Analyte detection system for multiple analytes

• US 8,140,140 B2
• Filed: 12/21/2005
• Issued: 03/20/2012
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Sterling, Bernhard B., Braig, James R., Witte, Kenneth G., Rule, Peter, Keenan, Richard, Hall, W. Dale
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US11/314,176
• Publication Number:
  US 20060189858A1
• Time in Patent Office: 2,281 Days
• Field of Search: 600/310, 600/316, 600/322, 600/341, 600/342, 356/39, 422/68.1, 422/82.05, 422/82.06, 422/82.09, 250/339.01, 250/339.05, 250/340, 250/341.1
• US Class Current: 600/316
• 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 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, and a sample draw mode in which the pump unit is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus further comprises a spectroscopic analyzer positioned to analyze at least a portion of the sample; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain measurements of two or more properties of the sample. In one implementation, the pump unit comprises a first pump operable in the infusion mode but not in the sample draw mode, and a second pump operable in the sample draw mode but not in the infusion mode.

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;

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

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

a processor in communication with or incorporated into said spectroscopic analyzer, said processor configured to execute stored program instructions to obtain measurements of two or more properties of said sample when a first analyte and a second analyte in said sample have overlapping spectral features, wherein the program instructions are configured to cause the fluid analyzer to;

subject the at least a portion of the sample to a test that comprises obtaining a spectral characterization of the at least a portion of the sample;

analyze results from the test to obtain a measurement of the first property of the two or more properties, the first property comprising the level of the first analyte in the at least a portion of the sample; and

analyze the at least a portion of the sample to obtain a measurement of the second property of the two or more properties by analyzing the same results from the test, the second property comprising the level of the second analyte in the at least a portion of the sample;

wherein subjecting the at least a portion of the sample to the test comprises obtaining a single spectral characterization including the spectral features of both the first analyte and the second analyte.

2. The apparatus of claim 1, where said bodily fluid is blood, and where one of said two or more properties is the hematocrit.

3. The apparatus of claim 1, where said at least a portion of the sample is whole blood.

4. The apparatus of claim 1, where said at least a portion of the sample is blood plasma.

5. The apparatus of claim 1, where said pump unit comprises a first pump operable in said infusion mode but not in said sample draw mode, and a second pump operable in said sample draw mode but not in said infusion mode.

6. The apparatus of claim 1, wherein said spectroscopic analyzer is an infrared spectroscopic analyzer.

7. A method for analyzing the composition of a bodily fluid in a patient, the method 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;

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

subjecting the at least a portion of the sample in the fluid analyzer to a spectroscopic test that is sensitive to at least a first property and a second property of the at least a portion of the sample; and

analyzing the at least a portion of the sample in the fluid analyzer to obtain two or more properties of the sample by;

analyzing the results from the test to obtain a measurement of the first property of the two or more properties; and

further analyzing the results from the same test to obtain a measurement of the second property of the two or more properties.

8. The method of claim 7, where said at least a portion includes whole blood, blood plasma, or blood serum.

9. The method of claim 7, where said two or more properties includes the presence of at least one analyte.

10. The method of claim 7, wherein said fluid analyzer is an infrared spectroscopic analyzer.

11. The method of claim 10, where

the spectroscopic test includes obtaining a spectral characterization of the sample;

and

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

12. The method of claim 7, where at least one of said two or more properties is an estimate of the concentration of an analyte, said analyzing includes:

identifying one or more interferents to the estimate of the concentration of said analyte, and

reducing errors in the estimate of the concentration of said analyte.

13. 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;

a controller in operative engagement with the fluid handling network, the controller having an infusion mode in which the controller is configured to cause the fluid handling network to deliver infusion fluid to the patient through the patient end, and a sample draw mode in which the controller is configured to cause the fluid handling network to draw a sample of the bodily fluid from the patient through the patient end;

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

a processor in communication with or incorporated into the fluid analyzer, said processor configured to execute stored program instructions;

to obtain measurements of two or more properties of the portion of the sample, wherein the program instructions are configured to cause the fluid analyzer to;

subject the portion of the sample to an optical test that is sensitive to at least a first property and a second property of the portion of the sample;

analyze results from the test to obtain a measurement of the first property; and

analyze the portion of the sample to obtain a measurement of the second property by analyzing the same results from the test.

14. The apparatus of claim 13, wherein the measurements of two or more properties comprises a measurement of the presence of at least one analyte.

15. The apparatus of claim 14, wherein the at least one analyte includes glucose.

16. The apparatus of claim 14, wherein the at least one analyte includes blood urea nitrogen (BUN), hemoglobin, or lactate.

17. The apparatus of claim 14, wherein the presence is an estimate of the concentration, further comprising stored program instructions executable by the processor to identify one or more interferents to the estimate of the concentration of at least one of analyte, and reduce errors in the estimate of the concentration of the at least one analyte.

18. The apparatus of claim 14, wherein the fluid analyzer comprises a spectroscopic analyzer configured to obtain a spectrum including spectral features of the at least one analyte.

19. The apparatus of claim 14, wherein the fluid analyzer comprises a spectroscopic analyzer configured to obtain two or more spectra, each of the two or more spectra including spectral features of the at least one analyte.

20. The apparatus of claim 13, wherein the first property comprises the level of a first analyte in the at least a portion of the sample, and wherein the second property comprises the level of a second analyte in the at least a portion of the sample.