Specimen collection device

• US 20070208275A1
• Filed: 03/01/2006
• Published: 09/06/2007
• Est. Priority Date: 03/01/2006
• Status: Active Grant

• Current Assignee: Pwnhealth Chicago LLC
• Original Assignee: Home Access Health Corp. (Everly Well, Inc.)
• Inventors: Vinogradov, Ilia, Powell, Tracey, Steck, John
• Granted Patent: US 9,119,577 B2
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 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 fluid receiving side having an aperture for receiving a fluid and permitting deposition of the fluid onto a fluid collector, the fluid collector being inclined with respect to the resting plane and having a normally upper portion disposed proximal said aperture thereby permitting fluid to flow away from said aperture upon deposition of a fluid onto said fluid collector.

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

3. A fluid collection device according to claim 1, said housing being provided with a plurality of air permitting apertures.

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

5. A fluid collection device according to claim 4, said inclined surface comprising a mat of glass fibers at least substantially bound with polyvinyl alcohol.

6. A fluid collection device according to claim 5, wherein said fibers define a plurality of pores, the pores in said mat 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 fluid collection device according to claim 5, wherein said fluid collector is coated with a saccharide.

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

9. A fluid collection device according to claim 1, said housing being provided with a plurality of spaced apart supports for said fluid collector, said fluid 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 fluid collector is exposed

10. A fluid collection device according to claim 1, said aperture being disposed in a dimpled region of said fluid receiving side.

11. A fluid collection device according to claim 10, the aperture being defined by a perimeter that includes a plurality of protruding portions.

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

13. A fluid collection device according to claim 1, 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 fluid.

14. A kit for fluid collection, the kit comprising:

a collection device comprising a housing and a normally inclined fluid collector; and

one or more of a lancet;

instructions for using the collection device;

a requisition form;

the requisition form permitting indication of the type of test to be conducted on the fluid to be collected by the collection device;

a desiccant, the desiccant being provided in an amount effective to provide a desiccating effect for the collection device; and

a barrier film pouch sized for receiving said fluid collection device and optionally said desiccant.

15. A kit according to claim 14, said kit including at least two of a lancet;

instructions for using the collection device;

a requisition form;

the requisition form permitting indication of the type of test to be conducted on the fluid to be collected by the collection device;

a desiccant, the desiccant being provided in an amount effective to provide a desiccating effect for the collection device; and

a barrier film pouch sized for receiving said fluid collection device and optionally said desiccant.

16. A kit according to claim 14, said kit including at least three of a lancet;

instructions for using the collection device;

a requisition form;

the requisition form permitting indication of the type of test to be conducted on the fluid to be collected by the collection device;

a desiccant, the desiccant being provided in an amount effective to provide a desiccating effect for the collection device; and

a barrier film pouch sized for receiving said fluid collection device and optionally said desiccant.

17. A kit according to claim 14, said kit including a lancet;

instructions for using the collection device;

a requisition form;

the requisition form permitting indication of the type of test to be conducted on the fluid to be collected by the collection device;

a desiccant, the desiccant being provided in an amount effective to provide a desiccating effect for the collection device; and

a barrier film pouch sized for receiving said fluid collection device and optionally said desiccant.

18. A method for obtaining a medical specimen, the method comprising:

providing a fluid collection device, the 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 fluid receiving side having an aperture for receiving a fluid and permitting deposition of the fluid onto a fluid collector, the fluid collector being inclined with respect to the resting plane and having a normally upper portion disposed proximal said aperture thereby permitted inclined fluid flow away from said aperture upon deposition of a fluid onto said fluid collector;

introducing a fluid specimen into said fluid collection device thereby causing at least a portion of said fluid to become collected onto said fluid collector.

19. A method according to claim 18, said fluid comprising blood.

20. A method according to claim 19, said fluid collector comprising a mat of glass fibers at least substantially bound with polyvinyl alcohol.

21. The method according to claim 18, wherein the fluid collection device further includes a specimen adequacy indicator to indicate when sufficient fluid has been received.

22. A method for blood testing, comprising:

receiving a 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 fluid receiving side having an aperture for receiving a fluid and permitting deposition of the fluid onto a fluid collector, the fluid collector being inclined with respect to the resting plane and having a normally upper portion disposed proximal said aperture thereby permitted inclined fluid flow away from said aperture upon deposition of a fluid onto said fluid collector, said fluid collector having disposed therein a blood specimen, said blood specimen having been separated into a first portion containing blood cells and a second portion containing blood fluid and a relatively small number of blood cells compared to said first portion; and

in either order, performing a blood test on said first portion and performing a blood test on said second portion.