Method of manufacturing analyte test strip for accepting diverse sample volumes

• US 8,187,658 B2
• Filed: 06/24/2008
• Issued: 05/29/2012
• Est. Priority Date: 06/24/2008
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Mahoney, John, Chu, Caroline, Perasso, Herb, Tannenbaum, Susan, Jones, Janice, Leong, Koon-Wah, Davis, John Christopher
• Primary Examiner(s): LEE, DORIS L
• Application Number:
  US12/145,341
• Publication Number:
  US 20090314425A1
• Time in Patent Office: 1,435 Days
• Field of Search: 427/2.11
• US Class Current: 427/2.11
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

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.

Claims

1. A method of manufacturing an analyte test strip, the method comprising:

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 insulating layer and the second insulating layer, the channel having;

a sample-receiving chamber therein;

a first port; and

a second port;

applying a reagent layer to the first insulating layer such that the reagent layer is disposed beneath the channel;

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, the third insulating layer including a platform portion that extends beyond the first insulating layer and the second insulating layer, the platform portion having an upper surface;

wherein the first port and the second port are in fluidic communication with the sample-receiving chamber; and

wherein the upper surface of the platform portion is configured to receive a first 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

wherein the second port is configured to receive a second bodily fluid sample of lesser volume than the first bodily fluid sample and for filling the sample-receiving chamber with a portion of the second bodily fluid sample.

2. The method of claim 1 wherein at least one of the first insulating layer and the second insulating layer includes a conductive layer on a surface thereof and the first insulating layer has a first conductive layer thereon that includes a first electrode and the second insulating layer has a second conductive layer thereon that includes a second electrode.

3. The method of claim 1 further comprising the step of:

adhering a bodily fluid absorbent pad to a portion of the platform portion in a manner that provides for the bodily fluid absorbent pad to contain excess of the first bodily fluid sample.

4. The method of claim 1 wherein the third insulating layer has a notch configured to provide visual guidance to a user during application of a first bodily fluid sample to the platform portion.