Sensor calibration

• US 9,097,687 B2
• Filed: 03/26/2012
• Issued: 08/04/2015
• Est. Priority Date: 06/28/2006
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Lightship Medical Limited
• Inventors: Crane, Barry, Francis, Ian, Perkins, Robert, Paterson, William
• Primary Examiner(s): WEST, PAUL M
• Application Number:
  US13/430,066
• Publication Number:
  US 20120240656A1
• Time in Patent Office: 1,226 Days
• Field of Search: 73/10.2, 73/615.9, 436/8, 436/14
• US Class Current: 1/1
• 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 method of calibrating a sensor in a sensor kit, the method comprising:

exposing a sensing region of a sensor to a first compartment of a calibration chamber so that a first calibration solution is in contact with the sensing region;

determining the sensor output for the first calibration solution;

breaking a breakable dividing material of the calibration chamber, to form a second calibration solution comprising a mixture of the first calibration solution and a source of analyte, wherein the source of analyte is in solid form prior to breaking or removing the dividing material of the calibration chamber;

determining the sensor output for the second calibration solution; and

using the determined sensor output readings to calibrate the sensor.

2. The method of claim 1, wherein the source of analyte is stored in an inert gas atmosphere prior to breaking the dividing material of the calibration chamber.

3. The method of claim 1 wherein the first calibration solution is substantially free of analyte.

4. The method of claim 1, wherein the source of analyte comprises glucose.

5. The method of claim 1, which further comprises a step of mixing the second calibration solution prior to determining the sensor output for the second calibration.

6. The method of claim 1, wherein the calibration chamber comprises a third compartment containing a second 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 second source of analyte and determining the sensor output for the third calibration solution.

7. The method of claim 6, wherein the second source of analyte is in solid form.

8. The method of claim 6, further comprising mixing the third calibration solution prior to determining the sensor output for the third calibration solution.

9. The method of claim 1, 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.

10. The method of claim 1, wherein the steps are automated.

11. The method of claim 1, further comprising sterilizing the calibration chamber prior to exposing the sensing region of the sensor to the first compartment of the calibration chamber.

12. The method of claim 1, wherein the calibration chamber is sterilized using γ

-ray irradiation.

13. The method of claim 1, comprising (i) sterilizing the calibration chamber to provide a pre-sterilized calibration chamber, and (ii) inserting the pre-sterilised calibration chamber, sensor and sensor housing into a container, sealing the container and sterilising the container, sensor and sensor housing.