TRANSCUTANEOUS ANALYTE SENSOR
First Claim
1. A method for inserting a transcutaneous analyte sensor in a host, the method comprising:
- providing an assembly for inserting a transcutaneous analyte sensor into a host, wherein the assembly comprises an applicator releasably connected with a housing, wherein the housing is configured to be placed adjacent to the host'"'"'s skin, and wherein the assembly further comprises a sensor configured to be inserted into the host;
inserting the sensor into the host; and
connecting an electronics unit with the housing, wherein the applicator is configured to release from the housing in response to connection of the electronics unit with the housing.
1 Assignment
0 Petitions

Accused Products

Abstract
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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DexCom Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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Abbott Diabetes Care Incorporated
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21 Claims
-
1. A method for inserting a transcutaneous analyte sensor in a host, the method comprising:
-
providing an assembly for inserting a transcutaneous analyte sensor into a host, wherein the assembly comprises an applicator releasably connected with a housing, wherein the housing is configured to be placed adjacent to the host'"'"'s skin, and wherein the assembly further comprises a sensor configured to be inserted into the host; inserting the sensor into the host; and connecting an electronics unit with the housing, wherein the applicator is configured to release from the housing in response to connection of the electronics unit with the housing. - View Dependent Claims (2, 3, 4, 5, 6, 7)
-
-
8. A method for measuring an analyte in a host, the method comprising:
-
providing an assembly for inserting an analyte sensor into a host, wherein the assembly comprises an applicator releasably connected with a housing, wherein the housing is configured to be placed adjacent to the host'"'"'s skin, and wherein the assembly further comprises a sensor configured to be inserted into the host; inserting the sensor into the host; connecting an electronics unit with the housing; and transferring information from the assembly to the electronics unit. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16)
-
-
17. A method for measuring an analyte in a host, the method comprising:
-
providing an assembly for inserting an analyte sensor into a host, wherein the assembly comprises a housing configured to be placed adjacent to the host'"'"'s skin, and wherein the assembly further comprises a sensor configured to be inserted into the host; inserting the sensor into the host; connecting sensor electronics with the sensor; and transferring information to the sensor electronics. - View Dependent Claims (18, 19, 20, 21)
-
1 Specification
This application is a continuation of U.S. application Ser. No. 11/157,746 filed Jun. 21, 2005, which claims the benefit of U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004; U.S. Provisional Application No. 60/587,800 filed Jul. 13, 2004; U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and U.S. Provisional Application No. 60/614,764 filed Sep. 30, 2004; each of which is incorporated by reference herein in its entirety, and each of which is hereby made a part of this specification.
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.
Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are so far spread apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. It is not only unlikely that a person with diabetes will take a timely SMBG value, it is also likely that he or she will not know if his or her blood glucose value is going up (higher) or down (lower) based on conventional method. This inhibits the ability to make educated insulin therapy decisions.
In a first aspect, a sensor system for measuring an analyte in a host is provided, the system comprising: a sensor adapted for transcutaneous insertion into a host'"'"'s skin; a housing adapted for placement adjacent to the host'"'"'s skin; an electronics unit configured to be releasably attachable to the housing; and an applicator configured to insert the sensor through the housing and into the skin of the host, wherein the applicator is adapted to releasably mate with the housing, and wherein the applicator is configured to release from the housing when the electronics unit is attached to the housing.
In an embodiment of the first aspect, the electronics unit is configured to slide-fit into the housing.
In an embodiment of the first aspect, the electronics unit is tapered to guide the slide-fit of the electronics unit into the housing.
In an embodiment of the first aspect, the electronics unit has an architecture configured to self-align with the housing.
In an embodiment of the first aspect, the electronics unit and housing each comprise a mutually engaging contact, and wherein the electronics unit and housing are configured to seal the mutually engaging contacts when mated.
In an embodiment of the first aspect, the system further comprises a safety latch mechanism configured to lock the sensor within the applicator prior to release of the safety latch mechanism.
In an embodiment of the first aspect, the electronics unit releasably mated to the housing together comprise a subassembly, and wherein the subassembly has a volume of less than or equal to about 8 cm3.
In an embodiment of the first aspect, a major surface of the subassembly has a surface area of less than or equal to about 8 cm2, and wherein the major surface of the subassembly is configured to lie adjacent to the host'"'"'s skin when in use.
In a second aspect, a sensor system for measuring an analyte in a host is provided, the system comprising: a sensor adapted for transcutaneous insertion into a host'"'"'s skin; and a housing comprising an electronics unit adapted for placement adjacent to the host'"'"'s skin; and an applicator configured to insert the sensor through the housing and into the skin of the host upon application of a force, wherein the applicator comprises a safety latch mechanism configured to lock the sensor within the applicator prior to release of the safety latch mechanism.
In an embodiment of the second aspect, the applicator comprises a plunger configured to insert the sensor into the host'"'"'s skin upon application of force to the plunger.
In an embodiment of the second aspect, the safety latch mechanism is configured to lock the plunger in a stationary position.
In a third aspect, a method for implanting a transcutaneous analyte sensor system in a host is provided, the method comprising: providing an applicator for inserting a transcutaneous analyte sensor into the host, wherein the applicator is releasably mated to a housing, and wherein the housing comprises a sensor configured to be inserted into a host; placing a housing adjacent to the host'"'"'s skin; inserting the sensor into the host; and inserting an electronics unit into the housing, wherein the applicator is configured to release from the housing when the electronics unit is attached to the housing.
In an embodiment of the second aspect, the step of inserting the electronics unit comprises sliding the electronics unit into the housing.
In an embodiment of the second aspect, the electronics unit has a taper configured to guide the sliding of the electronics unit into the housing.
In an embodiment of the second aspect, the electronics unit has an architecture configured to self-align the electronics unit with the housing.
In an embodiment of the second aspect, the electronic unit comprises at least one contact configured to mutually engage with at least one contact on the housing, and wherein the step of inserting the electronics unit further comprises releasably attaching the electronics unit to the housing, thereby sealing the mutually engaging contacts from moisture.
In an embodiment of the second aspect, the applicator further comprises a safety latch mechanism configured to lock the sensor within the applicator prior to release of the safety latch mechanism.
In an embodiment of the second aspect, the method further comprises the step of releasing the safety latch mechanism prior to inserting the sensor into the host.
The following description and examples illustrate some exemplary embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be deemed to limit the scope of the present invention.
In order to facilitate an understanding of the preferred embodiments, a number of terms are defined below.
The term “analyte” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenyloin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky'"'"'s disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA).
The term “host” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to mammals, particularly humans.
The term “exit-site” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to the area where a medical device (for example, a sensor and/or needle) exits from the host'"'"'s body.
The phrase “continuous (or continual) analyte sensing” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to the period in which monitoring of analyte concentration is continuously, continually, and or intermittently (regularly or irregularly) performed, for example, about every 5 to 10 minutes.
The term “electrochemically reactive surface” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to the surface of an electrode where an electrochemical reaction takes place. For example, a working electrode measures hydrogen peroxide produced by the enzyme-catalyzed reaction of the analyte detected, which reacts to create an electric current. Glucose analyte can be detected utilizing glucose oxidase, which produces H2O2 as a byproduct. H2O2 reacts with the surface of the working electrode, producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2), which produces the electronic current being detected.
The term “electronic connection” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to any electronic connection known to those in the art that can be utilized to interface the sensing region electrodes with the electronic circuitry of a device, such as mechanical (for example, pin and socket) or soldered electronic connections.
The term “interferant” and “interferants,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, to refer to species that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte measurement. In one example of an electrochemical sensor, interferants are compounds with oxidation potentials that overlap with the analyte to be measured.
The term “sensing region” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to the region of a monitoring device responsible for the detection of a particular analyte. The sensing region generally comprises a non-conductive body, a working electrode (anode), a reference electrode (optional), and/or a counter electrode (cathode) passing through and secured within the body forming electrochemically reactive surfaces on the body and an electronic connective means at another location on the body, and a multi-domain membrane affixed to the body and covering the electrochemically reactive surface.
The term “high oxygen solubility domain” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to a domain composed of a material that has higher oxygen solubility than aqueous media such that it concentrates oxygen from the biological fluid surrounding the membrane system. The domain can act as an oxygen reservoir during times of minimal oxygen need and has the capacity to provide, on demand, a higher oxygen gradient to facilitate oxygen transport across the membrane. Thus, the ability of the high oxygen solubility domain to supply a higher flux of oxygen to critical domains when needed can improve overall sensor function.
The term “domain” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to a region of the membrane system that can be a layer, a uniform or non-uniform gradient (for example, an anisotropic region of a membrane), or a portion of a membrane.
The phrase “distal to” as used herein is a broad term and is used in its ordinary sense, including, without limitation, the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively far from the reference point than another element.
The term “proximal to” as used herein is a broad term and is used in its ordinary sense, including, without limitation, the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively near to the reference point than another element.
The terms “in vivo portion” and “distal portion” as used herein are broad terms and are used in their ordinary sense, including, without limitation, to refer to the portion of the device (for example, a sensor) adapted for insertion into and/or existence within a living body of a host.
The terms “ex vivo portion” and “proximal portion” as used herein are broad terms and are used in their ordinary sense, including, without limitation, to refer to the portion of the device (for example, a sensor) adapted to remain and/or exist outside of a living body of a host.
The terms “raw data stream” and “data stream,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, to refer to an analog or digital signal from the analyte sensor directly related to the measured analyte. For example, the raw data stream is digital data in “counts” converted by an A/D converter from an analog signal (for example, voltage or amps) representative of an analyte concentration. The terms broadly encompass a plurality of time spaced data points from a substantially continuous analyte sensor, each of which comprises individual measurements taken at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer.
The term “count,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to a unit of measurement of a digital signal. For example, a raw data stream measured in counts is directly related to a voltage (for example, converted by an A/D converter), which is directly related to current from the working electrode.
The term “physiologically feasible,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to one or more physiological parameters obtained from continuous studies of glucose data in humans and/or animals. For example, a maximal sustained rate of change of glucose in humans of about 4 to 6 mg/dL/min and a maximum acceleration of the rate of change of about 0.1 to 0.2 mg/dL/min/min are deemed physiologically feasible limits. Values outside of these limits are considered non-physiological and are likely a result of, e.g. signal error.
The term “ischemia,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to local and temporary deficiency of blood supply due to obstruction of circulation to a part (for example, a sensor). Ischemia can be caused, for example, by mechanical obstruction (for example, arterial narrowing or disruption) of the blood supply.
The term “matched data pairs”, as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to reference data (for example, one or more reference analyte data points) matched with substantially time corresponding sensor data (for example, one or more sensor data points).
The term “Clarke Error Grid”, as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to an error grid analysis, for example, an error grid analysis used to evaluate the clinical significance of the difference between a reference glucose value and a sensor generated glucose value, taking into account 1) the value of the reference glucose measurement, 2) the value of the sensor glucose measurement, 3) the relative difference between the two values, and 4) the clinical significance of this difference. See Clarke et al., “Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose”, Diabetes Care, Volume 10, Number 5, September-October 1987, the contents of which are hereby incorporated by reference herein in their entirety and are hereby made a part of this specification.
The term “Consensus Error Grid,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to an error grid analysis that assigns a specific level of clinical risk to any possible error between two time corresponding measurements, e.g. glucose measurements. The Consensus Error Grid is divided into zones signifying the degree of risk posed by the deviation. See Parkes et al., “A New Consensus Error Grid to Evaluate the Clinical Significance of Inaccuracies in the Measurement of Blood Glucose”, Diabetes Care, Volume 23, Number 8, August 2000, the contents of which are hereby incorporated by reference herein in their entirety and are hereby made a part of this specification.
The term “clinical acceptability,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to determination of the risk of an inaccuracy to a patient. Clinical acceptability considers a deviation between time corresponding analyte measurements (for example, data from a glucose sensor and data from a reference glucose monitor) and the risk (for example, to the decision making of a person with diabetes) associated with that deviation based on the analyte value indicated by the sensor and/or reference data. An example of clinical acceptability can be 85% of a given set of measured analyte values within the “A” and “B” region of a standard Clarke Error Grid when the sensor measurements are compared to a standard reference measurement.
The term “sensor” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to the component or region of a device by which an analyte can be quantified.
The term “needle,” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to a slender hollow instrument for introducing material into or removing material from the body.
The terms “operably connected” and “operably linked” as used herein are broad terms and are used in their ordinary sense, including, without limitation, to refer to one or more components linked to one or more other components. The terms can refer to a mechanical connection, an electrical connection, or a connection that allows transmission of signals between the components. For example, one or more electrodes can be used to detect the amount of analyte in a sample and to convert that information into a signal; the signal can then be transmitted to a circuit. In such an example, the electrode is “operably linked” to the electronic circuitry.
The term “baseline” as used herein is a broad term and is used in its ordinary sense, including, without limitation, is the component of an analyte sensor signal that is not related to the analyte concentration. In one example of a glucose sensor, the baseline is composed substantially of signal contribution due to factors other than glucose (for example, interfering species, non-reaction-related hydrogen peroxide, or other electroactive species with an oxidation potential that overlaps with hydrogen peroxide). In some embodiments wherein a calibration is defined by solving for the equation y=m×+b, the value of b represents the baseline of the signal.
The terms “sensitivity” and “slope,” as used herein are broad terms and are used in their ordinary sense, including, without limitation, to refer to an amount of electrical current produced by a predetermined amount (unit) of the measured analyte. For example, in one preferred embodiment, a sensor has a sensitivity (or slope) of about 3.5 to about 7.5 picoAmps of current for every 1 mg/dL of glucose analyte.
The term “membrane system,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to a permeable or semi-permeable membrane that can be comprised of two or more domains and is typically constructed of materials of a few microns thickness or more, which is permeable to oxygen and is optionally permeable to, e.g. glucose or another analyte. In one example, the membrane system comprises an immobilized glucose oxidase enzyme, which enables a reaction to occur between glucose and oxygen whereby a concentration of glucose can be measured.
The terms “processor module” and “microprocessor,” as used herein, are broad terms and are used in their ordinary sense, without limitation, to refer to a computer system, state machine, processor, or the like designed to perform arithmetic or logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
The terms “smoothing” and “filtering,” as used herein, are broad terms and are used in their ordinary sense, without limitation, to refer to modification of a set of data to make it smoother and more continuous or to remove or diminish outlying points, for example, by performing a moving average of the raw data stream.
The term “algorithm,” as used herein, is a broad term and is used in its ordinary sense, without limitation, to refer to a computational process (for example, programs) involved in transforming information from one state to another, for example, by using computer processing.
The term “regression,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to finding a line for which a set of data has a minimal measurement (for example, deviation) from that line. Regression can be linear, non-linear, first order, second order, or the like. One example of regression is least squares regression.
The term “calibration,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to the process of determining the relationship between the sensor data and the corresponding reference data, which can be used to convert sensor data into meaningful values substantially equivalent to the reference data. In some embodiments, namely, in continuous analyte sensors, calibration can be updated or recalibrated over time as changes in the relationship between the sensor data and reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, or the like.
The terms “interferants” and “interfering species,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, to refer to effects and/or species that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte concentration. In one example of an electrochemical sensor, interfering species are compounds with an oxidation potential that overlap that of the analyte to be measured, thereby producing a false positive signal.
The terms “chloridization” and “chloridizing,” as used herein, are broad terms and are used in their ordinary sense, including, without limitation, to refer to treatment or preparation with chloride. The term “chloride” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to C1− ions, sources of C1− ions, and salts of hydrochloric acid. Chloridization and chloridizing methods include, but are not limited to, chemical and electrochemical methods.
A transcutaneous analyte sensor system is provided that includes an applicator for inserting the transdermal analyte sensor under a host'"'"'s skin. The sensor system includes a sensor for sensing the analyte, wherein the sensor is associated with a mounting unit adapted for mounting on the skin of the host. The mounting unit houses the electronics unit associated with the sensor and is adapted for fastening to the host'"'"'s skin. In certain embodiments, the system further includes a receiver for receiving and/or processing sensor data.
The mounting unit (housing) 14 includes a base 24 adapted for mounting on the skin of a host, a sensor adapted for transdermal insertion through the skin of a host (see
In one embodiment, an applicator 12 is provided for inserting the sensor 32 through the host'"'"'s skin at the appropriate insertion angle with the aid of a needle (see
The electronics unit 16 includes hardware, firmware, and/or software that enable measurement of levels of the analyte via the sensor. For example, the electronics unit 16 can comprise a potentiostat, a power source for providing power to the sensor, other components useful for signal processing, and preferably an RF module for transmitting data from the electronics unit 16 to a receiver (see
After insertion of the sensor using the applicator 12, and subsequent release of the applicator 12 from the mounting unit 14 (see
In preferred embodiments, the mounting unit 14, also referred to as a housing, comprises a base 24 adapted for fastening to a host'"'"'s skin. The base can be formed from a variety of hard or soft materials, and preferably comprises a low profile for minimizing protrusion of the device from the host during use. In some embodiments, the base 24 is formed at least partially from a flexible material, which is believed to provide numerous advantages over conventional transcutaneous sensors, which, unfortunately, can suffer from motion-related artifacts associated with the host'"'"'s movement when the host is using the device. For example, when a transcutaneous analyte sensor is inserted into the host, various movements of the sensor (for example, relative movement between the in vivo portion and the ex vivo portion, movement of the skin, and/or movement within the host (dermis or subcutaneous)) create stresses on the device and can produce noise in the sensor signal. It is believed that even small movements of the skin can translate to discomfort and/or motion-related artifact, which can be reduced or obviated by a flexible or articulated base. Thus, by providing flexibility and/or articulation of the device against the host'"'"'s skin, better conformity of the sensor system 10 to the regular use and movements of the host can be achieved. Flexibility or articulation is believed to increase adhesion (with the use of an adhesive pad) of the mounting unit 14 onto the skin, thereby decreasing motion-related artifact that can otherwise translate from the host'"'"'s movements and reduced sensor performance.
In certain embodiments, the mounting unit 14 is provided with an adhesive pad 8, preferably disposed on the mounting unit'"'"'s back surface and preferably including a releasable backing layer 9. Thus, removing the backing layer 9 and pressing the base portion 24 of the mounting unit onto the host'"'"'s skin adheres the mounting unit 14 to the host'"'"'s skin. Additionally or alternatively, an adhesive pad can be placed over some or all of the sensor system after sensor insertion is complete to ensure adhesion, and optionally to ensure an airtight seal or watertight seal around the wound exit-site (or sensor insertion site) (not shown). Appropriate adhesive pads can be chosen and designed to stretch, elongate, conform to, and/or aerate the region (e.g., host'"'"'s skin).
In preferred embodiments, the adhesive pad 8 is formed from spun-laced, open- or closed-cell foam, and/or non-woven fibers, and includes an adhesive disposed thereon, however a variety of adhesive pads appropriate for adhesion to the host'"'"'s skin can be used, as is appreciated by one skilled in the art of medical adhesive pads. In some embodiments, a double-sided adhesive pad is used to adhere the mounting unit to the host'"'"'s skin. In other embodiments, the adhesive pad includes a foam layer, for example, a layer wherein the foam is disposed between the adhesive pad'"'"'s side edges and acts as a shock absorber.
In some embodiments, the surface area of the adhesive pad 8 is greater than the surface area of the mounting unit'"'"'s back surface. Alternatively, the adhesive pad can be sized with substantially the same surface area as the back surface of the base portion. Preferably, the adhesive pad has a surface area on the side to be mounted on the host'"'"'s skin that is greater than about 1, 1.25, 1.5, 1.75, 2, 2.25, or 2.5, times the surface area of the back surface 25 of the mounting unit base 24. Such a greater surface area can increase adhesion between the mounting unit and the host'"'"'s skin, minimize movement between the mounting unit and the host'"'"'s skin, and/or protect the wound exit-site (sensor insertion site) from environmental and/or biological contamination. In some alternative embodiments, however, the adhesive pad can be smaller in surface area than the back surface assuming a sufficient adhesion can be accomplished.
In some embodiments, the adhesive pad 8 is substantially the same shape as the back surface 25 of the base 24, although other shapes can also be advantageously employed, for example, butterfly-shaped, round, square, or rectangular. The adhesive pad backing can be designed for two-step release, for example, a primary release wherein only a portion of the adhesive pad is initially exposed to allow adjustable positioning of the device, and a secondary release wherein the remaining adhesive pad is later exposed to firmly and securely adhere the device to the host'"'"'s skin once appropriately positioned. The adhesive pad is preferably waterproof. Preferably, a stretch-release adhesive pad is provided on the back surface of the base portion to enable easy release from the host'"'"'s skin at the end of the useable life of the sensor, as is described in more detail with reference to
In some circumstances, it has been found that a conventional bond between the adhesive pad and the mounting unit may not be sufficient, for example, due to humidity that can cause release of the adhesive pad from the mounting unit. Accordingly, in some embodiments, the adhesive pad can be bonded using a bonding agent activated by or accelerated by an ultraviolet, acoustic, radio frequency, or humidity cure. In some embodiments, a eutectic bond of first and second composite materials can form a strong adhesion. In some embodiments, the surface of the mounting unit can be pretreated utilizing ozone, plasma, chemicals, or the like, in order to enhance the bondability of the surface.
A bioactive agent is preferably applied locally at the insertion site (exit-site) prior to or during sensor insertion. Suitable bioactive agents include those which are known to discourage or prevent bacterial growth and infection, for example, anti-inflammatory agents, antimicrobials, antibiotics, or the like. It is believed that the diffusion or presence of a bioactive agent can aid in prevention or elimination of bacteria adjacent to the exit-site. Additionally or alternatively, the bioactive agent can be integral with or coated on the adhesive pad, or no bioactive agent at all is employed.
In the illustrated embodiment, the sealing member 36 is formed with a raised portion 37 surrounding the contacts 28. The raised portion 37 enhances the interference fit surrounding the contacts 28 when the electronics unit 16 is mated to the mounting unit 14. Namely, the raised portion surrounds each contact and presses against the electronics unit 16 to form a tight seal around the electronics unit.
Contacts 28 fit within the seal 36 and provide for electrical connection between the sensor 32 and the electronics unit 16. In general, the contacts are designed to ensure a stable mechanical and electrical connection of the electrodes that form the sensor 32 (see
In preferred embodiments, the contacts 28 are formed from a conductive elastomeric material, such as a carbon black elastomer, through which the sensor 32 extends (see
In an alternative embodiment, a conductive, stiff plastic forms the contacts, which are shaped to comply upon application of pressure (for example, a leaf-spring shape). Contacts of such a configuration can be used instead of a metallic spring, for example, and advantageously avoid the need for crimping or soldering through compliant materials; additionally, a wiping action can be incorporated into the design to remove contaminants from the surfaces during connection. Non-metallic contacts can be advantageous because of their seamless manufacturability, robustness to thermal compression, non-corrosive surfaces, and native resistance to electrostatic discharge (ESD) damage due to their higher-than-metal resistance.
Preferably, the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host'"'"'s skin, and a proximal portion 40, also referred to as an ex vivo portion, adapted to remain above the host'"'"'s skin after sensor insertion and to operably connect to the electronics unit 16 via contacts 28. Preferably, the sensor 32 includes two or more electrodes: a working electrode 44 and at least one additional electrode, which can function as a counter electrode and/or reference electrode, hereinafter referred to as the reference electrode 46. A membrane system is preferably deposited over the electrodes, such as described in more detail with reference to
In alternative embodiments, the contacts 28 are formed into a variety of alternative shapes and/or sizes. For example, the contacts 28 can be discs, spheres, cuboids, and the like. Furthermore, the contacts 28 can be designed to extend from the mounting unit in a manner that causes an interference fit within a mating cavity or groove of the electronics unit, forming a stable mechanical and electrical connection therewith.
In preferred embodiments, each electrode is formed from a fine wire with a diameter of from about 0.001 or less to about 0.010 inches or more, for example, and is formed from, e.g. a plated insulator, a plated wire, or bulk electrically conductive material. Although the illustrated electrode configuration and associated text describe one preferred method of forming a transcutaneous sensor, a variety of known transcutaneous sensor configurations can be employed with the transcutaneous analyte sensor system of the preferred embodiments, such as are described in U.S. Pat. No. 6,695,860 to Ward et al., U.S. Pat. No. 6,565,509 to Say et al., U.S. Pat. No. 6,248,067 to Causey III, et al., and U.S. Pat. No. 6,514,718 to Heller et al.
In preferred embodiments, the working electrode comprises a wire formed from a conductive material, such as platinum, platinum-iridium, palladium, graphite, gold, carbon, conductive polymer, alloys, or the like. Although the electrodes can by formed by a variety of manufacturing techniques (bulk metal processing, deposition of metal onto a substrate, or the like), it can be advantageous to form the electrodes from plated wire (e.g. platinum on steel wire) or bulk metal (e.g. platinum wire). It is believed that electrodes formed from bulk metal wire provide superior performance (e.g. in contrast to deposited electrodes), including increased stability of assay, simplified manufacturability, resistance to contamination (e.g. which can be introduced in deposition processes), and improved surface reaction (e.g. due to purity of material) without peeling or delamination.
The working electrode 44 is configured to measure the concentration of an analyte. In an enzymatic electrochemical sensor for detecting glucose, for example, the working electrode measures the hydrogen peroxide produced by an enzyme catalyzed reaction of the analyte being detected and creates a measurable electronic current For example, in the detection of glucose wherein glucose oxidase produces hydrogen peroxide as a byproduct, hydrogen peroxide reacts with the surface of the working electrode producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2), which produces the electronic current being detected.
In preferred embodiments, the working electrode 44 is covered with an insulating material 45, for example, a non-conductive polymer. Dip-coating, spray-coating, vapor-deposition, or other coating or deposition techniques can be used to deposit the insulating material on the working electrode. In one embodiment, the insulating material comprises parylene, which can be an advantageous polymer coating for its strength, lubricity, and electrical insulation properties. Generally, parylene is produced by vapor deposition and polymerization of para-xylylene (or its substituted derivatives). While not wishing to be bound by theory, it is believed that the lubricious coating (e.g. parylene) on the sensors of the preferred embodiments contributes to minimal trauma and extended sensor life.
The reference electrode 46, which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, silver/silver chloride, or the like. Preferably, the reference electrode 46 is juxtapositioned and/or twisted with or around the working electrode 44; however other configurations are also possible (e.g. an intradermal or on-skin reference electrode). In the illustrated embodiments, the reference electrode 46 is helically wound around the working electrode 44. The assembly of wires is then optionally coated or adhered together with an insulating material, similar to that described above, so as to provide an insulating attachment.
In some embodiments, a silver wire is formed onto the sensor as described above, and subsequently chloridized to form silver/silver chloride reference electrode. Advantageously, chloridizing the silver wire as described herein enables the manufacture of a reference electrode with optimal in vivo performance. Namely, by controlling the quantity and amount of chloridization of the silver to form silver/silver chloride, improved break-in time, stability of the reference electrode, and extended life has been shown with the preferred embodiments (see
In embodiments wherein an outer insulator is disposed, a portion of the coated assembly structure can be stripped or otherwise removed, for example, by hand, excimer lasing, chemical etching, laser ablation, grit-blasting (e.g. with sodium bicarbonate or other suitable grit), or the like, to expose the electroactive surfaces. Alternatively, a portion of the electrode can be masked prior to depositing the insulator in order to maintain an exposed electroactive surface area. In one exemplary embodiment, grit blasting is implemented to expose the electroactive surfaces, preferably utilizing a grit material that is sufficiently hard to ablate the polymer material, while being sufficiently soft so as to minimize or avoid damage to the underlying metal electrode (e.g. a platinum electrode). Although a variety of “grit” materials can be used (e.g. sand, talc, walnut shell, ground plastic, sea salt, and the like), in some preferred embodiments, sodium bicarbonate is an advantageous grit-material because it is sufficiently hard to ablate, e.g. a parylene coating without damaging, e.g. an underlying platinum conductor. One additional advantage of sodium bicarbonate blasting includes its polishing action on the metal as it strips the polymer layer, thereby eliminating a cleaning step that might otherwise be necessary.
In the embodiment illustrated in
In some applications, cellular attack or migration of cells to the sensor can cause reduced sensitivity and/or function of the device, particularly after the first day of implantation. However, when the exposed electroactive surface is distributed circumferentially about the sensor (e.g. as in a radial window), the available surface area for reaction can be sufficiently distributed so as to minimize the effect of local cellular invasion of the sensor on the sensor signal. Alternatively, a tangential exposed electroactive window can be formed, for example, by stripping only one side of the coated assembly structure. In other alternative embodiments, the window can be provided at the tip of the coated assembly structure such that the electroactive surfaces are exposed at the tip of the sensor. Other methods and configurations for exposing electroactive surfaces can also be employed.
In some embodiments, the working electrode has a diameter of from about 0.001 inches or less to about 0.010 inches or more, preferably from about 0.002 inches to about 0.008 inches, and more preferably from about 0.004 inches to about 0.005 inches. The length of the window can be from about 0.1 mm (about 0.004 inches) or less to about 2 mm (about 0.078 inches) or more, and preferably from about 0.5 mm (about 0.02 inches) to about 0.75 mm (0.03 inches). In such embodiments, the exposed surface area of the working electrode is preferably from about 0.000013 in2 (0.0000839 cm2) or less to about 0.0025 in2 (0.016129 cm2) or more (assuming a diameter of from about 0.001 inches to about 0.010 inches and a length of from about 0.004 inches to about 0.078 inches). The preferred exposed surface area of the working electrode is selected to produce an analyte signal with a current in the picoAmp range, such as is described in more detail elsewhere herein. However, a current in the picoAmp range can be dependent upon a variety of factors, for example the electronic circuitry design (e.g. sample rate, current draw, A/D converter bit resolution, etc.), the membrane system (e.g. permeability of the analyte through the membrane system), and the exposed surface area of the working electrode. Accordingly, the exposed electroactive working electrode surface area can be selected to have a value greater than or less than the above-described ranges taking into consideration alterations in the membrane system and/or electronic circuitry. In preferred embodiments of a glucose sensor, it can be advantageous to minimize the surface area of the working electrode while maximizing the diffusivity of glucose in order to optimize the signal-to-noise ratio while maintaining sensor performance in both high and low glucose concentration ranges.
In some alternative embodiments, the exposed surface area of the working (and/or other) electrode can be increased by altering the cross-section of the electrode itself. For example, in some embodiments the cross-section of the working electrode can be defined by a cross, star, cloverleaf, ribbed, dimpled, ridged, irregular, or other non-circular configuration; thus, for any predetermined length of electrode, a specific i