System for in-vivo measurement of an analyte concentration

• US 20080234561A1
• Filed: 03/20/2008
• Published: 09/25/2008
• Est. Priority Date: 03/20/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Rasch-Menges, Juergen, Roesicke, Bernd
• Granted Patent: US 8,577,437 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid

Abstract

Human or animal body fluids can be measured in-vivo to determine analyte concentrations, such as glucose. The measurement system comprises an exchangeable sensor for in-vivo placement, a data carrier with calibration data for the sensor, a housing having a first chamber for receiving a sterile sensor and a second chamber for receiving a data carrier, and a base station that couples to the housing for transmitting measurement signals to an evaluation unit. Replacement sterile sensors can be packaged in a sterile package and the data carrier associated with the replacement sensor can be packaged in a non-sterile package.

Claims

1. A system for the in-vivo measurement of an analyte concentration in a human or animal body, comprising:

a sensor for the generating of measuring data that correlate to the analyte concentration to be measured;

a data carrier with calibration data for the sensor;

a base station to configured for carrying the sensor and the data carrier; and

,

a housing adapted to an interface of the base station so that the sensor contained in the housing and the data carrier can be connected to the base station, the housing comprising a first chamber containing the sensor under sterile conditions and a second chamber the data carrier with the sensor'"'"'s calibration data.

2. The system as in claim 1, further comprising an evaluation unit carried in the base station that evaluates measurement data according to the calibration data.

3. The system as in claim 1, further comprising a battery to supply power to the base station, the battery carried in the housing wherein the battery can be connected to the base station by interfacing the housing with the base station.

4. The system as in claim 1, further comprising a rupture joint contained in the housing for the removal of the housing part that seals the chamber containing the sensor.

5. The system as in claim 1 wherein the sensor is an electro-chemical sensor configured for coupling to a potentiostat provided in the base station.

6. The system as in claim 1 wherein the evaluation unit is carried in the base station.

7. The system as in claim 1 wherein the housing is configured to be either totally or partially removed from the base station prior to the carrying out of an in-vivo measurement.

8. The system as in claim 1 wherein the housing or the base station are provided with a spring element that, upon setting the housing to the interface of the base station, facilitates connecting of the sensor or the data carrier to the base station.

9. A system for the in-vivo measurement of an analyte concentration in a human or animal body, comprising:

a sensor as a consumable component for the generating of measuring data that correlate to the analyte concentration to be measured,

a data carrier with calibration data of such a sensor,

a base station to which the exchangeable sensor and the data carrier can be connected so that, while in operation, measuring signals generated by the sensor are transmitted to an evaluation unit that evaluates the measuring signals generated by the sensor by means of the calibration data,

a means for housing the sensor under sterile conditions and the data carrier under non-sterile conditions wherein the housing is configured to couple to the base station.

10. The system as in claim 9 wherein the sensor is an electro-chemical sensor configured for coupling to a potentiostat provided in the base station.

11. The system as in claim 9 wherein the evaluation unit is carried in the base station.

12. The system as in claim 9 wherein the housing is configured to be either totally or partially removed from the base station prior to the carrying out of an in-vivo measurement.

13. The system as in claim 9 wherein the housing or the base station are provided with a spring element that, upon setting the housing to the interface of the base station, facilitates connecting of the sensor or the data carrier to the base station.

14. A packaging system for the exchangeable components of an in-vivo measuring system, comprising:

a housing having a first chamber configured for sterilization and a second chamber;

a sensor for the generating of measuring signals that correlate to an analyte concentration to be measured carried in the first chamber, the sensor being sterile; and

,

a data carrier in which are stored the calibration data of the sensor carried in the second chamber.

15. The packaging system as in claim 14 wherein the first chamber is configured for sterilization by irradiation.

16. The packaging system as in claim 14 wherein the sensor is an electro-chemical sensor configured for coupling to a potentiostat provided in the base station.

17. The packaging system as in claim 14, further comprising a rupture joint contained in the housing for the removal of the housing part that seals the chamber containing the sensor.

18. A method for the packaging of a sensor and data carrier for the in-vivo measurement of an analyte concentration, comprising:

arranging a sensor in a first housing chamber;

sealing of the first housing chamber;

sterilizing of the sensor in the first housing chamber by means of irradiation;

arranging a data carrier in a second housing chamber; and

,

closing of the second housing chamber.

19. The method as in claim 18, further comprising, rupturing a rupture joint contained in the first housing chamber to expose the sensor.

20. The method as in claim 18 wherein the sensor is an electro-chemical sensor configured for coupling to a potentiostat provided in the base station.

21. The method as in claim 18, further comprising a battery carried in the second housing chamber.