Whole blood collection device and method

• US 6,406,919 B1
• Filed: 12/16/1999
• Issued: 06/18/2002
• Est. Priority Date: 12/16/1999
• Status: Expired due to Fees

• Current Assignee: Biosafe Laboratories, Inc.
• Original Assignee: Biosafe Laboratories, Inc.
• Inventors: Tyrrell, Steven P.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/464,757
• Time in Patent Office: 915 Days
• Field of Search: 436/63, 436/174, 436/176, 436/177, 436/179, 436/180, 436/164, 436/169, 422/99, 422/102, 422/58, 422/61, 435/287.3, 435/288.4, 435/288.5, 600/573, 600/577, 600/578
• US Class Current: 436/174
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25625 Dilution
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A system for collecting whole blood includes a metering chamber and a reservoir. A movable gasket or seal is positioned to a fill position, and whole blood is added to the metering chamber until the metering chamber is full. Then the gasket is moved to a closed position, thereby moving blood from the metering chamber to the reservoir and sealing the reservoir. A diluting liquid contained in the reservoir is mixed with the whole blood to dilute and stabilize the whole blood in the reservoir for later analysis of one or more selected blood components.

Claims

1. A whole blood collection device comprising:

a reservoir;

a metering chamber that empties into the reservoir;

a fill port that empties into the metering chamber; and

a seal comprising a sweeping element movable between a fill position, in which the seal isolates the reservoir from the metering chamber while allowing fluid flow from the fill port into the metering chamber;

an intermediate position, in which the seal isolates the metering chamber from the fill port and from the reservoir; and

a closed position, in which the seal isolates the fill port from the metering chamber and allows fluid flow into the reservoir from the metering chamber;

said reservoir, metering chamber, fill port and seal forming a portable, handheld unit.

2. The invention of claim 1 wherein the seal comprises a first side that faces the fill port and a second side that faces the reservoir and the metering chamber.

3. The invention of claim 1 wherein the metering chamber comprises a capillary channel.

4. The invention of claim 3 further comprising a view port in fluid communication with the capillary channel, said view port spaced from the fill port along the channel.

5. The invention of claim 4 wherein the seal closes the fill port and the view port in the closed position.

6. The invention of claim 1 wherein the sweeping element is sized to fit within the metering chamber, wherein the sweeping element moves along the metering chamber to sweep fluid from the metering chamber to the reservoir as the seal moves from the fill position to the closed position.

7. The invention of claim 6 wherein the fill port is formed in an upper plate, wherein the metering chamber and the reservoir are formed in a lower plate, and wherein the seal is disposed between the upper and lower plates.

8. The invention of claim 6 wherein the seal is mounted for rotation relative to the upper and lower plates about an axis, and wherein the sweeping element and the metering chamber are concentric with the axis.

9. The invention of claim 8 wherein the seal extends over an arc of about 270 degrees and the metering chamber extends over an arc of about 90 degrees.

10. The invention of claim 6 wherein the metering chamber and the sweeping element are arcute in shape.

11. The invention of claim 1 wherein the reservoir comprises a diluting liquid.

12. The invention of claim 11 wherein the metering chamber defines a first volume, and wherein the diluting liquid has a volume at least as great as the first volume.

13. The invention of claim 11 wherein the metering chamber defines a first volume, and wherein the diluting liquid has a volume at least as great as three times the first volume.

14. The invention of claim 11 wherein the metering chamber defines a first volume, and wherein the diluting liquid has a volume at least as great-as six times the first volume.

15. The invention of claim 11 wherein the metering chamber defines a first volume, and wherein the diluting liquid has a volume at least as great as nine times the first volume.

16. The invention of claim 11 wherein the diluting liquid comprises a blood stabilizing composition.

17. The invention of claim 1 further comprising a porous pad disposed between the fill port and the metering chamber, wherein the pad comprises an anticoagulant.

18. The invention of claim 1 wherein the seal closes the fill port in the closed position.

19. The invention of claim 1 wherein the reservoir and the metering chamber are fixedly positioned with respect to one another.

20. The invention of claim 1 wherein the reservoir and the metering chamber remain in a fixed spatial position relative to one another as the seal is moved from the fill position to the closed position.

21. The invention of claim 1 further comprising a snap latch operative to retain the seal in the closed position.

22. A method for collecting a metered sample of a biological sample, said method comprising:

(a) providing a handheld collection device comprising a reservoir, a metering chamber that empties into the reservoir, and a fill port that empties into the metering chamber, said reservoir containing a diluting liquid;

(b) filling the metering chamber with a biological sample while isolating the reservoir from the metering chamber;

(c) sweeping the biological sample from the metering chamber into the reservoir with a sweeping element that moves along the metering chamber to dilute the biological sample with the diluting liquid; and

(d) sealing the reservoir.

23. The method of claim 22 further comprising:

(e) providing a stabilizing composition in the diluting liquid.

24. The method of claim 22 wherein the biological sample of (b) comprises whole blood and wherein the method further comprises:

(e) adding an anticoagulant to the whole blood during (b).

25. The method of claim 22 further comprising:

(e) shipping the collection device after (d) to a remote site for analysis.

26. The method of claim 22 wherein the biological sample of (b) comprises whole blood.

27. The method of claim 22 or 26 wherein the biological sample swept into the reservoir in (c) is no greater in volume than the diluting liquid in the reservoir.

28. The method of claim 22 or 26 wherein the biological sample swept into the reservoir in (c) is no greater in volume than one-third the volume of the diluting liquid in the reservoir.

29. The method of claim 22 or 26 wherein the biological sample swept into the reservoir in (c) is no greater in volume than one-sixth the volume of the diluting liquid in the reservoir.

30. The method of claim 22 or 26 wherein the biological sample swept into the reservoir in (c) is no greater in volume than one-ninth the volume of the diluting liquid in the reservoir.

31. A whole blood collection device comprising:

a reservoir;

a metering chamber that empties into the reservoir;

a fill port that empties into the metering chamber; and

a seal movable between a fill position, in which the seal isolates the reservoir from the metering chamber while allowing fluid flow from the fill port into the metering chamber; and

a closed position, in which the seal isolates the fill port from the metering chamber and allows fluid flow into the reservoir from the metering chamber;

wherein the seal comprises a first side that faces the fill port and a second side that faces the reservoir and the metering chamber.

32. A whole blood collection device comprising:

a reservoir;

a metering chamber that empties into the reservoir;

a fill port that empties into the metering chamber; and

a seal movable between a fill position, in which the seal isolates the reservoir from the metering chamber while allowing fluid flow from the fill port into the metering chamber; and

a closed position, in which the seal isolates the fill port from the metering chamber and allows fluid flow into the reservoir from the metering chamber;

wherein the seal comprises a sweeping element sized to fit within the metering chamber, wherein the sweeping element moves along the metering chamber to sweep fluid from the metering chamber to the reservoir as the seal moves from the ill position to the closed position.

33. A whole blood collection device comprising:

a reservoir;

a metering chamber that empties into the reservoir;

a fill port that empties into the metering chamber; and

a seal movable between a fill position, in which the seal isolates the reservoir from the metering chamber while allowing fluid flow from the fill port into the metering chamber; and

a closed position, in which the seal isolates the fill port from the metering chamber and allows fluid flow into the reservoir from the metering chamber;

wherein the seal closes the fill port in the closed position.

34. A whole blood collection device comprising:

a reservoir;

a metering chamber that empties into the reservoir;

a fill port that empties into the metering chamber; and

a seal movable between a fill position, in which the seal isolates the reservoir from the metering chamber while allowing fluid flow from the fill port into the metering chamber; and

a closed position, in which the seal isolates the fill port from the metering chamber and allows fluid flow into the reservoir from the metering chamber;

wherein the metering chamber comprises a capillary channel;

further comprising a view port in fluid communication with the capillary channel, said view port spaced from the fill port along the channel;

wherein the seal closes the fill port and the view port in the closed position.