Analysis device

• US 8,597,574 B2
• Filed: 03/08/2002
• Issued: 12/03/2013
• Est. Priority Date: 03/09/2001
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Siemens AG
• Inventors: Gumbrecht, Walter, Stanzel, Manfred
• Primary Examiner(s): LUDLOW, JAN M
• Application Number:
  US10/471,166
• Publication Number:
  US 20040115094A1
• Time in Patent Office: 4,288 Days
• Field of Search: 73/10.1, 73/10.2, 422/50, 422/56, 422/57, 422/58, 422/68.1, 422/100, 422502-507, 422401-404, 422 81- 8209, 436/43, 436/63, 436/66, 436/86
• US Class Current: 422/82.01
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 27/416 Systems G01N27/27 takes precedence

Abstract

A microfluidic diagnosis kit used in biochemical analysis obtains a premeasured amount of reagents in an applicator for an analysis system. The required reagents are proportioned as non-volatile agents and a microfluidic system is provided, whereby the reagents are automatically dissolved in a solvent and fed to a sensor module to carry out measurement.

Claims

1. An analysis device for use in biochemical analytics, comprising:

an applicator for decentralized use, including

a first housing providing at least one channel for a microfluidic system,

at least one reagent in a pre-portioned amount included within the at least one channel of the first housing, the at least one reagent being a solid, non-volatile substance, and

a chip module provided adjacent to the first housing, the chip module having a sensitive side that is microfluidically accessible to the at least one channel and an electrical contact side opposite the sensitive side;

a second housing, removably connected to said first housing and said chip module, to receive signals from the chip module to form a measuring and analysis system; and

a channel configured to provide a solvent to dissolve the pre-portioned amount of the at least one reagent and form a solution within the at least one channel of the first housing to be fed to the sensitive side of the chip module when the first housing is inserted into the second housing.

2. The analysis device as claimed in claim 1, wherein the electrical contact side of the chip module has an electrical contacting zone for feeding in and tapping electrical signals.

3. The analysis device as claimed in claim 1, wherein said channel includes a solvent reservoir and said second housing provides the solvent reservoir coupled to the channel for the microfluidic system.

4. The analysis device as claimed in claim 1, wherein the channel includes a solvent reservoir and the solvent reservoir is arranged in said applicator.

5. The analysis device as claimed in claim 1, wherein one defined quantity of each of different reagents is present in said applicator.

6. The analysis device as claimed in claim 1, wherein the at least one reagent is in a stable form.

7. The analysis device as claimed in claim 1, wherein the at least one reagent is a pure solid substance.

8. The analysis device as claimed in claim 1, wherein the at least one reagent is in one of a dissolved and mixed form in an adjuvant.

9. The analysis device as claimed in claim 8, wherein the adjuvant is one of solid and liquid.

10. The analysis device as claimed in claim 9, wherein the adjuvant is a water-soluble polymer.

11. The analysis device as claimed in claim 8, wherein the adjuvant dilutes the at least one reagent and transports the at least one reagent to a container in said applicator to provide geometric definition and good adhesion.

12. The analysis device as claimed in claim 11, wherein the container in said applicator further includes a microchannel with a cross section and a length.

13. The analysis device as claimed in claim 12, wherein the at least one reagent diluted by the adjuvant is arranged in a quantitative gradient along the microchannel.

14. The analysis device as claimed in claim 1, wherein said applicator comprises a plastic card provided with microfluidic components.

15. The analysis device as claimed in claim 14, wherein the plastic card is a chip card.

16. The analysis device as claimed in claim 15, wherein said second housing comprises a reader, into which said applicator is inserted.

17. The analysis device as claimed in claim 16, wherein when said applicator is inserted into the reader, the at least one reagent and the solvent are brought together.

18. The analysis device as claimed in claim 17, wherein at least one continuous fluid channel is formed between said applicator and the reader via at least one seal provided between the applicator and the reader.

19. The analysis device as claimed in claim 18, wherein the channel configured to provide the solvent includes a solvent reservoir and the solvent reservoir is provided in the reader and holds water for multiple analyses.

20. The analysis device as claimed in claim 18, further comprising a container to receive waste sample material and used reagents.

21. The analysis device as claimed in claim 20, wherein the container is arranged in one of the first housing of said applicator and the second housing of the reader.

22. The analysis device as claimed in claim 21, wherein the reader includes the channel configured to provide the solvent and conveys the solvent through the at least one continuous fluid channel to the sensor module and then to said container.

23. The analysis device as claimed in claim 22, wherein the at least one continuous fluid channel causes the solvent to pass over a geometrically shaped reagent-adjuvant mixture to produce the solution.

24. The analysis device as claimed in claim 23, further comprising means for keeping the solvent at a predetermined solvent temperature.

25. The analysis device as claimed in claim 24, further comprising temperature maintenance means for maintaining a predetermined temperature at the chip module.

26. The analysis device as claimed in claim 25, wherein said temperature maintenance means comprises a Peltier element in the second housing exerting a thermostatically controlling effect to cool the chip module.

27. The analysis device as claimed in claim 26, wherein the biochemical analytics is DNA analysis.

28. The analysis device as claimed in claim 26, wherein the biochemical analytics uses a Polymer Chain Reaction and said analysis device speeds cooling during the Polymer Chain Reaction.

29. The analysis device as claimed in claim 24, wherein the biochemical analytics is food monitoring.

30. The analysis device as claimed in claim 24, wherein the biochemical analytics is environmental measuring.

31. The analysis device as claimed in claim 24, wherein the biochemical analytics is forensics.

32. The analysis device as claimed in claim 24, wherein the biochemical analytics is medical diagnostics.

33. The analysis device as claimed in claim 32, wherein the biochemical analytics is blood gas/blood electrolyte analysis.

34. The analysis device as claimed in claim 32, wherein the biochemical analytics is diagnosis of infectious diseases.

35. The analysis device as claimed in claim 32, wherein the biochemical analytics is therapy control.

36. The analysis device as claimed in claim 32, wherein the biochemical analytics is early detection of diseases.