TEST MAGAZINE AND METHOD FOR PROCESSING THE SAME

• US 20070038150A1
• Filed: 10/02/2006
• Published: 02/15/2007
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Calasso, Irio, Roe, Steven, Kopp, Martin, Raney, Charles
• Granted Patent: US 7,959,581 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15167 Characterized by a folded strip
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15184 Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

A test magazine with two film strips (12, 14), which are joined to one another in a sandwich-like manner, can be wound up, and between which holding cells (16) for test elements are kept free. The test magazine also comprises a multitude of test elements (18, 20) each having a puncturing unit (18) for inserting into body tissue and a test unit (20) for being subjected to body fluid. To this end, the puncturing units (18) and test units (20) are placed in separate holding cells (16) whereby separating them from one another.

Claims

1. Test magazine comprising two spoolable foil tapes (12, 14) joined together in a sandwich-like manner and between which holding cells (16) are kept free for test elements, and a plurality of test elements (18, 20) which each comprise a lancing unit (18) for puncturing body tissue and a test unit (20) to which body fluid can be applied, characterized in that the lancing units (18) and test units (20) are arranged separately from one another in separate holding cells (16).

2. Test magazine according to claim 1, characterized in that the lancing units (18) and test units (20) are arranged alternately in the tape direction or adjacent to one another in pairs at right angles to the tape direction in associated holding cells (16).

3. Test magazine according to claim 1, characterized in that the lancing units (18) in the associated holding cells (16) are sterilized by irradiation preferably through a mask in order to screen the test units (20).

4. Test magazine according to claim 1, characterized in that the foil tapes (12, 14) are joined to a test tape (30) over their length and that cells on the test tape (30) are exposed by perforations (34) in the foil tapes (12, 14) to form the test units (20).

5. Test magazine according to claim 1, characterized in that a desiccant (36) for the test units (20) is stored in the holding cells (16).

29. Process for processing a test magazine (10) according to claim 1 in which the lancing units (18) optionally in conjunction with integrated test units (20) are individually exposed by pulling apart the foil tapes (12, 14), are then moved into a working position that is distant from the associated holding cell (16) and are subsequently stored again on one of the foil tapes (12, 14).

30. Process according to claim 29, characterized in that body fluid is collected in the working position by means of the lancing units (18) and is subsequently transferred onto the test units (20).

6. Test magazine comprising two spoolable foil tapes (12, 14) joined together in a sandwich-like manner and between which holding cells (16) are kept free for test elements (18, 20), and a plurality of test elements (18, 20) arranged in the holding cells (16) which each comprise a lancing unit (18) for puncturing body tissue and a test unit (20) to which body fluid can be applied, characterized in that at least the lancing units (18) can be removed by transport means (50, 74) from their respective holding cell and can be moved into a working position which is separate from the foil tapes (12, 14).

7. Test magazine according to claim 6, characterized in that the transport means (50, 74) comprises a tape tensioning device (50) to pull apart the foil tapes (12, 14) in different directions.

8. Test magazine according to claim 7, characterized in that the tape tensioning device (50) has two deflecting cylinders (58) that can rotate in opposite directions or are stationary and are arranged laterally spaced apart from one another at a dispensing site (56) and has take-up spools (52, 54) for the foil tapes (12, 14) downstream of the deflecting cylinders (58).

9. Test magazine according to claim 6, characterized in that the transport means (50, 74) are in operative connection with a test unit (20) and/or disposal site located on the foil tapes (12, 14) in order to return a lancing unit (18).

10. Test magazine according to claim 6, characterized in that the transport means (50, 74) comprise a handling device (74) to pick up and position a lancing unit (18) that has been exposed by pulling apart the foil tapes (12, 14) at a dispensing position (56).

11. Test magazine according to claim 10, characterized in that at least one of the foil tapes (12, 14) has positioning holes (38) especially in the region of the holding cells (16) for the test units (20) to enable the handling device (74) to engage.

12. Test magazine according to claim 6, characterized in that the lancing units (18) are physically joined to the test units (20) as integrated test elements (18, 20).

13. Test magazine according to claim 6, characterized in that at least one of the foil tapes (12, 14) is provided with a withdrawal structure (40) for the preferably adhesive or clamping fixation of used lancing elements (18).

14. Test magazine according to claim 6, characterized in that the lancing units (18) are arranged flat between the foil tapes (12, 14) as flat material components.

15. Test magazine according to claim 6, characterized in that the foil tapes (12, 14) have a planar design and rest laminarly against the lancing units (18) free of blisters.

16. Test magazine according to claim 6, characterized in that the lancing units (18) exposed at a dispensing site can be redispensed at a return position on one of the foil tapes (12, 14).

17. Test magazine according to claim 6, characterized in that the lancing units (18) have a capillary structure (24) that is preferably formed by a semi-open channel to collect body fluid.

18. Test magazine according to claim 6, characterized in that the lancing units (18) are formed on the test units (20) in order to transfer collected body fluid.

19. Test magazine according to claim 6, characterized in that the holding cells (16) are delimited by linear foil connections (28), preferably welded or adhesive seams between the foil tapes (12, 14).

20. Test magazine according to claim 19, characterized in that the holding cells (16) are sealed against one another and against the environment in a material-tight manner by the foil connections (28).

21. Test magazine according to claim 19, characterized in that the linear foil connections (28′

) extend obliquely to the tape longitudinal direction of the foil tapes (12, 14).

22. Test magazine according to claim 6, characterized in that the lancing units (18) are immobilized in a fixed position in their assigned holding cell (16) by form-locking bordering foil connections or foil connections (28) that engage in recesses (44).

23. Test magazine according to claim 6, characterized in that at least one of the foil tapes (12, 14) has or forms a transparent measuring window for an optical measurement of the test units (20).

24. Test magazine according to claim 6, characterized in that the foil tapes (12, 14) with the test elements (18, 20) located therein are held ready as a folded package (48) in a zigzag folding.

25. Test magazine according to claim 6, characterized by a cassette (64) that receives the foil tapes (12, 14) with the test elements (18, 20) located therein.

26. Test magazine according to claim 25, characterized in that the cassette (64) is designed as a dispenser for test elements (18, 20) such that the individually dispensed test elements can be used in a separate test device.

27. Test magazine according to claim 6, characterized in that the test units (20) are designed to detect an analyte in the body fluid.

28. Test device for processing a test magazine (10) or test elements (18, 20) dispensed therefrom according to claim 6.