USE OF AN EQUILIBRIUM INTRAVASCULAR SENSOR TO ACHIEVE TIGHT GLYCEMIC CONTROL

• US 20090177143A1
• Filed: 11/20/2008
• Published: 07/09/2009
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: GluMetrics, Inc.
• Inventors: Markle, William H., Markle, David R.
• Granted Patent: US 8,088,097 B2
• Time in Patent Office: Days
• 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 achieving tight glycemic control in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within a blood vessel in the patient, coupling the sensor to a monitor that displays the blood glucose concentration, and administering a blood glucose regulator when the blood glucose concentration varies outside of the predetermined concentration range. The blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range, thereby achieving tight glycemic control.

Claims

1. A method for achieving tight glycemic control in a patient in need thereof, comprising:

deploying an equilibrium glucose sensor within a blood vessel in the patient;

coupling the sensor to a monitor that displays the blood glucose concentration; and

administering a blood glucose regulator when the blood glucose concentration varies outside of a predetermined concentration range, wherein the blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range, thereby achieving tight glycemic control.

2. The method of claim 1, wherein an alarm signal is generated when the blood glucose concentration varies outside of the predetermined concentration range.

3. The method of claim 1, wherein the monitor displays the rate and direction of change in the blood glucose concentration.

4. The method of claim 3, wherein the blood glucose concentration has a rising or falling trend and the blood glucose regulator is administered in an amount sufficient to reverse the rising or falling trend.

5. The method of claim 4, wherein an alarm signal is generated when the rate and direction of change in the blood glucose concentration varies outside a predetermined range.

6. The method of claim 1, wherein the predetermined concentration range is from about 60 to about 180 mg/dl glucose.

7. The method of claim 6, wherein the predetermined concentration range is from about 60 to about 130 mg/dl glucose.

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

9. The method of claim 1, wherein the blood glucose regulator is insulin or an analog or derivative thereof.

10. The method of claim 1, wherein blood glucose regulator is glucose.

11. The method of claim 1, wherein the equilibrium glucose sensor comprises a fluorophore and an analyte binding moiety.

12. The method of claim 11, wherein the fluorophore is chosen from a group consisting of a fluorescent organic dye, an organometallic compound, a metal chelate, a fluorescent conjugated polymer, quantum dots or nanoparticles, and combinations of the above.

13. The method of claim 11, 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 is stable against photo-oxidation, hydrolysis, and biodegradation.

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

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

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

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

20. The method of claim 11, wherein the analyte binding moiety comprises a boronic acid functionalized viologen quencher.

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

-oBBV quencher.

22. The method of claim 11, wherein the fluorescent dye and the analyte binding moiety are physically immobilized within a semi-permeable membrane.

23. The method of claim 22, wherein the fluorescent dye and the analyte binding moiety are sufficiently greater in size than the glucose, wherein the semi-permeable membrane allows passage of glucose but blocks passage of the fluorescent dye and the analyte binding moiety.

24. The method of claim 11, wherein the fluorescent dye and the analyte binding moiety are physically immobilized within a hydrogel matrix.

25. The method of claim 11, wherein the fluorescent dye and the analyte binding moiety are covalently bonded to a hydrogel matrix.

26. The method of claim 11, wherein the fluorescent dye and the analyte binding moiety are covalently bonded to each other.

27. The method of claim 1, further comprising simultaneously measuring the concentration of glucose and a second analyte.

28. The method of claim 27, wherein the second analyte is a hydrogen ion.

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

30. The method of claim 29, wherein the optical fiber is coupled to a light source.

31. The method of claim 30, wherein the optical fiber is coupled to an emission light detector.

32. A method for achieving tight glycemic control in a patient in need thereof, comprising:

deploying an equilibrium glucose sensor within a blood vessel in the patient, wherein the equilibrium glucose sensor comprises a fluorescent dye operably coupled to a boronic acid functionalized quencher;

coupling the sensor to a monitor that displays the blood glucose concentration and the rate and direction of change in the blood glucose concentration; and

administering a blood glucose regulator when the blood glucose concentration varies outside of a predetermined concentration range, wherein the blood glucose regulator is administered in an amount sufficient to return the blood glucose concentration to within the predetermined concentration range or reverse a rising or falling trend in the blood glucose concentration, thereby achieving tight glycemic control.

33. The method of claim 32, wherein the quencher is a viologen.