Method for improving non-invasive determination of the concentration of analytes in a biological sample

• US 6,654,620 B2
• Filed: 04/16/2001
• Issued: 11/25/2003
• Est. Priority Date: 05/18/1998
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Khalil, Omar S., Jeng, Tzyy-Wen, Hanna, Charles F., Wu, Xiaomao, Yeh, Shu-Jen
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/835,705
• Publication Number:
  US 20020055671A1
• Time in Patent Office: 953 Days
• Field of Search: 600/310, 600/322, 600/323, 600/326, 600/334, 600/344, 600/473, 356/39, 356/41, 250/341.1, 250/341.2, 250/341.5, 250/341.6, 250/339.03, 250/339.09
• US Class Current: 600/310
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: G01N 21/4795 spatially resolved investigating of object in scattering medium in vivo A61B

Abstract

A method for determining the concentration of an analyte in a biological sample comprising the steps of:

(1) providing an optical measuring instrument comprising a thermally controllable optical measuring element that comes into contact with the surface of the biological sample;

(2) applying a coupling agent to the optical measuring element or to the surface of the biological sample or to both so that the coupling agent will be disposed at the interface of the surface of the biological sample and the optical measuring element;

(3) measuring optical properties of the biological sample by means of the optical measuring instrument; and

(4) correlating the optical properties of the biological sample with the concentration of the analyte in the biological sample.

The coupling agent can be selected from the group consisting of silicone oil, mineral oil, polyethylene glycols, and oils from natural resources.

Claims

1. A method for determining the concentration of analyte in a biological sample comprising the steps of:

(a) providing an optical measuring instrument that comprises at least one thermally controllable optical measuring element that comes into contact with a surface of said biological sample;

(b) applying an inert, thermally conductive, optically transparent coupling agent to said at least one optical measuring element or to said surface of said biological sample or both so that said coupling agent will be disposed at the interface of said surface of said biological sample and said at least one optical measuring element, said coupling agent selected from the group consisting of silicone oil, mineral oil, polyethylene glycols, and oils from natural resources;

(c) measuring at least one optical property of said biological sample by means of said at least one optical measuring element; and

(d) correlating the at least one optical property of said biological sample with the concentration of said analyte in said biological sample.

2. The method of claim 1, wherein said coupling agent is mineral oil.

3. The method of claim 2 wherein said mineral oil is a mixture of liquid hydrocarbons.

4. The method of claim 1, wherein said coupling agents silicone oil.

5. The method of claim 2, wherein said silicone oil is any fluidic organosilicon oxide polymer having the repeating structural unit —

R₂Si—

O—

, where R represents a monovalent organic radical.

6. The method of claim 1, wherein said optical measurement is ed while tissue temperature is controlled between 10°

C. and 45°

C.

7. A method for measuring the concentration of an analyte in a tissue of a body part comprising the steps of:

(a) providing an optical measuring instrument that comprises at least one thermally controllable optical measuring element that comes into contact with the surface of said tissue;

(b) applying an inert, thermally conductive, optically transparent coupling agent to said at least one optical measuring element or to the surface of said tissue or both so that said coupling agent will be disposed at the interface of said surface of said tissue and said at least one optical measuring element, said coupling agent selected from the group consisting of silicone oil, mineral oil, polyethylene glycols, and oils from natural resources;

(c) inducing a change in the concentration of said analyte in said tissue over a defined period of time;

(d) measuring the change in at least one optical property of said tissue by means of said at least one optical measuring element during said defined period of time;

(e) determining the change in the concentration of said analyte in said tissue by means of a reference method that involves taking a sample from said tissue for analysis during said defined period of time;

(f) correlating the change in said at least one optical property of said tissue with the change in the concentration of the analyte in said tissue to derive calibration data; and

(g) using said calibration data to determine the concentration of said analyte in said tissue.

8. The method of claim 7, wherein said coupling agent is mineral oil.

9. The method of claim 8 wherein said mineral oil is a mixture of liquid hydrocarbons.

10. The method of claim 7, wherein said coupling agent is silicone oil.

11. The method of claim 10, wherein said silicone oil is any fluidic organosilicon oxide polymer having the repeating structural unit —

R₂Si—

O—

, where R represents a monovalent organic radical.

12. The method of claim 7, wherein said optical measurement is performed while tissue temperature is controlled between 10°

C. and 45°

C.