US5520787A
Expired / Lapsed
US
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Diagnostic flow cell device
Assignee: Abbott Laboratories
•
Filing: 1995-03-03
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Granted: 1996-05-28
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Expires: 2015-03-03
Abstract
Abstract The present invention provides a diagnostic flow cell for determining the presence or amount of an analyte which may be contained in a test sample. The flow cell comprises a spacing layer having a longitudinal void disposed between a pair of opposed substrates. The spacing layer and the opposed substrates define a flow channel wherein reagent means can be immobilized. When the immobilized reagent means is contacted with an analyte, the reagent means can produce an electrically, optically, or electrically and optically detectable response to the analyte. Hence, the reagent means that is immobilized within the flow channel can comprise (i) a counter electrode, a reference electrode and a working electrode, (ii) an optically sensitive dye or (iii) a counter electrode, a reference electrode and a working electrode and an optically sensitive dye. The flow cell can be interfaced with means for introducing a test sample into and out of the flow cell's flow channel and detection means for detecting a signal generated by the immobilized reagent means. The present invention also provides methods for detecting the presence or amount of an analyte which may be contained in a test sample.
Inventors
- 👤 Ted J. Hanagan
- 👤 Lance K. Safford
- 👤 Steven G. Schultz
- 👤 Jay R. Ford
- 👤 Edmund T. Marciniec
- 👤 Kenneth S. Johnson
- 👤 John D. Norlie, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 05:45
CPC Classifications
B; B01; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5027; C; C12; C12Q; C12Q1/00; C12Q1/001; B01L2200/00; B01L2200/06; B01L2200/0689; B01L2300/00; B01L2300/06; B01L2300/0627; B01L2300/0636; B01L2300/0645; B01L2300/0654; B01L2300/08; B01L2300/0809; B01L2300/0816; B01L2300/0861; B01L2300/0877; B01L2300/0887; B01L2400/00; B01L2400/04; B01L2400/0403; B01L2400/0406; B01L3/502707; Y; Y10; Y10S; Y10S435/00; Y10S435/817
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
152 words
A multi flat-layered diagnostic flow cell for determining the presence or amount of an analyte in a test sample, said flow cell being reusable for a plurality of test samples, and comprising: i) a hydrophobic spacing layer disposed between a first and a second opposed substrate, said first and second substrates being chemically inert and non-conductive, and wherein said spacing layer has a longitudinal void and wherein said spacing layer and said opposed substrates define a flow channel; ii) fastening means for coupling said spacing layer and said opposed substrates; iii) inlet means for permitting said sample to enter said flow channel; iv) outlet means for permitting said sample to exit said flow channel; and v) means for producing a detectable signal, wherein said means is at least partially contained within said flow channel; said means comprising a working electrode containing an immobilized bioreagent enzyme dispersed within a latex resin binding reagent.
Claim 2
Dependent Claim
152 words
A multi flat-layered diagnostic flow cell for determining the presence or amount of an analyte in a test sample, said flow cell being reusable for a plurality of test samples, and comprising: i) a hydrophobic spacing layer disposed between a first and a second opposed substrate, said first and second substrates being chemically inert and non-conductive, and wherein said spacing layer has a longitudinal void and wherein said spacing layer and said opposed substrates define a flow channel; ii) fastening means for coupling said spacing layer and said opposed substrates; iii) inlet means for permitting said sample to enter said flow channel; iv) outlet means for permitting said sample to exit said flow channel; and v) means for producing a detectable signal, wherein said means is at least partially contained within said flow channel; said means comprising a working electrode containing an immobilized bioreagent enzyme dispersed within a latex resin binding reagent.
Claim 3
Dependent Claim
30 words
The flow cell of claim 1 wherein said first opposed substrate comprises a material selected from the group consisting of glass, silicon, polyester, polycarbonate, polystyrene, molded plastics and film plastics.
Claim 4
Dependent Claim
30 words
The flow cell of claim 1 wherein said second opposed substrate comprises a material selected from the group consisting of glass, silicon, polyester, polycarbonate, polystyrene, molded plastics and film plastics.
Claim 5
Dependent Claim
38 words
The flow cell of claim 1 wherein said spacing layer comprises a material selected from the group consisting of printing inks, latexes, urethanes, vinyls, polyesters, and combinations of one or more printing inks, latexes, urethanes, vinyls and polyesters.
Claim 6
Dependent Claim
16 words
The flow cell of claim 1 further comprising a hydrophobic mask layer disposed between said substrates.
Claim 7
Dependent Claim
38 words
The flow cell of claim 5 wherein said mask layer comprises a material selected from the group consisting of printing inks, latexes, urethanes, vinyls, polyesters and combinations of one or more printing inks, latexes, urethanes, vinyls and polyesters.
Claim 8
Dependent Claim
30 words
The flow cell of claim 1 wherein said fastening means is selected from the group consisting of a rivet, a nut and a bolt, a sonic weld and an adhesive.
Claim 9
Dependent Claim
33 words
The flow cell of claim 7 wherein said adhesive is selected from the group consisting of an ultraviolet cured pressure sensitive adhesive, a heat cured pressure sensitive adhesive and a pressure activated adhesive.
Claim 10
Dependent Claim
18 words
The flow cell of claim 1 wherein said fastening means is a polyurethane ultraviolet cured pressure sensitive adhesive.
Claim 11
Dependent Claim
23 words
The flow cell of claim 1 wherein said means for producing a detectable signal further comprises a reference electrode, and a counter electrode.
Claim 12
Dependent Claim
19 words
The flow cell of claim 10 wherein said reference electrode comprises a redox couple and a first conductive trace.
Claim 13
Dependent Claim
26 words
The flow cell of claim 11 wherein said redox couple is selected from the group consisting of silver/silver chloride/graphite, mercury/mercurous chloride, silver/silver iodide and silver/silver chloride.
Claim 14
Dependent Claim
13 words
The flow cell of claim 11 wherein said redox couple comprises silver/silver chloride.
Claim 15
Dependent Claim
51 words
The flow cell of claim 11 wherein said conductive trace comprises a material selected from the group consisting of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide, indium tin oxide and combinations of one or more of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide and indium tin oxide.
Claim 16
Dependent Claim
16 words
The flow cell of claim 11 wherein said conductive trace comprises graphite and screen printed ink.
Claim 17
Dependent Claim
14 words
The flow cell of claim 11 wherein said conductive trace is a flat layer.
Claim 18
Dependent Claim
51 words
The flow cell of claim 10 wherein said counter electrode comprises a material selected from the group consisting of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide, indium tin oxide and combinations of one or more of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide and indium tin oxide.
Claim 19
Dependent Claim
16 words
The flow cell of claim 10 wherein said counter electrode comprises graphite and screen printed ink.
Claim 20
Dependent Claim
16 words
The flow cell of claim 10 wherein said reagent means further comprises an optically active dye.
Claim 21
Dependent Claim
29 words
The flow cell of claim 19 wherein said dye is selected from the group consisting of a pH sensitive dye, an oxygen sensitive dye and an ion sensitive dye.
Claim 22
Dependent Claim
12 words
The flow cell of claim 19 wherein said dye comprises platinum tetra(pentafluorophenyl)porphyrin.
Claim 23
Dependent Claim
15 words
The flow cell of claim 10 wherein said working electrode comprises a second conductive trace.
Claim 24
Dependent Claim
51 words
The flow cell of claim 22 wherein said conductive trace comprises a material selected from the group consisting of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide, indium tin oxide and combinations of one or more of carbon, gold, nickel, silver, palladium, ruthenium, rhodium, tin oxide and indium tin oxide.
Claim 25
Dependent Claim
16 words
The flow cell of claim 22 wherein said conductive trace comprises graphite and screen printed ink.
Claim 26
Dependent Claim
24 words
The flow cell of claim 22, wherein said enzyme is immobilized to a solid phase material and is further immobilized to said conductive trace.
Claim 27
Dependent Claim
38 words
The flow cell of claim 25, wherein said enzyme is selected from the group consisting of glucose oxidase, glutamate oxidase, lactate oxidase, glycerol phosphate oxidase, cholesterol oxidase, cholesterol esterase, lipase, glycerol kinase, glutamate dehydrogenase, creatine deaminase, and uricase.
Claim 28
Dependent Claim
28 words
The flow cell of claim 26, wherein said latex resin is selected from the group consisting of acrylic latex, styrene acrylic latexes, vinyl acetate latex and polyurethane latex.
Claim 29
Dependent Claim
39 words
The flow cell of claim 27, wherein said solid phase material is selected from the group consisting of agarose and derivatives thereof, polyacrylamide and derivatives thereof, silicas, aluminosilicates, aluminum oxides, carbon or graphite particles, and platinum group metal oxides.
Claim 30
Dependent Claim
14 words
The flow cell of claim 22 wherein said conductive trace is a flat layer.
Claim 31
Dependent Claim
15 words
The flow cell of claim 1 wherein said reagent means comprises an optically active dye.
Claim 32
Dependent Claim
29 words
The flow cell of claim 30 wherein said dye is selected from the group consisting of a pH sensitive dye, an oxygen sensitive dye and an ion sensitive dye.
Claim 33
Dependent Claim
12 words
The flow cell of claim 30 wherein said dye comprises platinum tetra(pentafluorophenyl)prophyrin.
Claim 34
Dependent Claim
54 words
The flow cell of claim 1 wherein said flow cell further comprises flow means for introducing said test sample into said flow channel wherein said flow means is interfaced with said inlet and outlet means; and detection means for detecting a detactable signal wherein said detection means is interfaced with said immobilized reagent means.
Claim 35
Dependent Claim
23 words
The flow cell of claim 1, wherein said inlet means and said outlet means comprises a pair of apertures within said second substrate.
Claim 36
Dependent Claim
22 words
The flow cell of claim 34, wherein said apertures are aligned within said second substrate at opposite ends of said flow channel.
Claim 37
Dependent Claim
38 words
The flow cell of claim 1, wherein said enzyme is selected from the group consisting of glucose oxidase, glutamate oxidase, lactate oxidase, glycerol phosphate oxidase, cholesterol oxidase, cholesterol esterase, lipase, glycerol kinase, glutamate dehydrogenase, creatine deaminase, and uricase.
Claim 38
Dependent Claim
28 words
The flow cell of claim 36, wherein said latex resin is selected from the group consisting of acrylic latex, styrene acrylic latexes, vinyl acetate latex and polyurethane latex.
Claim 39
Dependent Claim
153 words
A multiflat-layered diagnostic flow cell for determining the presence or amount of one or more analytes in a test sample, said flow cell being reusable for a plurality of test samples, and comprising: i) a hydrophobic spacing layer disposed between a first and second opposed substrate, said first and second substrates being chemically inert and non-conductive, and wherein said spacing layer has a longitudinal void and wherein said spacing layer and said opposed substrates define a flow channel; ii) fastening means for coupling said spacing layer and said opposed substrates; iii) inlet means for permitting said sample to enter said flow channel; iv) outlet means for permitting said sample to exit said flow channel; and v) means for producing a detectable signal, wherein said means is at least partially contained within said flow channel; said means comprising a working electrode containing at least one immobilized bioreagent dispersed within a latex resin binding reagent.
Claim 40
Dependent Claim
153 words
A multiflat-layered diagnostic flow cell for determining the presence or amount of one or more analytes in a test sample, said flow cell being reusable for a plurality of test samples, and comprising: i) a hydrophobic spacing layer disposed between a first and second opposed substrate, said first and second substrates being chemically inert and non-conductive, and wherein said spacing layer has a longitudinal void and wherein said spacing layer and said opposed substrates define a flow channel; ii) fastening means for coupling said spacing layer and said opposed substrates; iii) inlet means for permitting said sample to enter said flow channel; iv) outlet means for permitting said sample to exit said flow channel; and v) means for producing a detectable signal, wherein said means is at least partially contained within said flow channel; said means comprising a working electrode containing at least one immobilized bioreagent dispersed within a latex resin binding reagent.
Claim 41
Dependent Claim
18 words
The flow cell of claim 38 wherein working electrode comprises a conductive trace which is a flat layer.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-05-28 | 1999-11-27 | 2000-05-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-05-28 | 2003-11-27 | 2004-05-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-05-28 | 2007-11-27 | 2008-05-28 | $7700.00 | Window Closed / Lapsed |