Optical assembly and method for determining analyte concentration

• US 8,970,843 B2
• Filed: 07/01/2011
• Issued: 03/03/2015
• Est. Priority Date: 07/07/2010
• Status: Active Grant

• Current Assignee: Melys Diagnostics Ltd.
• Original Assignee: Melys Diagnostics Ltd.
• Inventors: Parker, Dawood, Enderby, John
• Primary Examiner(s): NGUYEN, SANG H
• Application Number:
  US13/808,635
• Publication Number:
  US 20130155410A1
• Time in Patent Office: 1,341 Days
• Field of Search: 356/246, 356/445, 356 36- 41, 436/164, 436/172, 436/805, 250/201.2, 250/225
• US Class Current: 356/445
• 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 21/35 using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/55 Specular reflectivity
• CPC Class Codes: G01N 21/552 Attenuated total reflection

Abstract

An optical assembly and method for the non-invasive determination of a concentration of an analyte in a tissue sample is disclosed. The assembly comprises an optical arrangement comprising a first optical interface for reflecting light incident thereon and a second optical interface for reflecting light incident thereon. The second interface comprises an interface between an optical element of the arrangement and the tissue sample under investigation. The light reflected from the first and second interfaces is arranged to combine to generate an interference pattern characteristic of a difference in phase between light reflected from the first interface with the light reflected from the second interface.

Claims

1. An optical assembly for the non-invasive determination of a concentration of an analyte in a tissue sample, the assembly comprising:

an optical arrangement comprising a first optical interface for reflecting light incident thereon and a second optical interface for reflecting light incident thereon, the light reflected from the first and second interfaces being arranged to combine to generate an interference pattern characteristic of a difference in phase between light reflected from the first interface with the light reflected from the second interface, wherein the second interface comprises an interface between an optical element of the arrangement and the tissue sample;

wherein the optical arrangement comprises a first optical element and a second optical element, the first and second elements being coupled together to form the first interface therebetween, the second element being arranged to contact a surface portion of the tissue to form the second interface, wherein the second element comprises a refractive index which is greater than a refractive index of the first element and the surface portion of the tissue.

2. An optical assembly according to claim 1, further comprising:

a light source for launching light upon the first and second interface.

3. An optical assembly according to claim 2, wherein:

the light source comprises a laser source.

4. An optical assembly according to claim 1, further comprising:

a monitor for monitoring the interference between the light from the first and second interface.

5. An optical assembly according to claim 1, further comprising:

a processor for processing the interference to determine the concentration of the analyte in the tissue sample.

6. An optical assembly according to claim 1, wherein:

the light is launched upon the first interface at an angle such that the light refracted into the second element becomes incident upon the second interface at an angle less than the critical angle for total internal reflection of the light within the second element.

7. An optical assembly according to claim 1, wherein:

the second element is thin compared with the first element.

8. An optical assembly according to claim 1, wherein:

the second element comprises a film disposed upon the first element.

9. An optical assembly according to claim 1, wherein:

the thickness of the second element is dependent on the wavelength of the incident light.

10. An optical assembly according to claim 1, wherein:

the first element comprises calcium fluoride and the second portion comprises parylene.

11. An optical assembly according to claim 1, wherein:

said optical arrangement further comprises a routing device which is arranged to route a first component of the light incident thereon toward the first element and a second component of the light incident thereon toward the second element, the first and second elements comprising a front and rear reflecting surface, wherein the front surface of each element comprises an anti-reflection coating for minimizing any reflection of light off the front surface of the respective element and the rear surface of the second element is arranged to contact the tissue sample.

12. An optical assembly according to claim 11, wherein:

the first interface comprises an interface of the rear surface of the first element with air, and the second interface comprises an interface between the rear surface of the second element with the tissue sample.

13. An optical assembly according to claim 11, wherein:

the interference pattern is characteristic of a difference in phase of the light incident on the second element with the light reflected off the second element.

14. An optical assembly according to claim 1, wherein:

the analyte comprises glucose.

15. An optical assembly according to claim 1, wherein:

the first and second elements are substantially transmissive for wavelengths in the infra-red region of the electromagnetic spectrum.

16. A method for the non-invasive determination of the concentration of an analyte in a tissue sample, the method comprising:

arranging the second element of the optical arrangement according to claim 1 in contact with the tissue sample;

launching light upon the first and second interfaces of the optical arrangement;

monitoring the interference between the light which becomes reflected off the first and second interfaces; and

,

configuring a processor to process the monitored light in order to determine the concentration of an analyte in the body fluid.

17. A method according to claim 16, wherein:

the optical arrangement utilizes attenuated total reflectance.

18. A glucose monitor for the non-invasive determination of the concentration of glucose in body fluid, the monitor comprising:

an optical assembly according to claim 1;

a light source for launching light upon the first and second interfaces; and

a monitor for monitoring the light which becomes reflected off the first and second interfaces.

19. An optical assembly according to claim 1, wherein:

light incident on the second surface penetrates into the tissue sample and reflects from the second interface while undergoing a phase change characteristic of the extinction coefficient of the tissue sample.

20. An optical assembly according to claim 19, wherein:

relative phase shift between the light reflected at the first interface and the light reflected as the second interface produces an interference pattern that is processed to in order to determine concentration of the analyte in the tissue sample.