METHOD AND APPARATUS FOR DETECTION OF MULTIPLE ANALYTES

• US 20100234703A1
• Filed: 05/24/2010
• Published: 09/16/2010
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: Bernhard B. Sterling, Hall W. Dale, James R. Braig, Jenifer H. Gable, Mark Wechsler, Peter Rule
• Original Assignee: Bernhard B. Sterling, Hall W. Dale, James R. Braig, Jenifer H. Gable, Mark Wechsler, Peter Rule
• Inventors: Gable, Jenifer H., Braig, James R., Sterling, Bernhard B., Wechsler, Mark, Rule, Peter, Hall, W. Dale
• Application Number:
  US12/786,244
• Publication Number:
  US 20100234703A1
• Time in Patent Office: Days
• US Class Current: 600/310
• 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

In some embodiments, an apparatus analyzes 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. A body fluid analysis apparatus comprising:

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

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

an infrared 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, wherein the program instructions are configured to cause the fluid analyzer to;

obtain a spectral characterization of the at least a portion of the sample, the spectral characterization incorporating one or more mid-infrared wavelengths;

analyze the spectral characterization to obtain a measurement of the level of a first analyte in at least a portion of the sample; and

analyze the same spectral characterization to obtain a measurement of the level of a second analyte in at least a portion of the sample when the first analyte and the second analyte have overlapping spectral features, such that the results of the spectral characterization are sensitive both the first analyte and the second analyte.

2. The apparatus of claim 1, wherein the spectral characterization includes wavelengths between about 5 μ

m and about 20 μ

m.

3. The apparatus of claim 1, wherein the spectral characterization includes wavelengths between about 5.25 μ

m and about 12.0 μ

m.

4. The apparatus of claim 1, wherein the at least a portion of the sample is whole blood.

5. The apparatus of claim 1, wherein the at least a portion of the sample is blood plasma.

6. The apparatus of claim 1, wherein the valve system 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.

7. A method of analyzing body fluid, 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 an infrared spectroscopic analyzer connected to the fluid handling network;

obtaining a spectral characterization from the at least a portion of the sample in the infrared spectroscopic analyzer, the spectral characterization including one or more mid-infrared wavelengths; and

analyzing the at least a portion of the sample in the infrared spectroscopic analyzer to obtain two or more analyte levels by;

analyzing the spectral characterization to obtain an estimate of a level of a first analyte in the at least a portion of the sample; and

analyzing the same spectral characterization to obtain an estimate of a level of a second analyte in the at least a portion of the sample.

8. The method of claim 7, wherein the at least a portion of the sample comprises whole blood, blood plasma, or blood serum.

9. The method of claim 7, wherein the spectral characterization includes wavelengths between about 5 μ

m and about 20 μ

m.

10. The apparatus of claim 7, wherein the spectral characterization includes wavelengths between about 5.25 μ

m and about 12.0 μ

m.

11. The method of claim 7, wherein analyzing the at least a portion of the sample comprises:

identifying one or more interferents to the estimate of the level of the first analyte, and

reducing errors in the estimate of the level of the first analyte.

12. The method of claim 11, wherein analyzing the at least a portion of the sample comprises:

identifying one or more interferents to the estimate of the level of the second analyte, and

reducing errors in the estimate of the level of the second analyte.

18. The method of claim 11, wherein the program instructions are configured to cause the infrared spectroscopic analyzer to:

identify one or more interferents to the estimate of the level of the second analyte, and

reduce errors in the estimate of the level of the second 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 valve system in operative engagement with the fluid handling network, the valve system having an infusion mode in which the valve system is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode in which the valve system is operable to draw a sample of the bodily fluid from the patient through the patient end;

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

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

stored program instructions executable by the processor to obtain measurements of the levels of two or more analytes in the at least a portion of the sample, wherein the program instructions are configured to cause the infrared spectroscopic analyzer to;

obtain a spectral characterization from the at least a portion of the sample in the infrared spectroscopic analyzer, the spectral characterization including one or more mid-infrared wavelengths;

analyze the spectral characterization to obtain an estimate of a level of a first analyte in the at least a portion of the sample; and

analyze the same spectral characterization to obtain an estimate of a level of a second analyte in the at least a portion of the sample.

14. The method of claim 13, wherein the at least a portion of the sample comprises whole blood, blood plasma, or blood serum.

15. The method of claim 13, wherein the spectral characterization includes wavelengths between about 5 μ

m and about 20 μ

m.

16. The apparatus of claim 13, wherein the spectral characterization includes wavelengths between about 5.25 μ

m and about 12.0 μ

m.

17. The method of claim 13, wherein the program instructions are configured to cause the infrared spectroscopic analyzer to:

identify one or more interferents to the estimate of the level of the first analyte, and

reduce errors in the estimate of the level of the first analyte.