Device for non-invasive determination of a glucose concentration in the blood of a subject

• US 6,016,435 A
• Filed: 11/25/1997
• Issued: 01/18/2000
• Est. Priority Date: 11/26/1996
• Status: Expired due to Term

• Current Assignee: Panasonic Healthcare Holdings Co., Ltd.
• Original Assignee: Matsushita Electric Industrial Company Limited (Panasonic Holdings Corporation)
• Inventors: Shimizu, Keisuke, Oka, Masami, Maruo, Katsuhiko
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/978,266
• Time in Patent Office: 784 Days
• Field of Search: 600/310, 600/316, 600/322, 600/326, 600/473, 600/476, 250/339.11, 250/339.12, 356/39
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• 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: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

A device for non-invasive determination of a glucose concentration in the blood of a subject which includes a light source for producing near-infrared radiation having successive wavelengths within a range of 1300 nm to 2500 nm, a light projecting unit for projecting the near-infrared radiation on a skin of the subject, a light receiving unit for receiving a resulting radiation emitted from the inside of the skin, and a spectrum analyzing unit for making a spectrum analysis of the resulting radiation, and determining the glucose concentration according to the spectrum analysis. The light receiving unit is separated from the light projecting unit by a distance defined within a range of 0.1 mm to 2 mm to selectively sense the resulting radiation emitted from a dermis layer positioned under an epidermis layer of the skin. The glucose concentration in the blood is determined at the spectrum analyzing unit by using the spectrum analysis and a statistically-obtained correlation between glucose concentration in dermis region and glucose concentration in blood of test subjects.

Claims

1. A device for performing non-invasive determination of a glucose concentration in the blood of a subject, said device comprising:

a light source for producing near-infrared radiation having successive wavelengths within a range of 1300 nm to 2500 nm;

light projecting means for projecting said near-infrared radiation on a skin of said subject;

light receiving means for receiving a resulting radiation emitted from the inside of said skin; and

spectrum analyzing means for making a spectrum analysis of the resulting radiation and determining said glucose concentration in the blood of said subject according to the spectrum analysis,

wherein

said light receiving means is separated from said light projecting means by a distance in a range of 0.1 mm to 2 mm to permit selective sensing of the resulting radiation emitted from a dermis layer positioned under an epidermis layer of said skin,

wherein said spectrum analyzing means determines said glucose concentration in the blood of said subject according to the spectrum analysis and a statistically-obtained correlation between glucose concentration in the dermis layer and glucose concentration in blood,

wherein said light projecting means is formed with a plurality of first optical fibers, each of which is connected at a first end to said light source, and provides said near-infrared radiation from an opposite projection end, and

wherein said light receiving means is formed with a plurality of second optical fibers each of which is connected at a first end to said spectrum analyzing means, and receives the resulting radiation at an opposite receiving end.

2. The device as set forth in claim 1, wherein said near-infrared radiation comprises at least one of successive wavelengths from 1400 nm to 1800 nm, and successive wavelengths from 2000 nm to 2500 nm.

3. The device as set forth in claim 1, wherein said first optical fibers make a bundle in cooperation with said second optical fibers, and the projection ends of said first optical fibers and the receiving ends of said second optical fibers are exposed on an end surface of said bundle in a pattern such that a center of each of said projection ends is separated from a center of an adjacent receiving end by said distance.

4. The device as set forth in claim 3, wherein said bundle is formed with a plurality of sub-bundles, in each of which a projection end of said first optical fiber is disposed on the end surface of said bundle at a center of a hexagonal pattern and six receiving ends of said second optical fibers are disposed at corners of said hexagonal pattern.

5. The device as set forth in claim 4, wherein at least one of said receiving ends of each of said sub-bundles is common with an adjacent sub-bundle.

6. The device as set forth in claim 4, further comprising supplemental light receiving means which is formed with a plurality of third optical fibers, wherein each of said third optical fibers is connected at a first end to said spectrum analyzing means, and selectively receives at an opposite receiving end the resulting radiation emitted from said epidermis layer, and wherein said receiving end of each of said third optical fibers is disposed on the end surface of said bundle between said projection end and one of said receiving ends in said hexagonal pattern.

7. The device as set forth in claim 3, wherein said bundle is formed with a plurality of sub-bundles, in each of which a projection end of said first optical fiber is disposed on the end surface of said bundle at a center of a rectangular pattern and four receiving ends of said second optical fibers are disposed at corners of said rectangular pattern.

8. The device as set forth in claim 3, wherein said bundle is formed with a plurality of sub-bundles, in each of which five projection ends of said first optical fibers are disposed on the end surface of said bundle at a center of a square pattern and at four corners of said square pattern, and four receiving ends of said second optical fibers are disposed on four sides of said square pattern between adjacent projection ends.

9. The device as set forth in claim 8, wherein one receiving end and two projection ends of each of said sub-bundles are common with an adjacent sub-bundle.

10. The device as set forth in claim 3, wherein said projection ends are disposed on the end surface of said bundle along a circular pattern and inside of said circular pattern, and said receiving ends are disposed along said circular pattern and outside of said circular pattern.

11. The device as set forth in claim 3, wherein said second optical fibers have at least two different diameters.

12. The device as set forth in claim 11, wherein said bundle is formed with a plurality of sub-bundles, in each of which a projection end of said first optical fiber and two receiving ends of said second optical fibers having different diameters are disposed on the end surface of said bundle in a circular pattern.

13. The device as set forth in claim 12, further comprising supplemental light receiving means which is formed with a plurality of third optical fibers, wherein each of said third optical fibers is connected at a first end to said spectrum analyzing means, and selectively receives at an opposite receiving end the resulting radiation emitted from said epidermis layer, and wherein said receiving end of each of said third optical fibers is disposed on the end surface of said bundle so as to be closer to said projection end than said receiving ends of said second optical fibers in said circular pattern.

14. The device as set forth in claim 3, further comprising a spacer for providing a predetermined interval between each of said projection ends and the adjacent receiving end.

15. The device as set forth in claim 3, wherein the center of each of said projection ends is at least separated from the center of the adjacent receiving end by a distance L expressed by the following equation:

##EQU5## wherein d1 is a diameter of said first optical fiber, and d2 is a diameter of said second optical fiber.

16. The device as set forth in claim 3, wherein said distance is in a range of 0.2 mm to 1 mm.

17. The device as set forth in claim 1, wherein each of said first and second optical fibers has a diameter between 70 μ

m and 1000 μ

m.

18. The device as set forth in claim 1, wherein the number of said first optical fibers is equal to one half of the number of said second optical fibers.

19. The device as set forth in claim 1, further comprising supplemental light receiving means which is formed with a plurality of third optical fibers, and wherein each of said third optical fibers is connected at a first end to said spectrum analyzing means, and selectively receives at an opposite receiving end the resulting radiation emitted from said epidermis layer.

20. The device as set forth in claim 1, wherein said distance is in a range of 0.2 mm to 1 mm.

21. A device for performing non-invasive determination of a glucose concentration in the blood of a subject, said device comprising:

a light source for producing near-infrared radiation having successive wavelengths within a range of 1300 nm to 2500 nm;

a light projecting member which projects said near-infrared radiation on a skin of said subject;

a light receiving member which receives a resulting radiation emitted from the inside of said skin; and

a spectrum analyzer which makes a spectrum analysis of the resulting radiation and determines said glucose concentration in the blood of said subject according to the spectrum analysis,

wherein said light receiving member is separated from said light projecting member by a distance in a range of 0.1 mm to 2 mm to permit selective sensing of the resulting radiation emitted from a dermis layer positioned under an epidermis layer of said skin, and said spectrum analyzer determines said glucose concentration in the blood of said subject according to the spectrum analysis and a statistically-obtained correlation between glucose concentration in the dermis layer and glucose concentration in blood

wherein said light projecting member is formed with a plurality of first optical fibers, each of which is connected at a first end to said light source, and provides said near-infrared radiation from an opposite projection end, and

wherein said light receiving member is formed with a plurality of second optical fibers each of which is connected at a first end to said spectrum analyzer and receives the resulting radiation at an opposite receiving end.

22. The device as set forth in claim 21, wherein said distance is in a range of 0.2 mm to 1 mm.