Capillary flow device

• US 4,756,884 A
• Filed: 07/01/1986
• Issued: 07/12/1988
• Est. Priority Date: 08/05/1985
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Biotrack, Inc. (Novartis Ag)
• Inventors: Allen, Jim, Gibbons, Ian, Hillman, Robert S., Cobb, Michael E., Winfrey, Laura J., Ostoich, Vladimir
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Johnston, Jill
• Application Number:
  US06/880,793
• Time in Patent Office: 742 Days
• Field of Search: 422/68, 422/72, 422/73, 422/81, 422/312, 422/82, 422/57, 422/102, 73/55, 73/56, 73/61.1 R, 356/28, 356/28.5, 436/69, 436/180, 435/810
• US Class Current: 422/73
• CPC Class Codes: B01F 21/00 Dissolving separating by dissolving B01D; dissolving to effect cooling F25D5/00
• CPC Class Codes: B01F 2101/23 Mixing of laboratory samples e.g. in preparation of analysing or testing properties of materials
• CPC Class Codes: B01F 23/56 by introducing solids in liquids, e.g. dispersing or dissolving
• CPC Class Codes: B01F 25/4316 the baffles being flat pieces of material, e.g. intermeshing, fixed to the wall or fixed on a central rod
• CPC Class Codes: B01F 25/433 Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
• CPC Class Codes: B01F 25/4338 Mixers with a succession of converging-diverging cross-sections, i.e. undulating cross-section
• CPC Class Codes: B01F 33/30 Micromixers
• CPC Class Codes: B01F 35/7172 using capillary forces
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0694 vents used to stop and induce flow, backpressure valves
• 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 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B29C 45/00 Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor injection blow-moulding B29C49/06
• CPC Class Codes: B29C 59/16 by wave energy or particle radiation , e.g. infrared heating B29C59/007 takes precedence
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/4895 Solvent bonding, i.e. the surfaces of the parts to be joined being treated with solvents, swelling or softening agents, without adhesives
• CPC Class Codes: B29C 66/30223 : said melt initiators being rib-like
• CPC Class Codes: B29C 66/54 : Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/9513 : characterised by specific vibration frequency values or ranges
• CPC Class Codes: B29K 2025/06 : PS, i.e. polystyrene
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2055/02 : ABS polymers, i.e. acrylonitrile-butadiene-styrene polymers
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/756 : Microarticles, nanoarticles
• CPC Class Codes: G01N 2015/1016 : Particle flow simulating, e.g. liquid crystal cell
• CPC Class Codes: G01N 2021/0346 : Capillary cells; Microcells
• CPC Class Codes: G01N 2035/00514 : Stationary mixing elements
• CPC Class Codes: G01N 21/47 : Scattering, i.e. diffuse reflection G01N21/25, G01N21/41 take precedence G01N21/55 takes precedence
• CPC Class Codes: G01N 21/49 : within a body or fluid
• CPC Class Codes: G01N 21/82 : producing a precipitate or turbidity
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 366/03 : Micromixers: variable geometry from the pathway influences mixing/agitation of non-laminar fluid flow
• CPC Class Codes: Y10S 435/81 : Packaged device or kit

Abstract

Methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal. As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutination particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the device.

Claims

1. An analytical device for detecting the presence of an analyte in a physiological fluid sample, comprising:

a housing containing an inlet port, a chamber unit, an exit port, a first capillary unit for independently pumping a liquid from said inlet port to said chamber unit, and a second capillary unit positioned between and operatively connected to said chamber unit and said exit port for independently pumping a liquid from said chamber unit to said exit port;

wherein said inlet port, first capillary unit, chamber unit, second capillary unit, and exit port are present in a continuous capillary pathway;

said housing further containing a reagent in said capillary pathway comprising a member selected from the group consisting of compounds affecting blood clotting and antibodies capable of causing a change in flow rate of said fluid sample in said pathway.

2. The device of claim 1, wherein said reagent comprises an antibody.

3. The device of claim 1, wherein said device comprises at least two chamber units in said pathway.

4. The device of claim 1, further comprising a sealable vent in said capillary pathway proximal to a juncture between a chamber unit and a capillary unit.

5. The device of claim 1, further comprising a third capillary unit substantially in parallel with said first capillary unit and directing fluid into said chamber unit.

6. The device of claim 1, wherein said reagent comprises a member selected from the group consisting of components of natural blood clotting cascades and reagents which activate a components of a natural clotting cascade.

7. The device of claim 6, wherein said reagent is thromboplastin.

8. The device of claim 1, wherein said housing comprises a substantially hydrophobic material having at least a portion of the walls of said capillary pathway treated to provide hydrophilicity.

9. The device of claim 8, wherein said material is a plastic.

10. The device of claim 1, said device being fabricated from at least two sheets of a substantially hydrophobic plastic, at least one of which is molded to provide depressions for production of said capillary and chamber units, said depressions being treated to provide hydrophilicity, wherein at least one sheet has means defining an orifice forming said inlet port or exit port, said capillary and chamber units being formed by the joining of said sheets to form said housing.

11. The device of claim 10, wherein said chamber unit contains said reagent and said reagent comprises a member selected from the group consisting of components of natural clotting cascades and reagents which activate a component of a natural clotting cascade.

12. The device of claim 10, wherein said reagent comprises thromboplastin in said chamber unit.