Biological fluid analysis device

• US 20040014023A1
• Filed: 04/23/2003
• Published: 01/22/2004
• Est. Priority Date: 11/02/2000
• Status: Active Grant

• Current Assignee: Pall Corporation (Danaher Corporation)
• Original Assignee: Pall Corporation (Danaher Corporation)
• Inventors: Meserol, Peter, Chindilis, Andrey, Pascale, Frank, Wenz, Barry
• Granted Patent: US 7,144,496 B2
• Time in Patent Office: Days
• US Class Current: 435/2
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

A biological fluid analysis device (100) including a biosensor (50) comprising an electrochemical-enzymatic sensor including a working electrode (51) and a reference electrode (52), is disclosed.

Claims

1. A biological fluid analysis device comprising:

a housing including a biological fluid analysis chamber suitable for receiving a plasma-containing portion of biological fluid;

a vent communicating with the analysis chamber, the vent comprising a porous medium having a bacterial blocking pore rating; and

a biosensor communicating with the analysis chamber, the biosensor comprising an electrochemical-enzymatic sensor including a working electrode and a reference electrode, wherein the biosensor is arranged to detect the oxygen concentration in the analysis chamber.

3. The device of claim 1, or the system of claim 2, wherein the biosensor includes laccase.

4. The device of claim 1 or 3, including a self-contained power source.

5. The device of claim 1, 3, or 4, arranged to monitor the oxygen concentration in the analysis chamber over a period of time.

6. The device of claim 5, arranged to monitor the oxygen concentration in the analysis chamber over at least about a 4 hour period of time.

7. The device of any one of claims 1, and 3-6, arranged to detect a change in the oxygen concentration over at least about a 4 hour period of time.

8. The device of claim 7, further comprising at least one visible marker that is activated while the change in oxygen concentration is monitored.

9. The device of claim 5 or 6, further comprising at least one visible marker that is activated while the oxygen concentration is monitored.

10. The device of claim 8 or 9, further comprising at least a second visible marker that is activated when a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation.

11. The device of any one of claims 1, and 3-10, comprising a first indicator lamp that is activated when the oxygen concentration is monitored, and at least a second indicator lamp that is activated when a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation.

12. The device of any one of claims 1, and 3-10, comprising a first indicator lamp that is activated when the oxygen concentration is monitored, and at least a second indicator lamp that is either activated when, within a predetermined period of time, a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation, or the oxygen concentration does not reach a preset reference, threshold value or algorithm calculation.

13. The device of claim 11 or 12, wherein the first indicator lamp has a different visible wavelength than the second indicator lamp.

14. The device of any one of claims 1, and 3-13, further comprising a heater arranged to raise the temperature of the plasma-containing fluid in the chamber over the ambient temperature for a desired period of time.

15. The device of any one of claims 1, and 3-14, wherein the analysis chamber has an internal volume suitable for receiving about 10 ml of biological fluid or less.

16. The device of claim 15, wherein the internal volume is suitable for receiving about 2 to about 5 ml of biological fluid.

17. The device of any one of claims 1, and 3-16, further comprising a flexible blood bag in fluid communication with the biological fluid analysis device.

31. A method for processing a biological fluid comprising:

passing a portion of a biological fluid into the analysis chamber of the device of any one of claims 1-30; and

detecting the oxygen concentration in the analysis chamber.

32. The method of claim 31, including monitoring the oxygen concentration in the analysis chamber over at least about a 4 hour period of time.

33. The method of claim 31, including monitoring a change in the oxygen concentration in the analysis chamber over at least about a 6 hour period of time.

34. The method of any one of claims 31-33, including raising the temperature of the biological fluid in the analysis chamber to at least about 30°

C. for at least about 6 hours.

35. The method of any one of claims 31-34, including passing the portion of biological fluid through a filter to that allows microorganisms to pass through while depleting the fluid of at least one of leukocytes, red blood cells and platelets, before passing the portion of biological fluid into the analysis chamber.

36. The method of any one of claims 31-35, further comprising activating a first indicator lamp when a change in oxygen concentration is monitored, and activating at least a second indicator lamp when a decrease in the oxygen concentration reaches a preset reference value.

2. A biological fluid processing system comprising:

a biological fluid analysis device comprising a housing including a biological fluid analysis chamber suitable for receiving a plasma-containing portion of biological fluid, the plasma-containing fluid possibly including microorganisms; and

a biosensor communicating with the chamber, the biosensor comprising an electrochemical-enzymatic sensor including a working electrode and a reference electrode, wherein the biosensor is arranged to detect the oxygen concentration in the analysis chamber; and

a flexible blood bag in fluid communication with the biological fluid analysis device.

18. The system of claim 2 or 3, including a self-contained power source.

19. The system of any one of claims 2, 3, or 18, arranged to monitor the oxygen concentration in the analysis chamber over a period of time.

20. The system of claim 19, arranged to monitor the oxygen concentration in the analysis chamber over at least about a 12 hour period of time.

21. The system of any one of claims 2, 3, and 18-20, arranged to detect a change in the oxygen concentration over at least about a 12 hour period of time.

22. The system of claim 21, further comprising at least one visible marker that is activated while the change in oxygen concentration is monitored.

23. The system of claim 19 or 20, further comprising at least one visible marker that is activated while the oxygen concentration is monitored.

24. The system of claim 22 or 23, further comprising at least a second visible marker that is activated when a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation.

25. The system of any one of claims 2, 3, and 18-24, comprising a first indicator lamp that is activated when the oxygen concentration is monitored, and at least a second indicator lamp that is activated when a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation.

26. The system of any one of claims 2, 3, and 18-24, comprising a first indicator lamp that is activated when the oxygen concentration is monitored, and at least a second indicator lamp that is either activated when, within a predetermined period of time, a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation, or the oxygen concentration does not reach a preset reference, threshold value or algorithm calculation.

27. The system of claim 25 or 26, wherein the first indicator lamp has a different visible wavelength than the second indicator lamp.

28. The system of any one of claims 2, 3, and 18-27, further comprising a heater arranged to raise the temperature of the plasma-containing fluid in the chamber over the ambient temperature for a desired period of time.

29. The system of any one of claims 2, 3, and 18-28, wherein the analysis chamber has an internal volume suitable for receiving about 10 ml of biological fluid or less.

30. The system of claim 29, wherein the internal volume is suitable for receiving about 2 to about 5 ml of biological fluid.

37. A method for processing a biological fluid comprising:

passing a portion of a biological fluid possibly containing microorganisms into an analysis chamber, the analysis chamber communicating with a biosensor, the biosensor comprising an electrochemical-enzymatic sensor including a working electrode and a reference electrode, wherein the biosensor is arranged to detect the oxygen concentration in the analysis chamber; and

detecting the oxygen concentration in the analysis chamber.

38. The method of claim 37, including detecting the oxygen concentration in the analysis chamber over at least about a 6 hour period of time.

39. The method of claim 37 or 38, including raising the temperature of the biological fluid in the analysis chamber to at least about 30°

C. for at least about 6 hours.

40. The method of any one of claims 37-39, including detecting a decrease in the oxygen concentration in the analysis chamber over at least about a 6 hour period of time.

41. The method of any one of claims 37-40, further comprising activating a first indicator lamp when a change in oxygen concentration is monitored, and activating at least a second indicator lamp when the decrease in oxygen concentration reaches a preset reference value.

42. The method of any one of claims 37-40, further comprising activating a first indicator lamp when the oxygen concentration is monitored, and activating at least a second indicator lamp when, within a predetermined period of time, either a decrease in oxygen concentration reaches a preset reference, threshold value or algorithm calculation, or the oxygen concentration does not reach a preset reference, threshold value or algorithm calculation.