Self-contained method for determining blood glucose levels from an IR beam reflected from the surface of the skin

• US 6,424,849 B1
• Filed: 09/22/2000
• Issued: 07/23/2002
• Est. Priority Date: 10/13/1998
• Status: Expired due to Fees

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Medoptix Incorporated
• Inventors: Roe, Jeffrey N., Berman, Herbert L.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/668,848
• Time in Patent Office: 669 Days
• Field of Search: 600/309-310, 600/322-324, 600/316, 600/365, 600/473
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/245 Means for cleaning the sensor in-situ or during use, e.g. hygienic wipes
• 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 21/552 Attenuated total reflection

Abstract

This involves a non-invasive glucose measurement device and a process for determining blood glucose level in the human body using the device. In typical operation, the glucose measurement device is self-normalizing in that it does not employ an independent reference sample in its operation. The device uses attenuated total reflection (ATR) infrared spectroscopy. Preferably, the device is used on a fingertip and compares two specific regions of a measured infrared spectrum to determine the blood glucose level of the user. Clearly, this device is especially suitable for monitoring glucose levels in the human body, and is especially beneficial to users having diabetes mellitus. The device and procedure may be used for other analyte materials which exhibit unique mid-IR signatures of the type described herein and that are found in appropriate regions of the outer skin.

Claims

1. A method for determining the blood glucose level of a human being having skin with a skin surface, comprising the acts of:

a.) irradiating said skin surface with light containing at least an IR component so to produce a reflected IR beam from said skin surface indicative of said blood glucose level,

b.) detecting said reflected IR beam, and

c.) calculating said blood glucose level based solely on said reflected IR beam.

2. The method of claim 1, including repeating acts a.), b.), and c.) until a consistent glucose level reading is obtained.

3. The method of claim 1, wherein said IR component contains mid-IR wavelengths.

4. The method of claim 1, further comprising an act of maintaining said skin surface against an ATR plate at an adequate pressure during the act of irradiating said skin surface with light containing at least an IR component so to produce a reflected IR beam from said skin surface indicative of said blood glucose level.

5. The method of claim 1, wherein said IR component further comprises a referencing wavelength and a measuring wavelength.

6. The method of claim 5, wherein said referencing wavelength is between about 8.25 μ

m and about 8.1 μ

m.

7. The method of claim 5, wherein said measuring wavelength is between about 9.50 μ

m and about 10.00 μ

m.

8. The method of claim 5, wherein said act of calculating said blood glucose level comprises an act of comparing an absorbance of said reflected IR beam at said referencing wavelength and said measuring wavelength.

9. The method of claim 8, wherein said act of comparing is done with a digital computer.

10. The method of claim 9, further comprising an act of providing a digital signal indicative of blood glucose concentration.

11. The method of claim 1, wherein said act of detecting further comprises an act of absorbing said reflected IR beam with at least two IR sensors.

12. The method of claim 1, wherein said act of calculating said blood glucose level further comprises calculating using stored calibration constants.