Disposable sub-microliter volume sensor and method of making
First Claim
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1. A disposable electrode strip for testing a fluid sample comprising:
- a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer having a conductive layer disposed thereon, said conductive layer having a scribe line delineated thereon and forming three electrode paths, a channel forming layer carried on said base layer, and a cover;
an enclosed channel between said first strip end and said vent opening, said enclosed channel sized to hold a volume of said fluid sample less than one microliter;
a reagent matrix containing at least an enzyme;
a stabilizer, wherein said stabilizer is a polyalkylene glycol; and
a redox mediator disposed on said base layer in said enclosed channel;
conductive contacts at said second strip end and insulated from said enclosed channel.
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Abstract
A disposable electrode strip for testing a fluid sample including a laminated strip with a first and second end, a vent, an open path for receiving a fluid sample of less than one microliter beginning from the first end and connecting to the vent, a working electrode, a reference electrode and a pseudo-working electrode embedded in the laminated strip within the open path and proximate to the first end, a reagent matrix coextensive within the open path and covering the three electrodes, and conductive contacts located at the second end of the laminated strip.
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Citations
38 Claims
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1. A disposable electrode strip for testing a fluid sample comprising:
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a laminated strip having a first strip end, a second strip end and a vent opening spaced from said first strip end, said laminated strip comprising a base layer having a conductive layer disposed thereon, said conductive layer having a scribe line delineated thereon and forming three electrode paths, a channel forming layer carried on said base layer, and a cover;
an enclosed channel between said first strip end and said vent opening, said enclosed channel sized to hold a volume of said fluid sample less than one microliter;
a reagent matrix containing at least an enzyme;
a stabilizer, wherein said stabilizer is a polyalkylene glycol; and
a redox mediator disposed on said base layer in said enclosed channel;
conductive contacts at said second strip end and insulated from said enclosed channel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A disposable electrode strip for detecting or measuring the concentration of an analyte in a fluid sample, said electrode strip comprising:
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an insulating base strip having a first base end and a second base end;
a conductive layer disposed on one side of said base strip, said conductive layer having a pattern scribed into said conductive layer, said pattern delineating three electrically-distinct conductive paths insulated from each other;
a middle insulator sized smaller than said insulating base strip and overlaying a substantial portion of said conductive layer, said middle insulator having a cutout portion spaced from said first base end, said cutout portion exposing a limited area of said three conductive paths;
an electrode material comprising an enzyme, a redox mediator;
a stabilizer, wherein said stabilizer is a polyalkylene glycol, a binder, a surfactant, and a buffer, said electrode material being disposed in said cutout portion; and
a covering insulator sized to fit over and be coextensive with said middle insulator creating a sample fluid channel, said covering insulator having a covering insulator aperture spaced from said first base end and configured to expose at least a small portion of said cutout portion of said middle insulator. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A method of making multiple, disposable sensors wherein each sensor has at least a working electrode, a reference electrode, a pseudo-working electrode, and a reagent matrix, wherein said reagent matrix contains an enzyme capable of catalyzing a reaction involving a substrate for the enzyme, said working electrode and said reference electrode being disposed in a fluid sample channel for measuring a fluid sample, said method comprising:
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obtaining a base strip of an insulating material having a layer of conductive material disposed thereon, said base strip having a first edge and a second edge;
scribing in said conductive material a plurality of lines in a repetitive pattern wherein said plurality of lines contain a repetitive pattern capable of forming three conductive paths in each of said repetitive pattern;
disposing a middle layer of insulating material over said base strip, said middle layer having a repetitive pattern of an elongated cutout wherein each cutout of each of said repetitive pattern exposes an electrode portion of each of said three conductive paths of each repetitive pattern wherein said repetitive pattern of said elongated cutout are spaced from said first edge of said base strip, and wherein said middle layer is sized to expose a contact portion of each of said two conductive paths of each repetitive pattern for a distance from said second edge of said base strip;
disposing an reagent material, wherein said reagent material contains a polyalkylene glycol stabilizer, into each elongated cutout of said repetitive pattern;
drying said reagent material at a temperature and for a length of time sufficient to solidify said reagent material in each of said elongated cutout;
disposing a top layer of insulating material over and coextensive with said middle layer, said top layer having a plurality of vent openings in a repetitive pattern wherein each of said vent openings exposes a portion of a corresponding repetitive pattern of said elongated cutout of said middle layer furthest from said first edge of said base strip, said base strip, said middle layer and said top layer forming a laminated strip;
cutting along and parallel to said first edge of said laminated strip a predetermined distance creating a sample inlet port in each of said elongated cutout for each of said repetitive pattern;
cutting along and parallel to said second edge of said laminated strip a predetermined distance creating two separate contacts for each of said repetitive pattern; and
separating each of said repetitive pattern at predetermined intervals along said laminated strip. - View Dependent Claims (37, 38)
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Specification