Capillary biosensor analysis system

• US 7,638,023 B2
• Filed: 03/24/2005
• Issued: 12/29/2009
• Est. Priority Date: 09/26/2002
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Marquant, Michael
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US11/088,305
• Publication Number:
  US 20050230253A1
• Time in Patent Office: 1,741 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 422 55- 58
• US Class Current: 204/403.02
• CPC Class Codes: B01L 2300/0812 Bands; Tapes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A capillary biosensor analysis system is provided for analyzing a liquid sample, comprising a plurality of longitudinally arranged and consecutively provided and aligned capillary biosensors having a capillary channel enclosed by at least two wall parts and containing one or more reagents, and an evaluation instrument which has a holder to position a forward-most capillary biosensor in a measurement position for performing an analysis. The plurality of capillary biosensors are implemented as a multiple capillary-biosensor strip. A multiple capillary-biosensor strip is guided and held in the holder in such a manner that one capillary biosensor of the strip at a time is located in the measurement position. The multiple capillary-biosensor strip is movable in the evaluation instrument in such a manner that consecutive capillary biosensors of the multiple capillary-biosensor strip are transported one after the other into the measurement position.

Claims

1. A multiple capillary-biosensor strip for an analysis system adapted for analyzing a sample liquid, said strip comprising:

a plurality of capillary biosensors arranged longitudinally along the strip and consecutively provided one after the other, each said biosensor including a capillary channel delimited by at least two wall parts and having an inlet on one end thereof for drawing the sample liquid therein by capillary forces and a vent, the capillary channel of each said biosensor containing at least one reagent, the reaction of the sample liquid with the at least one reagent resulting in a measurable change of a measurement variable which is characteristic for the desired analysis of the sample liquid.

2. The multiple capillary-biosensor strip according to claim 1, wherein the wall parts are formed from at least two tapes.

3. The multiple capillary-biosensor strip according to claim 1 or claim 2, said strip being implemented as a resiliently flexible band adapted for being wound up in a curved state for being removably inserted into an evaluation instrument.

4. The multiple capillary-biosensor strip according to claim 3, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

5. The multiple capillary-biosensor strip according to claim 4, wherein the flow obstruction comprises an aperture extending through at least one of the wall parts and over the width of the capillary channel.

6. The multiple capillary-biosensor strip according to claim 5, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

7. The multiple capillary-biosensor strip according to claim 6, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

8. The multiple capillary-biosensor strip according to claim 3, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

9. The multiple capillary-biosensor strip according to claim 8, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

10. The multiple capillary-biosensor strip according to claim 4, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

11. The multiple capillary-biosensor strip according to claim 10, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

12. The multiple capillary-biosensor strip according to claim 1 or claim 2, said wall parts comprising at least an upper tape and a lower tape, each said tape generally continuously extending over the longitudinal length of the strip for delimiting the capillary channels of each consecutively provided biosensor.

13. The multiple capillary-biosensor strip according to claim 12, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

14. The multiple capillary-biosensor strip according to claim 13, wherein the flow obstruction comprises an aperture extending through at least one of the wall parts and over the width of the capillary channel.

15. The multiple capillary-biosensor strip according to claim 14, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

16. The multiple capillary-biosensor strip according to claim 15, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

17. The multiple capillary-biosensor strip according to claim 13, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

18. The multiple capillary-biosensor strip according to claim 17, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

19. The multiple capillary-biosensor strip according to claim 12, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

20. The multiple capillary-biosensor strip according to claim 19, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

21. The multiple capillary-biosensor strip according to claim 1 or claim 2, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall pans, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

22. The multiple capillary-biosensor strip according to claim 21, wherein the flow obstruction comprises an aperture extending through at least one of the wall parts and over the width of the capillary channel.

23. The multiple capillary-biosensor strip according to claim 22, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

24. The multiple capillary-biosensor strip according to claim 23, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

25. The multiple capillary-biosensor strip according to claim 21, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

26. The multiple capillary-biosensor strip according to claim 25, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

27. The multiple capillary-biosensor strip according to claim 1 or claim 2, each said biosensor comprising an electrochemical capillary sensor having a working electrode, a counter electrode, and means for electrically connecting the working and counter electrodes to an evaluation instrument configured for measuring the measurement variable.

28. The multiple capillary-biosensor strip according to claim 27, wherein said working electrode comprises a first electrically conductive layer extending over a capillary-channel facing surface of one said wall part, and said counter electrode comprises a second electrically conductive layer extending over a capillary-channel facing surface of the other said wall part, each said layer being electrically isolated from the other along the multiple capillary-biosensor strip.

29. The multiple capillary-biosensor strip of claim 1, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each how obstruction being provided in conjunction with at least one capillary channel and being configured to obstruct the flow of sample liquid through the capillary channel to prevent flow from continuing into the inlet of the following biosensor.

30. A capillary biosensor analysis system for analyzing a sample liquid, such as a bodily fluid of humans and other animals, with respect to an analyte contained therein, comprising:

a plurality of capillary biosensors, said biosensors each including a capillary channel delimited by at least two wall parts and having an inlet for the sample liquid and a vent, the capillary channel of each said biosensor containing at least one reagent, the reaction of the sample liquid with the at least one reagent resulting in a measurable change of a measurement variable which is characteristic for the analysis;

and an evaluation instrument, said instrument comprising a holder configured for positioning one of said capillary biosensors in a measurement position for performing the analysis, said measurement position being such that said inlet of said one capillary biosensor is accessible for bringing a sample liquid to be assayed into contact with the inlet, whereby the sample liquid is drawn by capillary forces into the capillary channel; and

an electrical measurement and evaluation device in said instrument for measuring the measurement variable and determining the desired analysis information on the basis of the measured value resulting from the measurement;

wherein the plurality of capillary biosensors are provided in a multiple capillary-biosensor strip comprising said plurality of capillary biosensors arranged longitudinally and consecutively provided one after the other, said multiple capillary-biosensor strip being guided and held in the holder of the evaluation instrument in such a manner that one capillary biosensor of the strip at a time is located in the measurement position and its inlet is accessible for contact with sample liquid, and said multiple capillary-biosensor strip being movable in the evaluation instrument in such a manner that consecutive capillary biosensors of the multiple capillary-biosensor strip are transported one after the other into the measurement position.

31. The capillary biosensor analysis system according to claim 30, the evaluation instrument further comprising a cutting device by which, after performing a measurement with the forward-most capillary biosensor being in the measurement position, the used forward-most capillary biosensor is cut off from the multiple capillary-biosensor strip.

32. The capillary biosensor analysis system according to claim 30 or claim 31, wherein the capillary biosensors of the multiple capillary-biosensor strip are electrochemical capillary biosensors, each of which has a working electrode, a counter electrode, and at least two conductive leads, one said conductive lead being electrically connected at its one end to the working electrode and at its other end to a first contact, another said conductive lead being electrically connected at its one end to the counter electrode and at its other end to a second contact, said first and second contacts being in electrical contact with corresponding first and second device contacts electrically connected to the electrical measurement and evaluation device.

33. The capillary biosensor analysis system according to claim 32, wherein said working electrode and said counter electrode each comprise an electrically conductive layer, each said layer being electrically isolated from the other, each said layer extending without electrical separation into each capillary biosensor along the multiple capillary-biosensor strip.

34. The capillary biosensor analysis system according to claim 33, said multiple capillary-biosensor strip being implemented as a resiliently flexible band adapted for being wound up in a curved state for being removably inserted into said evaluation instrument, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

35. The capillary biosensor analysis system according to claim 32, said multiple capillary-biosensor strip being implemented as a resiliently flexible band adapted for being wound up in a curved state for being removably inserted into said evaluation instrument, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

36. The capillary biosensor analysis system according to claim 31, said multiple capillary-biosensor strip being implemented as a resiliently flexible band adapted for being wound up in a curved state for being removably inserted into said evaluation instrument, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

37. The capillary biosensor analysis system according to claim 30, said multiple capillary-biosensor strip being implemented as a resiliently flexible band adapted for being wound up in a curved state for being removably inserted into said evaluation instrument, the capillary channels for the consecutively provided biosensors generally being in alignment such that the inlet for a following said biosensor generally oppositely faces the vent for the biosensor preceding said following biosensor, the strip further comprising a plurality of spaced apart flow obstructions provided on at least one of the wall parts, each flow obstruction being provided in conjunction with at least one capillary channel and proximate each vent-inlet interface, each said flow obstruction being configured to obstruct the flow of sample liquid through each capillary channel proximate its respective vent to prevent flow from continuing into the inlet of the following biosensor.

38. The capillary biosensor analysis system of claim 30, wherein each capillary channel of the multiple capillary sensor strip comprises at least one flow obstruction formed by a recess which extends through at least one of the wall parts and over the width of the capillary channel, by which flow obstruction the flow of a sample liquid entering via its inlet is stopped and the sample liquid is thus prevented from advancing into the next following capillary sensor of the multiple capillary sensor strip.