Method and apparatus for detection of multiple analytes

• US 7,722,537 B2
• Filed: 12/21/2005
• Issued: 05/25/2010
• Est. Priority Date: 02/14/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Hall, W. Dale, Gable, Jennifer H., Braig, James R., Sterling, Bernhard B., Wechsler, Mark, Rule, Peter
• Primary Examiner(s): Nasser; Robert L
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/314,173
• Publication Number:
  US 20060200071A1
• Time in Patent Office: 1,616 Days
• Field of Search: 600/366, 600/347, 600/308, 600/360, 600/365
• US Class Current: 600/365
• 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, the apparatus comprising:

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

at least one pump in operative engagement with the fluid handling network, the at least one pump having a sample draw mode in which the pump is operable to draw a sample of the bodily fluid from the patient through the patient end;

a controller configured to operate the at least one pump in the sample draw mode at intervals;

a fluid analyzer positioned to analyze at least a portion of the sample;

a processor in communication with or incorporated into the fluid analyzer;

and stored program instructions executable by the processor to determine the concentrations of two or more analytes in the sample, wherein the program instructions are configured to cause the fluid analyzer to;

subject the at least a portion of the sample to one or more tests;

analyze results from the one or more tests to estimate the concentration of a first analyte;

determine whether the results from the one or more tests are sensitive to a second analyte in the sample; and

analyze the at least a portion of the sample to estimate the concentration of the second analyte, wherein analyzing the at least a portion of the sample comprises analyzing the same results from the one or more tests when it is determined that the results from spectral features of the second analyte overlap spectral features of the first analyte.

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, and where said stored program instructions are further configured to cause the fluid analyzer 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 spectra includes spectral features of said two or more analytes.

9. 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.

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

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

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

13. 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.

14. A method for automatically analyzing the composition of a bodily fluid in a patient, the method comprising:

a) automatically 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;

b) directing at least a portion of the sample to a fluid analyzer connected to the fluid handling network;

c) obtaining a spectral characterization of at least a portion of the sample in the fluid analyzer;

d) analyzing the spectral characterization to estimate the concentration of a first analyte in the sample, the first analyte being apart from any interferents to the measurement of the first analyte;

e) determining whether a second analyte in the sample is associated with spectral features that overlap spectral features associated with the first analyte, the second analyte being apart from any interferents to the measurement of the second analyte;

f) analyzing the at least a portion of the sample to estimate the concentration of the second analyte, wherein analyzing the at least a portion of the sample comprises analyzing the spectral characterization when spectral features of the second analyte overlap spectral features of the first analyte;

g) automatically drawing another sample of the bodily fluid of the patient through the fluid handling network after an interval has elapsed; and

h) repeating steps b)-f) using the newly-drawn sample.

15. The method of claim 14, where said portion includes whole blood, blood plasma, or blood serum.

16. The method of claim 14, wherein said spectral characterization includes an infrared spectrum.

17. The method of claim 14, where said spectral characterization includes spectral features of the first analyte and the second analyte.

18. The method of claim 14, where one of the first analyte and the second analyte is glucose.

19. The method of claim 14, where at least one of the first analyte and the second analyte is a sugar.

20. The method of claim 14, where at least one of the first analyte and the second analyte is glucose, blood urea nitrogen (BUN), hemoglobin, or lactate.

21. The method of claim 14, where said bodily fluid is blood, and said method further comprises obtaining a measurement of the hematocrit of the blood.