Biological fluid micro-sample management device

• US 9,873,117 B2
• Filed: 04/11/2017
• Issued: 01/23/2018
• Est. Priority Date: 03/10/2015
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ivosevic, Milan, Bokka Srinivasa Rao, Kishore K., Skutnik, Peter, Torris, Anthony V.
• Primary Examiner(s): LEVKOVICH, NATALIA A
• Application Number:
  US15/484,420
• Publication Number:
  US 20170216835A1
• Time in Patent Office: 287 Days
• Field of Search: 422550, 422549
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/154 Devices using pre-evacuated means
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/14 Process control and prevention of errors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/048 enabling gas exchange, e.g. vents
• CPC Class Codes: B01L 2300/0609 Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2300/0838 Capillaries
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2300/168 Specific optical properties, e.g. reflective coatings
• CPC Class Codes: B01L 2400/0475 specific mechanical means and fluid pressure
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/049 vacuum
• CPC Class Codes: B01L 3/0272 Dropper bottles
• CPC Class Codes: B01L 3/0293 : for liquids
• CPC Class Codes: B01L 3/0296 : from piercable tubing, e.g. in extracorporeal blood sampling
• 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: G01N 1/14 : Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A biological fluid collection device includes a collection module and an outer housing. The collection module includes a housing comprising a first end having a sample introduction opening, a second end having a sample dispensing opening, and a passageway extending between the sample introduction opening and the sample dispensing opening. A mixing chamber and a holding chamber are in fluid communication with the passageway such that a sample introduced into the sample introduction opening passes through the mixing chamber and subsequently into the holding chamber. The biological fluid collection device further includes a closure covering the first end, a cap covering the second end and including a vented plug, and an activation member adapted to force a sample contained in the holding chamber out of the sample dispensing opening. The collection module is positioned inside of the outer housing and the closure closes the open end of the outer housing.

Claims

1. A biological fluid collection device comprising:

a collection module comprising;

a housing comprising;

a first end having a sample introduction opening;

a second end having a sample dispensing opening;

a passageway extending between the sample introduction opening and the sample dispensing opening; and

a holding chamber in fluid communication with the passageway;

a closure covering the first end of the housing;

a cap covering the second end of the housing; and

an activation member defining at least a portion of the holding chamber and adapted to force a sample contained in the holding chamber out of the sample dispensing opening; and

an outer housing having an open end and a closed end,

wherein the collection module is positioned inside the outer housing and the closure closes the open end of the outer housing.

2. The biological fluid collection device of claim 1, further comprising a mixing chamber in fluid communication with the passageway, wherein a sample introduced into the sample introduction opening passes through the mixing chamber and subsequently into the holding chamber.

3. The biological fluid collection device of claim 2, wherein the mixing chamber includes an anticoagulant or a blood stabilizer within an interior of the mixing chamber.

4. The biological fluid collection device of claim 2, wherein the mixing chamber is filled with an open cell foam.

5. The biological fluid collection device of claim 4, wherein the open cell foam comprises a sponge material.

6. The biological fluid collection device of claim 1, wherein the cap is adapted to allow air to pass therethrough and prevent a blood sample from passing therethrough.

7. The biological fluid collection device of claim 1, wherein the cap includes a vented plug which allows air to pass therethrough and prevents a blood sample from passing therethrough.

8. The biological fluid collection device of claim 2, wherein the mixing chamber is positioned closer to the first end of the housing than the holding chamber such that a blood sample introduced into the sample introduction opening passes through the mixing chamber before passing into the holding chamber.

9. The biological fluid collection device of claim 1, wherein the housing defines a recess extending from an exterior of the housing to the passageway, the recess defining at least a portion of the holding chamber.

10. The biological fluid collection device of claim 9, wherein the activation member comprises an elastic sleeve enclosing at least a portion of the recess.

11. The biological fluid collection device of claim 10, wherein with the cap removed from the collection module, an inward pressure on the elastic sleeve is configured to force a blood sample contained in the holding chamber out of the sample dispensing opening.

12. The biological fluid collection device of claim 1, wherein the cap includes a vented plug, and wherein the vented plug is a porous plug.

13. The biological fluid collection device of claim 1, wherein the cap comprises a flange made from an optically clear material.

14. The biological fluid collection device of claim 13, wherein an outer surface of the flange comprises a convex shape for magnifying the vented plug.

15. The biological fluid collection device of claim 1, wherein the closure comprises a luer lock connection passing through a stopper.