System using a portable detection device for detection of an analyte through body tissue

• US 6,694,158 B2
• Filed: 04/11/2001
• Issued: 02/17/2004
• Est. Priority Date: 04/11/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Motorola, Inc. (Motorola Solutions, Inc.)
• Inventors: Polak, Anthony
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): DAHBOUR, HENRY
• Application Number:
  US09/832,521
• Publication Number:
  US 20020151772A1
• Time in Patent Office: 1,042 Days
• Field of Search: 600/310, 600/309, 600/316, 600/317, 600/322, 600/365, 600/347, 600/300, 128/903, 435/14
• US Class Current: 600/310
• 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 5/681 Wristwatch-type devices

Abstract

A portable optical system includes interrogation of an implanted sensor located in a body tissue. The sensor contains a labeled analogue and a reference, which emit light at different wavelengths. The external optical instrument detects and discriminates between light from the labeled analogue and light from the reference. Logic in the detector receives and processes signals from the detector and generates an indication of the detected analyte level.

Claims

1. An optical detection system comprising:

a sensor disposed beneath a user'"'"'s dermal tissue, the sensor comprising;

a labeled analogue that emits a first electromagnetic signal of a first wavelength upon being irradiated by radiation; and

a reference that emits a second electromagnetic signal of a second wavelength upon being irradiated by radiation; and

a portable instrument disposed external to the user'"'"'s dermal tissue and above and adjacent to the sensor, the portable instrument comprising;

an optical excitation-source that generates radiation, the radiation penetrating the dermal tissue and irradiating the sensor;

a receiver that detects and discriminates between the first and second electromagnetic signals and produces a first electrical signal corresponding to the first electromagnetic signal and a second electrical signal corresponding to the second electromagnetic signal; and

logic that receives and processes the first and second electrical signals and generates from the first and second electrical signals an indication of a detected analyte level.

2. The system of claim 1, the receiver comprising:

a first detector that detects the first electromagnetic signal and produces the first electrical signal; and

a second detector that detects the second electromagnetic signal and produces the second electrical signal,

wherein, of the first and second electromagnetic signals, the first detector detects only the first electromagnetic signal and the second detector detects only the second electromagnetic signal.

3. The system of claim 2, the first detector comprising a first broad band detector that detects the first and second electromagnetic signals and a first filter that filters the second electromagnetic signal, the first filter disposed such that the first and second electromagnetic signals impinge on the first filter before the first broad band detector, the second detector comprising a second broad band detector that detects the first and second electromagnetic signals and a second filter that filters the first electromagnetic signal, the second filter disposed such that the first and second electromagnetic signals impinge on the second filter before the second broad band detector.

4. The system of claim 3, further comprising an enclosure having a substantially hemispherical cavity and opposing the receiver, a reflecting film on an inner surface of the cavity, the first and second electromagnetic signals reflected by the reflecting film and impinging on the receiver.

5. The system of claim 1, further comprising an optical element disposed between the sensor and the receiver, the optical element having a first surface exposed to air, the first surface of the optical element having a first anti-reflection coating, the optical element directing the first and second electromagnetic signals that are transmitted through the optical element such that the first and second electromagnetic signals transmitted through the optical element substantially impinge on the receiver at an angle less than about 20°

from normal.

6. The system of claim 5, the optical element further comprising a second surface exposed to the dermal tissue, the second surface of the optical element having a second anti-reflection coating, wherein the optical element is disposed between the sensor and the excitation-source.

7. The system of claim 1, wherein the logic determines a concentration of the analyte.

8. The system of claim 7, the first and second electrical signals consisting of a first and a second current, the logic comprising an analog-to-digital converter to convert the first and second electrical signals to corresponding digital signals and a microprocessor to manipulate the digital signals.

9. The system of claim 7, further comprising a transmitter to transmit the digital signals to external devices.

10. The system of claim 7, the portable instrument further comprising a display to display the concentration of the analyte.

11. The system of claim 1, further comprising an optically opaque medium having an aperture, the excitation-source and receiver disposed in the aperture, the aperture defining an area of irradiation of the first and second electromagnetic signals on the receiver and substantially collimating the first and second electromagnetic signals.

12. The system of claim 11, further comprising an optical element disposed in the aperture and disposed between the sensor and the receiver, the optical element having a first surface exposed to air, the first surface of the optical element having a first anti-reflection coating, the optical element directing the first and second electromagnetic signals that are transmitted through the optical element such that the first and second electromagnetic signals transmitted through the optical element substantially impinge on the receiver at an angle less than about 20°

from normal.

13. The system of claim 12, the optical element further comprising a second surface exposed to the dermal tissue, the second surface of the optical element having a second anti-reflection coating, wherein the optical element is disposed between the sensor and the excitation-source.

14. The system of claim 1, the excitation-source comprising a first excitation laser to selectively excite the labeled analogue and a second excitation laser to selectively excite the reference.

15. The system of claim 1, the excitation-source comprising a semiconductor laser diode that emits energy having a wavelength of from about 400 nm to about 2 μ

m.

16. The system of claim 1, the excitation-source irradiating substantially an entire volume of the sensor.

17. The system of claim 1, the first electromagnetic signal having a wavelength of greater than about 630 nm, the second electromagnetic signal having a wavelength of greater than about 670 nm, the first and second electromagnetic signals having wavelengths that do not substantially overlap.

18. The system of claim 1, wherein the receiver is disposed more distal to the sensor than the excitation-source.

19. The system of claim 1, wherein the receiver has a surface opposing the sensor upon which the first and second electromagnetic signals substantially impinge on the surface at an angle less than about 20°

from normal to the surface.

20. The system of claim 1, wherein the analogue is a fluorescently labeled analogue and the reference is a quantum dot or an organic dye.

21. An optical detection system comprising:

a sensor disposed beneath a user'"'"'s dermal tissue, the sensor comprising;

a labeled analogue that emits a first electromagnetic signal of a first wavelength upon being irradiated by radiation; and

a reference that emits a second electromagnetic signal of a second wavelength upon being irradiated by radiation; and

a portable instrument disposed external to the user'"'"'s dermal tissue and above and adjacent to the sensor, the portable instrument comprising;

an optical excitation-source that generates radiation, the radiation penetrating the dermal tissue and irradiating the sensor;

a receiver that detects and discriminates between the first and second electromagnetic signals and produces a first electrical signal corresponding to the first electromagnetic signal and a second electrical signal corresponding to the second electromagnetic signal and having a surface opposing the sensor;

an optical element that receives the first and second electromagnetic signals and directs the first and second electromagnetic signals to substantially impinge on the receiver at an angle less than about 20°

from normal; and

logic that receives and processes the first and second electrical signals and generates from the first and second electrical signals an indication of a detected analyte level.

22. The system of claim 21, the receiver comprising

a first detector that detects the first electromagnetic signal and produces the first electrical signal; and

a second detector that detects the second electromagnetic signal and produces the second electrical signal,

wherein, of the first and second electromagnetic signals, the first detector detects only the first electromagnetic signal and the second detector detects only the second electromagnetic signal.

23. The system of claim 22, the first detector comprising a first broad band detector that detects the first and second electromagnetic signals and a first filter that filters the second electromagnetic signal, the first filter disposed such that the first and second electromagnetic signals impinge on the first filter before the first broad band detector, the second detector comprising a second broad band detector that detects the first and second electromagnetic signals and a second filter that filters the first electromagnetic signal, the second filter disposed such that the first and second electromagnetic signals impinge on the second filter before the second broad band detector.

24. The system of claim 21, wherein the optical element is a lens.

25. The system of claim 21, wherein the optical element is an aperture.

26. A method of determining a concentration of an analyte in an implanted optical irradiation system, the method comprising:

implanting a sensor beneath a user'"'"'s dermal tissue, the sensor comprising a labeled analogue that emits a first electromagnetic signal of a first wavelength upon being irradiated by radiation and a reference that emits a second electromagnetic signal of a second wavelength upon being irradiated by and absorbing radiation;

providing a portable instrument comprising an excitation-source and a detector;

positioning the portable instrument external to the user'"'"'s dermal tissue and above and adjacent to the sensor;

irradiating the labeled analogue and the reference contained in the sensor through the dermal tissue such that the radiation penetrates the user'"'"'s dermal tissue and the labeled analogue absorbs energy emitted from the excitation-source and emits the first electromagnetic signal and the reference absorbs energy emitted from the excitation-source and emits the second electromagnetic signal;

detecting the first and second electromagnetic signals impinging on the detector;

discriminating between the first and second electromagnetic signals detected by the receiver;

producing a first electrical signal corresponding to the first electromagnetic signal and a second electrical signal corresponding to the second electromagnetic signal; and

generating from the first and second electrical signals an indication of a detected analyte level.

27. The method of claim 26, further comprising filtering the first and second electromagnetic signals prior to the first and second electromagnetic signals impinging on the detector.

28. The method of claim 26, further comprising directing the first and second electromagnetic signals toward the receiver such that the first and second electromagnetic signals substantially impinge on the detector at the angle less than about 20°

from normal to the surface.

29. The method of claim 28, the directing being provided by an aperture.

30. The method of claim 28, the directing being provided by a lens treated with different anti-reflection coatings on opposing surfaces between the excitation-source and the sensor.

31. The method of claim 26, further comprising converting the first and second electrical signals to corresponding digital signals, and transmitting the digital signals to a microprocessor.

32. The method of claim 31, further comprising transmitting the digital signals to an external device.

33. The method of claim 26, further comprising converting the first and second electrical signals to corresponding voltages, calculating a ratio between the first and second voltages, normalizing the first voltage using the ratio, converting the normalized voltage to a digital signal, and locally determining the concentration of the analyte from the digital signal.

34. The method of claim 33, further comprising transmitting the concentration to an external device.

35. The method of claim 26, further comprising converting the first and second electrical signals to corresponding voltages, calculating a ratio between the first and second voltages, normalizing the first voltage using the ratio, converting the normalized voltage to a digital signal, transmitting the digital signal to an external device, and remotely determining the concentration of the analyte from the transmitted signal.

36. The method of claim 26, further comprising determining a concentration of analyte from a single excitation pulse of the excitation-source.

37. The method of claim 26, further comprising determining the concentration of analyte from a plurality of excitation pulses of the excitation-source.

38. The method of claim 37, the determination comprising establishing the concentration of analyte by monitoring a change of intensity of the first and second electromagnetic signals over time.

39. The method of claim 26, further comprising displaying a concentration of the analyte.

40. The method of claim 26, further comprising selecting the excitation-source to emit energy having a wavelength of greater than about 600 nm.

41. The method of claim 26, the irradiating comprising irradiating substantially an entire volume of the sensor.

42. A method of determining a concentration of an analyte in an implanted optical irradiation system, the method comprising:

implanting a sensor beneath a user'"'"'s dermal tissue, the sensor comprising a labeled analogue and a reference that emits electromagnetic signals upon being irradiated by and absorbing radiation;

providing a portable instrument comprising an excitation-source and a detector;

positioning the portable instrument external to the user'"'"'s dermal tissue and above and adjacent to the sensor;

irradiating the labeled analogue and the reference contained in the sensor through the dermal tissue such that the radiation penetrates the user'"'"'s dermal tissue and the labeled analogue and the reference absorbs energy emitted from the excitation-source and emit the electromagnetic signals;

directing the electromagnetic signals such that electromagnetic signals impinging on the detector substantially impinge on the detector at an angle less than about 20°

from normal;

detecting the electromagnetic signals impinging on the detector;

producing a electrical signals corresponding to the electromagnetic signals; and

generating from the electrical signals an indication of a detected analyte level.

43. The method of claim 42, further comprising filtering the electromagnetic signals prior to the electromagnetic signals impinging on the detector.

44. The method of claim 42, the directing being provided by an aperture.

45. The method of claim 42, the directing being provided by a lens treated with different anti-reflection coatings on opposing surfaces between the excitation-source and the sensor.

46. The method of claim 42, further comprising converting the electrical signals to corresponding digital signals, and transmitting the digital signals to a microprocessor.

47. The method of claim 46, further comprising transmitting the digital signals to an external device.

48. The method of claim 42, further comprising converting the signals to corresponding voltages, calculating a ratio between the voltages, normalizing one of the voltages using the ratio, converting the normalized voltage to a digital signal, and locally determining the concentration of the analyte from the digital signal.

49. The method of claim 48, further comprising transmitting the concentration to an external device.

50. The method of claim 42, further comprising converting the electrical signals to corresponding voltages, calculating a ratio between the voltages, normalizing one of the voltages using the ratio, converting the normalized voltages to a digital signal, transmitting the digital signal to an external device, and remotely determining the concentration of the analyte from the transmitted signal.

51. The method of claim 42, further comprising determining a concentration of analyte from a single excitation pulse of the excitation-source.

52. The method of claim 42, further comprising determining the concentration of analyte from a plurality of excitation pulses of the excitationsource.

53. The method of claim 52, the determination comprising establishing the concentration of analyte by monitoring a change of intensity of the electromagnetic signals over time.

54. The method of claim 42, further comprising displaying a concentration of the analyte.

55. The method of claim 42, further comprising selecting the excitation-source to emit energy having a wavelength of greater than about 600 nm.

56. The method of claim 42, the irradiating comprising irradiating substantially an entire volume of the sensor.