Method and apparatus for calibrating an analyte detection system with a calibration sample

• US 20060200070A1
• Filed: 12/21/2005
• Published: 09/07/2006
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Zheng, Peng, Sterling, Bernhard B., Wechsler, Mark, Keenan, Richard, Hall, W. Dale, Callicoat, David N., Witte, Kenneth G.
• Application Number:
  US11/314,161
• Publication Number:
  US 20060200070A1
• Time in Patent Office: Days
• US Class Current: 604/66
• 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 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 1/14 : Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 21/05 : Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/274 : Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence

Abstract

A fluid sampling and analysis system. The system comprises a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid of a patient; a sample analysis chamber accessible by the fluid handling network; and a pump unit in operative engagement with the fluid handling network. The pump unit has an infusion mode in which the pump unit is operable to deliver infusion fluid to the patient through the patient end; a sample draw mode in which the pump unit is operable to draw a sample of bodily fluid from the patient through the patient end, and provide a portion of the sample to the sample analysis chamber; and an optical calibration mode in which the pump unit is operable to supply calibration fluid to the sample analysis chamber. The system further comprises a spectroscopic analyzer configured to obtain spectra of the contents of the sample analysis chamber; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain a measurement of one or more analytes in the portion of the sample from the spectra.

Claims

1. A fluid sampling and analysis system comprising:

a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid of a patient;

a sample analysis chamber accessible by said fluid handling network;

a pump unit in operative engagement with said fluid handling network, said pump unit having;

an infusion mode in which said pump unit is operable to deliver infusion fluid to said patient through said patient end,

a sample draw mode in which said pump unit is operable to draw a sample of bodily fluid from said patient through said patient end, and provide a portion of said sample to said sample analysis chamber, and

an optical calibration mode in which said pump unit is operable to supply calibration fluid to said sample analysis chamber;

a spectroscopic analyzer configured to obtain spectra of the contents of said sample analysis chamber;

a processor in communication with or incorporated into said spectroscopic analyzer; and

stored program instructions executable by said processor to obtain a measurement of one or more analytes in the portion of said sample from said spectra.

2. The apparatus of claim 1, where said bodily fluid is blood.

3. The apparatus of claim 2, where said portion of the sample is whole blood.

4. The apparatus of claim 2, where said portion of the sample is blood plasma.

5. The apparatus of claim 2, where said portion of the sample is blood serum.

6. The apparatus of claim 1, where said spectroscopic analyzer includes an infrared analyzer.

7. The apparatus of claim 1, where one of said one or more analytes is glucose.

8. The apparatus of claim 1, where one of said one or more analytes is a sugar.

9. The apparatus of claim 1, where one of said one or more analytes is blood urea nitrogen (BUN), hemoglobin, or lactate.

10. The apparatus of claim 2, further comprising a hematocrit analyzer configured to analyze blood.

11. The apparatus of claim 1, where said fluid handling network includes a first fluid passageway from an infusion fluid source to said patient end, and a second fluid passageway from patient end to said spectroscopic analyzer.

12. The apparatus of claim 11, where said sample draw mode first draws fluid through said first fluid passageway, then draws fluid through said second fluid passageway.

13. The apparatus of claim 11, where said bodily fluid is blood, where said sample draw mode draws fluid through said first fluid passageway, and then directs blood through said second fluid passageway to said spectroscopic analyzer.

14. The apparatus of claim 13, where said patient end includes a hematocrit analyzer to detect the presence of whole blood at the patient end, where said sample draw mode draws fluid through said first fluid passageway until the hematocrit analyzer detects whole blood in the patient end, and then directs blood through said second fluid passageway to said spectroscopic analyzer.

15. The apparatus of claim 11, where said patient end includes a gas injector, and where the gas injector injects gas bubbles into the fluid in the second fluid passageway.

16. The apparatus of claim 2, further comprising a separator to separate blood components, and where said portion is blood plasma.

17. The apparatus of claim 1, where said pump unit comprises multiple pumps, each of which is operable in one or more of said modes.

18. The apparatus of claim 1 further comprising:

stored program instructions executable by said processor to conduct a calibration measurement on saline solution in said sample analysis chamber, conduct a sample measurement on at least one component of said sample of bodily fluid while said at least one component is in said sample analysis chamber, and determine a concentration of at least one analyte based on said sample measurement.

19. The apparatus of claim 1, where said calibrating fluid is said infusing fluid.

20. The apparatus of claim 1, where said infusing fluid is an aqueous saline solution.

21. A method of optically calibrating an analysis system comprising:

providing a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient, a sample analysis chamber accessible by said fluid handling network, and a spectroscopic analyzer positioned to analyze the contents of said sample analysis chamber;

providing a calibration fluid to the sample analysis chamber;

determining a calibration of the sample analysis chamber provided with the calibration fluid;

providing at least a portion of a bodily fluid to the spectroscopic analyzer;

obtaining a spectra of said portion of bodily fluid; and

determining the concentration of at least one analyte of said sample from the obtained spectra and the calibration.

22. The method of claim 21, where said determining a calibration includes determining the optical pathlength of the sample analysis chamber.

23. An apparatus comprising:

means for providing a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient, a sample analysis chamber accessible by said fluid handling network, and a spectroscopic analyzer positioned to analyze the contents of said sample analysis chamber;

means for providing a calibration fluid to the sample analysis chamber;

means for determining a calibration of the sample analysis chamber provided with the calibration fluid;

means for providing at least a portion of a bodily fluid to the spectroscopic analyzer;

means for obtaining a spectra of said portion of bodily fluid; and

means for determining the concentration of at least one analyte of said sample from the obtained spectra and the calibration.

24. The apparatus of claim 23, where said means for determining a calibration includes means for determining the optical pathlength of the sample analysis chamber.