System for determining analyte concentrations in body fluids

• US 6,572,566 B2
• Filed: 02/27/2001
• Issued: 06/03/2003
• Est. Priority Date: 03/03/2000
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Effenhauser, Carlo
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Wingood, Pamela L
• Application Number:
  US09/794,464
• Publication Number:
  US 20010037099A1
• Time in Patent Office: 826 Days
• Field of Search: 600/309, 600/316, 600/326, 600/327, 600/340, 600/341, 600/584, 600/573-575
• US Class Current: 600/584
• CPC Class Codes: A61B 5/14528 invasively
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043

Abstract

The present invention concerns a system for determining the concentration of at least one analyte in a body fluid. The system has a first member and at least a second member of which at least one has a recess on its surface and the members are joined together in such a manner that the recess is closed by a surface of the other member to form a channel. The first and/or second member is composed at least partially of a membrane which is located either in the region of the recess or on the part of the other member that is opposite to the recess such that substances can be taken up from the surrounding fluid by means of the membrane. The system additionally has a sensor which can be used to determine the concentration of an analyte in the channel. Furthermore the system has at least one integrated reservoir which is connected to the channel.

Claims

1. A system for determining the concentration of at least one analyte in a liquid, the system comprising:

a first member and at least one second member each having a respective surface of which at least one has a recess and the first and second member are joined together so that the at least one recess is at least partially closed by the surface of the other member to form a channel, and at least one of the first and second members contain an exchange region that is formed to take up substances from the liquid,

a sensor located downstream of the exchange region and formed to determine the concentration of an analyte, and

wherein the system has at least one integrated reservoir which is connected to the channel.

2. System as claimed in claim 1, wherein at least a part of the channel is located in the exchange region.

3. System as claimed in claim 1, in which the at least one reservoir is formed by a recess in the first or/and the second member.

4. System as claimed in claim 1, which contains a pump for moving liquid through the channel by means of pressure or underpressure.

5. System as claimed in claim 4, in which the pump is integrated into the arrangement comprising the first and second member.

6. System as claimed in claim 1, in which the at least one reservoir or an additional reservoir is used to hold liquid and is located downstream of the sensor.

7. System as claimed in claim 1, which has a restrictor to limit flow in the channel.

8. System as claimed in claim 1, in which the member having the recess contains a plate and a foil with recesses that is attached to the plate such that the recess is formed by interaction of the plate and foil.

9. System as claimed in claim 1, in which all reservoirs necessary for the function of the system are integrated into the first and/or second member.

10. System as claimed in claim 4, in which the pump is integrated into the system.

11. System as claimed in claim 1, wherein the liquid is body fluid and at least a part of the channel can be inserted into the body.

26. The system of claim 1, wherein the exchange region comprises a membrane.

27. The system of claim 1, wherein the exchange region comprises microperfusion perforations.

12. A system for determining the presence of an analyte in a body fluid, the system comprising:

a first member having a first surface,

a second member having a second surface, at least one of the first and second surfaces including a recess, the second member being joined to the first member so that the recess is at least partially closed by the opposing surface to form a channel,

an exchange region formed in at least one of the first and second members, the exchange region being in fluid communication with the channel and formed to receive substances from the body fluid therein,

a reservoir in fluid communication with the channel, and

an analyte sensor located downstream of the exchange region.

13. The system of claim 12 wherein at least a part of the channel is located in the exchange region.

14. The system of claim 13 wherein at least one of the first and second members includes a plate and a foil and the recess is defined by the plate and the foil.

15. The system of claim 12 wherein the system includes two reservoirs.

16. The system of claim 12 further comprising a pump formed to provide pressure or underpressure to the channel.

17. The system of claim 16 wherein the pump is integrated into the arrangement comprising the first and second member.

18. The system of claim 12 further comprising a waste reservoir located downstream of the sensor.

19. The system of claim 12 wherein the channel is tapered.

20. The system of claim 12 wherein the member having the recess contains a plate and a foil with recesses that is attached to the plate such that the recess is formed by interaction of the plate and foil.

28. The system of claim 12, wherein the exchange region comprises a membrane.

29. The system of claim 12, wherein the exchange region comprises microperfusion perforations.

21. A system for determining the presence of an analyte in a body fluid, the system comprising:

a first member having a first surface and a reservoir having an opening extending through the first surface,

a second member joined to the first member, the second member having a second surface facing the first surface and extending across the opening, the second surface including a dialysis channel having an inlet and an outlet, a perfusate channel extending from the reservoir to the dialysis channel and being at least partially covered by the first surface, and a dialysate channel extending from the outlet of the dialysis channel, and

an analyte sensor in communication with the dialysate channel.

22. The system of claim 21 wherein the second member includes a plate and a foil and the dialysis channel is defined by the plate and the foil.

23. The system of claim 21 further comprising a pump formed to provide pressure or underpressure such that liquid is transported from the reservoir through the dialysis channel and to the sensor.

24. The system of claim 21 further comprising a bottom part coupled to the second member and the bottom part is formed to define a waste reservoir downstream of the sensor.

25. The system of claim 21, wherein the second member includes a plate and a foil with recesses that is attached to the plate such that the recess is formed by interaction of the plate and foil.