Electrochemical analyte sensor
First Claim
1. An in vivo glucose sensor, comprising:
- a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;
at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;
at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;
at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;
a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode;
at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts;
a sensing layer proximate to the at least one working electrode; and
a mass transport limiting layer proximate to the at least one working electrode;
wherein the flexibility of the sensor is varied along a continuum of the substrate.
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Accused Products
Abstract
An electrochemical analyte sensor formed using conductive traces on a substrate can be used for determining and/or monitoring a level of analyte in in vitro or in vivo analyte-containing fluids. For example, an implantable sensor may be used for the continuous or automatic monitoring of a level of an analyte, such as glucose, lactate, or oxygen, in a patient. The electrochemical analyte sensor includes a substrate and conductive material disposed on the substrate, the conductive material forming a working electrode. In some sensors, the conductive material is disposed in recessed channels formed in a surface of the sensor. An electron transfer agent and/or catalyst may be provided to facilitate the electrolysis of the analyte or of a second compound whose level depends on the level of the analyte. A potential is formed between the working electrode and a reference electrode or counter/reference electrode and the resulting current is a function of the concentration of the analyte in the body fluid.
593 Citations
23 Claims
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1. An in vivo glucose sensor, comprising:
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a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode; at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts; a sensing layer proximate to the at least one working electrode; and a mass transport limiting layer proximate to the at least one working electrode; wherein the flexibility of the sensor is varied along a continuum of the substrate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. An in vivo glucose sensor, comprising:
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a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode; at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts; and a sensing layer proximate to the at least one working electrode; wherein the length of the sensor is between 0.3 cm and 5 cm, and the flexibility of the sensor is varied along a continuum of the substrate. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. An in vivo glucose sensor, comprising:
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a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of first conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of first conductive contacts is in electrical communication with the working electrode, a second one of the plurality of first conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of first conductive contacts is in electrical communication with the counter electrode; at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of first conductive contacts; and a sensing layer proximate to the at least one working electrode; wherein the flexibility of the sensor is varied along a continuum of the substrate; and
furtherwherein the sensor has a period of operation of at least one week. - View Dependent Claims (18, 19, 20, 21, 22, 23)
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Specification