ACCURATE AND TIMELY BODY FLUID ANALYSIS

• US 20080072663A1
• Filed: 08/15/2007
• Published: 03/27/2008
• Est. Priority Date: 08/15/2006
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Chiou, Jeffrey, Callicoat, David, Recknor, Michael, Keenan, Richard, Braig, James, Gable, Jennifer, Tong, Roger, Li, Ken
• Application Number:
  US11/839,487
• Publication Number:
  US 20080072663A1
• Time in Patent Office: Days
• US Class Current: 73/61.41
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 2005/1404 : Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0478 : pistons
• CPC Class Codes: B01L 2400/0633 : with moving parts
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/52 : Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: G01N 21/35 : using infrared light G01N21/39 takes precedence
• 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

A method of extracting and analyzing bodily fluids from a patient at the point of care for the patient is provided. The method comprises establishing fluid communication between an analyte detection system and a bodily fluid in the patient. A portion of the bodily fluid is drawn from the patient. A first component of the bodily fluid is separated from the drawn portion, while the analyte detection system remains in fluid communication with the patient. The analyte detection system analyzes the first component to measure a concentration of an analyte in an accurate and timely manner.

Claims

1. An apparatus for obtaining a measurement of a concentration of an analyte in a sample, the apparatus comprising:

a fluid line configured to provide a full-time connection to a fluid vessel;

a sample cell;

a fluid system disposed between the fluid line and the sample cell, the fluid system comprising a pump

a controller configured to cause the pump to draw the sample from the fluid vessel into the fluid system;

an analyte detection system configured to measure a concentration of an analyte in the sample; and

a reporting system configured to report the concentration of the analyte in the sample to a user of the apparatus;

wherein one or more components of the apparatus for obtaining a measurement is configured to measure the concentration of the analyte in the sample such that a time interval between drawing the sample into the fluid system and reporting the concentration of the analyte in the sample does not exceed approximately 25 minutes.

2. The apparatus of claim 1, wherein a standard error of a measurement of the concentration of the analyte in the sample obtained by the analyte detection system does not exceed about 14 milligrams per deciliter.

3. The apparatus of claim 2, wherein the standard error of a measurement does not exceed about 10 milligrams per deciliter.

4. The apparatus of claim 1, wherein the analyte comprises glucose.

5. The apparatus of claim 1, wherein the sample comprises whole blood.

6. The apparatus of claim 5, further comprising a plasma separation system configured to separate plasma from other constituents of the sample.

7. The apparatus of claim 6, wherein the plasma separation system comprises a centrifuge.

8. The apparatus of claim 1, wherein the sample cell is disposed within a centrifuge.

9. The apparatus of claim 1, wherein the time interval between drawing the sample into the fluid system and reporting the concentration of the analyte in the sample does not exceed about 15 minutes.

10. The apparatus of claim 1, wherein the fluid system is configured to share the fluid line with at least one of a continuously-operating infusion pump or a pressure transducer.

11. A method for obtaining a measurement of a concentration of an analyte in a sample, the method comprising:

priming at least a portion of an extracorporeal fluid system with a saline solution;

drawing a sample from a fluid source into the fluid system;

returning at least some of the sample to the fluid source;

separating the sample into a plurality of constituent parts;

analyzing at least one of the plurality of constituent parts of the sample to obtain a measurement of the concentration of the analyte;

flushing at least a portion of the fluid system with a saline solution; and

reporting the measurement of the concentration of the analyte within about 25 minutes of drawing the sample.

12. The method of claim 11, further comprising drawing an air slug into the fluid system.

13. The method of claim 11, wherein analyzing at least one of the plurality of constituent parts of the sample to obtain the measurement of the concentration of the analyte comprises obtaining a measurement having a standard error of not more than 14 milligrams per deciliter.

14. The method of claim 11, wherein reporting the measurement of the concentration of the analyte comprises displaying the measurement of the concentration of the analyte on a display.

15. The method of claim 11, wherein reporting the measurement of the concentration of the analyte within about 25 minutes of drawing the sample comprises reporting the measurement of the concentration of the analyte within about 10 minutes of drawing the sample.

16. The method of claim 11, wherein drawing a sample from a fluid source into the fluid system comprises drawing whole blood from a blood vessel.

17. The method of claim 16, wherein drawing whole blood from a blood vessel comprises drawing from a direct connection to one selected from the group consisting of an arterial catheter, a central venous catheter, and a peripheral venous catheter.

18. The method of claim 11, wherein analyzing at least one of the plurality of constituent parts of the sample to obtain a measurement of the concentration of the analyte comprises obtaining a measurement of the concentration of glucose in the sample.

19. The method of claim 11, wherein analyzing at least one of the plurality of constituent parts of the sample to obtain a measurement of the concentration of the analyte comprises detecting a plurality of absorption spectra in the mid-infrared range.

20. The method of claim 11, wherein returning at least some of the sample to the fluid source comprises returning substantially all but about 40 microliters or less of the sample.

21. The method of claim 11, wherein analyzing at least one of the plurality of constituent parts of the sample to obtain a measurement of the concentration of the analyte comprises using a pre-collected spectrum of a pure interfering substance to reduce the effect of the interfering substance on the measurement.