Analyte detection system with reduced sample volume

• US 7,860,543 B2
• Filed: 08/15/2006
• Issued: 12/28/2010
• Est. Priority Date: 02/14/2005
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Zheng, Peng, Sterling, Bernhard B., Wechsler, Mark, Keenan, Richard, Rule, Peter
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US11/504,139
• Publication Number:
  US 20070083091A1
• Time in Patent Office: 1,596 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 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/15003 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 5/153 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: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: G01N 35/1095 for supplying the samples to flow-through analysers for a specific analyser see relevant groups, e.g. under G01N15/00, G01N21/00, G01N27/00, G01N30/00, H01J49/00

Abstract

In certain embodiments, a method samples a body fluid of a patient. The method includes providing a fluid handling system having one or more fluid passageways. The method further includes infusing an infusion fluid by way of a fluid handling system into a patient through one or more fluid passageways. The method further includes obtaining a sample of body fluid by way of a fluid handling system from a patient through one or more fluid passageways. The obtained sample is no more than 5 milliliters in volume. The method further includes analyzing at least an analyzed portion of the obtained sample by way of an analyte detection system operatively associated with the fluid handling system to determine a concentration of at least one analyte.

Claims

1. A method of sampling a body fluid of a patient and reducing sample dilution, said method comprising:

providing a fluid handling system configured to provide access to the body fluid of the patient, the fluid handling system comprising a patient end, a junction in fluid communication with the patient end, a first fluid passageway connected to the junction, and a second fluid passageway connected to the junction;

providing a body fluid detection sensor configured to detect the presence of substantially undiluted body fluid at a location in the fluid handling system and generate a signal;

with said fluid handling system, infusing an infusion fluid into said patient through the patient end;

positioning an air bubble at the entrance to the second fluid passageway adjacent the junction between the first and second fluid passageways;

with said fluid handling system, drawing at least a portion of a sample of said body fluid from said patient, through the patient end, through the junction, and into the first fluid passageway, wherein the body fluid detection sensor identifies substantially undiluted body fluid at the location in the fluid handling network and generates a signal to facilitate the introduction of substantially undiluted body fluid into the first fluid passageway such that substantially undiluted body fluid is positioned at the junction between the first and second fluid passageways;

with said fluid handling system, drawing at least a portion of the sample of said body fluid through the junction and into the second fluid passageway after the air bubble is positioned such that the leading portion of the sample that enters the second fluid passageway immediately following the air bubble is substantially undiluted blood, and wherein the air bubble is transported through the second fluid passageway forward of the sample such that the air bubble provides a barrier to reduce dilution of the leading portion of the sample that may result from contact with other fluids;

with said fluid handling system, delivering at least an analysis portion of the sample to an analyte detection system operatively associated with the fluid handling system;

with the analyte detection system, analyzing at least an analyzed portion of said sample to determine a concentration of at least one analyte.

2. The method of claim 1, wherein at least a portion of the sample that is drawn into the second fluid passageway is transferred from the first fluid passageway, through the junction, and into the second fluid passageway.

3. A body fluid handling system configured to reduce sample dilution, the system comprising:

a fluid handling network configured to provide access to a body fluid in a patient;

a body fluid detection sensor configured to detect the presence of body fluid at a location in the fluid handling network and generate a signal;

one or more air injectors configured to insert air into the fluid handling network;

a pump system coupled to the fluid handling network, the pump system having a first mode in which the pump system is operable to infuse an infusion fluid toward the patient via the fluid handling network and a second mode in which the pump system is operable to draw a sample of the body fluid from the patient into the fluid handling network such that the air is positioned immediately forward of a substantially undiluted leading portion of the sample to insulate the leading portion of the sample from dilution that may result from contact with other fluids, wherein the fluid handling system is configured to draw a predetermined volume of the body fluid using the signal from the body fluid detection sensor; and

an analyte detection system accessible via the fluid handling network and configured to measure a concentration of an analyte in at least an analysis portion of the sample.

4. The body fluid handling system of claim 3, wherein the body fluid detection sensor is a colorimetric sensor capable of distinguishing between the infusion fluid and the body fluid.

5. The body fluid handling system of claim 4, wherein the colorimetric sensor is configured to indicate the presence of substantially undiluted body fluid when the output of the colorimetric sensor levels to a constant value associated with the body fluid.

6. The body fluid handling system of claim 3, wherein the fluid handling system is configured to separate the sample into a first portion and a second portion, and to return the second portion to the patient without analyzing the second portion.

7. The body fluid handling system of claim 6, wherein the first portion has a volume from 10 microliters to 1 milliliter.

8. The body fluid handling system of claim 6, wherein the first portion has a volume from 10 microliters to 40 microlitiers.

9. The body fluid handling system of claim 3, wherein the sample is no more than 5 milliliters in volume.

10. The body fluid handling system of claim 3, wherein the sample is no more than 400 microliters in volume.

11. The body fluid handling system of claim 3, wherein the body fluid is blood and the analyte is glucose.

12. A method of sampling a body fluid of a patient and reducing dilution, the method comprising:

providing a fluid handling system configured to provide access to the body fluid of the patient, the fluid handling system comprising one or more fluid passageways;

providing a body fluid detection sensor configured to detect the presence of substantially undiluted body fluid at a location in the one or more fluid passageways and generate a signal;

with the fluid handling system, infusing an infusion fluid into the patient through the one or more fluid passageways;

inserting air into the one or more fluid passageways;

with the fluid handing system, drawing a sample of the body fluid from the patient into the one or more fluid passageways such that the air is positioned immediately forward of a substantially undiluted leading portion of the sample to insulate the leading portion of the sample from dilution that may result from contact with other fluids, wherein the fluid handling system is configured to draw a predetermined volume of the body fluid using the signal from the body fluid detection sensor; and

with an analyte detection system operatively associated with said fluid handling system, analyzing at least an analyzed portion of said sample to determine a concentration of at least one analyte.

13. The method of claim 12, wherein the body fluid detection sensor is a colorimetric sensor capable of distinguishing between the infusion fluid and the body fluid.

14. The method of claim 13, wherein the colorimetric sensor is configured to indicate the presence of substantially undiluted body fluid when the output of the colorimetric sensor levels to a constant value associated with the body fluid.

15. The method of claim 12, further comprising:

separating the sample into a first portion and a second portion; and

returning the second portion to the patient without analyzing the second portion.

16. The method of claim 15, wherein the first portion has a volume from 10 microliters to 1 milliliter.

17. The method of claim 15, wherein the first portion has a volume from 10 microliters to 40 microliters.

18. The method of claim 12, wherein the sample is no more than 5 milliliters in volume.

19. The method of claim 12, wherein the sample is no more than 400 microliters in volume.

20. The method of claim 12, wherein the body fluid is blood and the analyte is glucose.