SPACE-SAVING MAGAZINING OF ANALYTICAL AIDS

• US 20130324807A1
• Filed: 05/15/2013
• Published: 12/05/2013
• Est. Priority Date: 02/19/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: LIST, Hans, LEICHNER, Wilhelm, KRAEMER, Uwe, KUHR, Hans-Juergen
• Granted Patent: US 9,173,608 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

An analytical magazine is proposed, which comprises a plurality of analytical aids accommodated in chambers. The analytical magazine is arranged to be accommodated in at least two orientations in an analytical system. The analytical magazine is furthermore arranged to provide the analytical system, in the orientations, in each case with a plurality of analytical aids. At least one sampling movement can be executed by means of the analytical aids. The analytical magazine is arranged to make a remagazining of the analytical aids possible.

Claims

1-16. -16. (canceled)

17. An analytical magazine, wherein the analytical magazine has at least two chambers, in which analytical aids can be accommodated, wherein the analytical aids are accommodated in at least one of the chambers, wherein the analytical aids in each case comprise at least one microsampler for making at least one opening in a test subject'"'"'s skin and at least one test element with at least one test chemistry for detecting at least one analyte in a body fluid or other liquid sample, wherein the test chemistry is at least largely stable against moisture, wherein the stability is such that when stored at 32°

C., a relative humidity of the air of 85% at normal pressure for a period of three weeks an activity of the test chemistry of the analytical aid decreases by less than 50%, wherein the analytical magazine has a packing density of the analytical aids of more than 5 analytical aids per cm³.

18. The analytical magazine according to claim 17, wherein the analytical magazine has a housing, wherein the housing has a wall thickness of not more than 1.2 mm.

19. The analytical magazine according to claim 17, wherein the analytical magazine is of drying agent-free design.

20. The analytical magazine according to claim 17, wherein the analytical magazine has a housing with at least two parts, wherein the at least two parts are joined together by a laser welding process, wherein at least one weld seam is provided with a weld seam width of max. 0.5 mm.

21. The analytical magazine according to claim 17, wherein the analytical magazine has a housing, wherein the housing has a material selected from the following materials:

a polycarbonate;

an acrylonitrile-butadiene-styrene;

a cyclo-olefin copolymer;

a polymethylmethacrylate;

a polystyrene; and

a polyethylene terephthalate.

22. The analytical magazine according to claim 17, wherein the analytical magazine is arranged to be accommodated in at least two orientations in an analytical system, wherein the analytical magazine is arranged to supply, in the orientations, in each case a plurality of analytical aids to the analytical system, wherein by means of the analytical aids at least one sampling movement can be executed, wherein the analytical aids comprise at least one transfer element for one or both of receiving a sample of a body fluid and transferring the sample, wherein the analytical magazine is arranged to make a remagazining of the analytical aids possible, wherein the analytical magazine is arranged to hold the analytical aids in place in the chambers after remagazining, wherein the analytical magazine comprises at least two essentially identical partial magazines, wherein each of the partial magazines comprises a plurality of similar analytical aids.

23. The analytical magazine according to claim 22, wherein the analytical system is provided at least partially with a symmetry.

24. The analytical magazine according to claim 22, wherein the analytical magazine comprises at least one indicating element, wherein the indicating element is designed to be detected by the analytical system and to supply at least one piece of information about a current orientation to the analytical system.

25. The analytical magazine according to claim 22, wherein the analytical magazine has a shape of a round disk, wherein the analytical aids are aligned in a radial arrangement in the analytical magazine, wherein the analytical aids are arranged in different levels of aids with an angular offset relative to one another.

26. The analytical magazine according to claim 22, wherein the analytical magazine is arranged to permit access in all orientations to one or both of a chamber located in an application position of the analytical system and at least one analytical aid accommodated in said chamber from at least two directions.

27. The analytical magazine according to claim 22, wherein the analytical aids are arranged at least partially to collect a sample of a body fluid during the sampling movement and transfer it to a test element, wherein sample transfer takes place during remagazining of the analytical aid.

28. The analytical magazine according to claim 22, wherein the analytical aids in each case comprise at least one test element with at least one test chemistry, wherein the test chemistry is arranged to change at least one detectable property when the at least one analyte is present, wherein the test chemistry is integrated at least partially in a housing of the analytical magazine.

29. The analytical magazine according to claim 24, wherein the analytical magazine comprises a number of indicating elements corresponding to the number of possible orientations.

30. The analytical magazine according to claim 26, wherein the magazine is arranged to permit the access in directions opposite to one another.

31. The analytical magazine according to claim 28, wherein the test chemistry is integrated at least partially in a wall of the chambers.

32. An analytical magazine, wherein the analytical magazine has at least two chambers, in which analytical aids can be accommodated, wherein the analytical aids are accommodated in at least one of the chambers, wherein the analytical aids in each case comprise at least one microsampler for making at least one opening in a test subject'"'"'s skin and at least one test element with at least one test chemistry for detecting at least one analyte in a body fluid or other liquid sample, wherein the test chemistry is at least largely stable against moisture, wherein the stability is such that when stored at 32°

C., a relative humidity of the air of 85% at normal pressure for a period of three weeks an activity of the test chemistry of the analytical aid decreases by less than 50%, wherein the chambers are designed so that they are separate from one another, in such a way that an exchange of moisture between the chambers is possible, wherein the chambers have chamber walls, wherein gaps or other openings with an opening width of not more than 20 micrometers are provided in or next to the chamber walls, which on the one hand permit exchange of air humidity between the chambers, but which as a rule hold back coarser contaminants or microbes, wherein the analytical magazine is arranged for remagazining the analytical aids in at least one of the chambers after use.

33. The analytical magazine according to claim 32, wherein the analytical magazine has a housing, wherein the housing has a wall thickness of not more than 1.2 mm.

34. The analytical magazine according to claim 32, wherein the analytical magazine is of drying agent-free design.

35. The analytical magazine according to claim 32, wherein the analytical magazine has a housing with at least two parts, wherein the at least two parts are joined together by a laser welding process, wherein at least one weld seam is provided with a weld seam width of max. 0.5 mm.

36. The analytical magazine according to claim 32, wherein the analytical magazine has a housing, wherein the housing has a material selected from the following materials:

a polycarbonate;

an acrylonitrile-butadiene-styrene;

a cyclo-olefin copolymer;

a polymethylmethacrylate;

a polystyrene; and

a polyethylene terephthalate.

37. The analytical magazine according to claim 32, wherein the analytical magazine is arranged to be accommodated in at least two orientations in an analytical system, wherein the analytical magazine is arranged to supply, in the orientations, in each case a plurality of analytical aids to the analytical system, wherein by means of the analytical aids at least one sampling movement can be executed, wherein the analytical aids comprise at least one transfer element for one or both of receiving a sample of a body fluid and transferring the sample, wherein the analytical magazine is arranged to make a remagazining of the analytical aids possible, wherein the analytical magazine is arranged to hold the analytical aids in place in the chambers after remagazining, wherein the analytical magazine comprises at least two essentially identical partial magazines, wherein each of the partial magazines comprises a plurality of similar analytical aids.

38. The analytical magazine according to claim 32, wherein at least one of the chambers is arranged for remagazining the analytical aids in one of the chambers after use.

39. An analytical system for detecting at least one analyte in a body fluid, comprising at least one analytical magazine, wherein the analytical system is arranged to accommodate the analytical magazine in at least two different orientations, wherein the analytical magazine comprises a plurality of analytical aids accommodated in chambers, wherein the analytical magazine is arranged to be accommodated in at least two orientations in the analytical system, wherein the analytical magazine is arranged to provide the analytical system with in each case a plurality of analytical aids in the orientations, wherein the analytical magazine comprises at least two essentially identical partial magazines, wherein each of the partial magazines comprises a plurality of similar analytical aids, wherein the analytical system is furthermore arranged to execute at least one sampling movement by means of the analytical aids accommodated in the analytical magazine, wherein the analytical aids comprise at least one lancet for making at least one opening in a test subject'"'"'s skin, wherein the analytical aids comprise at least one transfer element for receiving a sample of a body fluid and/or for transferring the sample, wherein the analytical system is furthermore arranged to execute a remagazining of the analytical aids, wherein the analytical magazine is arranged to hold the analytical aids in place in the chambers after the remagazining, wherein the chambers are of such design that the lancets are bent in the chambers and are pressed against a chamber wall by a restoring force.

40. The analytical system according to claim 39, wherein the analytical system has at least one application position, wherein the analytical system is arranged to access, in at least two different orientations of the analytical magazine, at least one chamber and/or at least one analytical aid in the application position and to detect the at least one analyte.

41. The analytical system according to claim 39, wherein the analytical system is arranged to acquire one or more of the following pieces of information:

an orientation of the analytical magazine;

a number of analytical aids of the analytical magazine already used in the current orientation;

a number of aids of the analytical magazine still remaining in the current orientation;

information about orientations of the analytical magazine already used; and

information about orientations of the analytical magazine still remaining.