System, for monitoring the concentration of analytes in body fluids

• US 7,276,027 B2
• Filed: 02/02/2002
• Issued: 10/02/2007
• Est. Priority Date: 02/06/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/467,592
• Publication Number:
  US 20040249311A1
• Time in Patent Office: 2,068 Days
• Field of Search: 600/309, 600/322, 600/341, 600/362, 600/365, 600/367
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool

Abstract

The invention concerns a system for monitoring the concentration of analytes in body fluids, in particular in interstitial fluid and comprises a catheter having an implantable region and an outlet opening for withdrawing fluid in particular body fluid. A first and a second analytical zone are contacted sequentially with fluid from the catheter and undergo a detectable change when an analyte is present. The analytical zones can be contacted manually with fluid and also preferably in an automated fashion by means of a device. A system according to the invention additionally has an analytical device for analysing the analytical zones in order to determine the concentration of the analyte on the basis of changes caused by the analyte. A further subject matter of the present invention are catheters for use in systems according to the invention as well as magazines containing test zones.

Claims

1. System for monitoring the concentration of analytes in body fluids, comprising

a) a catheter having an implantable region and an outlet opening for the withdrawal of fluid,

b) a first and a second analytical zone which, after contact with the withdrawn fluid, undergo a detectable change when an analyte is present in the fluid,

c) a device configured to contact the first analytical zone with fluid from the catheter and to subsequently contact the second analytical zone with fluid from the catheter,

d) an analytical device configured to analyze the changes on the analytical zones caused by the analyte-containing fluid in order to determine the concentration of an analyte to be monitored, and

e) a pump configured to apply underpressure to the outlet opening in order to convey liquid,

wherein the analytical device or an additional application detection device detects the presence of fluid or the presence of an adequate amount of fluid in or on the analytical zones and interrupts the application of the underpressure to the outlet opening based thereon,

and wherein the first and second analytical zones are areas of a continuous test element, and the continuous test element is a tape.

2. System as claimed in claim 1, wherein the device is configured to contact the first analytical zone and the second analytical zone with the fluid from the catheter by bringing together the outlet opening and the first and second analytical zones.

3. System as claimed in claim 1, wherein the device is configured to contact the first analytical zone and the second analytical zone with the fluid from the catheter by moving portions of the fluid out of the catheter onto the first and second analytical zones via an ejector unit.

4. System as claimed in claim 1, in which the first and second analytical zones are separate objects that are attached to a common support.

5. System as claimed in claim 1, in which the catheter is designed such that no liquid emerges from the outlet opening until the underpressure is applied to the outlet opening.

6. System as claimed in claim 1, further comprising a control device which synchronizes the bringing together of the first and second analytical zones with the outlet opening.

7. System as claimed in claim 1, in which the amount of fluid taken up by either of the first and second analytical zones is essentially equal to or more than the active inner volume of the catheter.

8. System as claimed in claim 1, wherein the device is configured to contact the first analytical zone and the second analytical zone with the fluid from the catheter while the catheter remains implanted.

9. System as claimed in claim 1, wherein the analytical zones are configured to be used once.

10. System as claimed in claim 1, in which the system further comprises a carrying unit for carrying the system on the body and a magazine in which the analytical zones are disposed and which is configured to be inserted into the carrying unit.

11. System as claimed in claim 1, in which the amount of fluid taken up by an analytical zone is less than 100 nl.

12. System as claimed in claim 1, in which the analytical device is configured to optically analyze the first and second analytical zones.

13. The system of claim 1, wherein the fluid is an interstitial body fluid.

14. A system for monitoring the concentration of analytes in body fluids, the system comprising:

a) a catheter having an implantable region and an outlet opening for the withdrawal of fluid,

b) a first and a second analytical zone which, after contact with the withdrawn fluid, undergo a detectable change when an analyte is present in the fluid,

c) a device configured to contact the first analytical zone with fluid from the catheter and to subsequently contact the second analytical zone with fluid from the catheter,

d) an analytical device configured to analyze the changes on the analytical zones caused by the analyte-containing fluid in order to determine the concentration of an analyte to be monitored, and

e) a pump configured to apply underpressure to the outlet opening in order to convey liquid,

wherein the device is configured to contact the first analytical zone and the second analytical zone with the fluid from the catheter in synchronization with the application of the underpressure such that liquid emerging from the outlet opening is taken up by the analytical zones,

and wherein the first and second analytical zones are areas of a continuous test element, and the continuous test element is a tape.

15. System as claimed in claim 14, in which the analytical device or an additional application detection device is configured to detect the presence of fluid or the presence of an adequate amount of fluid in or on the analytical zones and to interrupt further contact of the analytical zones with fluid.

16. A system for monitoring analyte concentration in body fluid comprising,

a carrying unit configured to be carried on the body, the carrying unit having a catheter comprising an implantable region and an outlet opening for withdrawing fluid and a tape comprising two or more analytical zones which undergo a detectable change when an analyte is present in the fluid, and a device configured to contact the fluid with the two or more analytical zones while the catheter remains implanted, and

an analytical device located in the carrying unit or present separately and configured to analyze changes caused by the analyte-containing fluid on the two or more analytical zones in order to determine the concentration of the analyte.

17. The system as claimed in claim 16, wherein the two or more analytical zones comprise at least a first analytical zone and a second analytical zone, and wherein the device is further configured to either bring together the first analytical zone with the outlet opening in order to contact the first analytical zone with fluid and to subsequently bring together the second analytical zone with the outlet opening in order to contact the second analytical zone with fluid, or to apply underpressure to the outlet opening to convey the fluid such that fluid emerging from the outlet opening contacts the first analytical zone and the second analytical zone in synchronization with the application of the underpressure.