Use of an equilibrium sensor to monitor glucose concentration

• US 8,979,790 B2
• Filed: 09/11/2013
• Issued: 03/17/2015
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Markle, William H., Markle, David R.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/024,384
• Publication Number:
  US 20140018646A1
• Time in Patent Office: 552 Days
• Field of Search: 604 65- 67, 604131-133, 514/765, 424/9.6, 424/1.11, 424/1.65, 424/9.1
• US Class Current: 604/66
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A method for monitoring blood glucose concentration in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within interstitial fluid in the patient in need and coupling the equilibrium glucose sensor to a monitor configured to detect a signal and configured to display the blood glucose concentration.

Claims

1. A method for continuously monitoring blood glucose concentration, comprising:

deploying an equilibrium glucose sensor in interstitial fluid in a patient, wherein the equilibrium glucose sensor comprises an indicator system comprising a fluorophore and a glucose binding moiety, wherein the indicator system is configured to generate a signal related to the blood glucose concentration; and

coupling the sensor to a monitor configured to detect the optical signal, and determine and display the patient'"'"'s blood glucose concentration, and a rate and direction of change in the blood glucose concentration.

2. The method of claim 1, further comprising administering a blood glucose regulator when the displayed blood glucose concentration varies outside of a predetermined concentration range.

3. The method of claim 2, wherein the blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range.

4. The method of claim 2, wherein the blood glucose regulator is administered by operator action.

5. The method of claim 2, wherein an alarm signal is generated when the blood glucose concentration varies outside of the predetermined concentration range.

6. The method of claim 2, wherein the blood glucose regulator is administered in an amount sufficient to reverse a rising or falling trend in the blood glucose concentration.

7. The method of claim 2, wherein the predetermined concentration range is from about 60 to about 180 mg/dl glucose.

8. The method of claim 7, wherein the predetermined concentration range is from about 60 to about 130 mg/dl glucose.

9. The method of claim 7, wherein the predetermined concentration range is from about 80 to about 110 mg/dl.

10. The method of claim 2, wherein the blood glucose regulator is insulin or an analog or derivative thereof.

11. The method of claim 2, wherein the blood glucose regulator is glucose.

12. The method of claim 1, wherein glucose binding to the glucose binding moiety causes a change in fluorescence lifetime or intensity of the fluorophore, wherein said change is related to the blood glucose concentration.

13. The method of claim 1, wherein the fluorophore is a fluorescent dye.

14. The method of claim 13, wherein the fluorescent dye is capable of being excited by light of a wavelength greater than about 400 nm.

15. The method of claim 13, wherein the fluorescent dye comprises a HPTS-triCysMA dye.

16. The method of claim 13, wherein the fluorescent dye comprises SNARF-1.

17. The method of claim 13, wherein the fluorescent dye comprises SNAFL-1.

18. The method of claim 13, wherein the fluorescent dye comprises TSPP.

19. The method of claim 1, wherein the glucose binding moiety comprises a boronic acid functionalized viologen.

20. The method of claim 19, wherein the boronic acid functionalized viologen comprises 3,3′

-oBBV.

21. The method of claim 1, wherein the fluorophore and the glucose binding moiety are physically immobilized within a semi-permeable membrane.

22. The method of claim 1, wherein the fluorophore and the glucose binding moiety are physically immobilized within a hydrogel matrix.

23. The method of claim 1, wherein the fluorophore and the glucose binding moiety are covalently bonded to a hydrogel matrix.

24. The method of claim 1, wherein the fluorophore and the glucose binding moiety are covalently bonded to each other.

25. The method of claim 1, wherein the equilibrium glucose sensor comprises an optical fiber.

26. The method of claim 25, wherein the optical fiber is coupled to a light source.

27. The method of claim 25, wherein the optical fiber is coupled to an emission light detector.