Device and method for in vitro determination of analyte concentrations within body fluids

• US 7,061,593 B2
• Filed: 08/14/2002
• Issued: 06/13/2006
• Est. Priority Date: 11/08/2001
• Status: Expired due to Fees

• Current Assignee: LDS Test And Measurement, Inc.
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Hartstein, Philip C., Rule, Peter
• Primary Examiner(s): Toatley, Jr., Gregory J.
• Assistant Examiner(s): Punnoose, Roy M.
• Application Number:
  US10/219,627
• Publication Number:
  US 20030086075A1
• Time in Patent Office: 1,399 Days
• Field of Search: 356/39, 356/40, 356/41, 356/42, 356/244, 356/246, 356/319, 356/326, 250/339.07
• 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 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• 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

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 method for determining a concentration of an analyte in a body fluid, said method comprising:

collecting a sample of a body fluid having less than 1 μ

L in total volume;

holding said sample in a nonflowing manner; and

using optical transmission spectroscopy to determine said concentration, without the use of a reagent.

2. The method of claim 1, wherein said optical transmissive spectroscopy is the measurement of energy transmitted from a source and passed through said sample.

3. The method of claim 1, wherein said body fluid comprises saliva.

4. The method of claim 1, wherein said body fluid comprises urine.

5. The method of claim 1, wherein said body fluid comprises sweat.

6. The method of claim 1, wherein said collecting further comprises using a sample extractor to create a small wound in said patient.

7. The method of claim 6, wherein said sample extractor comprises a lance.

8. The method of claim 6, wherein said sample extractor comprises a laser lance.

9. The method of claim 6, wherein said sample extractor comprises an iontophoretic sampler.

10. The method of claim 6, wherein said sample extractor comprises a gas-jet perforator.

11. The method of claim 6, wherein said sample extractor comprises a fluid-jet perforator.

12. The method of claim 6, wherein said sample extractor comprises a particle-jet perforator.

13. The method of claim 1, wherein said body fluid comprises whole-blood.

14. The method of claim 1, wherein said body fluid comprises blood components.

15. The method of claim 1, wherein said body fluid comprises interstitial fluid.

16. The method of claim 1, wherein said body fluid comprises intercellular fluid.

17. The method of claim 1, wherein said sample of body fluid is 0.5 μ

L or less in total volume.

18. The method of claim 1, wherein said sample of body fluid is 0.3 μ

L or less in total volume.

19. The method of claim 1, wherein said collecting includes holding said sample of body fluid in at least one of a sample supply passage of a sample element and a chamber of said sample element, and said chamber is connected to said sample supply passage.

20. The method of claim 19, wherein said sample supply passage and chamber together are configured to hold no more than 1 μ

L in total volume.

21. The method of claim 1, wherein said collecting includes holding and containing said sample in a sample element that is adapted to hold no more than 1 μ

L of fluid.

22. A method for determining a concentration of an analyte in a body fluid, said method comprising:

collecting a sample of body fluid of 1 L or less;

filling a chamber of a sample element with at least a portion of said sample;

holding said sample within said chamber in a non-flowing manner; and

determining said concentration of said analyte in said sample using a reagentless technique.

23. The method of claim 22, wherein said reagentless technique comprises an optical technique.

24. The method of claim 23, wherein said optical technique comprises a spectroscopic technique.

25. The method of claim 24, wherein said spectroscopic technique is transmissive spectroscopy.

26. The method of claim 25, wherein said transmissive spectroscopy is the measurement of energy transmitted from a source and passed through said sample.

27. The method of claim 26, wherein said measurement is performed on the same side of the sample as the source.

28. The method of claim 26, wherein said measurement is performed on the opposite side of the sample in reference to the source.

29. The method of claim 22, wherein said body fluid comprises saliva.

30. The method of claim 22, wherein said body fluid comprises urine.

31. The method of claim 22, wherein said body fluid comprises sweat.

32. The method of claim 22, wherein said collecting further comprises using a sample extractor to create a small wound in said patient.

33. The method of claim 32, wherein said sample extractor comprises a lance.

34. The method of claim 32, wherein said sample extractor comprises a laser lance.

35. The method of claim 32, wherein said sample extractor comprises an iontophoretic sampler.

36. The method of claim 32, wherein said sample extractor comprises a gas-jet perforator.

37. The method of claim 32, wherein said sample extractor comprises a fluid-jet perforator.

38. The method of claim 32, wherein said sample extractor comprises a particle-jet perforator.

39. The method of claim 22, wherein said body fluid comprises whole-blood.

40. The method of claim 22, wherein said body fluid comprises blood components.

41. The method of claim 22, wherein said body fluid comprises interstitial fluid.

42. The method of claim 22, wherein said body fluid comprises intercellular fluid.

43. The method of claim 22, wherein said chamber is comprised of an infrared transmissive material.

44. The method of claim 43, wherein said infrared transmissive material is silicon.

45. The method of claim 43, wherein said infrared transmissive material is polyethylene.

46. The method of claim 43, wherein said infrared transmissive material is polypropylene.

47. The method of claim 43, wherein said infrared transmissive material allows for transmission of the infrared energy having specific wavelengths.

48. The method of claim 47, wherein said wavelengths are between 0.8 μ

m and 2.5 μ

m.

49. The method of claim 47, wherein said wavelengths are between 2.5 μ

m and 20 μ

m.

50. The method of claim 47, wherein said wavelengths are between 20 μ

m and 100 μ

m.

51. The method of claim 47, wherein said wavelengths are between 3.5 μ

m and 14 μ

m.

52. The method of claim 22, wherein said sample of body fluid is 0.5 μ

L or less.

53. The method of claim 22, wherein said sample of body fluid is 0.3 μ

L or less.

54. The method of claim 22, wherein said sample of body fluid is 0.1 μ

L or less.

55. The method of claim 22, wherein said collecting comprises holding said sample of body fluid in at least one of a sample supply passage of said sample element and said chamber, and said sample supply passage being connected to said chamber.

56. The method of claim 55, wherein said sample supply passage and said chamber together are configured to hold no more than 1 μ

L in total volume.

57. The method of claim 22, wherein said sample element is adapted to hold no more than 1 μ

L in total volume of a body fluid.

58. A method for determining a concentration of an analyte in a body fluid, said method comprising:

creating an unassisted flow of said body fluid from a patient;

transporting a sample comprising 1 μ

L or less of said body fluid into a chamber of a sample element so that at least some of said sample is adjacent to a window of said sample element;

holding said sample in a non-flowing manner within said chamber of said sample element; and

determining said concentration of said analyte in said body fluid from said sample transported into said sample element without causing said sample to react with a reagent.

59. The method of claim 58, wherein said collecting further comprises holding said sample element stationary while said sample enters a sample supply passage of said sample element and transports into said chamber.

60. The method of claim 58, wherein said body fluid comprises saliva.

61. The method of claim 58, wherein said body fluid comprises urine.

62. The method of claim 58, wherein said body fluid comprises sweat.

63. The method of claim 58, wherein said creating comprises using a sample extractor to create a small wound in said patient.

64. The method of claim 63, wherein said sample extractor comprises a lance.

65. The method of claim 63, wherein said sample extractor comprises a laser lance.

66. The method of claim 63, wherein said sample extractor comprises an iontophoretic sampler.

67. The method of claim 63, wherein said sample extractor comprises a gas-jet perforator.

68. The method of claim 63, wherein said sample extractor comprises a fluid-jet perforator.

69. The method of claim 63, wherein said sample extractor comprises a particle-jet perforator.

70. The method of claim 58, wherein said body fluid comprises whole-blood.

71. The method of claim 58, wherein said body fluid comprises blood components.

72. The method of claim 58, wherein said body fluid comprises interstitial fluid.

73. The method of claim 58, wherein said body fluid comprises intercellular fluid.

74. A method for determining a concentration of an analyte in a body fluid of an animal, said method comprising:

causing a flow of body fluid from a site on said animal using a sample extractor having an operating path near a chamber, said chamber defined by at least one inner surface, all of said at least one inner surface comprising a material which is inert with respect to said body fluid; and

collecting at least a portion of said body fluid in said chamber without displacement of said chamber, said chamber being configured to hold at most 1 μ

L of said body fluid.

75. The sample element of claim 74, wherein said chamber has a volume, and said volume is inert with respect to said body fluid.

76. The method of claim 74, wherein said causing comprises using said sample extractor to create a small wound in said animal.

77. The method of claim 76, wherein said sample extractor comprises a lance.

78. The method of claim 76, wherein said sample extractor comprises a laser lance.

79. The method of claim 76, wherein said sample extractor comprises an iontophoretic sampler.

80. The method of claim 76, wherein said sample extractor comprises a gas-jet perforator.

81. The method of claim 76, wherein said sample extractor comprises a fluid-jet perforator.

82. The method of claim 76, wherein said sample extractor comprises a particle-jet perforator.

83. The method of claim 74, wherein said body fluid comprises whole-blood.

84. The method of claim 74, wherein said body fluid comprises blood components.

85. The method of claim 74, wherein said body fluid comprises interstitial fluid.

86. The method of claim 74, wherein said body fluid comprises intercellular fluid.

87. The method of claim 74, wherein said chamber is configured to hold no more than 0.5 μ

L of body fluid.

88. The method of claim 74, wherein said chamber is configured to hold less than 0.3 μ

L of body fluid.