Foldover sensors and methods for making and using them
First Claim
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1. An analyte sensor apparatus comprising:
- a base substrate comprising a planar sheet of a flexible material, wherein the base substrate is folded to form a fixed bend;
a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes disposed upon a first surface of the base substrate;
a plurality of contact pads disposed upon the first surface of the base substrate;
a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality or counter electrodes or the plurality of reference electrodes and the plurality of contact pads;
an analyte sensing layer disposed over at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; and
an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough;
wherein;
the base substrate comprises the fixed bend so as to form a configuration characterized in that;
at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; and
at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend andthe plurality of contact pads are disposed on the first side of the fixed bend.
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Abstract
The invention disclosed herein includes sensors having three dimensional configurations that allow expansive “360°” sensing (i.e. sensing analyte from multiple directions) in the environments in which such sensors are disposed. Embodiments of the invention provide analyte sensors having foldable substrates adapted to produce optimized configurations of electrode elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.
245 Citations
19 Claims
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1. An analyte sensor apparatus comprising:
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a base substrate comprising a planar sheet of a flexible material, wherein the base substrate is folded to form a fixed bend; a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes disposed upon a first surface of the base substrate; a plurality of contact pads disposed upon the first surface of the base substrate; a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality or counter electrodes or the plurality of reference electrodes and the plurality of contact pads; an analyte sensing layer disposed over at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; and an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; wherein; the base substrate comprises the fixed bend so as to form a configuration characterized in that; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; and at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend and the plurality of contact pads are disposed on the first side of the fixed bend. - View Dependent Claims (2, 3, 4, 5, 12, 13)
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6. A method of making an analyte sensor apparatus, the method comprising the steps of:
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providing a base substrate formed from a planar sheet of a flexible material having a first surface and a second surface and adapted to transition from a first configuration to a second configuration when folded; forming a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes on the first surface of the base substrate; forming a plurality of contact pads on the first surface of the base substrate; forming a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes and the plurality of contact pads; forming an analyte sensing layer on at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; forming an analyte modulating layer on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and folding the base substrate so as to introduce a fixed bend that results in a configuration characterized in that; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend; and the plurality of contact pads are disposed on the first side of the fixed bend;
so that the analyte sensor apparatus is formed. - View Dependent Claims (7, 8, 9, 10, 11)
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14. An analyte sensor apparatus comprising:
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a base substrate comprising a planar sheet of a flexible material wherein the base substrate is folded to form a fixed bend; a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes disposed upon a first surface of the base substrate; a plurality of contact pads disposed upon the first surface of the base substrate; a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes and the plurality of contact pads; an analyte sensing layer disposed over at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; and an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; wherein; the base substrate comprises the fixed bend so as to form a configuration characterized in that; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend; and the plurality of contact pads are disposed on the first side of the fixed bend; the base substrate comprises; a rectangular body; a first longitudinal arm extending outward from the rectangular body; a second longitudinal arm extending outward from the rectangular body; wherein the first longitudinal arm and the second longitudinal arm are parallel to each other; the at least one of the plurality of working electrodes is disposed on the first longitudinal arm and the at least one of the plurality of working electrodes is disposed on the second longitudinal arm. - View Dependent Claims (15, 16)
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17. An analyte sensor apparatus comprising:
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a base substrate comprising a planar sheet of a flexible material, wherein the base substrate is folded to form a fixed bend; a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes disposed upon a first surface of the base substrate; a plurality of contact pads disposed upon the first surface of the base substrate; a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes and the plurality of contact pads; an analyte sensing layer disposed over at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; and an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; wherein; the base substrate comprises the fixed bend so as to form as configuration characterized in that; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend; and the plurality of contact pads are disposed on the first side of the fixed bend; the base substrate comprises; a rectangular body; a first longitudinal arm extending outward from the rectangular body; a second longitudinal arm extending outward from the rectangular body; wherein the first longitudinal arm and the second longitudinal arm are parallel to each other; and a locking member disposed on the base substrate and adapted to inhibit movement of the first longitudinal arm or the second longitudinal arm.
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18. A method of making an analyte sensor apparatus, the method comprising the steps of:
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providing a base substrate formed from a planar sheet of a flexible material having a first surface and a second surface and adapted to transition from a first configuration to a second configuration when folded; shaping the base substrate to form a rectangular body, a first longitudinal arm extending outward from the rectangular body; and
a second longitudinal arm extending outward from the rectangular body, wherein the base substrate is folded so that a first side of the base substrate that results from folding the base substrate is in a plane of at least 45 or 90 degrees off of a second side of the base substrate that results from folding the base substrate;forming a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes on the first surface of the base substrate; forming a plurality of contact pads on the first surface of the base substrate; forming a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes and the plurality of contact pads; forming an analyte sensing layer on at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; forming an analyte modulating layer on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and folding the base substrate so as to introduce a fixed bend that results in a configuration characterized in that; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend; and the plurality of contact pads are disposed on the first side of the fixed bend; so that the analyte sensor apparatus is formed.
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19. A method of making an analyte sensor apparatus, the method comprising the steps of:
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providing a base substrate formed from a planar sheet of a flexible material having a first surface and a second surface and adapted to transition from a first configuration to a second configuration when folded; shaping the base substrate to form a rectangular body, a first longitudinal arm extending outward from the rectangular body; and
a second longitudinal arm extending outward from the rectangular body;forming a plurality of working electrodes, a plurality of counter electrodes and a plurality of reference electrodes on the base substrate, wherein the plurality of working electrodes, counter electrodes and reference electrodes are clustered together in units consisting essentially of one working electrode, one counter electrode and one reference electrode; forming a plurality of contact pads on the first surface of the base substrate; forming a plurality of electrical conduits disposed upon the first surface of the base substrate, wherein the plurality of electrical conduits are adapted to transmit electrical signals between the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes and the plurality of contact pads; forming an analyte sensing layer on at least one of the plurality of working electrodes, wherein the analyte sensing layer detectably alters the electrical current at the at least one of the plurality of working electrodes in the presence of an analyte; forming an analyte modulating layer on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and folding the base substrate so as to introduce a fixed bend that results in a configuration characterized in that; the clustered units are longitudinally distributed the first longitudinal arm of the base substrate in a repeating pattern of units; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a first side of the fixed bend; at least one of the plurality of working electrodes, the plurality of counter electrodes or the plurality of reference electrodes is disposed on a second side of the fixed bend; and the plurality of contact pads are disposed on the first side of the fixed bend;
so that the analyte sensor apparatus is formed.
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Specification