Optical reagent format for small sample volumes

• US 7,964,412 B2
• Filed: 05/07/2010
• Issued: 06/21/2011
• Est. Priority Date: 10/29/2002
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Brenneman, Allen J.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Turk; Neil
• Application Number:
  US12/776,083
• Publication Number:
  US 20100248384A1
• Time in Patent Office: 410 Days
• Field of Search: None
• US Class Current: 436/164
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence

Abstract

An optical waveguiding optical format enables consistent optical analysis of small sample volumes with minimal variation in light path length among optical formats. The optical format is comprised of an input guide, an output guide, and a sample cavity adapted to allow light to pass through a sample on its way from the input guide to the output guide. A lid removed from the light pathway within the format may be provided with a reagent for assisting fluid analysis.

Claims

1. A method of optically analyzing a fluid sample comprising:

placing a sample-side surface of an optical format against a skin surface, the optical format including an optical communication path formed by an input light guide coupled with an input reflector, an output light guide coupled with an output reflector, and a sample cavity disposed between the input reflector and the output reflector, the optical communication path being continuous and closed between a first end of the input light guide and the input reflector and being continuous and closed between a first end of the output light guide and the output reflector;

puncturing the skin surface with a lancet in communication with the sample cavity to obtain the fluid sample;

collecting the fluid sample in the sample cavity;

interacting the fluid sample with a reagent;

directing light entering the input light guide through the sample cavity;

detecting light which has passed through the sample cavity; and

optically analyzing the fluid sample using the detected light.

2. The method of claim 1, wherein the optical format further includes a venting channel connected to the sample cavity, and wherein the lancet is positioned within the venting channel.

3. The method of claim 1, wherein the input light guide defines a first portion of the optical communication path, and wherein the input reflector is disposed at about a 45-degree angle to the first portion of the optical communication path.

4. The method of claim 3, wherein the output light guide defines a second portion of the optical communication path, and wherein the output reflector is disposed at about a 45-degree angle to the second portion of the optical communication path.

5. The method of claim 1, wherein the lancet has a first end for collecting test material and a second end for depositing test material within the sample cavity.

6. The method of claim 1, wherein the input light guide is formed by a first four-sided wall structure and the output light guide is formed by a second four-sided wall structure.

7. The method of claim 1, wherein the reagent is provided on a lid adjacent the sample cavity.

8. A method of using an optical format, the method comprising:

engaging the optical format against skin of a user, the optical format including an optical communication path formed by an input light guide coupled with an input reflector, an output light guide coupled with an output reflector, and a sample cavity disposed between the input reflector and the output reflector, the optical communication path being continuous and closed between the input light guide and the input reflector and being continuous and closed between the output light guide and the output reflector;

receiving the fluid sample from the skin in the sample cavity; and

directing light entering the input light guide through the sample cavity.

9. The method of claim 8, further comprising puncturing the skin with a lancet in communication with the sample cavity and drawing the fluid sample from the user using the lancet.

10. The method of claim 8, wherein the directing light entering the input light guide through the sample cavity includes directing light along the optical communication path from a light input, through the input light guide, to the input reflector, and then through the sample cavity.

11. The method of claim 10, further comprising directing light which has passed through the sample cavity along the optical communication path from the sample cavity, to the output reflector, through the output light guide, and to a light output.

12. The method of claim 11, further comprising detecting light which has passed through the sample cavity.

13. The method of claim 12, further comprising determining an analyte concentration in the fluid sample using the detected light.

14. A method for determining an analyte concentration in a fluid sample comprising:

puncturing skin of a user with a lancet;

allowing the fluid sample to accumulate on a surface of the skin;

engaging an optical format against the skin of the user, the optical format including an optical communication path formed by an input light guide coupled with an input reflector, an output light guide coupled with an output reflector, and a sample cavity disposed between the input reflector and the output reflector, the input light guide being formed by a first four-sided wall structure and the output light guide being formed by a second four-sided wall structure, the optical communication path being continuous and closed between the input light guide and the input reflector and being continuous and closed between the output light guide and the output reflector;

collecting at least a portion of the accumulated fluid sample in the sample cavity of the optical format;

interacting the fluid sample with a reagent provided on a lid adjacent the sample cavity;

directing light entering the input light guide through the sample cavity, at least a portion of the entering light passing through the sample cavity;

detecting light which has passed through the sample cavity; and

determining the analyte concentration in the fluid sample using the detected light.

15. The method of claim 14, wherein the directing light entering the input light guide through the sample cavity includes directing light along the optical communication path from a light input, through the input light guide, to the input reflector, and then through the sample cavity.

16. The method of claim 15, further comprising directing light which has passed through the sample cavity along the optical communication path from the sample cavity, to the output reflector, through the output light guide, and to a light output.