Fluidic device for medical diagnostics

• US 7,022,286 B2
• Filed: 12/26/2002
• Issued: 04/04/2006
• Est. Priority Date: 07/20/1998
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Shartle, Robert Justice, Lemke, John, Pan, Victor, Cizdziel, Philip
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/330,790
• Publication Number:
  US 20030156984A1
• Time in Patent Office: 1,195 Days
• Field of Search: 422/58, 422/61, 422/101, 422/62, 422/68.1, 422/67, 422/100, 422/103, 436 69- 71, 436/164, 436/169, 436/177, 436/43, 436/46, 436/165, 356/39, 356/256, 356/427
• US Class Current: 422/67
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0822 Slides
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• 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 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2333/7454 Tissue factor (tissue thromboplastin, Factor III)
• CPC Class Codes: G01N 2333/96447 Factor VII (3.4.21.21)
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G01N 33/54388 : based on lateral flow
• CPC Class Codes: G01N 33/558 : using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 436/112499 : with sample on test slide
• CPC Class Codes: Y10T 436/25375 : Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A fluidic medical diagnostic device permits measurement of analyte concentration or a property of a biological fluid, particularly the coagulation time of blood. The device has at one end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement area. A channel carries the sample from the sample port to the measurement area, and a stop junction, between the measurement area and bladder, halts the sample flow. The desired measurement can be made by placing the device into a meter which measures a physical property of the sample—typically, optical transmittance—after it has interacted with a reagent in the measurement area.

Claims

1. An optical meter that can determine when sample has been applied to the surface of a test strip inserted into it, said meter comprising:

(a) means for collecting reflectance data from a region of said meter occupied by a sample application location of said test strip when present in said meter, wherein said means comprises;

(i) a light source for irradiating said region of said meter; and

(ii) a detector for detecting reflected light from said region of said meter;

(b) means for comparing said reflectance data to a reference value to obtain a sample present signal; and

(c) means for depressing a bladder of said test strip in response to said sample present signal.

2. The optical meter according to claim 1, wherein said meter further comprises said test strip.

3. The optical meter according to claim 1, wherein said test strip is present in said meter.

4. The optical meter according to claim 1, wherein said test strip is a non-porous test strip.

5. The optical meter according to claim 1, wherein said light source is a source of visible light.

6. The optical meter according to claim 5, wherein said light has a wavelength ranging from about 550 nm to 590 nm.