Analyte monitoring sensor system for monitoring a constituent in body tissue

• US 8,942,778 B2
• Filed: 05/18/2011
• Issued: 01/27/2015
• Est. Priority Date: 06/17/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Ocvirk, Gregor, Rinne, Helmut, Staib, Arnulf
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US13/110,335
• Publication Number:
  US 20110218490A1
• Time in Patent Office: 1,350 Days
• Field of Search: 600/365, 600/345, 600/347, 600/346, 600/584, 600/309, 600/316, 600/322, 600/327, 600/332, 600/333, 600/354, 600/373, 600/486, 600/578, 204/400, 204/401, 2044031-40315, 204/435, 204/436
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

The invention generally relates to a sensor system. In particular to a sensor for glucose monitoring. The invention also also relates to an arrangement and a method for monitoring a constituent and in particular glucose in body tissue using a sensor system.

Claims

1. An analyte monitoring sensor system comprising:

a support that can be at least partially inserted into body tissue;

a fluid channel arranged on the support for passing through a liquid; and

a sensor that responds to a constituent of the liquid and/or the body tissue, wherein the sensor is arranged on the support and configured for direct contact with the body tissue separately from the fluid channel, and wherein the fluid channel is in fluid communication with a metering unit to feed a liquid into the body tissue.

2. The sensor system of claim 1, wherein the sensor is arranged on a surface of the support which, when inserted, is in contact with the body tissue.

3. The sensor system of claim 2, wherein the sensor in a multielectrode configuration has several electrodes arranged on the surface of the support which engages with the body tissue.

4. The sensor system of claim 1, wherein the sensor responds directly to the constituent independently of the amount of the locally present tissue fluid.

5. The sensor system of claim 1, wherein the sensor is in direct engagement with the body tissue at a distance from an opening of the fluid channel on an active sensor region side.

6. The sensor system of claim 1, wherein an interstitial fluid and/or a calibration solution can be fed via the fluid channel to a calibration device for the sensor that is located outside of the body tissue.

7. The sensor system of claim 6, wherein the calibration device has a reference sensor to calibrate the output signals of the sensor.

8. The sensor system of claim 1, wherein the fluid channel is connected to a pumping unit to remove interstitial fluid from the body tissue.

9. The sensor system of claim 1, wherein the analyte is glucose and the liquid fed into the body tissue is insulin.

10. The sensor system of claim 1, wherein the fluid channel is connected to a conveying unit to feed a calibration solution into the body tissue.

11. The sensor system of claim 1, wherein the sensor has an active sensor region that can be brought into contact with the body tissue.

12. The sensor system of claim 1, wherein the sensor is designed to continuously detect glucose as a constituent in the interstitial fluid.

13. The sensor system of claim 1, wherein the support is formed by a flexible flat substrate and wherein the fluid channel and the sensor are designed as a thin layer structure integrated on the substrate as a composite part.

14. The sensor system of claim 13, wherein the flexible support is configured for insertion into the body tissue by utilizing an insertion aid.

15. The sensor system of claim 1, wherein the fluid channel has at least one opening on an active region side, at least one opening located outside of the body tissue and at least one flow path between the openings that is a capillary flow path.

16. The sensor system of claim 1, wherein the fluid channel is integrated into an optionally multi-part support by laser treatment, hot stamping or photolithography.

17. The sensor system of claim 1, wherein the fluid channel has a flow cross-section of less than 1 mm².

18. The sensor system of claim 1, wherein the fluid channel opens onto the surface of the support carrying the sensor in a detection area of the sensor.

19. The sensor system of claim 1, wherein the fluid channel flows into a part of the support that faces away from or is distant from the sensor and is outside of the detection area of the sensor.

20. The sensor system of claim 1, wherein the sensor comprises at least two single sensors that are at different distances from an opening of the fluid channel on the tissue side.

21. The sensor system of claim 1, wherein the sensor has a single sensor for glucose and a single sensor for an active substance that can be passed into the body tissue through the fluid channel.

22. The sensor system of claim 1, wherein the support is configured for partial insertion into a subcutaneous tissue.