Biological fluid analysis device

• US 7,144,496 B2
• Filed: 11/02/2001
• Issued: 12/05/2006
• Est. Priority Date: 11/02/2000
• Status: Expired due to Fees

• Current Assignee: Pall Corporation (Danaher Corporation)
• Original Assignee: Pall Corporation (Danaher Corporation)
• Inventors: Pascale, Frank, Ghindilis, Andrey, Wenz, Barry
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/415,035
• Publication Number:
  US 20040014023A1
• Time in Patent Office: 1,859 Days
• Field of Search: 204/403.01, 204/403.15, 204/431, 205/792, 205/798.2, 205/798.5, 205/783
• US Class Current: 205/792
• 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 monitor oxygen concentration in the analysis chamber over at least about a 4 hour time period; and

at least one visible marker that is activated while a change in oxygen concentration is monitored.

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

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

4. The device of claim 3, wherein the first visible marker comprises a first indicator lamp that is activated when the oxygen concentration is monitored, the device further comprising 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 or threshold value, or the oxygen concentration does not reach a preset reference or threshold value.

5. The device claim 1, 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.

6. The device of claim 1, wherein the analysis chamber has an internal volume suitable for receiving about 10 ml of biological fluid or less.

7. The device of claim 6, wherein the internal volume is suitable for receiving about 2 to about 5 ml of biological fluid.

8. The device of claim 1, wherein the analysis chamber contains sodium polyanethol sulfonate.

9. 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 includes laccase and is arranged to detect oxygen concentration in the analysis chamber;

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

10. The device of claim 9, arranged to monitor the oxygen concentration in the analysis chamber over a period of time.

11. The device of claim 10, arranged to monitor the oxygen concentration in the analysis chamber over at least about a 4 hour period of time.

12. The device of claim 11, further comprising at least one visible marker that is activated while the oxygen concentration is monitored.

13. The device of claim 9, arranged to detect a change in the oxygen concentration over at least about a 4 hour period of time.

14. The device of claim 13, further comprising at least one visible marker that is activated while a change in oxygen concentration is monitored.

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

16. The device of claim 9, 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 or threshold value.

17. The device of claim 16, wherein the first indicator lamp has a different visible wavelength than the second indicator lamp.

18. The device of claim 9, 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.

19. The device of claim 18, wherein the heater includes a thermistor.

20. The device of claim 18, wherein the heater includes a conductive trace.

21. A method for processing a biological fluid comprising:

passing a portion of a biological fluid into an analysis chamber of 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 monitor oxygen concentration in the analysis chamber;

detecting the oxygen concentration in the analysis chamber;

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.

22. The method of claim 21, including monitoring the oxygen concentration in the analysis chamber over at least about a 4 hour period of time.

23. The method of claim 21, including monitoring a change in the oxygen concentration in the analysis chamber over at least about a 6 hour period of time.

24. The method of claim 21, including raising the temperature of the biological fluid in the analysis chamber to at least about 30°

C. for at least about 6 hours.

25. The method of claim 21, including passing the portion of biological fluid through a filter 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.

26. 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 monitor oxygen concentration in the analysis chamber over at least about a 4 hour period of time; and

at least one visible market that is activated while the oxygen concentration is monitored.