Sensor with layered electrodes
First Claim
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1. A planar flexible analyte sensor comprising:
- a base layer;
a first electrode layer disposed on the base layer and including a first electrode;
a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed;
a second electrode layer disposed on the first insulative layer and including a second electrode; and
a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed,wherein each of said base layer, first and second electrode layers, and first and second insulative layers is planar, wherein the first and second electrodes are in a staggered configuration, wherein said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body, and wherein the maximum height of the flexible analyte sensor is about 25 microns.
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Abstract
A thin film sensor, such as a glucose sensor, is provided for transcutaneous placement at a selected site within the body of a patient. The sensor includes several sensor layers that include conductive layers and includes a proximal segment defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment with sensor electrodes for transcutaneous placement. The sensor electrode layers are disposed generally above each other, for example with the reference electrode above the working electrode and the working electrode above the counter electrode. The electrode layers are separated by dielectric layer.
146 Citations
42 Claims
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1. A planar flexible analyte sensor comprising:
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a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; and a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed, wherein each of said base layer, first and second electrode layers, and first and second insulative layers is planar, wherein the first and second electrodes are in a staggered configuration, wherein said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body, and wherein the maximum height of the flexible analyte sensor is about 25 microns. - 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, 25, 26, 27)
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28. An analyte monitoring system comprising:
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(a) a planar flexible analyte sensor comprising; a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed; and a third electrode layer disposed on the second insulative layer and including a third electrode, wherein the first electrode layer further includes a first conductive trace leading from the first electrode to a first conductive pad configured to electrically couple to sensor electronics, the second electrode layer further includes a second conductive trace leading from the second electrode to a second conductive pad configured to electrically couple to sensor electronics, the third electrode layer further includes a third conductive trace leading from the third electrode to a third conductive pad configured to electrically couple to sensor electronics, the first, second, and third electrodes are in a staggered configuration, and the maximum height of the flexible analyte sensor is about 25 microns; and wherein each of said base layer, said first, second, and third electrode layers, and said first and second insulative layers is planar, and said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body; (b) sensor electronics electrically connected to the first, second, and third conductive pads; and (c) an analyte monitor, wherein the sensor electronics and the analyte monitor are configured to communicate with one another. - View Dependent Claims (29, 30, 31)
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32. An analyte monitoring system comprising:
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(a) a planar, flexible analyte sensor comprising; a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed; a third electrode layer disposed on the second insulative layer and including a third electrode; an enzyme layer including glucose oxidase disposed over the first, second, and third electrodes; and a glucose limiting membrane disposed over the enzyme layer, wherein the first, second, and third electrodes are in a staggered configuration, and wherein the maximum height of the flexible analyte sensor is about 25 microns; and wherein each of said base layer, said first, second, and third electrode layers, and said first and second insulative layers is planar, and said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body; (b) sensor electronics in electrical communication with the first, second and third electrodes; and (c) an analyte monitor, wherein the sensor electronics and the analyte monitor are configured to communicate with one another. - View Dependent Claims (33, 34, 35)
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36. An analyte monitoring system comprising:
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(a) a planar flexible analyte sensor comprising; a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed; a third electrode layer disposed on the second insulative layer and including a third electrode; and a third insulative layer disposed on the third electrode layer, wherein said third insulative layer leaves at least a portion of the third electrode exposed, wherein the first electrode layer is disposed directly on the base layer without any intervening layers, the first insulative layer is disposed directly on the first electrode layer without any intervening layers, the second electrode layer is disposed directly on the first insulative layer without any intervening layers, the second insulative layer is disposed directly on the second electrode layer without any intervening layers, the third electrode layer is disposed directly on the second insulative layer without any intervening layers, and the third insulative layer is disposed directly on the third electrode layer without any intervening layers; wherein each of said base layer, said first, second, and third electrode layers, and said first, second, and third insulative layers is planar, and said exposed portion of the first electrode, said exposed portion of the second electrode, and said exposed portion of the third electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body; and wherein the second electrode layer is directly above the first electrode layer, the third electrode layer is directly above the second electrode layer, the first, second, and third electrodes are in a staggered configuration, and the maximum height of the flexible analyte sensor is about 25 microns; (b) sensor electronics in electrical communication with the first, second, and third electrodes; and (c) an analyte monitor, wherein the sensor electronics and the analyte monitor are configured to communicate with one another. - View Dependent Claims (37)
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38. A planar flexible analyte sensor comprising:
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a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed; an enzyme layer disposed directly over said exposed portions of the electrodes; a glucose limiting membrane disposed directly over said enzyme layer; and a hydrophilic membrane disposed directly over the glucose limiting membrane, wherein each of said base layer, said first and second electrode layers, and said first and second insulative layers is planar, wherein the first and second electrodes are in a staggered configuration, wherein said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body, and wherein the maximum height of the flexible analyte sensor is about 25 microns. - View Dependent Claims (39, 40)
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41. An analyte monitoring system comprising:
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(a) a planar flexible analyte sensor comprising; a base layer; a first electrode layer disposed on the base layer and including a first electrode; a first insulative layer disposed on the first electrode layer, wherein said first insulative layer leaves at least a portion of the first electrode exposed; a second electrode layer disposed on the first insulative layer and including a second electrode; a second insulative layer disposed on the second electrode layer, wherein said second insulative layer leaves at least a portion of the second electrode exposed; an enzyme layer disposed directly over said exposed portions of the electrodes; a glucose limiting membrane disposed directly over said enzyme layer; and a hydrophilic membrane disposed directly over the glucose limiting membrane, wherein each of said base layer, said first and second electrode layers, and said first and second insulative layers is planar, wherein said exposed portion of the first electrode and said exposed portion of the second electrode are configured to be in direct contact with a patient'"'"'s bodily fluids for measuring said analyte within the patient'"'"'s body, and wherein the second electrode layer is directly above the first electrode layer, the first and second electrodes are in a staggered configuration, and the maximum height of the flexible analyte sensor is about 25 microns; (b) sensor electronics in electrical communication with the first and second electrodes; and (c) an analyte monitor, wherein the sensor electronics and the analyte monitor are configured to communicate wirelessly with one another. - View Dependent Claims (42)
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Specification