Method and apparatus for blood sampling

• US 20050148993A1
• Filed: 10/01/2004
• Published: 07/07/2005
• Est. Priority Date: 07/29/1999
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Blickhan, Bryan, Mathias, Jean-Marie, Bischof, Daniel F., Haldiman, Stephanie, Bernes, Jean-Claude, Servi, Larry Jr.
• Granted Patent: US 7,824,343 B2
• Time in Patent Office: Days
• US Class Current: 604/409
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/150992 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 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0236 with sampling means, e.g. sample bag or sampling port

Abstract

Methods and apparatus for collecting blood samples in vacuum sample tubes are disclosed. The samples, including the initial blood sample, are substantially free of excess air.

Claims

1. A method for obtaining a blood sample from a donor comprising:

withdrawing blood from the donor;

introducing blood from said donor into a chamber of a sample container through an internal flow path that extends substantially into the said chamber;

withdrawing blood from the sample container through the same internal flow path that extends substantially into said container chamber.

2. The method of claim 1 comprising introducing an initial portion of the withdrawn blood from said donor into said chamber.

3. The method of claim 1 comprising exhausting any resident air from said internal flow path into said chamber.

4. The method of claim 3 comprising exhausting any resident air from said internal flow path into said chamber by introducing a portion of the withdrawn blood into said tube.

5. The method of claim 3 comprising exhausting any resident air from said internal flow path into said chamber prior to introducing a portion of the withdrawn blood into said chamber.

6. The method of claim 1 comprising placing a vacuum tube holder in communication with said internal flow path.

7. The method of claim 1 comprising introducing a vacuum sample tube into a pre-attached sample tube holder in flow communication with said internal flow path.

8. The method of claim 1 comprising withdrawing blood from said sample container chamber through said internal flow path and introducing said blood into a vacuum sample tube.

9. The method of claim 1 wherein blood is withdrawn from said chamber through a sample tube holder communicating with said plastic tube and includes orienting said tube holder such that said sample container hangs substantially vertically downwardly from said tube holder;

and

inserting a said vacuum sample tube into said tube holder in a position above said sample container.

10. The method of claim 8 comprising:

a predetermined amount of blood into a first vacuum sample tube from said chamber;

introducing said predetermined amount of blood into a subsequent vacuum sample tube from said chamber.

11. The method of claim 1 comprising introducing a first vacuum sample tube into said holder and substantially filling said vacuum sample tube with blood.

12. The method of claim 1 comprising providing a blood processing set including a flow path between said donor and a sample access site and a vacuum tube holder pre-attached to said access site.

13. The method of claim 1 wherein said internal flow path is defined by a plastic tube that extends substantially into said interior chamber.

14. The method of claim 1 wherein said internal flow path is defined by an interior seal in said sample container.

15. A method of collecting a plurality of substantially air-free blood samples in a multi-sample operation comprising:

introducing blood into a chamber of a sample container through an internal flow path that extends substantially into said chamber;

establishing communication between said internal flow path and a first of a plurality of vacuum sample tubes;

withdrawing blood from said chamber into said first sample tube through said internal flow path;

establishing communication between said internal flow path and a subsequent sample tube of said plurality of said sample tubes;

withdrawing blood from said internal flow path into said subsequent sample tube of said plurality of vacuum sample tubes

wherein said sample tubes are substantially free of air from said plastic tube and said container.

16. The method of claim 15 wherein said internal flow path is defined by a plastic tube that extends substantially into said chamber.

17. The method of claim 15 wherein said internal flow path is defined by an interior seal in said sample container.

18. A method of collecting a substantially air-free, initial sample of blood from a sample pouch comprising:

introducing blood into a chamber of a sample pouch through an internal flow path that extends substantially into said chamber;

establishing communication between said internal flow path and a vacuum sample tube;

withdrawing an initial sample of blood from said sample pouch into a vacuum sample tube whereby said sample tube is substantially filled with blood and substantially free of air from said internal flow path and said pouch.

19. A biological fluid sampling system comprising:

a plastic container including an interior chamber;

a sample access site external to and spaced from said container by a preselected distance;

an internal flow path communicating with said access site and extending substantially into said interior chamber, said internal flow path providing the only path for blood flow into and from said chamber.

20. The sampling system of claim 19 further comprising an intermediate tube defining a flow path with one end of said tube communicating with said sample access site and the other end communicating with said internal flow path.

21. The sampling system of claim 19 wherein said interior chamber has a generally circular profile.

22. The sampling system of claim 19 wherein said interior chamber includes a fluid receiving well.

23. The sampling system of claim 22 wherein the distal end of said internal flow path extending substantially into said interior chamber is disposed within said well.

24. The sampling system of claim 19 wherein said container comprises a pair of oppositely facing walls sealed together, at least one of said walls being generally translucent, including indicia thereon for indicating the volume of fluid within said chamber.

25. The sampling system of claim 19 comprising a vacuum tube holder pre-attached to said access site.

26. The sampling system of claim 19 wherein said internal flow path is defined by a plastic tube than extends substantially into said chamber interior.

27. The sampling system of claim 19 wherein said internal flow path is defined by an interior seal in said plastic container.