Specimen collection device

• US 9,119,577 B2
• Filed: 03/01/2006
• Issued: 09/01/2015
• Est. Priority Date: 03/01/2006
• Status: Active Grant

• Current Assignee: Pwnhealth Chicago LLC
• Original Assignee: Home Access Health Corp. (Everly Well, Inc.)
• Inventors: Powell, Tracey, Steck, John Edward, Vinogradov, Ilia V.
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/365,963
• Publication Number:
  US 20070208275A1
• Time in Patent Office: 3,471 Days
• Field of Search: 600/573, 600/561, 600/405, 600/309, 600/398, 600/399, 600/579, 600/583, 600/584
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150755 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

Disclosed is a fluid collection device that comprises a housing having a normally obverse fluid receiving side and an opposing side. The fluid receiving side has an aperture for receiving a fluid and permitting deposition of the fluid into a fluid collector. The fluid collector is normally inclined to permit inclined fluid flow away from the aperture. Also disclosed is a kit that includes the fluid collection device, and various methods for use of the fluid collection device.

Claims

1. A blood fluid collection device comprising a housing having a normally obverse fluid receiving side and an opposing side having a support surface that defines a resting plane, the blood receiving side having an aperture for receiving blood and permitting deposition of the blood onto a blood collector disposed within and not integral to the housing made of paper or glass fiber substrate for the separation of blood cells, the blood collector being inclined with respect to and spaced apart from the resting plane and having normally upper portion disposed proximal said aperture thereby permitting blood to flow away from said aperture upon deposition of a blood onto said blood collector;

wherein said opposing side of said housing is provided with a plurality of spaced apart supports for said blood collector, said blood collector being in the form of a strip having a supported side and an unsupported side, whereby a majority of the surface area of said supported side of said blood collector is exposed to ambient air.

2. A blood collection device according to claim 1, wherein the blood receiving side having a window disposed over a portion of said blood collector remote from said normally upper portion.

3. A blood collection device according to claim 1, wherein said opposing side of said housing is provided with a plurality of air permitting apertures.

4. A blood collection device according to claim 1, wherein said blood collector comprising an absorbent substrate.

5. A blood collection device according to claim 4, wherein said inclined surface of the blood collector comprises a substrate substantially bound with polyvinyl alcohol.

6. A blood collection device according to claim 5, wherein said fibers define a plurality of pores, the pores in said blood collector having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of a blood fluid component from blood cells via differential fluid flow.

7. A blood collection device according to claim 5, wherein said blood collector is coated with a saccharide.

8. A blood collection device according to claim 7, wherein said saccharide is L-xylose.

9. A blood collection device according to claim 1, wherein said aperture'"'"'s disposed in a dimpled region of said blood receiving side.

10. A blood collection device according to claim 9, wherein the aperture defined by a perimeter that includes a plurality of protruding portions that extend inwardly in a radial direction from the perimeter.

11. A blood collection device according to claim 10, wherein said protruding portions being shaped and positioned to impede contact between the finger of a user and said blood collector but to allow blood to fluidically communicate with said blood collector.

12. A blood collection device according to claim 1, wherein said device including a specimen adequacy indicator window, said indicator window having a perimeter that is generally arrow-shaped and that points in the direction of the aperture for receiving blood.

13. A blood collection device according to claim 1, wherein the housing is made of a top portion and a bottom portion which includes the opposing side, wherein the top portion includes the aperture and the bottom portion includes a plurality of nubs extending away substantially perpendicularly from an exterior surface of the bottom portion for providing the resting plane.

14. A blood collection device according to claim 3, wherein the plurality of air permitting apertures comprise a plurality of longitudinally transversely disposed slots disposed on said opposing side of said housing.

15. A blood collection device according to claim 1, further comprising:

wherein said housing comprises a first end proximate said aperture and a second end disposed opposite the first end;

wherein said plurality of spaced apart supports for said blood collector further comprise a first plurality of supports located on said opposing side proximate said first end and a second plurality of supports located on said opposing side proximate said second end and said first plurality of supports extend farther from said opposing side than said second plurality of supports;

wherein a first plurality of ribs is located on said blood receiving side proximate said first end and a second plurality of ribs is located on said blood receiving side proximate said second end, and said second plurality of ribs extends farther from said blood receiving side than said first plurality of ribs; and

wherein a first end of said strip is secured between said first plurality of supports and said first plurality of ribs and a second end of said strip is secured between said second plurality of supports and said second plurality of ribs, such that said supported side is adjacent to but separated from said opposing side and said unsupported side is adjacent to but separated from said blood receiving side.