Sensor system as well as an arrangement and method for monitoring a constituent and in particular glucose in body tissue

• US 7,967,752 B2
• Filed: 06/19/2006
• Issued: 06/28/2011
• Est. Priority Date: 06/17/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Staib, Arnulf, Ocvirk, Gregor, Rinne, Helmut
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/425,020
• Publication Number:
  US 20060287591A1
• Time in Patent Office: 1,835 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: 600/365
• 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. A sensor system especially for glucose monitoring, the sensor system comprising:

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

a fluid channel integrated on the support for passing through an interstitial fluid;

a sensor that responds to a constituent of the body tissue, wherein the sensor is integrated on the support and configured for direct contact with the body tissue separately from the fluid channel;

a signal processor electrically coupled to the sensor for generating a measurement result;

a calibration device configured to be located outside the body tissue to calibrate an output signal of the sensor, the calibration device having a reference sensor that is fluidly coupled to the fluid channel for passing through the interstitial fluid and electrically coupled to the signal processor; and

a pumping unit for removing interstitial fluid not in contact with the sensor through the fluid channel and into the calibration device for use in calibrating the sensor.

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

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

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

7. The sensor system according to claim 1, wherein the fluid channel is connected to a metering unit to feed a medication liquid.

8. The sensor system according to claim 7, wherein the medication liquid is insulin.

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

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

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

12. The sensor system according to claim 11, wherein the flexible support can be inserted into the body tissue by means of an insertion aid.

13. The sensor system according to claim 1, wherein the fluid channel has at least one opening on an active sensor 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.

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

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

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

17. The sensor system according to 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.

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

19. The sensor system according to claim 1, wherein the sensor has a single sensor for an analyte and a single sensor for an active substance that can be passed into the body tissue through the fluid channel.

20. The sensor system according to claim 1, wherein the support is partially inserted into a subcutaneous tissue.

21. A method for monitoring a constituent in body tissue, the method comprising:

inserting a support into body tissue;

removing interstitial fluid from the body tissue by means of a fluid channel integrated on the support;

monitoring a constituent of the body tissue with the aid of a sensor wherein the sensor is integrated to the support and configured for direct contact with the body tissue separately from the fluid channel;

pumping interstitial fluid from the body tissue through the fluid channel into a calibration device for calibrating the sensor; and

,

calibrating an output signal of the sensor using the calibration device located outside the body tissue the calibration device having a reference sensor that is fluidly coupled to the fluid channel and electrically coupled to a signal processor.

22. The method according to claim 21, wherein an interstitial fluid is removed via the fluid channel and the constituent is detected by means of the calibration device.

23. The method according to claim 21, wherein a calibration solution is delivered via the fluid channel and is used to calibrate the sensor that is in contact with the body tissue.

24. The method according to claim 22, wherein the calibration is carried out automatically at specified time intervals.

25. The method according to claim 21, wherein the liquid transport through the fluid channel is controlled or regulated as a function of an output signal of the sensor.

26. The method according to claim 21, wherein an alarm is triggered when the detected concentration of the constituent falls below or exceeds a preset threshold value.

27. The method according to claim 21, wherein an alarm is triggered when the voltage falls below a minimum supply voltage for the sensor system.

28. The method of claim 21, wherein the support is partially inserted into the subcutaneous tissue.