Analyte detection system with reduced sample volume

• US 7,860,542 B2
• Filed: 12/21/2005
• 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:
  US11/316,686
• Publication Number:
  US 20060195046A1
• Time in Patent Office: 1,833 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 400 microliters 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 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, the fluid handling network 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;

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

a pump system coupled to said fluid handling network, said pump system having an infusion mode in which said pump system is operable to infuse an infusion fluid toward said patient via said fluid handling network;

one or more air injectors configured to position an air bubble at the entrance to the second fluid passageway adjacent the junction between the first and second passageways;

said pump system being configured to;

draw 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 positioning of substantially undiluted body fluid at the junction between the first and second passageways,

draw at least a portion of the sample 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

maintain the air bubble immediately forward of the undiluted leading portion of the sample as the sample is transported through the second fluid passageway such that the air bubble provides a barrier to reduce dilution of the leading portion of the sample that enters the second fluid passageway by insulating the leading portion of the sample from dilution that may result from contact with other fluids; and

an analyte detection system accessible via said fluid handling network and configured to measure an analyte in an analyzed a portion of said drawn sample of body fluid.

2. A method of sampling a body fluid of a patient and reducing sample 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 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;

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

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

with said fluid handling system, drawing at least a portion of a sample of the body fluid from the patient, through the patient end, through the junction, and 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 through the junction and into the second fluid passageway after the air is positioned at the entrance to the second fluid passageway such that a leading portion of the sample that enters the second fluid passageway immediately following the air is substantially undiluted body fluid thereby insulating the leading portion of the sample that enters the second fluid passageway from dilution 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; and

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

3. The method of claim 2, wherein drawing at least a portion of the sample into the second fluid passageway comprises transferring at least a portion of the sample from the first fluid passageway, through the junction, and into the second fluid passageway.

4. The method of claim 3, wherein the last portion of the sample that enters the first fluid passageway is the first portion of the sample to enter the second fluid passageway from the first fluid passageway.

5. The method of claim 2, wherein a leading portion of the sample that enters the first fluid passageway is diluted with the infusion fluid.

6. The method of claim 2, further comprising:

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

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

7. The method of claim 2, further comprising separating the sample into two or more sample portions by inserting one or more air bubbles between the two or more sample portions, wherein one or more leading sample portions are transported through the second fluid passageway to flush the second fluid passageway, and wherein a sample portion following the one or more leading sample portions is the analysis portion delivered to the analyte detection system for analysis.

8. The method of claim 2, wherein positioning the air comprises positioning air across the junction such that the at least a portion of the sample that is drawn across the junction and into the first fluid passageway divides the air thereby positioning the air at the entrance to the second fluid passageway.

9. The method of claim 2, wherein the steps are performed in the recited order.

10. The method of claim 2, wherein drawing at least a portion of the sample into the second fluid passageway comprises drawing at least a portion of the sample through the junction and into the second fluid passageway without entering the first fluid passageway.

11. The method of claim 2, wherein the body fluid is blood and the analyte is glucose.

12. The method of claim 2, wherein the sample is no more than 3 milliliters in volume.

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

a fluid handling network configured to provide access to body fluid of a patient, the fluid handling network 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;

a pump system coupled to the fluid handling network, the pump system having an infusion mode in which the pump system is operable to infuse an infusion fluid toward the patient via the fluid handling network;

one or more air injectors configured to position air at the entrance to the second fluid passageway adjacent the junction between the first and second passageways;

the pump system being configured to;

draw at least a portion of a sample of the body fluid from the patient, through the patient end, through the junction, and into the first fluid passageway, such that substantially undiluted body fluid is positioned at the junction between the first and second fluid passageways;

draw at least a portion of the sample through the junction and into the second fluid passageway such that a leading portion of the sample that enters the second fluid passageway immediately following the air is substantially undiluted body fluid;

maintain the air forward of the undiluted leading portion of the sample as it is transported through the second fluid passageway such that the air provides a barrier to reduce dilution of the leading portion of the sample that enters the second fluid passageway by insulating the leading portion of the sample from dilution that may result from contact with other fluid; 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.

14. The body fluid handling system of claim 13, wherein the pump system is configured to transfer at least a portion of the sample from the first fluid passageway, through the junction, and into the second fluid passageway.

15. The body fluid handling system of claim 14, wherein the pump system is configured to transfer the at least a portion of the sample to the second fluid passageway such that the last portion of the sample that enters the first fluid passageway is the first portion of the sample to enter the second fluid passageway from the first fluid passageway.

16. The body fluid handling system of claim 13, wherein the fluid handling network is configured to infuse the infusion fluid through the first fluid passageway such that when the at least a portion of the sample is drawn into the first fluid passageway, a leading portion of the sample that enters the first fluid passageway is diluted with the infusion fluid.

17. The body fluid handling system of claim 13, wherein the fluid handling system is configured to separate said sample into a first portion and a second portion and return the second portion to the patient without analyzing the second portion.

18. The body fluid handling system of claim 13, wherein the one or more air injectors are configured to separate the sample into two or more sample portions such that one or more leading sample portions are transported through the second fluid passageway to flush the second fluid passageway, and wherein a sample portion following the one or more leading sample portions is the analysis portion delivered to the analyte detection system for analysis.

19. The body fluid handling system of claim 13, wherein the pump system is configured to first draw a portion of the sample into the first fluid passageway and hold it there while another portion is drawn through the junction and into the second fluid passageway without entering the first fluid passageway.

20. The body fluid handling system of claim 13, wherein the body fluid is blood and the analyte is glucose.