Collection well for body fluid tester

• US 6,375,626 B1
• Filed: 02/25/2000
• Issued: 04/23/2002
• Est. Priority Date: 03/12/1999
• Status: Expired due to Term

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Allen, John J., Racchini, Joel R.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/513,013
• Time in Patent Office: 788 Days
• Field of Search: 600/573, 600/576, 600/578, 600/584, 600/317, 606/180, 606/181, 606/182
• US Class Current: 600/584
• 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. An apparatus 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;

a capillary test space positioned to be in contact with said fluid in said reservoir after said fluid has accumulated within said reservoir to a transfer volume of fluid; and

said capillary test space sized to wick said fluid from said reservoir when said fluid in said reservoir attains said transfer volume.

2. An apparatus according to claim 1 further comprising:

test components within said capillary test space for testing said fluid for said analyte.

3. An apparatus according to claim 2 wherein:

said test components include electrodes for electro-chemically testing said fluid;

said electrodes positioned within said capillary test space to be in contact with said fluid after said fluid is wicked into said capillary test space.

4. An apparatus according to claim 1 wherein:

said reservoir includes first and second spaced-apart ends;

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

said capillary test space is disposed adjacent said second end.

5. An apparatus according to claim 4 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.

6. An apparatus according to claim 1 wherein said capillary test space is vented.

7. An apparatus according to claim 1 wherein material defining said capillary test space is more hydrophilic than material defining said reservoir.

8. An apparatus according to claim 1 wherein:

said conduit is a needle extending from a penetration end to said discharge end;

said needle penetration end being exposed for penetration into a patient'"'"'s skin to access body fluid for said fluid to flow along said needle and discharged into said reservoir at said discharge end.

9. An apparatus according to claim 1 wherein said reservoir is vented.

10. An apparatus according to claim 1 comprising a porous material in said capillary space.

11. An apparatus according to claim 1 comprising a test membrane positioned to receive fluid from said capillary space and hold said fluid for testing.