Systems and methods for blood glucose sensing
First Claim
1. A test strip for measuring glucose in a blood sample, said test strip comprising:
- a base layer, said base layer having a proximal end and a distal end, said proximal end being narrower than said distal end;
at least four electrodes disposed on said base layer, said at least four electrodes including a working electrode, a counter electrode, a fill-detect anode, and a fill-detect cathode;
a plurality of electrical contacts disposed on said base layer, said plurality of electrical contacts including a working electrode contact, a counter electrode contact, a fill-detect anode contact, and a fill-detect cathode contact;
a plurality of conductive traces disposed on said base layer, said plurality of conductive traces electrically connecting said working electrode to said working electrode contact, said counter electrode to said counter electrode contact, said fill-detect anode to said fill-detect anode contact, said fill-detect cathode to said fill-detect cathode contact;
an auto-on conductor disposed on said base layer;
a first dielectric layer disposed on said base layer, said first dielectric layer covering portions of said working electrode and said counter electrode, so as to define an exposed working electrode portion and an exposed counter electrode portion;
a second dielectric layer disposed on said base layer, said second dielectric layer having a slot, said working electrode, said counter electrode, said fill-detect anode, and said fill-detect cathode being disposed in said slot, said slot having a proximal end and a distal end, said proximal end of said slot being aligned with said proximal end of said base layer;
a reagent layer disposed in said slot, said reagent layer including glucose oxidase and a mediator; and
a porous cover disposed on said second dielectric layer, wherein said slot defines a testing zone for testing said blood sample, said slot being dimensioned to draw said blood sample in through said proximal end of said slot by capillary action.
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Accused Products
Abstract
A system for measuring a glucose level in a blood sample includes a test strip and a meter. The test strip includes a sample chamber or other testing zone, a working electrode, a counter electrode, fill-detect electrodes, and an auto-on conductor. A reagent layer is disposed in the testing zone. The auto-on conductor causes the meter to wake up and perform a test strip sequence when the test strip is inserted in the meter. The meter uses the working and counter electrodes to initially detect the blood sample in the sample chamber and uses the fill-detect electrodes to check that the blood sample has mixed with the reagent layer. The meter applies an assay voltage between the working and counter electrodes and measures the resulting current. The meter calculates the glucose level based on the measured current and calibration data saved in memory from a removable data storage device associated with the test strip.
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Citations
33 Claims
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1. A test strip for measuring glucose in a blood sample, said test strip comprising:
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a base layer, said base layer having a proximal end and a distal end, said proximal end being narrower than said distal end;
at least four electrodes disposed on said base layer, said at least four electrodes including a working electrode, a counter electrode, a fill-detect anode, and a fill-detect cathode;
a plurality of electrical contacts disposed on said base layer, said plurality of electrical contacts including a working electrode contact, a counter electrode contact, a fill-detect anode contact, and a fill-detect cathode contact;
a plurality of conductive traces disposed on said base layer, said plurality of conductive traces electrically connecting said working electrode to said working electrode contact, said counter electrode to said counter electrode contact, said fill-detect anode to said fill-detect anode contact, said fill-detect cathode to said fill-detect cathode contact;
an auto-on conductor disposed on said base layer;
a first dielectric layer disposed on said base layer, said first dielectric layer covering portions of said working electrode and said counter electrode, so as to define an exposed working electrode portion and an exposed counter electrode portion;
a second dielectric layer disposed on said base layer, said second dielectric layer having a slot, said working electrode, said counter electrode, said fill-detect anode, and said fill-detect cathode being disposed in said slot, said slot having a proximal end and a distal end, said proximal end of said slot being aligned with said proximal end of said base layer;
a reagent layer disposed in said slot, said reagent layer including glucose oxidase and a mediator; and
a porous cover disposed on said second dielectric layer, wherein said slot defines a testing zone for testing said blood sample, said slot being dimensioned to draw said blood sample in through said proximal end of said slot by capillary action. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A test strip for testing a blood sample, said test strip comprising:
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a first substrate;
a second substrate, said second substrate defining a testing zone for testing said blood sample;
at least four electrodes, disposed on said first substrate, for measuring at least one electrical characteristic of said blood sample in said testing zone, said at least four electrodes including a working electrode, a counter electrode, a fill-detect anode, and a fill-detect cathode;
a plurality of electrical contacts disposed on said first substrate and electrically connected to said at least four electrodes; and
at least one auto-on electrical contact disposed on said first substrate and electrically isolated from said at least four electrodes. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of making a plurality of test strips, said method comprising:
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forming a plurality of test strip structures on an insulating sheet, wherein each test strip structure is formed by;
(a) forming a first conductive pattern on said insulating sheet, said first conductive pattern including at least four electrodes, said at least four electrodes including a working electrode, a counter electrode, a fill-detect anode, and a fill-detect cathode;
(b) forming a second conductive pattern on said insulating sheet, said second conductive pattern including a plurality of electrode contacts for said at least four electrodes, a plurality of conductive traces electrically connecting said at least four electrodes to said plurality of electrode contacts, and an auto-on conductor;
(c) applying a first dielectric layer over portions of said working electrode and said counter electrode, so as to define an exposed working electrode portion and an exposed counter electrode portion;
(d) applying a second dielectric layer to said first dielectric layer, said second dielectric layer defining a slot, said working electrode, said counter electrode, said fill-detect anode, and said fill-detect cathode being disposed in said slot;
(e) forming a reagent layer in said slot, said reagent layer including glucose oxidase and a mediator; and
(f) attaching a porous cover to said second dielectric layer; and
separating said plurality of test strip structures into said plurality of test strips, each of said test strips having a proximal end and a distal end, with said slot extending to said proximal end, said proximal end being narrower than said distal end. - View Dependent Claims (22, 23, 24, 25)
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26. A method of making a plurality of test strips, said method comprising:
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forming a plurality of test strip structures on one sheet, each of said test strip structures including;
(a) a spacer defining a testing zone;
(b) a plurality of electrodes formed on said sheet, including a working electrode, a counter electrode, a fill-detect anode, and a fill-detect cathode;
(c) a plurality of electrical contacts, formed on said sheet and electrically connected to said plurality of electrodes; and
(d) at least one auto-on electrical contact, formed on said sheet and electrically isolated from said plurality of electrodes; and
separating said test strip structures into said plurality of test strips. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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Specification