Fiber optic device for sensing analytes and method of making same

• US 20050113658A1
• Filed: 10/19/2004
• Published: 05/26/2005
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Herdman, Christopher, Alarcon, Javier, Weidemaier, Kristin, Keith, Steven, Jacobson, Ross W.
• Granted Patent: US 7,787,923 B2
• Time in Patent Office: Days
• US Class Current: 600/342
• 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 a target analyte in a sample comprising:

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

a sensing element in optical proximity to the distal end of the tip body 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.

2. The device of claim 1, further comprising an optical fiber having a proximal end and a distal end.

3. The device of claim 2, wherein the optical fiber is housed at least partially within at least one tip body and the sensing element is in optical proximity to the distal end of the optical fiber.

4. The device of claim 3, wherein the sensing element is contained within at least one tip body.

5. The device of claim 3, wherein at least one tip body comprises a needle.

6. The device of claim 5, wherein the sensing element is attached to the inner surface of the needle and the needle is attached to the optical fiber.

7. The device of claim 2, wherein the sensing element is directly attached to the distal end of the optical fiber.

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 fiber.

10. The device of claim 8, wherein the polymer matrix is attached to the inner surface of a needle wherein the needle is attached to the optical fiber.

11. The device of claim 2, wherein the sensing element is attached to a polymer chain.

12. The device of claim 11, wherein said polymer chain is attached to the distal end of the optical fiber.

13. The device of claim 11, wherein the polymer chain is attached to the inner surface of a needle wherein the needle is attached to an optical fiber.

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

15. The device of claim 1, further comprising at least one reference group associated with a protein.

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

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

18. The device of claim 1, wherein the tip body and sensing element are sterile.

19. 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.

20. The device of claim 19, wherein the one or more ports allow access of the analyte to the sensing element.

21. The device of claim 19, wherein the one or more ports allow delivery of a therapeutic agent therethrough.

22. The device of claim 1, wherein at least a portion of at least one tip body extends through the skin of a patient.

23. A fiber optic biosensor tip device for sensing a target analyte in a sample comprising:

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

a sensing element in optical proximity to the distal end of the optical fiber comprising at least one luminescent labeled periplasmic binding protein adapted to undergo a luminescence change upon binding of the binding protein to the target analyte,

wherein the sensing element is entrapped in or attached to a polymer matrix, and

wherein the matrix is attached to the optical fiber.

24. The device of claim 23, wherein the matrix extends from the distal end of the optical fiber a distance between about 5 microns to about 1000 microns.

25. The device of claim 23, wherein the matrix includes a proximal surface attached to the optical fiber and a distal surface spaced from the proximal surface, wherein the distal surface comprises a reflective or scattering surface.

26. The device of claim 23, wherein the matrix includes light scattering particles.

27. The device of claim 23, further comprising a cannulated needle and wherein the optical fiber and sensing element are housed within the cannulated needle.

28. The device of claim 26, wherein the needle extends from a proximal end to a distal end and the sensing element is positioned adjacent the distal end of the needle.

29. The device of claim 27, wherein the distal end includes a beveled tip.

30. The device of claim 23, wherein the fiber optical tip device further comprises at least one tip body having one or more ports.

31. The device of claim 30, wherein the one or more ports allow access of the analyte to the sensing element.

32. The device of claim 30, wherein the one or more ports allow delivery of a therapeutic agent therethrough.

33. The device of claim 23, further comprising a temperature sensing element for sensing the temperature of the sample.

34. The device of claim 27, wherein the distal end of the needle includes a bent tip portion extending distally beyond and adjacent the sensing element.

35. The device of claim 34, wherein the bent tip portion includes a light reflecting surface facing the optical fiber.

36. A needle assembly insertable into the body of a patient for sensing a target analyte in a sample comprising:

a cannulated needle having a proximal end and a distal end;

an optical fiber at least partially contained within the needle cannula and having a proximal end and a distal end; and

a sensing element in optical proximity to the distal end of the optical fiber comprising at least one luminescent labeled periplasmic binding protein adapted to undergo a luminescence change upon binding of the binding protein to the target analyte.

37. The needle assembly of claim 36, wherein the sensing element is entrapped in or attached to a polymer matrix, and wherein the matrix is attached to the optical fiber.

38. The needle assembly of claim 36, wherein the distal end of the needle includes a beveled tip.

39. The needle assembly of claim 36, wherein the sensing element is positioned adjacent to the distal end of the needle.

40. The needle assembly of claim 36, wherein the needle further comprises one or more ports positioned between the proximal end and the distal end.

41. The needle assembly of claim 40, wherein the one or more ports allow access of the analyte to the sensing element.

42. The needle assembly of claim 36, further comprising a temperature sensing element for sensing the temperature of the sample.

43. A method of making a biosensor tip for sensing a target analyte in a sample comprising:

providing a cannulated needle having a proximal end and a distal end including a beveled tip;

inserting a distal end of an optical fiber into the needle cannula;

providing a sensing element adjacent the distal end of the needle and in optical proximity to the distal end of the optical fiber, wherein the sensing element comprises at least one luminescent labeled periplasmic binding protein adapted to undergo a luminescence change upon binding of the binding protein to the target analyte.

44. The method of claim 43, further comprising immobilizing the sensing element in a polymer matrix.

45. The method of claim 44, further comprising attaching the matrix to the distal end of the optical fiber.

46. The method of claim 44, further comprising attaching the matrix to the needle cannula adjacent the distal end of needle.

47. A biosensor tip device wearable on the body of a patient for sensing a target analytein a sample, comprising:

at least one tip body having a proximal end and a distal end, wherein the distal end of the tip body is insertable into the body of the patient and the proximal end of the tip body is configured and dimensioned to receive an optical fiber therein; and

a sensing element in optical proximity to the distal end of the tip body, wherein the sensing element is configured to transmit an optical signal in response to a target analyte.

48. The device of claim 47, wherein at least one tip body comprises a needle.

49. The device of claim 47, further comprising an optical fiber having a proximal end and a distal end, wherein the distal end of the optical fiber is housed within at least one tip body and the sensing element is in optical proximity to the distal end of the optical fiber.

50. The device of claim 47, wherein at least a portion of the proximal end of at least one tip body is configured to remain outside the body of the patient when the device is worn, and wherein at least a portion of the distal end of the tip body is configured to remain inside the body of the patient when the device is worn.

51. The device of claim 50, further comprising a depth limiting device attached to at least one tip body wherein the depth limiting device limits the depth that the distal end of the tip body may be inserted into the body of the patient.

52. The device of claim 50, wherein the proximal end of at least one tip body is attached to a patch and the patch is configured and dimensioned to be worn on the exterior skin of the patient.

53. The device of claim 50, wherein the proximal end of at least one tip body is attached to a watch and the watch is configured and dimensioned to be worn on the exterior wrist area of the patient.

54. The device of claim 47, wherein the sensing element comprises 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.

55. The device of claim 47, wherein the sensing element is configured to transmit an optical signal in response to sensing glucose.

56. The device of claim 47, further comprising a temperature sensing element for sensing the temperature of the sample.

57. The device of claim 47, wherein the tip body and sensing element are sterile.

58. The device of claim 47, wherein at least one tip body further comprises one or more ports positioned between the proximal end and the distal end.

59. The device of claim 58, wherein the one or more ports allow access of the analyte to the sensing element.

60. The device of claim 58, wherein the one or more ports allow delivery of a therapeutic agent therethrough.

61. A sub-assembly for a biosensor tip for sensing a target analyte in a sample comprising:

a tip body having a proximal end and a distal end; and

a polymer matrix attached to the tip body adjacent the distal end, wherein the polymer matrix is configured to receive a sensing element for sensing a target analyte in a sample.

62. The device of claim 61, wherein the tip body is a needle.

63. The device of claim 62, further comprising an optical fiber at least partially housed within the needle.

64. The device of claim 61, further comprising a temperature sensing element for sensing the temperature of the sample.

65. The device of claim 61, further comprising a sensing element attached to the polymer matrix, wherein the sensing element comprises at least one luminescent labeled periplasmic binding protein adapted to undergo a luminescence change upon binding of the binding protein to the target analyte.

66. The device of claim 65, wherein the sensing element is covalently attached to the matrix.

67. The device of claim 65, wherein the sensing element is immobilized in the polymer matrix.

68. The device of claim 61, wherein the tip body and polymer matrix are sterile.

69. The device of claim 61, wherein the tip body further comprises one or more ports positioned between the proximal end and the distal end.

70. The device of claim 69, wherein the one or more ports allow access of the analyte to the sensing element.

71. The device of claim 61, further comprising a temperature sensing element for sensing the temperature of the sample.