US6984307B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Dual glucose-hydroxybutyrate analytical sensors
Assignee: Individual
•
Filing: 2002-10-03
•
Granted: 2006-01-10
•
Expires: 2022-10-03
Abstract
Abstract Diagnostic dry reagent tests capable of reacting with a single drop of whole blood and reporting both glucose and beta-hydroxybutyrate levels are taught. Such dry reagent tests may employ electrochemical detection methodologies, optical detection methodologies, or both methodologies. These tests help facilitate the early detection of the onset of ketoacidosis in diabetes.
Inventors
- 👤 Stephen Eliot Zweig
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 01:44
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/001; C12Q1/005; C12Q1/006; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; G01N33/523; G01N33/66
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
182 words
A dry reagent diagnostic device for the simultaneous enzymatic analysis of two different analytes in a single application of a single 1–20 ul sample of whole blood, wherein the fast analyte is determined by a fast reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines the second analyte; a fluid bridge formed by the applied sample connects the two reaction zones; said first reaction zone and second reaction zone having reaction materials and geometry; selected to allow simultaneous rehydration and activation of both zones by a single unseparated whole blood drop; said reaction zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood; said reaction zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood; said detectable sample application signal being capable of triggering an automated reaction zone reader which is capable of performing subsequent test timing in an automated manner; and at least one of the reaction zones produces a detectable change in an optical signal.
Claim 2
Dependent Claim
182 words
A dry reagent diagnostic device for the simultaneous enzymatic analysis of two different analytes in a single application of a single 1–20 ul sample of whole blood, wherein the fast analyte is determined by a fast reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines the second analyte; a fluid bridge formed by the applied sample connects the two reaction zones; said first reaction zone and second reaction zone having reaction materials and geometry; selected to allow simultaneous rehydration and activation of both zones by a single unseparated whole blood drop; said reaction zone materials and geometry being selected so as to return detectable analyte signals in the presence of whole blood; said reaction zone materials and geometry being selected as to generate a detectable sample application signal upon initial contact with whole blood; said detectable sample application signal being capable of triggering an automated reaction zone reader which is capable of performing subsequent test timing in an automated manner; and at least one of the reaction zones produces a detectable change in an optical signal.
Claim 3
Dependent Claim
14 words
The device of claim 1 , in which the analytes are glucose and beta-hydroxybutyrate.
Claim 4
Dependent Claim
44 words
The device of claim 2 , in which one reaction zone is an electrochemical reaction zone, and the reaction detected is an electrochemical reaction, wherein said device has at least one working electrode for said electrochemical reaction zone, and at least one reference electrode.
Claim 5
Dependent Claim
16 words
The device of claim 3 , in which said at least one electrode contains carbon particles.
Claim 6
Dependent Claim
41 words
The device of claim 3 , in which said electrochemical reaction zone detects glucose, said electrochemical reaction zone contains a glucose sensing electrode, and said glucose electrode contains or is associated with a glucose oxidase enzyme and an electron transfer mediator.
Claim 7
Dependent Claim
40 words
The device of claim 3 , in which said electrochemical reaction zone detects glucose, said electrochemical reaction zone contains a glucose sensing electrode, and said glucose electrode contains or is associated with glucose dehydrogenase enzyme and an electron transfer mediator.
Claim 8
Dependent Claim
40 words
The device of claim 3 , in which said electrochemical reaction zone detects beta-hydrozybutyrate, said electrochemical reaction zone contains a beta-hydroxybutyrate sensing electrode, and said beta-hydroxybutyrate electrode contains or is associated with beta-hydroxybutyrate dehydrogenase enzyme and an electron transfer mediator.
Claim 9
Dependent Claim
40 words
The device of claim 3 , in which one or more layers of a microporus, microparticle and binder composition, which allows plasma to pass but blocks red cells, cover said at least one working electrode for said electrochemical reaction zone.
Claim 10
Dependent Claim
26 words
The device of claim 8 , in which one or more layers of the microporus, microparticle and binder composition are rendered microporous through a freeze-drying step.
Claim 11
Dependent Claim
25 words
The device of claim 8 , in which the microporous microparticle composition is composed of spherical particles with a diameter between 0.1 and 50 microns.
Claim 12
Dependent Claim
22 words
The device of claim 2 , in which said optical signal is selected from group consisting of colorimetric, fluorescent, or luminescent signals.
Claim 13
Dependent Claim
50 words
The device of claim 11 , in which said analyte determined by said reaction zone producing a detectable change in an optical signal is glucose and said reaction zone of the device contains or is associated with a glucose oxidase enzyme, peroxidase, and a hydrogen peroxide sensitive optical indicator dye.
Claim 14
Dependent Claim
50 words
The device of claim 11 , in which said analyte determined by said reaction zone producing a detectable change in an optical signal is glucose and said reaction zone of the device contains or is associated with a glucose dehydrogenase enzyme, NAD, diaphorase, and a NADH sensitive optical indicator dye.
Claim 15
Dependent Claim
50 words
The device of claim 11 , in which said analyte determined by said reaction zone producing a detectable change in an optical signal is beta-hydroxybutyrate and said reaction zone of the device contains or is associated with a beta-hydroxybutyrate dehydrogenase enzyme, NAD, diaphorase, and a NADH sensitive optical indicator dye.
Claim 16
Dependent Claim
48 words
The device of claim 1 , in which a chemical sample application signal detection means is incorporated into at least one of the reaction zones, and in which the chemical sample application signal detection means changes its colorimetric, fluorescent, or luminescent state upon contact with the liquid sample.
Claim 17
Dependent Claim
41 words
The device of claim 15 , in which an increase in reflectance on at least one wavelength of the chemical sample application signal detection means is used to trigger the start of an automated meter system that monitors the reaction optically.
Claim 18
Dependent Claim
29 words
The device of claim 1 , in which the first analyte produces an electrochemical signal, and in which the second analyte produces a detectible change in an optical signal.
Claim 19
Dependent Claim
28 words
The device of claim 17 , in which the device contains conducting electrodes to transmit the electrochemical signal, and an optical wave guide to transmit the optical signal.
Claim 20
Dependent Claim
17 words
The device of claim 18 , in which the optical wave guide is a single optical fiber.
Claim 21
Independent Claim
182 words
A method for determining the concentration of two or more analytes in a single sample of whole blood with a volume under 20 ul, comprising the steps of; applying said blood sample to a dry reagent diagnostic device in a single application, said dry reagent diagnostic device containing at least two reaction zones; wherein a first analyte in said sample is determined by a first reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines a second analyte in said sample; forming a fluid bridge with the applied blood sample to connect; all reaction zones on said device; said first reaction zone and second reaction zone having reaction zone materials and geometry; and selected to allow simultaneous rehydration and activation of all zones by a single unseparated whole blood drop; said reaction zone materials and geometry being selected as to return detectable analyte signals in the presence of whole blood; and determining the concentration of at least one of said analytes from at least one of said reaction zones by a detectable change in an optical signal.
Claim 22
Independent Claim
182 words
A method for determining the concentration of two or more analytes in a single sample of whole blood with a volume under 20 ul, comprising the steps of; applying said blood sample to a dry reagent diagnostic device in a single application, said dry reagent diagnostic device containing at least two reaction zones; wherein a first analyte in said sample is determined by a first reaction zone, and a second reaction zone, physically separated from the first reaction zone, determines a second analyte in said sample; forming a fluid bridge with the applied blood sample to connect; all reaction zones on said device; said first reaction zone and second reaction zone having reaction zone materials and geometry; and selected to allow simultaneous rehydration and activation of all zones by a single unseparated whole blood drop; said reaction zone materials and geometry being selected as to return detectable analyte signals in the presence of whole blood; and determining the concentration of at least one of said analytes from at least one of said reaction zones by a detectable change in an optical signal.
Claim 23
Dependent Claim
31 words
The method of claim 20 , in which at least one analyte produces an electrochemical signal, and in which at least one analyte produces a detectible change in an optical signal.
Claim 24
Dependent Claim
41 words
The method of claim 20 , in which the dry reagent diagnostic device contains conducting electrodes to transmit an analyte produced change in an electrochemical signal, and an optical wave guide to transmit an analyte produced change in an optical signal.
Claim 25
Dependent Claim
57 words
The method of claim 20 , in which said reaction zone materials and geometry are selected as to generate a detectable sample application signal upon initial contact with whole blood; and said detectable sample application signal being capable of triggering an automated reaction zone reader which is capable of performing subsequent test timing in an automated manner.
References Cited (Backward Citations)
US3814668A
Cited
US4147514A
Cited
US4225410A
Cited
US4545382A
Cited
US4397956A
Cited
US4548907A
Cited
US4682895A
Cited
US5049487A
Cited
US5843692A
Cited
US5126275A
Cited
US5139685A
Cited
US5968836A
Cited
US5344754A
Cited
US5597532A
Cited
US5695949A
Cited
US6027692A
Cited
US5628890A
Cited
US5951836A
Cited
US5708247A
Cited
US6143164A
Cited
US6090251A
Cited
US6277641B1
Cited
US6231920B1
Cited
WO1999058709A1
Cited
EP1113263A2
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2009-01-09 | 2009-07-11 | 2010-01-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2013-01-09 | 2013-07-11 | 2014-01-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2017-01-09 | 2017-07-11 | 2018-01-10 | $7700.00 | Window Closed / Lapsed |