Systems and methods for measuring multiple analytes in a sample

• US 9,091,676 B2
• Filed: 06/08/2011
• Issued: 07/28/2015
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Rule, Peter, Braig, James R., Keenan, Richard II, Callicoat, David
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US13/156,295
• Publication Number:
  US 20110306856A1
• Time in Patent Office: 1,511 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150801 Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
• 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: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01N 2021/3174 : Filter wheel
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 2201/1215 : for interfering gases
• CPC Class Codes: G01N 2201/1293 : resolving multicomponent spectra
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence

Abstract

Systems and methods for analyzing multiple components of a fluid sample are provided. In certain embodiments, a system can include an analyte detection system configured to measure first analyte data in a first component of a fluid sample received from a patient and measure second analyte data in a second component of a fluid sample. In some embodiments, one or more portions of an optical system is movable with respect to other portions of the system in order to optically and/or electrochemically analyze multiple components of a fluid sample. In other embodiments, optical and/or electrochemical analysis can be performed simultaneously on multiple components of a fluid sample. In some embodiments, a first analyte can be measured in a sample (e.g., whole blood) before the sample is separated into its components (e.g., plasma, red blood cells, etc.), and a second analyte can be measured in a component of the sample after separation.

Claims

1. A patient monitoring system for analyzing multiple analytes in a fluid sample, the patient monitoring system comprising:

a fluid handling system configured to draw a fluid sample from a patient;

a fluid analyzer comprising a sample cell configured to receive at least a portion of the fluid sample from the fluid handling system;

a controller comprising one or more computer processors; and

a non-transitory computer-readable medium encoded with instructions executable by the one or more processors to cause the fluid analyzer to;

measure a first analyte in at least a portion of the fluid sample while the at least a portion of the fluid sample is in the sample cell;

separate the at least a portion of the fluid sample into a plurality of components while the at least a portion of the fluid sample is in the sample cell after measuring the first analyte; and

measure a second analyte in one of the plurality of components while the one of the plurality of components is in the sample cell.

2. The patient monitoring system of claim 1, wherein the fluid sample comprises whole blood.

3. The patient monitoring system of claim 2, wherein the one of the plurality of components comprises plasma.

4. The patient monitoring system of claim 1, wherein the first analyte is hemoglobin.

5. The patient monitoring system of claim 1, wherein the second analyte is glucose.

6. The patient monitoring system of claim 1, wherein the fluid analyzer is configured to measure the first analyte in an optical path between an optical energy source and a detector.

7. The patient monitoring system of claim 6, the fluid analyzer is configured to placing the one of the plurality of components of the at least a portion of the fluid sample in the optical path between the same optical energy source and detector used to measure the first analyte.

8. The patient monitoring system of claim 1, wherein the sample cell is held by a sample cell holder, wherein the sample cell holder is a centrifuge wheel with a central axis on which the centrifuge wheel is rotatable.

9. The patient monitoring system of claim 1, wherein fluid analyzer is configured to measure the level of the first analyte prior to measuring the level of the second analyte.

10. The patient monitoring system of claim 1, wherein the fluid analyzer is further configured to measure a level of a third analyte in one of the plurality of components of the fluid sample.

11. The patient monitoring system of claim 1, wherein the fluid analyzer is configured to electrochemically measure at least one of the first analyte and the second analyte.

14. The patient monitoring system of claim 1, wherein the fluid analyzer comprises a centrifuge rotor configured to rotate the sample cell to separate the at least a portion of the fluid sample into a plurality of components.

15. The patient monitoring system of claim 1, wherein the fluid analyzer is configured to measure one of the first analyte and the second analyte using mid-infrared light.

16. The patient monitoring system of claim 1, wherein the fluid analyzer comprises an optical system configured to emit near-infrared light.

17. The patient monitoring system of claim 1, wherein the first analyte is hematocrit.

12. A patient monitoring system for analyzing multiple analytes in a fluid sample, the patient monitoring system comprising:

a fluid handling system configured to draw a fluid sample from a patient;

a fluid analyzer configured to receive at least a portion of the fluid sample from the fluid handling system;

a controller comprising one or more computer processors; and

a non-transitory computer-readable medium encoded with instructions executable by the one or more processors to cause the fluid analyzer to;

measure a first analyte in at least a portion of the fluid sample while the at least a portion of the fluid sample is in a first sample cell;

separate the at least a portion of the fluid sample into a plurality of components after measuring the first analyte; and

measure a second analyte in one of the plurality of components after separation while the one of the plurality of components is in a second sample cell.

18. The patient monitoring system of claim 12, further comprising relocating at least the one of the plurality of components from the first sample cell to the second sample cell.

19. The patient monitoring system of claim 12, wherein the fluid analyzer is configured to separate the at least a portion of the fluid sample into the plurality of components while the at least a portion of the fluid sample is in a first sample cell.

20. The patient monitoring system of claim 12, wherein the fluid analyzer is configured to measure the first analyte using infrared light.

21. The patient monitoring system of claim 20, wherein the fluid analyzer is configured to measure the second analyte using infrared light.

22. The patient monitoring system of claim 20, wherein the fluid analyzer is configured to measure the second analyte electrochemically.

23. The patient monitoring system of claim 12, wherein the fluid sample comprises whole blood.

24. The patient monitoring system of claim 23, wherein the one of the plurality of components comprises plasma.

25. The patient monitoring system of claim 12, wherein the first analyte is hemoglobin.

26. The patient monitoring system of claim 12, wherein the first analyte is hematocrit.

27. The patient monitoring system of claim 12, wherein the second analyte is glucose.

28. The patient monitoring system of claim 12, wherein the fluid analyzer comprises a centrifuge rotor configured to rotate at least one of the first sample cell and the second sample cell to separate the at least a portion of the fluid sample into a plurality of components.

13. A patient monitoring system for analyzing multiple analytes in a fluid sample, the patient monitoring system comprising:

a fluid handling system configured to draw a fluid sample from a patient;

a fluid analyzer configured to receive at least a portion of the fluid sample from the fluid handling system;

a controller comprising one or more computer processors; and

a non-transitory computer-readable medium encoded with instructions executable by the one or more processors to cause the fluid analyzer to;

measure a first analyte in at least a portion of the fluid sample in an optical path between an optical energy source and a detector;

separate at least a portion of the fluid sample into a plurality of components after measuring the first analyte; and

measure a second analyte in one of the plurality of components in the optical path between the same optical energy source and detector used to measure the first analyte.

29. The patient monitoring system of claim 13, wherein the first analyte is hematocrit.

30. The patient monitoring system of claim 13, wherein the fluid sample comprises whole blood.

31. The patient monitoring system of claim 30, wherein the one of the plurality of components comprises plasma.

32. The patient monitoring system of claim 13, wherein the fluid analyzer comprises a centrifuge rotor configured to rotate the sample cell to separate the at least a portion of the fluid sample into a plurality of components.

33. The patient monitoring system of claim 13, wherein the fluid analyzer is configured to measure one of the first analyte and the second analyte using mid-infrared light.

34. The patient monitoring system of claim 33, wherein the fluid analyzer comprises an optical system configured to emit near-infrared light.