Reagent-less whole-blood glucose meter

• US 20030090649A1
• Filed: 01/21/2002
• Published: 05/15/2003
• Est. Priority Date: 11/08/2001
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: Hercules Technology Growth Capital, Inc.
• Inventors: Fennell, Martin J., Sheill, Jane J., Gable, Jennifer H., Braig, James R., Zheng, Peng, Li, Kenneth I., Sterling, Bernhard B., Hartstein, Philip C., Rule, Peter, Goldberger, Daniel S., Hall, W. Dale, Witte, Kenneth G., Gaffney, Robert D., Cortella, Julian M., Agostino, Mark D., Klonoff, David C., Munrow, Mike A., Smith, Heidi M.
• Granted Patent: US 6,958,809 B2
• Time in Patent Office: Days
• US Class Current: 356/39
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15136 by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1514 by use of gaseous agents, e.g. using suction aspiration or pressurized gas
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 33/48 : Biological material, e.g. blood, urine G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence; Haemocytometers counting blood corpuscules distributed over a surface by scanning the surface G06M11/02

Abstract

A reagentless whole-blood analyte detection system that is capable of being deployed near a patient has a source capable of emitting a beam of radiation that includes a spectral band. The whole-blood system also has a detector in an optical path of the beam. The whole-blood system also has a housing that is configured to house the source and the detector. The whole-blood system also has a sample element that is situated in the optical path of the beam. The sample element has a sample cell and a sample cell wall that does not eliminate transmittance of the beam of radiation in the spectral band.

Claims

1. A reagentless whole-blood analyte detection system capable of being deployed near a patient comprising:

a source capable of emitting a beam of radiation comprising a spectral band having a center wavelength;

a detector in an optical path of the beam;

a housing configured to house the source and the detector; and

a sample element situated in the optical path of the beam and configured to be filled with a sample, the sample element comprising;

a sample cell wall that does not eliminate transmittance of the radiation in the spectral band; and

a sample cell.

2. The whole-blood system of claim 1, wherein the sample element is configured to be advanced into the housing.

3. The whole-blood system of claim 1, wherein the sample cell is oriented about vertically.

4. The whole-blood system of claim 1, wherein the sample cell is oriented about horizontally.

5. The whole-blood system of claim 1, wherein the sample element comprises a cuvette.

6. The whole-blood system of claim 1, wherein the sample element comprises a test strip.

7. The whole-blood system of claim 1, wherein the sample element comprises a disposable test strip.

8. The whole-blood system of claim 7, wherein the disposable test strip is configured for a single use.

9. The whole-blood system of claim 7, wherein the disposable test strip is configured for at least one use.

10. The whole-blood system of claim 1, wherein the near-patient test system is configured to be used by a patient.

11. The whole-blood system of claim 1, wherein the near-patient test system is configured to be used by a medical practitioner.

12. The whole-blood system of claim 1, wherein the near-patient test system is configured to be used in a clinical setting.

13. The whole-blood system of claim 1, wherein the sample element is configured to receive blood that has been withdrawn from the patient but that has not been otherwise processed.

14. The whole-blood system of claim 1, further comprising a filtering system in the optical path of the beam, the filter system configured to transmit the spectral band of radiation.

15. The whole-blood system of claim 14, wherein the filtering system further comprises a tunable filter.

16. The whole-blood system of claim 14, wherein the filtering system is configured to transmit the spectral band of radiation between about 0.8 μ

m and about 2.5 μ

m.

17. The whole-blood system of claim 14, wherein the filtering system is configured to transmit the spectral band of radiation between about 2.5 μ

m and about 20 μ

m.

18. The whole-blood system of claim 14, wherein the filtering system is configured to transmit the spectral band of radiation between about 20 μ

m and about 100 μ

m.

19. The whole-blood system of claim 14, wherein the filtering system is configured to transmit radiation at least at one spectral band between about 3.5 μ

m and about 14 μ

m.

20. The whole-blood system of claim 14, wherein the filtering system is configured to transmit radiation at least at about one of the following center wavelengths:

4.2 μ

m, 5.25 μ

m, 6.12 μ

m, 7.4 μ

m, 8.0 μ

m, 8.45 μ

m, 9.25 μ

m, 9.65 μ

m, 10.4 μ

m, 12.2 μ

m.

21. The whole-blood system of claim 1, wherein the sample element comprises an optical pathlength of less than about 1.22 mm.

22. The whole-blood system of claim 1, wherein the sample element comprises an optical pathlength of less than about 100 μ

m.

23. The whole-blood system of claim 1, wherein the sample element comprises an optical pathlength of less than about 80 μ

m.

24. The whole-blood system of claim 1, wherein the sample element comprises an optical pathlength between about 1 μ

m and about 50 μ

m.

25. The whole-blood system of claim 1, wherein the sample element comprises an optical pathlength between about 15 μ

m and about 35 μ

m.

26. The whole-blood system of claim 1, further comprising a sample extractor.

27. The whole-blood system of claim 26, wherein the sample extractor is selected from the group consisting of:

a lance, laser lance, single-motion lance, iontophoretic sampler, gas-jet, fluid-jet or particle-jet perforator.

28. The whole-blood system of claim 26, wherein the sample element further comprises an opening in fluid communication with the sample cell, and the sample extractor is positioned so that it creates a wound proximate the opening.

29. The whole-blood system of claim 1, wherein the sample cell wall comprises polyethylene.

30. The whole-blood system of claim 1, wherein the sample cell wall comprises polypropylene.

31. The whole-blood system of claim 1, wherein the sample cell wall comprises a polymer having an isotactic structure.

32. The whole-blood system of claim 1, wherein the sample cell wall comprises a polymer having an atactic structure.

33. The whole-blood system of claim 1, wherein the sample cell wall comprises a polymer having a syndiotactic structure.

34. The whole-blood system of claim 1, wherein the sample cell wall comprises a material configured to enhance flow of the sample.

35. The whole-blood system of claim 1, wherein the sample element is configured to be advanced automatically into the housing.

36. The whole-blood system of claim 1, wherein the sample element is configured to be advanced manually into the housing.

37. An reagentless whole-blood analyte detection system capable of being deployed near a patient comprising:

a radiation generating system comprising a filter and a source capable of generating electromagnetic radiation in at least one spectral band between about 4.2 μ

m and about 12.2 μ

m;

an optical detector positioned in the optical path of the spectral band of radiation responsive to the spectral band of radiation to generate at least one signal;

a signal processor configured to receive the signal, to process the signal and to generate an output;

a display configured to receive the output;

a sample extractor; and

a portable housing configured to house at least partially each of the radiation generating system, the optical detector, the signal processor, and the sample extractor, the housing adapted to house a sample element having at least one optically transmissive portion.

38. The whole-blood system of claim 37, wherein the sample extractor is selected from the group consisting of:

a lance, laser lance, single-motion lance, iontophoretic sampler, gas-jet, fluid-jet or particle-jet perforator.

39. The whole-blood system of claim 37, wherein the display comprises an audible display.

40. The whole-blood system of claim 37, wherein the display comprises a visual display.

41. The whole-blood system of claim 37, wherein the display is a separable device.

42. The whole-blood system of claim 41, wherein the separable device is a portable computing device.

43. A reagentless whole-blood analyte detection system comprising:

a source configured to emit electromagnetic radiation;

an optical detector positioned in an optical path of the radiation; and

a sample element situated in the optical path of the radiation;

whereby the detection system performs optical analysis on a sample of whole-blood to assess at least one constituent of the whole-blood.

44. The whole-blood system of claim 43, wherein the sample element is configured to be advanced into the optical path of the radiation.

45. The whole-blood system of claim 43, wherein the sample cell is oriented about vertically.

46. The whole-blood system of claim 43, wherein the sample cell is oriented about horizontally.

47. The whole-blood system of claim 43, further comprising a portable housing configured to house at least partially the source and the optical detector.

48. The whole-blood system of claim 43, wherein the constituent is glucose in an analyzed concentration.

49. The whole-blood system of claim 43, wherein the sample element is configured to be advanced automatically into the optical path of the radiation.

50. The whole-blood system of claim 43, wherein the sample element is configured to be advanced manually into the optical path of the radiation.

51. A reagentless whole-blood detection system capable of being deployed near a patient comprising:

an optical calibration system; and

an optical analysis system;

wherein the optical calibration system is adapted to calibrate the whole-blood system at about the same time that the optical analysis system analyzes the sample of whole-blood.

52. The whole-blood system of claim 51, wherein the optical calibration system is adapted to calibrate the whole-blood system at the same time that the optical analysis system analyzes the sample of whole-blood.

53. The whole-blood system of claim 51, wherein the optical calibration system is adapted to calibrate the whole-blood system before the optical analysis system analyzes the sample of whole-blood.

54. The whole-blood system of claim 51, wherein the optical calibration system is adapted to calibrate the whole-blood testing system after the optical analysis system analyzes the sample of whole-blood.

55. The whole-blood system of claim 51, wherein the system further comprises:

a radiation source system capable of generating an analyte transmission beam;

a detector in an optical path of the analyte transmission beam; and

a sample element configured to be advanced into the optical path of the analyte transmission beam, the sample element comprising;

an analysis portion having a sample cell that extends between a first window and a second window

56. The whole-blood system of claim 55, wherein the sample element further comprises a calibration portion and the radiation source system is capable of generating a calibration beam that impinges upon the calibration portion of the sample element.

57. A method of performing whole-blood detection comprising:

providing a reagentless whole-blood detection system capable of being deployed near a patient, the whole-blood system comprising an optical calibration system, an optical analysis system, and a sample cell;

filling a substantial portion of the sample cell with a sample;

taking a first calibration measurement of the sample cell; and

taking an analytical measurement of a sample of whole-blood in the sample cell.

58. The method of claim 57 further comprising calibrating the whole-blood system;

wherein the step of calibrating is performed before the step of filling.

59. The method of claim 57, further comprising calibrating the whole-blood system;

wherein the step of calibrating is performed after the step of taking an analytical measurement.

60. The method of claim 57, further comprising taking a second calibration measurement;

wherein the step of taking a first calibration measurement is performed before the step of filling the sample cell and the step of taking a second calibration measurement is performed after the step of filling a substantial portion of the sample cell.

61. The method of claim 60, further comprising evacuating a substantial portion of the sample cell;

wherein the step of taking a second calibration measurement is performed after the step of evacuating a substantial portion of the sample cell.

62. A method for reagentless whole-blood analyte detection comprising:

providing a source, a detector in an optical path of the source, a housing configured to house the source and the detector, and a sample element comprising a sample cell and an optical pathlength;

drawing a sample of fluid from a portion of tissue;

positioning an opening of the sample element adjacent the sample of fluid so that the fluid is drawn into the sample element;

positioning the sample element in the housing so that the sample cell is in the optical path of the source;

emitting an emitted radiation beam comprising at least one spectral band having a center wavelength from the source to the sample cell of the sample element; and

detecting a transmitted radiation beam comprising the radiation transmitted through the sample element.

63. The method of claim 62, wherein the housing is configured to be portable.

64. The method of claim 62, wherein the sample of fluid is a sample of whole-blood.

65. The method of claim 62, wherein the optical pathlength of the sample cell is less than about 1.22 mm.

66. The method of claim 62, wherein the optical pathlength of the sample cell is less than about 100 μ

m.

67. The method of claim 62, wherein the optical pathlength of the sample cell is less than about 80 μ

m.

68. The method of claim 62, wherein the optical pathlength of the sample cell is between about 1 μ

m and about 50 μ

m.

69. The method of claim 62, wherein the optical pathlength of the sample cell is between about 15 μ

m and about 35 μ

m.

70. The method of claim 62, wherein the sample element further comprises an opening in fluid communication with the sample cell, and wherein the slicing step is performed proximate the opening.

71. The method of claim 62, further comprising filtering the emitted radiation beam to transmit at least the spectral band of radiation.

72. The method of claim 71, wherein the filtering is performed by a tunable filter.

73. The method of claim 71, wherein the filtering is performed to transmit radiation between about 0.8 μ

m and about 2.5 μ

m.

74. The method of claim 71, wherein the filtering is performed to transmit radiation between about 2.5 μ

m and about 20 μ

m.

75. The method of claim 71, wherein the filtering is performed to transmit radiation between about 20 μ

m and about 100 μ

m.

76. The method of claim 71, wherein the filtering is performed to transmit radiation between about 3.5 μ

m and about 14 μ

m.

77. The method of claim 71, wherein the filtering is performed to transmit radiation at least at about one of the following center wavelengths:

4.2 μ

m, 5.25 μ

m, 6.12 μ

m, 7.4 μ

m, 8.0 μ

m, 8.45 μ

m, 9.25 μ

m, 9.65 μ

m, 10.4 μ

m, 12.2 μ

m.

78. A method for reagentless whole-blood analyte detection that can be performed near a patient comprising:

providing a source configured to emit electromagnetic radiation, an optical detector positioned in an optical path of the radiation, a portable housing configured to house at least partially the source and the optical detector, and a sample element containing a sample of whole-blood, the sample element situated in the optical path of the radiation;

emitting an emitted beam of electromagnetic radiation from the source; and

detecting a transmitted beam of radiation that is transmitted through the sample of whole-blood to assess at least one constituent of the sample of whole-blood.

79. The method claim 78, wherein the sample element is configured to be advanced into the housing.

80. The method claim 78, wherein the sample element is oriented about vertically.

81. The method claim 78, wherein the sample element is oriented about horizontally.

82. The method claim 78, wherein the constituent is glucose.

83. A method of operating a reagentless whole-blood analyte detection system capable of being deployed near a patient, the whole-blood system having an optical calibration system and an optical analysis system, the method comprising:

inserting a sample element comprising a calibration portion and an analysis portion having a sample of whole-blood into the whole-blood analysis system; and

transmitting a first beam of electromagnetic radiation through the analysis portion of the sample element to determine an optical property of the sample of whole-blood and the sample element.

84. The method of claim 83, further comprising transmitting a second beam of electromagnetic radiation through the calibration portion of the sample element to determine an optical property of the sample element.

85. The method of claim 84, wherein the step of transmitting the first beam and the step of transmitting the second beam are performed about at the same time.

86. The method of claim 85, wherein the step of transmitting the first beam and the step of transmitting the second beam are performed contemporaneously.

87. The method of claim 85, wherein the step of transmitting the first beam is performed before the step of transmitting the second beam.

88. The method of claim 85, wherein the step of transmitting the first beam is performed after the step of transmitting the second beam.

89. An automatic reagentless whole-blood analyte detection system comprising:

a source capable of generating radiation comprising at least one wavelength of electromagnetic radiation;

an optical detector positioned in the optical path of the radiation responsive to the radiation to generate at least one signal;

a sample extractor configured to draw a sample of fluid from a portion of tissue;

a sample cell situated in the optical path of the radiation and configured to receive the sample of fluid; and

a signal processor that processes the signal;

wherein the testing system is configured to draw the sample of fluid, to receive the sample of fluid, to generate the radiation, to detect the radiation, and to process the signal without any intervention from the patient.

90. The automatic whole-blood system of claim 89, wherein the sample extractor is selected from the group consisting of:

a lance, laser lance, single-motion lance, iontophoretic sampler, gas-jet, fluid-jet or particle-jet perforator.

91. The automatic whole-blood system of claim 89, further comprising:

a housing configured to house at least partially at least one of the source, the optical detector, the sample extractor, the sample cell, and the signal processor.

92. The automatic whole-blood system of claim 91, wherein the sample cell is configured to be advanced into the housing.

93. The automatic whole-blood system of claim 91, wherein the sample cell is oriented about vertically.

94. The automatic whole-blood system of claim 91, wherein the sample cell is oriented about horizontally.