OPTICAL SENSOR CONFIGURATION AND METHODS FOR MONITORING GLUCOSE ACTIVITY IN INTERSTITIAL FLUID

• US 20120053427A1
• Filed: 08/30/2011
• Published: 03/01/2012
• Est. Priority Date: 08/31/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: GluMetrics, Inc.
• Inventors: Markle, David R., Gamsey, Soya, Peyser, Thomas A., Markle, William
• Application Number:
  US13/221,696
• Publication Number:
  US 20120053427A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence

Abstract

Embodiments of the invention are directed to an optical sensor for detecting blood glucose by deploying the optical sensor into the interstitial fluid. The sensor comprises a chemical indicator system capable of generating an optical signal related to the blood glucose activity. The sensor further comprises a means for generating and detecting an optical reference signal unrelated to the blood glucose activity, such that ratiometric correction of blood glucose measurements for artifacts in the optical system is enabled.

Claims

1. A method for monitoring blood glucose in a subject, the method comprising:

providing a glucose sensor, comprising;

an optical fiber configured for subcutaneous deployment and capable of propagating light along a light path, and further comprising an equilibrium, non-consuming chemical indicator system disposed within the light path of the optical fiber, wherein the chemical indicator system comprises a fluorophore capable of generating a fluorescent emission signal in response to an excitation light signal, and a glucose binding moiety operably associated with the fluorophore and adapted to modify the intensity of the fluorescent emission signal in relation to the amount of glucose bound;

deploying the glucose sensor into subcutaneous tissue of the subject;

interrogating the chemical indicator system with an excitation light signal; and

detecting the intensity of the fluorescent emission light signal.

2. The method of claim 1, further comprising:

obtaining a blood sample from the subject;

measuring the glucose concentration of the blood sample independent of the chemical indicator system;

calculating a correction factor by comparing the emission light signal with the glucose concentration measured independently of the chemical indicator system; and

adjusting the blood glucose concentration measurement of the chemical indicator system with the correction factor.

3. The method of claim 1, wherein a distal end of the glucose sensor comprises an atraumatic tip portion formed from at least one material selected from the group consisting of plastics, polymers, gels, metals and composites.

4. The method of claim 3, wherein the atraumatic tip portion is configured to reduce trauma within the subcutaneous tissues and has a shape selected from the group consisting of hemispherical, parabolic, and elliptical.

5. The method of claim 1, wherein the chemical indicator system is further immobilized by a hydrogel within a gap in the optical fiber.

6. The method of claim 1, wherein the glucose binding moiety further comprises:

a viologen quencher capable of quenching the emission intensity of the fluorophore; and

a benzyl boronic acid group capable of binding glucose, wherein the benzyl boronic acid group is coupled to the viologen quencher, such that the degree of emission quenching is related to the degree of glucose binding.

7. The method of claim 1, wherein the glucose sensor further comprises a reference material, and the method further comprises;

reflecting a portion of the excitation light signal off of the reference material to generate a reflected portion of the excitation light signal; and

detecting the reflected portion of the excitation light signal.

8. The method of claim 1, wherein the glucose sensor further comprises a reference material, comprising a second fluorophore, and the method further comprises;

interrogating the reference material with the excitation light signal such that the reference material generates a second emission light signal, wherein the intensity of the second emission light signal is not related to the amount of glucose bound; and

detecting the second emission light signal.

9. The method of claim 8, wherein the reference material is encased in a glucose impermeable membrane.

10. The method of claim 1, wherein the glucose sensor further comprises a coating comprising heparin and benzalkonium is coated on a porous membrane covering the chemical indicator system.

11. The method of claim 1, further comprising:

contacting a temperature sensing element with the subcutaneous tissue of the subject, wherein the temperature sensing element is configured to generate a signal indicative of a temperature of the subcutaneous tissue of the subject;

detecting the signal indicative of a temperature of the subcutaneous tissue of the subject; and

determining a glucose concentration of the subcutaneous tissue of the subject using the detected intensity of the fluorescent emission light signal using a modified Michaelis-Menten equation comprising Michaelis-Menten parameters, wherein the Michaelis-Menten parameters are set based on data comprising,

temperature calibration data, and

the detected signal indicative of temperature.

12. The method of claim 1, further comprising:

contacting a pH sensing element with the subcutaneous tissue of the subject, wherein the pH sensing element is configured to generate a signal indicative of a pH of the subcutaneous tissue of the subject;

detecting the signal indicative of the pH of the subcutaneous tissue of the subject; and

wherein the Michaelis-Menten parameters are set based on data further comprising,

pH calibration data, and

the detected signal indicative of pH.