Fiber optic device for sensing analytes and method of making same

• US 7,787,923 B2
• Filed: 10/19/2004
• Issued: 08/31/2010
• Est. Priority Date: 11/26/2003
• Status: Expired due to Fees

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Amis, Terry J., DeNuzzio, John D., Alarcon, Javier, Sherman, Douglas B., Pitner, J. Bruce, Weidemaier, Kristin, Keith, Steven, Jacobson, Ross W., Herdman, Christopher C.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Berhanu; Etsub D
• Application Number:
  US10/967,220
• Publication Number:
  US 20050113658A1
• Time in Patent Office: 2,142 Days
• Field of Search: 600/317, 600/322, 600/341, 600/342
• US Class Current: 600/316
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• 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 2201/1211 for temperature
• 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. A sensing element is attached to the distal end of an 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 optical conduit and sensing element may be housed within a cannulated bevel.

Claims

1. A biosensor tip device for sensing glucose in a sample comprising:

at least one tip body having a proximal end and a distal end;

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

a sensing element in optical proximity to the distal end of the tip body, the sensing element comprising at least one glucose galactose binding protein (GGBP), said GGBP being adapted to bind with at least glucose, and at least one reporter group associated with the GGBP, wherein the reporter group is adapted to undergo a luminescence change upon binding of the binding protein to the glucose, and wherein the sensing element is entrapped in or attached to a polymer matrix, wherein the polymeric matrix comprises reactive groups and the polymeric matrix is attached to the distal end of the optical fiber through amine groups that are on the surface of the optical fiber.

2. The device of claim 1, further comprising an optical coupling member configured and dimensioned to receive an attachable optical component thereto.

3. The device of claim 1, further comprising at least one reference group associated with the GGBP.

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

5. The device of claim 1, further comprising a temperature sensing element for sensing the temperature of the sample.

6. The device of claim 1, wherein at least one tip body further comprises one or more ports positioned between the proximal end and the distal end.

7. The device of claim 6, wherein the one or more ports is configured for delivery of a therapeutic agent therethrough.

8. The device of claim 1, wherein the tip body is a needle.

9. The needle assembly of claim 8, wherein the needle further comprises one or more ports positioned between the proximal end and the distal end.

10. The device of claim 8, wherein the needle comprises a bent tip portion that extends distally beyond and adjacent to the sensing element.

11. The device of claim 8, wherein the device comprises a plurality of tip bodies.

12. The device of claim 8, wherein the device comprises two tip bodies.

13. The device of claim 12, wherein the first of the two tip bodies comprises the sensing element, and the second of the two tip bodies comprises a delivery means for delivering the therapeutic agent to the patient.

14. The device of claim 13, wherein the sensing element is further attached to the inner surface of the first tip body via the polymeric matrix.

15. The device of claim 14, further comprising a mount.

16. The device of claim 8, wherein the sensing element is attached to the inner surface of the needle.

17. The device of claim 16, wherein the sensing element comprises a polymeric matrix and the sensing element is attached to the inner surface of the needle via the polymeric matrix.

18. The device of claim 17, wherein the polymeric matrix is further attached to the distal end of said optical fiber through reactive groups on said polymer.

19. The device of claim 18, wherein the reactive groups on the polymer bind to amine groups that are on the surface of the optical fiber.

20. The device of claim 19, wherein the needle comprises a bent tip portion that extends distally beyond and adjacent to the sensing element.

21. The device of claim 19, wherein the device comprises a plurality of tip bodies.

22. The device of claim 21, wherein the device comprises two tip bodies.

23. The device of claim 22, wherein the first of the two tip bodies comprises the sensing element, and the second of the two tip bodies comprises a delivery means for delivering the therapeutic agent to the patient.

24. The device of claim 23, further comprising a mount.

25. A method of detecting levels of glucose in a sample comprising

a. acquiring access to said sample;

b. inserting the device of claim 1 into said sample;

c. allowing said sensing element to interact with said sample; and

d. determining the extent of luminescence change of said reporter group,

wherein the extent of luminescence change is indicative of the levels of said glucose in said sample.

26. The method of claim 25 wherein the sample is selected from the group consisting of blood, plasma, serum and interstitial fluid.

27. The method of claim 26, wherein the sample is blood.

28. The method of claim 27, wherein said sample is in vitro.

29. The method of claim 27, wherein said sample is in vivo.

30. The method of claim 29, further comprising accessing said sample through the skin of said subject.

31. The method of claim 30, wherein said sample is accessed subcutaneously.

32. The method of claim 30, wherein said sample is accessed intradermally.

33. The method of claim 30, wherein said sample is accessed using a needle.

34. The method of claim 30, wherein said sensing element is placed directly into said sample, without removing said sample from said subject.

35. The method of claim 30, wherein a portion of said sample is removed from said subject prior to placing said sensing element into said sample.