Fiber optic device for sensing analytes

• US 20050113657A1
• Filed: 11/26/2003
• Published: 05/26/2005
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: DeNuzzio, John D., Alarcon, Javier, Sherman, Douglas B., Pitner, J. Bruce, Weidemaier, Kristin, Amiss, Terry J., Herdman, Christopher C., Jacobson, Ross Wayne
• Granted Patent: US 7,496,392 B2
• Time in Patent Office: Days
• US Class Current: 600/342
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 33/542 with steric inhibition or signal modification, e.g. fluorescent quenching
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

A device for sensing analyte concentration, and in particular glucose concentration, in vivo or in vitro is disclosed. An optical conduit, preferably an optical fiber has an optical system at the proximal end of the optical conduit. A sensing element is attached to the distal end of the optical conduit, and comprises at least one binding protein adapted to bind with at least one target analyte. The sensing element further comprises at least one reporter group that undergoes a luminescence change with changing analyte concentrations. Optionally, the sensing element includes reference groups with luminescence properties that are substantially unchanged by variations in the analyte concentrations.

Claims

1. A device for sensing a target analyte in a sample comprising:

an optical conduit having a proximal end and a distal end;

an optical system at the proximal end of the optical conduit comprising at least one electromagnetic energy emitter and at least one electromagnetic energy detector; and

a sensing element in optical proximity to the distal end of the optical conduit comprising at least one binding protein adapted to bind with at least one target analyte and at least one reporter group associated with the binding protein, wherein the reporter group is adapted to undergo a luminescence change upon binding of the binding protein to the target analyte, and

optionally, at least one reference group.

2. The device of claim 1, further comprising a tip.

3. The device of claim 2, wherein the sensing element is contained within the tip.

4. The device of claim 3, wherein the sensing element is attached to the inner surface of the tip and the tip is directly attached to the distal end of the optical conduit.

5. The device of claim 1, wherein the sensing element is directly attached to the distal end of the optical conduit.

6. The device of claim 1, further comprising one or more connectors.

7. The device of claim 6, wherein the sensing element is attached to the distal end of the optical conduit through a connector.

8. The device of claim 1, wherein the sensing element is entrapped in or attached to a polymer matrix.

9. The device of claim 8, wherein the polymer matrix is directly attached to the distal end of the optical conduit.

10. The device of claim 8, wherein the polymer matrix is attached to the inner surface of a tip wherein the tip is directly attached to the distal end of the optical conduit.

11. The device of claim 8, wherein the polymer matrix is attached to the inner surface of a tip wherein the tip is directly attached to a connector that is directly attached to the distal end of the optical conduit.

12. The device of claim 1, wherein the sensing element is attached to a polymer chain.

13. The device of claim 12, wherein said polymer chain is attached to the distal end of the optical conduit.

14. The device of claim 12, wherein the polymer chain is attached to the inner surface of a tip wherein the tip is directly attached to the distal end of the optical conduit.

15. The device of claim 12, wherein the polymer chain is attached to the inner surface of a tip wherein the tip is directly attached to a connector that is directly attached to the distal end of the optical conduit.

16. The device of claim 6, wherein the optical system is attached to the proximal end of the optical conduit through the connector.

17. The device of claim 6, wherein the sensing element is attached to the distal end of the optical conduit through a connector and the optical system is attached to the proximal end of the optical conduit through a connector.

18. The device of claims 16 and 17, further comprising a tip wherein the tip is attached to the distal end of the optical conduit through a connector.

19. The device of claim 1, wherein the optical conduit comprises at least one optical fiber.

20. The device of claim 1, wherein the electromagnetic energy emitter is selected from the group consisting of an arc lamp, light emitting diode, and laser diode.

21. The device of claim 1, wherein the electromagnetic energy detector is a photodiode, photomultiplier tube, or charge coupled device.

22. The device of claim 1, wherein said optical system further comprises optical elements adapted to distinguish multiple wavelengths.

23. The device of claim 22, wherein said optical elements further comprise optical filters, dichroic components, holographic components, or combinations thereof.

24. The device of claim 21, wherein said electromagnetic energy detector is adapted to detect energy emitted by said reporter group substantially continuously.

25. The device of claim 21 wherein said electromagnetic energy detector is adapted to detect energy emitted by said reporter group periodically.

26. The device of claim 1, wherein said optical system further comprises electrical or optoelectronic elements for modulation of the signal from the electromagnetic energy emitter.

27. The device of claim 1, wherein said optical system further comprises electrical or optoelectronic elements for modulation of the luminescence signal received by the electromagnetic energy detector.

28. The device of claim 1, wherein the optical system is adapted to measure the intensity of the luminescence signal.

29. The device of claim 1, wherein the optical system is adapted to measure the wavelength of the luminescence signal.

30. The device of claim 1, wherein the optical system is adapted to measure the lifetime of the luminescence signal.

31. The device of claim 1, wherein the optical system is adapted to measure the polarization of the luminescence signal.

32. The device of claim 1, wherein the optical system is adapted to measure the energy transfer efficiency of the reporter group.

33. The device of claim 2, wherein said tip further comprises a metal frame.

34. The device of claim 1, wherein at least one reference group is associated with a protein.

35. The device of claim 1, wherein said sensing element is further adapted to be inserted into or through the skin of a patient.

36. The device of claim 1, wherein at least one reporter group and at least one reference group are excited at the same wavelengths.

37. The device of claim 1, wherein at least one reporter group and at least one reference group are excited at different wavelengths.

38. The device of claim 1, wherein the luminescence of at least one reporter group and at least one reference group is detected at different wavelengths.

39. The device of claim 1, wherein the luminescence of at least one reporter group and at least one reference group is detected at the same wavelengths.

40. The device of claim 1, wherein the reporter group comprises a pair of organic dyes chosen so that the energy transfer efficiency between the pair changes upon analyte binding.

41. The device of claim 1, wherein the reporter group comprises a pair of fusion proteins chosen so that the energy transfer efficiency between the pair changes upon analyte binding.

42. The device of claim 1, wherein the reporter group comprises an organic dye and a fusion protein chosen so that the energy transfer efficiency between the organic dye and the fusion protein changes upon analyte binding.