Sensor calibration

• US 8,141,409 B2
• Filed: 06/28/2007
• Issued: 03/27/2012
• Est. Priority Date: 06/28/2006
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Glysure Ltd
• Inventors: Francis, Ian, Perkins, Robert, Paterson, William, Crane, Barry
• Primary Examiner(s): Williams, Hezron E
• Assistant Examiner(s): West, Paul
• Application Number:
  US12/308,865
• Publication Number:
  US 20090277242A1
• Time in Patent Office: 1,734 Days
• Field of Search: 73/10.2, 73/615.9
• US Class Current: 73/1.02
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 35/00693 Calibration

Abstract

A sensor kit comprising a sensor for detecting an analyte, a sensor housing and a calibration chamber. The calibration chamber comprises a first compartment containing a first calibration solution and a second compartment containing a source of the analyte to be detected. A dividing material is located between the first and second compartments enabling them to be mixed on breakage or removal of the dividing material. Further compartment(s) containing further source(s) of the analyte may optionally be provided. Calibration can carried out by (a) taking a reading of the analyte concentration of the first calibration solution, (b) mixing the contents of the first and second compartments by breaking or removing the dividing material, and (c) taking a reading of the analyte concentration of the resulting mixture. Steps (b) and (c) can be repeated for further compartment(s) to provide further reading(s) if desired.

Claims

1. A sensor kit comprising:

(i) a sensor for detecting an analyte, said sensor having a sensing region comprising a receptor for said analyte;

(ii) a sensor housing containing said sensor, at least a part of said sensor housing being penetrable by water or aqueous solutions; and

(iii) a calibration chamber, said calibration chamber comprising at least a first and a second compartment, the first compartment containing a first calibration solution comprising water or an aqueous solution and the second compartment containing a source of said analyte, said first and second compartments being separated by a water-impermeable dividing material, wherein the dividing material comprises a breakable or removable section configured such that on breakage or removal of the section contents of the first and second compartments are mixed.

2. A sensor kit according to claim 1, wherein the second compartment of the calibration chamber contains the analyte in solid form.

3. A sensor kit according to claim 2, wherein the second compartment of the calibration chamber additionally contains a second source of said analyte, said second source being a slow release capsule containing the analyte.

4. A sensor kit according to claim 2, wherein the second compartment of the calibration chamber contains the analyte in solid form in an inert gas atmosphere.

5. A sensor kit according to claim 1, wherein the calibration chamber comprises a third compartment containing a further source of analyte.

6. A sensor kit according to claim 1, wherein the dividing material is either an elastomeric material which is under tension, or is a plastic-laminated metal foil.

7. A sensor kit according to claim 1, wherein the first compartment of the calibration chamber is sealed from the sensor.

8. A sensor kit according to claim 1, wherein the calibration chamber comprises a mixing arrangement for mixing the contents of the chamber.

9. A sensor kit according to claim 1, wherein at least a part of the sensor housing and the sensing region of the sensor are located within the first compartment of the calibration chamber.

10. A sensor kit according to claim 1, wherein the sensor, sensor housing and calibration chamber are contained within a sealed container.

11. A sensor kit according to claim 10, wherein the container comprises a lid, at least a part of which is gas permeable.

12. A method of sterilising a sensor kit according to claim 10, which method comprises sterilising the calibration chamber, preferably using γ

-ray irradiation, inserting the pre-sterilised calibration chamber, sensor and sensor housing into the container, sealing the container and sterilising the container, sensor and sensor housing.

13. A method according to claim 12, additionally comprising the step of, following sterilisation, removing or breaking a seal which separates the sensor from the first compartment of the calibration chamber, so that the sensor is exposed to the first compartment of the calibration chamber.

14. A method according to claim 12, wherein the calibration chamber is sterilised using x-ray irradiation and the container, sensor, and sensor housing are sterilised using ethylene oxide sterilisation.

15. A sensor kit according to claim 10, wherein the sensor, sensor housing and calibration chamber are contained within a sealed, sterile container.

16. A sensor kit according to claim 1, wherein the sensor includes a temperature sensor.

17. A sensor kit according to claim 1, wherein the sensor is a glucose sensor and the analyte is glucose.

18. A sensor kit according to claim 17, wherein the sensor comprises an optical fibre having a sensing region and a connection end, wherein a glucose receptor material is immobilised to or in the sensing region of the fibre, and wherein the sensing region of the fibre is located within a glucose-permeable membrane casing.

19. A calibration chamber for calibrating a sensor for the detection of an analyte, said calibration chamber being as defined in claim 1.

20. A method of calibrating a sensor in a sensor kit, wherein said sensor kit comprises:

(a) said sensor for detecting an analyte, said sensor having a sensing region comprising a receptor for said analyte,

(b) a sensor housing containing said sensor, at least a part of said sensor housing being penetrable by water or aqueous solutions, and

(c) a calibration chamber, said calibration chamber comprising at least a first and a second compartment, the first compartment containing a first calibration solution comprising water or an aqueous solution and the second compartment containing a source of said analyte, said first and second compartments being separated by a water-impermeable dividing material,

the method comprising;

(i) optionally exposing the sensing region of the sensor to the first compartment of the calibration chamber so that the first calibration solution is in contact with the sensing region,

(i) determining the sensor output for the first calibration solution;

(ii) breaking or removing the dividing material of the calibration chamber, to form a second calibration solution comprising a mixture of the first calibration solution and the source of analyte;

(iii) determining the sensor output for the second calibration solution; and

(iv) using the determined sensor output readings to calibrate the sensor.

21. A method according to claim 20, wherein the calibration chamber comprises a third compartment containing a further source of the analyte, said third compartment being separated from the remainder of the calibration chamber by a second dividing material, and wherein said method comprises breaking or removing the second dividing material to form a third calibration solution comprising a mixture of the second calibration solution and the further source of analyte and determining the sensor output for the third calibration solution.

22. A method according to claim 20 which further comprises a step of mixing the second calibration solution prior to determining the sensor output for the second calibration solution in step (iv), and optionally comprises a further step of mixing the third calibration solution prior to determining the sensor output for the third calibration solution.

23. A method according to claim 20, wherein the sensing region of the sensor is exposed to the first compartment of the calibration solution by breaking or removing a seal which separates the sensor from the first compartment.

24. A method according to claim 20, wherein steps (i) to (v) are automated.

25. A sensor kit comprising:

(i) a sensor for detecting an analyte, said sensor having a sensing region comprising a receptor for said analyte;

(ii) a sensor housing containing said sensor, at least a part of said sensor housing being penetrable by water or aqueous solutions; and

(iii) a calibration chamber, said calibration chamber comprising at least a first and a second compartment, the first compartment containing a first calibration solution comprising water or an aqueous solution and the second compartment containing a source of said analyte in solid form, said first and second compartments being separated by a water-impermeable dividing material.

26. A sensor kit according to claim 25, wherein the second compartment of the calibration chamber additionally contains a second source of said analyte, said second source being a slow release capsule containing the analyte.

27. A sensor kit according to claim 25, wherein the dividing material is either an elastomeric material which is under tension, or is a plastic-laminated metal foil.

28. A sensor kit according to claim 25, wherein the calibration chamber comprises a mixing arrangement for mixing the contents of the chamber.

29. A sensor kit according to claim 25, wherein the sensor is a glucose sensor and the analyte is glucose.

30. A sensor kit according to claim 29, wherein the sensor comprises an optical fibre having a sensing region and a connection end, wherein a glucose receptor material is immobilised to or in the sensing region of the fibre, and wherein the sensing region of the fibre is located within a glucose-permeable membrane casing.