Lifescan Corporation

John Mahoney

Koon-Wah Leong

John Christopher Davis

Herb Perasso

Janice Jones

Caroline Chu

Susan Tannenbaum

A method of manufacturing an analyte test strip includes positioning a patterned spacer layer between a first insulating layer and a second insulating layer such that the second insulating is disposed above the first insulating layer and a channel is defined between the first and second insulating layers. Moreover, the channel thus defined has a sample-receiving chamber therein, a first port, and a second port. The method also includes coupling a third insulating layer to the first insulating layer such that the third insulating layer is disposed at least partially below the first insulating layer. In the coupling step, the third insulating layer includes a platform portion that extends beyond the first insulating layer and the second insulating layer and the platform portion has an upper surface. In this manufacturing method, the first and second ports are in fluidic communication with the sample-receiving chamber; the upper surface of the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and for filling the sample-receiving chamber with a portion of the first bodily fluid sample, and the second port is configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and for filling the sample-receiving chamber with a portion of the small bodily fluid sample.

Method of manufacturing analyte test strip for accepting diverse sample volumes

A method for determining (e.g., detecting and/or measuring the concentration of) an analyte in a bodily fluid sample includes obtaining a bodily fluid sample, applying the bodily fluid sample to an analyte test strip, transferring the applied bodily fluid sample to a sample-receiving chamber of the analyte test strip, and determining an analyte in the bodily fluid sample. The analyte test strip employed in the method includes a first port in fluidic communication with the sample-receiving chamber and proximate a platform portion of the analyte test strip. Moreover, the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port. The analyte test strip also includes a second port in fluidic communication with the sample-receiving chamber and an outer edge of the analyte test strip, the second port configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and for transferring at least a portion of the second bodily fluid sample to sample-receiving chamber. In addition, the applying step involves applying the bodily fluid sample to one of the second port and the platform portion of the analyte test strip depending on the volume of the bodily fluid sample.

Method for determining an analyte in a bodily fluid

An analyte test strip for accepting diverse bodily fluid sample volumes includes a first insulating layer, a second insulating layer disposed above the first insulating layer, and a third insulating layer disposed below the first insulating layer. The third insulating layer has a platform portion that extends beyond the first and second insulating layers and an upper surface. The analyte test strip also has a patterned spacer layer positioned between the first and second layers. The patterned spacer layer defines a channel between the first and second insulating layers that has a sample-receiving chamber, a first port proximate the platform portion and a second port at an outer edge of the analyte test strip. Moreover, the first port and the second port are in fluidic communication with the sample-receiving chamber. In addition, the upper surface of the platform portion is configured to receive a first (relatively large) bodily fluid sample of at least 5 micro-liters and transfer at least a portion of the first bodily fluid sample to the sample-receiving chamber via the first port. The second port is configured to receive a second (relatively small) bodily fluid sample of lesser volume than the first bodily fluid sample and to transfer at least a portion of the second bodily fluid sample to the sample-receiving chamber.

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San Carlos, CA, United States of America

John Mahoney