Analyte detection system with reduced sample volume

• US 20070083091A1
• Filed: 08/15/2006
• Published: 04/12/2007
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Zheng, Peng, Keenan, Richard, Rule, Peter, Braig, James, Gable, Jennifer, Sterling, Bernhard, Weschler, Mark
• Granted Patent: US 7,860,543 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• 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, said method comprising:

providing a fluid handling system having one or more fluid passageways;

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

with said fluid handling system, obtaining a sample of said body fluid from said patient through said one or more fluid passageways, said obtained sample being no more than 5 milliliters in volume; and

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

2. The method of claim 1, further comprising separating said obtained sample into a first portion and a second portion, said second portion to be returned to the patient without being analyzed.

3. The method of claim 2, wherein said first portion has a volume of from 10 microliters to 1 milliliters.

4. The method of claim 2, wherein said first portion has a volume of no more than 100 microliters.

5. The method of claim 2, wherein said first portion has a volume of no more than 40 microliters.

6. The method of claim 1, wherein said analyte is glucose, lactate, or carbon dioxide.

7. The method of claim 1, wherein said body fluid is blood.

8. The method of claim 7, further comprising separating plasma from said blood, wherein analyzing at least a portion of said obtained sample comprises analyzing said plasma.

9. The method of claim 1, wherein said obtained sample is no more than 3 milliliters in volume.

10. The method of claim 1, wherein said obtained sample is no more than 400 microliters in volume.

11. The method of claim 1, wherein said obtained sample is no more than 50 microliters in volume.

12. The method of claim 1, further comprising returning a portion of said obtained sample to said patient.

13. The method of claim 1, wherein said obtained sample has a volume which is sufficient to facilitate transport of at least a portion of said obtained sample to said analyte detection system and measurement of said analyte concentration.

14. The method of claim 1, wherein obtaining a sample comprises drawing said sample past a patient end of said one or more fluid passageways.

15. The method of claim 1, wherein analyzing at least a portion of said obtained sample comprises optically analyzing at least a portion of said obtained sample.

16. The method of claim 15, wherein optically analyzing at least a portion of said obtained sample comprises spectroscopically analyzing at least a portion of said obtained sample.

17. A body fluid handling system comprising:

a fluid handling network having a patient end, said fluid handling network configured to provide access to a body fluid in a patient;

a pump system coupled to said fluid handling network, said pump system having a first mode in which said pump system is operable to infuse an infusion fluid toward said patient via said fluid handling network and a second mode in which said pump system is operable to draw a sample of said body fluid from said patient into said fluid handling network;

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

said fluid handling network having a maximum draw region associated with a maximum draw state of the fluid handling system; and

said maximum draw region having a volume of no more than 5 milliliters.

18. The fluid handling system of claim 17, further comprising a sample preparation unit configured to separate said drawn sample into a first portion and a second portion, said second portion to be returned to the patient without being analyzed.

19. The fluid handling system of claim 18, wherein said first portion has a volume of from 10 microliters to 1 milliliters.

20. The fluid handling system of claim 18, wherein said first portion has a volume of no more than 100 microliters.

21. The fluid handling system of claim 18, wherein said first portion has a volume of no more than 40 microliters.

22. The fluid handling system of claim 17, wherein said analyte is glucose.

23. The fluid handling system of claim 17, wherein said body fluid is blood.

24. The fluid handling system of claim 23, further comprising a separator accessible via said fluid handling network, said separator configured to separate at least one component from said drawn sample of body fluid.

25. The fluid handling system of claim 24, wherein said body fluid is blood and said at least one component is plasma, and said analyte detection system is configured to measure said analyte in said plasma.

26. The fluid handling system of claim 17, wherein said maximum draw region is no more than 3 milliliters in volume.

27. The fluid handling system of claim 17, wherein said maximum draw region is no more than 400 microliters in volume.

28. The fluid handling system of claim 17, wherein said maximum draw region is no more than 50 microliters in volume.

29. The fluid handling system of claim 17, wherein said maximum draw state is a state of said fluid handling system in which a maximum amount of said body fluid is present in said fluid handling network during a normal operating cycle of said fluid handling system, excluding any waste body fluid in said fluid handling network.

30. The fluid handling system of claim 17, wherein said maximum draw region is that portion of said fluid handling network occupied by said body fluid when at said maximum draw state.

31. The fluid handling system of claim 17, wherein said maximum draw region is bounded by said patient end of said fluid handling network.

32. The fluid handling system of claim 17, wherein said analyte detection system comprises an optical detection system.

33. The fluid handling system of claim 32, wherein the optical detection system comprises a spectroscopic detection system.

34. The fluid handling system of claim 17, wherein said pump system comprises a first single-mode pump operable in said first mode and a second single-mode pump operable in said second mode.

35. A body fluid analysis system comprising:

a fluid passageway;

an analyzer accessible via said fluid passageway and configured to provide information relating to a measurement of an analyte in a sample;

a processor in communication with said analyzer; and

stored program instructions executable by said processor such that said system, upon execution of said stored program instructions, is operable to;

(a) infuse an infusion fluid toward a patient end of the fluid passageway;

(b) draw said sample through said fluid passageway away from said patient end and toward said analyzer, said drawn sample being no more than 5 milliliters in volume; and

(c) analyze at least a portion of said drawn sample to determine a concentration of at least one analyte.

36. The system of claim 35, further comprising a sample preparation unit configured to separate said drawn sample into a first portion and a second portion, said second portion to be returned to the patient without being analyzed.

37. The system of claim 36, wherein said first portion has a volume of no more than 60 microliters.

38. The system of claim 36, wherein said first portion has a volume of no more than 40 microliters.

39. The system of claim 35, wherein said analyzer comprises a spectroscopic analyzer.

40. The system of claim 35, wherein said at least one analyte is selected from the group consisting of glucose, carbon dioxide, lactate, and hemoglobin.

41. The system.of claim 35, wherein said drawn sample is no more than 3 milliliters in volume.

42. The system of claim 35, wherein said drawn sample is no more than 400 microliters in volume.

43. The system of claim 35, wherein said drawn sample is no more than 50 microliters in volume.

44. The system of claim 35, further comprising a sample preparation unit accessible via said fluid passageway.

45. The system of claim 44, wherein said sample preparation unit is configured to separate at least one component from said drawn sample.

46. The system of claim 45, wherein said sample preparation unit comprises a centrifuge.

47. The system of claim 45, wherein said sample preparation unit comprises a filter.

48. A fluid handling module usable with a body fluid analyzer having a pump system and an analyte detection system, said fluid handling module comprising:

a fluid transport network having a patient end and an interface portion spaced from said patient end and configured to engage said pump system, said fluid transport network configured to obtain a body fluid from a patient;

a sample analysis cell accessible via said fluid transport network and configured to interface with said analyte detection system;

said fluid transport network having a maximum draw region associated with a maximum draw state of the network;

said maximum draw region having a volume of no more than 5 milliliters.

49. The module of claim 48, further comprising a sample preparation unit configured to separate said body fluid obtained from said patient into a first portion and a second portion, said second portion to be returned to the patient without being analyzed.

50. The module of claim 49, wherein said first portion has a volume of from 10 microliters to 1 milliliters.

51. The module of claim 48, wherein said maximum draw region has a volume of no more than 2 milliliters.

52. The module of claim 48, wherein said maximum draw region has a volume of no more than 100 microliters.

53. The module of claim 48, wherein said maximum draw region has a volume of no more than 50 microliters.

54. The module of claim 48, wherein said maximum draw state is a state of said fluid handling module in which a maximum amount of said body fluid is present in said fluid transport network during a normal operating cycle of said module, excluding any waste body fluid in said fluid transport network.

55. The module of claim 48, wherein said maximum draw region is that portion of said fluid transport network occupied by said body fluid when at said maximum draw state.

56. The module of claim 48, further comprising a sample preparation unit accessible via said fluid transport network.

57. The module of claim 56, wherein said sample preparation unit is configured to separate at least one component from said body fluid obtained from said patient.