Method and apparatus for detection of multiple analytes

• US 20060200071A1
• Filed: 12/21/2005
• Published: 09/07/2006
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Sterling, Bernhard B., Wechsler, Mark, Rule, Peter, Hall, W. Dale
• Granted Patent: US 7,722,537 B2
• 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

An apparatus for analyzing the composition of bodily fluid. The apparatus comprises a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient and at least one pump intermittently operable to draw a sample of bodily fluid from the patient. The apparatus further comprises a fluid analyzer positioned to analyze at least a portion of the sample and measure the presence of two or more analytes. Also disclosed is a method for analyzing the composition of a bodily fluid in a patient. The method comprises drawing a sample of the bodily fluid of the patient through a fluid handling network configured to maintain fluid communication with a bodily fluid in a patient. The method further comprises analyzing the at least a portion of the sample in a fluid analyzer to estimate the concentration of two or more analytes in the sample.

Claims

1. An apparatus for analyzing the composition of bodily fluid comprising:

a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient and at least one pump intermittently operable to draw a sample of bodily fluid from the patient; and

a fluid analyzer positioned to analyze at least a portion of the sample and measure the presence of two or more analytes.

2. The apparatus of claim 1, where said fluid analyzer analyzes the presence of at least one analyte in whole blood.

3. The apparatus of claim 1, where said fluid analyzer analyzes the presence of at least one analyte in blood plasma.

4. The apparatus of claim 1, where said fluid analyzer analyzes the presence of at least one analyte in blood serum.

5. The apparatus of claim 1, where said fluid analyzer includes a spectroscopic analyzer.

6. The apparatus of claim 5, where said spectroscopic analyzer is an infrared spectroscopic analyzer.

7. The apparatus of claim 5, where said spectroscopic analyzer obtains a spectra of said at least a portion of the sample, where said apparatus further includes a processor in communication with or incorporated into said spectroscopic analyzer, and where said apparatus further comprises stored program instructions executable by said processor to determine the presence of at least one of said two or more analytes from the spectra.

8. The apparatus of claim 7, where said apparatus further comprises stored program instructions executable by said processor to identify one or more interferents to the determination of the concentration of said at least one of said two or more analytes, and to reduce errors in the estimation of the concentration of said at least one of said two or more analytes.

9. The apparatus of claim 7, where said spectra includes spectral features said two or more analytes.

10. The apparatus of claim 7, where said spectra includes two or more spectra each including spectral features of one of said two or more analytes.

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

12. The apparatus of claim 1, where at least one of said two or more analytes is a sugar.

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

14. The apparatus of claim 1, where said bodily fluid is blood, and where said fluid analyzer accepts a sample of the bodily fluid from the fluid handling network and obtain a measurement of the hematocrit of the blood.

15. A method for analyzing the composition of a bodily fluid in a patient comprising:

drawing a sample of the bodily fluid of the patient through a fluid handling network configured to maintain fluid communication with a bodily fluid in a patient; and

analyzing the at least a portion of the sample in a fluid analyzer to estimate the concentration of two or more analytes in the sample.

16. The method of claim 15, where said portion includes whole blood, blood plasma, or blood serum.

17. The method of claim 15, where said analyzing includes:

obtaining a spectral characterization of the sample; and

determining an estimate of the concentration of two or more analytes in the sample from said spectral characterization.

18. The method of claim 17, wherein said spectral characterization includes an infrared spectrum.

19. The method of claim 17, where said determining includes:

identifying one or more interferents to the determining of said estimate; and

reducing errors in said estimate.

20. The method of claim 17, where said spectral characterization includes spectral features of said two or more analytes.

21. The method of claim 15, where one of said two or more analytes is glucose.

22. The method of claim 15, where at least one of said two or more analytes is a sugar.

23. The method of claim 15, where at least one of said two or more analytes is glucose, blood urea nitrogen (BUN), hemoglobin, or lactate.

24. The method of claim 15, where said bodily fluid is blood, and said method further comprises obtaining a measurement of the hematocrit of the blood.

25. An apparatus for analyzing the composition of bodily fluid comprising:

means for drawing a sample of the bodily fluid of the patient through a fluid handling network configured to maintain fluid communication with a bodily fluid in a patient; and

means for analyzing the at least a portion of the sample in a fluid analyzer to estimate the concentration of two or more analytes in the sample.

26. The apparatus of claim 25, where said portion includes whole blood, blood plasma, or blood serum.

27. The apparatus of claim 25, where said means for analyzing includes:

means for obtaining a spectral characterization of the sample; and

means for determining an estimate of the concentration of two or more analytes in the sample from said spectral characterization.

28. The apparatus of claim 27, wherein said spectral characterization includes an infrared spectrum.

29. The apparatus of claim 27, where said means for determining includes:

means for identifying one or more interferents to the determining of said estimate; and

means for reducing errors in said estimate.

30. The apparatus of claim 27, where said spectral characterization includes spectral features of said two or more analytes.

31. The apparatus of claim 25, where one of said two or more analytes is glucose.

32. The apparatus of claim 25, where at least one of said two or more analytes is a sugar.

33. The apparatus of claim 25, where at least one of said two or more analytes is blood urea nitrogen (BUN), hemoglobin, or lactate.

34. The apparatus of claim 25, where said bodily fluid is blood, and said apparatus further comprises means for obtaining a measurement of the hematocrit of the blood.