ANALYTE DETECTION SYSTEM WITH PERIODIC SAMPLE DRAW AND BODY FLUID ANALYZER

• US 20090192367A1
• Filed: 12/23/2008
• Published: 07/30/2009
• Est. Priority Date: 12/21/2005
• Status: Abandoned Application

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Rule, Peter
• Application Number:
  US12/343,421
• Publication Number:
  US 20090192367A1
• Time in Patent Office: Days
• US Class Current: 600/311
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/14539 for measuring pH
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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: A61B 5/4839 combined with drug delivery
• 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 5/14232 : Roller pumps
• CPC Class Codes: G01N 27/3271 : Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

An embodiment of a system for analyzing a body fluid of a patient comprises a fluid transport network having a patient end configured to provide fluid communication with the body fluid in the patient and a fluid delivery point spaced from the patient end. A pump system is coupled to the fluid transport network. The pump system has an infusion mode in which the pump system is operable to pump an infusion fluid toward the patient end of the fluid transport network and a draw mode in which the pump system is operable to draw the body fluid from the patient into the fluid transport network through the patient end. At least one electrochemical test element is located near the fluid delivery point of the fluid transport network. The electrochemical test element is positioned to receive a portion of the body fluid delivered to the delivery point by the fluid transport network. An analyte detection system is configured to receive the test element and to measure at least one analyte in the portion of the body fluid.

Claims

1. An combined analyte detection system and sample preparation unit for analyzing fluid components, the system comprising:

a sample preparation unit configured to prepare a fluid sample for more accurate chemical and/or optical analysis and deliver the sample to an analyte detection system;

the analyte detection system comprising a first and a second analyzer configured to use a combination of optical and/or electrochemical techniques to measure characteristics of the fluid sample.

2. The system of claim 1, wherein the sample preparation unit is further configured to add one or more reagents to the fluid sample to facilitate chemical reactions.

3. The system of claim 2, wherein at least one of the reagents is selected from the group consisting of:

an enzyme, a catalyst, a mediator, an organic compound, and an inorganic compound.

4. The system of claim 1, wherein the sample preparation unit is further configured to extract blood plasma from the sample.

5. The system of claim 1, wherein the sample preparation unit is further configured to regulate the temperature of the sample.

6. The system of claim 1, wherein the sample preparation unit is further configured to regulate the pH of the sample.

7. The system of claim 1, wherein one of the analyzers of the analyte detection system comprises a spectroscopic device.

8. The system of claim 1, wherein one of the analyzers of the analyte detection system is configured to use an electrochemical technique comprising measurement of electrical current.

9. The system of claim 1, wherein one of the analyzers of the analyte detection system is an optical analyzer configured to measure concentration of an analyte in the fluid sample in the presence of interferents that are also in the fluid sample.

10. The system of claim 9, wherein one of the analyzers of the analyte detection system is an electrochemical analyzer configured to measure pH of the sample fluid.

11. The system of claim 1, wherein the two analyzers are optical and electrochemical and are each configured to measure the same fluid parameter.

12. The system of claim 11, wherein:

the fluid parameter is concentration of glucose in the fluid sample;

the electrochemical analyzer is configured to amperometrically measure the oxidation of glucose in the presence of an enzyme; and

the optical analyzer is configured to use mid-infrared spectroscopy to determine glucose concentration.

13. The system of claim 12, wherein the optical analyzer is positioned such that it has access to the fluid sample before the electrochemical analyzer so optical analysis is accomplished before any enzyme or other reagent has been added to the fluid sample.

14. The system of claim 1, wherein the two analyzers are optical and electrochemical and the sample preparation unit separates the fluid sample into two separate portions, one for each analyzer, to avoid cross-contamination and all optical and electrochemical measurements to take place at the same time.

15. A method of producing accurate analyte detection from an analyte detection system, the method comprising:

using an optical analyzer in an analyte detection system to measure an analyte using an optical technique;

using an electrochemical analyzer in the analyte detection system to measure an analyte using an electrochemical technique; and

using a processor in the analyte detection system to generate an accurate status report by using combined results from the optical measurement and the electrochemical measurement to correct for interferences.

16. A system for analyzing a body fluid of a patient, said system comprising:

a fluid transport network having a patient end configured to provide fluid communication with said body fluid in said patient, and a fluid delivery point spaced from said patient end;

a pump system configured to be coupled to said fluid transport network, said pump system having an infusion mode in which said pump system is operable to pump an infusion fluid toward said patient end of said fluid transport network, and a draw mode in which said pump system is operable to draw said body fluid from said patient into said fluid transport network through said patient end; and

a sampling system configured to be in fluid communication with the fluid transport network and to receive a sample of said body fluid, the sampling system comprising a first analyte detection system and a second analyte detection system,

wherein the fluid transport network is configured to deliver a first portion of the sample to the first analyte detection system and a second portion of the sample to the second analyte detection system.

17. The system of claim 16, further comprising a sample preparation unit configured to separate the sample into the first portion for delivery to the first analyte detection system and the second portion for delivery to the second analyte detection system.

18. The system of claim 16, wherein the second portion of the sample comprises at least some of the first portion of the sample.

19. The system of claim 16, wherein the first analyte detection system and the second analyte detection system are configured to be in fluid communication via a series fluid connection.

20. The system of claim 16, wherein the first analyte detection system and the second analyte detection system are configured to be in fluid communication via a parallel fluid connection.

21. The system of claim 16, wherein the first analyte detection system is configured to measure a first analyte in the first portion of the sample and the second analyte detection system is configured to measure a second analyte in the second portion of the sample.

22. The system of claim 21, wherein the first analyte is the same as the second analyte.

23. The system of claim 21, wherein the first analyte detection system is configured to use an optical technique to measure the first analyte and the second analyte detection system is configured to use a non-optical technique to measure the second analyte.

24. The system of claim 23, wherein the non-optical technique comprises an electrochemical technique or an electrical technique.

25. The system of claim 21, wherein the first analyte comprises glucose and the second analyte comprises lactate.

26. The system of claim 21, wherein the first analyte comprises glucose and the second analyte comprise pH.

27. The system of claim 21, wherein the system is further configured to use at least the measurement of the first analyte and the measurement of the second analyte to correct for interferences among at least the first analyte and the second analyte.

28. A method for analyzing a body fluid of a patient with an analysis system having a fluid transport network with a patient end providing fluid communication with said body fluid in said patient, and a fluid delivery point spaced apart from said patient end, said method comprising:

through said patient end of said fluid transport network, infusing said patient with an infusion fluid and drawing said body fluid from said patient;

delivering, to a first analyte detection system located near said fluid delivery point of said fluid transport network, at least a first portion of said drawn body fluid;

delivering, to a second analyte detection system located near said fluid delivery point of said fluid transport network, at least a second portion of said drawn body fluid;

measuring, with the first analyte detection system, a first analyte in the first portion of said drawn body fluid; and

measuring, with the second analyte detection system, a second analyte in the second portion of said drawn body fluid.

29. The method of claim 28, wherein measuring a first analyte and measuring a second analyte are performed substantially simultaneously.

30. The method of claim 28, further comprising separating said drawn body fluid sample into the first portion and the second portion.

31. The method of claim 30, wherein said separating comprises centrifuging or filtering at least a portion of said drawn body fluid sample.

32. The method of claim 28, wherein delivering at least a second portion comprises delivering to the second analyte detection system at least some of the first portion of said drawn body fluid sample.

33. The method of claim 28, wherein the drawn body fluid sample comprises blood and the first analyte comprises glucose.

34. The method of claim 33, wherein the second analyte comprises lactate.

35. The method of claim 28, wherein measuring the first analyte comprises using an optical method and measuring the second analyte comprises using an electrochemical or electrical method.