Methods for collecting body fluid

• US 6,860,873 B2
• Filed: 03/24/2003
• Issued: 03/01/2005
• 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): KIM, SUN U
• Application Number:
  US10/396,973
• Publication Number:
  US 20030175169A1
• Time in Patent Office: 708 Days
• Field of Search: 436/150, 436/180, 422/50, 422/100, 422/102, 600/573, 600/576, 600/577, 600/584, 604/290, 604/317
• US Class Current: 604/317
• 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. A method for collecting a body fluid for testing for an analyte contained within said body fluid, said method comprising:

providing an apparatus comprising a conduit, a reservoir having a reservoir volume and a capillary test space having a test volume;

penetrating said conduit into a patient'"'"'s skin to access body fluid therein;

flowing said body fluid from the patient'"'"'s skin through said conduit;

discharging said body fluid from said conduit into said reservoir;

accumulating said body fluid within said reservoir; and

wicking a test volume of said accumulated body fluid from said reservoir to said capillary test space when said accumulated fluid attains said reservoir volume, wherein said reservoir volume is greater than said test volume.

2. The method of claim 1 wherein said step of flowing said body fluid through said conduit comprises applying suction to said body fluid.

3. The method of claim 1 further comprising wetting at least one electrode within said capillary test space with said test volume of body fluid.

4. The method of claim 1 further comprising:

wetting a first electrode within said capillary test space with said test volume of body fluid; and

wetting a second electrode within said capillary test space with said test volume of body fluid.

5. The method of claim 1 wherein said body fluid is interstitial fluid.

6. The method of claim 1 wherein said body fluid is blood.

7. The method of claim 1 further comprising contacting said test volume of liquid to electrodes within said capillary test space.

8. The method of claim 1 wherein said reservoir volume is 0.7 microliters.

9. The method of claim 1 wherein said capillary test space is defined by an electrochemical test strip.

10. The method of claim 1 wherein said body fluid accumulates in said reservoir over a first period of time and said test volume of said accumulated body fluid wicks from said reservoir into said capillary test space over a second period of time, wherein said reservoir volume is sufficiently greater than said test volume wherein said first period of time is substantially greater than said second period of time.

11. A method for collecting a body fluid for testing for an analyte contained within said body fluid, said method comprising:

providing an apparatus comprising a conduit, a reservoir having a reservoir volume and a capillary test space having a electrochemical test strip having at least one electrode and defining a test volume;

penetrating said conduit into a patient'"'"'s skin to access body fluid therein;

flowing said body fluid from the patient'"'"'s skin through said conduit;

discharging said body fluid from said conduit into said reservoir;

accumulating said body fluid within said reservoir; and

wicking a test volume of said accumulated body fluid from said reservoir to said test strip when said accumulated fluid attains said reservoir volume, wherein said reservoir volume is sufficiently greater than said test volume.

12. The method of claim 11 further comprising wetting said at least one electrode within said capillary test space with said test volume of body fluid.

13. The method of claim 11 further comprising:

wetting a first electrode within said capillary test space with said test volume of body fluid; and

wetting a second electrode within said capillary test space with said test volume of body fluid.