Use of an equilibrium intravascular sensor to achieve tight glycemic control

• US 8,535,262 B2
• Filed: 12/09/2011
• Issued: 09/17/2013
• 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.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/316,397
• Publication Number:
  US 20120116191A1
• Time in Patent Office: 648 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 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 continuously monitoring blood glucose concentration in an ICU patient in need thereof, comprising:

deploying an equilibrium glucose sensor in the 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 an optical 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 ICU 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 the blood glucose regulator is administered by an ICU staff member.

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

7. 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.

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

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

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

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

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

13. The method of claim 1, wherein the equilibrium glucose sensor is deployed in a blood vessel.

14. The method of claim 1, wherein the equilibrium glucose sensor is deployed in tissue.

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

16. The method of claim 1, wherein an alarm signal is generated when the rate and direction of change in the blood glucose concentration varies outside a predetermined range.

17. The method of claim 1, wherein the fluorophore is chosen from the 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.

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

19. The method of claim 18, wherein the fluorescent dye is capable of being excited by light of a wavelength greater than about 400 nm.

20. The method of claim 18, wherein the fluorescent dye is stable against photo-oxidation, hydrolysis, and biodegradation.

21. The method of claim 18, wherein the fluorescent dye comprises a HPTS-triCysMA dye.

22. The method of claim 18, wherein the fluorescent dye comprises SNARF-1.

23. The method of claim 18, wherein the fluorescent dye comprises SNARL-1.

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

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

26. The method of claim 25, wherein the boronic acid functionalized viologen comprises 3,3′

-oBBV.

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

28. The method of claim 27, wherein the fluorophore and the glucose binding moiety are sufficiently greater in size than glucose so that the semi-permeable membrane allows passage of glucose but blocks passage of the fluorophore and the glucose binding moiety.

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

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

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

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

33. The method of claim 32, wherein the optical fiber is coupled to a light source.

34. The method of claim 33, wherein the optical fiber is coupled to an emission light detector.