Biological specimen collection and analysis system

• US 20050048670A1
• Filed: 01/27/2004
• Published: 03/03/2005
• Est. Priority Date: 08/25/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Dai, Jieling, Yang, Ying, Wu, Yuzhang, Tung, Hsiaoho Edward
• Granted Patent: US 7,517,495 B2
• Time in Patent Office: Days
• US Class Current: 436/180
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/049 Valves integrated in closure
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Disclosed is a device for collecting a fluid specimen. The device comprises a container that can receive a fluid specimen; a plunger movably positioned within the container, wherein the plunger can move from an initial position at an upper region of the container to a secondary position below the first position; a fluid segregation chamber that can receive a portion of the fluid specimen from the container, wherein any fluid in the segregation chamber is segregated from the fluid specimen in the container; a fluid flow lumen that provides a passageway for at least a portion of the fluid specimen to flow into the fluid segregation chamber, wherein a first end of the passageway has a first opening that opens into the fluid segregation chamber and a second end of the passageway has a second opening that can receive at least a portion of the fluid specimen; and a seal member that covers the first opening or the second opening to prevent fluid from flowing therethrough. A test element can be used to push the plunger from the initial position toward the secondary position to break the seal member and cause at least a portion of the fluid specimen to flow through the second opening into the fluid flow lumen and into the fluid segregation chamber through the first opening.

Claims

1. A device for collecting a fluid specimen, comprising:

a container that can receive a fluid specimen;

a plunger movably positioned within the container, wherein the plunger can move from an initial position at an upper region of the container to a secondary position below the first position;

a fluid segregation chamber that can receive a portion of the fluid specimen from the container, wherein any fluid in the segregation chamber is segregated from the fluid specimen in the container;

a fluid flow lumen that provides a passageway for at least a portion of the fluid specimen to flow into the fluid segregation chamber, wherein a first end of the passageway has a first opening that opens into the fluid segregation chamber and a second end of the passageway has a second opening that can receive at least a portion of the fluid specimen; and

a seal member that covers the first opening or the second opening to prevent fluid from flowing therethrough;

wherein a test element can be used to push the plunger from the initial position toward the secondary position to break the seal member and cause at least a portion of the fluid specimen to flow through the second opening into the fluid flow lumen and into the fluid segregation chamber through the first opening.

2. The device of claim 1, additionally comprising a cap that couples to the container.

3. The device of claim 1, additionally comprising a slot extending through the cap and communicating with the fluid segregation chamber, the slot sized to receive the test element therethrough, and wherein the test element can be inserted into the slot to break the seal member and push the plunger from the initial position toward the secondary position, and wherein at least a portion of the test element moves into the fluid segregation chamber as the test element pushes the plunger from the initial position toward the secondary position.

4. The device of claim 2, additionally comprising a plunger housing that extends downwardly from the cap into the container, the plunger housing including sidewalls and a bottom wall, and wherein a plunger shaft is located within the plunger housing, the plunger being slidably positioned in the plunger shaft.

5. The device of claim 4, wherein a reservoir chamber is positioned in a lower region of the plunger housing beneath the plunger, and wherein at least one fluid entry port is located in the side wall of the plunger housing so as to communicate with the reservoir chamber, the fluid entry port providing a pathway through which at least a portion of the fluid specimen can flow into the reservoir chamber from the container.

6. The device of claim 5, wherein the second opening of the fluid flow lumen opens into the reservoir chamber, and wherein at least a portion of the plunger blocks fluid from flowing into the fluid entry port when the plunger moves from the initial position toward the secondary position such that fluid in the reservoir must flow into the fluid flow lumen as the plunger moves toward the second position.

7. The device of claim 1, wherein the fluid flow lumen is located within the plunger.

8. The device of claim 4, wherein the plunger housing is removably attached to the cap.

9. A method of analyzing a fluid specimen, comprising:

providing a container that contains the fluid specimen, the container including a fluid segregation chamber that can segregate at least a first portion of the fluid specimen from a second portion of the fluid specimen, wherein a fluid flow lumen provides a fluid passageway for a portion of the fluid specimen to flow from the container into the fluid segregation chamber, the fluid flow lumen having a seal that prevents fluid from flowing into the fluid flow lumen;

inserting a test element into the container so that the seal is punctured and the test element depresses a plunger to cause at least a portion of fluid in the container to flow into the fluid flow lumen and into the fluid segregation chamber, wherein at least a portion of the test element moves into the fluid segregation chamber in contact with the portion of the fluid specimen in the fluid segregation chamber.

10. The method of claim 9, additionally comprising coupling a cap onto the container, wherein the cap is coupled to a plunger housing that defines a plunger shaft in which the plunger is movably positioned.

11. The method of claim 10, wherein at least a portion of the fluid specimen flows into a reservoir chamber in a bottom region of the plunger housing when the cap is coupled to the container, and wherein the plunger decreases the volume of the reservoir chamber as the plunger is depressed to thereby force the portion of the fluid specimen in the reservoir chamber to flow into the fluid flow lumen.

12. The method of claim 11, wherein the portion of the fluid specimen flows into the reservoir chamber through at least one fluid entry port in the plunger housing, and wherein the plunger blocks the portion of the fluid specimen from flowing out of the reservoir chamber through the fluid entry port as the plunger is depressed.

13. The method of claim 10, wherein inserting the test element into the container comprises inserting the test element through a slot in the cap.

14. A device for collecting a fluid specimen, comprising:

a container that defines a main chamber that can receive a fluid specimen;

a fluid segregation chamber coupled to the container for segregating at least a portion of the fluid specimen from the main chamber;

a fluid flow lumen that provides a passageway for fluid to flow into the fluid segregation chamber from the main chamber, the fluid flow lumen having an upper opening that opens into the segregation chamber;

a seal that covers the upper opening of the fluid flow lumen to prevent fluid from flowing through the upper opening; and

a plunger coupled to the container, wherein the plunger can be moved in a downward direction to force at least a portion of the fluid specimen to flow into the fluid flow lumen toward the fluid segregation chamber, wherein the seal must be broken in order for the plunger to be moved in a downward direction.

15. The device of claim 14, additionally comprising a cap that couples to the container, wherein the cap includes a plunger housing that extends downwardly into the container when the cap is coupled to the container, and wherein the plunger is movably positioned in a shaft in the plunger housing.

16. The device of claim 14, wherein a lower region of the plunger housing forms a reservoir chamber, and wherein the fluid specimen in the main chamber flows into the reservoir chamber through a fluid entry port in the plunger housing when the cap is coupled to the container.

17. The device of claim 16, wherein the fluid flow lumen has a lower opening that opens into the reservoir chamber and wherein the plunger blocks fluid in the reservoir chamber from flowing through the fluid entry port as the plunger moves downward, and wherein, as the plunger moves downward, the plunger displaces the fluid specimen in the reservoir chamber to cause the fluid in the reservoir chamber to flow into the fluid flow lumen toward the segregation chamber.

18. The device of claim 14, wherein a test element can be inserted into the container such that the test element breaks the seal and moves the plunger in a downward direction.

19. The device of claim 14, wherein the fluid flow lumen is positioned inside the plunger.