Optical-based sensing devices

• US 6,330,464 B1
• Filed: 08/26/1999
• Issued: 12/11/2001
• Est. Priority Date: 08/26/1998
• Status: Expired due to Term

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Sensors For Medicine and Science Incorporated
• Inventors: Lynn, Robert W., Dale, Gregory A., Colvin, Arthur E. Jr., Zerwekh, Paul Samuel, Lesho, Jeffery C.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/383,148
• Time in Patent Office: 838 Days
• Field of Search: 600/310, 600/316, 600/317, 600/322, 600/341, 600/342, 600/343, 600/473, 600/476, 128/903
• US Class Current: 600/316
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: G01N 2021/7773 Reflection
• CPC Class Codes: G01N 2021/7783 Transmission, loss
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/552 Attenuated total reflection
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/648 using evanescent coupling or surface plasmon coupling for the excitation of fluorescence
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• 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 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

An optical-based sensor for detecting the presence or amount of an analyte using both indicator and reference channels. The sensor has a sensor body with a source of radiation embedded therein. Radiation emitted by the source interacts with indicator membrane indicator molecules proximate the surface of the body. At least one optical characteristic of these indicator molecules varies with analyte concentration. For example, the level of fluorescence of fluorescent indicator molecules or the amount of light absorbed by light-absorbing indicator molecules can vary as a function of analyte concentration. In addition, radiation emitted by the source also interacts with reference membrane indicator molecules proximate the surface of the body. Radiation (e.g., light) emitted or reflected by these indicator molecules enters and is internally reflected in the sensor body. Photosensitive elements within the sensor body generate both indicator channel and reference channel signals to provide an accurate indication of the concentration of the analyte. Preferred embodiments are totally self-contained and are sized and shaped for use in vivo in a human being. Such embodiments preferably include a power source, e.g. an inductor, which powers the source of radiation using external means, as well as a transmitter, e.g. an inductor, to transmit to external pickup means the signal representing the level of analyte.

Claims

1. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an optically transmissive sensor body which function as an optic wave guide, said sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element; and

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element.

2. The sensor of claim 1, wherein the sensor is self-contained with a power source contained within said sensor body and a transmitter contained within said sensor body.

3. The sensor of claim 2, wherein at least one of said power source and said transmitter is powered by an external means.

4. The sensor of claim 2, wherein at least one of said power source and said transmitter includes an inductor.

5. The sensor of claim 4, wherein said transmitter includes an inductor which generates electromagnetic radiation that is detectable by a signal pickup device that is located exterior to said sensor body and said power source includes an inductor and said radiation source is caused to emit radiation by exposing the sensor to a field of electromagnetic radiation that is generated exterior to said sensor body.

6. The sensor of claim 1, wherein electrical circuitry within said sensor is fully contained within said sensor without any leads or wires extending through said outer peripheral surface of said sensor.

7. The sensor of claim 1, wherein said radiation source and said photosensitive element are mounted on a circuit substrate that is entirely contained within said sensor body.

8. The sensor of claim 1, wherein said indicator element includes indicator molecules distributed proximate to the surface of the sensor body.

9. The sensor of claim 8, wherein said indicator molecules are contained within an indicator membrane that is permeable to the analyte to be sensed.

10. The sensor of claim 9, wherein said indicator molecules have a fluorescence characteristic that is a function of the concentration of the analyte to which said indicator molecules are exposed, said indicator membrane permitting radiation from said radiation source to interact with said indicator molecules.

11. The sensor of claim 10, wherein said photosensitive element senses fluorescent light emitted by said indicator molecules and is configured to provide a response signal indicative of a characteristic of such detected fluorescent light and hence the presence or concentration of the analyte.

12. The sensor of claim 8, wherein said indicator molecules include fluorescent indicator molecules.

13. The sensor of claim 12, further including a filter which allows fluorescent light emitted by said indicator molecules and passing into said sensor body to strike said photosensitive element, said filter substantially preventing radiation emitted by said source from striking said photosensitive element.

14. The sensor of claim 8, wherein the optical characteristics of said indicator molecules vary as a function of the concentration of oxygen.

15. The sensor of claim 8, wherein said indicator molecules include light-absorbing indicator molecules.

16. The sensor of claim 15, wherein said photosensitive element is disposed so as to detect radiation emitted by said radiation source and not absorbed by said indicator molecules and is configured to provide a response signal indicative of the amount of such detected non-absorbed radiation and hence the presence or concentration of said analyte.

17. The sensor of claim 15, further including a filter which allows radiation emitted by said source and a wavelength absorbed by said light-absorbing indicator molecules to strike said photosensitive element and which substantially prevents radiation emitted by said source and not at a wavelength absorbed by said light-absorbing indicator molecules from striking said photosensitive element.

18. The sensor of claim 8, wherein the optical characteristics of said indicator molecules vary as a function of the concentration of glucose.

19. The sensor of claim 8, wherein said indicator molecules include indicator molecules having an isosbestic point substantially at a particular wavelength and wherein a reference channel detects light substantially at the isosbestic wavelength.

20. The sensor of claim 8, wherein said indicator molecules interact with the radiation emitted by said radiation source by means of evanescent excitation.

21. The sensor of claim 8, wherein said indicator molecules interact with the radiation emitted by said radiation source by means of surface plasmon resonance-type excitation.

22. The sensor of claim 8, wherein said indicator molecules interact with the radiation emitted by said radiation source by means of direct illumination.

23. The sensor of claim 8, wherein said sensor body includes an optically transmissive encapsulant material that encapsulates at least a region between said photosensitive element and said indicator molecules.

24. The sensor of claim 8, wherein said sensor body includes an optically transmissive encapsulant material that encapsulates at least a region between said radiation source and said indicator molecules and said indicator molecules and said photosensitive element.

25. The sensor of claim 8, wherein said sensor body includes a capsule shell.

26. The sensor of claim 8, wherein said indicator molecules are disposed within a matrix layer coated on the surface of said sensor body, said matrix layer being permeable to the analyte and said matrix layer permitting radiation emitted by the radiation source to enter therein.

27. The sensor of claim 8, wherein said indicator molecules include different first and second indicator molecules disposed on the surface of said sensor body.

28. The sensor of claim 27, wherein said first and second indicator molecules are each responsive to changes in the concentration of the same analyte in said medium.

29. The sensor of claim 28, wherein said first and second indicator molecules have the same optical characteristic that is affected by the presence or concentration of the analyte.

30. The sensor of claim 28, wherein said first and second indicator molecules have different optical characteristics that are affected by the presence or concentration of the analyte.

31. The sensor of claim 27, wherein said first indicator molecules are responsive to changes in the concentration of a first analyte in said medium and said second indicator molecules are responsive to changes in the concentration of a different second analyte in said medium.

32. The sensor of claim 31, wherein said first and second indicator molecules have the same optical characteristic that is affected by the presence or concentration of the analytes.

33. The sensor of claim 31, wherein said first and second indicator molecules have different optical characteristics that are affected by the presence or concentration of the analytes.

34. The sensor of claim 8, wherein said indicator molecules include first and second indicator molecules disposed on the surface of said sensor body, said first indicator molecules having an optical characteristic that is responsive to changes in the concentration of an analyte to which said first indicator molecules are exposed and said second indicator molecules having an optical characteristic that is responsive to changes in the concentration of an analyte to which said second indicator molecules are exposed;

said radiation source includes a source that emits radiation that interacts with said first indicator molecules in accordance with the analyte-responsive optical characteristic thereof and a source which emits radiation that interacts with said second indicator molecules in accordance with the analyte-responsive optical characteristic thereof; and

said photosensitive element includes first and second photosensitive elements embedded within said sensor body, said first photosensitive element providing a response signal indicative of the level of interaction of said first indicator molecules with radiation interacting therewith and hence indicative of the presence or concentration of the analyte to which said first indicator molecules are exposed, and said second photosensitive element providing a response signal indicative of the level of interaction of said second indicator molecules with radiation interacting therewith and hence indicative of the presence or concentration of the analyte to which said second indicator molecules are exposed.

35. The sensor of claim 8, wherein said sensor body includes a peripheral sleeve that contains said indicator molecules.

36. The sensor of claim 35, wherein said sleeve is removable such that said indicator and reference membranes can be removed and replaced.

37. The sensor of claim 35, wherein said sleeve is made with an elastomeric material.

38. The sensor of claim 1, wherein said sensor has an oblong, rounded shape whereby said sensor can be disposed within the body of a animal.

39. The sensor of claim 38, wherein said sensor has an overall length of approximately 500 microns to approximately 0.5 inch and a diameter of approximately 300 microns to approximately 0.3 inch.

40. The sensor of claim 1, further including a sensor/tissue interface layer around at least a portion of said sensor body.

41. The sensor of claim 40, wherein said tissue/sensor interface layer retards formation of fibrotic encapsulation or scar tissue.

42. The sensor of claim 40, wherein said tissue/sensor interface layer includes a sublayer which promotes tissue ingrowth therein.

43. The sensor of claim 42, wherein said tissue ingrowth comprises vascularization.

44. The sensor of claim 40, wherein said tissue/sensor interface layer includes a molecular sieve sublayer which performs a molecular weight cutoff function.

45. The sensor of claim 40, wherein said indicator element includes indicator molecules and said tissue/sensor interface layer is selectively permeable so as to permit said analyte to contact said indicator molecules while preventing cells or macromolecules from contacting said indicator molecules.

46. The sensor of claim 40, wherein said tissue/sensor interface layer is biocompatible.

47. The sensor of claim 1, further including a reflection enhancement layer disposed over a portion of the surface of said sensor body to enhance reflection within said sensor body of radiation emitted by said source and/or fluorescent light emitted by said indicator molecules and passing into said sensor body.

48. The sensor of claim 1, wherein said radiation source includes a light-emitting diode.

49. The sensor of claim 1, wherein said radiation source includes a radioluminescent light source.

50. The sensor of claim 1, wherein said indicator element includes a portion of said sensor body at the surface thereof having an index of refraction, such that the optical characteristic that is affected by the presence or concentration of the analyte involves the amount of radiation passing out of said sensor body varying as a function of the ratio of said index of refraction to an index of refraction of the medium containing the analyte and hence as a function of the concentration of said analyte in said medium, at least some of the radiation passing out of said sensor body being reflected internally within said sensor body before passing out of said sensor body.

51. The sensor of claim 1, further including a reference photosensitive element located in said sensor body and positioned to receive radiation that is substantially unaffected by the presence or concentration of the analyte for providing a reference channel reading.

52. The sensor of claim 51, wherein said indicator element includes indicator molecules disposed within a indicator membrane proximate the periphery of said sensor body, said indicator membrane containing indicator molecules that are affected by the presence or concentration of an analyte and positioned to receive radiation from said radiation source, and a reference membrane disposed proximate the periphery of said sensor body and positioned to receive radiation from said radiation source, said reference membrane being substantially unaffected by the presence or concentration of the analyte.

53. The sensor of claim 52, wherein said indicator membrane is permeable to the analyte to be sensed.

54. The sensor of claim 52, wherein said reference membrane is substantially not-permeable to said analyte.

55. The sensor of claim 52, wherein said reference membrane is perm-selectable.

56. The sensor of claim 52, wherein said reference membrane is permeable to said analyte, but includes control indicator molecules that are substantially non-responsive to said analyte.

57. The sensor of claim 52, wherein said reference membrane contains control indicator molecules.

58. The sensor of claim 52, wherein said radiation source includes an LED that is mounted such that a top side of the LED faces generally toward one of said indicator and reference membranes and a bottom side of the LED faces generally toward the other of said indicator and reference membranes, said LED emitting light through both said top side and said bottom side of said LED to sufficiently illuminate both of said indicator and reference membranes.

59. The sensor of claim 58, wherein said radiation source and said photosensitive element are mounted on a substantially transparent substrate.

60. The sensor of claim 51, having at least two LEDs as the radiation source.

61. The sensor of claim 51, wherein said radiation source is a single LED.

62. The sensor of claim 51, wherein said photosensitive element, said reference photosensitive element, and said radiation source are mounted upon a substantially optically transparent substrate.

63. The sensor of claim 62, wherein said photosensitive element detects radiation impinging upon its top and bottom sides, radiation impinging upon said bottom side passing through said substantially optically transparent substrate.

64. The sensor of claim 52, wherein at least one of said membranes is made with a sol-gel or an ormosil inorganic polymer support matrix.

65. The sensor of claim 52, wherein said sensor body includes a peripheral sleeve that contains at least one of said indicator membrane and said reference membrane.

66. The sensor of claim 1, wherein said radiation source includes an LED that is mounted such that light is transmitted from both its top and bottom sides.

67. The sensor of claim 66, further including an optical deflector having a generally triangular cross-section extending around a circumference of the sensor body and located to deflect light emitted from said LED.

68. The sensor of claim 66, wherein said LED is mounted on a circuit board having a hole or window through which radiation emitted from the bottom side of the LED passes.

69. The sensor of claim 1, wherein said photosensitive element and said radiation source are mounted upon a substantially optically transparent substrate.

70. The sensor of claim 69, wherein said photosensitive element detects radiation impinging upon its top and bottom sides, radiation impinging upon said bottom side passing through said substantially optically transparent substrate.

71. The sensor of claim 1, further including a heater located inside of said sensor body, said heater being configured to limit condensation on a periphery of said sensor.

72. The sensor of claim 71, wherein said sensor is adapted to provide a sensor response time of under about 100 milliseconds.

73. The sensor of claim 72, wherein said sensor response time is under about 60 milliseconds.

74. The sensor of claim 72, wherein said analyte is oxygen.

75. The sensor of claim 1, wherein said sensor is adapted to provide a sensor response time of under about 100 milliseconds.

76. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body, said indicator element including indicator molecules distributed proximate to the surface of the sensor body and wherein said indicator molecules are contained within an indicator membrane that is permeable to the analyte to be sensed;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator molecules; and

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element.

77. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

wherein said indicator element includes indicator molecules distributed proximate to the surface of the sensor body, said indicator molecules including indicator molecules having an isosbestic point substantially at a particular wavelength and wherein a reference channel detects light substantially at the isosbestic wavelength.

78. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body, said sensor body having a sensor/tissue interface layer around at least a portion of said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element; and

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element.

79. The sensor of claim 78, wherein said tissue/sensor interface layer retards formation of fibrotic encapsulation or scar tissue.

80. The sensor of claim 78, wherein said tissue/sensor interface layer includes a sublayer which promotes tissue ingrowth therein.

81. The sensor of claim 80, wherein said tissue ingrowth comprises vascularization.

82. The sensor of claim 78, wherein said tissue/sensor interface layer includes a molecular sieve sublayer which performs a molecular weight cutoff function.

83. The sensor of claim 78, wherein said indicator element includes indicator molecules and said tissue/sensor interface layer is selectively permeable so as to permit said analyte to contact said indicator molecules while preventing cells or macromolecules from contacting said indicator molecules.

84. The sensor of claim 78, wherein said tissue/sensor interface layer is biocompatible.

85. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

said sensor body including a reflection enhancement layer disposed over a portion of the surface of said sensor body to enhance reflection within said sensor body of radiation emitted by said source and/or light emitted by said indicator element and passing into said sensor body.

86. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body, said indicator element including indicator molecules distributed proximate to the surface of the sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

wherein said indicator molecules include different first and second indicator molecules disposed on the surface of said sensor body.

87. The sensor of claim 86, wherein said first and second indicator molecules are each responsive to changes in the concentration of the same analyte in said medium.

88. The sensor of claim 87, wherein said first and second indicator molecules have the same optical characteristic that is affected by the presence or concentration of the analyte.

89. The sensor of claim 87, wherein said first and second indicator molecules have different optical characteristics that are affected by the presence or concentration of the analyte.

90. The sensor of claim 86, wherein said first indicator molecules are responsive to changes in the concentration of a first analyte in said medium and said second indicator molecules are responsive to changes in the concentration of a different second analyte in said medium.

91. The sensor of claim 90, wherein said first and second indicator molecules have the same optical characteristic that is affected by the presence or concentration of the analytes.

92. The sensor of claim 90, wherein said first and second indicator molecules have different optical characteristics that are affected by the presence or concentration of the analytes.

93. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element;

wherein said indicator element includes indicator molecules disposed within an indicator membrane proximate the periphery of said sensor body, said indicator membrane containing indicator molecules that are affected by the presence or concentration of an analyte and positioned to receive radiation from said radiation source, and a reference membrane disposed proximate the periphery of said sensor body and positioned to receive radiation from said radiation source, said reference membrane being substantially unaffected by the presence or concentration of the analyte; and

wherein said radiation source includes an LED that is mounted such that a top side of the LED faces generally toward one of said indicator and reference membranes and a bottom side of the LED faces generally toward the other of said indicator and reference membranes, said LED emitting light through both said top side and said bottom side of said LED to sufficiently illuminate both of said indicator and reference membranes.

94. The sensor of claim 93, wherein said radiation source and said photosensitive element are mounted on a substantially transparent substrate.

95. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element, said photosensitive element and said radiation source being mounted upon a substantially optically transparent substrate;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

wherein said photosensitive element detects radiation impinging upon its top and bottom sides, radiation impinging upon said bottom side passing through said substantially optically transparent substrate.

96. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body, said radiation source including an LED that is mounted such that light is emitted from both its top and bottom sides;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element; and

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element.

97. The sensor of claim 96, further including an optical deflector having a generally triangular cross-section extending around a circumference of the sensor body and located to deflect light emitted from said LED.

98. The sensor of claim 96, wherein said LED is mounted on a circuit board having a hole or window through which radiation emitted from the bottom side of the LED passes.

99. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element; and

a heater located inside of said sensor body, said heater being configured to limit condensation on a periphery of said sensor.

100. The sensor of claim 99, wherein said sensor is adapted to provide a sensor response time of under about 100 milliseconds.

101. The sensor of claim 100, wherein said sensor response time is under about 60 milliseconds.

102. The sensor of claim 100, wherein said analyte is oxygen.

103. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

wherein said sensor body includes a peripheral sleeve that contains said indicator element.

104. The sensor of claim 103, wherein said indicator element on said sleeve indicator molecules disposed within an indicator membrane proximate the periphery of said sensor body, said indicator membrane containing indicator molecules that are affected by the presence or concentration of an analyte and positioned to receive radiation from said radiation source, and a reference membrane disposed proximate the periphery of said sensor body and positioned to receive radiation from said radiation source, said reference membrane being substantially unaffected by the presence or concentration of the analyte.

105. The sensor of claim 103, wherein said sleeve is removable such that said indicator elements can be removed and replaced.

106. The sensor of claim 103, wherein said sleeve is made with an elastomeric material.

107. The sensor of claim 103, wherein said sleeve has an outer annular flange.

108. The sensor of claim 107, wherein said outer annular flange is constructed to prevent migration of the sensor within a medium within which is applied or inserted.

109. The sensor of claim 107, wherein said outer annular flange is made of a biodegradable material.

110. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element; and

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element; and

wherein said sensor body includes a removable film positioned on said sensor body that contains said indicator element.

111. The sensor of claim 110, wherein said removable film contains an indicator element having a reference membrane containing reference molecules and an indicator membrane containing indicator molecules.

112. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element;

wherein said sensor body contains an optically opaque, substantially non-reflective shielding sleeve positioned on said sensor body, said shielding sleeve having one or more holes extending therethrough from its outer surface to said indicator element on said sensor body.

113. The sensor of claim 112, wherein said holes on said shielding sleeve are formed at an angle with respect to a direction of propagation of light from said radiation source to said indicator element.

114. An optical-based sensor for determining the presence or concentration of an analyte in a medium, said sensor comprising:

an enclosed sensor body having an outer surface surrounding said sensor body;

a radiation source in said sensor body which emits radiation within said sensor body;

an indicator element having an optical characteristic that is affected by the presence or concentration of an analyte, said indicator element being positioned on said sensor body to receive radiation that travels from said radiation source, and which transmits radiation into said sensor body;

a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body and which emits a signal responsive to radiation received from said indicator element;

said sensor body being configured such that some of the radiation received by said photosensitive element is reflected internally within said sensor body before striking said photosensitive element;

said indicator element including first and second indicator molecules disposed on the surface of said sensor body, said first indicator molecules having an optical characteristic that is responsive to changes in the concentration of an analyte to which said first indicator molecules are exposed and said second indicator molecules having an optical characteristic that is responsive to changes in the concentration of an analyte to which said second indicator molecules are exposed;

said radiation source including a source that emits radiation that interacts with said first indicator molecules in accordance with the analyte-responsive optical characteristic thereof and a source which emits radiation that interacts with said second indicator molecules in accordance with the analyte-responsive optical characteristic thereof; and

said photosensitive element including first and second photosensitive elements embedded within said sensor body, said first photosensitive element providing a response signal indicative of the level of interaction of said first indicator molecules with radiation interacting therewith and hence indicative of the presence or concentration of the analyte to which said first indicator molecules are exposed, and said second photosensitive element providing a response signal indicative of the level of interaction of said second indicator molecules with radiation interacting therewith and hence indicative of the presence or concentration of the analyte to which said second indicator molecules are exposed.