NEAR-INFRARED SPECTROSCOPY AND OPTICAL REPORTER

• US 20150217002A1
• Filed: 08/09/2013
• Published: 08/06/2015
• Est. Priority Date: 08/10/2012
• Status: Abandoned Application

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Sitharaman, Balaji, Mujica-Parodi, Lilianne R., Dedora, Daniel, Chowdhury, Sayan Mullick
• Application Number:
  US14/420,124
• Publication Number:
  US 20150217002A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 2576/00 Medical imaging apparatus involving image processing or analysis A61B1/00009, A61B6/52 and A61B8/52 take precedence; image processing per se G06T; details of algorithms for analysing medical images G06T7/0012
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• 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 5/6833 Adhesive patches
• CPC Class Codes: A61K 49/0063 characterised by a special physical or galenical form, e.g. emulsions, microspheres
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53

Abstract

The method of the present disclosure is directed towards a method for determining the concentration of an analyte in a mammal'"'"'s bloodstream. This method includes the following steps; applying a patch to the mammal'"'"'s skin, the patch configured to transmit a reporter through the mammal'"'"'s skin, wherein the reporter is configured to have an affinity for the analyte and is capable of exhibiting a detectable change in fluorescence upon binding to the analyte, subjecting a portion of the mammal'"'"'s skin to Near Infrared Spectroscopy (NIRS), detecting fluorescence emission intensity and calculating the concentration of the analyte based on the detected fluorescence emission. The system of the present disclosure is directed towards an analyte monitoring system. The system includes the following, a patch and a receiver

Claims

1. A method for determining the concentration of an analyte in a mammal'"'"'s bloodstream, the method comprising:

applying a patch to the mammal'"'"'s skin, the patch configured to transmit a reporter through the mammal'"'"'s skin, wherein the reporter is configured to have an affinity for the analyte and is capable of exhibiting a shift in fluorescence upon binding to the analyte;

subjecting a portion of the mammal'"'"'s skin to Near Infrared Spectroscopy (NIRS);

detecting fluorescence emission spectrum; and

calculating the concentration of blood analyte based on measured fluorescence.

2. The method of claim 1, wherein the reporter comprises a boronic acid derivative and a non-specific fluorophore bound to a cyclic chain-sugar molecule.

3. The method of claim 2, wherein the reporter comprises a boronic acid derivative co-ordinated with at least one of an indocyanine green-labeled cyclodextrin complex, an ICG β

-cyclodextrin complex, an ICG hydroxypropyl-β

-cyclodextrin complex and an ICG methyl-β

-cyclodextrin complex.

4. The method of claim 2, wherein the analyte binds with the boronic acid derivative, displacing the non-specific fluorophore bound to the sugar molecule.

5. The method of claim 1, further comprising a step of monitoring the concentration of the analyte over a period of time.

6. The method of claim 1, wherein the analyte comprises glucose, insulin, hormones, drugs and combinations thereof.

7. The method of claim 6, wherein the analyte is glucose.

8. The method of claim 1, wherein the patch delivers the reporter for up to 7 days.

9. The method of claim 1, wherein a unit delivers a substance in response to concentration of the analyte.

10. The method of claim 9, wherein the unit is an insulin pump.

11. The method of claim 1, wherein the step of detecting fluorescence emission spectrum allows calculation of glucose concentration, [glucose], by solving the equilibrium equation:

k=[reporter][glucose]/[reporter+glucose]

wherein k is an empirically derived binding constant between the reporter complex and glucose in blood, and [reporter] and [reporter+glucose] is a ratio acquired from measuring fluorescence at two wavelengths, representing the unbound and bound states of said reporter.

12. The method of claim 1, wherein the shift in fluorescence is a shift in fluorescence wavelength

13. The method of claim 1, wherein the shift in fluorescence is a modulation in fluorescence intensity.

14. An analyte monitoring system, the system comprising:

a patch containing a reporter that is configured to be transmitted through a mammal'"'"'s skin,

a NIRS emitter and a NIRS detector operably connected to a processor, a power supply and a transmitter; and

a receiver capable of receiving information from the transmitter.

15. The analyte monitoring system of claim 14, wherein the NIRS emitter, the NIRS detector, the processor and the transmitter are integrated in the patch.

16. The analyte monitoring system of claim 14, wherein the analyte concentration is transmitted once every time period, wherein the time period is from about 1 second to about 24 hours.

17. The analyte monitoring system of claim 14, wherein the reporter comprises a boronic acid derivative and a non-specific fluorophore bound to a cyclic ring-sugar molecule.

18. The analyte monitoring system of claim 14, wherein the reporter comprises a boronic acid derivative co-ordinated with at least one of an indocyanine green-labeled cyclodextrin complex, an ICG β

-cyclodextrin complex, an ICG hydroxypropyl-β

-cyclodextrin complex and an ICG methyl-β

-cyclodextrin complex.

19. The analyte monitoring system of claim 14, wherein the analyte comprises glucose, insulin, hormones, drugs and combinations thereof.

20. The analyte monitoring system of claim 19, wherein the analyte is glucose.