Immunoassay device with improved sample closure

• US 7,981,387 B2
• Filed: 11/13/2009
• Issued: 07/19/2011
• Est. Priority Date: 09/10/2003
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Maczuszenko, Andy, Miller, Cary James
• Primary Examiner(s): Alexander; Lyle
• Application Number:
  US12/618,557
• Publication Number:
  US 20100061890A1
• Time in Patent Office: 613 Days
• Field of Search: 422/401, 422/403, 422/568, 436/165, 436/174
• US Class Current: 422/568
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/046 Chemical or electrochemical formation of bubbles
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: Y10T 436/25 : including sample preparation
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

An apparatus and method for sealing a fluid sample collection device, comprising loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop.

Claims

1. A fluid sample collection device, comprising:

a housing comprising at least one substantially planar surface and at least one slidable sealing element,

wherein said sealing element comprises prongs separated by a gap permitting slidable movement of said sealing element relative the substantially planar surface,

wherein said substantially planar surface has an orifice that is in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop, and

wherein said slidable sealing element is slidably movable over the orifice of the fluid sample collection device prior to insertion into a reader and over at least a portion of the substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within the holding chamber, and inhibits the fluid sample from prematurely breaking through the capillary stop to an analysis location, wherein the device is configured to expel a metered portion of the sample through the capillary stop.

2. The device of claim 1, which is a blood sample collection device and the fluid sample comprises a blood sample.

3. The device of claim 1, wherein the sealing element is made of a plastic selected from the group consisting of polyesters, ABS and acetals.

4. The device of claim 1, wherein the slidable sealing element has a locking feature that engages once the sealing element covers said orifice, where said engagement abuts the slidable sealing element to said housing in an air-tight manner in the region surrounding the orifice.

5. The device of claim 2, wherein the housing includes an overflow chamber to receive blood displaced from the orifice.

6. The device of claim 2, wherein the overflow chamber is hollow or includes a blood-absorbing pad.

7. The device of claim 2, wherein a fixed volume of sample is retained in said holding chamber in the range 1 uL to 1 mL and preferably 5-50 uL.

8. The device of claim 7, wherein the volume of sample is 5-50 uL.

9. The device of claim 1, wherein the orifice is circular or oval.

10. The device of claim 1, wherein the orifice is at the proximal end of the holding chamber and the capillary stop is at the distal end, and where the internal conduit is connected to a capillary stop.

11. The device of claim 9, wherein the diameter of the circular orifice is in the range 1-2 mm or the perimeter of the oval is 1-15 mm.

12. The device of claim 1, wherein the region around the orifice is hydrophobic or hydrophilic.

13. The device of claim 1, wherein the region around the orifice is an adhesive capable of forming an airtight seal with said sealing means.

14. The device of claim 1, wherein the sealing means locks into a sealed position when a tooth on the sealing means enters a slot on said housing.

15. The device of claim 1, wherein said housing comprises a groove for directing the motion of said slidable sealing element in the plane of said orifice.

16. The device of claim 15, wherein said slidable sealing element comprises a first facet and a second facet, where said first facet provides a sealing surface and said second facet moves in said groove.

17. The device of claim 16, where in moving from an initial position to a sealed position, the second facet flexes to provide a force to the first facet to seal the orifice.

18. The device of claim 1, wherein the collection device has sensing elements for assaying a component of the sample conduit.

19. The device of claim 1, which incorporates an immunosensor in an internal conduit for assaying a component of the sample.

20. The device of claim 1, wherein the collection device incorporates an electrochemical sensor in an internal conduit for assaying a component of the sample.

21. The device of claim 1, wherein the slidable sealing element is slidably movable over the orifice in a first direction that is substantially perpendicular to a second direction of insertion into the reader.