Analyte sensors and methods for making and using them
First Claim
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1. An analyte sensor apparatus for implantation within a mammal, the analyte sensor apparatus comprising:
- a base layer;
a conductive layer disposed upon the base layer wherein the conductive layer includes a working electrode;
an analyte sensing layer disposed on the conductive layer, wherein the analyte sensing layer detectably alters the electrical current at the working electrode in the conductive layer in the presence of an analyte;
an adhesion promoting layer disposed on the analyte sensing layer, wherein the adhesion promoting layer promotes the adhesion between the analyte sensing layer and an analyte modulating layer disposed on the analyte sensing layer; and
an analyte modulating layer disposed on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and
wherein;
the analyte sensor apparatus is structured to function via anodic polarization such that the alteration in current can be detected at the anode working electrode in the conductive layer of the analyte sensor apparatus; and
the alteration in current that can be detected at the anode working electrode can be correlated with the concentration of the analyte.
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Abstract
Embodiments of the invention provide analyte sensors having stabilized coating compositions and methods for making and using such sensors. Illustrative embodiments include electrochemical glucose sensors having stabilized glucose oxidase coatings.
419 Citations
41 Claims
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1. An analyte sensor apparatus for implantation within a mammal, the analyte sensor apparatus comprising:
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a base layer;
a conductive layer disposed upon the base layer wherein the conductive layer includes a working electrode;
an analyte sensing layer disposed on the conductive layer, wherein the analyte sensing layer detectably alters the electrical current at the working electrode in the conductive layer in the presence of an analyte;
an adhesion promoting layer disposed on the analyte sensing layer, wherein the adhesion promoting layer promotes the adhesion between the analyte sensing layer and an analyte modulating layer disposed on the analyte sensing layer; and
an analyte modulating layer disposed on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough; and
wherein;
the analyte sensor apparatus is structured to function via anodic polarization such that the alteration in current can be detected at the anode working electrode in the conductive layer of the analyte sensor apparatus; and
the alteration in current that can be detected at the anode working electrode can be correlated with the concentration of the analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 41)
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20. A method of making a sensor apparatus for implantation within a mammal comprising the steps of:
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providing a base layer;
forming a conductive layer on the base layer, wherein the conductive layer includes a working electrode;
forming an analyte sensing layer on the conductive layer, wherein the analyte sensing layer includes a composition that can alter the electrical current at the working electrode in the conductive layer in the presence of an analyte;
optionally forming a protein layer on the analyte sensing layer;
forming an adhesion promoting layer on the analyte sensing layer or the optional protein layer;
forming an analyte modulating layer disposed on the adhesion promoting layer, wherein the analyte modulating layer includes a composition that modulates the diffusion of the analyte therethrough; and
forming a cover layer disposed on at least a portion of the analyte modulating layer, wherein the cover layer further includes an aperture over at least a portion of the analyte modulating layer. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method of sensing an analyte within the body of a mammal, the method comprising implanting an analyte sensor in to the mammal, the analyte sensor comprising:
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a base layer;
a conductive layer disposed upon the base layer wherein the conductive layer includes a working electrode, a reference electrode and a counter electrode;
an analyte sensing layer disposed on the conductive layer, wherein the analyte sensing layer detectably alters the electrical current at the working electrode in the conductive layer in the presence of an analyte;
an optional protein layer disposed on the analyte sensing layer;
an adhesion promoting layer disposed on the analyte sensing layer or the optional protein layer, wherein the adhesion promoting layer promotes the adhesion between the analyte sensing layer and an analyte modulating layer disposed on the analyte sensing layer; and
an analyte modulating layer disposed on the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of the analyte therethrough;
a cover layer disposed on at least a portion of the analyte modulating layer, wherein the cover layer further includes an aperture over at least a portion of the analyte modulating layer; and
sensing an alteration in current at the working electrode and correlating the alteration in current with the presence of the analyte, so that the analyte is sensed. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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Specification