Article and method for applying a coupling agent for a non-invasive optical probe

• US 20050226912A1
• Filed: 04/13/2004
• Published: 10/13/2005
• Est. Priority Date: 04/13/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Lowery, Michael G.
• Granted Patent: US 8,219,168 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor

Abstract

This invention provides an article of manufacture and method for controlling the application of a coupling agent, such as a silicone oil or mineral oil, on a surface of a tissue prior to contacting the tissue with an apparatus for non-invasive optical measurement of the concentration of an analyte. Such an apparatus is shown in WO 99/59464. The article ensures that a specific quantity of the coupling agent is deposited in a uniform layer over the entire target area of the tissue, thereby enhancing both the optical signal and the repeatability of thermal and optical coupling with the components of the apparatus. The coupling agent can comprise any of the coupling agents described in U.S. Pat. No. 6,241,663 that have desirable coupling properties for this application. In one embodiment, the article comprises (a) a backing and (b) a layer of coupling agent on at least one major surface of the backing. In this embodiment, the material of the backing must not absorb an excessive amount of the coupling agent. In an alternative embodiment, the article can comprises (a) a backing, (b) a layer of fibrous or non-fibrous material overlying the backing, and (c) a layer of coupling agent on the major surface of the layer of fibrous or non-fibrous material not in contact with the backing. In the alternative embodiment, the layer of layer of fibrous or non-fibrous material prevents the coupling agent from being absorbed by the backing.

Claims

1. An article for applying of a coupling agent to the surface of a tissue, the article comprising a backing and a layer of coupling agent on at least one major surface of the backing.

2. The article of claim 1, wherein the coupling agent is selected from the group consisting of mineral oil, silicon oil, dimethyl siloxane, fluorocarbons, and glycols.

3. The article of claim 1, wherein the backing comprises a non-permeable material.

4. The article of claim 1, wherein the thickness of the layer of coupling agent on the backing is less than about 100 μ

m.

5. The article of claim 1, wherein the thickness of the coupling agent on the backing is from about 7 μ

m to about 20 μ

m.

6. The article of claim 1, wherein the area of the backing is from about 10 cm² about 40 cm².

7. The article of claim 1, wherein the backing has an area greater than the area of the layer of coupling agent.

8. The article of claim 1, further including a substrate layer interposed between the backing layer and the layer of coupling agent.

9. The article of claim 8, wherein the substrate layer comprises a fibrous material.

10. The article of claim 8, wherein the substrate layer comprises a non-fibrous material.

11. A method for improving the precision of a non-invasive optical measurement, said method comprising the steps of:

(a) providing the article of claim 1;

(b) applying a specified amount of a coupling agent to the surface of a tissue or a body part;

(c) bringing an optical measuring device in contact with said tissue or said body part, wherein said coupling agents enhances optical and thermal coupling between said device and said tissue or said body part; and

(d) performing a non-invasive determination of the concentration of an analyte in said tissue or said body part.

12. The method of claim 11, wherein said optical measurement is one of diffuse reflectance measurements, localized reflectance measurements, time domain measurements, frequency domain measurement, photoacoustic measurements or optical coherence tomography measurements.

13. The method in claim 1, wherein said analyte is selected from the group consisting of glucose, hemoglobin, glycated hemoglobin, triglycerides, and cholesterol.