Analyte concentration measurement using a hollow frustum

• US 5,753,429 A
• Filed: 08/09/1996
• Issued: 05/19/1998
• Est. Priority Date: 08/09/1996
• Status: Expired due to Term

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Pugh, Jerry Thomas
• Primary Examiner(s): Kight, John
• Assistant Examiner(s): JONES, DAMERON LEVEST
• Application Number:
  US08/694,972
• Time in Patent Office: 648 Days
• Field of Search: 435/4, 435/14
• US Class Current: 435/4
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: B01L 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

A method for measuring the concentration of an analyte in a sample of a biological fluid involves a hollow, frustum-shaped disposable device. The smaller end of the frustum has a porous membrane, to which the sample is applied. Preferably, a reagent in the membrane reacts with the analyte to cause a color change. The device is mounted on a meter, which measures the color change and computes from the change the analyte concentration in the sample. Preferably, the devices are released from the meter without touching them, to protect against contamination.

Claims

1. A method for measuring a concentration of an analyte in a sample of a biological fluid comprising

(a) providing a device that comprises a hollow frustum having open ends of unequal size, whose smaller end is substantially closed by a membrane that has

(ii) a first outward facing surface for accepting the sample and

(ii) a reagent for reacting with the analyte to cause, in a physically detectable parameter of the membrane, measurable change that is related to the concentration of the analyte in the sample;

(b) applying the sample to the first surface;

(c) measuring the change in the parameter; and

(d) determining the analyte concentration from the measurement of the parameter change.

2. The method of claim 1 in which the device is provided on an end of an elongated meter, which both supports the device and measures the parameter change.

3. The method of claim 2 in which the elongated meter has a frustum-shaped distal section for mating engagement with the device for making the measurement.

4. The method of claim 3 in which providing the device on the end of the meter comprises removably engaging a peripheral groove on the distal section of the meter with indentations on a perimeter of the device, without a user directly contacting the device.

5. The method of claim 1 in which the reagent reacts with the analyte to cause a color change, and the membrane parameter whose change is measured is a reflectance of a second, inward facing surface, opposite to the first surface.

6. The method of claim 5 in which the sample is whole blood and the analyte is blood glucose.

7. The method of claim 1 further comprising the step of removing the device from the meter, without directly contacting the device.