Infrared ATR glucose measurement system utilizing a single surface of skin

• US 6,430,424 B1
• Filed: 09/22/2000
• Issued: 08/06/2002
• 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:
  US09/667,987
• Time in Patent Office: 683 Days
• Field of Search: 600/309-310, 600/316, 600/322-324, 600/365, 356/39-42
• 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 blood glucose level measuring device for measuring said blood glucose level from a single skin surface comprising:

a.) an infrared source for emitting an IR beam into an ATR plate, said IR beam having components at least in the region of a referencing wavelength and a measuring wavelength, in which said wavelengths are indicative of said glucose level,

b.) said ATR plate having a first measurement surface for contact with said skin surface and for directing said IR beam against said skin surface and producing a reflected IR beam and a second surface for emitting said reflected IR beam, wherein said IR beam passes into said skin surface but does not pass substantially therewithin,

c.) IR sensors for sensing said reflected IR beam from said second surface and measuring absorbance of at least said referencing wavelength and said measuring wavelength, and

d.) a calculator for determining said blood glucose level only from said referencing wavelength and said measuring wavelength.

2. The blood glucose level measuring device of claim 1, wherein said skin surface is substantially unvascularized.

3. The blood glucose level measuring device of claim 1, wherein said single skin surface absorbs at least partially said IR beam.

4. The blood glucose level measuring device of claim 1, wherein said skin surface is held in contact with said first measurement surface at an adequate pressure to produce said reflected IR beam.

5. A blood glucose level measuring device for measuring said blood glucose level from a single skin surface comprising:

a.) an infrared source for emitting an IR beam onto a single skin surface and producing a reflected IR beam from said single skin surface, wherein said IR beam passes into said skin surface but does not pass substantially therewithin,

b.) IR sensors for sensing said reflected IR beam from said single skin surface, and

c.) a calculator for determining said blood glucose level only from said reflected IR beam.

6. The blood glucose level measuring device of claim 5, wherein said skin surface is substantially unvascularized.

7. The blood glucose level measuring device of claim 5, wherein said single skin surface absorbs at least partially said IR beam.

8. The blood glucose level measuring device of claim 5, wherein said skin surface is held in contact with said first measurement surface at an adequate pressure to produce said reflected IR beam.

9. The blood glucose level measuring device of claim 5, wherein there are