Methods for collecting body fluid

• US 20050180881A1
• Filed: 02/28/2005
• Published: 08/18/2005
• Est. Priority Date: 03/12/1999
• Status: Abandoned Application

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Allen, John J., Racchini, Joel R.
• Application Number:
  US11/069,392
• Publication Number:
  US 20050180881A1
• Time in Patent Office: Days
• US Class Current: 422/58
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• 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: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A body fluid is collected for testing for an analyte contained within the body fluid. The fluid is collected in an apparatus including a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit. A capillary test space is in fluid flow communication with the reservoir. The capillary test space is positioned to be in contact with the fluid in the reservoir after the fluid has accumulated to a predetermined transfer volume of fluid. The capillary test space is sized to wick the fluid from the reservoir when the fluid contacts the capillary test space.

Claims

1-8. -8. (canceled)

9. An apparatus for use with a test strip and for collecting a body fluid for testing for an analyte contained within said body fluid, said apparatus comprising:

a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit; and

a test strip opposing surface for contacting a surface of said test strip wherein, when said test strip is in contact with said test strip opposing surface, a capillary test space is formed there between wherein said capillary test space is positioned to be in fluid communication with said reservoir and sized to wick a transfer volume of said body fluid from said reservoir when said fluid in said reservoir attains said transfer volume.

10. The apparatus of claim 9, wherein said test strip opposing surface defines at least one step wherein said capillary test space is defined between said surface of said test strip and said at least one step.

11. The apparatus of claim 10, wherein a space having an enlarged volume is provided on each side of said at least one step.

12. The apparatus of claim 9, wherein said test strip comprises at least one electrode positioned opposing said at least one step.

13. The apparatus of claim 10, wherein said test strip opposing surface defines two steps separated by a hydrophobic volume wherein a first capillary test space is defined between said test strip surface and a first step and a second capillary test space is defined between said test strip surface and a second step.

14. The apparatus of claim 13 wherein said test strip comprises a first electrode positioned opposing said first step and a second electrode positioned opposing said second step, wherein the configuration of said test strip opposing surface provides for the wetting of said first electrode by said transfer volume of body fluid prior to the wetting of said second electrode by said transfer volume.

15. The apparatus of claim 13 wherein said hydrophobic volume comprises a ramped surface.

16. The apparatus of claim 15 wherein said ramped surface is U-shaped.

17. The apparatus of claim 9 wherein one or both of the reservoir and capillary test space are filled with an absorbent material.

18. The apparatus of claim 9 wherein:

said reservoir includes first and second spaced-apart ends;

said discharge end of said conduit is disposed adjacent said first end; and

said capillary test space is disposed adjacent said second end.

19. The apparatus of claim 18 wherein a volume of said reservoir between said first and second ends of said reservoir is sized to be at least as great as said transfer volume.

20. The apparatus of claim 9 wherein said reservoir has a size and geometry providing a surface tension which assures said fluid is retained within said reservoir.

21. The apparatus of claim 9 further comprising an enlarged volume adjacent said reservoir wherein said enlarged volume is greater than the volume of said reservoir.

22. The apparatus of claim 21 wherein said enlarged volume is defined by a hydrophobic material.

23. The apparatus of claim 9 further comprising a groove comprising a shape corresponding to the outer periphery of the test strip.

24. An apparatus for use with a test strip and for collecting a body fluid for testing for an analyte contained within said body fluid, said apparatus comprising:

a conduit comprising a fluid access end and a fluid discharge end, said conduit configured for wicking said body fluid from said access end to said discharge end; and

a test strip opposing surface for contacting a surface of said test strip wherein, when said test strip is in contact with said test strip opposing surface, a capillary test space is formed there between wherein said capillary test space is proximal to said conduit discharge end and sized to wick a transfer volume of said body fluid from said conduit when said fluid in said conduit attains said transfer volume.