dimensional cell-shaped region of the film packet. Accordingly, a first aspect of the invention consists in that the lancing unit and the test unit are arranged separately from one another in separate receiving chambers. The cells can be realized simply by means of intermediate regions between the film strips which are not further shaped. By means of this separation, the advantage is also achieved that the needling elements can be pretreated independently of one another, in particular can be disinfected and hydrophilically treated independently of one another, without damaging the test chemicals, and that there is no risk of the test chemicals entering the body during the needling process. The solution is further characterized by the possibility of simple production, in particular by a roll-to-roll production method, wherein a particularly flat, rollable structure can be achieved.

The lancing units and the test units are preferably arranged next to one another in pairs in the associated receiving cells, alternately in the direction of the strip or transversely thereto.

According to a particularly preferred embodiment, the irradiation is preferably carried out through a masking device for isolating the test unit, in order to sterilize the lancing unit in the associated receiving chamber.

It is also possible to connect the film strip over its entire length to a test strip and to make the test strip available to the person in a cell-by-cell manner by way of perforations in the film strip in the case of test cells, thereby simplifying the production process

It is also preferable to put a desiccant in the housing chamber for the test unit in view of long durability.

Another inventive idea is that at least the needling units can be removed from their respective receiving chamber by the transport device and can be moved into a working position completely separated from the film web. In this way, a fully automatic process flow can be achieved without storage being impeded, wherein the used units can also be cleaned in a simple manner to meet hygienic requirements.

In order to make the individual units available to the user in a simple and continuous manner, the transport device preferably comprises a pull-off mechanism for pulling the film strip in different directions. This can be achieved by the fact that the draw-off mechanism packet has two laterally spaced guide rollers which are rotatable in opposite directions or are stationary in a supply position, and a winding shaft for the film web which is arranged downstream of the guide rollers.

In order to be able to easily continue the treatment of the body fluid to be analyzed after the collection process, the delivery means is preferably provided for resetting a lancing unit into operative connection with a test unit and/or a cleaning station on the film strip.

A further improvement is achieved in that the transport device comprises an actuating mechanism for gripping and positioning a needling unit exposed in a supply position by the film webs being pulled apart from one another. It is advantageous here if at least one of the film strips has a positioning hole for the engagement of the actuating means, in particular in the region of the receiving chamber of the test unit.

The individual sampling and handling is also suitable for integrated test elements on which the needle unit is integrally connected to the test unit (koerperlich).

In a particularly preferred development of the invention, at least one of the film strips is provided with a retraction mechanism for preferably adhesively or clampingly securing the used puncturing element. In this way, the soiled unit can be cleaned particularly easily.

In order to increase the integration density, the needling unit is preferably arranged as a flat material piece between the film webs. The film web should have a flat surface and lie flat against the needling unit without air holes or spatial recesses being produced.

In a further preferred embodiment, the needling unit exposed at a supply point is returned to one of the film webs at a recovery point remote from the supply point. This further avoids restrictions when the needling unit is individually handled and, if necessary, when the test elements connected thereto are individually handled.

The lancing unit preferably has a capillary structure for collecting body fluid, preferably formed by a half-open channel. A further development consists in that the lancing unit is provided for transferring the received body fluid to the test unit.

For producing the cell structure, it is advantageous to have the receiving cells bound between the film strips by a thread-like film connection, preferably by a weld seam or adhesive seam. A further development is achieved in that the receiving chambers are sealed off from one another and from the environment by a film connection.

To simplify the pulling-apart of the film packs, the thread-like film connections preferably extend obliquely to the longitudinal direction of the film strips.

The needle unit is preferably fixed in a positionally fixed manner in the associated receiving chamber by a film connection that is surrounded by a positive-fit connection or engages in a recess.

It is also advantageous if at least one of the film strips has or forms a transparent measuring window for the optical measurement of the test unit, so that a contactless scanning can be carried out through the strip.

The film strip with the test elements therein is prepared in a zigzag-folded form as a folded package, whereby also a high packing density can be achieved.

The film strip with the test elements therein is preferably held in a magazine. The test element can be provided exclusively as a reagent-coated indicator zone for indicating an analyte, in particular glucose, in a body fluid.

The subject of the invention is also a test meter for using said test cartridge.

In terms of method, the task mentioned at the outset is solved by the fact that the lancing unit, optionally in combination with the integrated test unit, is individually made available to a person by pulling the film strips apart, then moved into a working position remote from the associated receiving chamber, and then stored again on one of the film strips. In this case, it is particularly advantageous if the body fluid is collected by means of a lancing unit in the operating position and subsequently transferred to a test unit.

Drawings

The invention will be explained in more detail below on the basis of an embodiment which is shown schematically in the drawing. The figures show:

FIG. 1 shows a top view of a cut-out portion of a membrane cassette for blood glucose testing;

FIG. 2 shows a top view of a cut-away portion of another thin film cassette or test cassette;

fig. 3 shows an exploded view of the individual components of the film cassette according to fig. 2;

FIGS. 4 and 5 show top views of cut-outs of other embodiments of the thin film cassette;

FIG. 6 shows a diagrammatic schematic view of an embodiment having a bellows for a supply of test elements;

FIG. 7 shows a perspective view of a test cartridge in a cartridge body in a cut-away condition;

fig. 8 shows a hand-held instrument using the test cartridge according to fig. 7.

Detailed Description

The test cartridge shown in the figures comprises, as a film packet 10, two film strips 12, 14 connected to one another in a sandwich-like manner, between which two film strips 12, 14 a receiving region or receiving chamber 16 is left, and in which test elements 18, 20 are provided for use one after the other.

As can be seen from fig. 1, a lancing unit 18 and a test unit 20, which are arranged in pairs with one another and are arranged separately from one another in a separate receiving chamber 16, are provided as test elements. In the embodiment shown, the lancing units 18 and the test units 20 are arranged alternately, viewed in the direction of the tape. It is also conceivable to arrange or integrate test elements laterally alongside one another or diagonally staggered transversely to the tape direction, wherein the needling unit 18 is integrally connected to the test unit 20.

The lancing unit 18 is a flat formed part made of thin high-quality steel plate and has a distal lancing mechanism 22 in the form of a microneedle for lancing, for example, a finger of a subject to take out blood. The lancing mechanism 22 is connected to a holding area 26 for collecting and transferring blood by a semi-open channel-shaped capillary channel 24. For this purpose, the respective lancing unit 18 can be connected to an associated test unit 20 after the collection process, so that the test unit 20 is loaded with the collected blood for indicating the analyte (glucose) contained therein in a single measurement. This can be indicated in a known manner by a color reaction of the strip-shaped test element 20 and by photometric measurements. For this purpose, at least one of the film strips 12, 14 is made of a transparent material as an optical window.

The receiving chamber 16 is open between the flat film strips 12, 14 as an intermediate region extending substantially in two dimensions for receiving the test elements 18, 20 in a flat manner. The film strips 12, 14 are thus in flat contact with the flat test element without air holes or trough-like recesses, so that they can be wound compactly or folded in a space-saving manner. For example, the needling unit 18 may have an area size of 5 x 10 mm, so that an acceptable winding diameter for use in hand-held instruments is achieved even with about 100 needling units.

For separating and, if necessary, fixing the test elements, the receiving chamber 16 is delimited by a linear connection 28 between the film strips 12, 14. In fig. 1, a stepped structure of welds or adhesive seams is provided for this purpose, which seals the receiving cells 16 against one another and against the surrounding environment.

By the separate arrangement, the packaged lancing unit 18 can be sterilized by radiation independently of the test unit 20 without damaging the sensitive test chemicals of the test unit. This can be done by an isolation mask mechanism, not shown, which only allows energy-rich radiation (X-rays or electron beams) to be transmitted through the needling unit 18. Furthermore, the isolation allows the needling unit 18 to be hydrophilized by a surface treatment to effectively absorb fluids without consideration of the test chemicals. Another advantage is that the chemicals used for the indication do not enter the subject's body during the needle stick.

Fig. 2 and 3 show an advantageous embodiment for assembling a film-strip packaging 10 with alternating needling and testing units 18, 20. The prefabricated needling unit 18 is enclosed flat between the film strips 12, 14, wherein the adhesive threads 28 arranged on the inside on the film strip 12 delimit the receiving chamber 16. A continuous test strip 30 is fixed to the outer side of the film strip 14 by means of an adhesive tape 32. The test strips 30 are loaded with body fluid or blood through the perforations 34 in the carrier strip 14 in every second receiving cell 16, thereby forming an individual test element 20. With the described multi-film structure, mass production at high roll-to-roll throughput is simplified.

In the cell region of the test unit 20, a drying agent 36 can be contained, which is also a section of the film strip if necessary. Furthermore, positioning holes 38 are punched in the film web 14 in these regions, so that the needling unit 18 can be positioned precisely after the collecting process, as will be explained in more detail below. It is particularly advantageous if the adhesive structure 40, in particular in the form of a line or dots, on one of the film strips 14 allows a simple restocking of the used lancing unit 18 or of the integrated test elements. Positioning points 42 may also be provided in the chambers of the lancing unit 18 for the releasable fastening of the lancing unit 18.

The embodiment of fig. 4 and 5 shows a similar blister pack 10, wherein identical parts as previously described are provided with the same reference numerals. The connection 28 between the film strips 12, 14 lying one above the other on the broadside is distinguished here by an additional function. On the one hand, the stationary fixing of the needling unit 18 is ensured by the engagement in the recesses 44 of the needling unit and the edge-side contact at the support points 46. On the other hand, the connecting seam 28' running obliquely to the longitudinal direction of the film web ensures that the film webs 12, 14 tear off smoothly without force peaks, in order to be able to use the needling unit 18.

Fig. 6 illustrates in a schematic representation, in a very simple manner, the method by which individual test elements or lancing units are fed from a film cassette. In the embodiment shown, the film strips 12, 14 with the test elements contained therein are stored in a zigzag shape as folded packs 48. In order to expose the needling units 18 one after the other, a draw-off belt mechanism 50 is provided in a housing, not shown, which draw-off belt mechanism 50 comprises two reels 52, 54 for the film webs 12, 14 and guide rollers 58 arranged in front of the two reels and laterally spaced apart from one another at a feed point 56. In the region of the guide rollers 58, the film webs 12, 14 are separated from one another, so that the needling unit 18 is available for further use. The rotation of the reels 52, 54 is synchronized in order to always keep the film webs 12, 14 in a tensioned state. One such configuration may be provided as a dispenser for dispensing individual lancing units 18, the lancing units 18 then being loaded, for example manually, into a separate meter.

Figure 7 shows a preferred arrangement in a partially sectioned cassette 60. The film package 10 is placed there on a supply roll 62, from which supply roll 62 the film webs 12, 14 connected to one another are drawn off by the guide roller 58, and the two film webs 12, 14 are separated from one another in the case of a test element intended for human use. After use, the test element is returned, if necessary, at a retrieval position 63 remote from the dispensing position 56, to the inner side of the film web 12, the adhesive tape 40 serving as a support. In this way, the used test element 18 can be wound onto the reel 52 and can thus be cleaned simply.

The test cartridge 64 may be used as a disposable product in a hand-held instrument 66, as shown schematically in fig. 8. One such instrument 66 includes all the necessary working equipment for performing a glucose measurement, such as an energy source 68, measurement and display electronics 70, and an actuator 72 for operating the individual lancing units 18 dispensed from the film tape cartridges 10, as well as a set of measurement mirrors 76. In the embodiment shown, an actuating mechanism 74 is provided as part of the actuating mechanism 72 for receiving the elements 18 in the supply position 56, placing them in a transverse puncturing position remote from the film strips 12, 14, performing the puncturing movement through a housing opening and, after the blood has been collected, returning them back to the film strip 12. Where a contactless optical measurement is carried out by means of the measuring unit 76, in order to be able to subsequently display the detection result to the user. In this way, even laymen can carry out self-checks in a fully automatic measuring process, wherein a large number of tests can be carried out by storing the lancing units. Spent test cartridges 64 may be removed from instrument 66 as a complete unit without having to individually clean the blood-contaminated parts.

Claims (51)

1. Test cartridge having two web-like, rollable films (12, 14) connected to one another in a sandwich-like manner, and having a plurality of test elements (18, 20), between which two film webs (12, 14) a receiving chamber (16) for the test elements remains, and in which the test elements (18, 20) each comprise a lancing unit (18) for lancing body tissue and a test unit (20) for applying body fluid, characterized in that the lancing unit (18) and the test unit (20) are arranged separately from one another in the individual receiving chamber (16).

2. Test cartridge according to claim 1, characterized in that the lancing unit (18) and the test unit (20) are arranged in pairs adjacent to one another in the direction of the film web, alternately or transversely to the direction of the film web, in associated receiving chambers (16).

3. Test cartridge according to claim 1 or 2, characterized in that the lancing unit (18) is sterilized in the associated receiving chamber (16) by means of radiation.

4. Test cartridge according to claim 1 or 2, characterized in that the film strips (12, 14) are connected over their entire length to a test strip (30), and that the test strip (30) is made available to the person in a cell-by-cell manner by means of perforations (34) of the film strips (12, 14) in the case of a test cell (20).

5. The test cartridge as claimed in claim 1 or 2, characterized in that a drying agent (36) is introduced into the receiving chamber (16) for the test element (20).

6. A test kit according to claim 3, characterized in that the radiation is sterilized through a masking means for isolating the test element (20).

7. Test cartridge according to claim 1 or 2, characterized in that at least one of the film strips (12, 14) is provided with a retraction structure (40) for securing the consumed lancing element (18).

8. The test cartridge of claim 7, wherein the securing is by adhesive or clamping.

9. Test cartridge according to claim 1 or 2, characterized in that the needling unit (18) is arranged flat as a flat material piece between the film webs (12, 14).

10. Test cartridge according to claim 1 or 2, characterized in that the film strips (12, 14) are of flat construction and lie flat against the needling unit (18) without air bubbles.

11. A cartridge according to claim 1 or 2, characterized in that the lancing unit (18) for human use at a supply location (56) is returned to one of the film strips (12, 14) at a retrieval location remote from the supply location (56).

12. Test cartridge according to claim 1 or 2, characterized in that the lancing unit (18) has a capillary structure (24) for collecting body fluid.

13. The cartridge of claim 12, wherein said capillary structure (24) is formed by a half-open channel.

14. Test cartridge according to claim 1 or 2, characterized in that the lancing unit (18) is designed to transfer the collected body fluid to the test unit (20).

15. Test cartridge according to claim 1 or 2, characterized in that the receiving chamber (16) is delimited by a linear film connection (28) between the film strips (12, 14).

16. Test cartridge according to claim 15, characterized in that the linear film connection (28) is a weld seam or a glue seam.

17. The test cartridge as claimed in claim 15, characterized in that the receiving chambers (16) are sealed from one another and from the surroundings by a film connection (28).

18. Test cartridge according to claim 15, characterized in that the linear film connections (28') extend obliquely to the longitudinal direction of the film strips (12, 14).

19. Test cartridge according to claim 1 or 2, characterized in that the lancing unit (18) is fixed in a positionally fixed manner in the receiving chamber (16) associated therewith by a film connection (28) which surrounds the lancing unit in a form-fitting connection or engages in a recess (44).

20. The test cassette as claimed in claim 1 or 2, characterized in that at least one of the foil strips (12, 14) has or forms a transparent measuring window for optical measurements of the test element (20).

21. Test cartridge according to claim 1 or 2, characterized in that the film strips (12, 14) with the test elements (18, 20) therein are provided in a zigzag-folded form as folding packs (48).

22. The test cassette as claimed in claim 1 or 2, characterized in that it is formed by a magazine (64) which receives the film strips (12, 14) with the test elements (18, 20) therein.

23. The test cartridge of claim 22, wherein the cartridge (64) is a dispenser of test elements (18, 20) such that a single dispensed test element can be loaded into a single tester.

24. The test cartridge according to claim 1 or 2, characterized in that the test element (20) is adapted to indicate an analyte in a body fluid.

25. Test cartridge having two wraparound film strips (12, 14) connected to one another in a sandwich-like manner and having a plurality of test elements (18, 20) arranged in a receiving chamber (16), between which two film strips (12, 14) the receiving chamber (16) for the test elements (18, 20) is retained, and in which the test elements (18, 20) each comprise a lancing unit (18) for lancing body tissue and a test unit (20) for loading body fluid, characterized in that at least the lancing unit (18) can be removed from its respective receiving chamber by means of a delivery device (50, 74) and can be moved into an operating position separated by the film strips (12, 14).

26. The cartridge according to claim 25, characterized in that the transport means (50, 74) comprise a pull-off mechanism (50) for pulling the film strips (12, 14) away from one another in different directions.

27. The test magazine as claimed in claim 26, characterized in that the draw-off mechanism (50) has two laterally spaced apart guide rollers (58) which are arranged at a supply location (56) and can be rotated in opposite directions or are stationary, and a winding shaft (52, 54) for the film webs (12, 14) which is arranged behind the guide rollers (58).

28. The test cassette according to any of claims 25 to 27, characterized in that the transport means (50, 74) are designed to return a lancing unit (18) into operative connection with a test unit (20) located on the film strip (12, 14) and/or the cleaning position.

29. The test cartridge as claimed in one of claims 25 to 27, characterized in that the transport device (50, 74) comprises an actuating mechanism (74), which actuating mechanism (74) serves to grip and position a lancing unit (18) which is separated from one another by the film strips (12, 14) and is intended for human use at a supply position (56).

30. The cassette of claim 29, wherein at least one of the film strips (12, 14) has a registration aperture (38) for engaging the actuator (74).

31. The test cartridge as claimed in claim 30, characterized in that the positioning opening (38) is arranged in the region of the test element (20) which accommodates the chamber (16).

32. The test cartridge as claimed in any of claims 25 to 27, characterized in that the lancing unit (18) is connected integrally with the test unit (20) as an integrated test element (18, 20).

33. The test cartridge as claimed in any of claims 25 to 27, characterized in that at least one of the film strips (12, 14) is provided with a retraction structure (40) for securing the used-up lancing element (18).

34. The test kit of claim 33, wherein said securing is by adhesive or clamping.

35. The test cartridge as claimed in one of claims 25 to 27, characterized in that the needling unit (18) is arranged flat as a flat material piece between the film webs (12, 14).

36. The test cartridge as claimed in any of claims 25 to 27, characterized in that the film strips (12, 14) are of flat construction and lie flat against the needling unit (18) in the absence of air bubbles.

37. The test cartridge as claimed in any of claims 25 to 27, characterized in that the needling unit (18) for human use at a supply location (56) returns one of the film webs (12, 14) to a retrieval location remote from the supply location (56).

38. The test cartridge according to any of claims 25 to 27, wherein the lancing unit (18) has a capillary structure (24) for collecting body fluid.

39. The cartridge of claim 38, wherein said capillary structure (24) is formed by a half-open channel.

40. Test cartridge according to one of claims 25 to 27, characterized in that the lancing unit (18) is designed to transfer the collected body fluid to the test unit (20).

41. The test cassette according to any of claims 25 to 27, characterized in that the receiving chamber (16) is delimited by a linear film connection (28) between the film strips (12, 14).

42. The test cassette of claim 41, wherein the linear film connection (28) is a weld or adhesive seam.

43. The test cartridge as claimed in claim 41, characterized in that the receiving chambers (16) are sealed from one another and from the surroundings by a film connection (28).

44. The test cassette as claimed in claim 41, characterized in that the linear film connections (28') extend obliquely to the longitudinal direction of the film strips (12, 14).

45. The test cartridge as claimed in one of claims 25 to 27, characterized in that the lancing unit (18) is fixed in a positionally fixed manner in the receiving chamber (16) associated therewith by a film connection (28) which surrounds the lancing unit in a form-fitting connection or engages in a recess (44).

46. The test cassette according to any of claims 25 to 27, characterized in that at least one of the foil strips (12, 14) has or forms a transparent measuring window for optical measurements of the test element (20).

47. The test cartridge as claimed in one of claims 25 to 27, characterized in that the film strips (12, 14) with the test elements (18, 20) therein are provided in a zigzag-folded form as a folded package (48).

48. The test cassette as claimed in any of claims 25 to 27, characterized in that it is formed by a magazine (64) which receives the film strips (12, 14) with the test elements (18, 20) therein.

49. The test cassette of claim 48, wherein said magazine (64) is a dispenser of test elements (18, 20) such that a single dispensed test element can be loaded into a single tester.

50. The test cartridge according to any of claims 25 to 27, wherein the test element (20) is adapted to indicate an analyte in a body fluid.

51. Test meter for use with a test cartridge (10) according to any one of the preceding claims or with test elements (18, 20) dispensed therefrom.